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初始药物治疗非 ST 段抬高型急性冠脉综合征(TRILOGY ACS 试验)患者接受下游血运重建的结局。

Outcomes of Patients Receiving Downstream Revascularization After Initial Medical Management for Non-ST-Segment Elevation Acute Coronary Syndromes (From the TRILOGY ACS Trial).

机构信息

Division of General Internal Medicine, Duke University School of Medicine, Durham, North Carolina.

Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.

出版信息

Am J Cardiol. 2018 Oct 15;122(8):1322-1329. doi: 10.1016/j.amjcard.2018.06.052. Epub 2018 Jul 19.

Abstract

Patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) are sometimes treated with medical management alone rather than an invasive strategy. Among those medically managed without revascularization and discharged, a proportion will require revascularization later on, but little is known about this population. In TRILOGY ACS, 9,326 patients with NSTE ACS who were selected for medical management alone were randomized to treatment with prasugrel or clopidogrel and discharged without revascularization. Patient characteristics and ischemic and bleeding outcomes through 30 months were compared between patients who underwent downstream revascularization after the index hospitalization and those who did not. A total of 662 patients (7.1%) underwent later revascularization by percutaneous coronary intervention (73.1%), coronary artery bypass graft surgery (26.4%), or the two (0.5%). Median time to revascularization was 121 days (twenty-fifth, seventy-fifth percentiles: 41, 326). Revascularized patients were younger, more likely to be male, and had higher rates of hyperlipidemia, diabetes mellitus, prior myocardial infarction, and prior revascularization compared with those not revascularized. Europe and North America had the highest rates of revascularization. During the follow-up period, those who underwent revascularization had a higher rate of the composite outcome of cardiovascular death, myocardial infarction, or stroke occurring after revascularization compared with those not revascularized (hazard ratio [HR] 2.73 [95% confidence interval {CI} 2.21 to 3.38], p < 0.001) as well as a higher rate of each of the individual outcomes. Major bleeding was also higher in those who underwent revascularization (GUSTO severe or life-threatening: HR 2.61 [95% CI 1.02 to 6.67], p = 0.045; TIMI major: HR 2.24 [95% CI 1.12 to 4.48], p = 0.022). There was no evidence that bleeding and ischemic outcomes varied by treatment with clopidogrel versus prasugrel. In conclusion, among patients initially medically managed after NSTE ACS, a small proportion later require revascularization and have a high rate of ischemic and major bleeding outcomes compared with those not requiring downstream revascularization.

摘要

非 ST 段抬高型急性冠状动脉综合征(NSTE ACS)患者有时仅接受药物治疗,而非介入治疗策略。在未接受血运重建而出院的药物治疗患者中,一部分人之后将需要血运重建,但对于这部分人群,我们知之甚少。在 TRILOGY ACS 研究中,9326 名 NSTE ACS 患者入选并接受单纯药物治疗,随机分至普拉格雷或氯吡格雷组,并在未行血运重建的情况下出院。通过比较出院后行指数住院期间后下游血运重建的患者与未行血运重建的患者,比较两组患者的特征以及缺血和出血结局。共有 662 例(7.1%)患者接受了后续经皮冠状动脉介入治疗(73.1%)、冠状动脉旁路移植术(26.4%)或两者联合(0.5%)血运重建。血运重建中位时间为 121 天(第 25 百分位数至第 75 百分位数:41,326)。与未行血运重建的患者相比,行血运重建的患者更年轻,男性比例更高,且高脂血症、糖尿病、既往心肌梗死和既往血运重建的发生率更高。欧洲和北美行血运重建的比例最高。在随访期间,与未行血运重建的患者相比,行血运重建的患者在血运重建后发生心血管死亡、心肌梗死或卒中等复合终点的发生率更高(风险比[HR]2.73[95%置信区间{CI}2.21 至 3.38],p<0.001),以及各单项结局的发生率也更高。行血运重建的患者大出血发生率也更高(GUSTO 严重或危及生命:HR 2.61[95%CI 1.02 至 6.67],p=0.045;TIMI 主要:HR 2.24[95%CI 1.12 至 4.48],p=0.022)。没有证据表明氯吡格雷与普拉格雷治疗的出血和缺血结局存在差异。总之,在 NSTE ACS 后初始接受药物治疗的患者中,一小部分患者之后需要血运重建,与无需下游血运重建的患者相比,其缺血和大出血发生率较高。

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