Problem Stable CAD
Format Multi-center RCT
Treatment PCI
Control Optimal medical therapy
Population 2287 patients
Inclusion criteria Stable CAD or Canadian Cardiovascular Society (CCS) class IV angina subsequently stabilized medically
Stenosis of at least 70% in at least one proximal coronary artery
Objective evidence of myocardial ischaemia (substantial changes in ST-segment depression or T-wave inversion on the resting electrocardiogram or inducible ischemia with either exercise or pharmacologic vasodilator stress) or at least one coronary stenosis of at least 80% and classic angina without provocative testing.
Exclusion criteria Persistent CCS class IV angina
Markedly positive stress test (substantial ST-segment depression or hypotensive response during stage 1 of the Bruce protocol)
Refractory heart failure or cardiogenic shock
An ejection fraction of less than 30%
Revascularization within the previous 6 months
Coronary anatomy not suitable for PCI.
Follow-up Median 4.6 years
Primary endpoint Composite of death from any cause and nonfatal myocardial infarction
Secondary endpoint(s) Composite of death, myocardial infarction, and stroke
Hospitalization for unstable angina with negative biomarkers
Details For OMT, all patients received aspirin (81–325 mg/day) or clopidogrel (75 mg/day). All patients received simvastatin alone or in combination with ezetimibe to reduce LDL-cholesterol levels (target of 1.55–2.220 mmol/L).

Exercise, fibrates and/or extended release niacin were used to raise HDL-cholesterol levels (target 1.03 mmol/L) and to reduce triglyceride levels (target of 1.69 mmol/L).

Both groups received anti-ischemic therapy (metoprolol, amlodipine and/or isosorbide mononitrate) with lisinopril or losartan.
Brief summary: PCI w/ bare-metal stents in stable CAD non-superior to medical therapy
PAPER: Optimal medical therapy with or without PCI for stable coronary disease.
Date 12 Apr 2007
Journal N Engl J Med. 2007 Apr 12;356(15):1503-16.
Information PCI (with BMS) vs. medical therapy in stable CAD
-No difference in composite of all-cause mortality and non-fatal MI
-No difference in ACS hospitalisation
PAPER: Effect of PCI on quality of life in patients with stable coronary disease.
Date 14 Aug 2008
Journal N Engl J Med. 2008 Aug 14;359(7):677-87.
Information PCI vs. medical therapy
-At 3 months
--53% in PCI group angina-free vs. 42% medical-therapy (P<0.001)
-Benefit observed until 24 months
-No significant difference at 36 months
--Likely represents progression of CAD
PAPER: Cost-effectiveness of percutaneous coronary intervention in optimally treated stable coronary patients.
Date 1 Sep 2008
Journal Circ Cardiovasc Qual Outcomes. 2008 Sep;1(1):12-20.
Information Cost-effectiveness analysis for PCI vs. medical therapy in stable CAD
-Cost ~$10,000, without significant gain in life-years or quality-adjusted life-years
-$168,000-$300,000 per QALY