Based Upon the Results of the COURAGE Clinical Trial, What Is the Best Treatment for Stable Angina?

Based Upon the Results of the COURAGE Clinical Trial, What Is the Best Treatment for Stable Angina?

Raymond J. Gibbons, MD; George D. Lundberg, MD

Medscape General Medicine. 2007;9(4):49. ©2007 Medscape

Posted 12/05/2007


Dr. Lundberg: It was a forerunner of a lot of good things. Let's talk about cardiology, and let's talk about angina pectoris: stable, unstable. Stable is more common?

Dr. Gibbons: Stable is much more common, and I think it's of more current interest. Our management of stable angina has obviously consisted of medications. But we knew from randomized trials in bypass surgery conducted 20 years ago that certain patients with very severe problems, particularly left main disease and 3-vessel disease with prior abnormal ventricular function, benefited from surgery from the standpoint of survival. As percutaneous coronary intervention [PCI] came along, we thought that patients who had less severe coronary artery disease probably would benefit, from the standpoint of survival and myocardial infarction, from PCI.



Dr. Lundberg: That's sensible.

Dr. Gibbons: And that was incorporated into national guidelines. This year, however, there have been 2 studies that have been published, OAT and COURAGE, that have both challenged that assumption. I think the study that is most pertinent to chronic stable angina is COURAGE. In a large trial conducted in the VA [Veterans Administration], certain other academic medical centers in the United States, including my own, and Canada, the investigators showed that with optimal medical therapy.



Dr. Lundberg: Okay. What do you call that? What is optimal medical therapy?

Dr. Gibbons: Well, previous trials had focused on just relieving angina. That trial had a different comprehensive approach: risk factor reduction. They just didn't treat angina, they also treated the risk factors very aggressively, and did very well even after 5 years at meeting targets for LDL [low density lipoprotein], for blood pressure, getting patients to stop smoking, getting them to exercise. And compared to optimal therapy, optimal therapy plus PCI did not convey an advantage with respect to heart attack or death. That was news, challenging the assumption that we had all along. It has led to a decrease, already, in the use of stents in the country. And I think it poses a challenge for practicing physicians to do as well with medical therapy in treating risk factors and symptoms, as occurred in the trial.



Dr. Lundberg: And of course, one of the things they have to do is handle patient compliance in terms of long-term use of whatever they're supposed to do.

Dr. Gibbons: I think they need to be very clear on educating the patient about the importance of, not just treatment for their chest pain, but treatment for the plaque and underlying coronary artery disease to prevent events. The patients have to understand the importance of taking aspirin, the importance of lowering their cholesterol to appropriate targets -- ideally an LDL of less than 100 -- and also not to smoke.



Dr. Lundberg: Of course, we live in a society with a medical-industrial complex with huge amounts of money that flow through the system into lots of people's pockets. If you're going to do surgery, or if you're going to do percutaneous stent implants, etc, it probably accrues a lot more money to people who are doing it, and it costs the insurance companies and the government a lot more to do that. So, there must be a tension developing there.

Dr. Gibbons: There's a clear tension, and I think there is an undercurrent of concern raised about the trial. For example, there's a tendency to point out there was a modest difference in pain relief, but it was modest. It was less than 10% of the patients had more complete pain relief by PCI at a year, and that [number] diminished over subsequent management of the patients. And a very comprehensive quality-of-life cost-effectiveness analysis presented here at the American Heart Association meeting this year by Dr. Weintraub, an expert in cost-effectiveness, showed that no matter what assumption you made, the effect on quality of life was minimal and very cost-ineffective.



Dr. Lundberg: So, for a stable angina at this time, optimal medical therapy is the best way to go?

Dr. Gibbons: It's clearly the best way to go. The challenge for all of us in the healthcare system is to do the best job we can of getting patients to comply with guideline-indicated medications.



Dr. Lundberg: There you are. Thank you all for being with us today. We've been talking with Dr. Raymond Gibbons, professor of medicine at the Mayo Clinic College of Medicine and a former president of the American Heart Association. Thank you for being with us. And thank you for being with us.


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Readers are encouraged to respond to the author at gibbons.raymond@mayo.edu or to Paul Blumenthal, MD, Deputy Editor of MedGenMed, for the editor's eyes only or for possible publication as an actual Letter in MedGenMed via email: pblumen@stanford.edu
Raymond J. Gibbons, MD, Arthur M. and Gladys D. Gray Professor of Medicine, Mayo Clinic, Rochester, MinnesotaGeorge D. Lundberg, MD, Editor-in-Chief, Medscape General Medicine; Adjunct Professor of Health Policy, Harvard School of Public Health, Boston, Massachusetts; Consulting Professor, Stanford University School of Medicine, Stanford, CaliforniaAuthor's email: gibbons.raymond@mayo.edu

Stent implants in U.S. declined in April - Wall Street Journal

Stent implants in U.S. declined in April-WSJ

Thu May 17, 2007 4:41am ET


NEW YORK, May 17 (Reuters) - The number of coronary stents implanted in the United States dropped in April, the Wall Street Journal reported on its Web site on Thursday, citing a market research firm.

