TCT.12: Miami sun shines light on clinical gray zones

The 24th annual Transcatheter Cardiovascular Therapeutics (TCT) conference took place in Miami for the first time this year, and the venue brought in a record-breaking approximate 12,000 attendees, according to TCT Chair Gregg W. Stone, MD.  

Over the course of the nearly weeklong meeting the focus remained on the science, as folks ignored the sun to attend packed sessions and trials. However, the late-breaking trials may have presented less concrete evidence-based medicine from which to make clear-cut clinical decisions, and presented more questions.

The blockbuster trials this year were RESPECT and PC, both of which failed to meet their primary endpoints. Despite the fact that these are clearly negative trials for employing percutaneous patent formulae ovale (PFO) closure for secondary prevention of thromboembolism or cryptogenic stroke, the physicians at TCT.12 spoke to the patient population.

“Patients age 20 to 54 are now a larger percentage of all stroke patients, and among first-ever strokes in the younger population there is growth in ischemic strokes,” explained RESPECT’s lead investigator John Carroll, MD, medical director of the Cardiac and Vascular Center at the University of Colorado in Denver.   

Because physicians must treat these relatively young patients over a lifetime after they’ve already had a first stroke, study panelist Alice B. Jacobs, MD, of Boston Medical Center, called the stroke reduction results “heartening,” compared with medical therapy.

Study panelist Ajay J. Kirtane, MD, told Cardiovascular Business that it comes down to discussing the risks and benefits with patients, if the device becomes available on the U.S. market. “We really don’t know what to do with these patients,” he added. “We really don’t know if medical therapy even works.”

Also, speaking to the young profile of this patient population, study panelist Ted E. Feldman, MD, of North Shore University Health System of Chicago, said that “doctors don’t treat numbers, we treat patients. If you’re facing a 25-year-old patient who’s had a stroke, and you discover a treatment that may result in an infrequent recurrence of another stroke, the conversation takes a different tone. Sometimes a disabling stroke can be more impactful than a mortality endpoint.”

These trials are different from CLOSURE I, which had a negative outcome and also saw an increase in serious adverse events, including atrial fibrillation. Also, the RESPECT and PC trials used the newer generation Amplatzer device, which the panelists agreed is a better device.

The use of PFO closure to prevent stroke is currently an off-label procedure in the U.S., as it’s not approved by the FDA. While the answer to this clinical question remains unclear, cardiologist experts at TCT.12 certainly were touting its potential for managing a difficult population. Now, it’s time for the FDA to weigh in on this clinical gray zone.

Next year’s meeting returns to San Francisco for its silver anniversary, and the science is sure to raise new and exciting questions—and maybe a few answers.

On these topics, or any others please feel free to contact me.

Justine Cadet, editorial director