NEJM: CABG + ventricular reconstruction does not reduce death, hospitalization
Adding surgical ventricular reconstruction to coronary artery bypass grafting (CABG) reduced the left ventricular volume, compared with CABG alone. However, the combination did not result in improved symptoms or exercise tolerance, or reduced deaths or hospitalizations, according to the STITCH trial published in the April 23 issue of the New England Journal of Medicine.
George Sopko, MD, from the National Heart, Lung and Blood Institute and the National Institutes of Health in Bethesda, Md., and STITCH investigators conducted a trial to address whether surgical ventricular reconstruction added to CABG would decrease the rate of death or hospitalization for cardiac causes, as compared with CABG alone.
Between September 2002 and January 2006, the researchers randomly assigned a total of 1,000 patients with an ejection fraction of 35 percent or less, coronary artery disease that was amenable to CABG and dominant anterior left ventricular dysfunction that was amenable to surgical ventricular reconstruction to undergo either CABG alone (499 patients) or CABG with surgical ventricular reconstruction (501 patients). The primary outcome was a composite of death from any cause and hospitalization for cardiac causes. The median follow up was 48 months.
Sopko and colleagues found that the surgical ventricular reconstruction reduced the end-systolic volume index by 19 percent, compared to a reduction of 6 percent with CABG alone. Cardiac symptoms and exercise tolerance improved from baseline to a similar degree in the two study groups.
However, no significant difference was observed in the primary outcome, which occurred in 59 percent who were assigned to undergo CABG alone and in 58 percent, who were assigned to undergo CABG with surgical ventricular reconstruction, according to the authors.
Sopko and colleagues said that the negative outcome of this trial could be attributable to the decision to enroll patients for whom surgical ventricular reconstruction would prove unnecessary, instead of enrolling all concurrently evaluated patients for whom physicians were confident the procedure would be beneficial.
"Making such precise decisions about patient selection is not consistent with the diverse opinions about the eligibility of specific patients for randomized assignment to surgical ventricular reconstruction," the authors wrote.
George Sopko, MD, from the National Heart, Lung and Blood Institute and the National Institutes of Health in Bethesda, Md., and STITCH investigators conducted a trial to address whether surgical ventricular reconstruction added to CABG would decrease the rate of death or hospitalization for cardiac causes, as compared with CABG alone.
Between September 2002 and January 2006, the researchers randomly assigned a total of 1,000 patients with an ejection fraction of 35 percent or less, coronary artery disease that was amenable to CABG and dominant anterior left ventricular dysfunction that was amenable to surgical ventricular reconstruction to undergo either CABG alone (499 patients) or CABG with surgical ventricular reconstruction (501 patients). The primary outcome was a composite of death from any cause and hospitalization for cardiac causes. The median follow up was 48 months.
Sopko and colleagues found that the surgical ventricular reconstruction reduced the end-systolic volume index by 19 percent, compared to a reduction of 6 percent with CABG alone. Cardiac symptoms and exercise tolerance improved from baseline to a similar degree in the two study groups.
However, no significant difference was observed in the primary outcome, which occurred in 59 percent who were assigned to undergo CABG alone and in 58 percent, who were assigned to undergo CABG with surgical ventricular reconstruction, according to the authors.
Sopko and colleagues said that the negative outcome of this trial could be attributable to the decision to enroll patients for whom surgical ventricular reconstruction would prove unnecessary, instead of enrolling all concurrently evaluated patients for whom physicians were confident the procedure would be beneficial.
"Making such precise decisions about patient selection is not consistent with the diverse opinions about the eligibility of specific patients for randomized assignment to surgical ventricular reconstruction," the authors wrote.