Pharmacy and Therapeutics Office, Group Corporate Development, National Healthcare Group, Singapore City, Singapore.
Department of Cardiology, National University Heart Centre, Singapore City, Singapore.
Cardiovasc Ther. 2018 Apr;36(2). doi: 10.1111/1755-5922.12319. Epub 2018 Jan 30.
The safety and efficacy of BP-DES compared to second-generation DP-DES remain unclear in the real-world setting. We compared the clinical outcomes of biodegradable polymer drug-eluting stents (BP-DES) with second-generation durable polymer drug-eluting stents (DP-DES) in an all-comer percutaneous coronary intervention (PCI) registry.
METHODS/RESULTS: The study included a cohort of 1065 patients treated with either BP-DES or DP-DES from January 2009 through October 2015. Propensity score matching was performed to account for potential confounders and produced 497 matched pairs of patients. The primary endpoint was target lesion failure (TLF) at one-year follow-up. The rates of TLF were comparable between BP-DES and DP-DES (8.7% vs 9.1%, P = .823) at 1 year. The rates of stent thrombosis at 30 days (0.4% vs 0.4%, P = 1.00) and 1 year (0.8% vs 0.8%, P = 1.00) did not differ between BP-DES and DP-DES. There were no significant differences in other clinical outcomes including target vessel failure (8.9% vs 9.5%, P = .741), in-stent restenosis (1.8% vs 1.0%, P = .282), and cardiac death (6.4% vs 7.4%, P = .533) at 1 year. Multivariate cox regression analysis showed that the risk of TLF at one-year did not differ significantly between BP-DES and DP-DES (hazard ratio 0.94, P = .763).
Efficacy and safety of BP-DES were not better than DP-DES at one-year follow-up.
在真实环境中，BP-DES 与第二代 DP-DES 的安全性和疗效仍不清楚。我们比较了全人群经皮冠状动脉介入治疗（PCI）登记处中生物可降解聚合物药物洗脱支架（BP-DES）与第二代耐用聚合物药物洗脱支架（DP-DES）的临床结果。
方法/结果：这项研究纳入了 2009 年 1 月至 2015 年 10 月期间接受 BP-DES 或 DP-DES 治疗的 1065 例患者。采用倾向评分匹配法来考虑潜在的混杂因素，产生了 497 对匹配的患者。主要终点是 1 年随访时的靶病变失败（TLF）。1 年时，BP-DES 与 DP-DES 的 TLF 发生率相当（8.7% vs 9.1%，P=0.823）。30 天（0.4% vs 0.4%，P=1.00）和 1 年（0.8% vs 0.8%，P=1.00）的支架血栓形成率在 BP-DES 和 DP-DES 之间没有差异。其他临床结局，包括靶血管失败（8.9% vs 9.5%，P=0.741）、支架内再狭窄（1.8% vs 1.0%，P=0.282）和心脏死亡（6.4% vs 7.4%，P=0.533），在 1 年时也没有显著差异。多变量 Cox 回归分析显示，BP-DES 和 DP-DES 在 1 年时的 TLF 风险无显著差异（风险比 0.94，P=0.763）。
BP-DES 在 1 年随访时的疗效和安全性并不优于 DP-DES。
