COMPASS Analysis Examines Rivaroxaban Plus Aspirin to Reduce Major Adverse Limb Events in PAD Patients


March 11, 2018—Results from an analysis of the COMPASS trial evaluating of the use of rivaroxaban (Xarelto, Janssen Research & Development, LLC) to reduce high mortality after a major adverse limb events (MALE) in peripheral artery disease (PAD) were presented in a Featured Clinical Research session at the American College of Cardiology's (ACC) 67th annual scientific session held March 10–12 in Orlando, Florida. The study findings were simultaneously published in Journal of the American College of Cardiology.

The purpose of this analysis is to determine the predictors of MALE and the prognosis of PAD patients after their occurrence.

The COMPASS investigators found that compared to aspirin, low-dose rivaroxaban plus aspirin significantly lowered the incidence of MALE, amputations, peripheral vascular interventions, and total peripheral vascular hospitalizations. MALE is associated with a substantial and six-fold increase in major adverse cardiovascular events (MACEs) or vascular amputations and a four-fold increase in death. Therefore, preventing MALE in patients with PAD is of major clinical importance, concluded the investigators at ACC.

The background of the study is that rivaroxaban 2.5 mg twice daily and aspirin used in combination significantly lowered MALE in PAD patients compared to aspirin alone; however, the prognosis after MALE is not well documented.

A MALE was defined as severe limb ischemia leading to an intervention or major vascular amputation. Outcomes that were evaluated after MALE include: MACE, total amputation, and mortality.

In the randomized, double-blind, placebo-controlled COMPASS trial, rivaroxaban 2.5 mg twice daily plus aspirin and rivaroxaban 5 mg twice daily were each compared to aspirin alone in patients with coronary artery disease and/or PAD. This analysis included 5,551 patients with PAD of the lower extremity who were followed for 21 months.

The investigators found that compared with aspirin alone, rivaroxaban 2.5 mg administered twice daily plus aspirin lowered the incidence of MALE by 43% (P = .01), total vascular amputations by 58% (P = .01), peripheral vascular interventions by 24% (P = .03), and all peripheral vascular outcomes by 24% (P = .02).

A total of 128 patients experienced MALE, after which, the 1-year cumulative risk of a subsequent hospitalization was 95.4%, 22.9% for vascular amputations, 8.7% for deaths, and 3.8% for MACE. The MALE index event significantly increased the risk to experience subsequent hospitalizations (hazard ratio [HR], 7.21; P < .0001), subsequent amputations (HR, 197.5; P < .0001), and death (HR, 3.23; P < .001).

Concluding her presentation, Dr. Anand summarized the findings as follows. Predictors of MALE include previous revascularization, amputation, critical limb ischemia, or randomization to aspirin arm. MALE is associated with a poor prognosis, including a three-fold increase in death and 200-fold increase in amputation. Compared to aspirin, the rivaroxaban plus aspirin combination prevents MALE, vascular interventions, and total peripheral vascular outcomes. By comparison, outcomes after MALE are worse for aspirin-treated patients. Finally, antithrombotic management after MALE is very heterogeneous.


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