By Annette M. Boyle
BOSTON—In a move that reanimated a long-standing controversy in cardiology, a recently published study supports and extends the findings of landmark research done by the VA more than a decade ago. The debate centers on the value of percutaneous coronary intervention (PCI) for stable coronary artery disease (CAD). The findings are especially important because that procedure is so widely practiced at the VA and elsewhere.
In the COURAGE study in 2007, VA researchers demonstrated that percutaneous coronary intervention (PCI) neither reduced the risk of myocardial infarction nor provided a greater survival benefit to patients with stable angina than optimized medical therapy.1 A follow-up to COURAGE found that PCI plus medical therapy produced no survival benefit compared to medical therapy alone, even after 15 years.2
The new ORBITA trial published in November in The Lancet showed that PCI also did not improve exercise time, a common proxy for symptom improvement, or reduce patient reported physical limitation, angina frequency or angina stability more than placebo.3
“ORBITA addresses the last sacred cow. In the years leading up to COURAGE, everyone thought PCI would reduce myocardial infarction and death. Then, they said we do it to reduce angina,” said the lead author of the COURAGE trial, William Boden, MD, scientific director, clinical trials network, Massachusetts Veterans Epidemiology Research and Information Center at the VA New England Healthcare System. “But in a sham-controlled study, could they show benefit? They couldn’t.”
The results of the study have important implications for practice at the VA. A study published this fall in the Journal of the American Heart Association found that 59.6% of veterans with newly diagnosed obstructive coronary artery disease identified through elective coronary angiograms had revascularization within 30 days. Of those, two-thirds had PCI, although the rate of PCI varied substantially among the 51 facilities included, ranging from 23.2% to 80.6%.4
That study “found no major clinical differences in patient demographics and comorbidities between VA hospitals more and less likely to pursue revascularization” rather than medical therapy alone, the authors said.
“Outside of acute presentations of CAD or the diagnosis of 3‐vessel, left main, or proximal LAD coronary disease that confers a mortality benefit with revascularization, current guidelines suggest reservation of revascularization for medically refractory, stable, ischemic heart disease,” they noted. But they also acknowledged that physician and patient preferences, patient symptoms and angiographic findings factor into the decision to proceed with PCI, as may a tendency to “overemphasize the benefits of PCI in management of stable obstructive CAD.”
The ORBITA trial calls into question two frequent reasons for PCIs—relief of angina and patient quality of life. The trial randomized 200 patients with stable angina, 105 received PCI and 95 had a placebo procedure. All had more than 70% single-vessel stenoses and had experienced angina for an average of nine months. Lesions had a mean area of stenosis of 84.4%. Patients had fractional flow reserve of 0.69, and 69% had significant left anterior descending (LAD) coronary artery disease; 98% of patients were Canadian Cardiovascular Society angina severity grade 2 or 3.
All participants had six weeks of medication optimization followed by either PCI with drug-eluting stents or the sham procedure. All received dual antiplatelet therapy prior to and following the procedure. Neither patients nor physicians outside the catheter laboratory staff, who had no further contact with patients, knew who had PCI or placebo.