NEW YORK (Reuters Health) – Deferring percutaneous coronary intervention (PCI) and treating high-risk heart disease patients with optimal medical therapy alone does not increase the risk of death, MI, or worsening angina, a large multicenter study shows.

There is, however, a high rate of crossover to revascularization, according to the report in the American Journal of Cardiology for October 15.

“Our findings suggest…that even among patients with acute coronary syndrome that have stabilized, an initial conservative approach with aggressive medical therapy can be elected and PCI deferred until dictated by persistent or progressive symptoms, without an increased risk of cardiovascular events or detriment to the quality of life,” lead author Dr. David J. Maron, from Vanderbilt University, Nashville, and colleagues state.

Subjects in the study, all participants in the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial, were randomized to receive optimal medical therapy alone or combined with PCI. The main findings from the study, reported in 2007, indicated that both approaches had comparable rates of death and MI.

The present post hoc analysis focused on 264 patients who were considered high risk due to the onset of class III angina within 2 months or stabilized acute coronary syndrome within 2 weeks before enrollment. Compared with the other 2023 patients in the study, those in the high risk group had a 56% increased risk of death or MI during 4.6 years of follow-up (p = 0.0008).

Consistent with the main study findings, no significant difference in death or MI rates was noted in high-risk patients based on the treatment approach received. A total of 35 events were logged in the medical therapy-only group versus 32 in the medical therapy plus PCI group. Similarly, 1-year angina rates were comparable in each group.

The medical therapy-only approach was, however, linked to high rates of cross-over to revascularization; 30% at 1 year, 42% during the median follow-up period of 4.6 years.

“The very high crossover rate observed in patients assigned to optimal medical therapy alone calls into question the wisdom of withholding PCI when >40% of such patients will ultimately require revascularization,” the authors state. It would be preferable to be able to identify, a priori, which high-risk patients will require revascularization for symptom control and tailor the therapy accordingly.”

Reference:
Am J Cardiol 2009;104:1055-1062.