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Effect of Aspirin in Vascular Surgery in Patients from a Randomized Clinical Trial (POISE-2).

B. M. Biccard,A. Sigamani,M. T. Chan,D. Sessler,A. Kurz,J. G. Tittley,T. Rapanos,J. Harlock,D. Szalay, M. E. Tiboni,E. Popova,S. M. Vasquez,B. Kabon,M. Amir,M. Mrkobrada, B. R. Mehra, H. El Beheiry, E. Mata,B. Tena, S. Sabate, M. K. Zainal Abidin, V. R. Shah, K. Balasubramanian,P. J. Devereaux

British Journal of Surgery(2018)SCI 1区

Groote Schuur Hosp | Narayana Hrudayalaya Ltd | Chinese Univ Hong Kong | Cleveland Clin | McMaster Univ | Biomed Res Inst IIB St Pau | Univ Autonoma Bucaramanga | Med Univ Vienna | Shifa Tameer E Millat Univ | Western Univ | Mahatma Gandhi Inst Med Sci | Univ Toronto | Hosp Univ La Princesa | Hosp Clin Barcelona | Fdn Puigvert IUNA | Sarawak Gen Hosp | Viroc Hosp | Populat Hlth Res Inst

Cited 28|Views22
Abstract
Background: In the POISE-2 (PeriOperative ISchemic Evaluation 2) trial, perioperative aspirin did not reduce cardiovascular events, but increased major bleeding. There remains uncertainty regarding the effect of perioperative aspirin in patients undergoing vascular surgery. The aim of this substudy was to determine whether there is a subgroup effect of initiating or continuing aspirin in patients undergoing vascular surgery. Methods: POISE-2 was a blinded, randomized trial of patients having non-cardiac surgery. Patients were assigned to perioperative aspirin or placebo. The primary outcome was a composite of death or myocardial infarction at 30days. Secondary outcomes included: vascular occlusive complications (a composite of amputation and peripheral arterial thrombosis) and major or life-threatening bleeding. Results: Of 10010 patients in POISE-2, 603 underwent vascular surgery, 319 in the continuation and 284 in the initiation stratum. Some 272 patients had vascular surgery for occlusive disease and 265 had aneurysm surgery. The primary outcome occurred in 13.7 per cent of patients having aneurysm repair allocated to aspirin and 9.0 per cent who had placebo (hazard ratio (HR) 1.48, 95 per cent c.i. 0.71 to 3.09). Among patients who had surgery for occlusive vascular disease, 15.8 per cent allocated to aspirin and 13.6 per cent on placebo had the primary outcome (FIR 1.16,0.62 to 2.17). There was no interaction with the primary outcome for type of surgery (P = 0.294) or aspirin stratum (P = 0.623). There was no interaction for vascular occlusive complications (P=0.413) or bleeding (P= 0.900) for vascular compared with non-vascular surgery. Conclusion: This study suggests that the overall POISE-2 results apply to vascular surgery. Perioperative withdrawal of chronic aspirin therapy did not increase cardiovascular or vascular occlusive complications.
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Postoperative Complications,Perioperative
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要点】:POISE-2子研究表明,围手术期阿司匹林在血管手术患者中的效果与非心脏手术患者一致,不减少心血管事件,反而增加大出血风险。

方法】:本子研究为盲随机对照试验,对接受非心脏手术的患者给予围手术期阿司匹林或安慰剂。

实验】:在10010例POISE-2试验中,603例接受血管手术,319例继续使用阿司匹林,284例开始使用。结果显示,阿司匹林组与安慰剂组在主要结局(死亡或心肌梗死30天内)上无显著差异。