Department of Cardiology, The First Affiliated Hospital of Dalian Medical University, Dalian City, China.
Cardiac Center/Division of Cardiovascular Diseases, Beijing Friendship Hospital, Capital Medical University, 95 Yong'an Road, Beijing City, 100053, People's Republic of China.
Cardiovasc Drugs Ther. 2020 Feb;34(1):101-111. doi: 10.1007/s10557-020-06937-7.
The aim of this study was to explore the safety and efficacy of bivalirudin in elderly patients undergoing percutaneous coronary intervention (PCI).
An electronic search was conducted for randomized controlled trials with outcomes of interest in the elderly (≥ 65 years of age). Pooled risk ratios (RR) and 95% confidence interval (CI) using random effects Der Simonian-Laird models were calculated. Primary outcomes were net adverse clinical events (NACE) and major bleeding events at 30 days. Secondary outcomes were major adverse cardiac events (MACE) at 30 days. MACE, all-cause mortality, and NACE at 6-12 months were also examined.
Eleven trials that randomized a total of 15,895 elderly patients undergoing PCI to bivalirudin versus heparin were included. At 30 days, bivalirudin was associated with a reduced risk of NACE (0.86 [0.75-0.99], p = 0.04), mainly driven by reduction in major bleeding events (0.66 [0.54-0.80], p < 0.0001), as compared with heparin. On subgroup analyses based on the use of GPI in the heparin arm, benefit of major bleeding associated with bivalirudin appeared to be equally evident when GPI was used as a bailout (0.66 [0.46-0.94], p = 0.02) versus routine (0.67 [0.51-0.88], p = 0.004) adjunctive therapy with heparin. Subgroup analyses stratified by clinical presentation showed that benefit of bivalirudin in reducing NACE was even more obvious in the elderly group presenting with ST segment elevation myocardial infarction (STEMI) (0.76 [0.65-0.89], p = 0.0007), as compared with the overall (acute coronary syndrome or stable ischemic heart disease) group. No difference in MACE (0.94 [0.82-1.09], p = 0.42) was demonstrated between the two groups. Bivalirudin was associated with a similar risk of NACE (0.74 [0.39-1.42], p = 0.36) at 6 months and MACE (0.90 [0.68-1.19], p = 0.45) at 6-12 months, while a non-statistically significant trend toward lower all-cause mortality (0.70 [0.47-1.06], p = 0.09) at 1 year.
In elderly patients undergoing PCI, bivalirudin was associated with a lower risk of major bleeding events and the magnitude of benefit was not related to the use of GPI and irrespective of clinical presentation. Bivalirudin may reduce the NACE, particularly in elderly patients presenting with STEMI or in the setting of routine GPI use in the heparin arm, while no difference in MACE was demonstrated between the two groups.
本研究旨在探讨比伐卢定在接受经皮冠状动脉介入治疗（PCI）的老年患者中的安全性和疗效。
对有兴趣的老年（≥65 岁）结局的随机对照试验进行电子检索。使用随机效应 Der Simonian-Laird 模型计算汇总风险比（RR）和 95%置信区间（CI）。主要结局为 30 天净不良临床事件（NACE）和主要出血事件。次要结局为 30 天主要不良心脏事件（MACE）。还检查了 6-12 个月的 MACE、全因死亡率和 NACE。
共纳入 11 项随机对照试验，共纳入 15895 名接受 PCI 的老年患者，将其分为比伐卢定组和肝素组。30 天时，与肝素相比，比伐卢定降低 NACE 的风险（0.86 [0.75-0.99]，p=0.04），主要是由于大出血事件减少（0.66 [0.54-0.80]，p<0.0001）。基于肝素组中是否使用 GPI 的亚组分析表明，当 GPI 作为 bailout （0.66 [0.46-0.94]，p=0.02）与常规（0.67 [0.51-0.88]，p=0.004）联合肝素辅助治疗时，比伐卢定与大出血相关的益处同样明显。根据临床表现进行的亚组分析表明，与总体（急性冠脉综合征或稳定型缺血性心脏病）组相比，比伐卢定降低 NACE 的益处在因 ST 段抬高型心肌梗死（STEMI）就诊的老年患者中更为明显（0.76 [0.65-0.89]，p=0.0007）。两组之间 MACE（0.94 [0.82-1.09]，p=0.42）无差异。与肝素相比，比伐卢定在 6 个月时 NACE（0.74 [0.39-1.42]，p=0.36）和 MACE（0.90 [0.68-1.19]，p=0.45）的风险相似，而在 1 年时全因死亡率（0.70 [0.47-1.06]，p=0.09）呈非统计学意义的下降趋势。
在接受 PCI 的老年患者中，比伐卢定与大出血事件风险降低相关，且获益的程度与 GPI 的使用无关，且与临床表现无关。比伐卢定可能降低 NACE，特别是在因 STEMI 就诊的老年患者中，或在肝素组常规使用 GPI 的情况下，两组之间的 MACE 无差异。
