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The STICH trial (Surgical Treatment for Ischemic Heart Failure): mode-of-death results.

ABSTRACT: This study sought to assess the effect of the addition of coronary artery bypass grafting (CABG) to medical therapy on mode of death in heart failure.Although CABG therapy is widely used in ischemic cardiomyopathy patients, there are no prospective clinical trial data on mode of death.The STICH (Surgical Treatment for Ischemic Heart Failure ) trial compared the strategy of CABG plus medical therapy to medical therapy alone in 1,212 ischemic cardiomyopathy patients with reduced ejection fraction. A clinical events committee adjudicated deaths using pre-specified definitions for mode of death.In the STICH trial, there were 462 deaths over a median follow-up of 56 months. The addition of CABG therapy tended to reduce cardiovascular deaths (hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.68 to 1.03; p = 0.09) and significantly reduced the most common modes of death: sudden death (HR: 0.73; 95% CI: 0.54 to 0.99; p = 0.041) and fatal pump failure events (HR: 0.64; 95% CI: 0.41 to 1.00; p = 0.05). Time-dependent estimates indicate that the protective effect of CABG principally occurred after 24 months in both categories. Deaths post-cardiovascular procedures were increased in CABG patients (HR: 3.11; 95% CI: 1.47 to 6.60), but fatal myocardial infarction deaths were lower (HR: 0.07; 95% CI: 0.01 to 0.57). Noncardiovascular deaths were infrequent and did not differ between groups.In the STICH trial, the addition of CABG to medical therapy reduced the most common modes of death: sudden death and fatal pump failure events. The beneficial effects were principally seen after 2 years. Post-procedure deaths were increased in patients randomized to CABG, whereas myocardial infarction deaths were decreased.

SUBMITTER: Carson P

PROVIDER: S-EPMC3829618 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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The STICH trial (Surgical Treatment for Ischemic Heart Failure): mode-of-death results.

Carson Peter P Wertheimer John J Miller Alan A O'Connor Christopher M CM Pina Ileana L IL Selzman Craig C Sueta Carla C She Lilin L Greene Deborah D Lee Kerry L KL Jones Robert H RH Velazquez Eric J EJ

JACC. Heart failure 20130911 5

<h4>Objectives</h4>This study sought to assess the effect of the addition of coronary artery bypass grafting (CABG) to medical therapy on mode of death in heart failure.<h4>Background</h4>Although CABG therapy is widely used in ischemic cardiomyopathy patients, there are no prospective clinical trial data on mode of death.<h4>Methods</h4>The STICH (Surgical Treatment for Ischemic Heart Failure ) trial compared the strategy of CABG plus medical therapy to medical therapy alone in 1,212 ischemic c ...[more]

PMID: 24621972

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Project description:BACKGROUND:Female sex is conventionally considered a risk factor for coronary artery bypass grafting (CABG) and has been included as a poor prognostic factor in multiple cardiac operative risk evaluation scores. We aimed to investigate the association of sex and the long-term benefit of CABG in patients with ischemic left ventricular dysfunction enrolled in the prospective STICH trial (Surgical Treatment for Ischemic Heart Failure Study). METHODS:The STICH trial randomized 1212 patients (148 [12%] women and 1064 [88%] men) with coronary artery disease and left ventricular ejection fraction ?35% to CABG+medical therapy (MED) versus MED alone. Long-term (10-year) outcomes with each treatment were compared according to sex. RESULTS:At baseline, women were older (63.4 versus 59.3 years; P=0.016) with higher body mass index (27.9 versus 26.7 kg/m2; P=0.001). Women had more coronary artery disease risk factors (diabetes mellitus, 55.4% versus 37.2%; hypertension, 70.9% versus 58.6%; hyperlipidemia, 70.3% versus 58.9%) except for smoking (13.5% versus 21.8%) and had lower rates of prior CABG (0% versus 3.4%; all P<0.05) than men. Moreover, women had higher New York Heart Association class (class III/IV, 66.2% versus 57.0%), lower 6-minute walk capacity (300 versus 350 m), and lower Kansas City Cardiomyopathy Questionnaire overall summary scores (51 versus 63; all P<0.05). Over 10 years of follow-up, all-cause mortality (49.0% versus 65.8%; adjusted hazard ratio, 0.67; 95% confidence interval, 0.52-0.86; P=0.002) and cardiovascular mortality (34.3% versus 52.3%; adjusted hazard ratio, 0.65; 95% confidence interval, 0.48-0.89; P=0.006) were significantly lower in women compared with men. With randomization to CABG+MED versus MED treatment, there was no significant interaction between sex and treatment group in all-cause mortality, cardiovascular mortality, or the composite of all-cause mortality or cardiovascular hospitalization (all P>0.05). In addition, surgical deaths were not statistically different (1.5% versus 5.1%; P=0.187) between sexes among patients randomized to CABG per protocol as initial treatment. CONCLUSIONS:Sex is not associated with the effect of CABG+MED versus MED on all-cause mortality, cardiovascular mortality, the composite of death or cardiovascular hospitalization, or surgical deaths in patients with ischemic left ventricular dysfunction. Thus, sex should not influence treatment decisions about CABG in these patients. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov. Unique identifier: NCT00023595.

