Impact of oral nicorandil administration prior to primary percutaneous coronary intervention on no-reflow: a randomized controlled trial
摘要
Prior studies and meta-analyses showed cardioprotective benefits of intravenous or intracoronary nicorandil administration in ST-segment elevation myocardial infarction (STEMI). However, little is known about the efficacy of oral nicorandil in this context, especially that parenteral forms are not widely available.
AimTo investigate the impact of oral nicorandil administered before primary percutaneous coronary intervention (PPCI) on no-reflow and to assess the in-hospital and 3-month major adverse cardiac events (MACE).
MethodsA total of 302 patients with STEMI undergoing PPCI were randomly assigned in a 1:1 fashion to the Nicorandil-group, who received pre-PPCI oral nicorandil 20 mg followed by maintenance 20 mg b.i.d. for 3 months, and the Control-group. The primary endpoint was no-reflow defined as TIMI flow ≤ 2. Secondary endpoints included myocardial blush grade (MBG), ST-segment resolution, electrocardiographic repolarization dispersion, and in-hospital and 3-month MACE. Baseline and follow-up echocardiography were performed. A 3-month cardiac magnetic resonance (CMR) was performed in a subset of 50 patients.
ResultsNicorandil-group showed significantly lower rates of no-reflow (11.9% vs 24.5%, p = 0.005), better MBG, higher rates of complete ST-resolution, and better indices of repolarization dispersion compared to the Control-group. Pre-PPCI nicorandil was among the independent protectors against no-reflow (OR = 0.43, 95%CI = 0.23–0.81, p = 0.01). The Nicorandil-group demonstrated significantly better LV function and lower MACE at follow-up. Three-month CMR data showed microvascular obstruction in two patients among the Control-group and none among the Nicorandil-group (p = 0.14).
ConclusionOral nicorandil was associated with post-PPCI lower rates of no-reflow and improved myocardial reperfusion. Moreover, it showed improved LVEF and reduced MACE at 3 months.
Graphical abstract