TCTMD’s Top 10 Most Popular Stories for January 2019

Fallout from the December 2018 meta-analysis showing a late mortality signal with paclitaxel-based balloons and stents in PAD—including two paused trials, a US Food and Drug Administration “Dear Doctor” letter, and pushback from industry and investigators—continued to hold TCTMD readers’ attention this month. Other FDA activity also grabbed headlines, with yet another antihypertensive drug recall, an advisory committee meeting on the gout drug febuxostat, and a newly approved TAVR device.

Two TCTMD features rang in the new year: an exploration of veterinarian-cardiologist teamwork and our rundown of physicians’ picks for the news that rocked their fields in 2018. Other topics to make the Top 10 list for January 2019 were operator radiation exposure in relation to the rising obesity epidemic and the long-running dispute over the choice between ACE inhibitors and angiotensin receptor blockers (ARBs).

1. FDA Alerts Doctors to Potential Late Risks With Paclitaxel-Coated Balloons and Stents in PAD

The “Dear Doctor” letter noted that the FDA is following up on a recent meta-analysis pointing to increased mortality and urges close reporting of events.

2. FDA: Contaminated Irbesartan Now Under Voluntary Recall

Not unlike the prior valsartan recalls, one company recalled the irbesartan lots because of contamination with a possible carcinogen.

3. Rover’s Regurgitation: Veterinarian-Cardiologist Teamwork Could Speed Device Innovation, Training

Beloved household dogs develop many of the same structural heart diseases as people—why aren’t we fixing those to learn more about human therapy?

4. Industry, Investigators Push Back With Patient-Level Data Showing No Increased Death From Paclitaxel-Based PAD Therapies

Major device manufacturers presented new numbers at the LINC meeting, amid news that an independent, pooled patient-level analysis is in the works.

5. Year in Review: Physicians Pick the Biggest News of 2018

TCTMD reporters asked a range of experts about developments that rocked their fields in 2018 and may profoundly affect patients in years to come.

6. Time for Guidelines to Recommend ARBs Over ACE Inhibitors?

The long-running dispute as to the supremacy of these two drug classes should be put to bed once and for all, say the authors of a new review.

7. Febuxostat Emerges Relatively Unscathed After FDA Advisory Committee Review

Concerns about CV risk are prompting calls to update the label, but most panel members said the drug has a favorable risk-benefit balance.

8. Operators’ Radiation Exposure in the Cath Lab Directly Tied to Patient BMI

The interventional community should be doing more to promote radiation safety during the ongoing obesity epidemic, new data suggest.

9. Two Trials Halted in Wake of Study Linking Paclitaxel-Coated Devices to Deaths in PAD

A special meeting will be held in the coming months to review the issue. The lead author says he’s pleased endovascular specialists are taking it seriously.

10. FDA Clears Next-Generation Sapien 3 Ultra TAVR Valve

This latest-iteration transcatheter heart valve features design changes and a new delivery system.