Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial.
Cortese Bernardo,Di Palma Gaetano,Guimaraes Marcos Garcia,Piraino Davide,Orrego Pedro Silva,Buccheri Dario,Rivero Fernando,Perotto Anna,Zambelli Giulia,Alfonso Fernando
JACC. Cardiovascular interventions
OBJECTIVES:This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions. BACKGROUND:Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes. METHODS:The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months. RESULTS:Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm. CONCLUSIONS:In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).
Paclitaxel Drug-Coated Balloon Angioplasty Suppresses Progression and Inflammation of Experimental Atherosclerosis in Rabbits.
Chowdhury Mohammed M,Singh Kanwarpal,Albaghdadi Mazen S,Khraishah Haitham,Mauskapf Adam,Kessinger Chase W,Osborn Eric A,Kellnberger Stephan,Piao Zhonglie,Lino Cardenas Christian L,Grau Madeleine S,Jaff Michael R,Rosenfield Kenneth,Libby Peter,Edelman Elazer R,Lindsay Mark E,Tearney Guillermo J,Jaffer Farouc A
JACC. Basic to translational science
Paclitaxel drug-coated balloons (DCBs) reduce restenosis, but their overall safety has recently raised concerns. This study hypothesized that DCBs could lessen inflammation and reduce plaque progression. Using 25 rabbits with cholesterol feeding- and balloon injury-induced lesions, DCB-percutaneous transluminal angioplasty (PTA), plain PTA, or sham-PTA (balloon insertion without inflation) was investigated using serial intravascular near-infrared fluorescence-optical coherence tomography and serial intravascular ultrasound. In these experiments, DCB-PTA reduced inflammation and plaque burden in nonobstructive lesions compared with PTA or sham-PTA. These findings indicated the potential for DCBs to serve safely as regional anti-atherosclerosis therapy.
New technologies aimed at percutaneous intervention in the small coronary artery.
Bromage Daniel I,Lim Joanna C E,Ramcharitar Steve
Expert review of cardiovascular therapy
Percutaneous coronary intervention (PCI) of small vessels can be complicated by technically difficult access to the target lesion, an increased risk of major adverse cardiac events and in-stent restenosis requiring repeat revascularization. Conventional management of such lesions is with drug-eluting stent implantation; however, these have only partly attenuated the problem. In response, several medical device companies are competing to produce new technologies aimed at PCI in small coronary arteries. Such innovations include thin-strutted stents, stent-on-a-wire systems, drug-coated balloons, endothelial progenitor cell-catching stents and biodegradable stent systems. To date, none of these techniques have been sufficiently validated for use in small coronary arteries to justify a change in practice; however, small-vessel coronary artery disease is an increasingly common problem, and PCI of target lesions with reference vessel diameter <3.0 mm is likely to increase, especially in view of the increasing prevalence of diabetes, warranting further well-designed studies. The prospect of mounting a self-expandable biodegradable drug-eluting stent directly onto a guidewire could potentially be an exciting future development.
Results From the International Drug Coated Balloon Registry for the Treatment of Bifurcations. Can a Bifurcation Be Treated Without Stents?
Bruch Leonhard,Zadura Mariusz,Waliszewski Matthias,Platonic Zeljko,Eränen Jaako,Scheller Bruno,Götting Bettina,Herberger Denny,Palmieri Cataldo,Sinicròpi Giuseppe,Motz Wolfgang
Journal of interventional cardiology
OBJECTIVES:This observational study assessed the 9-month clinical outcomes in patients with coronary bifurcation lesions suitable for drug-coated balloon (DCB) angioplasty. It was the intention to use DCB's without additional stenting (DCB-only strategy) in selected patients for this chosen strategy. Bail-out main branch (MB) and/or side branch (SB) stenting, however, were permissible when flow limiting dissections or excessive recoil occurred. BACKGROUND:A multitude of interventional strategies have been studied to treat bifurcation lesions. With the availability of DCB angioplasty, investigators have been using this interventional tool with the optional implantation of bare metal stents (BMS). METHODS:This study is an international, prospective, multicenter registry enrolling patients with coronary bifurcation lesions including a side branch ≥2 mm in diameter. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit bifurcation lesion of any Medina classification type were recruited. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included 9-month major adverse cardiac events (death, myocardial infarction, or TLR), technical success, in-hospital outcomes and vessel thrombosis rates. RESULTS:A total 127 patients 66.1 ± 10.1 years of age were enrolled. Demographic characteristics were 80.3% (102/127) male gender, 31.5% (40/127) diabetes, 91.3% (116/127) hypertension, 7.1% (9/127) ST-elevation myocardial infarction (STEMI), and 9.4% (12/127) non ST-elevation myocardial infarction (NSTEMI). The 130 lesions were treated with 184 DCB's and 64 BMS. In 53.8% (70/130) of all lesions the DCB-only strategy could be used while 34.6% (45/130) of lesions had at least 1 stent (BMS) in the main branch, 8.5% (11/130) had at least 1 stent in the side branch and 3.1% (4/130) needed at least 1 stent in the main and side branch. 94.5% patients (121/127) were available for follow-up after 9.8 ± 2.0 months. The TLR rate was 4.6% in the absence of any thrombotic events in the treated vessels whereas the 9-month MACE rate was 6.2%. CONCLUSION:This observational study suggests that the DCB-only strategy is safe and effective to treat selected bifurcations while benefiting from a shortened dual antiplatelet therapy (DAPT).
Treatment of large de novo coronary lesions with paclitaxel-coated balloon only: results from a Chinese institute.
Yu Xue,Ji Fusui,Xu Feng,Zhang Wenduo,Wang Xinyue,Lu Dan,Yang Chenguang,Wang Fang
Clinical research in cardiology : official journal of the German Cardiac Society
BACKGROUND:To evaluate the efficacy of paclitaxel-coated balloons (SeQuent Please) for large de novo coronary lesions with diameters greater than 2.8 mm. METHODS:We performed a retrospective study of 527 consecutive patients with 595 de novo lesions (222 lesions) that comprised the large vessel disease (LVD) group, with a reference diameter (RD) ≥ 2.8 mm; the other 373 lesions comprised the small vessel disease (SVD) group, with a RD < 2.8 mm who received drug-coated balloon (DCB) angioplasty at the Beijing Hospital, Beijing, China. Sixty-eight patients with 91 lesions, including 45 LVD lesions, underwent coronary angiography at an average 10.7 months after DCB intervention. Clinical characteristics were recorded, and coronary angiograms were analysed with Quantitative Coronary Angiography (QCA) software. RESULTS:The patients in the LVD group were much younger than those in the small vessel group (61.7 ± 11.3 vs. 63.8 ± 11.7, P = 0.003), and fewer LVD patients had diabetes (27.0 vs. 57.8%, P = 0.001), three-vessel disease (37.5 vs. 52.6%, P = 0.003) and complex lesions (37.8 vs. 48.8%, P = 0.009) than those in the SVD group. Lesion preparations for LVD were more complicated than for SVD, such as 40.1% of lesions required the additional use of a cutting or scoring balloon (P = 0.004), and 21.2% lesions required non-compliant (NC) balloons (P < 0.001). Coronary dissections occurred in 63(28.3%) lesions in the LVD group but bail-out drug-eluting stent (DES) implantation was required only in one lesion (0.5%), which were both comparable with those in the SVD group. The success rate of DCB intervention was quite high and also similar in the LVD group and SVD group (99.5 vs. 99.7%, P > 0.05). QCA analysis showed that the follow-up minimal lumen diameter (MLD) was significantly increased compared with the MLD immediately post angioplasty both in the SVD group (1.75 ± 0.48 vs. 1.58 ± 0.31 mm, P = 0.008) and the LVD group (2.26 ± 0.66 vs. 2.09 ± 0.40 mm, P = 0.067). At an average of 10.1 months of clinical follow-up, the major adverse cardiovascular event (MACE) rate was 0% in the LVD group and 1.4% in the SVD group, with target lesion revascularization (TLR) rates of 0% and 1.1%, respectively. No death was observed in either group. CONCLUSIONS:DCB for de novo coronary lesions with diameters greater than 2.8 mm was as safe and effective as for small vessel lesions, suggesting that the DCB-only strategy is also feasible in large de novo lesions intervention.
