Background: Prospective randomized trials comparing the coronary artery disease-related health status outcomes (changes in symptom grade, physical functional capacity and health-related quality of life) after percutaneous coronary intervention at hospitals with and without on-site cardiac surgical backup have not been reported earlier.
Methods: We randomly assigned 609 consecutive patients fulfilling pre-specified procedural low-risk criteria to undergo percutaneous coronary intervention at either a community hospital without or a regional hospital with on-site surgical backup. Five hundred and seventy-six patients completed the health status evaluation at baseline and at 6 months follow-up.
Results: At baseline, 91.4% had symptoms, and the mean (standard deviation) Canadian Cardiovascular Society's classification was 2.5 (0.9). The procedural success rates and the changes in health status measures were similar at the two hospitals. Overall there was a substantial relief of symptoms with a reduction in Canadian Cardiovascular Society's classification of 1.9 (1.2), increase in exercise time [1.4 (1.9) min] and reduction in use of antianginal drugs [0.6 (0.9) less drugs] at follow-up compared with baseline (all P<0.001). Health-related quality of life was evaluated with the Short-Form 36 health survey. There were significant and similar improvements in nearly all multi-item and summary scores from baseline to follow-up at the two hospitals. The largest improvements were seen in items related to physical functioning [overall change in Physical Component Score from baseline to follow-up 6.9 (9.1) points, P<0.001] and lowest in the mental health domains [change in Mental Component Score 3.3 (10.7) points, P<0.001].
Interpretation: This study shows that a substantial and comparable gain in coronary artery disease-related health status can be achieved at hospitals both with and without surgical backup.