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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On the basis of FAME 2, yrial would need to perform PCI in stable patients to prevent 9 urgent revascularizations — only 4 coruage 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 couragge risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. 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.

Optimal medical therapy with or without PCI for stable coronary disease. There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke 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.

Thursday, September 13, – This randomization process will reduce referral bias.

Fame 2 Update | The ISCHEMIA Study

coyrage 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. With an anticipated 8, subjects followed for an average of 3. Breaking News Cardiology Journal Club. Submit a Question for courqge Panel Optional. Recruitment was halted prematurely tral 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: 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.

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The primary endpoint was a composite of death, MI, or urgent revascularization.

The trial trual and consent were finalized after FAME 2 announced its decision to halt recruitment. During a mean follow up of 4. In both trials there was no difference between treatment groups in the incidence of death or MI. In FAME 2, Boden and colleagues compared outcomes by patient sex and treatment assignment after adjustment for relevant baseline characteristics. Enter the email you used to register to reset your password. Boden WE et al. 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.

Chronic CAD patients usually develop collaterals and aggressive revascularization may risk reperfusion injury of the myocardium already adjusted to lower oxygen load.

Therefore, patients were clinically referred for cath and neither the physicians nor investigators were blinded to the coronary anatomy of vourage randomized to the medical-therapy group.

In the NEJM paper, the researchers reported an unadjusted hazard ratio of 0. For the subanalysis, Dr.

Copyright Massachusetts Medical Society. Revascularization at the drop of the hat became the in thing for interventional cardiologists, without taking into consideration the courgae of collateral circulation, degree of coronary reserve and the risk of reperfusion injury.

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Fame 2 Update

I hope this study will raises public awareness of the routine overuse of revascularization as a primary treatment modality for coronary heart disease. The nemj was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group see Table. Secondary endpoints included hospitalization for acute coronary syndrome, stroke, rates of MI and death.

The new adjusted analysis, Dr. These are the most important components of the FAME 2 primary endpoint composite. Nat Clin Pract Cardiovasc Med. Both of the study groups received optimization of medical therapy, including aspirin along with aggressive lipid and blood pressure lowering.

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. There were primary events in the PCI group and events in the medical-therapy group.

What I find surprising is the surprised reaction of many commentators. 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. 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.