Project description:The rationale and design of the Surgical Treatment for Ischemic Heart Failure trial is described. Before the Surgical Treatment for Ischemic Heart Failure trial, less than 1000 patients with ischemic cardiomyopathy had been studied in randomized comparisons of medical therapy versus coronary artery bypass grafting. Trial data reflect how these therapies were delivered more than 20 years ago and do not indicate the relative benefits of medical therapy versus coronary artery bypass grafting in contemporary practice.Randomization of consenting patients with heart failure, left ventricular ejection fraction of 0.35 or less, and coronary artery disease is based on whether patients are judged by attending physicians to be candidates only for coronary artery bypass grafting or can be treated with medical therapy without coronary artery bypass grafting. Patients eligible for surgical ventricular reconstruction because of significant anterior wall akinesis or dyskinesis but ineligible for medical therapy are randomly assigned to coronary artery bypass grafting with or without surgical ventricular reconstruction. Patients eligible for medical therapy are randomly assigned between medical therapy only and medical therapy with coronary artery bypass grafting. Patients eligible for all 3 are randomly assigned evenly to medical therapy only, medical therapy and coronary artery bypass grafting, or medical therapy and coronary artery bypass grafting and surgical ventricular reconstruction. Major substudies will examine quality of life, cost-effectiveness, changes in left ventricular volumes, effect of myocardial viability, selected biomarkers, and selected polymorphisms on treatment differences.Enrollment is now complete in both STICH hypotheses. Follow-up will continue until sufficient end points are available to address both hypotheses with at least 90% power. The primary outcome of hypothesis 2 is expected to be reported in 2009. The primary outcome of hypothesis 1 is expected to be reported in 2011.The Surgical Treatment for Ischemic Heart Failure trial is a National Heart, Lung, and Blood Institute-funded multicenter international randomized trial addressing 2 specific primary hypotheses: (1) coronary artery bypass grafting with intensive medical therapy improves long-term survival compared with survival with medical therapy alone, and (2) in patients with anterior left ventricular dysfunction, surgical ventricular reconstruction to a more normal left ventricular size plus coronary artery bypass grafting improves survival free of subsequent hospitalization for cardiac cause when compared with that with coronary artery bypass grafting alone.

Project description:BackgroundPatients with severe left ventricular dysfunction, ischemic heart failure, and coronary artery disease suitable for coronary artery bypass grafting (CABG) are at higher risk for surgical morbidity and mortality. Paradoxically, those patients with the most severe coronary artery disease and ventricular dysfunction who derive the greatest clinical benefit from CABG are also at the greatest operative risk, which makes decision making regarding whether to proceed to surgery difficult in such patients. To better inform such decision making, we analyzed the Surgical Treatment for Ischemic Heart Failure (STICH) CABG population for detailed information on perioperative risk and outcomes.Methods and resultsIn both STICH trials (hypotheses), 2136 patients with a left ventricular ejection fraction of ≤35% and coronary artery disease were allocated to medical therapy, CABG plus medical therapy, or CABG with surgical ventricular reconstruction. Relationships of baseline characteristics and operative conduct with morbidity and mortality at 30 days were evaluated. There were a total of 1460 patients randomized to and receiving surgery, and 346 (≈25%) of these high-risk patients developed a severe complication within 30 days. Worsening renal insufficiency, cardiac arrest with cardiopulmonary resuscitation, and ventricular arrhythmias were the most frequent complications and those most commonly associated with death. Mortality at 30 days was 5.1% and was generally preceded by a serious complication (65 of 74 deaths). Left ventricular size, renal dysfunction, advanced age, and atrial fibrillation/flutter were significant preoperative predictors of mortality within 30 days. Cardiopulmonary bypass time was the only independent surgical variable predictive of 30-day mortality.ConclusionsCABG can be performed with relatively low 30-day mortality in patients with left ventricular dysfunction. Serious postoperative complications occurred in nearly 1 in 4 patients and were associated with mortality.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00023595.

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The STICH trial (Surgical Treatment for Ischemic Heart Failure): mode-of-death results.

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The STICH trial (Surgical Treatment for Ischemic Heart Failure): mode-of-death results.

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