Icahn School of Medicine at Mount Sinai, The Zena and Michael A. Wiener Cardiovascular Institute, One Gustave L. Levy Place, New York, United States of America.
Cardiocentro Ticino Institute and Università della Svizzera italiana (USI), Lugano, Switzerland.
Int J Cardiol. 2023 Jul 15;383:24-32. doi: 10.1016/j.ijcard.2023.04.027. Epub 2023 Apr 18.
Biodegradable polymer biolimus-eluting stents (BP-BES) may be associated with better outcomes in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) compared to other current-generation limus-eluting stents (LES).
To compare BP-BES with other current-generation LES in ACS patients undergoing PCI.
We pooled individual data of Non-ST-segment elevation (NSTE)-ACS patients from two large randomized controlled trials (GLASSY and TWILIGHT). The BP-BES groups consisted mostly of GLASSY patients, while the control group (other current-generation LES) included exclusively TWILIGHT patients. The primary outcome was major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, or stent thrombosis; the key secondary outcome was target-vessel failure (TVF). To account for trial design differences, outcomes were assessed at 3 months (short-term) and between 3 and 12 months (long-term) after PCI and subsequently pooled to estimate the 12-month hazards.
Of 7107 and 6053 NSTE-ACS patients included in the short- and long-term analysis, 32.7% and 36.5% received a BP-BES, respectively. Risk of MACE associated with BP-BES versus other LES was similar at short-term (1.1% vs 1.3%, adjusted HR 0.86, 95%CI 0.53-1.38), lower at long-term (1.7% vs 3.1%, adjusted HR 0.49, 95%CI 0.34-0.72), and lower in the entire 12-month period (pooled adjusted HR 0.61, 95%CI 0.45-0.82). The cumulative 12-month risk of TVF was reduced with BP-BES (adjusted HR 0.52, 95%CI 0.38-0.70).
BP-BES was associated with lower 12-month risks of MACE and TVF compared to other current generation LES among NSTE-ACS patients treated with abbreviated or standard ticagrelor-based DAPT. These non-randomized findings are hypothesis-generating.
Differences in clinical outcomes may exist between biodegradable polymer biolimus-eluting stents (BP-BES) and other current-generation limus-eluting stent (LES) in patients with acute coronary syndrome (ACS). We pooled individual data of about 7000 Non-ST-segment elevation ACS patients undergoing PCI and treated with ticagrelor with or without aspirin from two large randomized controlled trials (GLASSY and TWILIGHT). BP-BES patients derived very largely from GLASSY and other LES patients from TWILIGHT. In this population, BP-BES compared to other current generation LES, were associated with a lower 12-month risk of major adverse cardiovascular events and target-vessel failure.
在接受经皮冠状动脉介入治疗（PCI）的急性冠状动脉综合征（ACS）患者中，可生物降解聚合物雷帕霉素洗脱支架（BP-BES）与其他当前代雷帕霉素洗脱支架（LES）相比，可能具有更好的结果。
比较 BP-BES 与 ACS 患者 PCI 中使用的其他当前代 LES。
我们汇总了来自两项大型随机对照试验（GLASSY 和 TWILIGHT）的非 ST 段抬高（NSTE）ACS 患者的个体数据。BP-BES 组主要由 GLASSY 患者组成，而对照组（其他当前代 LES）仅包括 TWILIGHT 患者。主要终点是主要不良心血管事件（MACE），包括心血管死亡、心肌梗死或支架血栓形成；关键次要终点是靶血管失败（TVF）。为了考虑试验设计差异，在 PCI 后 3 个月（短期）和 3 至 12 个月（长期）评估结果，并随后进行汇总以估计 12 个月的危险。
在纳入短期和长期分析的 7107 名和 6053 名 NSTE-ACS 患者中，分别有 32.7%和 36.5%接受了 BP-BES。与其他 LES 相比，BP-BES 与 MACE 相关的风险在短期（1.1%比 1.3%，调整 HR 0.86，95%CI 0.53-1.38）、长期（1.7%比 3.1%，调整 HR 0.49，95%CI 0.34-0.72）和整个 12 个月（汇总调整 HR 0.61，95%CI 0.45-0.82）相似。BP-BES 降低了 12 个月 TVF 的累积风险（调整 HR 0.52，95%CI 0.38-0.70）。
与其他当前代 LES 相比，在接受缩短或标准替格瑞洛双联抗血小板治疗的 NSTE-ACS 患者中，BP-BES 与 12 个月时 MACE 和 TVF 的风险降低相关。这些非随机发现是产生假说的。
