Interpreting the COURAGE trial. PCI is no better than medical therapy for stable angina? Seeing is not believing.

Kereiakes, Dean J.

doi:10.3949/ccjm.74.9.637

Cited by 10 publications

(5 citation statements)

References 30 publications

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“…. .2 patient populations" (1 at high risk and 1 at low risk), which biased the conclusions against PCI (30,31). In fact, there is nothing suspicious about this pattern.…”

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confidence: 80%

“…If anginal frequency (f ) is log normally distributed, with mean and median m, then log(f ) is unimodal with mean log(m) and variance 2log(/m)(32). Given ϭ 10 and m ϭ 3, (as reported in the COURAGE trial[3,30]), 12.2% of patients are angina free (0 episodes per week) and 27.7% manifest more than daily angina (Ͼ7 episodes per week). In the COURAGE trial, 12.4% were angina free and 21.1% manifested New York Heart Association functional class III angina at baseline.…”

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confidence: 98%

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COURAGE Under Fire

Diamond

Kaul

2007

Journal of the American College of Cardiology

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The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial showed that coronary interventional procedures added little to optimal medical therapy with respect to the long-term outcome of patients with stable coronary disease when used as initial therapy. Detractors opine that: 1) the trial was unrealistic in design and the findings were not unexpected; 2) the use of coronary interventional procedures was suboptimal; and 3) the results of COURAGE are not applicable to current clinical practice. We herein reevaluate the evidence with regard to each of these points, and conclude that COURAGE indeed provides relevant new information to assist the practitioner in the appropriate management of patients with stable coronary disease.

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“…. .2 patient populations" (1 at high risk and 1 at low risk), which biased the conclusions against PCI (30,31). In fact, there is nothing suspicious about this pattern.…”

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confidence: 80%

mentioning

confidence: 98%

COURAGE Under Fire

Diamond

Kaul

2007

Journal of the American College of Cardiology

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“…Because event rates in COURAGE were lower than initially projected, Kereiakes et al 48 suggest that the trial was underpowered to evaluate the benefits of early revascularization. However, given the virtually identical event rates in both groups, it seems unlikely that any clinically meaningful benefit of revascularization was missed.…”

Section: Strengths and Limitations Of The Courage Trialmentioning

confidence: 97%

Management of stable patients with coronary heart disease: Clinical implications of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial

Brown

Bittner

2007

Journal of Clinical Lipidology

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“…The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial demonstrated no difference in mortality between patients with SCAD who were treated invasively and those who treated using optimal medical therapy [ 4 ]. Although the COURAGE trial was composed of a wider spectrum of patients than previous studies [ 5 – 11 ], there were concerns regarding its design, related to potential selection biases [ 12 ]. A meta-analysis by Boden et al [ 4 ] demonstrated that, in patients with SCAD, percutaneous coronary intervention did not offer any benefit in terms of mortality, incidence of myocardial infarction or need for subsequent revascularization over optimal medical therapy; however, a more recent meta-analysis by Windecker et al [ 13 ] provided evidence regarding improved survival with the use of new-generation drug-eluting stents as opposed to balloon angioplasty, bare metal stents or early-generation drug-eluting stents.…”

Section: Introductionmentioning

confidence: 99%

Who is eligible for randomized trials? A comparison between the exclusion criteria defined by the ISCHEMIA trial and 3102 real-world patients with stable coronary artery disease undergoing stent implantation in a single cardiology center

Wasilewski

Poloński

Lekston

et al. 2015

Trials

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BackgroundRandomized controlled trials are the gold standard for evaluating therapy; however, controversy exists regarding the applicability of such results to daily practice, as patients are often pre-selected and may not reflect real-world clinical settings. We studied the eligibility criteria for 3102 “real-life” patients with stable coronary artery disease (SCAD) according to the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial exclusion criteria. The aim of our analysis was to estimate the percentage of real-life patients who would have met the exclusion criteria for the ISCHEMIA trial.MethodsWe analyzed 3102 patients with SCAD referred to the Silesian Center for Heart Disease who underwent both coronary angiography and stent implantation between January 2006 and December 2011. The patients were divided into two groups. Group A was composed of patients with SCAD who would have been excluded from the ongoing ISCHEMIA trial, whereas group B represented the remaining patients.ResultsA total of 1900 (61.3 %) patients met at least one of the exclusion criteria. The most frequent exclusion criterion noted was revascularization within the previous 12 months (938 patients; 49.4 %), followed by unacceptable level of angina symptoms (532 patients; 28 %), low ejection fraction (467 patients; 24.6 %), and acute coronary syndrome within the previous 2 months (456 patients; 24 %). Patients from our cohort who would have been excluded from the ISCHEMIA trial were older, had more comorbidities, and experienced worse long-term outcomes.ConclusionsThe ISCHEMIA trial exclusion criteria ruled out the majority of the patients with SCAD undergoing percutaneous coronary intervention in “real life”. Our cohort of patients who would have been excluded from the ISCHEMIA trial had more comorbidities and experienced significantly worse long-term outcomes than patients who did not meet the ISCHEMIA trial exclusion criteria.Trial registrationClinicalTrials.gov NCT01471522.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0934-4) contains supplementary material, which is available to authorized users.

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Interpreting the COURAGE trial. PCI is no better than medical therapy for stable angina? Seeing is not believing.

Cited by 10 publications

References 30 publications

COURAGE Under Fire

COURAGE Under Fire

Management of stable patients with coronary heart disease: Clinical implications of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial

Who is eligible for randomized trials? A comparison between the exclusion criteria defined by the ISCHEMIA trial and 3102 real-world patients with stable coronary artery disease undergoing stent implantation in a single cardiology center

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