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Rivaroxaban-aspirin combo cuts MALE in COMPASS

Elvira Manzano
16 Mar 2018

The combination of low-dose rivaroxaban and aspirin reduces the incidence of major adverse limb events (MALE) in patients with stable lower-extremity peripheral artery disease (PAD), a sub-study of the COMPASS* trial has shown.

“Today, we’ve shown a very important finding … we’ve shown the impact of rivaroxaban plus aspirin in reducing MALE,” said lead investigator Dr Sonia Anand from the Population Health Research Institute in Hamilton, Canada at ACC.18. “We’ve also shown that patients who developed MALE have a very adverse prognosis thereafter, with a 200-fold increase in vascular amputations and a threefold increase in death.”

MALE, in the context of COMPASS, refers to patients with PAD who develop an acute limb ischaemia or a chronic limb ischaemia requiring an intervention (operation or thrombolytic therapy), or those who have major vascular amputations, said Anand.

Few therapies to reduce MALE

In 7,740 patients with PAD in COMPASS, rivaroxaban plus aspirin reduced the incidence of MALE by 49 percent, peripheral vascular interventions by 29 percent, peripheral vascular hospitalizations by 28 percent, and amputations by 55 percent. [ACC.18, 18-LB-18937]

“The large risk reduction is a very important outcome,” said Anand. “Before COMPASS, there are only a few-to-no therapies that have shown such a reduction in MALE.”

In the sub-study, the risk of developing MACE or vascular amputations was increased by 6.57-fold after MALE. All-cause death also increased by 3.69-fold vs those who did not have MALE.  In patients who experienced MALE, those treated with the combination therapy fared better.

COMPASS was a large randomized trial of 27,395 patients with stable CAD, PAD, or both, comparing rivaroxaban 2.5 mg twice daily plus aspirin in one arm, rivaroxaban in the second arm, and aspirin in the third arm. The key findings, which were published previously, showed that low-dose rivaroxaban plus aspirin significantly reduced major adverse cardiovascular events (MACE) and MALE, and related complications. The trial was stopped for superiority of rivaroxaban-aspirin combination after a median follow-up of 23 months. [N Engl J Med 2017; 377:1319-1330]

There was an increase in major bleeding with the rivaroxaban-aspirin combination vs aspirin alone (3.2 percent vs 2.0 percent, HR 1.61), but the rate of severe bleeding was not significantly elevated (1.1 percent vs 0.8 percent, HR 1.32), said Anand.

Who should receive the combo therapy

In COMPASS, 60 percent of patients enrolled had concomitant coronary artery disease (CAD).

“In patients with CAD and PAD, I would give the rivaroxaban-aspirin combination. However, in patients with mild, intermittent claudication with a borderline low ABI [ankle-brachial index] who are otherwise completely healthy, that’s the group where may be a single antiplatelet therapy like clopidogrel or aspirin is enough,” said Anand. She clarified there are many other factors to consider such as how well these patients are treated with statins, ACE inhibitor, and angiotensin receptor blocker, and what are their bleeding risks.

“Certainly, if they are at high risk for bleeding or had a previous GI bleed, I would worry about giving them rivaroxaban plus aspirin. We need more debates and discussions regarding mild PAD patients without CAD,” said Anand. “But in the vast majority of PAD patients with concomitant CAD, it is no-brainer.”

“If we select our patients carefully, essentially weeding out the patients that COMPASS excluded from entering the trial, we will be in a pretty good shape to use this therapy,” she concluded.

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