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

Acute postoperative hypertension is an important clinical challenge after cardiac surgery1–3 that has been associated with myocardial injury, cerebral ischemia, hemorrhagic stroke, and surgical bleeding. Perioperative hypertension in cardiac surgery patients is characterized by peripheral vasoconstriction and reduced baroreceptor sensitivity. Despite its importance, there are no established guidelines for the treatment of postoperative hypertension in this population. For patients needing intensive arterial blood pressure control in the postcardiac surgery setting, the ideal treatment would be a short-acting parenteral drug with fast onset and offset that can be rapidly and predictably titrated to the target arterial blood pressure range, without unwanted drug side effects. The antihypertensive drugs most commonly used for this purpose are nitroglycerin or sodium nitroprusside, with a smaller percentage of patients receiving either ß-adrenergic receptor blockers or calcium channel blockers.

Clevidipine is a third-generation dihydropyridine calcium channel blocker that exhibits rapid onset and offset because of its metabolism by blood esterases. The half-life of clevidipine after IV administration is approximately 1 min.9–11,13,14 Clevidipine acts specifically on vascular smooth muscle as an arterial-specific vasodilating drug that reduces arterial blood pressure without inducing myocardial depression.12–14 Given this pharmacologic profile, clevidipine could be a promising drug for the treatment of postoperative hypertension. Prior, smaller, and dose-response studies have suggested that clevidipine may be effective in treating postoperative hypertension in cardiac surgery patients.12–15 The purpose of this randomized, doubleblind study was to assess the efficacy of clevidipine compared with placebo in treating postoperative hypertension after cardiac surgery. The safety and tolerability of clevidipine were further assessed.