Drug-coated balloons for the treatment of in-stent restenosis in diabetic patients: A review of currently available scientific data.
Minacapelli Alberto,Piraino Davide,Buccheri Dario,Cortese Bernardo
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
After the introduction of drug eluting stent (DES) the rate of in-stent restenosis (ISR) has decreased if compared to the BMS era; however, treatment of patients with ISR remained a major issue for the interventional cardiologist. DES has been largely used with good results also as second layer for the treatment of ISR, but the overall percentage of patients suffering from restenosis still remains high, especially in some subgroups of patients as ones with diabetes mellitus (DM). In this clinical scenario, drug coated balloon (DCB) has been gaining an important role for the treatment of ISR. In fact, it allows to release an antiproliferative drug, namely paclitaxel, without the addition of a second metallic strut, which can lead to a persistent inflammatory stimulus and further narrow the vessel. This could be an advantage in patients with an already increased systemic inflammatory burden and stiffer vessels as those with DM. Despite differences in terms of efficacy and safety between DES and DCB have already been evaluated in different clinical trials, just few of these focused on diabetic patients. The aim of this paper is to review the available data for treatment of ISR both with DES, DCB, and a comparison between these two devices, in patients affected by DM. © 2017 Wiley Periodicals, Inc.
Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies.
Krishnan Prakash,Faries Peter,Niazi Khusrow,Jain Ash,Sachar Ravish,Bachinsky William B,Cardenas Joseph,Werner Martin,Brodmann Marianne,Mustapha J A,Mena-Hurtado Carlos,Jaff Michael R,Holden Andrew H,Lyden Sean P
BACKGROUND:Drug-coated balloons (DCBs) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Because of the differences in excipients, paclitaxel dose, and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of 2 studies investigating the pharmacokinetic and clinical outcomes of a new DCB to treat femoropopliteal disease. METHODS:In the ILLUMENATE Pivotal Study (Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon), 300 symptomatic patients (Rutherford class 2-4) were randomly assigned to DCB (n=200) or standard angioplasty (percutaneous transluminal angioplasty [PTA]) (n=100). The primary safety end point was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months. The primary effectiveness end point was primary patency through 12 months. In the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon), paclitaxel plasma concentrations were measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 days postprocedure) until no longer detectable. RESULTS:In the ILLUMENATE Pivotal Study, baseline characteristics were similar between groups: 50% had diabetes mellitus, 41% were women, mean lesion length was 8.3 cm, and 44% were severely calcified. The primary safety end point was met (92.1% for DCB versus 83.2% for PTA, =0.025 for superiority) and the primary patency rate was significantly higher with DCB (76.3% for DCB versus 57.6% for PTA, =0.003). Primary patency per Kaplan-Meier estimates at day 365 was 82.3% for DCB versus 70.9% for PTA (=0.002). The rate of clinically driven target lesion revascularization was significantly lower in the DCB cohort (7.9% versus 16.8%, =0.023). Improvements in ankle-brachial index, Rutherford class, and quality of life were comparable, but the PTA cohort required twice as many revascularizations. Pharmacokinetic outcomes showed that all patients had detectable paclitaxel levels after DCB deployment that declined within the first hour (54.4±116.9 ng/mL to 1.4±1.0 ng/mL). CONCLUSIONS:The data demonstrate superior safety and effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour. CLINICAL TRIAL REGISTRATION:URL: http://clinicaltrials.gov. Unique identifiers: NCT01858428 and NCT01912937.
Merging the properties of a sirolimus coated balloon with those of a bioresorbable polymer sirolimus eluting stent to address the "diabetes issue". Results from the En-Abl multicenter registry.
Testa Luca,Dani Sameer,Desai Dewang,Pandya Rashmit,Parekh Pritesh,Bhalani Nirav,Sharma Arvind,Seth Chirag,Doshi Mainish,Sojitra Prakash,Chodvadiya Poonam,Dutta Gopee,Bedogni Francesco
BACKGROUND:Patients with diabetes mellitus (DM) have poorer outcomes after percutaneous coronary intervention than patients without diabetes. The Abluminus DES+™ drug-eluting stent (DES) features a novel technology of fusion coating of PLLA bioresorbable polymer on both the abluminal surface of the stent and exposed parts of the balloon. The aim of this study was to evaluate the efficacy/safety profile of the Abluminus DES+ in an all-comers population with minimal exclusion criteria and with a specific focus on diabetic patients. METHODS:Multicenter, prospective, all-comers registry performed in 31 centers in India. Patients were analyzed according to the diagnosis of DM and insulin dependency (ID or Non ID): non-DM (1256 patients), NIDDM (498 patients), IDDM (99 patients). The primary endpoint was a composite of device-oriented major adverse cardiac events (MACE): cardiac death, target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)/ target vessel revascularization (TVR) at 1 year. Stent thrombosis (ST) at any time point was also recorded. RESULTS:The MACE rate at 1 year in the overall population was 2.3% and it was mainly driven by a 1.57% rate of TLR/TVR. Although patients with IDDM showed slightly higher figures for MACE (non-DM 2.3%, NIDDM 2.8%, IDDM 4%, P=0.09), as well as for single end-points, none of them reached statistical significance. The rate of ST was 0.56%, 0.4%, 1% for non-DM, NIDDM and IDDM group, respectively (P=0.6). CONCLUSIONS:The performance of the Abluminus DES+ is consistent among patients with or without diabetes, regardless the insulin dependency.
Outcomes with Drug-Coated Balloons in Percutaneous Coronary Intervention in Diabetic Patients.
Megaly Michael,Ali Abdelrahman,Abraham Bishoy,Khalil Charl,Zordok Magdi,Shaker Marco,Tawadros Mariam,Hennawy Bassam S,Elbadawi Ayman,Omer Mohamed,Saad Marwan
Cardiovascular revascularization medicine : including molecular interventions
BACKGROUND:Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains associated with inferior clinical outcomes and an increased risk of restenosis compared with non-diabetics even in the era of drug-eluting stents (DES). The outcomes with drug-coated balloons (DCBs) in diabetic patients have received limited study. METHODS:We performed a meta-analysis of all studies published between January 2000 and January 2019 reporting the outcomes with DCB vs. DES after PCI of de-novo coronary lesions in diabetic patients. Outcomes included major adverse cardiovascular events (MACE), target lesion revascularization (TLR), binary restenosis by quantitative coronary angiography (QCA), and late lumen loss (LLL). RESULTS:Three studies with 378 patients (440 lesions) were included in the meta-analysis. During 17.3 ± 11.3 months follow-up, DCB were associated with a similar risk of MACE (OR: 0.63, 95% CI [0.36, 1.12], p = 0.11), TLR (OR: 0.51, 95% CI [0.25, 1.06] p = 0.07), binary restenosis (OR: 0.42, 95% CI [0.09, 1.92], p = 0.26), and LLL (mean difference: -0.13 mm, 95% CI [-0.41, 0.14], p = 0.34) compared with DES. CONCLUSION:In diabetic patients with de-novo coronary lesions undergoing PCI, DCBs are associated with similar outcomes compared with first-generation DES, with a signal toward potential benefit in lowering target lesion revascularization. Further randomized studies are needed to compare the newer-generation DCBs and DES in this setting.
IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population.
Chen Zhong,Guo Wei,Jiang Weiliang,Wang Feng,Fu Weiguo,Zou Yinghua,Deckers Stefanie,Li Pei,Popma Jeffrey J,Jaff Michael R
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
To confirm the safety and effectiveness of the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for de novo and native artery restenotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery in Chinese subjects. IN.PACT SFA China ( identifier NCT02118532) was a single-arm, independently adjudicated, prospective, premarket study that enrolled 143 subjects (mean age 66.8±7.7 years; 107 men) at 15 centers. The predominant risk factors were hypertension (104, 72.7%) and diabetes mellitus (66, 46.2%). The majority of subjects were classified as Rutherford category 2 or 3 [69 (48.3%) and 55 (38.5%), respectively]; 19 (13.3%) subjects had critical limb ischemia (Rutherford category 4). The mean lesion length was 10.4±6.51 cm; more than half of the lesions (75, 52.4%) were chronic total occlusions. Calcification was found in 66 (46.2%) lesions. Outcomes at 12 months were compared with DCB safety and effectiveness performance goals derived from the literature. The 30-day primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion revascularization (CD-TLR). The primary safety outcome was 99.3% at 30 days. Follow-up compliance at 12 months was 92.6%. Estimated 1-year primary patency using Kaplan-Meier analysis was 90.9% and freedom from CD-TLR was 97.1%. The rate of CD-TLR at 12 months was 2.9%. The Rutherford category status improved significantly (p<0.001) between baseline and 12 months. Results from IN.PACT SFA China demonstrated high rates of patency and low rates of CD-TLR in Chinese subjects through 12 months despite patient and lesion complexity. These data are consistent with the results of other IN.PACT DCB trials.
Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions: A Comprehensive Review.
Richelsen Rasmus Kapalu Broge,Overvad Thure Filskov,Jensen Svend Eggert
Cardiology and therapy
Drug-eluting balloons (DEBs) have emerged as a new application in percutaneous coronary intervention. DEBs have proven successful in the treatment of in-stent restenosis, but their role in de novo lesions is less clear. This paper provides a review of the current studies where DEBs have been used in coronary de novo lesions, either as part of a DEB-only strategy or in combination with another device, mainly a bare metal stent (BMS). By searching Pubmed and Embase we were able to identify 52 relevant studies, differing in design, intervention, and clinical setting, including patients with small vessel disease, bifurcation lesions, complex long lesions, acute myocardial infarction, diabetes mellitus, and elderly. In 23 studies, a DEB was combined with a BMS, 25 studies used a DEB-only strategy with only provisional BMS implantation, and four studies combined a DEB with a drug-eluting stent (DES). In the vast majority of studies, DEB in combination with BMS does not seem to improve clinical or angiographic outcome compared with DES, whereas a DEB-only strategy seems promising, especially when predilatation and geographical mismatch are taken into account. A lower risk of recurrent thrombosis with DEB compared with DES is not evident from the current studies. In conclusion, the main indication for DEB seems to be small vessel disease, especially in clinical scenarios in which a contraindication to dual antiplatelet therapy exists. The main approach should be a DEB-only strategy with only provisional bailout stenting, which has shown interesting results in different clinical scenarios. In general, larger randomized controlled studies with prolonged follow-up comparing DEB with best in class DES are warranted. Technical developments of DEBs including the use of different drugs might potentially improve the efficacy of such treatment.
Percutaneous Coronary Interventions for the Treatment of Stenoses in Small Coronary Arteries: A Network Meta-Analysis.
Siontis George C M,Piccolo Raffaele,Praz Fabien,Valgimigli Marco,Räber Lorenz,Mavridis Dimitris,Jüni Peter,Windecker Stephan
JACC. Cardiovascular interventions
OBJECTIVES:This study evaluated the most appropriate percutaneous coronary intervention (PCI) for the treatment of stenoses in small coronary arteries. BACKGROUND:PCI in small coronary arteries is associated with an increased risk of lesion failure and restenosis. METHODS:Randomized trials comparing different PCI strategies were identified through a broad search of published reports. Primary angiographic outcome was %DS (%DS). A pairwise meta-analysis was performed by using random effects model, followed by a network meta-analysis synthesizing direct and indirect evidence. RESULTS:Overall, 19 trials were eligible, which included 5,072 patients comprising a network without closed loops among 5 identified interventions (early generation sirolimus-eluting stents [SES], paclitaxel-eluting stents [PES], drug-coated balloons [DCB], bare-metal stents [BMS], and balloon angioplasty [BA]). No dedicated trial was identified evaluating new generation drug-eluting stents. Early generation SES yielded the best angiographic results according to %DS. For %DS, SES was ranked as the most effective treatment, followed by PES (standardized mean differences [SMD]: -0.44; 95% confidence interval [CI]: -0.92 to 0.05 vs. SES) and DCB (SMD: -0.89; 95% CI: -1.53 to -0.25 vs. SES). In terms of absolute differences, SES yielded a reduction of 18% in diameter stenosis compared to DCB. SES significantly reduced the risk of target-lesion revascularization compared to PES (odds ratio [OR]: 0.39; 95% CI: 0.16 to 0.93), DCB (OR: 0.34; 95% CI: 0.10 to 0.97), BMS (OR: 0.21; 95% CI: 0.13 to 0.36), and BA (OR: 0.16; 95% CI: 0.09 to 0.29). CONCLUSIONS:Early generation SES yielded the most favorable angiographic and clinical outcomes for the treatment of stenoses in small coronary arteries. New generation DES need to be evaluated against this standard in future randomized trials.
Paclitaxel drug-coated balloons: a review of current status and emerging applications in native coronary artery de novo lesions.
Loh Joshua P,Waksman Ron
JACC. Cardiovascular interventions
The paclitaxel drug-coated balloon (DCB) is an emerging device in percutaneous coronary intervention, which has shown promising results by means of a high-concentration, rapid local release of an antirestenotic drug without the use of a durable polymer or metal scaffold. DCB have already proven effective in clinical trials for the treatment of in-stent restenosis. Its coronary applications may potentially be widened to a host of complex coronary de novo lesion subsets, such as small-caliber vessels, diabetes, and diffuse lesions, where the use of stents may be hampered by suboptimal results. Recently, this technology has rapidly evolved with newer studies added to assess the value of DCB in coronary applications other than in-stent restenosis. We present a review of the role of DCB in de novo coronary lesions based on this latest clinical evidence.
The development of novel biodegradable bifurcation stents for the sustainable release of anti-proliferative sirolimus.
Lee Cheng-Hung,Chen Chia-Jung,Liu Shih-Jung,Hsiao Chao-Ying,Chen Jan-Kan
Annals of biomedical engineering
In this report, a balloon-expandable, biodegradable, drug-eluting bifurcation stent (DEBS) that provides a sustainable release of anti-proliferative sirolimus was developed. Biodegradable bifurcation stents, made of polycaprolactone, were first manufactured by injection molding and hot spot welding techniques. Various properties of the fabricated stents, including compression strengths, collapse pressures, and flow pattern in a circulation test, were characterized. The experimental results showed that biodegradable bifurcation stents exhibited comparable mechanical properties with those of metallic stents and superior flow behavior to that of metallic bifurcation stents deployed via the T And small Protrusion approach. Polylactide-polyglycolide (PLGA) copolymer and sirolimus were then dissolved in acetonitrile and coated onto the surface of the stents by a spray coating device. An elution method and a high performance liquid chromatography analysis were utilized to examine the in vitro release characteristics of sirolimus. Biodegradable bifurcation stents released high concentrations of sirolimus for more than 6 weeks, and the total period of drug release could be prolonged by increasing the drug loading of the PLGA/sirolimus coating layers. In addition, the eluted drug could effectively inhibit the proliferation of smooth muscle cells. The developed DEBS in this study may provide a promising strategy for the treatment of cardiovascular bifurcation lesions.
One-year outcomes with angiographic follow-up of paclitaxel-eluting balloon for the treatment of in-stent restenosis: insights from Spanish multicenter registry.
Vaquerizo Beatriz,Serra Antonio,Miranda-Guardiola Faustino,Martínez Vanesa,Antoni Gómez-Hospital Joan,Iñiguez Andrés,Fernández Eduardo,Ramón Rumoroso José,Bosa Francisco,Otaegui Imanol
Journal of interventional cardiology
INTRODUCTION:Even in the drug-eluting stent (DES) era treatment of in-stent restenosis (ISR) is still a relatively common problem for which a satisfactory solution is yet to be found. We wished to assess the efficacy of a new paclitaxel-coated drug-eluting balloon (DEB) in the treatment of these lesions. METHODS:In this prospective multicenter registry 126 patients with ISR, treated with a new paclitaxel-eluting balloon (3.0 μg/m(2) balloon surface area), were included. All lesions were predilated using conventional balloon angioplasty. The DEB was inflated for a minimum of 60 seconds. Dual antiplatelet therapy was recommended for at least 1 month. The only exclusion criteria were acute STEMI and cardiogenic shock. RESULTS:Thirty-three percent of patients were diabetic and 51% presented acutely. Interestingly, 48% had ISR of DES, 54% had ISR in a small vessel, and 29% involved bifurcation lesions. The pattern of ISR was focal in 59% and the most treated artery was the left anterior descending artery (LAD). Angiographic success was 96%. In 2 centers, repeat angiography was performed in 79% and restenosis observed in 6 patients (17.6%). MACE rate at a median of 12 (6-13) months was 16.7% (4.0% cardiac death, 4.0% MI, and 12.0% TLR). There was only 1 probable thombotic event (ARC). As compared with BMS-ISR, patients with DES-ISR were more often diabetic (40 vs. 28%) and had more re-restenosis (TLR 14.8 vs. 9.2%). CONCLUSION:In a real-world population, treatment of ISR (including 48% DES-ISR) with this DEB provides good mid-term results with 12% TLR at 1 year, especially in ISR pattern IC (9% MACE).
