VIVA

VIVA

Source:

Hess CN, et al. Late-breaking clinical trials. Presented at: VIVA 20; Nov. 6-8, 2020 (virtual meeting).

Disclosures: VOYAGER PAD was funded by Bayer and Janssen. Hess reports she received research funding from Amgen, Bayer and Janssen.
November 08, 2020
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Drug-coated devices associated with less unplanned limb revascularization: VOYAGER PAD

Source:

Hess CN, et al. Late-breaking clinical trials. Presented at: VIVA 20; Nov. 6-8, 2020 (virtual meeting).

Disclosures: VOYAGER PAD was funded by Bayer and Janssen. Hess reports she received research funding from Amgen, Bayer and Janssen.
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Among patients with peripheral artery disease who had an endovascular procedure, treatment with a drug-coated device was linked to lower risk for unplanned limb revascularization, according to new data from the VOYAGER PAD trial.

Those who were treated with drug-coated devices had similar rates of major adverse limb events, defined as acute limb ischemia or major amputation of a vascular etiology, Connie N. Hess, MD, MHS, interventional cardiologist and associate professor of medicine at the University of Colorado and clinician-scientist at CPC Clinical Research, said during a presentation at the virtual VIVA 20.

normal artery
Source: Adobe Stock

Among the VOYAGER PAD cohort, 4,379 patients underwent an endovascular procedure, of whom 31% were treated with a drug-coated device. The researchers used inverse probability of treatment weighting to account for differences between those who had an endovascular procedure with a drug-coated device (mean age, 68 years; 28% women) and those had an endovascular procedure with an uncoated device (mean age, 68 years; 29% women). Median follow-up was 28 months. The analysis included 4,059 patients for whom 3-year limb-related data were available.

At 3 years, 21.5% of those treated with drug-coated devices had unplanned index limb revascularization compared with 24.6% of those treated with an uncoated device (HR = 0.84; 95% CI, 0.76-0.92; absolute risk reduction, 2.6%; number needed to treat to prevent one event = 39), Hess said during the presentation.

Connie N. Hess

“The curves do split relatively early,” she said. “At 6 months, there is already an absolute risk reduction of 2.3%, with a number needed to treat of 44. This benefit is persistent.”

However, there were no differences between the groups at 3 years in major adverse limb events (drug-coated group, 6.6%; uncoated group, 6.5%; HR = 1.08; 95% CI, 0.9-1.3), she said.

In the main results of VOYAGER PAD, those assigned low-dose rivaroxaban (Xarelto, Janssen/Bayer) plus aspirin had reduced risk for major adverse limb events and CV events compared with those assigned aspirin alone. In an analysis presented at TCT Connect in October, among those who had an endovascular procedure, there was no difference in mortality at 3.5 years between those treated with a drug-coated device and those treated with an uncoated device, and the treatment effect of rivaroxaban was consistent regardless of device used in revascularization.

“Although the debate does continue, the weight of data support that there’s no safety signal for excess mortality associated with drug-coated device use in peripheral artery disease,” Hess said during the presentation. “Patency does remain a challenge, and we showed here that drug-coated devices are associated with a reduction in clinically unplanned index limb revascularization. We also know that rivaroxaban 2.5 mg twice daily plus aspirin reduces this risk, as well as the risk of major adverse cardiovascular and limb events, irrespective of device type. Taken together, these observations suggest that a combination pharmacoinvasive approach combining innovative devices and effective medical therapies may be used to optimize outcomes in peripheral artery disease.”

In a discussion after the presentation on the mortality controversy with paclitaxel-coated devices, Misti Malone, PhD, chief of the peripheral interventional devices branch of the FDA’s Center for Devices and Radiological Health, said “these subanalyses are definitely interesting and exciting to hear.”

She added that “there is a lot of evidence coming along now and shortly into the future that we hope to reevaluate this. When there is enough information available, we hope to communicate on it.”