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A complete list of investigators participating in the hypothesis 1 component of the Surgical Treatment for Ischemic Heart Failure (STICH) trial is provided in the Supplementary Appendix , available at NEJM.org.
It is estimated that 5.8 million patients in the United States1 and 15 million in Europe2 have heart failure. Coronary artery disease is the most common substrate for heart failure in industrialized nations.3 However, the role of coronary-artery bypass grafting (CABG) in the treatment of patients with coronary artery disease and heart failure has not been clearly established.
In three landmark clinical trials in the 1970s, a total of 2234 patients with chronic stable angina were randomly assigned to undergo CABG or receive medical therapy alone.4 -6 The findings from these trials led to recommendations supporting the use of CABG to relieve disabling symptoms of angina, particularly among high-risk subgroups with extensive coronary artery disease.7 ,8 These trials excluded patients with severe left ventricular dysfunction (patients with an ejection fraction of <35%). A meta-analysis of the trials showed that 7.2% of the patients who underwent randomization had an ejection fraction of 40% or less, and only 4.0% had primary symptoms of heart failure rather than angina.9 Furthermore, these trials predate the major developments in medical therapy and cardiac surgery that have led to the current guidelines.10 -13 More recently, observational analyses supporting a benefit of CABG14 and the proliferation of contemporary evidence-based medical and device-associated therapies have led to substantial clinical uncertainty regarding the incremental benefits of CABG relative to its risks in patients with ischemic cardiomyopathy.15 ,16
We designed the Surgical Treatment for Ischemic Heart Failure (STICH) trial to evaluate the role of cardiac surgery in the treatment of patients with coronary artery disease and left ventricular systolic dysfunction. A major hypothesis of the trial was that CABG plus intensive medical therapy based on current guidelines, as compared with medical therapy alone, would reduce mortality.
Methods
Study Design
The design of the STICH trial has been described previously.17 ,18 We conducted a multicenter, nonblinded, randomized study at 127 clinical sites in 26 countries. The trial protocol (available with the full text of this article at NEJM.org) was designed by several of the authors and was approved by the principal investigator and the ethics...