Opportunities and limitations of drug-coated balloons in interventional therapies.
Drug-coated balloons (DCB) represent a novel clinical treatment modality for coronary and peripheral artery disease. Advantages over standard angioplasty and stent technologies including homogeneous drug delivery to the vessel wall, immediate drug release without the use of a polymer, the option of using balloon catheters alone or in combination with a bare metal stent, no foreign object that remains in the body, the potential of reducing antiplatelet therapy, and lower restenosis rates in some indications. As with drug-eluting stents (DES), one cannot assume a class effect for DCB. So far, data from randomized clinical trials identify the treatment of coronary in-stent restenosis (ISR) and of de novo and restenotic lesions in peripheral artery disease as viable options. Furthermore, treatment of de novo lesions in small coronary vessels, bifurcation lesions, long lesions, pediatric interventions, and cerebrovascular applications are potential beneficial indications. In the coronary application, a strategy of DCB angioplasty with provisional spot-stenting in the case of severe dissections may become a better alternative in long and complex lesions, bifurcations, or in patients with contraindications for DES.
Paclitaxel coated balloons, the time for awareness has come.
Cortese Bernardo,Sgueglia Gregory A,Granada Juan F
International journal of cardiology
Over the last decade, a myriad of small clinical studies using a wide variety drug coated balloons (DCB) has shown the potential efficacy profile of this technology in specific clinical settings, especially coronary in-stent restenosis and peripheral artery disease. However, also due to the negative results of some small clinical studies, a big sense of confusion and uncertainty still exists among device developers and clinicians on current DCB indications. The advantages of DCB consist in non-polymeric delivery of anti-proliferative drugs limited to the time of the highest activity of the neointimal restenotic process after vessel injury, maintenance of vessel anatomy and potential to decrease delayed healing. Moreover, this field is rapidly evolving and includes lower-dose formulations, dedicated drug delivery reservoirs and alternative drugs. As these technologies emerge, we hope that some of the lessons learned will bring to proper validation strategies and solid experimental and clinical experimentations.
Drug-coated balloons for coronary and peripheral interventional procedures.
Current cardiology reports
Paclitaxel-coated balloon (PCB) angioplasty reduces neointimal proliferation, restenosis, and clinical need for target lesion revascularization (TLR). PCB was superior for coronary restenosis in bare-metal and drug-eluting stents compared with uncoated balloon angioplasty and was noninferior compared with paclitaxel-eluting stents. PCB angioplasty should be considered for treatment of coronary in-stent restenosis. For de novo lesions, PCB plus endothelial progenitor cell capturing stents reduced restenosis and TLR in early reports. Among patients with de novo lesions and diabetes, the combination of PCB plus bare-metal stent revealed similar results in lesions compared with paclitaxel-eluting stents. The early results for PCB in small vessels are also very encouraging. Dual antiplatelet therapy duration may be shorter with PCB angioplasty compared with drug-eluting stents. Nevertheless, the risk for thrombotic vessel occlusion is minimized. Considering peripheral arterial disease, PCB angioplasty for femoropopliteal lesions was superior to uncoated balloon angioplasty. Registries indicate PCB to also be effective in lesions below the knee. Since there is no certain class effect, efficacy and safety have to be demonstrated for different types of PCB for coronary and peripheral interventions.
The paclitaxel-eluting PTCA-balloon in combination with a cobalt-chromium stent in two different sequences to treat de novo coronary artery lesions: an angiographic follow up study.
Kaul Upendra,Unverdorben Martin,Degenhardt Ralf,Seth Ashok,Bahl Vinay K,Hiremath Shirish M S,Chandra Praveen,Mullesari Ajit S,Sandhu P S,Rao Seshagiri,George Oommen,Ackermann Hanns,Boxberger Michael
Indian heart journal
INTRODUCTION:The paclitaxel-coated balloon catheter (DCB) based on the PACCOCATH(®) technology has yielded angiographic and clinical results superior to drug-eluting stents (DES) in situations like in-stent restenosis (ISR) and a trend towards superior results in small coronary vessels and side branches of coronary bifurcations. Using the DCB followed by cobalt-chromium stent (CoCr) deployment or with a reverse sequence may yield different outcomes in terms of late loss. METHODS:97 patients with de-novo coronary stenosis (55.6 ± 10.7 years, 79.4% male, ≥70%, length: ≤25 mm, vessel diameter: 2.5-4.0 mm) were randomly treated with the DCB (3 μg/mm²) followed by a CoCr-stent or stent first and DCB later. Six-month angiographic and one-year clinical follow-up intention-to-treat analyses were performed. RESULTS:Angiographic and demographic baseline data was comparable between the two groups. When comparing balloon first versus stent first technique, the primary outcome variables were not statistically different for mean in-segment (0.51 ± 0.56 mm vs. 0.36 ± 0.55 mm, p = 0.23) and in-stent (0.52 ± 0.55 mm vs. 0.46 ± 0.52 mm, p = 0.65) late lumen loss. The lesion related 12-month MACE rates were 5/49 (10.2%) and 2/48 (4.2%) (p = 0.44). Lesion related thrombotic events occurred in three patients in balloon first and in one patient in stent first group, two of which were associated with early discontinuation of continuous dual anti-platelet therapy, two with suboptimal PCI, and one each were performed in a thrombotic lesion and a bifurcation type 1.1.0. CONCLUSION:Drug-coated balloon first followed by cobalt chromium stent deployment versus a reverse sequence is not associated with statistically significantly different 6-month angiographic or 12-month clinical outcomes.
Drug eluting balloon: a multipurpose tool for coronary revascularization with optimal long-term follow-up results.
Pastormerlo Luigi Emilio,Ciardetti Marco,Trianni Giuseppe,Ravani Marcello,Shlueter Mathis,Vaghetti Marco,Coceani Michele,Rizza Antonio,Berti Sergio,Palmieri Cataldo
Journal of interventional cardiology
AIMS:This study aimed to evaluate safety and efficacy of drug-coated balloon (DCB) at long-term follow-up; a large series of real-life patients underwent revascularization with DCB for a wide spectrum of clinical and angiographic situations. METHODS AND RESULTS:One hundred ten patients underwent percutaneous revascularization using paclitaxel eluting balloon (Sequent Please, Braun, Germany). End-points were major adverse cardiac events (MACE; all-cause death, myocardial infarction [MI], target vessel revascularisation [TVR], and vessel thrombosis). DCB were used for stable angina (58%), unstable angina/nonST elevation MI (31%) and ST elevation MI (11%). DCB were used for in-stent restenosis (61%), small vessel disease (25%), with bare metal stent (BMS) to avoid long dual antiplatelet therapy (10%) or for impossibility to place a stent (4%). Cumulative MACE at follow-up (median 23 months, IQR 13-32) was 12.7%, with 8.2% all-cause death (1 fatal MI), 4.5% TVR, 3.6% TLR, and no vessel thrombosis. Three of four TLRs occurred in patients who received DEB for DES restenosis. CONCLUSIONS:DCB are a very effective tool for a variety of clinical and angiographic situations. DCB use seems to be affected by a low rate of complications and adequate results at long-term follow-up.
[New technologies and applications for drug-coated balloons].
