医学
血管成形术
再狭窄
临床终点
血运重建
靶病变
外科
不利影响
药物洗脱支架
严重肢体缺血
围手术期
内科学
依维莫司
随机对照试验
支架
心脏病学
心肌梗塞
经皮冠状动脉介入治疗
作者
Ramon L. Varcoe,Brian G. DeRubertis,Raghu Kolluri,Prakash Krishnan,D. Chris Metzger,Marc P. Bonaca,Mehdi H. Shishehbor,Andrew Holden,Danielle Bajakian,Lawrence A. Garcia,Steven Kum,John H. Rundback,Ehrin J. Armstrong,Jen‐Kuang Lee,Yazan Khatib,Ido Weinberg,Héctor M. García‐García,Karine Ruster,Nutte Teraphongphom,Yan Zheng,Jin Wang,Jennifer Jones-McMeans,Sahil A. Parikh
标识
DOI:10.1056/nejmoa2305637
摘要
Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan–Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, −3 percentage points; 95% CI, −6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.)
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