Five-Year Follow-Up of the Medicine, Angioplasty, or
Surgery Study (MASS-II)
Prologue to COURAGE
Spencer B. King III, MD
Clinical trials are organized for many different reasons.
Most drug and device trials are designed to demon-
strate 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 Sur-
gery Trial], BARI [Bypass Angioplasty Revascularization
Investigation], CABRI [Coronary Artery Bypass Revascular-
ization Investigation], RITA [Second Randomized Interven-
tion 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 Evalua-
tion]4 and BARI 2D [Bypass Angioplasty Revascularization
Investigation 2 Diabetes]5 trials.
Article p 1082
An assumption is made that patient groups can be identi-
fied 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 corona