Recent cardiology trials raise questions about percutaneous coronary intervention

Robert Roswell

NEW ORLEANS — The ORBITA trial has “thrown the cardiology world upside down,” a presenter here at the American College of Physicians Internal Medicine Meeting said.

“We are at a fascinating time in the history of cardiology and the role of percutaneous coronary interventions in cases of stable ischemic heart disease,” Robert Roswell, MD, FACC, FACP, director of the outpatient cardiology department at Bellevue Hospital in New York City told Healio Family Medicine.

He said ORBITA was comprised 200 patients with single vessel disease and angina who received “a very intense” optimization medical therapy phase and assessed participants’ responses to questions about their angina through validated surveys and correlation with stress echoes.

“What [trial organizers] did, that has never been done in cardiology before, is then they blindly assigned patients to receive cardiac catherization with percutaneous coronary interventions and cardiac intervention as a sham procedure, where nothing was actually done,” Roswell said, adding that ORBITA showed no statistical significant difference between the two groups in both primary and secondary outcomes.

“This trial was groundbreaking. There is now a lot of debate of what [percutaneous coronary interventions] are doing for patients,” he told meeting attendees. “We really need to reevaluate the way we approach percutaneous coronary interventions and trial designs. Every trial that looked at [percutaneous coronary interventions] probably has to be redone or reconfigured to include sham controls.”

The ISCHEMIA has also raised significant questions about how patients with moderate to severe ischemia respond to percutaneous coronary interventions.

The trial will involve about 8,000 patients and determine the best way to manage stable ischemic heart disease in patients with moderate or severe ischemia, with or without stress imaging, with patients being randomly assigned to optimal medical therapy or percutaneous coronary interventions.

ISCHEMIA organizers also prespecified that if the trial had too many participants with left vein disease they would change or add to the endpoints, which Roswell said the trial organizers ultimately had to do.

“There has been uproar in the cardiovascular community about changing those endpoints and debate over whether the trial is going to be negative before it’s even published,” Roswell said, saying data from the ISCHEMIA trial should become available next year.

“When [data] does become available, it will be the end all, be all of whether [percutaneous coronary intervention] has a role in mortality for heart disease. Meantime, the whole world is buzzing and talking about that we thought these interventions were doing a benefit, [and that may have been wrong].”

“With evolving data, it is clear that optimal medical therapy should be fully implemented,” Roswell said in the interview. “Percutaneous coronary interventions may have a role, but after all other alternatives have been tried.” – by Janel Miller

References:

Ischemiatrial.org. https://www.ischemiatrial.org/. Accessed April 19, 2018.

Roswell R. Evaluation of Cardiac Chest Pain and Chronic Management of Angina. Presented at: American College of Physicians Internal Medicine Meeting; April 17-21, 2018; New Orleans.

Disclosure: Roswell reports no relevant financial disclosures.