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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The authors of the study explain their results, in part, by the physiologic differences between vulnerable plaques which rupture and are associated with acute coronary syndromes and more fibrous plaques that can cause luminal narrowing and anginal symptoms in patients with stable disease such as those in enrolled in this study.
Fame 2 Update | The ISCHEMIA Study
For the subanalysis, Dr. Between andwe assigned patients to undergo PCI with optimal medical therapy PCI group and to receive optimal medical therapy alone medical-therapy group. Boden reports no relevant conflicts of interest. There were primary events in the PCI group and events in the medical-therapy group. Freedom from angina at 60 months was similar in men and women regardless of treatment strategy. This study is consistent with everything we know about chronic stable coronary heart disease, i.
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. N Engl J Med.
Although there was a statistically cuorage difference in the rate of patients who were free from angina between the study groups at 1 and 3 years, this difference was not significant at baseline or at 5 years of follow-up. The results from the study are surprising and somewhat unexpected.
Optimal medical therapy with or without percutaneous coronary intervention in women with stable coronary disease: Boden WE ccourage al. The COURAGE Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation trial was a randomized trial involving patients with stable but significant coronary artery disease who were randomized to either undergo PCI using bare metal stents or to receive optimal medical therapy alone.
Women also had higher LVEF, fewer diseased coronary vessels, and higher baseline HDL but worse kidney function and a slightly longer duration of angina. Half of the patients undergoing urgent revascularization had no objective evidence of ischemia i. Submit a Question for the Panel Optional. The new adjusted analysis, Dr. 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.
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.
We conducted a enjm trial involving patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U. The trial protocol and consent were finalized after FAME 2 announced its decision to halt recruitment.
Optimal medical therapy with or without PCI for stable coronary disease.
What I find surprising is the surprised reaction of many commentators. In FAME 2, 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. SAQ angina frequency score improved equally for both sexes over time with either treatment, although OMT patients overall improved less than those who also received PCI. Copyright Massachusetts Medical Society.
Secondary endpoints included hospitalization for acute coronary syndrome, stroke, rates of MI and death. With an anticipated 8, subjects followed coutage an average of 3. N Engl J Med Mar 27; [pub ahead of print]. If other, please specify. Commentary by Cara Litvin, PGY-3 The results of one of the more remarkable studies from the meeting of the American College of Cardiology were presented on Monday, along with the simultaneous early publishing of the study online in the New England Journal of Medicine.
The primary endpoint was a composite of death, MI, or urgent revascularization. The primary outcome was hejm from any cause and nonfatal myocardial infarction during a follow-up period of 2.
COURAGE – Wiki Journal Club
The mean follow-up was only 7 months, even though the original design was to follow patients for 1 year. 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. Both of the study groups received optimization of medical therapy, including aspirin along with aggressive lipid and blood pressure lowering. In the NEJM paper, the researchers reported an unadjusted hazard ratio of 0.
Women Often Shortchanged Dr.
The COURAGE Trial: PCI is not superior to medical therapy in patients with stable coronary disease
All secondary outcomes and individual components of the primary courag showed no significant differences between the study groups. However, women appeared to benefit more from PCI than men in terms of MI, hospitalization for heart failure, and need for subsequent revascularization table 1. Chronic CAD patients usually develop collaterals and aggressive revascularization may risk reperfusion injury of the myocardium already adjusted coourage lower oxygen load.
Revascularization at the drop of the hat became the in thing for interventional cardiologists, without taking into nekm 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 death or MI.
As noted by Dr. Comment in N Engl J Med.
This randomization process nemm reduce referral bias. There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke