Study Finds No Mortality Effect with Drug-Coated Devices for Peripheral Revascularization

BOSTON – Affecting an estimated 8 million Americans over 50 years of age, peripheral artery disease (PAD) is a narrowing of the blood vessels that serve the body’s extremities. Patients with severe PAD are at risk for painful cramping, wounds that won’t heal, gangrene and amputation. These patients may opt for revascularization procedures in which vascular specialists use stents or balloons to open up constricted vessels and restore blood flow to the lower extremities. These stents and balloons may be coated with a medication known to inhibit growth of the vascular walls (paclitaxel), which has been shown to keep constricted vessels open longer compared with stents and balloons without this drug coating.

Recently, an analysis of prior clinical trials reported an increased risk of long-term mortality in patients who were treated with these drug-coated devices for peripheral arterial disease. This spurred vascular specialists trained in these revascularization procedures at Beth Israel Deaconess Medical Center’s (BIDMC) Smith Center for Outcomes Research in Cardiology to rigorously assess the procedures’ outcomes. Examining data that included more than 16,500 Medicare beneficiaries who underwent revascularization procedures in 2016, the researchers found no difference in long-term mortality between those treated with drug-coated stents and balloons compared with nondrug-coated devices. The team – led by Eric Secemsky, MD, MSc, Interventional Cardiologist and Director of Vascular Intervention at BIDMC – published their findings today in the JAMA Cardiology.

“Our findings confirmed what we had hypothesized – that there would be no difference in long-term mortality depending on the type of device used for revascularization,” said Secemsky. “Our findings support the safety of these drug-coated devices and their ongoing use in clinical practice.”

Secemsky and colleagues conducted their investigation in reaction to a December 2018 meta-analysis published in the Journal of the American Heart Association that, while demonstrating no difference in mortality between patients treated with drug-coated and nondrug-coated devices at one year after revascularization, found an increase in deaths among patients treated with drug-coated devices at two and five years post-procedure. The unexpected finding led to the halting of two ongoing clinical trials involving these devices and the Food and Drug Administration (FDA) to embark on a wide-spread safety review.

“The findings had major implications, but they had not yet been replicated in other data sources,” said Secemsky. “We are among the first groups to investigate this further and have now shown no mortality difference between device types in a Medicare population.”

This analysis was funded by the Smith Center for Outcomes Research in Cardiology. One of the study’s co-authors, Robert W. Yeh, MD, MSc, Director of the Smith Center for Outcomes Research in Cardiology at BIDMC, is an advisory board member for Abbott Vascular, Boston Scientific and Medtronic. The authors have completed and submitted the International Committee of Medical Journals Editors (ICMJE) Form for Disclosure of Potential Conflicts of Interest. Please refer to the journal for additional information.