This single-center randomized trial evaluated intracoronary nicorandil in 63 patients with first-episode ST-segment elevation myocardial infarction undergoing primary PCI. The intervention group received 2 mg of nicorandil after guidewire crossing, while the control group received standard PCI. The primary outcome was final post-PCI AMR, with secondary outcomes including QFR-derived indices, reperfusion measures, hemodynamics, biomarkers, and clinical events.
In the nicorandil group, the rate of post-PCI TIMI grade 3 flow was 96.9%, compared with 74.2% in the control group (P = 0.013). Final AMR was significantly lower in the nicorandil group (1.4 ± 0.5) versus the control group (2.7 ± 0.5) (P < 0.05). Multiplicity was controlled using the Benjamini–Hochberg false discovery rate where applicable.
Safety and tolerability data, including adverse events, serious adverse events, discontinuations, and tolerability, were not reported. The study did not report follow-up duration. Effects on wire-free, angiography-derived measures of microvascular function are not well defined. Funding or conflicts of interest were not reported.
Clinical relevance remains uncertain given the small sample size, lack of safety data, and incomplete reporting of follow-up and broader outcomes. These findings suggest a potential benefit for microvascular reperfusion but require confirmation in larger trials with comprehensive safety profiles.
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BackgroundMicrovascular dysfunction remains a major driver of adverse outcomes after ST-segment elevation myocardial infarction (STEMI) despite successful restoration of epicardial patency by primary percutaneous coronary intervention (PCI). Nicorandil has nitrate-like vasodilatory properties and ATP-dependent potassium channel (KATP)-opening properties, effects that may improve reperfusion physiology. However, its effects on wire-free, angiography-derived measures of microvascular function are not well defined. We evaluated whether intracoronary nicorandil administered during primary PCI improves angiography-derived microvascular function assessed by angiographic microcirculatory resistance (AMR) and quantitative flow ratio (QFR).MethodsIn this prospective, single-center randomized trial, 63 patients with first-episode STEMI undergoing primary PCI were allocated 1:1 to intracoronary nicorandil (2 mg after guidewire crossing; n = 32) or control (standard PCI; n = 31). The prespecified primary endpoint was final post-PCI AMR. QFR-derived indices, reperfusion measures [Thrombolysis in Myocardial Infarction (TIMI) flow grade, no-reflow, ST-segment resolution], hemodynamics, biomarkers, and clinical events were analyzed as secondary/exploratory outcomes, with multiplicity controlled using the Benjamini–Hochberg false discovery rate (FDR) where applicable.ResultsBaseline characteristics were balanced between groups. Compared with control, intracoronary nicorandil was associated with a higher rate of post-PCI TIMI grade 3 flow (96.9% vs. 74.2%; overall P = 0.013). Final AMR was significantly lower in the nicorandil group (1.4 ± 0.5 vs. 2.7 ± 0.5; P