Key result
Preoperative nicorandil reduces early postoperative myocardial injury by ~14% absolute vs standard therapy.
Why the study?
The study was conducted to assess the prevalence of ischemic myocardial injury, the cardioprotective effect of nicorandil, and predictors of adverse cardiac events in stable CAD patients undergoing elective lower limb surgery.
Does a single preoperative dose of nicorandil reduce perioperative myocardial injury in patients with stable coronary artery disease undergoing elective lower limb surgery?
RCT (n=70)
Does a single preoperative dose of nicorandil reduce perioperative myocardial injury in patients with stable coronary artery disease undergoing elective lower limb surgery?
Absolute Event Rate: 0% vs 14%
p-value: p=0.027
A single 20 mg dose of nicorandil administered 2 hours before elective lower limb revascularization significantly prevents early postoperative myocardial injury in patients with stable coronary artery disease.
Supports preoperative nicorandil in stable CAD; extends perioperative cardioprotection evidence to elective lower limb surgery.
Aim. To assess the prevalence of ischemic myocardial injury and the cardioprotective effect of nicorandil by assessing high-sensitivity cardiac troponin (hs-cTn) in patients with stable coronary artery disease (CAD) during elective lower limb surgery, as well as to identify predictors of adverse cardiac events. Material and methods. The study included 70 patients with stable coronary artery disease hospitalized for elective autogenous femoropopliteal bypass (FPB) surgery. After randomization, all patients were divided into two following groups: control group — 35 patients; main group — 35 patients, who, in addition to standard therapy, were prescribed nicorandil (Cordinic, PIQ-PHARMA) in a single dose of 20 mg 2 hours before surgery. In the postoperative period, the incidence of myocardial injury was assessed by hs-cTn increase. The obtained primary data were subjected to mathematical processing using the R-Studio software package (R language). Results. At baseline, patients in both groups were comparable in clinical characteristics, therapy, and duration of vascular surgery. In the main group of patients receiving nicorandil, a significant decrease in the incidence of perioperative myocardial injury was noted. In 5 patients of the control group, hs-cTn level 24 hours after surgery exceeded the threshold value, which indicated myocardial injury in the early postoperative period. In the nicorandil group, there was no hs-cTn increase (14% vs 0%, p=0,027). Regression analysis identified a predictor of perioperative myocardial injury — left ventricular ejection fraction (LVEF) <50%. LVEF <50% increases the risk of myocardial injury in the early postoperative period by 7,36 times (p=0,04) and 9,15 times (p=0,048) according to univariate and multivariate regression analysis, respectively. Conclusion. Perioperative myocardial injury is a common complication in patients with CAD undergoing lower extremity revascularization. The use of nicorandil (Cordinic, PIQ-PHARMA) before elective revascularization surgery helps reduce the incidence of ischemic myocardial injury in the early postoperative period and is not accompanied by adverse reactions, which rationales this approach to improve the clinical outcomes of lower extremity revascularization in patients with stable CAD. A predictor of myocardial injury, determined by hs-cTn, is a LVEF <50%.
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Kudaev et al. (2023) conducted an RCT in Stable coronary artery disease undergoing elective lower limb surgery (n=70). Nicorandil vs. Standard therapy was evaluated on Incidence of myocardial injury assessed by hs-cTn increase 24 hours after surgery (p=0.027). A single 20 mg dose of nicorandil before elective lower limb surgery significantly reduced the incidence of early postoperative myocardial injury compared to standard therapy (0% vs 14%; p=0.027).
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