生物可吸收聚合物与耐久性聚合物药物洗脱支架的长期临床疗效比较:系统综述与荟萃分析。

Abdur Rehman, Ifra Eeman Ahmed, Ahmed Nouman, Rabia Irfan, Qareeha Rehman, Abdul Rehman Shah Syed, Syeda Javeria Zakir, Samar Mehdi, Maha Mushtaq Khosa, Satesh Kumar, Mahima Khatri, F N U Samiullah, Tamam Mohamad, Giustino Varrassi
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引用次数: 0

摘要

背景:美国有一百万人死于急性心肌梗死(MI),目前全球有三百万人受到影响。关于生物可降解聚合物药物洗脱支架(BP-DES)和耐久性聚合物药物洗脱支架早期和晚期疗效的现有数据并不一致。我们对 BP-DES 和 DP-DES 的安全性和有效性进行了荟萃分析:方法:使用 PubMed、Google Scholar、EMBASE、Cochrane、Ovid Medline 和 Clinical Trials.gov 数据库查找 BP-DES 与 DP-DES 的比较研究。所有分析均采用随机效应模型:本次荟萃分析共纳入了 18 项研究,涉及 28,874 名患者,其中 11,997 名患者接受了 BP 支架治疗,其余 16,578 名患者接受了 DP 支架治疗。透彻的分析表明,在随访两年或两年以下的研究中,BP-DES 组的全因死亡风险明显更高(5.4% 对 2.7%)(RR 1.22,P 0.02)。在随访两年以上的研究中,BP-DES 组的全因死亡率为 9.07% (599/6603),DP-DES 组为 9.47% (531/5602),但在统计学上未达到显著水平(RR 0.97,P 0.58):研究显示,随访两年以上,BP-DES 和 DP-DES 在全因死亡、心源性死亡、靶病变血运重建 (TLR)、晚期支架血栓形成、设备导向复合终点/靶病变失败 (DOCE/TLF)、心肌梗死 (MI)、靶血管 MI、靶血管血运重建 (TVR)、靶血管梗死 (TVI) 等方面的差异无临床意义(P 值 > 0.05)。此外,只有全因死亡结果在随访不到两年时有显著统计学差异,其余结果均无显著统计学差异。
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Comparison of long-term clinical outcomes of bioabsorbable polymer versus durable polymer drug-eluting stents: a systematic review and meta-analysis.

Background: One million individuals in the USA die from acute myocardial infarction (MI), which currently affects 3 million people globally. The available data about the early and late outcomes of both biodegradable polymer drug-eluting stents (BP-DES) and durable polymer drug-eluting stents exhibit inconsistency. We performed a meta-analysis comparing the safety and efficacy of BP-DES with DP-DES.

Methods: PubMed, Google Scholar, EMBASE, Cochrane, Ovid Medline, and Clinical Trials.gov databases were used to find out studies comparing BP-DES to DP-DES. All the analyses used the random-effects model.

Results: A total of 18 studies were incorporated in this meta-analysis that involved 28,874 patients, out of which 11,997 received the BP Stent, and the rest of 16,578 received the DP stent. Thorough analyses revealed that the risk of all-cause death was significantly higher in the BP-DES group (5.4% vs 2.7%) (RR 1.22, p 0.02) for two years or less than two-year follow-up. For studies with more than two years of follow-up, all-cause death was 9.07% (599/6603) in BP-DES and 9.47% (531/5602) in the DP-DES group but failed to achieve statistically significant levels (RR 0.97, p 0.58).

Conclusions: The study revealed no clinically significant (P value was > 0.05) differences in all-cause death, cardiac death, target lesion revascularization (TLR), late stent thrombosis, device-oriented composite endpoint/target lesion failure (DOCE/TLF), myocardial infarction (MI), target vessel MI, target vessel revascularization (TVR), target vessel infarction (TVI) between BP-DES and DP-DES for more than two years of follow-up. Additionally, all-cause death was only outcomes which found to have a statistically significant difference for less than two years of follow-up, while remaining were statistically non-significant.

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