Chronic stable angina COURAGE trial: Difference between revisions
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The COURAGE 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 which occured between 1999 and 2004, that assessed the benefits of [[PCI]] as an initial treatment strategy in patients with [[Chronic stable angina pathophysiology|stable angina]] but with significant underlying [[coronary artery disease]]. | The COURAGE 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 which occured between 1999 and 2004, that assessed the benefits of [[PCI]] as an initial treatment strategy in patients with [[Chronic stable angina pathophysiology|stable angina]] but with significant underlying [[coronary artery disease]]. | ||
===Study Population=== | |||
A total of '''2,287''' patients were randomized to either '''PCI''' (1,149 patients) which consisted of [[PCI]] with optimal medical therapy or '''medical therapy''' (1,138 patients) which consisted of upfront optimal medical therapy alone. It should be noted that medical therapy patients could cross over to [[PCI]]. | |||
===Treatment Strategies=== | |||
====PCI==== | |||
The trial has been criticized because the [[PCI]] patients were treated predominantly with [[bare metal stents]] and only 15% of the patients were treated with [[drug eluting stents]]. | |||
====Optimal Medical Therapy==== | |||
All patients who were randomized to optimal medical therapy alone 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 received [[aspirin]] along with aggressive lipid and [[Chronic stable angina treatment blood pressure control|blood pressure]] lowering as a part of optimal medical therapy. | |||
==Study 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 Classifications of Angina Pectoris|Canadian Cardiovascular Society CCS class II or III angina]]). Approximately, two thirds of the patients had multi-vessel disease. | |||
:*There was no significant difference reported in the primary event rate between the two treatment groups during the 4.6 | ===Exclusion Criteria=== | ||
Patients were excluded if they had [[Canadian Cardiovascular Society Classifications of Angina Pectoris|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 percent, or coronary lesions deemed unsuitable for [[PCI]]. | |||
==Primary Endpoint== | |||
The '''primary endpoint''' of the study was the composite endpoint of death from any cause or non-fatal [[MI]]. The duration of follow-up was 2.5 to 7 years. The median follow-up was 4.6 years. | |||
:*There was no significant difference reported in the primary endpoint event rate between the two treatment groups during the median follow-up of 4.6 years (range 2.5 to 7 years):19% in the PCI group and 18.5% in the medical therapy group, P=0.62). | |||
:*The secondary end points included hospitalization for [[acute coronary syndrome]], [[stroke]], rates of [[MI]] and death. There was no significant difference observed between the 2 groups. However, patients in the PCI group underwent significantly fewer subsequent revascularization procedures (21 versus 33 percent, HR 0.60, 95% CI 0.51-71). | :*The secondary end points included hospitalization for [[acute coronary syndrome]], [[stroke]], rates of [[MI]] and death. There was no significant difference observed between the 2 groups. However, patients in the PCI group underwent significantly fewer subsequent revascularization procedures (21 versus 33 percent, HR 0.60, 95% CI 0.51-71). | ||
Revision as of 20:40, 22 July 2011
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Clinical Outcomes Utilizing Revascularization and AGgressive Drug Evaluation (COURAGE) trial
The COURAGE trial [1], was a large-scale randomized multicenter, multinational trial which occured between 1999 and 2004, that assessed the benefits of PCI as an initial treatment strategy in patients with stable angina but with significant underlying coronary artery disease.
Study Population
A total of 2,287 patients were randomized to either PCI (1,149 patients) which consisted of PCI with optimal medical therapy or medical therapy (1,138 patients) which consisted of upfront optimal medical therapy alone. It should be noted that medical therapy patients could cross over to PCI.
Treatment Strategies
PCI
The trial has been criticized because the PCI patients were treated predominantly with bare metal stents and only 15% of the patients were treated with drug eluting stents.
Optimal Medical Therapy
All patients who were randomized to optimal medical therapy alone 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 received aspirin along with aggressive lipid and blood pressure lowering as a part of optimal medical therapy.
Study 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 percent, or coronary lesions deemed unsuitable for PCI.
Primary Endpoint
The primary endpoint of the study was the composite endpoint of death from any cause or non-fatal MI. The duration of follow-up was 2.5 to 7 years. The median follow-up was 4.6 years.
- There was no significant difference reported in the primary endpoint event rate between the two treatment groups during the median follow-up of 4.6 years (range 2.5 to 7 years):19% in the PCI group and 18.5% in the medical therapy group, P=0.62).
- The secondary end points included hospitalization for acute coronary syndrome, stroke, rates of MI and death. There was no significant difference observed between the 2 groups. However, patients in the PCI group underwent significantly fewer subsequent revascularization procedures (21 versus 33 percent, HR 0.60, 95% CI 0.51-71).
- The COURAGE trial also addressed the issue of whether patients who receive PCI plus optimal medical therapy have a better quality of life and less angina than those who receive optimal medical therapy alone.
- The rate of patients who were free from angina between the 2 groups at 1 and 3 years was statistically significant (74% patients who underwent PCI were angina free at 5 years in comparison to the 72% patients who received medical therapy alone, P=0.35).
- However, there was no statistically significant difference noted at baseline, or at 3 year follow up.
- 22% patients who underwent PCI were angina free at baseline.
- 53% patients who underwent PCI were angina free versus 42% patients who received medical therapy alone noted at 3-month.
- However, there was no significant difference between the 2 groups observed at 36 months (59% patients who underwent PCI versus 56% who received medical therapy alone).
- Patients in both groups showed significant improvements from baseline values in various measures of quality of life.
- At 6-month follow up, the percent of patients with clinically significant improvement in the parameters such as physical limitation, angina stability, angina frequency, and overall quality of life was significantly higher in the PCI group in comparison to that of the medical group.
- However, there was no significant difference in these rates at 36 months.
- The results of COURAGE trail demonstrate that no benefit was observed with revascularization by PCI over aggressive medical management when performed in patients with chronic stable angina and suggest that PCI may be deferred as long as medical therapy is optimized and maintained in patients with chronic stable disease.
Meta-analyses reflecting the results of COURAGE trial
- A meta-analysis [2] analyzed 61 eligible randomized trials that compared at least two of the four interventions (PTCA, BMS, DES, and medical therapy) in patients who experienced non-acute coronary artery disease that was observed in a study population of 25,388 patients. The study reported no statistically significant difference between the rates of death and MI in patients treated with either PCI or medical therapy.
- Another recent meta-analysis [3] analyzed 14 randomized trials that compared the degree of relief from angina in 7,818 patients with stable coronary artery disease treated with either PCI or medical therapy alone. The study reported that PCI offered a greater benefit on angina relief (odds ratio, 1.69 [95% CI, 1.24 to 2.30]) in comparison to that of medical therapy. However, this benefit was largely observed in recent trials that used more of evidence-based medications.
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