University Hospital Jean Minjoz, Department of Cardiology, Besançon, France; EA3920, University of Burgundy Franche-Comté, Besançon, France.
Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou (HEGP), Department of Cardiology, Paris, France; Université Paris-Descartes, Paris, France.
Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.
The COMPASS trial assessed the impact of adding low dose rivaroxaban to aspirin in selected patients (pts). After an acute myocardial infarction (MI), when dual antiplatelet treatment is no longer needed, patients might be eligible for aspirin/rivaroxaban co-therapy. The characteristics and risks of such a population are unclear.
Data were extracted from the FAST-MI 2005, 2010 and 2015 nationwide French registries. Characteristics and long-term mortality were compared according to COMPASS eligibility and between registry and trial populations.
Among 9954 patients alive and free of events at one year, 4402 (44%) were classified as COMPASS-Like (i.e. meeting COMPASS inclusion and without exclusion criteria), 1720 (17%) COMPASS-Excluded (i.e. meeting any exclusion criterion) and 3832 (39%) Non-COMPASS (i.e. meeting neither COMPASS inclusion nor exclusion criteria). COMPASS-Like patients were at higher risk and had higher 5-year mortality compared with Non-COMPASS patients. COMPASS-Excluded patients had the highest mortality. COMPASS enrichment criteria defined a population at increased risk of death: eligible pts. had 40% higher 5-year adjusted mortality (Hazard Ratio = 1.40 [1.15; 1.70]), while excluded pts. had 57% higher risk (Hazard Ratio = 1.57 [1.25; 1.97]). Patients meeting the COMPASS criteria one year after MI differed from those included in the randomized trial.
Based on the population included in the French FAST-MI registries, enrichment criteria used in COMPASS defined a population representing 44% of the overall population of MI patients surviving to one year, and these patients are at high risk of 5-year mortality. They were at higher risk compared to chronic stable vascular patients enrolled in the trial. Registered with Clinicaltrials.gov under the number: NCT00673036.
COMPASS 试验评估了在选定患者（pts）中添加低剂量利伐沙班对阿司匹林的影响。急性心肌梗死（MI）后，当不再需要双联抗血小板治疗时，患者可能有资格接受阿司匹林/利伐沙班联合治疗。此类人群的特征和风险尚不清楚。
从 2005 年、2010 年和 2015 年法国全国 FAST-MI 注册中提取数据。根据 COMPASS 的入选标准以及注册和试验人群比较特征和长期死亡率。
在 9954 例存活且无一年时事件的患者中，4402 例（44%）被归类为 COMPASS 相似（即符合 COMPASS 纳入标准且无排除标准），1720 例（17%）COMPASS 排除（即符合任何排除标准），3832 例（39%）非 COMPASS（即既不符合 COMPASS 纳入标准也不符合排除标准）。与非 COMPASS 患者相比，COMPASS 相似患者的风险更高，且 5 年死亡率更高。COMPASS 排除患者的死亡率最高。COMPASS 富集标准定义了一个死亡风险增加的人群：符合条件的患者 5 年调整死亡率增加 40%（风险比 = 1.40 [1.15；1.70]），而排除的患者风险增加 57%（风险比 = 1.57 [1.25；1.97]）。MI 一年后符合 COMPASS 标准的患者与随机试验中纳入的患者不同。
基于纳入法国 FAST-MI 注册的人群，COMPASS 中使用的富集标准定义了一个代表 MI 患者总体人群中存活至一年的 44%的人群，这些患者 5 年死亡率高。与试验中纳入的慢性稳定血管患者相比，他们的风险更高。在 Clinicaltrials.gov 注册，编号：NCT00673036。
