Authors
Velazquez E, Lee K, Deja M, et al for the STICH Investigators
Title
Coronary-artery bypass surgery in patients with left ventricular dysfunction.
References
N Engl J Med 2011; 364(17):1607-16
Background
At the time of the initiation of the study, the role of coronary-artery bypass grafting (CABG) in the treatment of patients with coronary artery disease and heart failure had not been clearly established.
Purpose
The STICH trial sought to address 2 hypotheses: (1) does CABG improve survival in addition to optimal medical therapy for patients with heart failure (HF) and coronary artery disease (CAD) with LVEF <35% who are acceptable candidates for cardiac surgery; and (2) does the addition of surgical ventricular reconstruction (SVR) of an akinetic/dyskinetic anterior wall provide better outcomes than isolated CABG for eligible individuals.
Design
A multicenter, non-blinded, randomized study at 127 clinical sites in 26 countries. Between July 2002 and May 2007, a total of 1212 patients with a LV ejection fraction (EF) ≤35% (with or without HF symptoms) and coronary artery disease amenable to CABG were randomly assigned to medical therapy alone (602 patients) or medical therapy plus CABG (610 patients). The primary outcome was the rate of death from any cause. Major secondary outcomes included the rates of death from cardiovascular causes and of death from any cause or hospitalization for cardiovascular causes. Patients were eligible for medical therapy alone if they did not have a stenotic lesion leading to loss of 50% or more of the diameter of the left main coronary artery and if they did not have Canadian Cardiovascular Society class III or IV angina while receiving medical therapy. Patients were eligible for surgical ventricular reconstruction if they had dominant anterior left ventricularakinesia or dyskinesia.
Exclusion Criteria
Failure to provide informed consent Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support Plan for percutaneous intervention of CAD Recent acute MI judged to be an important cause of left ventricular dysfunction History of more than 1 prior coronary bypass operation Noncardiac illness with a life expectancy of less than 3 years Noncardiac illness imposing substantial operative mortality Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode) Previous heart, kidney, liver, or lung transplantation Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device
Follow-Up
By the end of the follow up period (median, 56 months), 100 patients in the medical-therapy group (17%) underwent CABG, and 555 patients in the CABG group (91%) underwent CABG
Treatment Regimen
On the basis of the eligibility criteria, patients were assigned by the enrolling physician to one of three trial strata: Stratum A included patients who were eligible for either medical therapy alone or medical therapy plus CABG Stratum B included patients who were eligible for any of the three treatment options Stratum C included patients who were eligible for either medical therapy plus CABG or medical therapy plus CABG and surgical ventricular reconstruction Patients were then randomly assigned to one of the treatment options for which they were eligible. As a result, all the patients in stratum A and some of the patients in stratum B were randomly assigned to either medical therapy alone or medical therapy plus CABG
Results
Primary Endpoints The primary outcome (rate of death from any cause) occurred in 244 patients (41%) in the medical-therapy group and 218 (36%) in the CABG group (hazard ratio with CABG, 0.86; 95% confidence interval [CI], 0.72 to 1.04; P = 0.12) Secondary outcomes A total of 201 patients (33%) in the medicaltherapy group and 168 (28%) in the CABG group died from an adjudicated cardiovascular cause (hazard ratio with CABG, 0.81; 95% CI, 0.66 to 1.00; P = 0.05). Death from any cause or hospitalization for cardiovascular causes occurred in 411 patients (68%) in the medical-therapy group and 351 (58%) in the CABG group (hazard ratio with CABG, 0.74; 95% CI, 0.64 to 0.85; P<0.001).
Summary
In this randomized trial, there was no significant difference between medical therapy alone and medical therapy plus CABG with respect to the primary end point of death from any cause. Patients assigned to CABG, as compared with those assigned to medical therapy alone, had lower rates of death from cardiovascular causes and of death from any cause or hospitalization for cardiovascular causes.