至高生物可降解聚合物药物洗脱支架安全性和有效性的地理差异：先锋III研究结果
Geographic Variations on the Safety and Efficacy of the Supreme Biodegradable Polymer DES: Results From PIONEER III.
作者信息
Garot Philippe, Leon Martin B, Saito Shigeru, Baumbach Andreas, Kereiakes Dean J, Windecker Stephan, Pietras Cody, Dressler Ovidiu, Issever M Ozgu, Curtis Michael, Bertolet Barry D, Zidar James P, Smits Pieter C, Jiménez Diaz Victor Alfonso, McLaurin Brent, Cequier Angel R, Hofma Sjoerd H, Dib Nabil, Namiki Atsuo, Takahashi Akihiko, Kakuta Tsunekazu, Hirohata Atsushi, Lansky Alexandra J
机构信息
Institut Cardiovasculaire Paris-Sud, Hôpital Jacques Cartier, Ramsay-Santé, Massy, France.
NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York.
出版信息
J Soc Cardiovasc Angiogr Interv. 2022 Nov 25;2(1):100515. doi: 10.1016/j.jscai.2022.100515. eCollection 2023 Jan-Feb.
BACKGROUND
The PIONEER III trial showed the 12-month safety and efficacy of the Supreme drug-eluting stent (DES) vs the durable polymer everolimus-eluting stent. We sought to assess whether the characteristics and clinical outcomes of the Supreme DES in PIONEER III were consistent among patients by enrollment location.
METHODS
This subgroup analysis of the PIONEER III trial compared the characteristics and outcomes of patients recruited from North America, Europe, and Japan and the relative differences in patient outcomes according to the site recruitment volume.
RESULTS
From October 2017 to July 2019, 1629 patients were recruited in North America (816, 50.1%), Europe (650, 39.9%), and Japan (163, 10%). Procedural success was achieved in 1556 of 1611 procedures (96.6%), with no difference by the geographic location. Target lesion failure at 12 months for combined groups was observed in 84 of 1629 patients (5.2%), with no significant geographic differences (4.7%, 6.5%, and 2.5%, respectively; =.08), with similar results in the Supreme DES group alone (4.4%, 6.8%, and 3.7%, respectively, =.20). Cardiac death at 12 months occurred in 0.4%, 0.2%, and 0.0% ( =.79), target vessel-related myocardial infarction occurred in 2.2%, 4.7%, and 3.7%, ( =.10), and clinically driven target lesion revascularization was required in 2.1%, 3.1%, and 0%, respectively ( =.15). Compared with those from high-recruiting sites, results from low-recruiting sites were similar for target lesion failure, major adverse cardiac events, stent thrombosis, and mortality, with a nonsignificant trend for higher rates of myocardial infarction.
CONCLUSIONS
Despite regional differences in patient characteristics, the clinical outcomes between Supreme DES and durable polymer everolimus-eluting stent in the PIONEER III trial were not different, supporting the generalizability and robustness of the findings from this multicenter controlled trial.
背景
PIONEER III试验显示了Supreme药物洗脱支架（DES）与耐用聚合物依维莫司洗脱支架的12个月安全性和有效性。我们试图评估PIONEER III试验中Supreme DES的特征和临床结果在不同入组地点的患者中是否一致。
方法
PIONEER III试验的这项亚组分析比较了从北美、欧洲和日本招募的患者的特征和结果，以及根据招募地点数量的患者结果的相对差异。
结果
2017年10月至2019年7月，在北美招募了1629名患者（816名，50.1%），欧洲（650名，39.9%），日本（163名，10%）。1611例手术中有1556例获得手术成功（96.6%），不同地理位置之间无差异。1629例患者中有84例（5.2%）在12个月时出现联合组靶病变失败，无显著地理差异（分别为4.7%、6.5%和2.5%；P = 0.08），仅Supreme DES组结果相似（分别为4.4%、6.8%和3.7%，P = 0.20）。12个月时心源性死亡发生率分别为0.4%、0.2%和0.0%（P = 0.79），靶血管相关心肌梗死发生率分别为2.2%、4.7%和3.7%（P = 0.10），临床驱动的靶病变血运重建率分别为2.1%、3.1%和0%（P = 0.15）。与高招募地点的患者相比，低招募地点的患者在靶病变失败、主要不良心脏事件、支架血栓形成和死亡率方面结果相似，心肌梗死发生率有升高趋势但无统计学意义。
结论
尽管患者特征存在地区差异，但PIONEER III试验中Supreme DES与耐用聚合物依维莫司洗脱支架的临床结果并无差异，支持了这项多中心对照试验结果的普遍性和稳健性。
Zotero 插件