Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial.
BACKGROUND
Acute postoperative hypertension is a well-known complication of cardiac surgery and is associated with postoperative morbidity. Clevidipine, an ultrashort-acting, third-generation dihydropyridine calcium channel blocker, exerts vascular-selective, arterial-specific vasodilation to decrease arterial blood pressure without negatively impacting cardiac function. In this double-blind, placebo-controlled trial, we examined the efficacy and safety of clevidipine in treating postoperative hypertension in cardiac surgery patients.


METHODS
Two hundred six patients undergoing cardiac surgery were randomized preoperatively. Of these, 110 met postrandomization inclusion criteria for the study [systolic blood pressure (SBP) >or=140 mm Hg within 4 h of admission to a postoperative setting, and clinically assessed as needing SBP reduction by >or=15% from baseline]. Patients received an infusion of either clevidipine (0.4-8.0 microg kg(-1) min(-1)) or 20% lipid emulsion (placebo) for 30 min to a maximum of 1 h unless treatment failure occurred sooner. The primary end point was the incidence of treatment failure, defined as the inability to decrease SBP by >or=15% from baseline, or the discontinuation of study treatment for any reason within the 30-min period after study drug initiation.


RESULTS
Clevidipine-treated patients had a significantly lower incidence of treatment failure than placebo patients [8.2% (5 of 61) vs 79.6% (39 of 49), P < 0.0001]. Treatment success was achieved in 91.8% of clevidipine-treated patients. Median time to target SBP with clevidipine was 5.3 min (95% confidence interval, 4-7 min). No clinically significant increase in heart rate from baseline was observed. Adverse event rates were similar for both treatment groups.


CONCLUSIONS
Clevidipine is effective and safe in the rapid treatment of acute postoperative hypertension after cardiac surgery.
Singla
Neil
N
Department of Anesthesia, Huntington Memorial Hospital, Pasadena, California 91105, USA. neil@lotuscr.com.
Warltier
David C
DC
Gandhi
Sweeta D
SD
Lumb
Philip D
PD
Sladen
Robert N
RN
Aronson
Solomon
S
Newman
Mark F
MF
Corwin
Howard L
HL
D000208:Acute Disease; D000328:Adult; D000368:Aged; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy*; D011446:Prospective Studies; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure
D002121:Calcium Channel Blockers; D011725:Pyridines; C118563:clevidipine