Clinical Outcomes Utilizing Revascularization And Aggressive Drug Evaluation: Difference between revisions
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==Overview== | ==Overview== | ||
The COURAGE (Clinical Outcomes Utilizing Revascularization and AGgressive Drug Evaluation) trial <ref name="pmid17387127">Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ et al. (2007) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=17387127 Optimal medical therapy with or without PCI for stable coronary disease.] ''N Engl J Med'' 356 (15):1503-16. [http://dx.doi.org/10.1056/NEJMoa070829 DOI:10.1056/NEJMoa070829] PMID: [http://pubmed.gov/17387127 17387127]</ref>, was a large-scale, randomized, multicenter, multinational trial conducted between 1999 and 2004. The trial compared the | The COURAGE (Clinical Outcomes Utilizing Revascularization and AGgressive Drug Evaluation) trial <ref name="pmid17387127">Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ et al. (2007) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=17387127 Optimal medical therapy with or without PCI for stable coronary disease.] ''N Engl J Med'' 356 (15):1503-16. [http://dx.doi.org/10.1056/NEJMoa070829 DOI:10.1056/NEJMoa070829] PMID: [http://pubmed.gov/17387127 17387127]</ref>, was a large-scale, randomized, multicenter, multinational trial conducted between 1999 and 2004. The trial compared the outcomes of [[PCI]] versus optimal medical therapy as the initial treatment strategy in patients with [[Chronic stable angina pathophysiology|stable angina]] and significant underlying [[coronary artery disease]] on cardiac catheterization. The rates of death and [[MI]] did not differ between the two groups, but [[PCI]] was associated with an improvement in [[quality of life]] measures and [[angina]]l symptoms for up to 3 years. | ||
==Study Population== | ==Study Population== | ||
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==Treatment Strategies== | ==Treatment Strategies== | ||
===PCI=== | ===PCI=== | ||
The trial has been criticized because 85% of the PCI patients were treated with [[bare metal stents]] while only 15% of the patients were treated with [[drug eluting stents]] which further reduce angiographic restenosis and modestly reduce symptomatic restenosis. | The trial has been criticized because 85% of the PCI patients were treated with [[bare metal stents]] while only 15% of the patients were treated with [[drug eluting stents]] which further reduce angiographic restenosis and modestly reduce symptomatic restenosis. On the other hand, it should be noted that only 11% of patients underwent repeat revascularization by one year, so the potential impact of drug eluting stents in further reducing revascularization may be modest. | ||
===Optimal Medical Therapy=== | ===Optimal Medical Therapy=== | ||
All patients randomized to upfront optimal medical therapy were treated with [[Chronic stable angina beta blocker therapy|beta blockers]], [[Chronic stable angina calcium channel blocker therapy|calcium channel blockers]], [[Chronic stable angina nitrate therapy|nitrates]], [[antiplatelet]] therapy (either [[Chronic stable angina treatment aspirin|aspirin]] or [[Chronic stable angina treatment clopidogrel|clopidogrel]]), and aggressive [[Chronic stable angina treatment anti-lipid agents|lipid-lowering therapy]] with [[statin]] (attained median [[LDL]]-[[cholesterol]] was 72 mg/dL at five years). [[Chronic stable angina treatment physical activity|Exercise]] was recommended to achieve further improvements in the lipid profile when necessary. | All patients who were randomized to upfront optimal medical therapy were treated with [[Chronic stable angina beta blocker therapy|beta blockers]], [[Chronic stable angina calcium channel blocker therapy|calcium channel blockers]], [[Chronic stable angina nitrate therapy|nitrates]], [[antiplatelet]] therapy (either [[Chronic stable angina treatment aspirin|aspirin]] or [[Chronic stable angina treatment clopidogrel|clopidogrel]]), and aggressive [[Chronic stable angina treatment anti-lipid agents|lipid-lowering therapy]] with [[statin]] (attained median [[LDL]]-[[cholesterol]] was 72 mg/dL at five years). [[Chronic stable angina treatment physical activity|Exercise]] was recommended to achieve further improvements in the lipid profile when necessary. | ||
===Both Groups=== | ===Both Groups=== | ||
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==Results== | ==Results== | ||
===Primary Endpoint=== | ===Primary Endpoint=== | ||
The primary endpoint of all cause mortality or non-fatal [[MI]] during a median follow-up of 4.6 years (range 2.5 to 7 years) did not differ between the two groups: 19% in the PCI group and 18.5% in the medical therapy group (p=0.62). | |||
===Secondary Endpoints=== | ===Secondary Endpoints=== | ||
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*However, patients in the PCI group underwent significantly fewer subsequent revascularization procedures (21 versus 33 percent, HR 0.60, 95% CI 0.51-71). | *However, patients in the PCI group underwent significantly fewer subsequent revascularization procedures (21 versus 33 percent, HR 0.60, 95% CI 0.51-71). | ||
*During the first two years of follow-up, PCI was associated with improved quality of life and less angina compared with optimal medical therapy alone. By three years, however, there was no difference in quality of life or angina | *During the first two years of follow-up, PCI was associated with improved [[quality of life]] and less [[angina]] compared with optimal medical therapy alone. By three years, however, there was no difference in quality of life or angina between the two strategies. | ||
==Meta-analyses Including the COURAGE trial that Compare Medical and PCI Therapy== | ==Meta-analyses Including the COURAGE trial that Compare Medical and PCI Therapy== | ||
Revision as of 09:52, 23 July 2011
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Chronic stable angina Microchapters | ||
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Classification | ||
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Differentiating Chronic Stable Angina from Acute Coronary Syndromes | ||
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Diagnosis | ||
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Alternative Therapies for Refractory Angina | ||
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Discharge Care | ||
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Guidelines for Asymptomatic Patients | ||
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Case Studies | ||
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Overview
The COURAGE (Clinical Outcomes Utilizing Revascularization and AGgressive Drug Evaluation) trial [1], was a large-scale, randomized, multicenter, multinational trial conducted between 1999 and 2004. The trial compared the outcomes of PCI versus optimal medical therapy as the initial treatment strategy in patients with stable angina and significant underlying coronary artery disease on cardiac catheterization. The rates of death and MI did not differ between the two groups, but PCI was associated with an improvement in quality of life measures and anginal symptoms for up to 3 years.
