ORLANDO – Combination treatment with aspirin and a low dosage of the anticoagulant rivaroxaban had a broader benefit for reducing adverse events in patients with peripheral artery disease than initially reported from the COMPASS trial, which included more than 7,000 patients whose primary diagnosis at study entry was stable PAD.
Secondary analysis of data from the PAD patients enrolled in the COMPASS (Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease) trial showed that, compared with aspirin alone, treatment with 100 mg aspirin daily plus a low dosage of the anticoagulant rivaroxaban (2.5 mg b.i.d.) resulted in a statistically significant, 24% relative cut in the combined rate of vascular interventions: acute or chronic limb ischemia, vascular amputations, peripheral vascular bypass or percutaneous intervention, and vascular hospitalizations, Sonia S. Anand, MD, said at the annual meeting of the American College of Cardiology.
This finding plus the results in a prior report from COMPASS that rivaroxaban plus aspirin cut major adverse limb events (MALE) by 33%, compared with aspirin alone (Lancet. 2018 Jan 20;391:219-9), together show that rivaroxaban plus aspirin represent a new, effective regimen for a majority of PAD patients (in addition to treating with a statin and an ACE inhibitor) to cut adverse outcomes in a high-risk but historically undertreated patient population, Dr. Anand said in a video interview.
Additional analysis that Dr. Anand reported in her talk showed that patients with PAD who had an index MALE during follow-up had a very high rate of subsequent events. Among the 128 PAD patients in COMPASS who had an index MALE (major vascular amputation or severe limb ischemia that resulted in an intervention) and, compared with the PAD patients who did not have a MALE, the rate of subsequent death was more than three times higher, the rate of hospitalization increased more than 7-fold, and the rate of amputation increased nearly 200-fold.
Concurrently with Dr. Anand’s report at the meeting the results appeared in an article online in the Journal of the American College of Cardiology.Joshua A. Beckman, MD, professor of medicine and director of vascular medicine at Vanderbilt University in Nashville, Tenn.
The analysis of post-MALE outcomes, as well as the expanded vascular-outcomes analysis, focused on 6,391 of the COMPASS patients who had lower-extremity PAD and were randomized to either 100 mg aspirin daily or the low-dosage rivaroxaban plus aspirin regimen. COMPASS also randomized patients to a higher-dosage rivaroxaban-only regimen administered at 5 mg b.i.d., but this arm did not perform as well as the lower-dosage regimen, with an efficacy that equaled aspirin only and with more bleeding. The primary efficacy and safety data from COMPASS for all 27,395 enrolled patients, which included many patients with stable coronary artery disease and without diagnosed PAD, appeared in 2017 (N Engl J Med. Oct 5;377:1319-30).