Dive Brief:

• A revised analysis of Medtronic's IN.PACT Admiral paclitaxel-coated balloon study has been accepted for publication in the Journal of the American College of Cardiology (JACC).
• Medtronic said in a statement Friday the authors of the study issued a correction letter addressing key revisions to the data prior to publication of the updated analysis.
• The company reiterated that the initial conclusions of the analysis remain intact and the data found no correlation between paclitaxel dosing level and long-term patient survival.

Dive Insight:

The data error prompting a revision to the IN.PACT study adds another complication to an ongoing debate about the long-term safety of drug-coated balloons to treat patients with peripheral artery disease (PAD).

FDA in January alerted physicians to the potential for an increased risk of death in patients with PAD two years after treatment with paclitaxel-coated balloons and paclitaxel-eluting stents. The agency sent a letter to physicians flagging the risk following publication in the Journal of the American Heart Association (JAHA) of a meta-analysis that observed the higher risk compared to patients treated with control devices such as non-coated balloons or bare metal stents.

Medtronic responded a week later with the release of five-year data from the IN.PACT Admiral study that showed no statistical difference in all-cause mortality between patients treated with the device and those who underwent plain balloon angioplasty.

Two weeks ago, Medtronic announced it had become aware of a programming error in the data for the two- and three-year follow-up periods in the IN.PACT study. Due to the error, mortality data was omitted from summary tables in the analysis.

A component of the meta-analysis will have to be updated, the company said, but the revised analysis still supports earlier conclusions that there was no statistically significant difference in all-cause mortality between the IN.PACT Admiral drug-coated balloon and plain balloon angioplasty at five years. Further, there is no correlation between paclitaxel dosing and long-term survival in the studied population, and there was no difference in mean nominal dose of paclitaxel between overall survival in patients treated with drug-coated balloons and those who died, Medtronic said.

The deaths were previously included in the company's database and complaint system and in study exit forms, and adjudicated by an independent committee, the company added.

The company also pointed to a separate study published Feb. 12 in JAMA Cardiology that found no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared to non-drug-coated devices.

Medtronic said the updated IN.PACT analysis was scheduled to be presented this past weekend, March 1-2, at the VIVA Physicians Vascular Leaders Forum in Washington.