Comparison of clinical outcomes after drug-eluting balloon and drug-eluting stent use for in-stent restenosis related acute myocardial infarction: a retrospective study.
Fang Chih-Yuan,Fang Hsiu-Yu,Chen Chien-Jen,Yang Cheng-Hsu,Wu Chiung-Jen,Lee Wei-Chieh
PeerJ
BACKGROUND:Good results of drug-eluting balloon (DEB) use are achieved in in-stent restenosis (ISR) lesions, small vessel disease, long lesions, and bifurcations. However, few reports exist about DEB use in acute myocardial infarction (AMI) with ISR. This study's aim was to evaluate the efficacy of DEB for AMI with ISR. METHODS:Between November 2011 and December 2015, 117 consecutive patients experienced AMI including ST-segment elevation MI, and non-ST-segment elevation MI due to ISR, and received percutaneous coronary intervention (PCI). We divided our patients into two groups: (1) PCI with further DEB, and (2) PCI with further drug-eluting stent (DES). Clinical outcomes such as target lesion revascularization, target vessel revascularization, recurrent MI, stroke, cardiovascular mortality, and all-cause mortality were analyzed. RESULTS:The patients' average age was 68.37 ± 11.41 years; 69.2% were male. A total of 75 patients were enrolled in the DEB group, and 42 patients were enrolled in the DES group. The baseline characteristics between the two groups were the same without statistical differences except for gender. Peak levels of cardiac biomarker, pre- and post-PCI cardiac function were similar between two groups. The major adverse cardiac cerebral events rate (34.0% vs. 35.7%; = 0.688) and cardiovascular mortality rate (11.7% vs. 12.8%; = 1.000) were similar in both groups. CONCLUSIONS:DEB is a reasonable strategy for AMI with ISR. Compared with DES, DEB is an alternative strategy which yielded acceptable short-term outcomes and similar 1-year clinical outcomes.
10.7717/peerj.4646
Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial.
Scheller Bruno,Ohlow Marc-Alexander,Ewen Sebastian,Kische Stephan,Rudolph Tanja K,Clever Yvonne P,Wagner Andreas,Richter Stefan,El-Garhy Mohammad,Böhm Michael,Degenhardt Ralf,Mahfoud Felix,Lauer Bernward
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
AIMS:Drug-coated balloons (DCB) may avoid stent-associated long-term complications. This trial compared the clinical outcomes of patients with non-ST-elevation myocardial infarction (NSTEMI) treated with either DCB or stents. METHODS AND RESULTS:A total of 210 patients with NSTEMI were enrolled in a randomised, controlled, non-inferiority multicentre trial comparing a paclitaxel iopromide-coated DCB with primary stent treatment. The main inclusion criterion was an identifiable culprit lesion without angiographic evidence of large thrombus. The primary endpoint was target lesion failure (TLF; combined clinical endpoint consisting of cardiac or unknown death, reinfarction, and target lesion revascularisation) after nine months. Secondary endpoints included total major adverse cardiovascular events (MACE) and individual clinical endpoints. Mean age was 67±12 years, 67% were male, 62% had multivessel disease, and 31% were diabetics. One hundred and four patients were randomised to DCB, 106 to stent treatment. In the stent group, 56% of patients were treated with BMS, 44% with current-generation DES. In the DCB group, 85% of patients were treated with DCB only whereas 15% underwent additional stent implantation. During a follow-up of 9.2±0.7 months, DCB treatment was non-inferior to stent treatment with a TLF rate of 3.8% versus 6.6% (intention-to-treat, p=0.53). There was no significant difference between BMS and current-generation DES. The total MACE rate was 6.7% for DCB versus 14.2% for stent treatment (p=0.11), and 5.9% versus 14.4% in the per protocol analysis (p=0.056), respectively. CONCLUSIONS:In patients with NSTEMI, treatment of coronary de novo lesions with DCB was non-inferior to stenting with BMS or DES. These data warrant further investigation of DCB in this setting, in larger trials with DES as comparator (ClinicalTrials.gov Identifier: NCT01489449).
10.4244/EIJ-D-19-00723
First results of the DEB-AMI (drug eluting balloon in acute ST-segment elevation myocardial infarction) trial: a multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in primary percutaneous coronary intervention with 6-month angiographic, intravascular, functional, and clinical outcomes.
