Use of risk score to identify lower and higher risk subsets among COMPASS-Eligible patients with stable CAD. Insights from the CLARIFY Registry

Abstract

The COMPASS trial demonstrated efficacy of combination of aspirin and low dose rivaroxaban, compared to aspirin alone, but at the expense of increased bleeding. To evaluate the performance of the CHA 2 DS 2 VaSc (0–9), the REACH Recurrent Ischemic Score (RIS) (0–29) and the REACH Bleeding Risk Score (BRS) (0–22) to identify patients with the most favourable trade-off between ischemic and bleeding events, among CAD patients eligible to COMPASS. We identified the “COMPASS eligible population” (CEP) within the CLARIFY Registry ( n = 15.185). Patients at high bleeding risk (REACH BRS > 10) were excluded in accordance with COMPASS protocol. Patients were categorized as low-intermediate (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: CV death, MI or stroke. Bleeding outcome: bleeding leading to admission, transfusion, or haemorrhagic stroke (100 patients-year). The CEP comprised 5.142 patients (33.9%). Ischemic and bleeding outcome for CEP were 2.3 [2.1–2.5] and 0.5 [0.4–0.6]/100 patient-years, respectively. Patients with high CHA2DS2VaSc score, intermediate REACH BRS and RIS represented 95.5%, 83.8%, and 37.6% ( n = 1.934) of the population. Regarding ischemic risk, patients with intermediate REACH RIS had the higher ischemic risk (3.0 [2.6–3.4] vs. 1.9 [1.7–2.1], P < 0.001), followed by intermediate REACH BRS (2.5 [2.2–2.7] vs. 1.5 [1.2–2.0], P = 0.0003) and high CHA2DS2VaSc score (2.4 [2.2–2.6]). Patients with low CHA2DS2VaSc had the lowest ischemic risk (0.6 [0.3–1.3]). There were no differences in bleeding outcomes according to none of scores ( Fig. 1 ). Low CHA2DS2VaSc scores identify a small subset of patients with very low ischemic risk, which is unlikely to benefit from the adjunction of low dose rivaroxaban to standard therapy. Patients with intermediate REACH RIS had higher ischemic risk, without increased bleeding risk.