Cortese Bernardo,Di Palma Gaetano,Nerla Roberto,Micari Antonio
Giornale italiano di cardiologia (2006)
Drug-eluting stents (DES) represent nowadays the gold standard treatment for coronary artery disease. Despite the safety and efficacy, and favorable long-term clinical outcomes of new generation DES, their use is still associated with a not negligible risk of long-term events, related to the presence of a definitive prosthesis in the vessel wall. In addition, DES implantation is not always desirable in particular anatomic settings (small vessels, bifurcations) or in patients with higher bleeding risk. In recent years, drug-coated balloons (DCB) have been developed to overcome some of these limitations, offering a combined mechanical (balloon dilation) and biological therapy (drug-release). In the coronary setting, there is already a clear indication for the treatment of in-stent restenosis, but recent studies showed favorable results also when DCB are used for the treatment of de novo lesions.Regarding peripheral artery disease management, conventional transcatheter therapies with balloon angioplasty, atherectomy and stents are limited by high restenosis rates; in addition, stent implantation in lower limb vessels alter artery wall compliance, increasing stiffness, with a higher risk of restenosis and stent fracture. DCB represent a good alternative and have shown good safety and efficacy also in this setting.
Drug-coated balloons: "Do they still have a role in treating coronary artery disease?"
Shatila Wassim,Krajcer Zvonimir
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Small vessels with coronary artery disease (CAD) are at high risk of restenosis, despite the use of drug-eluting stents (DESs). Drug-coated balloon (DCB) therapy offers a viable alternative to DESs for the management of small vessel CAD. The literature regarding the use of DCBs in lieu of the newer generation DESs to treat small vessel CAD is controversial.
Drug-Coated Balloons Applications in Interventional Cardiology.
Rigatelli Gianluca,Zuin Marco
Current pharmaceutical design
BACKGROUNDS:Drug coated balloons (DCBs) are new on stented-based anti-proliferative drug delivery systems, recently introduced in interventional cardiology. Their primary aim is to transfer an anti-proliferative drug to reduce the subsequent neo-intima hyperplasia and to maintain the normal vessel diameter and function. METHODS:A review of the most recent influential studies about DCBs in all the fields of interventional cardiology has been performed. RESULTS:As demonstrated by different studies, DCBs have different theoretical advantages over Drug Eluting Stents (DESs), especially for the treatment of some endovascular lesions, as In-Stent Restenosis (ISR), coronary bifurcations, small vessels disease and peripheral artery disease at femoropopliteal and below the knee sites. CONCLUSION:Despite the need of further studies are needed to elucidate the optimal use of DCBs their current use in interventional cardiology appears promising.
Clinical Outcomes of Drug-Coated Balloons in Coronary Artery Disease Unsuitable for Drug-Eluting Stent Implantation.
Iijima Raisuke,Kougame Norihiro,Hara Hidehiko,Moroi Masao,Nakamura Masato
Circulation journal : official journal of the Japanese Circulation Society
BACKGROUND:The aim of this study was to investigate whether drug-coated balloon (DCB) treatment is effective for de novo coronary lesions that are unsuitable for drug-eluting stent (DES) implantation.Methods and Results:This retrospective study included 118 de novo lesions that were not suitable for DES implantation. Of the lesions, 40% was treated because of very small vessel disease. Patients with planned non-cardiac surgery and at high bleeding risk were 3% and 19%, respectively, and lesions that easily develop stent fracture comprised 26%. Clinically driven target lesion revascularization (TLR) was the primary endpoint. The rate of suboptimal lesion preparation before DCB treatment was set as the secondary endpoint. Optimal lesion preparation was defined as acquisition of Thrombolysis in Myocardial Infarction flow grade 3, minor coronary dissection, and residual stenosis ≤30%. The rate of suboptimal lesion preparation was 2.5% and 3 patients needed bail-out stenting. Accordingly, 115 patients were treated with a DCB. Clinically driven TLR had occurred in 8 patients (7.0%) at the 8-month follow-up. The presence of chronic total occlusion was identified as an independent predictor for TLR (odds 11.57; 95% confidence interval, 1.38-135.54; P=0.02). CONCLUSIONS:For lesions that are unsuitable for stent implantation, stent-less intervention using a DCB should be considered initially. The present study also highlighted that lesion preparation is key to a successful DCB strategy.
Outcomes With Drug-Coated Balloons for Treating the Side Branch of Coronary Bifurcation Lesions.
Megaly Michael,Rofael Michael,Saad Marwan,Shishehbor Mehdi,Brilakis Emmanouil S
The Journal of invasive cardiology
BACKGROUND:Treating coronary bifurcations remains limited by technical difficulties and suboptimal long-term outcomes, often affecting the side branch (SB). Drug-coated balloon (DCB) in SB treatment could reduce neointimal hyperplasia and the risk for restenosis. METHODS:We performed a systematic review of all studies published between January 2000 and February 2018 reporting the outcomes of DCB vs non-coated balloon angioplasty (BA) in the treatment of the SB in coronary bifurcation lesions. Outcomes included SB late lumen loss, SB binary restenosis, target-lesion revascularization (TLR), and major adverse cardiac event (MACE) rate. RESULTS:Four studies with 349 patients were included in the meta-analysis (three randomized controlled trials [RCTs] and one observational study). SB stenting was performed in 7.5% vs 8.6% in the DCB and BA groups, respectively. Angiographic follow-up performed after a mean follow-up of 9.1 ± 2.1 months demonstrated that DCB was associated with lower SB late lumen loss compared with BA (mean difference, -0.19 mm; 95% confidence interval [CI], -0.37 to -0.01; P=.04). There was no difference in the risk of SB binary restenosis (odds ratio [OR], 0.52; 95% CI, 0.18-1.47; P=.22). During a mean follow-up of 15.1 ± 5.8 months, DCB and BA had similar risk of MACE (OR, 0.76; 95% CI, 0.4-1.4; P=.40), and TLR (OR, 0.85; 95% CI, 0.3-2.4; P=.76). CONCLUSION:Assessment of DCB for SB treatment of coronary bifurcations is limited by low power due to the small number of patients studied. Use of DCB was associated with lower SB late lumen loss, but this did not translate into improved clinical outcomes.
Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months?
Unverdorben Martin,Kleber Franz X,Heuer Hubertus,Figulla Hans-Reiner,Vallbracht Christian,Leschke Matthias,Cremers Bodo,Hardt Stefan,Buerke Michael,Ackermann Hanns,Boxberger Michael,Degenhardt Ralf,Scheller Bruno
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
AIMS:The one-year outcome of lesions in small coronary arteries by using a paclitaxel-iopromide-coated (3 µg/mm²) balloon catheter (DCB) has yielded good six-month angiographic and one-year clinical data. We now report the three-year clinical follow-up. METHODS AND RESULTS:One hundred and twenty patients with >70% stenoses <22 mm in length in small coronary vessels (vessel diameter: 2.25-2.8 mm) were treated with the DCB. The primary endpoint was angiographic in-segment late lumen loss. The secondary endpoints encompassed all other angiographic and clinical data up to three years post intervention. In total 82/120 (68.3%) patients with a vessel diameter of 2.35±0.19 mm were treated with the DCB only, and 32/120 (26.7%) patients required additional bare metal stent (BMS) deployment. Both the 12- and 36-month major adverse cardiac event rates were 5/82 (6.1%) for DCB only and 12/32 (37.5%) for DCB+BMS, primarily due to the need for target lesion revascularisation in 4/82 (4.9%) patients and 9/32 (28.1%) (p<0.001) patients, respectively. Total MACE rate after 36 months was 18/120 (15%; intention-to-treat). CONCLUSIONS:Treatment of small vessel coronary artery disease with a paclitaxel-iopromide-coated balloon exhibited good six-month angiographic and one-year clinical data that persisted during the three-year follow-up period. Randomised trials will clarify its role as an alternative to drug-eluting stents in the treatment of small vessel coronary artery disease. (ClinicalTrials.gov Identifier: NCT00404144).
Drug-Coated Balloons: A Safe and Effective Alternative to Drug-Eluting Stents in Small Vessel Coronary Artery Disease.
