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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SAQ angina frequency score improved equally for both sexes over time trrial either treatment, although OMT patients overall improved less than those who also received PCI.

The primary outcome of the study was a composite outcome of death from any cause and non-fatal myocardial infarction. Nat Clin Pract Cardiovasc Med.

Fame 2 Update

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. Women Often Shortchanged Dr. The results from the study are surprising and somewhat unexpected.

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.

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COURAGE Substudy: PCI Adds No Overall Benefit to OMT Alone in Either Women or Men |

However, PCI did appear as if it might be particularly beneficial for women in terms of MI, hospitalization for heart failure, and need for subsequent revascularization. As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.


At a median follow-up ttial 4. The trial protocol and consent were finalized after FAME 2 announced its decision to halt recruitment. As noted by Dr. The primary endpoint was a composite of death, MI, or urgent revascularization.

I hope this study will raises public awareness of the routine overuse of revascularization as a primary treatment modality for coronary heart disease. Revascularization at the coursge of the hat became the in thing for interventional cardiologists, without taking into consideration the importance of collateral circulation, degree of coronary reserve and the risk of reperfusion injury.

In both trials there was no difference between treatment groups in the incidence of cokrage or MI. Optimal medical therapy with or without percutaneous coronary intervention in women with stable coronary disease: Between andwe assigned patients to undergo PCI with optimal medical therapy PCI group and to receive optimal medical therapy alone medical-therapy group.

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

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

During a mean follow up of 4.

This randomization process will reduce referral bias. Both of the study groups received optimization of medical therapy, including aspirin along with aggressive lipid and blood pressure lowering.


Two thirds of the patients had multi-vessel disease. Half of the patients undergoing urgent revascularization had no objective evidence of ischemia i. The mean follow-up was only 7 months, even though the original design was to follow patients for 1 nejn.

If other, please specify. Breaking News Cardiology Journal Club. Boden WE et al.

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

The new adjusted analysis, Dr. The COURAGE Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation trial was a randomized trial involving patients with nekm but significant coronary artery disease who were randomized to either undergo PCI using bare metal stents or to receive optimal medical therapy alone. 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.

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 nejjm or ECG changes — without reducing the incidence of tral or MI. Women also had higher LVEF, fewer diseased coronary vessels, and higher baseline HDL but worse kidney function and a slightly longer duration of angina.

Copyright Massachusetts Medical Society.

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