2007, PCI + medical therapy vs medical therapy only in stable coronary artery disease, NEJM
Courage Trial Summary
COURAGE was a randomized, open label, multicenter (50 centers in US & Canada), co-industry sponsored, clinical trial which tested the hypothesis that PCI with optimal medical therapy (OMT) is superior to OMT alone in reducing primary outcome of all cause death and nonfatal MI in patients with stable CAD.
Patients with >=70% stenosis in at least one proximal epicardial coronary artery with objective evidence of ischemia (ST segment depression or TWI on resting ECG, or inducible ischemia with exercise or pharmacologic vasodilator stress) or at least one coronary stenosis of >= 80% with classic angina without provocative test were included. Those with >=50% LM CAD, class IV angina, markedly positive stress test (ST depression or hypotension in Bruce stage I), coronary anatomy not suitable for PCI, in-stent restenosis, LVEF <30%, refractory HF, or revascularization in last 6 months were excluded.
Enrolled between 1999 and 2004, 2287 patient were randomized and followed for median of 4.6 years, with 9% lost to follow up. 85% were male, 86 % were white, 58% had class II or III angina, 69% had multivessel CAD and 34% had proximal LAD CAD. In those who received stents, only 31 had DES.
OMT included antiplatelet therapy with aspirin, anti-ischemic therapy with long acting metoprolol, amlodipine, or isosorbide mononitrate (alone or in combination), along with lisinopril or losartan and aggressive lipid therapy. In PCI group, in addition to OMT, patients received second antiplatelet agent (clopidogrel), and the target vessel revascularization was always attempted with complete revascularization as clinically appropriate.
Primary outcome (composite of all-cause death and nonfatal MI) was similar in PCI group (PCI + OMT) and medical therapy group (OMT alone) (19% vs 18.5% respectively; HR 1.05, 95% CI 0.87-1.27; P=0.62), and so were its individual components and secondary outcome (composite of death, MI and stroke). No difference was seen in terms of hospitalization for ACS and even with ethe xclusion of periprocedural MI, the primary outcome did differ in the 2 groups. Primary outcome was similar even in the prespecified subgroups of multivessel CAD, prior MI and diabetes. Substantial reduction in angina was seen in both groups, more so in the PCI group.
Authors (Boden WE et al) concluded :“as an initial management strategy in patients with stable CAD, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to OMT”.