Percutaneous coronary intervention plus optimal medical therapy was not more effective than medical therapy alone in stable CADPDF
ACP J Club. 2007 Jul-Aug;147:12. doi:10.7326/ACPJC-2007-147-1-012
Clinical Impact Ratings
Boden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356:1503-16. [PubMed ID: 17387127]
In patients with stable coronary artery disease (CAD), is percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) more effective than OMT alone for preventing cardiovascular events?
Design: Randomized controlled trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE] trial).
Allocation: Unclear allocation concealment.*
Blinding: Blinded (outcome adjudication committee).*
Follow-up period: Median 4.6 years (range 2.5 to 7.0 y).
Setting: 50 centers in the United States and Canada.
Patients: 2287 patients (mean age 62 y, 85% men) with stable CAD (stenosis ≥ 70% in ≥ 1 proximal epicardial coronary artery and objective evidence of myocardial ischemia, or ≥ 1 coronary stenosis ≥ 80% and classic angina without provocative testing). Exclusion criteria included persistent class IV angina, a markedly positive stress test, refractory heart failure or cardiogenic shock, ejection fraction < 30%, revascularization in ≤ 6 months, and coronary anatomy not suitable for PCI.
Intervention: PCI (with bare-metal stents in most patients) plus OMT (antiischemic therapy, aggressive therapy to optimize lipid levels, and a lifestyle intervention) (n = 1149) or OMT alone (n = 1138).
Outcomes: Composite endpoint of death or nonfatal myocardial infarction (MI). Secondary outcomes were a composite endpoint of death, MI, or stroke; hospitalization for unstable angina with negative biomarkers; and additional revascularization procedures.
Patient follow-up: 91% (intention-to-treat analysis).
Groups did not differ for the composite endpoint of death or MI; the composite endpoint of death, MI, or stroke; or hospitalization for unstable angina (Table). Risk for additional revascularization procedures was lower in the PCI plus OMT group (Table).
In patients with stable coronary artery disease, initial management with percutaneous coronary intervention plus optimal medical therapy was not more effective than optimal medical therapy alone for preventing cardiovascular events.
Sources of funding: U.S. Department of Veterans Affairs; Canadian Institutes of Health Research; Merck; Pfizer; Bristol-Myers Squibb; Fujisawa; Kos Pharmaceuticals; Datascope; Astra-Zeneca; Key Pharmaceutical; Sanofi-Aventis; First Horizon; GE Healthcare.
For correspondence: Dr. W.E. Boden, Buffalo General Hospital, Buffalo, NY, USA. E-mail firstname.lastname@example.org.
Table. Percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) vs OMT alone in stable coronary artery disease at median 4.6 years†
|Outcomes||PCI plus OMT||OMT alone||RRI (95% CI)||NNH|
|Death or MI||19.0%||18.5%||4.5% (−12 to 24)||Not significant|
|Death, MI, or stroke||20.0%||19.5%||4.5% (−12 to 23)||Not significant|
|Hospitalization for ACS||12.4%||11.8%||6.5% (−15 to 34)||Not significant|
|RRR (CI)||NNT (CI)|
|Additional revascularization||21%||33%||35% (25 to 44)||9 (7 to 13)|
†MI = myocardial infarction; ACS = acute coronary syndrome; other abbreviations defined in Glossary. RRI, RRR, NNH, NNT, and CI calculated from hazard ratios in article.
Most MIs occur from minimally occlusive CAD (1). Thus, it is not surprising that PCI of high-grade CAD is more effective than medical therapy in relieving angina pectoris but not in reducing MI or death in patients with chronic stable CAD (2). However, many clinicians refer patients with stable CAD to PCI without attempting OMT, for fear of litigation should the patient have an MI without PCI. The results of the COURAGE trial by Boden and colleagues suggest that these fears are unfounded. Although approximately 30% of patients randomized to OMT had subsequent PCI, the incidence of death or MI did not differ between groups. Early in the trial, a small decrease in prevalence of angina was shown in patients randomized to PCI; however, by 5 years results for the 2 groups were similar.
Some critics have pointed out that the use of drug-eluting stents in COURAGE was suboptimal; however, no evidence exists that drug-eluting stents decrease the incidence of death or MI compared with bare-metal stents. Others say that the results are less applicable to non–Veterans Administration centers. Yet others object to the decision for randomization being made after a diagnostic coronary angiogram was done—once the angiogram reveals a stenosis suitable for PCI according to guidelines, they claim that the risk associated with PCI is small, and the patient will benefit from immediate relief of angina. However, if one follows current guidelines for evaluation of patients with stable CAD (3) and excludes those with severe left ventricular dysfunction, evidence of left main CAD, or the acute coronary syndrome, most patients should be safely controlled on OMT, as defined in COURAGE. Such patients need to be referred for angiography only if they show evidence of progressive angina or myocardial ischemia. Even in patients with the acute coronary syndrome, the ICTUS trial recently suggested that a strategy of selective, symptom-determined angiography and revascularization may be as good as routine revascularization (4).
Only time will tell whether we can put the interests of our patients above our own economic interests and have the courage to implement OMT, as defined in COURAGE, with its resultant cost savings. If we fail this challenge, we risk having the decision imposed upon us, which would probably not benefit our patients or ourselves.
Bertram Pitt, MD
University of Michigan School of Medicine
Ann Arbor, Michigan, USA
1. Ambrose JA, Fuster V. The risk of coronary occlusion is not proportional to the prior severity of coronary stenoses [Editorial]. Heart. 1998;79:3-4. [PubMed ID: 9505906]
2. Katritsis DG, Ioannidis JP. Percutaneous coronary intervention versus conservative therapy in nonacute coronary artery disease: a meta-analysis. Circulation. 2005;111:2906-12. [PubMed ID: 15927966]
3. Smith SC Jr., Feldman TE, Hirshfeld JW Jr., et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention—summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to update the 2001 Guidelines for Percutaneous Coronary Intervention). Catheter Cardiovasc Interv. 2006;67:87-112. [PubMed ID: 16355367]
4. Hirsch A, Windhausen F, Tijssen JG, et al. Long-term outcome after an early invasive versus selective invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome and elevated cardiac troponin T (the ICTUS trial): a follow-up study. Lancet. 2007;369:827-35. [PubMed ID: 17350451]