Safety of Perioperative Aprotinin Administration During Isolated Coronary Artery Bypass Graft Surgery: Insights From the ART (Arterial Revascularization Trial)

Background There is still uncertainty about the safety of aprotinin for coronary artery bypass graft surgery. The ART (Arterial Revascularization Trial) was designed to compare survival after bilateral versus single internal thoracic artery grafting. Many of the ART patients (≈30%) received perioperative aprotinin. We investigated the association between perioperative aprotinin administration and short‐term (in‐hospital) and long‐term outcomes by performing a post hoc analysis of the ART. Methods and Results Among patients enrolled in the ART (n=3102) from 2004 to 2007, we excluded those who did not undergo surgery (n=18) and those with no information about use of perioperative aprotinin (n=9). Finally, 836 of 3076 patients (27%) received aprotinin. Propensity matching was used to select 536 pairs for final comparison. Aprotinin was also associated with an increased risk of hospital mortality (9 [1.7%] versus 1 [0.2%]; odds ratio, 9.12; 95% confidence interval [CI], 1.15–72.2; P=0.03), intra‐aortic balloon pump insertion (37 [6.9%] versus 17 [3.2%]; odds ratio, 2.26; 95% CI, 1.26–4.07; P=0.006), and acute kidney injury (102 [19.0%] versus 76 [14.2%]; odds ratio, 1.42; 95% CI, 1.03–1.97; P=0.03). Aprotinin was not associated with a lower incidence of transfusion (37 [6.9%] versus 28 [5.2%]; odds ratio, 1.34; 95% CI, 0.81–2.23; P=0.25) and reexploration (26 [4.9%] versus 19 [3.5%]; hazard ratio, 1.39; 95% CI, 0.76–2.53; P=0.28). At 5 years, all‐cause mortality was significantly increased in the aprotinin group (56 [10.6%] versus 38 [7.3%]; hazard ratio, 1.51; 95% CI, 1.0–2.28; P=0.045). Conclusions In the present post hoc ART analysis, aprotinin was associated with a significantly increased risk of early and late mortality

Ten-year outcomes after off-pump versus on-pump coronary artery bypass grafting:Insights from the Arterial Revascularization Trial

Objective We performed a post hoc analysis of the Arterial Revascularization Trial to compare 10-year outcomes after off-pump versus on-pump surgery. Methods Among 3102 patients enrolled, 1252 (40% of total) and 1699 patients received off-pump and on-pump surgery (151 patients were excluded because of other reasons); 2792 patients (95%) completed 10-year follow-up. Propensity matching and mixed-effect Cox model were used to compare long-term outcomes. Interaction term analysis was used to determine whether bilateral internal thoracic artery grafting was a significant effect modifier. Results One thousand seventy-eight matched pairs were selected for comparison. A total of 27 patients (2.5%) in the off-pump group required conversion to on-pump surgery. The off-pump and on-pump groups received a similar number of grafts (3.2 ± 0.89 vs 3.1 ± 0.8; P = .88). At 10 years, when compared with on-pump, there was no significant difference in death (adjusted hazard ratio for off-pump, 1.1; 95% confidence interval, 0.84-1.4; P = .54) or the composite of death, myocardial infarction, stroke, and repeat revascularization (adjusted hazard ratio, 0.92; 95% confidence interval, 0.72-1.2; P = .47). However, off-pump surgery performed by low volume off-pump surgeons was associated with a significantly lower number of grafts, increased conversion rates, and increased cardiovascular death (hazard ratio, 2.39; 95% confidence interval, 1.28-4.47; P = .006) when compared with on-pump surgery performed by on–pump-only surgeons. Conclusions The findings showed that in the Arterial Revascularization Trial, off-pump and on-pump techniques achieved comparable long-term outcomes. However, when off-pump surgery was performed by low-volume surgeons, it was associated with a lower number of grafts, increased conversion, and a higher risk of cardiovascular death.</p