Stents are tiny wire mesh tubes used to prop open diseased heart arteries. Stent makers include Boston Scientific Corp. (BSX.N: Quote, Profile , Research), Abbott Laboratories (ABT.N: Quote, Profile , Research) and Johnson & Johnson (JNJ.N: Quote, Profile , Research).

Doctors performed about 71,200 stentings in April, the Journal reported, citing estimates from Millennium Research Group, a Toronto firm that surveys about 140 U.S. hospitals. The number was down more than 10 percent from March and more than 15 percent from a year earlier, it said.

The Journal cited doctors as saying that the drop was an unusually quick response to a study showing the devices provided little advantage over drug therapy in some patients.


Wall Street Journal - FREE PREVIEW

Stent Implants Declined in April

By Keith J. Winstein

Companies Featured in This Article: Boston Scientific, Abbott Laboratories, Johnson & Johnson
The number of coronary stents implanted in the U.S. dropped sharply in April, according to a leading market researcher, in what doctors said was an unusually quick response to a study showing the devices provided little advantage over drug therapy in some patients.

The new figures are the latest evidence that the tiny scaffolds used to prop open arteries are no longer a powerful growth engine for the medical industry. Americans spent at least $14 billion on coronary-stent procedures last year, including surgical and hospital fees. World-wide sales of the devices totaled about $6 billion.

Doctors performed about 71,200 stentings ...

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COURAGE no NEJM

Recém publicado:

Abstrast and Full Text: FREE.

New England Journal of Medicine
Volume 356:1503-1516 April 12, 2007 Number 15

Optimal Medical Therapy with or without PCI for Stable Coronary Disease

Full Text: http://content.nejm.org/cgi/content/full/356/15/1503

Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial.

Resultado do Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial.
Publicado noNew England Journal of MedicinePublished at www.nejm.org March 26, 2007 (10.1056/NEJMoa070829) Optimal Medical Therapy with or without PCI for Stable Coronary Disease

William E. Boden, M.D., Robert A. O’Rourke, M.D., Koon K. Teo, M.B., B.Ch., Ph.D., Pamela M. Hartigan, Ph.D., David J. Maron, M.D., William J. Kostuk, M.D., Merril Knudtson, M.D., Marcin Dada, M.D., Paul Casperson, Ph.D., Crystal L. Harris, Pharm.D., Bernard R. Chaitman, M.D., Leslee Shaw, Ph.D., Gilbert Gosselin, M.D., Shah Nawaz, M.D., Lawrence M. Title, M.D., Gerald Gau, M.D., Alvin S. Blaustein, M.D., David C. Booth, M.D., Eric R. Bates, M.D., John A. Spertus, M.D., M.P.H., Daniel S. Berman, M.D., G.B. John Mancini, M.D., William S. Weintraub, M.D., for the COURAGE Trial Research Group

RESUMO:
Background: Permenece uma incerteza se em pacientes com Doença Arterial Coronariana (DAC) estável, a utilização de métodologia invasiva como a Intervenção Coronariana Percutânea (PCI) associada a terapia farmacológica e intervenção no estilo de vida (terapia médica ótima) é superior a terapia médica ótima (TMO) isoladamente na redução de eventos

Métodos: Os pesquisadores conduziram um trial randomizado envolvendo 2287 pacientes com evidência de isquemia miocárdica e DAC em 50 centros americanos e canadenses. Entre 1999 e 2004 foram especificados 1149 pacientes para serem submetidos a PCI com terapia médica ótima e 1138 para receber apenas terapia médica ótima. O desfecho primário foi morte por qualquer causa e não-fatal infarto do miocárdio durante um follow-up de 2.5 a 7.0 anos (média de 4.6 anos)

Resultados: Aconteceram 211 eventos primários no grupo PCI e 202 eventos no grupo TMO. A taxa de eventos cumulativos de 4.6 anos foi de 19% no grupo PCI e 18.5% no grupo TMO (Hazard Ratios para o grupo PCI, 1.05; 95% intervalo de confiança [IC], 0.87 to 1.27; p=0.62). Não houveram diferenças significativas entre o grupo PCI e o grupo TMO na composição de mortes, infarto do miocárdio e acidente vascular encefálico (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI 0.87 to 1.27; p=0.62); hospitalização para síndromes coronarianas agudas (12.4% vs. 11.8%; hazard ratio 1.07; 95% CI 0.84 to 1.37; p=0.56; ou infarto do miocárdio ((13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33).

Conclusão: PCI quando associado a TMO não reduz o risco de morte, infarto do miocárdio ou outros eventos cardiovasculares maiores, quando utilizado como terapêutica inicial em pacientes com DAC estável. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov] .)

Texto completo desse artigo: http://content.nejm.org/cgi/content/full/NEJMoa070829v1

The results COURAGE trial were presented at the American College of Cardiology, 27 March 2007 annual scientific sessions being held in New Orleans, Louisiana, and were published simultaneously advance online by the New England Journal of Medicine.