Belkacemi Anouar,Agostoni Pierfrancesco,Nathoe Hendrik M,Voskuil Michiel,Shao ChunLai,Van Belle Eric,Wildbergh Thierry,Politi Luigi,Doevendans Pieter A,Sangiorgi Giuseppe M,Stella Pieter R
Journal of the American College of Cardiology
OBJECTIVES:The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI). BACKGROUND:Concerns remain regarding the long-term safety of DES in STEMI. DEB could provide an attractive alternative in order to achieve potentially similar effectiveness but limiting the long-term hazards related to late-acquired stent malapposition and thus stent thrombosis. METHODS:In this randomized, international, 2-center, single-blinded, 3-arm study, STEMI patients were randomly assigned to group A: BMS; group B: DEB plus BMS; or group C: DES after successful thrombus aspiration. The primary endpoint was 6-month angiographic in-stent late-luminal loss. Secondary endpoints were in-stent binary restenosis, major adverse cardiac events (MACE: cardiac death, myocardial infarction, target vessel revascularization). In a subgroup of patients, stent (mal)apposition (by optical coherence tomography) and endothelial function (by acetylcholine infusion) was assessed. RESULTS:Overall, 150 patients were randomized. Procedural success was achieved in 96.7%. In groups A, B, and C, respectively, late-luminal loss was 0.74 ± 0.57 mm, 0.64 ± 0.56 mm, and 0.21 ± 0.32 mm (p < 0.01); binary restenosis was 26.2%, 28.6%, and 4.7% (p = 0.01); and MACE rates were 23.5%, 20.0%, and 4.1% (p = 0.02), respectively. The median percentage [25th to 75th interquartile range] of uncovered and malapposed stent struts per lesion was 0 [0 to 0.35], 2.84 [0 to 6.63], and 5.21 [3.25 to 14.5] (p < 0.01). Significant paradoxical vasoconstriction was seen in groups B and C. CONCLUSIONS:In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; NCT00856765).
10.1016/j.jacc.2012.02.027
Clinical outcomes of drug-eluting balloon for treatment of small coronary artery in patients with acute myocardial infarction.
Tan Qiang,Wang Qingsheng,Yang Hongmei,Jing Zhang,Ming Chen
Internal and emergency medicine
There were good clinical outcomes of drug-eluting balloon (DEB) use in de novo lesions and in-stent restenosis (ISR) lesions. However, few studies focused on DEB use in patients with acute myocardial infarction (AMI). The aim of this study was to retrospective evaluate the efficacy of DEB for patients of AMI with de novo small coronary artery disease. Between March 2016 and March 2018, patients of AMI with de novo small coronary artery (reference diameter 2.0-2.8 mm) and received percutaneous coronary intervention (PCI) were enrolled. 268 patients were divided into DEB group (PCI with further DEB, n = 56) and drug-eluting stent (DES) group (PCI with further DES, n = 212). The primary endpoint was major adverse cardiac events (MACE; all-cause death, non-fatal myocardial infarction, target lesion revascularization and target vessel revascularization) at 24 months. A subset of patients underwent angiographic follow-up. Clinical characteristics were balanced in the two groups. Mean reference vessel diameter was similar between the DEB and DES groups (2.64 ± 0.17 mm vs 2.65 ± 0.14 mm, P = 0.625). The 24-month MACE rates were 17.5% in DEB group and 16.4% in DES group (P = 0.853). Stent thrombosis was seen in three patients (1.46%) in DES group. There was no vessel thrombosis noted in the DEB group. Angiographic follow-up was performed in 35.71% of DEB group and 27.25% of DES group. Late lumen loss was similar between the two groups (DEB 0.14 ± 0.13 mm, DES 0.19 ± 0.12 mm, P = 0.442). DEB is a reasonable strategy for AMI with small coronary artery. Compared with DES, DEB is an alternative strategy which had similar 24-month clinical outcomes.
10.1007/s11739-020-02530-w
Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: the nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial.
