Surgery to reshape the scarred left ventricle not only failed to reduce deaths and hospitalisations in heart failure patients but also did not improve patients’ quality of life compared to bypass alone after four years of follow-up, according to the results of a large international clinical trial funded by the American National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.
These results from the Surgical Treatment for Ischemic Heart Failure Trial (STICH) were presented at the American College of Cardiology’s 58th Annual Scientific Session in Orlando, USA. The main mortality findings were also published online in the New England Journal of Medicine and will appear in the 23 April print issue; findings from a substudy of STICH are also published online on the American Heart Journal.
“This study is of tremendous public health importance since it provides much needed clinical trial-based evidence to help physicians choose the best treatment for their heart failure patients,” said NHLBI Director Dr Elizabeth G Nabel. “It is also a superb example of comparative effectiveness research, allowing evaluation of real world treatments in hopes of improving clinical care.”
The STICH trial is the largest study to date to compare the long-term benefits and risks for heart failure of both surgical ventricular reconstruction and coronary artery bypass surgery.
The newer surgery was designed to eliminate the ballooned, scarred, and thinned area of heart muscle that can result after a heart attack and contributes to heart failure.
The question asked by the STICH investigators was: Does the addition of surgical ventricular reconstruction offer added benefit to patients beyond bypass surgery or standard medical (drug and procedures) therapy?
In STICH, 1,000 patients from 96 medical centres in 23 countries were randomly assigned to undergo bypass surgery alone (499 patients), or bypass surgery plus surgical ventricular reconstruction (501 patients). All patients had moderate to severe heart failure; scarring of the heart; and poor (less than 35%) ejection fraction. All of the patients received intensive state-of-the-art medical therapy, including medications.
Although both types of surgeries improved symptoms such as angina and ability to exercise, after four years of follow-up, there were no significant differences between the two groups in combined rates of death and heart-related hospitalisations. There were 292 deaths/hospitalisations in patients assigned to bypass surgery compared to 289 deaths/hospitalisations in patients assigned to bypass with surgical ventricular reconstruction.
For the quality of life substudy, investigators conducted interviews with patients before and after their surgeries to collect information on physical and social limitations, satisfaction, and other measures of quality of life. Both treatment groups improved their quality of life after surgery but there was no difference between the two groups throughout three years of follow-up.