Efficacy of dual therapy with Aspirin and rivaroxaban in symptomatic peripheral artery disease: the DOLOMITI experience.

BACKGROUND

Peripheral artery disease (PAD) increases cardiovascular (CV) mortality risk. Dual therapy (DT) with aspirin and rivaroxaban reduces major CV adverse events and limb ischemia. An analysis of patients at high CV risk undergoing DT was conducted in a real-world setting. Major adverse events and bleedings were collected, comparing results with COMPASS and XATOA trials.

METHODS

A retrospective, observational, monocentric analysis was performed. Major-adverse-cardiovascular-events (MACE) and major-adverse-limb-events (MALE) defined the effectiveness of DT, whereases safety was assessed recording major and minor bleedings, according to the ISTH criteria. Blood pressure (BP), low-density-lipoprotein (LDL) levels, Rutherford's classes, Ankle-Brachial-Index (ABI) and Toe-Brachial-Index (TBI) were also evaluated.

RESULTS

Fifty-seven patients were considered from 2021 to 2024. The average follow-up was 24.5±10.1 months. The cumulative risk at 32 months of MACE, MALE and major or minor bleedings were 4.3%, 11% and 17.7% respectively. Comparing results with COMPASS and XATOA studies, there were more MALE, more minor bleedings and less MACE in DOLOMITI. There were more smokers, diabetics, hypertensives, patients with hypercholesterolemia, and patients with a history of limb revascularization in DOLOMITI. No differences in BP values were noticed at baseline and final valuations in DOLOMITI, whereases a reduction in LDL levels, an improvement in Rutherford's class, ABI and TBI resulted significative.

CONCLUSIONS

Low-dose rivaroxaban and acetylsalicylic acid have shown efficacy in reducing MACE in real-world contexts, with acceptable MALE events and bleeding risk. DT maximizes benefits by optimizing CV risk factors and improving PAD symptoms, but targeted studies are needed.