Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, Maryland.
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
Am J Cardiol. 2019 Oct 15;124(8):1198-1206. doi: 10.1016/j.amjcard.2019.07.016. Epub 2019 Jul 24.
Low-dose rivaroxaban was effective in secondary prevention of atherosclerotic cardiovascular disease (ASCVD) in the COMPASS trial. There is no established role, however, for oral anticoagulants in primary prevention. We evaluated whether coronary artery calcium (CAC) scoring identifies a high-risk primary prevention adult population who may benefit from low-dose rivaroxaban to prevent ASCVD events. We modeled expected outcomes of low-dose rivaroxaban in 5,196 Multiethnic Study of Atherosclerosis (MESA) cohort participants not already on antiplatelet or anticoagulant therapy. We applied relative risk ratios from COMPASS to absolute MESA event rates in order to estimate number needed to treat (NNT) to avoid a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, as well as number needed to harm (NNH) to cause 1 hospitalized bleed; with both NNT and NNH stratified by calculated ASCVD risk and by baseline CAC. MESA participants with CAC ≥300 had crude ASCVD event rate of 20 per 1000 patient-years, which is comparable to that observed in the COMPASS control-arm. CAC was independently associated with the composite ASCVD outcome (p <0.001 for trend). However, CAC was not independently associated with adjusted hazard ratio for hospitalized major bleeding. Predicted 5-year NNT (modeled from COMPASS) was 75 in persons with CAC 100-299 and 45 with CAC ≥300 despite NNH values of 252 and 98, respectively. In conclusion, CAC helps to distinguish estimated ASCVD benefit from estimated bleeding harm, thereby identifying very high-risk primary prevention adults without established cardiovascular disease who may derive net-benefit from low-dose rivaroxaban.
低剂量利伐沙班在 COMPASS 试验中对动脉粥样硬化性心血管疾病(ASCVD)的二级预防有效。然而,口服抗凝剂在一级预防中没有明确的作用。我们评估了冠状动脉钙(CAC)评分是否可以识别出高危的一级预防成年人群,他们可能受益于低剂量利伐沙班来预防 ASCVD 事件。我们对尚未接受抗血小板或抗凝治疗的 5196 名多民族动脉粥样硬化研究(MESA)队列参与者进行了低剂量利伐沙班的预期结果建模。我们将 COMPASS 的相对风险比应用于绝对 MESA 事件率,以估计避免心血管死亡、非致死性心肌梗死或非致死性卒中的复合事件所需的治疗人数(NNT),以及引起 1 例住院出血所需的治疗人数(NNH);NNT 和 NNH 均按计算的 ASCVD 风险和基线 CAC 分层。CAC≥300 的 MESA 参与者的 ASCVD 事件粗发生率为每 1000 例患者年 20 例,与 COMPASS 对照组观察到的发生率相当。CAC 与 ASCVD 复合结局独立相关(趋势 p<0.001)。然而,CAC 与住院主要出血的调整后的危险比无关。根据 COMPASS 预测的 5 年 NNT(模型预测),CAC 为 100-299 的患者为 75,CAC≥300 的患者为 45,尽管 NNH 值分别为 252 和 98。总之,CAC 有助于区分估计的 ASCVD 益处与估计的出血危害,从而识别出没有明确心血管疾病的高危一级预防成年人,他们可能从低剂量利伐沙班中获得净获益。