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.
Between andwe assigned patients to undergo PCI with optimal medical therapy PCI group and to receive optimal medical therapy alone medical-therapy group. Patients in whom all stenoses had an FFR of more than 0.
The mean follow-up was only 7 months, even though the original design was to follow patients for 1 year. This study is consistent with everything we know about chronic stable coronary heart disease, i.
The primary outcome of the study was a composite outcome of death from any cause and non-fatal myocardial infarction. 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.
COURAGE Substudy: PCI Adds No Overall Benefit to OMT Alone in Either Women or Men |
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. We conducted a randomized trial involving patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.
The results of one trual 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.
Breaking News Cardiology Journal Club. In FAME 2, If other, please specify.
Comment in N Engl J Med. Boden reports no relevant conflicts of interest.
Fame 2 Update
The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2. 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. 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.
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. Copyright Massachusetts Medical Society.
Secondary endpoints included hospitalization for acute coronary syndrome, stroke, rates of MI and death. During a mean follow up of 4. 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.
In the NEJM paper, the researchers reported an unadjusted hazard ratio of 0. N Engl J Med Mar 27; [pub ahead cojrage print]. 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.
The COURAGE Trial: PCI is not superior to medical therapy in patients with stable coronary disease
N Engl J Med. 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. Thursday, September 13, – As an initial management strategy in patients with stable coronary artery disease, PCI trkal not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.
What is ccourage newsworthy about the FAME 2 results is that there was no difference in the rates of death or MI between treatment groups.
The results from the study are surprising and somewhat unexpected. Knowing the coronary anatomy may have been a driver of early revascularization procedures in the medical therapy groups of both trials. Recruitment was halted prematurely after enrollment of patients randomized and enrolled in the registry because of a significant between-group difference in the percentage of patients who had a primary endpoint event: There were primary events in the PCI group and events in the medical-therapy group.
For the subanalysis, Dr. Women also had higher LVEF, fewer diseased coronary vessels, and higher baseline HDL but worse kidney function and a slightly longer duration of angina.