The Courage Trial - Optimal Medical Therapy with or without PCI for Stable Coronary Disease

Optimal Medical Therapy with or without PCI for Stable Coronary Disease

William E. Boden, M.D.,and others, NEJM april 12, 2007.

This study was performed to evaluate and compare optimal medical therapy with percutaneous coronary intervention (PCI).


In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI), combined with intensive pharmacologic therapy and lifestyle intervention (Optimal Medical Therapy, OMT) is superior to OMT alone in reducing the risk of cardiovascular events.

The trial involved 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease. Between 1999 and 2004, 1149 patients underwent PCI with optimal medical therapy and 1138 received OMT alone.

The outcome studied was death from any cause and non-fatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6).


All patients received optimal medical therapy that included:

  • Antiplatelet therapy with aspirin or clopidogrel, if aspirin intolerance was present. Patients undergoing PCI received aspirin and clopidogrel.
  • Beta blockers and Nitrates in both groups included long acting metoprolol, amlodipine, and isosorbide mononitrate, alone or in combination, along with either lisinopril or losartan as standard secondary prevention.
  • All patients received aggressive therapy for Hypercholesterolemia.

In patients undergoing PCI, target-lesion revascularization was always attempted, and complete revascularization was performed as clinically appropriate. Success after PCI as seen on angiography was defined as normal coronary-artery flow and less than 50% stenosis in the luminal diameter after balloon angioplasty and less than 20% after coronary stent implantation, as assessed by visual estimation of the angiograms before and after the procedure. Clinical success was defined as angiographic success plus the absence of inhospital myocardial infarction, emergency CABG, or death.  Drug-eluting stents were not approved for clinical use until the final 6 months of the study, so few patients received these intracoronarydevices.

  • A total of 2168 patients (95%) had objective evidence of myocardial ischemia and were studied for a median follow-up period was 4.6 years.
  • Average age was 60 years, but 85% were male patients, reflecting where the study was performed (VA hospitals).
  • All patients had normal heart function (EF:60%)and almost equal distributions of 1-, 2- or 3-vessel CAD.

Courage Outcomes

Kaplan–Meier Survival Curves

In Panel A, the estimated 4.6-year rate of the composite primary outcome of death from any cause and nonfatal myocardial infarction was 19.0% in the PCI group and 18.5% in the medical-therapy group. In Panel B, the estimated 4.6-year rate of death from any cause was 7.6% in the PCI group and 8.3% in the medical-therapy group. In Panel C, the estimated 4.6-year rate of hospitalization for acute coronary syndrome (ACS) was 12.4% in the PCI group and 11.8% in the medical-therapy group. In Panel D, the estimated 4.6-year rate of acute myocardial infarction was 13.2% in the PCI group and 12.3% in the medical-therapy group.


As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. Although the addition of PCI to optimal medical therapy reduced the prevalence of angina, it did not reduce long term rates of death, nonfatal myocardial infarction, and hospitalization for acute coronary syndromes.

Revascularization in Patients with Diabetes

The Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM) study enrolled 1,900 patients over a 5-year period from 2005 through 2010.

Contemporary PCI and CABG techniques and currently recommended ancillary medical therapies were examined to determine whether CABG or PCI with drug-eluting stents are the superior approach to revascularization in patients with diabetes and multivessel coronary artery disease.

The FAME 1&2 Trials

Posted on March 31, 2013 - 4:42pm

In 1995 Topol[1] first described what vascular surgeons have known for many years:

The pressure drop in a fluid flowing through a long cylindrical pipe such as a stenotic artery becomes functionally significant when the obstruction exceeds 70%, first described in the Poiseuille law in 1846[2].

As was stated in Topol's paper: “Accordingly, before the residual stenosis in an infarct vessel is addressed, there should be demonstration of either spontaneous or provocable signs of ischemia… clinicians and investigators rely excessively on angiography for clinical decision-making… Procedures should not be performed solely to improve the luminal appearance—so-called coronary “cosmetology".

