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Study shows no mortality increase if paclitaxel coats peripheral-artery devices

The New England Journal of Medicine
Reuters Health - 09/12/2020 - Analysis of data from a Swedish registry has failed to uncover any evidence that endovascular devices coated with paclitaxel increase mortality when used to treat symptomatic peripheral-artery disease (PAD).

A 2018 meta-analysis published in the Journal of the American Heart Association had suggested a risk for angioplasty balloons and stents used for lower-limb endovascular interventions.

The new assessment, in the New England Journal of Medicine, found a death rate of 25.5% after a mean of 2.5 years for 1,149 volunteers treated with paclitaxel-coated devices. The rate is virtually identical - 24.6% - for the 1,140 patients treated with uncoated devices.

When the research team looked at all-cause mortality at the one-year mark, the death rates were 10.2% and 9.9% respectively.

An evaluation based on clinical indication also produced no significantly different risk of death.

The rates were 33.4% versus 33.1% among patients treated for chronic limb-threatening ischemia and 10.9% compared to 9.4% for correcting intermittent claudication.

"It is very, very unlikely that there is any increase in mortality due to paclitaxel-coated devices used in patients with PAD," senior author Dr. Marten Falkenberg, a professor of vascular interventions at Gothenburg University told Reuters Health by email.

Publication of the 2018 meta-analysis had prompted Dr. Falkenberg and his colleagues in the open-label SWEDEPAD study to temporarily halt recruitment of patients with vascular problems. Based on the new findings, the SWEDEPAD study resumed enrollment in March, said Dr. Falkenberg.

The original goal of the study is to see whether drug-eluting devices lower the risk of odds of amputation and improve quality of life in people with serious limb ischemia and intermittent claudication. All-cause mortality is a secondary endpoint.

They decided to use the data collected thus far from 22 of Sweden's 28 vascular centers to assess the conclusions of the meta-analysis.

They weren't the only ones to halt research because of the concern. "Concerns regarding the safety of paclitaxel-coated devices in peripheral artery disease have led to a scientific and clinical deadlock," they write.

There was reason to be skeptical.

"Other meta-analyses reached diverging conclusions, despite the fact that they were based on similar target populations and vessel segments," the authors note. "Observational studies have not replicated the signal" and "no plausible mechanism for higher mortality has been identified."

And the data from the SWEDEPAD study should be convincing because it included more patients than previous trials and follow-up was longer than most studies that looked at the all-mortality question, they write.

The study did not have commercial funding.

SOURCE: https://bit.ly/2VUZ6rS The New England Journal of Medicine, online December 9, 2020.

By Gene Emery

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