Background: It remains undetermined whether second-generation drug-eluting stents (G2-DESs) outperform first-generation DESs (G1-DESs) in patients with acute coronary syndrome (ACS). We aimed to compare the efficacy and safety of G1-DES and G2-DES in ACS patients in a high-volume cardiovascular center.
Methods: In 2013, 10,724 consecutive patients underwent percutaneous coronary intervention in our institution. We included 4037 patients with ACS who underwent exclusively G1-DES or G2-DES implantation (n = 364 and n = 3673, respectively). We used propensity score matching to minimize the imbalance between the G1-DES and G2-DES groups and followed patients for 2 years. The efficacy endpoints were major adverse cardiac events (MACEs) and its components including target vessel-related myocardial infarction (TV-MI), target vessel revascularization/target lesion revascularization (TVR/TLR), and cardiac death. The safety endpoint was stent thrombosis. Continuous variables were compared by Mann-Whitney U-test, and categorical variables were compared using Pearson's Chi-square or Fisher's exact test. Kaplan-Meier curves were constructed to compare the event-free survival rates, and multivariate Cox proportional hazards regression analysis was used to assess whether stent type was an independent risk factor for the efficacy and safety endpoints.
Results: At the 2-year follow-up, the results for MACE and it components, as well as stent thrombosis, were similar for G1-DES and G2-DES (MACE, 5.2% vs. 4.3%, χ2 = 0.514, P = 0.474; TV-MI, 0.8% vs. 0.4%, P = 0.407; TVR, 4.9% vs. 3.7%, χ2 = 0.939, P = 0.333; TLR, 3.8% vs. 2.5%, χ2 = 1.610, P = 0.205; cardiac death, 0.3% vs. 0.5%, P = 0.670; and stent thrombosis, 0.5% vs. 0.4%, P > 0.999). Kaplan-Meier analysis indicated similar event-free survival rates between G1-DES and G2-DES after propensity score matching (all: log-rank P > 0.05). Multivariate analysis demonstrated that stent type was not an independent risk factor for the efficacy and safety endpoints (MACE, hazard ratio [HR] = 0.805, 95% confidence interval [CI]: 0.455-1.424, P = 0.456; TV-MI, HR = 0.500, 95% CI: 0.101-2.475, P = 0.395; TVR, HR = 0.732, 95% CI: 0.403-1.330, P = 0.306; TLR, HR = 0.629, 95% CI: 0.313-1.264, P = 0.193; cardiac death, HR = 1.991, 95% CI: 0.223-17.814, P = 0.538; and stent thrombosis, HR = 0.746, 95% CI: 0.125-4.467, P = 0.749).
Conclusion: G1-DES and G2-DES have similar efficacy and safety profiles in ACS patients at the 2-year follow-up.
第一代药物洗脱支架与第二代药物洗脱支架在急性冠脉综合征中的有效性与安全性比较研究摘要背景：在急性冠脉综合征（ACS）患者中，第一代药物洗脱支架（G1-DES）与第二代药物洗脱支架（G2-DES）的优劣比较尚无统一结论。本研究拟在ACS患者中比较G1-DES和G2-DES的有效性与安全性。 方法：在2013年，共有10,724名连续患者于阜外医院接受了冠状动脉介入治疗（PCI）。本研究纳入了4,037名置入G1-DES（n = 364）或G2-DES（n = 3,673）的ACS患者。采用倾向性评分匹配法（PSM）平衡两组间的基线差异。随访时间为2年。有效性终点为主要不良心脏事件（MACE）及其组成事件，包括靶血管相关心肌梗死（TV-MI）、靶血管/靶病变血运重建（TVR/TLR）、以及心脏性死亡。安全性终点为支架血栓。采用Mann-Whitney U检验法比较连续变量，采用χ2检验或Fisher确切概率法比较分类变量。通过Kaplan-Meier曲线比较两组间无事件生存率，并应用多因素Cox比例风险回归分析评估支架类型是否为终点事件的独立危险因素。 结果：经过2年随访发现，G1-DES组与G2-DES组之间MACE及其组成事件、以及支架血栓发生率无显著性差异（MACE，5.2% vs. 4.3%，χ2 = 0.514, P = 0.474；TV-MI，0.8% vs. 0.4%，Fisher确切概率P = 0.407；TVR，4.9% vs. 3.7%， χ2 = 0.939，P = 0.333；TLR，3.8% vs. 2.5%，χ2 = 1.610，P = 0.205；心脏性死亡，0.3% vs. 0.5%，Fisher确切概率P = 0.670；支架血栓，0.5% vs. 0.4%，Fisher确切概率P > 0.999）。与此相似，G1-DES组与G2-DES组之间上述事件的生存曲线无显著性差异（所有log-rank P值> 0.05）。多因素分析表明支架类型不是上述研究终点的危险因素（MACE，危险比 [HR] = 0.805，95%可信区间 [CI] 0.455-1.424，P = 0.456；TV-MI，HR = 0.500，95% CI 0.101-2.475，P = 0.395；TVR，HR = 0.732，95% CI 0.403-1.330P = 0.306；TLR，HR = 0.629，95% CI 0.313-1.264，P = 0.193；心脏性死亡，HR = 1.991，95% CI 0.223-17.814，P = 0.538；支架血栓，HR = 0.746，95% CI 0.125-4.467，P = 0.749）。 结论：经过2年随访研究发现，在ACS患者中G1-DES与G2-DES具有相似的有效性及安全性。.
Keywords: Acute Coronary Syndrome; First-Generation Drug-Eluting Stent; Percutaneous Coronary Intervention; Second-Generation Drug-Eluting Stent; Stent Thrombosis.