Sinaga Dasdo Antonius,Ho Hee Hwa,Watson Timothy James,Sim Alyssa,Nyein Thuzar Tint,Jafary Fahim H,Loh Jason K K,Ooi Yau Wei,Tan Julian K B,Ong Paul J L
Journal of interventional cardiology
BACKGROUND:Drug-coated balloons (DCB) have been used to treat de novo small vessel coronary disease (SVD), with promising results and shorter dual antiplatelet therapy (DAPT) duration compared to drug-eluting stents (DES). We compared safety and effectiveness of the two treatments at 1 year. METHODS:We reviewed 3,613 angioplasty cases retrospectively from 2011 to 2013 and identified 335 patients with SVD treated with device diameter of ≤2.5 mm. DCB-only angioplasty was performed in 172 patients, whereas 163 patients were treated with second-generation DES. RESULTS:DCB patients had smaller reference vessel diameter (2.22 ± 0.30 vs. 2.44 ± 0.19 mm, P < 0.001) and received smaller devices (median diameter 2.25 vs. 2.50 mm, P < 0.001) compared to the DES group. DES-treated vessels had larger acute lumen gain (1.71 ± 0.48 mm) than DCB (1.00 ± 0.53 mm, P < 0.001). Half the patients had diabetes mellitus. While there were more patients presenting with acute coronary syndrome (ACS) in the DCB group (77.9% vs. 62.2%, P = 0.013), they received shorter DAPT (7.4 ± 4.7 vs. 11.8 ± 1.4 months, P < 0.001) than the DES group. The 1-year composite major adverse cardiac event rate was 11.6% in the DCB arm and 11.7% in the DES arm (P = 1.000), with target lesion revascularization rate of 5.2% and 3.7%, respectively, (P = 0.601). CONCLUSIONS:In this high-risk cohort of patients, DCB-only angioplasty delivered good clinical outcome at 1 year. The results were comparable with DES-treated patients, but had the added benefit of a shorter DAPT regime.
State of the art: balloon catheter technologies - drug-coated balloon.
Alfonso Fernando,Scheller Bruno
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Four decades after its introduction into clinical practice, coronary balloon angioplasty is still used during most coronary interventions. Conventional balloon angioplasty is frequently used to predilate complex or severe lesions and remains of major value to optimise the results of stent implantation. Plain balloon angioplasty is still used alone in some anatomic scenarios where stent implantation is not desirable (very small vessels or diffuse lesions, large resistant thrombus burden, side branches of bifurcations). However, this technique is hampered by a relatively high restenosis risk. Recently, drug-coated balloons (DCB) have been shown to provide an attractive new tool for the "leave nothing behind" strategy. Many studies have demonstrated that DCB are indeed safe and effective. Evidence of the value of DCB in patients with ISR is overwhelming. DCB are attractive for selected de novo coronary lesions (small vessels, diffuse disease, side branches). DCB have also gained major evidence supporting their clinical efficacy in the peripheral arterial territory. Further studies are required to elucidate the relative value of DCB compared with alternative strategies (namely new-generation drug-eluting stents) in different clinical and anatomic scenarios.
Drug Coated Balloon-Only Strategy in De Novo Lesions of Large Coronary Vessels.
Journal of interventional cardiology
OBJECTIVES:We analyzed the efficacy of drug coated balloons (DCB) as a stand-alone-therapy in de novo lesions of large coronary arteries. DCBs seem to be an attractive alternative for the stent-free interventional treatment of de novo coronary artery disease (CAD). However, data regarding a DCB-only approach in de novo CAD are currently limited to vessels of small caliber. METHODS:By means of propensity score (PS) matching 234 individuals with de novo CAD were identified with similar demographic characteristics. This patient population was stratified in a 1:1 fashion according to a reference vessel diameter cut-off of 2.75 mm in small and large vessel disease. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 9 months. RESULTS:Patients with small vessel disease had an average reference diameter of 2.45 ± 0.23 mm, while the large vessel group averaged 3.16 ± 0.27 mm. Regarding 9-month major adverse cardiac event (MACE), 5.7% of the patients with small and 6.1% of the patients with large vessels had MACE (p=0.903). Analysis of the individual MACE components revealed a TLR rate of 3.8% in small and 1.0% in large vessels (p=0.200). Of note, no thrombotic events in the DCB treated coronary segments occurred in either group during the 9-month follow-up. CONCLUSIONS:Our data demonstrate for the first time that DCB-only PCI of de novo lesions in large coronary arteries (>2.75 mm) is safe and as effective. Interventional treatment for CAD without permanent or temporary scaffolding, demonstrated a similar efficacy for large and small vessels.
Drug coated balloon angioplasty in elderly patients with small vessel coronary disease.
Sinaga Dasdo A,Ho Hee Hwa,Zeymer Uwe,Waliszewski Matthias,Jafary Fahim H,Ooi Yau Wei,Loh Jason K K,Tan Julian K B,Ong Paul J L
Therapeutic advances in cardiovascular disease
BACKGROUND:Coronary angioplasty in advanced age is associated with higher rate of comorbidities and complications. Drug coated balloon only angioplasty (DCBA) has emerged as an alternative to treat small vessel coronary disease (SVCD), of reference vessel diameters <2.8 mm, with shorter duration of dual antiplatelet (DAPT). This is the first study to assess the DCBA efficacy in an elderly population with SVCD. METHODS AND RESULTS:We performed a prospective study of 447 patients (334 patients aged <75 and 113 patients aged ⩾75 years old) acquired from the SeQuent Please Small Vessel 'Paclitaxel-Coated Balloon Only' registry. In the older age group, more patients have hypertension (89% versus 77%; p = 0.006), renal insufficiency (21% versus 6%; p < 0.001), atrial fibrillation (17% versus 7%; p = 0.001), and calcified lesions (33% versus 20%; p = 0.006). At 30 days, there was one myocardial infarction requiring target lesion revascularization (TLR) in the younger group. No major adverse cardiac event (MACE) was observed in the older group. At 9 months, the MACE rate in the younger group was 4.2% and 6.1% in the older group (p = 0.453), with TLR rates at 3.9% and 3.0% (p = 0.704) respectively. There was no cardiac death observed. CONCLUSION:DBCA in the elderly with SVCD is as safe and effective compared with younger patients despite more complex anatomy and comorbidities.
A review of the coronary applications of the drug coated balloon.
Jackson Damon,Tong David,Layland Jamie
International journal of cardiology
The drug coated balloon (DCB) platform offers several theoretical benefits over stent-based technologies. It allows the homogenous transfer of an anti-proliferative drug to reduce neo-intimal hyperplasia whilst potentially maintaining normal vessel anatomy and function. They also avoid the introduction of an additional stent layer in the context of in-stent restenosis. The data pertaining to the treatment of de-novo coronary disease still favors the new generation of drug eluting stents. DCB may, however, have a role in the context of challenging coronary anatomy and small vessel disease where results with stent insertion are poor. The body of evidence supporting the role of DCB in the treatment of in-stent restenosis is more substantial and appears to yield similar results to DES without the introduction of an additional stent layer. Further trials are required to clarify the ideal duration of dual anti-platelet treatment following DCB use and to further elucidate the ideal clinical context for their use.
A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients with small vessel disease.
Funatsu Atsushi,Nakamura Shigeru,Inoue Naoto,Nanto Shinsuke,Nakamura Masato,Iwabuchi Masashi,Ando Kenji,Asano Ryuta,Habara Seiji,Saito Shigeru,Kozuma Ken,Mitsudo Kazuaki
Clinical research in cardiology : official journal of the German Cardiac Society
AIM:We investigated the efficacy and safety of using paclitaxel-coated balloon (PCB) to treat small vessel disease. METHODS AND RESULTS:In this multicenter, prospective, randomized controlled trial, one-hundred and thirty-five patients with native coronary lesions in small vessels were randomized into a PCB group and plain balloon angioplasty (POBA) group at a ratio of 2:1. There were no differences in target vessel failure (TVF) that was defined as cardiac death or target vessel-related myocardial infarction or target lesion revascularization (TLR), between the two groups (3.4 vs. 10.3%; P = 0.20), and TLR was slightly lower in the PCB group (2.3%) than that in the POBA group (10.3%) during 24 weeks follow-up. The late lumen loss (LLL) was significantly lower in the PCB group (0.01 ± 0.31 vs. 0.32 ± 0.34 mm; P < 0.01) and late lumen enlargement (LLE) was more frequently observed in the PCB group (48 vs. 15%; P < 0.01) by angiographic follow-up after 24 weeks. There were no cases of death, myocardial infarction, thrombosis and reocclusion in either group. CONCLUSIONS:This study was not able to demonstrate superiority of PCB compared with POBA.
