van Diepen Sean, Tricoci Pierluigi, Podder Mohua, Westerhout Cynthia M, Aylward Philip E, Held Claes, Van de Werf Frans, Strony John, Wallentin Lars, Moliterno David J, White Harvey D, Mahaffey Kenneth W, Harrington Robert A, Armstrong Paul W
Divisions of Critical Care and Cardiology, University of Alberta, Edmonton, Alberta, Canada (S.D.) Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada (S.D., M.P., C.M.W., P.W.A.).
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (P.T.).
J Am Heart Assoc. 2015 Dec 15;4(12):e002546. doi: 10.1161/JAHA.115.002546.
Perioperative antiplatelet agents potentially increase bleeding after non-ST-segment elevation (NSTE) acute coronary syndromes (ACS). The protease-activated receptor 1 antagonist vorapaxar reduced cardiovascular events and was associated with increased bleeding versus placebo in NSTE ACS, but its efficacy and safety in noncardiac surgery (NCS) remain unknown. We aimed to evaluate ischemic, bleeding, and long-term outcomes of vorapaxar in NCS after NSTE ACS.
In the TRACER trial, 2202 (17.0%) patients underwent major or minor NCS after NSTE ACS over 1.5 years (median); continuing study treatment perioperatively was recommended. The primary ischemic end point for this analysis was cardiovascular death, myocardial infarction, stent thrombosis, or urgent revascularization within 30 days of NCS. Safety outcomes included 30-day NCS bleeding and GUSTO moderate/severe bleeding. Overall, 1171 vorapaxar and 1031 placebo patients underwent NCS. Preoperative aspirin and thienopyridine use was 96.8% versus 97.7% (P=0.235) and 89.1% versus 86.1% (P=0.036) for vorapaxar versus placebo, respectively. Within 30 days of NCS, no differences were observed in the primary ischemic end point between vorapaxar and placebo groups (3.4% versus 3.9%; adjusted odds ratio 0.81, 95% CI 0.50 to 1.33, P=0.41). Similarly, no differences in NCS bleeding (3.9% versus 3.4%; adjusted odds ratio 1.41, 95% CI 0.87 to 2.31, P=0.17) or GUSTO moderate/severe bleeding (4.2% versus 3.7%; adjusted odds ratio 1.15, 95% CI, 0.72 to 1.83, P=0.55) were observed. In a 30-day landmarked analysis, NCS patients had a higher long-term risk of the ischemic end point (adjusted hazard ratio 1.62, 95% CI 1.33 to 1.97, P<0.001) and GUSTO moderate/severe bleeding (adjusted hazard ratio 5.63, 95% CI 3.98 to 7.97, P<0.001) versus patients who did not undergo NCS, independent of study treatment.
NCS after NSTE ACS is common and associated with more ischemic outcomes and bleeding. Vorapaxar after NSTE ACS was not associated with increased perioperative ischemic or bleeding events in patients undergoing NCS.
围手术期使用抗血小板药物可能会增加非ST段抬高型（NSTE）急性冠脉综合征（ACS）后的出血风险。蛋白酶激活受体1拮抗剂沃拉帕沙可降低心血管事件发生率，但与安慰剂相比，在NSTE ACS中会增加出血风险，但其在非心脏手术（NCS）中的疗效和安全性尚不清楚。我们旨在评估沃拉帕沙在NSTE ACS后行NCS时的缺血、出血及长期预后情况。
在TRACER试验中，2202例（17.0%）患者在NSTE ACS发生1.5年（中位数）后接受了大或小的NCS；建议围手术期继续研究治疗。该分析的主要缺血终点是NCS后30天内的心血管死亡、心肌梗死、支架血栓形成或紧急血运重建。安全结局包括30天NCS出血和GUSTO中/重度出血。总体而言，1171例使用沃拉帕沙的患者和1031例使用安慰剂的患者接受了NCS。术前阿司匹林和噻吩吡啶的使用率，沃拉帕沙组分别为96.8%和89.1%，安慰剂组分别为97.7%和86.1%（P = 0.235和P = 0.036）。在NCS后30天内，沃拉帕沙组和安慰剂组在主要缺血终点方面未观察到差异（3.4%对3.9%；调整后的优势比为0.81，95%置信区间为0.50至1.33，P = 0.41）。同样，在NCS出血（3.9%对3.4%；调整后的优势比为1.41，95%置信区间为0.87至2.31，P = 0.17）或GUSTO中/重度出血（4.2%对3.7%；调整后的优势比为1.15，95%置信区间为0.72至1.83, P = 0.55）方面也未观察到差异｡在一项30天的标志性分析中，与未接受NCS的患者相比，NCS患者发生缺血终点（调整后的风险比为1.62，95%置信区间为1.33至1.97，P<0.001）和GUSTO中/重度出血（调整后的风险比为5.63，95%置信区间为3.98至7.97，P<0.001）的长期风险更高，且与研究治疗无关｡
NSTE ACS后的NCS很常见，且与更多的缺血结局和出血相关。NSTE ACS后使用沃拉帕沙与接受NCS患者围手术期缺血或出血事件增加无关。
Zotero 插件
