Abstract
BackgroundThe COMPASS trial showed a reduction of ischemic events with low‐dose rivaroxaban and aspirin in chronic coronary syndromes (CCS) compared with aspirin alone, at the expense of increased bleeding.HypothesisThe CHA2DS2VaSc Score, REACH Recurrent Ischemic (RIS), and REACH Bleeding Risk Score (BRS) could identify patients with a favorable trade‐off between ischemic and bleeding events, among COMPASS‐eligible patients.MethodsWe identified the COMPASS‐eligible population within the CLARIFY registry (>30.000 patients with CCS). High‐bleeding risk patients (REACH BRS > 10) were excluded, as in the COMPASS trial. Patients were categorized as low (0–1) or high (≥ 2) CHA2DS2VaSc; low (0–12) or intermediate (13–19) REACH RIS, and low (0–6) or intermediate (7–10) REACH BRS. Ischemic outcome was the composite of cardiovascular death, myocardial infarction or stroke. Bleeding was defined as serious bleeding (haemorrhagic stroke, hospitalization for bleeding, transfusion).ResultsThe COMPASS‐eligible population comprised 5.142 patients with ischemic and bleeding outcome of 2.3 (2.1–2.5) and 0.5 (0.4–0.6) per 100 patient‐years, respectively. Patients with intermediate REACH RIS (n = 1934 [37.6%]) had the higher ischemic risk (3.0 [2.6–3.4]) with similar bleeding risk (0.5 [0.4–0.7]) as the overall population. Patients with low CHA2DS2VaSc (n = 229 [4.4%]) had a very low ischemic risk (0.6 [0.3–1.3]) with similar bleeding risk (0.5 [0.2–1.1]).ConclusionsIntermediate REACH RIS identified potential optimal candidates for adjunction of low‐dose rivaroxaban while patients with low CHA2DS2VaSc score .appears unlikely to benefit from the COMPASS regimen. None of the three risk scores predicted the occurrence of serious bleeding.
Highlights
In patients with chronic coronary syndromes (CCS) or peripheral arterial disease (PAD), antithrombotic treatment represents a cornerstone of medical therapy
The COMPASS6 trial demonstrated the efficacy of a combination of low-dose rivaroxaban and aspirin in reducing ischemic events in a broad population of high-risk patients with CCS and/or PAD, but with a 70% relative increase in the risk of major bleeding
For quantitative assessment of both ischemic and bleeding risk, risk scores have proven to be useful in various clinical settings, such as atrial fibrillation
Summary
In patients with chronic coronary syndromes (CCS) or peripheral arterial disease (PAD), antithrombotic treatment represents a cornerstone of medical therapy. We applied the COMPASS inclusion criteria to the remaining population: (1) PAD patients—encompassing peripheral artery disease and/or carotid disease—were included regardless of age; (2) CCS patients older than 65 years; and (3) CCS patients younger than 65 years had to fulfill the COMPASS 'enrichment criteria' (i.e., documented atherosclerosis or revascularization involving at least two vascular beds) or at least two additional risk factors (i.e., current smoker, diabetes, history of ischemic stroke more than 1 month ago, moderate renal failure with eGFR
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