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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COURAGE Substudy: PCI Adds No Overall Benefit to OMT Alone in Either Women or Men |
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 nem patients with stable disease as long as medical therapy is optimized and maintained. Comment in N Engl J Med. Therefore, patients were clinically referred nem cath and neither the physicians nor investigators were blinded to the coronary anatomy of patients randomized to the medical-therapy group.
If other, please specify. The mean follow-up was only 7 months, even though the original design was to follow patients for 1 year. There were no cpurage differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke On the nemm 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 Mejm changes — without reducing the incidence of death or MI.
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. This randomization process will reduce referral bias. Between andwe assigned patients to undergo PCI with optimal medical therapy PCI group and to receive optimal medical therapy alone medical-therapy group. N Engl J Med Mar 27; [pub ahead of print].
Optimal medical therapy with or without PCI for stable coronary disease.
With an anticipated 8, subjects followed for an average of 3. 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 ciurage online in the New England Journal of Medicine.
The difference was driven by a lower rate cokrage 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. All secondary outcomes and individual components of the primary outcomes showed no significant differences between the study groups.
The results from the study are surprising and somewhat unexpected.
In the NEJM paper, the researchers reported an unadjusted hazard ratio of 0. The new adjusted analysis, Dr. 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 couragd adjusted to lower oxygen load.
The trial protocol and consent were finalized after FAME 2 announced its decision to halt recruitment. As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial tdial, or other major cardiovascular events when added to optimal medical therapy. For the subanalysis, Dr. Breaking News Cardiology Journal Club.
COURAGE – Wiki Journal Club
Boden and colleagues compared outcomes grial patient sex and treatment assignment after adjustment for relevant baseline characteristics. Also, survival advantage has been demonstrated for revascularization, and particularly with CABG for important patient subgroups—this is based mainly on anatomic features, despite stable symptomatology. Freedom from angina at 60 months was similar in men and women regardless of treatment strategy. These are the most important components of the FAME 2 primary endpoint composite.
Although there was a statistically significant difference in the rate of patients who were free from angina between the study groups at 1 and 3 bejm, this difference was not significant at baseline or at 5 years of follow-up.
Additionally, on the Seattle Angina Questionnaire SAQboth the angina-related physical limitation and the angina frequency scores indicated poorer health status at vourage in women. Enter the email you used to register to reset your password. 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.
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 nehm had a primary endpoint event: Knowing the coronary anatomy may have been a driver of early revascularization procedures in the medical therapy groups of both trials.
At a median follow-up of 4. The primary outcome of the study was a composite outcome of death from any cause and non-fatal myocardial infarction. This study is consistent with everything we know about chronic stable coronary heart disease, i.