No association of mortality was observed in patients undergoing lower-extremity endovascular revascularization for peripheral artery disease (PAD) with paclitaxel drug-coated devices (DCD) vs. non-DCDs, according findings from the VOYAGER PAD trial presented Oct. 18 during TCT 2020. Additionally, the benefit of rivaroxaban (2.5 mg twice daily) with aspirin compared with placebo was consistent regardless of DCD use in reducing ischemic limb and cardiovascular outcomes after revascularization.

The VOYAGER PAD trial randomized 6,564 PAD patients to either 2.5 mg of rivaroxaban twice daily (N=3,286) or placebo (N=3,278). The median follow-up was 28 months. The primary objectives were all-cause mortality for DCD vs. non-DCD and acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, or cardiovascular death for rivaroxaban vs. placebo.

Results using inverse probability treatment weighting to adjust for known confounders showed no mortality risk or benefit associated with DCD, including in subgroups by device type, said Connie N. Hess, MD, FACC, et al. They also noted overall HR 0.85 for rivaroxaban vs. placebo (P=0.0085).

According to Hess and colleagues, the large sample size, long-term follow-up, adjudicated outcomes and well characterized cohort add to the growing body of evidence showing no increased mortality with DCD.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and Vascular Medicine

Keywords: TCT20, Transcatheter Cardiovascular Therapeutics, Percutaneous Coronary Intervention, Vascular Surgical Procedures, Peripheral Arterial Disease

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