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Clevidipine compared with nitroglycerin for blood pressure control in coronary artery bypass grafting: a randomized
Alan F Merry1, Edwin G Avery, Nancy A Nussmeier
1Faculty of Medical and Health Sciences, School of Medicine, The University of Auckland, Private Bag 92019, Auckland, 1003, New Zealand, a.merry@auckland.ac.nz.
Insights
Clevidipine demonstrated non-inferiority to nitroglycerin in controlling blood pressure before cardiopulmonary bypass during coronary artery bypass grafting. This finding supports clevidipine as an effective alternative for perioperative hypertension management in CABG patients.
Area of Science:
- Cardiovascular Pharmacology
- Anesthesiology
- Cardiac Surgery
Background:
- Perioperative hypertension is a common concern during coronary artery bypass grafting (CABG).
- Effective blood pressure management is crucial for patient outcomes in cardiac surgery.
- Rapidly acting antihypertensive agents are often required for precise hemodynamic control.
Purpose of the Study:
- To evaluate the non-inferiority of clevidipine compared to nitroglycerin (NTG) for blood pressure control before cardiopulmonary bypass (CPB) in patients undergoing CABG.
- To assess clevidipine's efficacy in maintaining mean arterial pressure (MAP) within a target range.
- To compare the safety and efficacy of clevidipine and NTG in this specific surgical context.
Main Methods:
- A double-blind, randomized study involving 100 patients undergoing CABG with CPB.
- Patients received intravenous infusions of clevidipine or NTG, titrated to maintain MAP within ±5 mmHg of a predetermined target.
- The primary endpoint was the area under the curve (AUC) for time MAP was outside the target range before CPB.
Main Results:
- Clevidipine was not inferior to NTG, with a geometric means ratio of 0.97 (95% CI 0.74 to 1.27) for the primary endpoint.
- Mean doses pre-bypass differed significantly (clevidipine 4.5 mg vs. NTG 6.9 mg, P < 0.05).
- No clinically significant differences in adverse events were observed between the groups.
Conclusions:
- Clevidipine is not inferior to nitroglycerin for blood pressure control prior to cardiopulmonary bypass in CABG surgery.
- Clevidipine offers a viable alternative for managing perioperative hypertension in this patient population.
- Further research may explore clevidipine's role in other surgical settings requiring precise blood pressure management.
Purpose:
We tested the hypothesis that clevidipine, a rapidly acting dihydropyridine calcium channel blocker, is not inferior to nitroglycerin (NTG) in controlling blood pressure before cardiopulmonary bypass (CPB) during coronary artery bypass grafting (CABG).
Methods:
In this double-blind study from October 4, 2003 to April 26, 2004, 100 patients undergoing CABG with CPB were randomized at four centres to receive intravenous infusions of clevidipine (0.2-8 μg·kg(-1)·min(-1)) or NTG (0.4 μg·kg(-1)·min(-1) to a clinician-determined maximum dose rate) from induction of anesthesia through 12 hr postoperatively. The study drug was titrated in the pre-CPB period with the aim of maintaining mean arterial pressure (MAP) within ± 5 mmHg of a clinician-predetermined target. The primary endpoint was the area under the curve (AUC) for the total time each patient's MAP was outside the target range from drug initiation to the start of CPB, normalized per hour (AUCMAP-D). The predefined non-inferiority criterion for the primary endpoint was a 95% confidence interval (CI) upper limit no greater than 1.50 for the geometric means ratio between clevidipine and NTG.
Results:
Total mean [standard deviation (SD)] dose pre-bypass was 4.5 (4.7) mg for clevidipine and 6.9 (5.4) mg for NTG (P < 0.05). The geometric mean AUCMAP-D for clevidipine was 283 mmHg·min·hr(-1) (n = 45) and for NTG was 292 mmHg·min·hr(-1) (n = 48); the geometric means ratio was 0.97 (95% CI 0.74 to 1.27). The geometric mean AUCMAP-D during aortic cannulation was 357.7 mmHg·min·hr(-1) for clevidipine compared with 190.5 mmHg·min·hr(-1) for NTG. Mean (SD) heart rate with clevidipine was 76.0 (13.8) beats·min(-1) compared with 81.5 (14.4) beats·min(-1) for NTG. There were no clinically important differences between groups in adverse events.
Conclusion:
During CABG, clevidipine was not inferior to NTG for blood pressure control pre-bypass.
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