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In the manufacturer-sponsored COMPASS trial, low-dose rivaroxaban (2.5 mg twice daily) plus aspirin was shown to have significant cardiovascular benefits, even after accounting for bleeding, in patients with stable coronary disease (NEJM JW Cardiol Oct 2017 and N Engl J Med 2017; 377:1319). Researchers have now focused on the 6391 COMPASS participants with lower-extremity peripheral artery disease (PAD), in particular those who suffered a major adverse limb event (MALE), defined as severe limb ischemia leading to an intervention or major vascular amputation.
Of the trial participants with lower-extremity PAD, 128 (2.0%) suffered an incident MALE during a median 21 months of follow-up. After the MALE, 1-year cumulative risks were 95.4% for a …