ABSTRACT
AIMS: Off-pump coronary artery bypass graft surgery (OPCAB) is an established alternative to on-pump surgical revascularization. Previous studies in patients with low or intermediate risk showed no significant differences between off-pump and on-pump surgical revascularization. The aim of this study was to compare the two techniques in patients with high operative risk. METHODS: PRAGUE-6 is a prospective randomized single-center study of 206 patients, with an additive EuroSCORE ≥ 6, scheduled for isolated coronary surgery: Group A - on-pump (n = 108) versus Group B - off-pump (n = 98). The primary outcome was a combined endpoint of all-cause deaths, stroke, myocardial infarction, or renal failure requiring new hemodialysis, within 30 days and 1 year after randomization. All data were analyzed using the "intention-to-treat" principle. RESULTS: Early postoperative myocardial infarction was detected in 12.1% (A) vs. 4.1% (B) of patients (P = 0.048, hazard ratio 0.32, 95% CI 0.11-0.99). There was a significantly higher incidence of primary combined end-point in group A (20.6% vs. 9.2%, P = 0.028, HR 0.41, 95% CI 0.19-0.91) in the first 30 days, but not after 1 year (30.8% vs. 21.4%, P = 0.117, HR 0.65, CI 0.37-1.12). CONCLUSION: Off-pump surgical revascularization in patients with high operative risks can significantly reduce the incidence of major postoperative complications during the first 30 days. There was no statistically significant difference in the incidence of these complications after 1 year.
Subject(s)
Coronary Artery Bypass/methods , Coronary Artery Disease/surgery , Acute Kidney Injury/etiology , Acute Kidney Injury/mortality , Adolescent , Adult , Aged , Coronary Artery Bypass/mortality , Coronary Artery Bypass, Off-Pump/methods , Coronary Artery Bypass, Off-Pump/mortality , Coronary Artery Disease/mortality , Humans , Kaplan-Meier Estimate , Middle Aged , Myocardial Infarction/etiology , Myocardial Infarction/mortality , Myocardial Revascularization/methods , Myocardial Revascularization/mortality , Postoperative Complications/etiology , Postoperative Complications/mortality , Prospective Studies , Risk Factors , Stroke/etiology , Stroke/mortality , Treatment Outcome , Young AdultABSTRACT
AIMS: Surgical ablation procedure can restore sinus rhythm (SR) in patients with atrial fibrillation (AF) undergoing cardiac surgery. However, it is not known whether it has any impact on long-term clinical outcomes. METHODS AND RESULTS: This multicentre study randomized 224 patients with AF scheduled for valve and/or coronary surgery: group A (left atrial surgical ablation, n = 117) vs. group B (no ablation, n = 107). The primary efficacy outcome was the SR presence (without any AF episode) during a 24 h electrocardiogram (ECG) after 1 year. The primary safety outcome was the combined endpoint of death/myocardial infarction/stroke/renal failure at 30 days. A Holter-ECG after 1 year revealed SR in 60.2% of group A patients vs. 35.5% in group B (P = 0.002). The combined safety endpoint at 30 days occurred in 10.3% (group A) vs. 14.7% (group B, P = 0.411). All-cause 1-year mortality was 16.2% (A) vs. 17.4% (B, P = 0.800). Stroke occurred in 2.7% (A) vs. 4.3% (B) patients (P = 0.319). No difference (A vs. B) in SR was found among patients with paroxysmal (61.9 vs. 58.3%) or persistent (72 vs. 50%) AF, but ablation significantly increased SR prevalence in patients with longstanding persistent AF (53.2 vs. 13.9%, P < 0.001). CONCLUSION: Surgical ablation improves the likelihood of SR presence post-operatively without increasing peri-operative complications. However, the higher prevalence of SR did not translate to improved clinical outcomes at 1 year. Further follow-ups (e.g. 5-year) are warranted to show any potential clinical benefit which might occur later.
