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Improvements found in patients with ischemia receiving PCI
COURAGE: More patients had reduced inducible ischemia after PCI combined with optimal medical therapy.
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ORLANDO — Researchers examining a substudy within the Clinical Outcomes Utilizing Revascularization and Aggressive Guideline-Driven Drug Evaluation trial found greater reductions in ischemia for patients undergoing percutaneous coronary intervention along with optimal medical therapy, compared with patients who underwent optimal medical therapy alone.
“It should be emphasized that this sample size was powered to look at changes in ischemia and not powered to look at changes in event rates,” said Leslee J. Shaw, PhD, professor of medicine at Emory University, Atlanta, and member of the Health Policy, Patient and Practice Issues section of the Cardiology Today Editorial Board, at a press conference. “So this is exploratory and for the purposes of hypothesis generating.” The research was presented here at the American Heart Association 30th Annual Scientific Sessions.
PCI reduced ischemic burden
The researchers on the nuclear substudy enrolled 314 of the 2,287 COURAGE patients into either the PCI arm with optimal medical therapy (n=159) or the arm using optimal medical therapy alone (n=155). All patients underwent myocardial perfusion single photon emission CT imaging and then again at six- to 18-months of follow-up.
More patients showed improvements in ischemic burden in the PCI-plus-optimal-medical-therapy-group (33%) than in the group receiving optimal therapy alone (19%). Along with the reductions in ischemia, patients in the PCI-plus-optimal-medical-therapy group showed greater improvements in angina symptoms when compared with those receiving optimal medical therapy alone. Patients who had reductions in inducible ischemia also had proportional reductions in risk of death or MI, particularly if baseline ischemia was moderate to severe. Although the study power for prognosis was low, the observed results appeared to conflict with conclusions of the COURAGE trial.
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“The best take-home message is to aggressively treat ischemia by whatever means works, monitored by repeat noninvasive imaging.”“I think there is a general sense from the original COURAGE trial, looking at the entire population, that revascularization and PCI specifically didn’t seem to make any difference in terms of death and MI,” Bonnie H. Weiner, MD, professor of medicine and interim chair of cardiovascular medicine at St. Vincent Hospital, Worcester, Mass., told Cardiology Today. “However, when you start to look at the patients who really have significant ischemia, which is what the nuclear substudy helped define, then there was clearly a mortality benefit for PCI.”
Although the substudy was of limited power, the messages patients and cardiologists could take from the substudy are significant, according to Weiner.
“It is important that we make sure that the message that gets to patients isn’t ‘nobody needs PCI,’” Weiner said. “It is also important for physicians to recognize that if patient symptoms change or if they do have follow-up stress tests or some diagnostic study looking for ischemia, that those patients who have ischemia really ought to be considered for revascularization.” — Eric Raible
This is an interesting substudy that suggests that PCI may provide superior amelioration of significant ischemia, which would be anticipated to improve outcomes similar to what was demonstrated in the ACIP trial performed some number of years ago. This substudy cannot answer specifically the question of whether PCI or optimal medical therapy is superior for this due to all the usual reasons: selective substudy, low power and absence of randomization for this outcome. So the best take-home message is to aggressively treat ischemia by whatever means works, monitored by repeat noninvasive imaging.
— C. Noel Bairey Merz, MD