Nijhoff Freek,Agostoni Pierfrancesco,Belkacemi Anouar,Nathoe Hendrik M,Voskuil Michiel,Samim Mariam,Doevendans Pieter A,Stella Pieter R
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
OBJECTIVE:To evaluate a paclitaxel drug-eluting balloon (DEB) only strategy in primary percutaneous coronary intervention (PPCI), aiming at a comparison with bare metal stent (BMS) alone, DEB followed by BMS, and paclitaxel eluting stent (PES), as assessed in the randomized Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction (DEB-AMI) trial. BACKGROUND:DEB-only seems an attractive strategy in PPCI, as it obviates the risk of stent thrombosis. METHODS:This study is a prospective registry with the same inclusion/exclusion criteria used in the DEB-AMI trial, as it constitutes the fourth, nonrandomized, treatment arm of this trial. Patients presenting with ST-elevation myocardial infarction were allocated to DEB-only (DIOR II, Eurocor GmbH, Bonn, Germany) after successful thrombus aspiration and predilatation. Primary endpoint was 6-month angiographic in-balloon/stent late-luminal loss (LLL). Secondary endpoints were in-balloon/stent binary restenosis and major adverse cardiac events (MACE: death, myocardial infarction, target-vessel revascularization). RESULTS:Forty patients underwent PPCI by DEB-only. Procedural success was achieved in 97.5% with bail-out stenting required in 10.0% of procedures. In DEB-only, LLL was 0.51 ± 0.59 mm as compared to 0.74 ± 0.57 mm in BMS (P = 0.44), 0.64 ± 0.56 mm in DEB+BMS (P = 0.88) and 0.21 ± 0.32 mm in PES (P < 0.01); in-balloon/stent binary restenosis rates were 22.2%, 23.8% (P = 0.67), 28.6% (P = 0.97), and 4.5% (P = 0.07), respectively; and MACE rates were 17.5%, 23.5% (P = 0.20), 20.0% (P = 0.26), and 4.1% (P = 0.90), respectively. No acute or late thrombotic events occurred in the DEB-only group. CONCLUSIONS:PPCI by DEB-only in selected patients yielded an angiographic outcome comparable to BMS alone and DEB followed by BMS. PES proved angiographic superiority to DEB-only. DEB-only is therefore a potential treatment alternative during PPCI in patients with contra-indications to drug-eluting stents.
10.1002/ccd.26060
Impact of paclitaxel-coated balloon versus newer-generation drug-eluting stent on periprocedural myocardial infarction in stable angina patients.
Her Ae-Young,Kim Yong Hoon,Garg Scot,Shin Eun-Seok
Coronary artery disease
OBJECTIVES:Periprocedural myocardial infarction (PMI) is reported to be associated with adverse long-term clinical outcomes. This study compared the rates of PMI following treatment of de novo coronary lesions using either a paclitaxel-coated balloon (PCB) or a newer-generation drug-eluting stent (DES). PATIENTS AND METHODS:We compared the incidence of PMI in propensity-matched patients with stable angina pectoris and single-vessel de novo coronary lesions who underwent treatment with a PCB or newer-generation DES. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics. RESULTS:After propensity matching, the study cohort included 108 patients (PCB: n=54 and DES: n=54). The peak mean values of creatine kinase-myocardial band (13.3±26.3 vs. 2.2±2.8 ng/ml, P=0.003) and high-sensitive troponin T (0.62±1.38 vs. 0.09±0.19 ng/ml, P=0.007) were significantly higher in the DES group compared with the PCB group. The incidence of PMI was significantly higher in the DES group [DES: 11 (20.4%) vs. PCB: one (1.9%); P=0.002]. Total occlusion of the side-branch occurred in two patients treated with DES, but no patients treated with PCB. Treatment with a newer-generation DES was found to be an independent predictor of PMI on multivariable analyses. CONCLUSION:In patients with stable angina using a PCB, compared with deployment of a newer-generation DES, is associated with a significant reduction in the risk of PMI.
10.1097/MCA.0000000000000620
A Comparison of Peri-Procedural Myocardial Infarction between Paclitaxel-Coated Balloon and Drug-Eluting Stent on De Novo Coronary Lesions.
