PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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; P =.08), with similar results in the Supreme DES group alone (4.4%, 6.8%, and 3.7%, respectively, P =.20). Cardiac death at 12 months occurred in 0.4%, 0.2%, and 0.0% (P =.79), target vessel-related myocardial infarction occurred in 2.2%, 4.7%, and 3.7%, (P =.10), and clinically driven target lesion revascularization was required in 2.1%, 3.1%, and 0%, respectively (P =.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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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; P =.08), with similar results in the Supreme DES group alone (4.4%, 6.8%, and 3.7%, respectively, P =.20). Cardiac death at 12 months occurred in 0.4%, 0.2%, and 0.0% (P =.79), target vessel-related myocardial infarction occurred in 2.2%, 4.7%, and 3.7%, (P =.10), and clinically driven target lesion revascularization was required in 2.1%, 3.1%, and 0%, respectively (P =.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.
UNASSIGNED: 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.
摘要：
■PIONEERIII试验显示了Supreme药物洗脱支架（DES）与耐用的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PIONEERIII中SupremeDES的特征和临床结局在患者之间是否一致。
这项PIONEERIII试验的亚组分析比较了从北美招募的患者的特征和结果，欧洲,和日本以及根据网站招募量的患者结局的相对差异。
■从2017年10月到2019年7月，北美招募了1629名患者（816，50.1%），欧洲（650，39.9%），和日本（163，10%）。在1611个程序中的1556个（96.6％）中实现了程序成功，地理位置没有区别。在1629例患者中，84例（5.2％）观察到联合组12个月时的靶病变失败，没有显著的地理差异(4.7%，6.5%,和2.5%，分别为；P=.08)，仅SupremeDES组的结果就相似(4.4%，6.8%,和3.7%，分别,P=.20）。12个月时的心源性死亡发生率为0.4%，0.2%，和0.0%（P=0.79），目标血管相关心肌梗死发生率为2.2%,4.7%，和3.7%，（P=.10），临床驱动的靶病变血运重建需要2.1%，3.1%,0%,分别(P=.15)。与那些来自高招聘网站的人相比，低招募部位的结果与靶病变失败相似，主要不良心脏事件，支架内血栓形成,和死亡率，心肌梗死发生率上升趋势不显著。
■尽管患者特征存在地区差异，在PIONEERIII试验中，SupremeDES和耐久聚合物依维莫司洗脱支架之间的临床结果没有差异，支持这项多中心对照试验结果的普遍性和稳健性.
这项PIONEERIII试验的亚组分析比较了从北美招募的患者的特征和结果，欧洲,和日本以及根据网站招募量的患者结局的相对差异。
■从2017年10月到2019年7月，北美招募了1629名患者（816，50.1%），欧洲（650，39.9%），和日本（163，10%）。在1611个程序中的1556个（96.6％）中实现了程序成功，地理位置没有区别。在1629例患者中，84例（5.2％）观察到联合组12个月时的靶病变失败，没有显著的地理差异(4.7%，6.5%,和2.5%，分别为；P=.08)，仅SupremeDES组的结果就相似(4.4%，6.8%,和3.7%，分别,P=.20）。12个月时的心源性死亡发生率为0.4%，0.2%，和0.0%（P=0.79），目标血管相关心肌梗死发生率为2.2%,4.7%，和3.7%，（P=.10），临床驱动的靶病变血运重建需要2.1%，3.1%,0%,分别(P=.15)。与那些来自高招聘网站的人相比，低招募部位的结果与靶病变失败相似，主要不良心脏事件，支架内血栓形成,和死亡率，心肌梗死发生率上升趋势不显著。
■尽管患者特征存在地区差异，在PIONEERIII试验中，SupremeDES和耐久聚合物依维莫司洗脱支架之间的临床结果没有差异，支持这项多中心对照试验结果的普遍性和稳健性.
