冠心病合并贫血患者中涂层可降解药物洗脱支架与第二代永久涂层药物洗脱支架的有效性和安全性比较

Efficacy and Safety of Biodegradable Polymer Coating Drug-eluting Stents Versus Second-generation Durable Polymer Coating Drug-eluting Stents in Patients With Coronary Artery Disease and Anemia

目的:在冠状动脉粥样硬化性心脏病(冠心病)合并贫血的患者中,比较涂层可降解药物洗脱支架(BP-DES)与第二代永久涂层药物洗脱支架(DP-DES)的有效性和安全性。方法:2013-01至2013-12连续入选10 724例在阜外医院行经皮冠状动脉介入治疗(PCI)的冠心病患者。贫血定义为介入术前血红蛋白男性<130 g/L,女性<120 g/L。最终纳入965例贫血患者,201例纳入BP-DES组,764例纳入DP-DES组;同时还对两组患者各201例进行了倾向性评分匹配分析。安全性终点为术后2年心原性死亡、心肌梗死和支架内血栓的复合终点构成的主要心血管不良事件(MACE);有效性终点为靶病变重建和靶血管重建。结果:(1)BP-DES组术后2年MACE(5.0%vs 2.0%,P=0.02)、靶血管重建(6.5%vs 3.0%,P=0.02)和靶病变重建(6.0%vs 1.8%,P<0.01)的发生率均高于DP-DES组。(2)倾向性评分匹配后两组间MACE的发生率不再有显著差异(P=0.30);BP-DES组靶病变重建的发生率仍高于DP-DES组(P=0.04),靶血管重建的发生率有高于DP-DES组的趋势,统计学意义处于临界水平(P=0.05)。(3)多因素Cox回归分析显示,置入BP-DES是靶病变重建的独立危险因素(HR=2.81,95%CI:1.24~6.38,P=0.01),但不是靶血管重建(P=0.12)或MACE(P=0.13)的独立危险因素。结论:在冠心病合并贫血的患者中,BP-DES与第二代DP-DES的安全性无显著差异,但BP-DES的靶病变重建风险更高。

Objectives： To evaluate the efficacy and safety of biodegradable polymer coating drug-eluting stents compared with the second-generation durable polymer coating drug-eluting stents in patients with coronary artery disease and anemia.Methods： From January to December 2013, consecutive patients who underwent percutaneous coronary intervention（PCI） in Fuwai Hospital were collected. Anemia was defined as hemoglobin130 g/L in men and 120 g/L in women. 965 patients with anemia implanted with only one type of new generation drug eluting stents were included in this study and were divided into biodegradable polymer coating drug-eluting stent group（BP-DES）（n=201） and second-generation durable polymer coating drug-eluting stent group（DP-DES）（n =764）. Analyses were also conducted in propensity score matched groups（each n=201）. The safety endpoint was the composite of cardiac death, myocardial infarction and in-stent thrombosis, ie, major adverse cardiovascular event（MACE）. The efficacy endpoints included target vessel revascularization and target lesion revascularization. Results：（1） Compared with DP-DES group, patients in BP-DES group had higher rates of MACE（5.0% vs 2.0%, P=0.02）, target vessel revascularization（6.5% vs 3.0%, P=0.02） and target lesion revascularization（6.0% vs 1.8%,P〈0.01）.（2） After propensity score matching, there was no statistically significant difference in the rates of MACE between two groups（P=0.30）. Compared with DP-DES group, patients in BP-DES group still had higher rates of target lesion revascularization（P=0.04）. There was a trend toward higher rates of target vessel revascularization in BP-DES group with a borderline level of statistical significance（P=0.05）.（3） The multivariable Cox regression analysis demonstrated that biodegradable polymer drug-eluting stents implantation was the independent risk factor of 2-year target lesion revascularization（HR=2.81,95% CI：1.24-6.38,P=0.01）, but not the independent risk factor of 2-year target vessel revascularization（P=0.12） or MACE（P=0.13）. Conclusions： In patients with coronary artery disease and anemia, the safety of BP-DES were similar to secondgeneration DP-DES. In terms of efficacy, BP-DES were associated with higher risk of target lesion revascularization.