Her Ae Young,Cho Kyoung Im,Singh Gillian Balbir,Garg Scot,Kim Yong Hoon,Koo Bon Kwon,Shin Eun Seok
Yonsei medical journal
PURPOSE:This study compared the impact of paclitaxel-coated balloons (PCB) or drug eluting stents (DES) on peri-procedural myocardial infarction (PMI) on de novo coronary lesion in stable patients. MATERIALS AND METHODS:In this observational study, we compared the incidence of PMI amongst patients with single vessel de novo coronary lesions who underwent treatment with a PCB or DES. Propensity score-matching analysis was used to assemble a cohort of patients with similar baseline characteristics. PMI was classified as myocardial infarction occurring within 48 hours after percutaneous coronary intervention with a threshold of 5 x the 99th percentile upper reference limit of normal for creatine kinase-myocardial band (CK-MB) or troponin T (TnT). RESULTS:One hundred four patients (52 receiving PCB and 52 receiving DES) were enrolled in this study. The peak mean values of CK-MB and TnT were significantly higher in the DES group. There was a significantly higher rate of PMI in the DES group (23.1% vs. 1.9%, p=0.002). Total occlusion of the side-branch occurred in two patients treated with DES, while no patients treated with PCB. In multivariable analysis, DES was the only independent predictor of PMI compared with PCB (odds ratio 42.85, 95% confidence interval: 3.44-533.87, p=0.004). CONCLUSION:Treatment with a PCB on de novo coronary lesion might be associated with a significant reduction in the risk of PMI compared to DES.
10.3349/ymj.2017.58.1.99
REVascularization with paclitaxEL-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarcTION-A randomized controlled trial: Rationale and design of the REVELATION trial.
Vos Nicola S,van der Schaaf Rene J,Amoroso Giovanni,Herrman Jean-Paul R,Patterson Mark S,Slagboom Ton,Vink Maarten A
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
AIM:In primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI), stenting has proved to reduce the need for repeat revascularization compared with balloon angioplasty alone. The incidence of cardiac death or recurrent myocardial infarction, though, is not reduced by stenting. This is in part attributable to stent-related complications like stent thrombosis which may occur even years after implantation. A strategy of drug coated balloon (DCB) angioplasty without stenting would abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty. Our aim is to evaluate the efficacy and safety of a DCB only strategy versus drug-eluting stents (DES) in PPCI for STEMI. STUDY DESIGN:The REVELATION trial is a prospective, single center, randomized study, in which 120 patients presenting with STEMI will be allocated to treatment with a DCB versus DES. Appertaining to the established prognostic value of fractional flow reserve (FFR) rather than angiographic lesion severity, the functional assessment of the infarct-related lesion by FFR at 9 months after initial treatment is the primary end point. Assuming an FFR value of 0.90 after stenting and an increased risk of adverse events if post-PCI FFR <0.85, we decided to accept an FFR value of ≥0.85 after DCB only at follow-up as noninferiority margin. Secondary end points include major adverse cardiac events up to 5-year follow-up. CONCLUSION:Our trial will address the efficacy and safety of DCB angioplasty versus DES in the setting of PPCI for STEMI. The REVELATION trial will introduce the recognized prognostic significance of physiologic assessment of the infarct-related lesion by FFR at 9 months follow-up as primary end point. © 2015 Wiley Periodicals, Inc.
10.1002/ccd.26241
[Efficacy comparison of primary percutaneous coronary intervention by drug-coated balloon angioplasty or drug-eluting stenting in acute myocardial infarction patients with de novo coronary lesions].
