COURAGE TRIAL NEJM PDF

It has not been clearly established whether percutaneous coronary intervention ( PCI) can provide an incremental benefit in quality of life over that provided by. tee and the members of the COURAGE. Trial Executive Committee are provided in the Supplementary Appendix, avail- able at was evaluated in the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) trial, in which patients were randomly.

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Between andwe assigned patients to undergo PCI with optimal medical therapy PCI group and to receive optimal medical therapy alone medical-therapy group. Therefore, patients were clinically referred for cath and neither the physicians nor investigators were blinded to the coronary anatomy of patients randomized to the medical-therapy group.

Copyright Massachusetts Medical Society.

The primary outcome of the study was a composite outcome of death from any cause and non-fatal myocardial infarction. As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other courge cardiovascular events when added to optimal medical therapy.

The primary endpoint was a composite of death, MI, or urgent revascularization. Patients in whom all stenoses had an FFR of more than 0. Additionally, on the Seattle Angina Questionnaire SAQboth the angina-related physical limitation and the angina frequency scores indicated poorer health status at baseline in women. There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial trjal, and stroke Freedom from angina at 60 months was similar in men and women regardless of treatment strategy.

Boden Vourage et al.

Optimal medical therapy with or without PCI for stable coronary disease.

Women Often Shortchanged Dr. In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of nej, coronary intervention PCI with intensive pharmacologic therapy nejmm lifestyle intervention optimal medical therapy is superior to optimal medical therapy alone in reducing the risk of cardiovascular events.

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Secondary endpoints included hospitalization for acute coronary syndrome, stroke, rates of MI and death. What is particularly newsworthy about the FAME 2 results is that there was no difference in the rates of death or MI between treatment groups.

On the basis of FAME 2, one would need to perform PCI in stable patients to prevent 9 urgent revascularizations — only 4 of which have positive biomarkers or ECG changes — without reducing the incidence of death or MI.

Nat Clin Pract Cardiovasc Med. All secondary outcomes and individual components of the primary outcomes showed no significant differences between the study groups.

COURAGE – Wiki Journal Club

Boden reports no relevant conflicts of interest. Two thirds courrage the patients had multi-vessel disease. In the NEJM paper, the researchers reported an unadjusted hazard ratio of 0.

What I find surprising is the surprised reaction of many commentators. There were primary events in the PCI group and events in the medical-therapy group. The mean follow-up was only 7 months, even though the original design was to follow patients for 1 year.

At a median follow-up of 4. N Engl J Med.

Fame 2 Update

Optimal medical therapy with or without PCI for stable coronary disease. You need to document perfusion defect with Myocardial Perfusion Imaging Stress Thallium as popularly known and of course take into account the clinical evaluation of the individual patient.

N Engl J Med Mar 27; [pub ahead of print]. Hospitalization for heart failure, even though it was not a prespecified endpoint, is an outcome of interest because it has been shown to powerfully predict adverse outcomes in patients with stable CAD and preserved ejection fraction, he commented.

In summary, this study reveals that PCI offers no benefit over aggressive medical management when performed in patients with stable coronary artery disease, and suggests that PCI may be deferred in patients with stable disease as long as medical therapy is optimized and maintained.

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Enter the email you used to register to reset your password. Half of the patients undergoing urgent revascularization had no objective evidence of ischemia i.

In both trials there was no difference between treatment groups in the incidence of death or MI. Compared with men enrolled in COURAGE, women were older 64 vs 62 years oldmore likely to be white and to have a family history of CAD, and less likely to have had prior revascularization.

Submit a Question for the Panel Optional. The new adjusted analysis, Dr. During a mean follow up of 4. The trial protocol and consent were finalized after FAME 2 announced its decision to halt recruitment. This randomization process will reduce referral bias.

Women also had higher LVEF, fewer diseased coronary vessels, and higher baseline HDL but worse kidney function and a slightly longer duration of angina. In FAME 2, Optimal medical therapy with or without percutaneous coronary intervention in women with stable coronary disease: If other, please specify. If COURAGE had included revascularization procedures as part of its primary endpoint, there would have been significantly more endpoint events in the medical therapy group at a comparable time period.

Optimal medical therapy with or without PCI for stable coronary disease.

Breaking News Cardiology Journal Club. I hope this study will raises public awareness of the routine overuse of revascularization as a primary treatment modality for coronary heart disease.

Comment in N Engl J Med. Thursday, September 13, –