Besic Kristina Maric, Strozzi Maja, Margetic Eduard, Bulum Josko, Kolaric Branko
Department of Cardiovascular Medicine, University Hospital Centre Zagreb, Zagreb, Croatia.
Department of Cardiovascular Medicine, University Hospital Centre Zagreb, Zagreb, Croatia.
J Cardiol. 2015 Mar;65(3):203-7. doi: 10.1016/j.jjcc.2014.05.007. Epub 2014 Jun 26.
We compared efficacy of bare-metal stent (BMS) and drug-eluting balloon (DEB) combination vs BMS alone, in patients with non-ST elevation acute coronary syndrome treated with percutaneous coronary intervention (PCI).
Patients with non-ST elevation myocardial infarction (NSTEMI) or unstable angina (UA) were randomized to BMS only or BMS+DEB group. Angiographic follow-up was performed after 6 months. The primary endpoints were binary in-stent restenosis (ISR) and late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR), stent thrombosis (ST), and new acute coronary syndrome (ACS).
A total of 85 patients were enrolled, 44 (BMS) and 41 (BMS+DEB). The median age was 67 (36-84) years and 68 (80%) were male. Fifty-two patients (61.2%) had NSTEMI and 33 patients (38.8%) UA. There was no difference in patient demographics, risk factors, and clinical characteristics, except for more smokers in the BMS+DEB group 18/41 (43.9%) vs 9/44 (20.5%). At follow-up, no significant difference in binary ISR was found; p=0.593, but LLL was significantly lower in the BMS+DEB group 0.68 (0.00-2.15) mm vs 0.22 (0.00-2.35) mm; p=0.002. The difference in major adverse cardiac events (MACE) rate combining TLR, ST, and ACS, between the groups was also non-significant, 29.5% (BMS) vs 24.4% (BMS+DEB); p=0.835. One patient had a subacute ST (BMS+DEB) due to clopidogrel resistance.
Patients treated with BMS+DEB combination for non-ST elevation acute coronary syndrome had significantly less LLL in comparison to patients treated with BMS alone but without an impact on patient clinical outcomes.
我们比较了裸金属支架(BMS)与药物洗脱球囊(DEB)联合使用与单独使用BMS,在接受经皮冠状动脉介入治疗(PCI)的非ST段抬高型急性冠状动脉综合征患者中的疗效。
将非ST段抬高型心肌梗死(NSTEMI)或不稳定型心绞痛(UA)患者随机分为单纯BMS组或BMS+DEB组。6个月后进行血管造影随访。主要终点为二元支架内再狭窄(ISR)和晚期管腔丢失(LLL),次要终点为靶病变血运重建(TLR)、支架血栓形成(ST)和新发急性冠状动脉综合征(ACS)。
共纳入85例患者,44例(BMS组)和41例(BMS+DEB组)。中位年龄为67岁(36-84岁),68例(80%)为男性。52例患者(61.2%)患有NSTEMI,33例患者(38.8%)患有UA。患者的人口统计学、危险因素和临床特征无差异,但BMS+DEB组吸烟者更多,为18/41(43.9%),而BMS组为9/44(20.5%)。随访时,二元ISR无显著差异;p=0.593,但BMS+DEB组的LLL显著更低,为0.68(0.00-2.15)mm,而BMS组为0.22(0.00-2.35)mm;p=0.002。两组之间联合TLR、ST和ACS的主要不良心脏事件(MACE)发生率差异也不显著,分别为29.5%(BMS组)和24.4%(BMS+DEB组);p=0.835。1例患者(BMS+DEB组)因氯吡格雷抵抗发生亚急性ST。
与单独使用BMS治疗的患者相比,使用BMS+DEB联合治疗非ST段抬高型急性冠状动脉综合征的患者LLL显著更低,但对患者临床结局无影响。