Zhang D P,Wang L F,Liu Y,Li K B,Xu L,Li W M,Ni Z H,Xia K,Zhang Z Y,Yang X C
Zhonghua xin xue guan bing za zhi
To compare the safety profile, angiographic and clinical outcomes between drug-coated balloon(DCB) only strategy versus drug eluting stent(DES) implantation in primary percutaneous coronary intervention(PCI) for acute myocardial infarction(AMI) patients. A total of 380 AMI patients who underwent primary PCI in Beijing Chaoyang Hospital from January 2016 to May 2019 were enrolled. They were allocated into DEB group(180) or DES group(200). The Primary endpoint was the major adverse cardiac events(MACE) in hospital and within 3 months after discharge, the composite event of cardiac death, non-fatal myocardial infarction(MI), target vessel revascularization(TVR) and in stent thrombosis. The secondary endpoints included: (1)TIMI blood flow grade and myocardial perfusion grade (TMP grade) of infarct-related vessels before and after PCI. (2)The degree of ST segment resolution(STR) between half hour and two hours after PCI, and STR was represented by percentage of summed ST-segment reduction between baseline and post-PCI. Using the most significant lead of ST segment elevation, calculating the rate of decline in the ST segment after treatment; or the most significant lead of the ST segment depression, to calculate the rate of recovery in the ST segment after treatment. STR<50% was defined as incomplete STR. (3)The occurrence of coronary artery dissection during operation. (4)The peak value of myocardial enzymes. (5)The incidence of bleeding in hospital and within 3 months after discharge. The inverse probability weighting method based on propensity score (IPTW) was used to compare the effects of the two treatments on MACE occurrence in the logistic regression model. There was no significant difference in sex, age, risk factors of coronary heart disease, type and site of AMI, interventional therapy data(0.05) between the two groups. The ratio of bifurcation lesions in DCB group was significantly higher than that in DES group, and the diameter of the DCB was smaller while the length was longer than that of DES (all 0.05). One death occurred in each group during hospitalization. Compared with the DES group, the incidence of MI ［2.8%(5/180) vs. 0.5% (1/200), 0.10］ and TVR ［2.8%(5/180) vs. 0.5%(1/200), 0.10］ in the DCB group during hospitalization showed an increasing trend, and were mostly associated with delayed coronary dissection. The incidence of MACE was similar between the two groups (3.3%(6/180) and 1.0%(2/200), 0.15) during hospitalization. There was no MACE occurred in the two groups within 3 months after discharge. There was no significant difference between the two groups in TIMI grade, TMP grade, incomplete STR rate and peak value of myocardial enzyme (all 0.05). The incidence of coronary artery dissection was significantly higher in DCB group than in DES group (8.3%(15/180) and 3.0%(6/200), 0.02), but most of them were type B or A dissection and did not need special treatment. There was no significant difference in bleeding event between the two groups(0.91). Logistic regression analysis showed that there was no difference in the risk of MACE during hospitalization between DES and DCB groups for AMI patients receiving PCI (compared with DCB, 0.35, 95 0.08-1.43, 0.13). The initial safety and efficacy profiles of DCB are similar with those of DES for the AMI patients during PCI. The study highlights that the incidence of coronary dissection (type A or B) is higher post DCB treatment than post DES, but it does not affect blood flow. However, the incidence of in-hospital MI due to delayed coronary dissection trends to be higher post DCB. So we should pay close attention to the risk of delayed coronary dissection after DCB in AMI patients with de novo lesion.
10.3760/cma.j.cn112148-20200327-00254
Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial.
Vos Nicola S,Fagel Nick D,Amoroso Giovanni,Herrman Jean-Paul R,Patterson Mark S,Piers Lieuwe H,van der Schaaf René J,Slagboom Ton,Vink Maarten A
JACC. Cardiovascular interventions
OBJECTIVES:This study sought to assess the efficacy and safety of a drug-coated balloon (DCB) strategy versus drug-eluting stent (DES) in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). BACKGROUND:In primary percutaneous coronary intervention for STEMI, stenting has proved to be beneficial with regard to repeat revascularization, but not recurrent myocardial infarction or death, compared with balloon angioplasty alone. A strategy of DCB angioplasty without stenting might abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty. METHODS:In the prospective, randomized, single-center REVELATION trial, we compared DCB with DES in patients presenting with STEMI. Patients with a new, nonseverely calcified culprit lesion in a native coronary artery and a residual stenosis of <50% after pre-dilatation were randomized to treatment with a DCB or DES. The primary endpoint was fractional flow reserve at 9 months, allowing for a functional measurement of the infarct-related lesion. RESULTS:A total of 120 patients were included. At 9 months after enrolment, the mean fractional flow reserve value was 0.92 ± 0.05 in the DCB group (n = 35) and 0.91 ± 0.06 in the DES group (n = 38) (p = 0.27). One abrupt vessel closure requiring treatment occurred after treatment with DCB. Up to 9-months follow-up, 2 patients required nonurgent target lesion revascularization (1 in each group). CONCLUSIONS:In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months. Furthermore, it seemed to be a safe and feasible strategy. (Revascularization With Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial Infarction [REVELATION]; NCT02219802).
10.1016/j.jcin.2019.04.016