Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent

The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors.

In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people treated with Cook Medical‘s Zilver PTX stent was 10.2% and 16.9% for the PTA group. But the correction reversed those numbers.

“We understand this is upsetting and we know that we made an error. We’ve corrected it. The numbers in one sentence of the article were transposed and an incorrect diagram was used. We welcome collaborative, transparent conversations about long-term patient outcomes,” Cook Medical wrote on Twitter.

Also this month, Medtronic (NYSE:MDT) reported that it inadvertently omitted mortality data for patients treated with its In.Pact Admiral paclitaxel-coated balloon in two analyses.

The data troubles for paclitaxel devices come as researchers are trying to better understand the long-term safety of paclitaxel-coated and paclitaxel-eluting devices. Earlier this year, a meta-analysis published in the Journal of the American Heart Association suggested that patients treated with paclitaxel devices for PAD could be at a higher risk for late death compared to people treated with uncoated devices.

Device-makers like Medtronic and Boston Scientific (NYSE:BSX) have stood behind the use of their paclitaxel products in PAD patients in the wake of these reports.

The FDA wrote a letter to healthcare providers after the meta-analysis was published in JAHA, saying that the “benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use.”

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