Investigators hit pause on trials following concerns over paclitaxel-coated devices

A meta-analysis published in the Journal of the American Heart Association last week suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons.

The results of the study prompted investigators for two trials to stop their studies. Meanwhile, leaders in the endovascular community have promised to hold a special forum to discuss the study’s findings.

Led by Dr. Konstantinos Katsanos, researchers looked at data from 28 trials and discovered that there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices after two years and a 93% relative risk increase after five years compared to therapy with an uncoated balloon.

The lead researcher told TCTMD that he was happy with the community’s response to his study.

“The role of regulatory agencies like the FDA is also very important here, and I know that a lot of people – including myself – are eagerly waiting for clarifications and a more in-depth assessment of the different devices,” he said.

In a notice to study centers, investigators for the Basil-3 trial wrote that recruitment for the study will be paused until January while a committee reviews the trial data.

“Whilst the population of the reviewed trials differs from those in the BASIL-3 trial, it is clearly important new information that may cause concerns for the BASIL-3 trial in relation to patient safety. As such, it raises the need to consider whether changes to the trial protocol and patient information are required. We have therefore decided to suspend recruitment to the trial, pending further discussions,” the researchers wrote.

Investigators for the Swedepad trial also stopped recruitment for its studies, citing Katsanos’ analysis.

Katsanos, however, told TCTMD that he is unsure why the investigators decided to hit pause on their trials.

“As long as there are no safety concerns from the study monitors, I personally believe that all clinical studies need to continue, as they may provide invaluable evidence to decide on the safety and effectiveness of paclitaxel treatments in general,” he told the news outlet. “In addition, it is imperative that already completed studies start collecting longer-term follow-up data of at least 2 years.”

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