October 09, 2019
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Another study finds no evidence of increased long-term mortality with paclitaxel-coated devices

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Eva Freisinger

Patients who underwent endovascular revascularization with a paclitaxel-based drug-eluting device did not have an increased mortality risk over an 11-year follow-up period, according to a safety analysis published in the European Heart Journal.

“Our findings now show on a large-scaled, real-world analysis on almost 65,000 patients that paclitaxel-based devices do not increase long-term mortality after its peripheral application,” Eva Freisinger, MD, senior physician in the department of cardiology at University Hospital Muenster in Germany, told Healio.

The debate on paclitaxel-coated devices was spurred in late 2018 after a meta-analysis found that the devices were associated with a long-term death risk in patients with peripheral artery disease. The FDA confirmed the findings in its own analysis.

The FDA’s Circulatory System Devices Panel met in June 2019 to discuss the signal of a late mortality risk associated with the devices, which resulted in the agency allowing the devices to remain on the market but with updated product labeling. Clinical trials were also recommended to be designed to follow patients long term and to improve adjudication of deaths. The latest action by the FDA was in August 2019, when the agency advised clinicians to discuss the risks of paclitaxel-coated devices with patients.

The present study is consistent with U.S. retrospective analyses from CMS data that have not shown any elevated mortality risk associated with paclitaxel-coated devices.

German health insurance data

Researchers analyzed data from 64,771 patients (mean age, 72 years; 45% women) who underwent 107,112 endovascular revascularization procedures with 23,137 drug-eluting devices between 2007 and 2015. Patients were categorized by their first endovascular revascularization procedure: drug-eluting stent (n = 676), drug-coated balloon (n = 2,648), bare-metal stent (n = 28,290) and percutaneous transluminal angioplasty (n = 33,157).

Follow-up was conducted until death or until December 2017 for a median of 92 months.

Although the use of paclitaxel-based DES were associated with increased hazards after 4 years, the link with increased long-term mortality was not statistically confirmed for up to 11 years after application, with an HR between 0.64 and 1.1 (P for all > .057).

During the first year, the use of DCBs was linked with decreased mortality (HR = 0.92; P < .001). There was an indifferent correlation in the years after its application (P for all > .202).

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Potential implications

Freisinger told Healio that she thinks that this evidence may aid in the agency’s decision on the use of these devices. “We expect that official authorities like the FDA and The Federal Institute for Drugs and Medical Devices will soon react on these new results and adapt their statements on paclitaxel-based drug-eluting devices,” she said. “Based on our results, drug-eluting devices should be able to be applied where indicated without concern of late-term mortality associated with its use.”

Even those these results may have an impact on decision-making, more research is needed in this area, Freisinger said. “The whole debate on this safety issue points at the need of critical surveillance of medical devices even after its introduction on the market and its regular use in everyday practice,” Freisinger added. “Administrative databases are a suitable approach to answer these demands for real-world evidence and will be of use for similar questions in the future. Particularly high-risk cohorts that are usually excluded from the pivotal trials should be object of further investigation.” – by Darlene Dobkowski

For more information:

Eva Freisinger, MD, can be reached at eva.freisinger@ukmuenster.de.

Disclosures: Freisinger reports she received grants from Bayer and Pfizer. Please see the study for all other authors’ relevant financial disclosures.