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Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI).
Circulation ( IF 35.5 ) Pub Date : 2020-03-17 , DOI: 10.1161/circulationaha.119.044598
Kevin R Bainey 1 , Robert C Welsh 1 , Stuart J Connolly 2 , Tamara Marsden 2 , Jackie Bosch 2 , Keith A A Fox 3 , P Gabriel Steg 4 , Dragos Vinereanu 5 , Derek L Connolly 6 , Scott D Berkowitz 7 , JoAnne M Foody 7 , Jeffrey L Probstfield 8 , Kelley R Branch 8 , Basil S Lewis 9 , Rafael Diaz 10 , Eva Muehlhofer 11 , Petr Widimsky 12 , Salim Yusuf 2 , John W Eikelboom 2 , Deepak L Bhatt 13 ,
Affiliation  

Background:The COMPASS trial (Cardiovascular Outcomes for People using Anticoagulation Strategies) demonstrated that dual pathway inhibition (DPI) with rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily versus aspirin 100 mg once daily reduced the primary major adverse cardiovascular event (MACE) outcome of cardiovascular death, myocardial infarction, or stroke, as well as, mortality, in patients with chronic coronary syndromes or peripheral arterial disease. Whether this remains true in patients with a history of percutaneous coronary intervention (PCI) is unknown.Methods:In a prespecified subgroup analysis from COMPASS, we examined the outcomes of patients with chronic coronary syndrome with or without a previous PCI treated with DPI versus aspirin alone. Among patients with a previous PCI, we studied the effects of treatment according to the timing of the previous PCI.Results:Of the 27 395 patients in COMPASS, 16 560 patients with a chronic coronary syndrome were randomly assigned to DPI or aspirin, and, of these, 9862 (59.6%) had previous PCI (mean age 68.2±7.8, female 19.4%, diabetes mellitus 35.7%, previous myocardial infarction 74.8%, multivessel PCI 38.0%). Average time from PCI to randomization was 5.4 years (SD, 4.4) and follow-up was 1.98 (SD, 0.72) years. Regardless of previous PCI, DPI versus aspirin produced consistent reductions in MACE (PCI: 4.0% versus 5.5%; hazard ratio [HR], 0.74 [95% CI, 0.61–0.88]; no PCI: 4.4% versus 5.7%; HR, 0.76 [95% CI, 0.61–0.94], P-interaction=0.85) and mortality (PCI: 2.5% versus 3.5%; HR, 0.73 [95% CI, 0.58–0.92]; no PCI: 4.1% versus 5.0%; HR, 0.80 [95% CI, 0.64–1.00], P-interaction=0.59), but increased major bleeding (PCI: 3.3% versus 2.0%; HR, 1.72 [95% CI, 1.34–2.21]; no PCI: 2.9% versus 1.8%; HR, 1.58 [95% CI, 1.15–2.17], P-interaction=0.68). In those with previous PCI, DPI compared with aspirin produced consistent (robust) reductions in MACE irrespective of time since previous PCI (as early as 1 year and as far as 10 years; P-interaction=0.65), irrespective of having a previous myocardial infarction (P-interaction=0.64).Conclusions:DPI compared with aspirin produced consistent reductions in MACE and mortality but with increased major bleeding with or without previous PCI. Among those with previous PCI 1 year and beyond, the effects on MACE and mortality were consistent irrespective of time since last PCI.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01776424.

中文翻译:

先前接受经皮冠状动脉介入治疗(COMPASS-PCI)的患者使用利伐沙班加阿司匹林与单独使用阿司匹林。

背景:COMPASS试验(使用抗凝策略的人的心血管结局)表明,利伐沙班每天两次2.5 mg加阿司匹林100 mg每天一次与阿司匹林100 mg每天一次两次相比,双途径抑制(DPI)减少了主要的主要不良心血管事件(MACE)慢性冠状动脉综合征或外周动脉疾病患者的心血管死亡,心肌梗塞或中风的预后以及死亡率。方法:在COMPASS的预先指定的亚组分析中,我们检查了有或没有DPI与阿司匹林治疗的先前PCI的慢性冠脉综合征患者的结局。单独。在先前有PCI的患者中,结果:在COMPASS的27 395例患者中,有16 560例患有慢性冠脉综合征的患者被随机分配至DPI或阿司匹林,其中9862例(占59.6%) )曾接受过PCI(平均年龄68.2±7.8,女性19.4%,糖尿病35.7%,先前的心肌梗塞74.8%,多支PCI 38.0%)。从PCI到随机分组的平均时间为5.4年(SD,4.4),随访时间为1.98(SD,0.72)年。不管以前的PCI是什么,DPI与阿司匹林都会使MACE持续降低(PCI:4.0%对5.5%;危险比[HR]为0.74 [95%CI,0.61-0.88];无PCI:4.4%对5.7%; HR, 0.76 [95%CI,0.61-0.94],16560例患有慢性冠状动脉综合征的患者被随机分配至DPI或阿司匹林,其中9862例(59.6%)曾接受过PCI(平均年龄68.2±7.8,女性19.4%,糖尿病35.7%,先前的心肌梗塞74.8% ,多血管PCI 38.0%)。从PCI到随机分组的平均时间为5.4年(SD,4.4),随访时间为1.98(SD,0.72)年。不管以前的PCI是什么,DPI与阿司匹林都会使MACE持续降低(PCI:4.0%对5.5%;危险比[HR]为0.74 [95%CI,0.61-0.88];无PCI:4.4%对5.7%; HR, 0.76 [95%CI,0.61-0.94],16560例患有慢性冠状动脉综合征的患者被随机分配至DPI或阿司匹林,其中9862例(59.6%)曾接受过PCI(平均年龄68.2±7.8,女性19.4%,糖尿病35.7%,先前的心肌梗塞74.8% ,多血管PCI 38.0%)。从PCI到随机分组的平均时间为5.4年(SD,4.4),随访时间为1.98(SD,0.72)年。不管以前的PCI是什么,DPI与阿司匹林都会使MACE持续降低(PCI:4.0%对5.5%;危险比[HR]为0.74 [95%CI,0.61-0.88];无PCI:4.4%对5.7%; HR, 0.76 [95%CI,0.61-0.94],P-互动= 0.85)和死亡率(PCI:2.5%vs 3.5%; HR,0.73 [95%CI,0.58–0.92];无PCI:4.1%vs 5.0%; HR,0.80 [95%CI,0.64-1.00] ],P-相互作用= 0.59),但严重出血增加(PCI:3.3%对2.0%; HR,1.72 [95%CI,1.34-2.21];无PCI:2.9%对1.8%; HR,1.58 [95% CI,1.15-2.17],P-相互作用= 0.68)。在既往有PCI的患者中,与自从先前PCI以来的时间无关(无论是早于1年还是长达10年;P-相互作用= 0.65),DPI与阿司匹林相比均使MACE持续(稳健)降低,而与先前是否有心肌病无关梗死(P-interaction = 0.64)。结论:与阿司匹林相比,DPI可使MACE和死亡率持续降低,但无论有无先前PCI,其大出血增加。在那些有过PCI 1年及以后的患者中,对MACE和死亡率的影响是一致的,与自上次PCI以来的时间无关。唯一标识符:NCT01776424。
更新日期:2020-04-06
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