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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In the NEJM paper, the researchers reported an unadjusted hazard ratio of 0. Boden WE et al. Secondary endpoints included hospitalization for acute coronary syndrome, stroke, rates of MI and death. What I find surprising is the surprised reaction of many commentators. Chronic CAD patients usually develop collaterals and aggressive revascularization may risk reperfusion injury of the myocardium already adjusted to lower oxygen load.
Knowing the coronary anatomy may have been a driver of early revascularization procedures in the medical therapy groups of both trials. Breaking News Cardiology Journal Club. Half of the patients undergoing urgent revascularization had no objective evidence of ischemia i. Boden ckurage no relevant conflicts of interest.
In summary, this study reveals that PCI offers no benefit over nem 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.
Optimal medical therapy with or without percutaneous coronary intervention in women with stable coronary disease: 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: The new adjusted analysis, Dr.
We conducted a randomized trial involving patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.
COURAGE – Wiki Journal Club
The trial protocol and consent were finalized after FAME 2 announced its decision to halt recruitment. During a mean follow up of 4. 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 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. Patients in whom all stenoses had an FFR of more than 0. Both of the study groups received optimization of medical therapy, including aspirin along with aggressive lipid and blood pressure lowering. 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.
N Engl J Med. If other, please specify. The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2. This study is consistent with everything we know about chronic stable coronary heart disease, i.
Fame 2 Update
If COURAGE had included revascularization procedures as part of its primary endpoint, there would have tria significantly more endpoint events in the medical therapy group at a comparable time period. 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.
The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group see Table. For the subanalysis, Dr. The primary endpoint was a composite of death, MI, or urgent revascularization. You need to document perfusion defect with Myocardial Perfusion Imaging Stress Thallium as popularly known and of course take into account the clinical evaluation of the individual patient.
Revascularization at the drop 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. 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. As noted by 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.
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. Submit a Question for the Panel Optional. In patients with 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 hrial.
There were primary events tial the PCI group and events in the medical-therapy group. Thursday, September 13, – Hospitalization for heart failure, even though it was not a prespecified endpoint, is an outcome of interest because it has nej shown to powerfully predict adverse troal in patients with stable CAD and preserved ejection fraction, he commented. Enter the email you used to register to reset your password. Women Often Shortchanged Dr. Copyright Massachusetts Medical Society.
The mean follow-up was only 7 months, even though the original design was to follow patients for 1 year. 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.
Boden and colleagues compared outcomes by patient sex and treatment assignment after adjustment for relevant baseline characteristics.
Optimal medical therapy with or without PCI for stable coronary disease.
Nat Clin Pract Cardiovasc Med. Freedom from angina at 60 months was similar in men and women regardless of treatment courxge. In FAME 2, 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.
All secondary outcomes and individual components of the primary outcomes showed no significant differences between the study groups. N Engl J Med Mar 27; [pub ahead of print]. 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.
Two thirds of the patients had multi-vessel disease. 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.
Comment in N Engl J Med.