Bilateral versus single internal-thoracic-artery grafts at 10 years

BACKGROUND Multiple arterial grafts may result in longer survival than single arterial grafts after coronary-artery bypass grafting (CABG) surgery. We evaluated the use of bilateral internal-thoracic-artery grafts for CABG. METHODS We randomly assigned patients scheduled for CABG to undergo bilateral or single internal-thoracic-artery grafting. Additional arterial or vein grafts were used as indicated. The primary outcome was death from any cause at 10 years. The composite of death from any cause, myocardial infarction, or stroke was a secondary outcome. RESULTS A total of 1548 patients were randomly assigned to undergo bilateral internal-thoracic-artery grafting (the bilateral-graft group) and 1554 to undergo single internal-thoracic-artery grafting (the single-graft group). In the bilateral-graft group, 13.9% of the patients received only a single internal-thoracic-artery graft, and in the single-graft group, 21.8% of the patients also received a radial-artery graft. Vital status was not known for 2.3% of the patients at 10 years. In the intention-to-treat analysis at 10 years, there were 315 deaths (20.3% of the patients) in the bilateral-graft group and 329 deaths (21.2%) in the single-graft group (hazard ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.12; P=0.62). Regarding the composite outcome of death, myocardial infarction, or stroke, there were 385 patients (24.9%) with an event in the bilateral-graft group and 425 patients (27.3%) with an event in the single-graft group (hazard ratio, 0.90; 95% CI, 0.79 to 1.03). CONCLUSIONS Among patients who were scheduled for CABG and had been randomly assigned to undergo bilateral or single internal-thoracic-artery grafting, there was no significant between-group difference in the rate of death from any cause at 10 years in the intention-to-treat analysis. Further studies are needed to determine whether multiple arterial grafts provide better outcomes than a single internal-thoracic-artery graft. (Funded by the British Heath Foundation and others; Current Controlled Trials number, ISRCTN46552265.

Ten-year outcomes after off-pump versus on-pump coronary artery bypass grafting: Insights from the Arterial Revascularization Trial

Objective We performed a post hoc analysis of the Arterial Revascularization Trial to compare 10-year outcomes after off-pump versus on-pump surgery. Methods Among 3102 patients enrolled, 1252 (40% of total) and 1699 patients received off-pump and on-pump surgery (151 patients were excluded because of other reasons); 2792 patients (95%) completed 10-year follow-up. Propensity matching and mixed-effect Cox model were used to compare long-term outcomes. Interaction term analysis was used to determine whether bilateral internal thoracic artery grafting was a significant effect modifier. Results One thousand seventy-eight matched pairs were selected for comparison. A total of 27 patients (2.5%) in the off-pump group required conversion to on-pump surgery. The off-pump and on-pump groups received a similar number of grafts (3.2 ± 0.89 vs 3.1 ± 0.8; P = .88). At 10 years, when compared with on-pump, there was no significant difference in death (adjusted hazard ratio for off-pump, 1.1; 95% confidence interval, 0.84-1.4; P = .54) or the composite of death, myocardial infarction, stroke, and repeat revascularization (adjusted hazard ratio, 0.92; 95% confidence interval, 0.72-1.2; P = .47). However, off-pump surgery performed by low volume off-pump surgeons was associated with a significantly lower number of grafts, increased conversion rates, and increased cardiovascular death (hazard ratio, 2.39; 95% confidence interval, 1.28-4.47; P = .006) when compared with on-pump surgery performed by on–pump-only surgeons. Conclusions The findings showed that in the Arterial Revascularization Trial, off-pump and on-pump techniques achieved comparable long-term outcomes. However, when off-pump surgery was performed by low-volume surgeons, it was associated with a lower number of grafts, increased conversion, and a higher risk of cardiovascular death.</p

Bilateral versus single internal-thoracic-artery grafts at 10 years

BACKGROUND Multiple arterial grafts may result in longer survival than single arterial grafts after coronary-artery bypass grafting (CABG) surgery. We evaluated the use of bilateral internal-thoracic-artery grafts for CABG. METHODS We randomly assigned patients scheduled for CABG to undergo bilateral or single internal-thoracic-artery grafting. Additional arterial or vein grafts were used as indicated. The primary outcome was death from any cause at 10 years. The composite of death from any cause, myocardial infarction, or stroke was a secondary outcome. RESULTS A total of 1548 patients were randomly assigned to undergo bilateral internal-thoracic-artery grafting (the bilateral-graft group) and 1554 to undergo single internal-thoracic-artery grafting (the single-graft group). In the bilateral-graft group, 13.9% of the patients received only a single internal-thoracic-artery graft, and in the single-graft group, 21.8% of the patients also received a radial-artery graft. Vital status was not known for 2.3% of the patients at 10 years. In the intention-to-treat analysis at 10 years, there were 315 deaths (20.3% of the patients) in the bilateral-graft group and 329 deaths (21.2%) in the single-graft group (hazard ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.12; P=0.62). Regarding the composite outcome of death, myocardial infarction, or stroke, there were 385 patients (24.9%) with an event in the bilateral-graft group and 425 patients (27.3%) with an event in the single-graft group (hazard ratio, 0.90; 95% CI, 0.79 to 1.03). CONCLUSIONS Among patients who were scheduled for CABG and had been randomly assigned to undergo bilateral or single internal-thoracic-artery grafting, there was no significant between-group difference in the rate of death from any cause at 10 years in the intention-to-treat analysis. Further studies are needed to determine whether multiple arterial grafts provide better outcomes than a single internal-thoracic-artery graft. (Funded by the British Heath Foundation and others; Current Controlled Trials number, ISRCTN46552265.