Intracoronary administration of anisodamine and nicorandil in individuals undergoing primary percutaneous coronary intervention for acute inferior myocardial infarction: A randomized factorial trial

Abstract

In acute inferior myocardial infarction (AIMI), numerous conventional drugs that are used to improve the myocardial microcirculation can significantly reduce blood pressure (BP) and coronary perfusion pressure, aggravate bradyarrhythmia and cause a deterioration in the hemodynamic state of the whole body, which greatly limits the application of these drugs in clinical settings. The aim of the present study was to assess the effect of anisodamine and nicorandil regimens on the prevention of no-reflow (NR) and the amelioration of myocardial reperfusion in patients with AIMI undergoing primary percutaneous coronary intervention (PCI). A total of 104 consecutive patients with AIMI were included in this study and randomly assigned to one of four groups: A (control group), B (anisodamine group), C (nicorandil group) and D (anisodamine and nicorandil group). Patients underwent PCI via transradial artery access and the angiographic results were evaluated. Coronary diastolic BP (DBP) and systolic and mean BPs were measured by invasive catheterization. The primary end-point was a post-PCI Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion grade (TMPG) of 3. Composite end-points (mortality + new MI + target vessel revascularization) were evaluated during the hospital stay and 30 days after discharge. Following the procedure, the proportion of patients achieving TMPG 3 was significantly higher in group D than that in the other groups (P=0.014); furthermore, the incidence of a postprocedural TIMI score of 3 was the highest in group D. Three days after the procedure, the peak creatine kinase-MB and cardiac troponin I levels were the lowest and the left ventricular ejection fraction was the highest in group D. A thrombus score of 3/4 and low DBP were the independent risk factors for poor myocardial reperfusion (expressed as TMPG <3), while 2 mg anisodamine plus 2 mg nicorandil prior to PCI was protective for optimal myocardial reperfusion following the procedure. The combination of anisodamine and nicorandil can effectively ameliorate myocardial reperfusion and protect cardiac function in patients with AIMI undergoing primary PCI.

Cardiovascular events associated with nicorandil administration prior to primary percutaneous coronary intervention in patients with acute ST-segment elevated myocardial infarction: a systematic review and meta-analysis

“…The mean age was 63.0 ± 10.0 years and 76.6% of the patients were male. All 10 studies were published in English [23][24][25][26][27][28][29][30][31] or Chinese [32]. Five studies had been conducted in Japan, four in China, and one in South Korea.…”

“…Three studies [24,26,27] failed to report follow-up, and in two studies [27,28], there was no incidence of NRP. Patients received nicorandil by intracoronary injection in five studies [23,24,29,31,32] and by intravenous injection in the others, with or without an oral dose later. We also recorded the time from onset of symptoms/STEMI to reperfusion.…”

“…Eight studies [23,24,[26][27][28][29]31,32] with 567 patients reported inhospital MACE with the outcomes of death (1.4% vs. 2.9%), reperfusion arrhythmia (9.5% vs. 19.5%), reperfusion angina (9.6% vs. 11.7%), new heart failure or worsening cardiac function (14.8% vs. 24.1%), and repeat revascularization (1.7% vs. 2.3%). Reperfusion angina and heart failure numbers were not available for one study [23]. Pooled analyses with a fixedeffects model suggested a significant reduction in in-hospital MACE in patients who received nicorandil (24.6% vs. 46.9%; OR 0.16, 95% CI 0.09-0.27; P = 0.00, P heterogeneity = 0.17, I 2 = 34.5%, Figure 1).…”

“…Pooled analyses with a fixedeffects model suggested a significant reduction in in-hospital MACE in patients who received nicorandil (24.6% vs. 46.9%; OR 0.16, 95% CI 0.09-0.27; P = 0.00, P heterogeneity = 0.17, I 2 = 34.5%, Figure 1). Seven studies [23,25,[28][29][30][31][32] with 876 patients reported follow-up MACE with the outcomes of death (2.3% vs. 4.8%), non-fatal myocardial infarction (1.4% vs. 2.5%), post-infarction angina (0.9% vs. 1.6%), repeat revascularization (7.3% vs. 8.0%), and re-hospitalization for congestive heart failure (3.4% vs. 8.0%). Our analysis suggested a significant reduction in follow-up MACE in patients who received nicorandil (15.3% vs. 24.9%; OR 0.53, 95% CI 0.37-0.75; P = 0.00, P heterogeneity = 0.87, I 2 = 0.0%, Figure 2).…”

Does Periprocedural Nicorandil Improve Cardiovascular Outcomes in Acute Myocardial Infarction? - Meta-Analysis

“…However, in our analysis, cardiac tamponade and pericardial effusion were excluded events from in-hospital outcomes (Lee HC et al, 16 Chen C et al, Miyazawa A et al, Ono H et al and Ito H et al). 11,13,18,21 The data collected in studies showed that there is insufficient evidence at the moment on Nicorandil's ability to improve MACE. Of the thirteen RCTs performed with Nicorandil, only four of them used MACE as an endpoint (Lee HC et al, Chen C et al, Miyazawa A et al and Ono H et al).…”