Table 1: Selected Randomised Controlled Trials on the Role of Medical Therapy and Revascularisation in Stable Coronary Artery Disease.
| Trial | CASS[2,3] | COURAGE[4,5] | FAME 2[6,7] | ISCHEMIA[1] |
|---|---|---|---|---|
| Years of recruitment | 1975–1979 | 1999–2004 | 2010–2012 | 2012–2018 |
| Sample size | 780 | 2,287 | 888 (randomised) | 5,179 |
| Comparison | Medical therapy versus CABG | Medical therapy versus PCI | Medical therapy versus FFR-guided PCI | Medical versus revascularisation (CABG/PCI) |
| Duration of follow up | 10 years | Median 6.2 years | 5 years | Median 3.2 years |
| Details of medical therapy | Antiplatelet 56–69% Anticoagulation 59–67% Lipid-lowering drugs 31–36% β-blockers 43–44% Nitrates 45–47% Other antihypertensive 17–21% Oral hypoglycaemic agents 26–28% |
Aspirin 95% Statin (mainly simvastatin) 95% ACEI/ARB 72% β-blockers 89% |
Aspirin 92% Clopidogrel/prasugrel 35% Statins (atorvastatin recommended) 100% ACEI/ARB 87% β-blockers 84% |
Antiplatelet/anticoagulation 100% Statin 95% (66% high intensity) Ezetimibe 24% ACEI/ARB 69% |
| Clinical outcomes | At 5 years Mortality: 8% medical therapy versus 5.5% CABG (NS) At 10 years Mortality: 21% medical therapy versus 18% CABG (NS) |
At median 4.6 years Mortality: 8.3% medical therapy versus 7.6% PCI (NS) MI: 12.3% medical therapy versus 13.2% PCI (NS) Mortality, MI, stroke: 19.5% medical therapy versus 20% PCI (NS) Revascularisation: 32.6% medical therapy versus 21.1% PCI (p<0.001) At median 6.2 years (n=1,211), Mortality: 24% medical therapy versus 25% PCI (NS) |
At 5 years Mortality: 5.2% medical therapy versus 5.1% PCI (NS) MI: 12% medical therapy versus 8.1% PCI (NS) Mortality, MI, urgent revascularisation: 27% medical therapy versus 13.9% PCI (significant at p<0.001) Urgent revascularisation: 21.1% medical therapy versus 6.3% PCI (95% CI [0.18–0.41]) Any revascularisation: 51% medical therapy versus 13.4% PCI (95% CI [0.14–0.26]) At 5 years Mortality: 8.3% medical therapy versus 9% invasive strategy (NS) MI: 11.9% medical therapy versus 10.3% invasive strategy (NS) CV mortality, MI, resuscitated cardiac arrest, hospitalisation for UAP/HF: 18.2% medical therapy versus 16.4% invasive strategy (NS) |
At 5 years Mortality: 8.3% medical therapy versus 9% invasive strategy (NS) MI: 11.9% medical therapy versus 10.3% invasive strategy (NS) CV mortality, MI, resuscitated cardiac arrest, hospitalisation for UAP/HF: 18.2% medical therapy versus 16.4% invasive strategy (NS) |
ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin II receptor blocker; CABG = coronary artery bypass grafting; CV = cardiovascular; FFR = fractional flow reserve; HF = heart failure; PCI = percutaneous coronary intervention; UAP = unstable angina pectoris.