Disagreement Between Randomized and Observational Evidence on the Use of Bilateral Internal Thoracic Artery Grafting: A Meta-Analytic Approach

Abstract

Background The ART (Arterial Revascularization Trial) showed no difference in survival at 10 years between patients assigned to the single versus bilateral internal thoracic artery grafting strategies. This finding is in contrast with the results of most observational studies, where the use of 2 internal thoracic arteries has been associated with improved survival. Methods and Results We selected propensity-matched studies from the most comprehensive observational meta-analysis on the long-term outcomes of patients receiving 1 versus 2 internal thoracic arteries. Individual participant survival data from each study and the ART were reconstructed using an iterative algorithm that was applied to solve the Kaplan-Meier equations. The reconstructed individual participant survival data were aggregated to obtain combined survival curves and Cox regression hazard ratios with 95% CIs. Individual participant survival data were obtained from 14 matched observational studies (24 123 patients) and the ART. The 10-year survival of the control group of ART was significantly higher than that of the matched observational studies (hazard ratio, 0.86; 95% CI, 0.80-0.93). The 10-year survival of the experimental group of ART was significantly lower than that of the bilateral internal thoracic artery group of the observational studies (hazard ratio, 1.11; 95% CI, 1.03-1.20). Conclusions Both the improved outcome of the control arm and the lower beneficial effect of the intervention had played a role in the difference between observational evidence and ART.

Keywords: coronary artery bypass graft surgery; coronary artery disease; revascularization.

Figure 1

Reconstructed Kaplan‐Meier curves from individual participant‐derived data from propensity score–matched observational studies and the ART (Arterial Revascularization Trial) intention‐to‐treat (left) and as‐treated analysis (right). The hazard ratios for the as‐treated analysis were as follows: single internal thoracic artery (SITA)–ART vs SITA‐observational (OBS), 0.84 (95% CI, 0.74–0.95); multiple arterial grafts (MAG)–ART vs bilateral internal thoracic artery (BITA)–OBS, 1.19 (95% CI, 1.05–1.35); MAG‐ART vs SITA‐ART, 0.78 (95% CI, 0.67–0.92); and MAG‐ART vs SITA‐OBS, 0.67 (95% CI, 0.59–0.75).