Drug-coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET-SMALL 2.
Gilgen Nicole,Farah Ahmed,Scheller Bruno,Ohlow Marc-Alexander,Mangner Norman,Weilenmann Daniel,Wöhrle Jochen,Jamshidi Peiman,Leibundgut Gregor,Möbius-Winkler Sven,Zweiker Robert,Krackhardt Florian,Butter Christian,Bruch Leonhard,Kaiser Christoph,Hoffmann Andreas,Rickenbacher Peter,Mueller Christian,Stephan Frank-Peter,Coslovsky Michael,Jeger Raban,
The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug-eluting stents (DES) have limited efficacy due to increased rates of instent-restenosis, mainly caused by late lumen loss. Drug-coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons vs. Drug-Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty-eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target-vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long-term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long-term safety and efficacy for the treatment of SVD in a large all-comer population.
Drug-coated balloon angioplasty for de novo small vessel disease including chronic total occlusion and bifurcation in real-world clinical practice.
Onishi Takayuki,Onishi Yuko,Kobayashi Isshi,Umezawa Shigeo,Niwa Akihiro
Cardiovascular intervention and therapeutics
The aim of this study is to validate the efficacy of drug-coated balloons (DCBs) for real-world de novo small vessel diseases including chronic total occlusion and bifurcation. DCB angioplasty has been reported to be effective in the treatment of de novo small vessel disease. However, the number of reports that have focused on complex lesions is limited. This observational study comprised consecutive patients who underwent DCB angioplasty for de novo small vessel disease with a reference diameter of less than 2.5 mm by visual estimation. Outcome parameters included late lumen loss, restenosis rate, and major adverse cardiac events, such as cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). Fifty-two patients underwent DCB angioplasty for 59 lesions with a reference vessel diameter of 1.93 ± 0.63 mm. Thirty-eight of the lesions (69%) were classified as type B2/C, including chronic total occlusions (20%) and bifurcations (33%). At the 8-month follow-up, late lumen loss was - 0.01 ± 0.44 mm with a restenosis rate of 20%. No cardiac deaths or myocardial infarctions were reported and only 5 (9%) angiographically driven TLRs were reported. DCB angioplasty offered an acceptable 8-month lumen patency and a stable clinical outcome for real-world complex de novo coronary diseases.
Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review.
Mohiaddin Hasan,Wong Tamar D F K,Burke-Gaffney Anne,Bogle Richard G
Cardiology and therapy
Percutaneous coronary intervention (PCI) with a drug coated balloon (DCB) is a novel treatment which seeks to acutely dilate a coronary stenosis and deliver an anti-proliferative drug to the vessel wall (reducing the risk of re-stenosis), without implanting a drug eluting stent (DES). In this study, we performed a systematic review of stentless DCB-only angioplasty in de novo coronary artery disease. We identified 41 studies examining the effects of DCB-only PCI in a variety of clinical scenarios including small vessels, bifurcations, calcified lesions, and primary PCI. DCB-only PCI appears to be associated with comparable clinical outcomes to DESs and superior angiographic outcomes to plain-old balloon angioplasty. Although current data are promising, there is still a need for further long-term randomized control trial data comparing a DCB-only approach specifically against a second- or third-generation DES. A 4-week period of dual antiplatelet therapy provides a real advantage for the DCB-only PCI approach, which is not possible with most DESs. Since rates of adverse clinical outcomes are very low for all PCI procedures attention should be turned to the development of robust endpoints with which to compare DCB-only PCI approaches to the standard treatment with a DES.
Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial.
Tang Yida,Qiao Shubin,Su Xi,Chen Yundai,Jin Zening,Chen Hui,Xu Biao,Kong Xiangqing,Pang Wenyue,Liu Yong,Yu Zaixin,Li Xue,Li Hui,Zhao Yanyan,Wang Yang,Li Wei,Tian Jian,Guan Changdong,Xu Bo,Gao Runlin,
JACC. Cardiovascular interventions
OBJECTIVES:The aim of this study was to evaluate the angiographic efficacy and clinical outcomes of the Restore paclitaxel-coated balloon in a randomized trial designed to enable its approval with an indication for small-vessel disease (SVD). BACKGROUND:Higher rates of restenosis and stent thrombosis limit the effectiveness of drug-eluting stent (DES) treatment of SVD. Whether a drug-coated balloon (DCB)-only strategy is effective in de novo SVD is not yet established. METHODS:In the noninferiority RESTORE SVD China trial, eligible patients with reference vessel diameter ≥2.25 and ≤2.75 mm were randomized to the Restore DCB or the RESOLUTE Integrity DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel registry. Angiographic and clinical follow-up were planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment percentage diameter stenosis. RESULTS:Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to the DCB group (n = 116) or DES group (n = 114); 32 patients were treated with the DCB in the very small vessel cohort. Nine-month in-segment percentage diameter stenosis was 29.6 ± 2.0% with the DCB versus 24.1 ± 2.0% with the DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of the DCB compared with the DES (p for noninferiority < 0.001). The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%, p = 0.72). CONCLUSIONS:In this multicenter randomized trial, the Restore DCB was noninferior to the RESOLUTE DES for 9-month in-segment percentage diameter stenosis. (Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; NCT02946307).
Meta-analysis of the effects of drug-coated balloons among patients with small-vessel coronary artery disease.
Yang Jing-Qi,Peng Jin-Hua,Xu Ting,Liu Li-Yun,Tu Jie-Hong,Li Shun-Hui,Chen Hui
OBJECTIVE:This study evaluated the clinical value of drug-coated balloons for patients with small-vessel coronary artery disease (SVD). METHODS:A computerized literature search was performed using the databases to conduct a meta-analysis and evaluate the clinical value of drug-coated balloons among patients with SVD. RESULTS:This review enrolling 1545 patients receiving drug-coated balloons and 1010 patients receiving stents (including drug-eluting stents and bare-metal stents). The meta-analysis results showed that the incidence of major adverse cardiovascular events among patients with SVD did not significantly differ between the drug-coated balloon group and the stent group within 1 postoperative year (odds ratio = 0.81, P = .5). A subgroup analysis showed that the incidence of myocardial infarction among the drug-coated balloon group was significantly lower than that among the stent group (odds ratio = 0.58, P = .04). Nevertheless, the late lumen loss of the drug-coated balloon group was significantly lower than that of the stent group (mean difference = 0.31, P = .01). CONCLUSIONS:Drug-coated balloons can be used to effectively reduce the incidence of myocardial infarction in patients with SVD within 1 year and decrease the extent of late lumen loss without increasing the incidence of major adverse cardiovascular events.
Drug-coated balloon versus drug-eluting stent in de novo small coronary vessel disease: A systematic review and meta-analysis.
Li Min,Guo Chen,Lv Yong-Hui,Zhang Ming-Bo,Wang Zhi-Lu
BACKGROUND:Drug-coated balloon as a novel therapeutic strategy has been used to treat restenosis in cases of bare metal and drug-eluting stents. However, evidence of its safety and efficacy is scarce in de novo small coronary artery vessel disease. This meta-analysis aimed to compare the safety and efficacy of the drug-coated balloon and the drug-eluting stent. METHODS:The PubMed, EMBASE, Web of Science, and Cochrane library databases were searched for studies published up to October 17, 2018. Studies comparing the drug-coated balloon with the drug-eluting stent strategy in patients with de novo small coronary artery vessel disease (reference diameter, <3 mm) were identified. The clinical outcomes were nonfatal myocardial infarction, cardiac death, all-cause death, target lesion revascularization, and target-vessel revascularization. Data were analyzed using the statistical software RevMan (version 5.3). Fixed effects models were performed to calculate the pooled odds ratios (ORs) and 95% confidence intervals (95% CIs). Sensitivity analyses were used to detect potential sources of heterogeneity, while subgroup analyses were implemented to assess the differential effects. RESULTS:Three randomized controlled trials and 3 nonrandomized controlled studies were identified. Six studies including a total of 1800 patients compared the differences between the drug-coated balloon and the drug-eluting stent strategies in patients with de novo small coronary artery vessel disease. The results indicated that the drug-coated balloon strategy was associated with a significant reduction in nonfatal myocardial infarction (OR 0.53, 95% CI 0.31-0.90, P = .02) compared with the drug-eluting stent strategy, while insignificant inter-strategy differences were observed in cardiac death (OR 1.56, 95% CI 0.73-3.33, P = .25), all-cause death (OR 0.56, 95% CI 0.25-1.23, P = .15), target lesion revascularization (OR 1.24, 95% CI 0.73-2.1, P = .43), and target-vessel revascularization (OR 0.95, 95% CI 0.59-1.52, P = .84). CONCLUSIONS:This meta-analysis suggests that the drug-coated balloon strategy is noninferior to the drug-eluting stent strategy, delivering a good outcome in nonfatal myocardial infarction, and can be recommended as an optimal treatment strategy in patients with de novo small coronary artery vessel disease. Larger randomized controlled studies with longer follow-up periods are needed to further confirm the benefits of the drug-coated balloon strategy.
Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group.
Her Ae-Young,Shin Eun-Seok,Bang Liew Houng,Nuruddin Amin Ariff,Tang Qiang,Hsieh I-Chang,Hsu Jung-Cheng,Kiam Ong Tiong,Qiu ChunGuang,Qian Jie,Ahmad Wan Azman Wan,Ali Rosli Mohd
Coronary artery disease (CAD) is currently the leading cause of death globally, and the prevalence of this disease is growing more rapidly in the Asia-Pacific region than in Western countries. Although the use of metal coronary stents has rapidly increased thanks to the advancement of safety and efficacy of newer generation drug eluting stent (DES), patients are still negatively affected by some the inherent limitations of this type of treatment, such as stent thrombosis or restenosis, including neoatherosclerosis, and the obligatory use of dual antiplatelet therapy (DAPT) with unknown optimal duration. Drug-coated balloon (DCB) treatment is based on a leave-nothing-behind concept and therefore it is not limited by stent thrombosis and long-term DAPT; it directly delivers an anti-proliferative drug which is coated on a balloon after improving coronary blood flow. At present, DCB treatment is recommended as the first-line treatment option in metal stent-related restenosis linked to DES and bare metal stent. For de novo coronary lesions, the application of DCB treatment is extended further, for conditions such as small vessel disease, bifurcation lesions, and chronic total occlusion lesions, and others. Recently, several reports have suggested that fractional flow reserve guided DCB application was safe for larger coronary artery lesions and showed good long-term outcomes. Therefore, the aim of these recommendations of the consensus group was to provide adequate guidelines for patients with CAD based on objective evidence, and to extend the application of DCB to a wider variety of coronary diseases and guide their most effective and correct use in actual clinical practice.
Drug-coated Balloons for Small Coronary Vessel Interventions: A Literature Review.
Nestelberger Thomas,Jeger Raban
Interventional cardiology (London, England)
Newer-generation drug-eluting stents (DES) are the standard of care for the treatment of symptomatic coronary artery disease. However, some lack of efficacy has been reported in small coronary arteries based on higher rates of target lesion restenosis, thrombosis and MI resulting in repeated interventions. Drug-coated balloons (DCBs) are an established treatment option for in-stent restenosis in both bare metal stents and DES and they can deliver an anti-proliferative drug into the vessel wall without implanting a stent. DCBs are a promising technique for selected coronary lesions, especially in small vessel disease. In this article, the current evidence for the treatment of small vessel disease with DCBs will be reviewed.
SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study.
Wöhrle Jochen,Zadura Mariusz,Möbius-Winkler Sven,Leschke Matthias,Opitz Christian,Ahmed Waqas,Barragan Paul,Simon Jean-Philippe,Cassel Graham,Scheller Bruno
Journal of the American College of Cardiology
OBJECTIVES:This study sought to assess the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in an international, multicenter, prospective, large-scale registry study. BACKGROUND:In small randomized trials, PCB angioplasty was superior to uncoated balloon angioplasty for treatment of bare-metal stent (BMS) and drug-eluting stent (DES) restenosis. METHODS:Patients treated with SeQuent Please PCBs were included. The primary outcome measure was the clinically driven target lesion revascularization (TLR) rate at 9 months. RESULTS:At 75 centers, 2,095 patients with 2,234 lesions were included. The TLR rate was 5.2% after 9.4 months. Definite vessel thrombosis occurred in 0.1%. PCB angioplasty was performed in 1,523 patients (72.7%) with DES or BMS restenosis and 572 patients (27.3%) with de novo lesions. The TLR rate was significantly lower in patients with PCB angioplasty for BMS restenosis compared with DES restenosis (3.8% vs. 9.6%, p < 0.001). The TLR rate did not differ for PCB angioplasty of paclitaxel-eluting stent and non-paclitaxel-eluting sten restenosis (8.3% vs. 10.8%, p = 0.46). In de novo lesions (small vessels), the TLR rate was low and did not differ between PCB angioplasty with and without additional BMS implantation (p = 0.31). CONCLUSIONS:PCB angioplasty in an all-comers, prospective, multicenter registry was safe and confirmed in a large population the low TLR rates seen in randomized clinical trials. PCB angioplasty was more effective in BMS restenosis compared with DES restenosis, with no difference regarding the type of DES.
Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial.
Jeger Raban V,Farah Ahmed,Ohlow Marc-Alexander,Mangner Norman,Möbius-Winkler Sven,Leibundgut Gregor,Weilenmann Daniel,Wöhrle Jochen,Richter Stefan,Schreiber Matthias,Mahfoud Felix,Linke Axel,Stephan Frank-Peter,Mueller Christian,Rickenbacher Peter,Coslovsky Michael,Gilgen Nicole,Osswald Stefan,Kaiser Christoph,Scheller Bruno,
Lancet (London, England)
BACKGROUND:Drug-coated balloons (DCB) are a novel therapeutic strategy for small native coronary artery disease. However, their safety and efficacy is poorly defined in comparison with drug-eluting stents (DES). METHODS:BASKET-SMALL 2 was a multicentre, open-label, randomised non-inferiority trial. 758 patients with de-novo lesions (<3 mm in diameter) in coronary vessels and an indication for percutaneous coronary intervention were randomly allocated (1:1) to receive angioplasty with DCB versus implantation of a second-generation DES after successful predilatation via an interactive internet-based response system. Dual antiplatelet therapy was given according to current guidelines. The primary objective was to show non-inferiority of DCB versus DES regarding major adverse cardiac events (MACE; ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation) after 12 months. The non-inferiority margin was an absolute difference of 4% in MACE. This trial is registered with ClinicalTrials.gov, number NCT01574534. FINDINGS:Between April 10, 2012, and February 1, 2017, 382 patients were randomly assigned to the DCB group and 376 to DES group. Non-inferiority of DCB versus DES was shown because the 95% CI of the absolute difference in MACE in the per-protocol population was below the predefined margin (-3·83 to 3·93%, p=0·0217). After 12 months, the proportions of MACE were similar in both groups of the full-analysis population (MACE was 7·5% for the DCB group vs 7·3% for the DES group; hazard ratio [HR] 0·97 [95% CI 0·58-1·64], p=0·9180). There were five (1·3%) cardiac-related deaths in the DES group and 12 (3·1%) in the DCB group (full analysis population). Probable or definite stent thrombosis (three [0·8%] in the DCB group vs four [1·1%] in the DES group; HR 0·73 [0·16-3·26]) and major bleeding (four [1·1%] in the DCB group vs nine [2·4%] in the DES group; HR 0·45 [0·14-1·46]) were the most common adverse events. INTERPRETATION:In small native coronary artery disease, DCB was non-inferior to DES regarding MACE up to 12 months, with similar event rates for both treatment groups. FUNDING:Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG.
Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study).
Giacoppo Daniele,Alfonso Fernando,Xu Bo,Claessen Bimmer E P M,Adriaenssens Tom,Jensen Christoph,Pérez-Vizcayno María J,Kang Do-Yoon,Degenhardt Ralf,Pleva Leos,Baan Jan,Cuesta Javier,Park Duk-Woo,Schunkert Heribert,Colleran Roisin,Kukla Pavel,Jiménez-Quevedo Pilar,Unverdorben Martin,Gao Runlin,Naber Christoph K,Park Seung-Jung,Henriques José P S,Kastrati Adnan,Byrne Robert A
European heart journal