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COURAGE causes stir over the importance of PCI
In patients with stable CAD, PCI did not provide benefit when added to optimal medical therapy.
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NEW ORLEANS — The first coronary angioplasty was performed in 1977 for stable coronary artery disease.
“Since that time, interventional cardiology has flourished amidst profound technological advances and continued evolution of more increasingly sophisticated catheter-based approaches,” said William Boden, MD, professor of medicine and public health and medicine at University at Buffalo School of Medicine and Biomedical Sciences.
“Percutaneous coronary intervention [PCI] has become common in the initial management of symptomatic patients with stable CAD in North America even though current treatment guidelines continue to advocate the role of aggressive medical therapy, risk factor reduction and lifestyle intervention,” Boden said.
PCI is now performed more than 1 million times a year in the United States alone, the majority of which are elective among patients with stable CAD.
While PCI is known to improve survival when done to restore blood flow in the early hours after acute myocardial infarction (MI), no study has examined the ability of PCI to improve outcomes above optimal medical therapy (OMT) in patients with stable CAD.
The Clinical Outcomes Utilizing Percutaneous Revascularization and Aggressive Guideline-Driven Drug Evaluation (COURAGE) trial did just that, and prompted experts to question the utility of percutaneous coronary intervention among stable patients.
“Percutaneous coronary intervention has very little value to offer in such patients,” said Salim Yusuf, MD, professor of medicine at McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada, during a panel discuss following the presentation of COURAGE at the 56th Annual American College of Cardiology Scientific Sessions here. “It doesn’t affect mortality. It doesn’t affect MI, does not prevent hospitalization for angina or strokes. If anything it may increase the risk of early MI. The COURAGE study is the fourth study to demonstrate that PCI in such patients is ineffective, except for a small impact on angina that is short-lived.”
PCI/OMT or OMT alone
Researchers enrolled 2,287 patients at 50 U.S. and Canadian hospitals between June 1999 and January 2004. They randomly assigned patients to either PCI and OMT (n=1,149) or OMT (n=1,138).
Results showed a similar 4.6-year cumulative primary event rate of death, MI or stroke among both populations (19% for PCI and OMT vs. 18.5% for OMT; HR 1.05; 95% CI, 0.87-1.27). There were 211 primary events in the percutaneous coronary intervention group vs. 202 in the OMT group.
Overall survival was similar (7.6% for percutaneous coronary intervention and OMT vs. 8.3% OMT; HR 0.87; 95% CI, 0.65-1.16); as was survival free of hospitalization for acute coronary syndromes (11.8% OMT vs. 12.4% percutaneous coronary intervention and OMT; HR 1.07; 95% CI, 0.84-1.37) and survival free of MI (12.3% OMT vs. 13.2% percutaneous coronary intervention and OMT; HR 1.13; 95% CI 0.89-1.43).
“As initial management strategy in patients with stable coronary artery disease, [percutaneous coronary intervention] did not reduce the risk of death, MI or other major cardiovascular events as compared with optimal medical therapy alone,” Boden said. “As expected, [percutaneous coronary intervention] resulted in better angina relief during most of the follow-up period but medical therapy was also remarkably effective with no between-group difference in angina-free status at five years.”
Per the health status and economic outcomes of COURAGE, William S. Weintraub, MD, the John H. Ammon Chair of Cardiology and director of the Christiana Center for Outcomes Research, Del., said, “Compared to OMT, [percutaneous coronary intervention] and OMT as a first choice of therapy for stable CAD is extremely expensive.”
PCI still has a role
Despite Yusuf’s statement that percutaneous coronary intervention is of little value as initial therapy for people with stable CAD, he said the COURAGE data does not undermine the value of percutaneous coronary intervention in acute MI.
“That stands,” he said, supporting studies for high-risk patients with unstable angina undergoing revascularization that includes both [percutaneous coronary intervention] and coronary artery bypass graft.
“Let’s not forget that the group of patients with ST segment elevation MI, with non-ST segment acute coronary syndromes and the high-risk refractory ischemic symptomatic patients continue to benefit from angioplasty. I don’t want that message to be lost,” said panelist Robert A. Harrington, MD, director of the Duke Clinical Research Institute.
“The reason for the extensive use of [percutaneous coronary intervention] is not based on scientific proof, nor related to proven medical benefit; instead it is sociological,” he said. “And we all suspect [it] but we don’t want to say it – it is also driven by economic force. It’s really time to confront this because the practice of medicine in this instance has been seriously misguided.”
The ACC will consider sanctions. – by Judith Rusk
For more information:
- Boden WE. A randomized trial of percutaneous coronary intervention added to optimal medical therapy in patients with stable coronary heart disease: Results of the Clinical Outcomes Utilizing Revascularization and Aggressive Guideline-Driven Drug Evaluation (COURAGE) trial.
- Weintraub WS. Quality of life and economic outcomes in the Clinical Outcomes Utilizing Percutaneous Coronary Revascularization and Aggressive Guideline-Driven Drug Evaluation (COURAGE) trial.
- Both presented during late-breaking clinical trials III at: The 56th Annual American College of Cardiology Scientific Sessions; March 25-27, 2007; New Orleans.