Five-Year Follow-Up of the Medicine, Angioplasty, or Surgery Study (MASS-II)

Abstract

Clinical trials are organized for many different reasons. Most drug and device trials are designed to demonstrate the safety and efficacy of a drug or device, not to prove that they are the optimal treatments for patients. On the other hand, treatment strategy trials are designed to study the value of one therapeutic regimen compared with another when equipoise or confusion exists regarding which course to pursue. Assumptions are based on prior knowledge and opinion; in the case of coronary artery disease, most trials have been divided into those studying patients who “need” revascularization (ie, EAST [Emory Angioplasty versus Surgery Trial], BARI [Bypass Angioplasty Revascularization Investigation], CABRI [Coronary Artery Bypass Revascularization Investigation], RITA [Second Randomized Intervention Treatment of Angina], GABI [German Angioplasty Bypass Intervention], ARTS [Arterial Revascularization Therapies Study], SOS [Stent or Surgery], ERACI II [Estudio Randomizado Argentino de Angioplastia vs Cirugia II], and meta-analyses of these trails1,2⇓) and those in whom medical therapy is judged to be a reasonable choice. The latter list is short—RITA-2 [Second Randomized Intervention Treatment of Angina]3 and the awaited COURAGE [Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation]4 and BARI 2D [Bypass Angioplasty Revascularization Investigation 2 Diabetes]5 trials. Article p 1082 An assumption is made that patient groups can be identified that will be suitable candidates either for equipoise between 2 revascularization choices or for medical therapy versus revascularization. The study by Hueb et al6 in this issue of Circulation enrolled patients, most of whom would have been eligible for percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) trials, to 3 arms including medical therapy only. Eligible patients had multivessel coronary artery disease (3 vessels, 58%; 2 vessels, 42%), and the left anterior descending artery was involved in 92% of the patients. Therefore, these patients seem …