TCTMD’s Top 10 Most Popular Stories for February 2019
Paclitaxel-based devices for PAD dominated the hottest news this month, followed by FDA actions, TAVR, DOAC dosing, and canakinumab’s retreat.
The top 10 stories on TCTMD this month were dominated by news about the mortality signal—or lack thereof—with paclitaxel-based balloons and stents in the treatment of PAD. Other hot topics included a range of US Food and Drug Administration alerts related to an Impella RP (Abiomed) investigation, the Orsiro stent (Biotronik) approval, and a pacemaker recall; a feature story exploring the fizzling future of canakinumab (Novartis) in CVD; an analysis of DOAC underdosing; and two new TAVR analyses.
The latest wallop to this fraught field came in the form of a correction notice showing a higher death rate for DES-treated patients at 5 years.
Interim results of a postapproval study show poorer survival compared with premarket studies, so the agency is digging deeper.
Medtronic says a “programming error” was responsible for 2- and 3-year mortality data not making it into the real-world global analysis.
The CANTOS sponsor has given up on a CV indication for its monoclonal antibody, leaving some to ask if marketing trumped medicine.
Fear of bleeding that drives lower dosing has origins in the warfarin era, but that’s not relevant for the newer agents, one expert says.
The extent of cardiac damage at baseline strongly correlated with both post-TAVR mortality and the risk of cardiac and noncardiac readmissions.
According to an FDA recall notice, the action affects 13,440 devices in the United States.
The metallic, sirolimus-eluting stent with a bioresorbable polymer has a strut thickness of just 60 µm for the 2.25- and 3.0-diameter devices.
Although the long-term analysis was underpowered, the difference between the devices had not been seen at 12 months.
Both studies followed patients beyond 5 years, finding low rates of clinically significant valve degeneration and failure.