Study Population
2,287 patients with chronic stable angina were randomized to either PCI along with optimal medical therapy (n=1,149) or an initial strategy of medical therapy with cross-over to PCI as needed (n=1,138).
Treatment Strategies
PCI
The trial has been criticized because 85% of the PCI patients were treated with bare metal stents while only 15% of the patients were treated with drug eluting stents which further reduce angiographic restenosis and modestly reduce symptomatic restenosis. On the other hand, it should be noted that only 11% of patients underwent repeat revascularization by one year, so the potential impact of drug eluting stents in further reducing revascularization may be modest.
Optimal Medical Therapy
All patients who were randomized to upfront optimal medical therapy were treated with beta blockers, calcium channel blockers, nitrates, antiplatelet therapy (either aspirin or clopidogrel), and aggressive lipid-lowering therapy with statin (attained median LDL-cholesterol was 72 mg/dL at five years). Exercise was recommended to achieve further improvements in the lipid profile when necessary.
Both Groups
Both groups were treated aspirin along with aggressive lipid and blood pressure lowering as a part of optimal medical therapy.
Study Entry Criteria
Inclusion Criteria
Patients were required to have both objective evidence of ischemia and significant coronary heart disease in a least one vessel (87% were symptomatic and 58% had Canadian Cardiovascular Society CCS class II or III angina). Approximately, two thirds of the patients had multi-vessel disease.
Exclusion Criteria
Patients were excluded if they had CCS class IV angina, ≥50 percent left main disease, a markedly positive treadmill test (significant ST segment depressions and/or a hypotensive response during stage I of the Bruce protocol), an LVEF less than 30%, or coronary lesions deemed unsuitable for PCI.
Results
Primary Endpoint
The primary endpoint of all cause mortality or non-fatal MI during a median follow-up of 4.6 years (range 2.5 to 7 years) did not differ between the two groups: 19% in the PCI group and 18.5% in the medical therapy group (p=0.62).
Secondary Endpoints
- There was no significant difference in hospitalization for acute coronary syndrome, stroke, MI or death.
- However, patients in the PCI group underwent significantly fewer subsequent revascularization procedures (21 versus 33 percent, HR 0.60, 95% CI 0.51-71).
- During the first two years of follow-up, PCI was associated with improved quality of life and less angina compared with optimal medical therapy alone. By three years, however, there was no difference in quality of life or angina between the two strategies.
Meta-analyses Including the COURAGE trial that Compare Medical and PCI Therapy
A meta-analysis of 25,388 patients with stable coronary artery disease [2] who were enrolled in 61 randomized trials comparing at least two of the four interventions (PTCA, BMS, DES, and medical therapy) demonstrated no statistically significant difference in the rates of death and MI among patients treated with either PCI or medical therapy.
Another recent meta-analysis [3] compared the angina relief in 7,818 patients with stable coronary artery disease who were enrolled in 14 randomized trials comparing PCI and medical therapy. Similar to COURAGE, PCI was associated with greater angina relief than medical therapy (odds ratio, 1.69 [95% CI, 1.24 to 2.30]), particularly in recent trials.
References
- ↑ Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ et al. (2007) Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 356 (15):1503-16. DOI:10.1056/NEJMoa070829 PMID: 17387127
- ↑ Trikalinos TA, Alsheikh-Ali AA, Tatsioni A, Nallamothu BK, Kent DM (2009) Percutaneous coronary interventions for non-acute coronary artery disease: a quantitative 20-year synopsis and a network meta-analysis. Lancet 373 (9667):911-8. DOI:10.1016/S0140-6736(09)60319-6 PMID: 19286090
- ↑ Wijeysundera HC, Nallamothu BK, Krumholz HM, Tu JV, Ko DT (2010) Meta-analysis: effects of percutaneous coronary intervention versus medical therapy on angina relief. Ann Intern Med 152 (6):370-9. DOI:10.1059/0003-4819-152-6-201003160-00007 PMID: 20231568