Debate on paclitaxel-coated stents continues; FDA releases 20-year data on medical devices

By PharmaCompass

2019-06-27

Impressions: 77 Article

Paclitaxel-coated devices, such as balloons and stents, received some bad press in late December 2018 after a meta-analysis showed an increased risk of death for patients treated with these devices.

Last week, after two days of presentations regarding the death risk that may be associated with paclitaxel-coated balloons and paclitaxel-eluting stents on the market and in clinical trials, FDA said it has a lot of work to do before any concrete decisions are made regarding the risk-benefit of the devices in question.

The FDA had conducted a preliminary analysis of long-term follow-up data (up to five years in some studies) of the pivotal premarket randomized trials for paclitaxel-coated products. Of the three trials with five-year follow-up data, each showed higher mortality in patients treated with paclitaxel-coated products. In total, among the 975 patients in these three trials, there was around 50 percent increased risk of mortality in subjects treated with paclitaxel-coated devices versus those treated with control devices (20.1 percent versus 13.4 percent crude risk of death at five years).

However, the FDA said the data should be interpreted with caution because there is large variability in the risk estimate of death due to the limited amount of long-term data, and because these studies were not originally designed to be pooled. Also, the agency noted that the specific cause and mechanism of the increased risk of death is unknown.

The FDA advisory committee has offered recommendations on how to use what is in place to understand mortality signals.

According to the panel, limited data on dose effect, toxicity and other potential factors have posed barriers for FDA and the industry to achieve a complete understanding of paclitaxel- or drug-coated balloons (DCBs) and paclitaxel- or drug-eluting stents (DESs) in peripheral arterial disease (PAD) patients.

Meanwhile, the FDA, which recently conducted its Alternative Summary Reporting (ASR) program for medical devices, made available on its website all adverse event reports received under ASR exemptions from 1999 to 2019.

With the agency’s release of more than six million records of ASR data over the last 20 years, FDA also made clear that users of the data should be cautious.

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