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The GALILEO trial of rivaroxaban (Xarelto) therapy after transcatheter aortic valve replacement (TAVR) has been stopped early after a preliminary analysis suggested harm, Bayer announced.

Bayer last week () that a preliminary analysis of the phase III trial showed excesses in key adverse events among rivaroxaban recipients compared with those getting clopidogrel (Plavix) along with aspirin:

• Thromboembolic events: 11.4% versus 8.8%
• All-cause mortality: 6.8% versus 3.3%
• Bleeding: 4.2% versus 2.4%

"We do not consider these preliminary data transferable to patients covered by Xarelto's approved indications. The benefit-risk profile of rivaroxaban in its approved indications remains positive based on large, controlled clinical studies and post-marketing pharmacovigilance information. Final study results are expected in Q1 2019," according to the statement from Janssen, which was a collaborator on GALILEO with sponsor Bayer.

GALILEO's data safety monitoring board had recommended in August that the trial be halted as it was being conducted at , including the U.S.

Study participants had been randomly assigned to a rivaroxaban group (10 mg rivaroxaban and aspirin once daily for 90 days, followed by rivaroxaban alone at the same dose; n=826) or a dual antiplatelet group (DAPT; 75-mg clopidogrel and aspirin once daily for 90 days, then aspirin alone; n=818). The trial excluded patients with atrial fibrillation.

The trial's primary efficacy endpoint was the combination of all-cause death, stroke, systemic embolism, MI, pulmonary embolism, deep vein thrombosis, and symptomatic valve thrombosis. The primary safety endpoint was combined life-threatening, disabling, and major bleeds.

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