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.
No Significant Improvement
At six weeks, PCI did not significantly improve exercise time, other exercise measures or patient-reported measures, including the Canadian Cardiovascular Society class or results of the Seattle Angina Questionnaire and EQ-5D-5L questionnaire compared to sham. Despite the lack of subjective improvement, the dobutamine stress echo wall-motion scores confirmed that PCI did substantially improve blood flow.
“ORBITA asked about symptom improvement and exercise duration, which are areas where PCI should have shown maximum benefit,” Boden said. And, the improvement should have been most notable immediately after the procedure, he added, suggesting, “PCI is woefully overused in many stable angina patients who would do just as well clinically with intensive medical therapy alone—and with far fewer complications from the angioplasty procedure and the increased bleeding due to the need to take anti-clotting drugs after the stent insertions for up to one year.”
Boden emphasized that the results of the studies should not be construed to mean that PCI is not a useful procedure. “It can be lifesaving in acute heart attack. There’s no debate there,” he said. “The faster you get to a cath lab and are opened up, the better off you’ll be.”
The clear benefit in acute myocardial infarction might be part of the problem, he posited, as patients could be expecting the same benefit from PCI in chronic angina, pointing out, “Patients have a totally naïve expectation of what PCI accomplishes.”
Physicians may feed into that confusion, he said, explaining, “No one says, ‘You have significant narrowing of a coronary artery. I may do a stent, and if I do, you will not live longer, avoid a future heart attack or necessarily feel better.’” Instead, patients typically see a significant blockage and think that fixing the obstruction will cure their disease, Boden stated.
“We need to explain the risks to patients in terms they understand,” he said. “Tell them they will need to take two blood thinners to prevent clotting off at the stent site, that 1% to 2% of patients have heart attacks afterward, 2% to 5% develop stent thrombosis and 30% require a repeat PCI.”
- Boden WE, O’Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. Epub 2007 Mar 26.
- Sedlis SP, Hartigan PM, Teo KK, Maron DJ, Spertus JA, Mancini GB, Kostuk W, Chaitman BR, Berman D, Lorin JD, Dada M, Weintraub WS, Boden WE; COURAGE Trial Investigators. Effect of PCI on Long-Term Survival in Patients with Stable Ischemic Heart Disease. N Engl J Med. 2015 Nov 12;373(20):1937-46.
- Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, Keeble T, Mielewczik M, Kaprielian R, Malik IS, Nijjer SS, Petraco R, Cook C, Ahmad Y, Howard J, Baker C, Sharp A, Gerber R, Talwar S, Assomull R, Mayet J, Wensel R, Collier D, Shun-Shin M, Thom SA, Davies JE, Francis DP; ORBITA investigators. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2017 Nov 1. pii: S0140-6736(17)32714-9.
- Sandhu A, Stanislawski MA, Grunwald GK, Guinn K, Valle J, Matlock D, Ho PM, Maddox TM, Bradley SM. Variation in Management of Patients With Obstructive Coronary Artery Disease: Insights From the Veterans Affairs Clinical Assessment and Reporting Tool (VA CART) Program. J Am Heart Assoc. 2017 Sep 12;6(9). pii: e006336.