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COURAGE - flawed trial as it compares optimum medical therapy with sub-optimum PCI

September 11, 2008

Analysis of:Heart Stents No Better Than Drugs for Chest Pain Over Time | www.bloomberg.com

There are major issues that need to be remembered when generalising the results of COURAGE trial 1.Patients with high grade anginal symptoms and strongly positive stress tests were excluded. Thus the COURAGE data applies to only the low risk subset of chronic stable angina 2. Optimum medical treatment with excellent compliance was employed in the medical treatment arm but sub-optimal treatment in the PCI arm - plain balloon angioplasty and bare metal stents. Though this may not matter in terms of mortality (though meta-analysis of registry data do show mortality benefit of DES over BMS), they would certainly matter in terms of MACE 3.69% of patients had multi-vessel disease and the revascularisation strategy in them -especially the diabetic subset- may have been CABG rather than PCI. Thus the revascularisation strategy in the majority of patients may have been in-appropriate

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