TCTMD’s Top 10 Most Popular Stories for February 2019

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.

1. ‘Inadvertent Reversal’ of Late Mortality Data Flips Advantage From Paclitaxel Zilver PTX Stent in PAD to PTA

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.

2. FDA Warns Healthcare Providers of Potential Rise in Death Rate With Impella RP

Interim results of a postapproval study show poorer survival compared with premarket studies, so the agency is digging deeper.

3. Mortality Data ‘Inadvertently Omitted’ From IN.PACT Analysis of Paclitaxel-Coated Balloons

Medtronic says a “programming error” was responsible for 2- and 3-year mortality data not making it into the real-world global analysis.

4. Hopes Fade for a CV Indication for Canakinumab: What’s Next for the Inflammatory Hypothesis?

The CANTOS sponsor has given up on a CV indication for its monoclonal antibody, leaving some to ask if marketing trumped medicine.

5. Off-Label Underdosing of DOACs Tied to Worse Outcomes in A-fib Patients

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.

6. Aortic Stenosis Staging System Validated in Real-World, All-Comers Cohort

The extent of cardiac damage at baseline strongly correlated with both post-TAVR mortality and the risk of cardiac and noncardiac readmissions.

7. Class I Recall for Certain Medtronic Pacemakers Due to Possible Circuit Error

According to an FDA recall notice, the action affects 13,440 devices in the United States.

8. FDA Approves Orsiro Ultrathin-Strut Stent for CAD

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.

9. REAL PTX: Head-to-Head DCB, DES Data in PAD Show Trend Favoring Stenting at 36 Months

Although the long-term analysis was underpowered, the difference between the devices had not been seen at 12 months.

10. NOTION and UK TAVI Report Good Long-term Function of Transcatheter Aortic Valves

Both studies followed patients beyond 5 years, finding low rates of clinically significant valve degeneration and failure.