Low-dose rivaroxaban benefits despite increased bleeding
Dr. Anand also reported on a comparison of the clinical and demographic profiles of the 128 PAD patients who developed MALE during follow-up and the 6,263 who did not, a 2% incidence during almost 2 years.
Multivariate analysis identified four significant factors that closely linked with MALE incidence: a history of peripheral surgery or angioplasty, prior limb amputation, baseline Fontaine classification of stage III or IV, and treatment in COMPASS with aspirin alone and not with rivaroxaban plus aspirin.
The new, additional analyses Dr. Anand reported also showed total peripheral vascular outcomes during follow-up in COMPASS in 8.0% of patients on aspirin only and 6.2% of patients on aspirin plus low-dosage rivaroxaban, a 24% relative risk reduction, and vascular interventions in 7.1% of aspirin-only patients and in 5.5% of the combined-regimen patients, also a 24% relative risk reduction. MALE occurred in 2.6% of the aspirin-only patients and in 1.5% of patients on both drugs, a 33% relative risk reduction. All three of these relative risk reductions were statistically significant, said Dr. Anand, a cardiologist and professor of medicine at McMaster University in Hamilton, Ont.
She estimated that about two-thirds of the PAD patients she sees in routine practice would qualify for treatment with aspirin plus low-dosage rivaroxaban once the 2.5 mg formulation becomes approved by regulators. The companies that jointly market rivaroxaban (Xarelto)have an application pending with the Food and Drug Administration to market a 2.5-mg pill based on the COMPASS results. Patients with stable PAD who are not good candidates for the COMPASS regimen are those with a history of a major bleed, those who require full-dose anticoagulation for a comorbidity such as atrial fibrillation or a mechanical heart valve, and patients with newly diagnosed, stable PAD without concurrent coronary artery disease who might receive adequate protection from aspirin alone, Dr. Anand said.