Villablanca Pedro A, Massera Daniele, Mathew Verghese, Bangalore Sripal, Christia Panagiota, Perez Irving, Wan Ningxin, Schulz-Schüpke Stefanie, Briceno David F, Bortnick Anna E, Garcia Mario J, Lucariello Richard, Menegus Mark, Pyo Robert, Wiley Jose, Ramakrishna Harish
Division of Cardiovascular Diseases, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY Division of Cardiology, Loyola University Stritch School of Medicine, Maywood, IL New York University School of Medicine Department of Internal Medicine, Jacobi Medical Center/Albert Einstein College of Medicine, New York, NY Deutsches Herzzentrum München, Technische Universität, Klinik für Herz- und Kreislauferkrankungen, Munich, Germany Division of Cardiovascular and Thoracic Anesthesiology, Mayo Clinic College of Medicine, Scottsdale, AZ.
Medicine (Baltimore). 2016 Dec;95(52):e5819. doi: 10.1097/MD.0000000000005819.
The benefit of ≤6-month compared with 12-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement remains controversial. We performed a meta-analysis and meta-regression of ≤6-month versus 12-month DAPT in patients undergoing PCI with DES placement.
We conducted electronic database searches of randomized controlled trials (RCTs) comparing DAPT durations after DES placement. For studies with longer follow-up, outcomes at 12 months were identified. Odds ratios and 95% confidence intervals were computed with the Mantel-Haenszel method. Fixed-effect models were used; if heterogeneity (I) > 40 was identified, effects were obtained with random models.
Nine RCTs were included with total n = 19,224 patients. No significant differences were observed between ≤6-month compared with 12-month DAPT in all-cause mortality (OR 0.87; 95% confidence interval (CI): 0.69-1.11), cardiovascular (CV) mortality (OR 0.89; 95% CI: 0.66-1.21), non-CV mortality (OR 0.85; 95% 0.58-1.24), myocardial infarction (OR 1.10; 95% CI: 0.89-1.37), stroke (OR 0.97; 95% CI: 0.67-1.42), stent thrombosis (ST) (OR 1.37; 95% CI: 0.89-2.10), and target vessel revascularization (OR 0.95; 95% CI: 0.77-1.18). No significant difference in major bleeding (OR 0.72; 95% CI: 0.49-1.05) was observed, though the all-bleeding event rate was significantly lower in the ≤6-month DAPT group (OR 0.76; 95% CI: 0.59-0.96). In the meta-regression analysis, a significant association between bleeding events and non-CV mortality with 12-month DAPT was found, as well as between ST and mortality in addition to MI with ≤6-month DAPT.
DAPT for ≤6 months is associated with similar mortality and ischemic outcomes but less bleeding events compared with 12-month DAPT after PCI with DES.
药物洗脱支架(DES)置入后经皮冠状动脉介入治疗(PCI),6个月及以内的双联抗血小板治疗(DAPT)与12个月的DAPT相比,其获益仍存在争议。我们对DES置入后接受PCI的患者进行了6个月及以内与12个月DAPT的荟萃分析和荟萃回归分析。
我们对比较DES置入后DAPT疗程的随机对照试验(RCT)进行了电子数据库检索。对于随访时间较长的研究,确定12个月时的结局。采用Mantel-Haenszel方法计算比值比和95%置信区间。使用固定效应模型;如果异质性(I)>40,则采用随机模型得出效应。
纳入9项RCT,共19224例患者。6个月及以内与12个月DAPT相比,在全因死亡率(比值比0.87;95%置信区间(CI):0.69-1.11)、心血管(CV)死亡率(比值比0.89;95%CI:0.66-1.21)、非CV死亡率(比值比0.85;95%CI:0.58-1.24)、心肌梗死(比值比1.10;95%CI:0.89-1.37)、卒中(比值比0.97;95%CI:0.67-1.42)、支架血栓形成(ST)(比值比1.37;95%CI:0.89-2.10)和靶血管血运重建(比值比0.95;95%CI:0.77-1.18)方面未观察到显著差异。在大出血方面未观察到显著差异(比值比0.72;95%CI:0.49-1.05),尽管6个月及以内DAPT组的全出血事件发生率显著较低(比值比0.76;95%CI:0.59-0.96)。在荟萃回归分析中,发现12个月DAPT的出血事件与非CV死亡率之间存在显著关联,以及6个月及以内DAPT的ST与死亡率和心肌梗死之外的情况之间存在显著关联。
与DES置入后PCI采用12个月DAPT相比,6个月及以内DAPT的死亡率和缺血性结局相似,但出血事件较少。