Applicability of the COMPASS clinical trial: Analysis of the prospective French registry COPART - 06/01/20
Résumé |
Background |
Lower extremity-peripheral artery disease (LE-PAD) is associated with an increased risk of cardiovascular death (CV death) and represents a heavy burden in cardiovascular morbidity and mortality. The COMPASS trial demonstrated an interest in giving rivaroxaban 2.5mg twice-daily plus acetylsalicylic acid for the prevention of atherothrombotic events in patients with high risk PAD or coronary artery disease. COPART (COhorte de Patients ARTériopathes) is the only French registry of consecutive hospitalized patients admitted for LE-PAD management, with a one-yean follow-up.
Aim |
The aim of the analysis was to estimate the percentage of patients with LE-PAD eligible to a treatment with rivaroxaban 2.5mg twice daily plus a low dose of ASA once daily and describe their characteristics and prognosis.
Results |
Among 2,513 patients included in the COPART registry 1,472 (58.6%, CI95 56.7%–60.5%] fulfilled the COMPASS criteria. The main reason for non -inclusion in the analysis was the need of double antiplatelet or anticoagulant therapy. Mean age was 70.5 years in the whole sample (69.3 in COMPASS-like patients), 75.1% of the patients were men (73.9% of COMPASS patients), 36.7% had a previous history of CAD (32.9% in COMPASS-like patients), 37.5% had renal failure (33.7% in COMPASS-like patients), 70% presented with Rutherford IV-V-VI (66% of COMPASS-like), 37.2% presented with hemodynamically proven critical limb ischemia (34.1% of COMPASS-like patients). Incidence rates of all cause death were 18.2 in the whole sample and 12.1/100 person-years among COMPASS-like patients. A total of 1,092 patients (49.8%) had at least one complication during the one-year follow-up period (543, 44.4%, COMPASS-like patients) (Fig. 1). Male gender, diabetes, cardiac failure, anemia at index hospitalization, and severe stage PAD (rest pain, ulcer or gangrene, acute ischemia) were associated with an increased one-year risk of complication in both groups.
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Vol 12 - N° 1
P. 14 - janvier 2020 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.