This principle was tested with the PCI Fractional Flow Reserve FAME 1[3]&2[4] trials:

SYNTAX Trial after Five Years: Final Results

Posted on November 13, 2012 - 6:03pm

In the SYNTAX trial 1800 patients with previously untreated left-main or three-vessel disease were randomized to CABG or PCI.

As expected, differences in long-term outcomes of Coronary Artery Bypass Grafting vs. PCI, already present after year one, have continued to become more obvious during the next four years:

SYNTAX five-year results for patients with three-vessel disease:

PCI vs. CABG outcomes in Washinton State

In a large comparative study, interventions for CAD were compared. From 1999-2007 more than 150000 interventions were performed in Washington State. During that period, the volume of PCI procedures increased by 71%, while simultaneously, CABG diminished by almost 40%. In final analysis, PCI was almost five times more likely to happen than CABG.

SYNTAX Trial: Four-year follow-up analysis

Posted on November 5, 2012 - 10:22am

SYNTAX was an 1800-patient trial randomizing patients with left main coronary disease and/or three-vessel disease to either CABG or PCI using the Taxus drug-eluting stent (DES).


In patients with severe, multi-vessel coronary disease, coronary artery bypass grafting (CABG) continues as the standard of care of revascularization. Death and MI rates did become significantly greater in the PCI group after four years:

Long Term Survival of Adenocarcinoma of the Esophagus

Posted on December 5, 2010 - 7:52pm

Carcinoma of the esophagus is a relatively rare but very lethal disease. 50% of all patients diagnosed will have adeno carcinoma, which has been associated with a very poor long term survival.

PCI & CABG for Diabetics with 3VD

Posted on November 5, 2010 - 4:23pm

A subset of patients with diabetes and 3VD was examined in a 2nd paper in 2010.

The MASS II Study

MASS II [i] is a small, single-center study designed to compare the long term effects of Medical Therapy (MT), Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) among patients with stable angina, multivessel CAD and preserved ventricular function. Patients selected were appropriate candidates for all 3 therapies.

The Courage Trial - Optimal Medical Therapy with or without PCI for Stable Coronary Disease

Optimal Medical Therapy with or without PCI for Stable Coronary Disease

William E. Boden, M.D.,and others, NEJM april 12, 2007.

This study was performed to evaluate and compare optimal medical therapy with percutaneous coronary intervention (PCI).

PCI vs. CABG – A Current Perspective

In all likelihood this article has only been read by cardiac surgeons. It provides "new" (actually old) information about what constitutes current and optimal therapy for CAD, and especially what long term outcomes can be expected. For this reason the article was printed in its entirety:

Percutaneous Coronary Intervention (PCI) – Risks & Benefits

Posted on December 30, 2009 - 3:55pm

Comments: If there is any area where primary PCI is of particular value, it is in STEMI. No other procedure promises better and/or quicker myocardial reperfusion, and this discussion illustrates this very well {From: Primary PCI for Myocardial Infarction with ST-Segment Elevation by Ellen C. Keeley, M.D., and L. David Hillis, M.D. (NEJM: Volume 356:47-54 January 4, 2007)}:

A 58-year-old man has chest pain at 9:30 a.m.; 3 hours later, he calls for an ambulance.

Survival of patients with diabetes and multivessel coronary artery disease

Posted on April 1, 2010 - 9:17pm

… Published the results of survival of patients with diabetes and MVD after surgical or percutaneous coronary revascularization. Their results showed that in 2766 risk matched diabetics PCI increased five-year mortality by 1.5–3.9 times...

In 2,766 patients with diabetes undergoing their first coronary revascularization procedure, improved survival with CABG was the initial revascularization demonstrated. The analysis supported that bypass surgery is preferable to coronary angioplasty for the revascularization of patients with diabetes with both 2VD- and 3VD:

Physical Activity and Weight Gain Prevention

In a paper, published in JAMA in 2010, the association of different amounts of physical activity with long-term weight changes among women consuming a usual diet was examined.

The BARI 2D Trial

Posted on April 30, 2010 - 5:50pm

The BARI 2D Study Group. A randomized trial of therapies for type 2 diabetes and coronary artery disease.

In this study, the authors report the findings of the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial, involving 2368 patients with both diabetes and coronary disease.