Intra-coronary adenosine or SNP during primary PCI did not reduce infarct size vs control (10.1% and 10.0% vs 8.3%; P=0.062 and P=0.160), while adenosine increased 6-month MACE.
RCT (n=247)
Open-label
1:1:1
Yes
Does intra-coronary high-dose adenosine or sodium nitroprusside reduce infarct size on CMR in STEMI patients undergoing primary PCI?
High-dose intra-coronary adenosine or sodium nitroprusside during primary PCI for STEMI does not reduce infarct size or microvascular obstruction, and adenosine may increase the risk of adverse clinical outcomes.
Absolute Event Rate: 10.1% vs 8.3%
p-value: p=0.062
BACKGROUND: Microvascular obstruction (MVO) following primary percutaneous coronary intervention (PPCI) treatment of ST-segment elevation myocardial infarction (STEMI) contributes to infarct expansion, left ventricular (LV) remodelling, and worse clinical outcomes. The REFLO-STEMI trial tested whether intra-coronary (IC) high-dose adenosine or sodium nitroprusside (SNP) reduce infarct size and/or MVO determined by cardiac magnetic resonance (CMR). METHODS AND RESULTS: REFLO-STEMI, a prospective, open-label, multi-centre trial with blinded endpoints, randomized (1:1:1) 247 STEMI patients with single vessel disease presenting within 6 h of symptom onset to IC adenosine (2-3 mg total) or SNP (500 μg total) immediately following thrombectomy and again following stenting, or to standard PPCI. The primary endpoint was infarct size % LV mass (%LVM) on CMR undertaken 24-96 h after PPCI (n = 197). Clinical follow-up was to 6 months. There was no significant difference in infarct size (%LVM, median, interquartile range, IQR) between adenosine (10.1, 4.7-16.2), SNP (10.0, 4.2-15.8), and control (8.3, 1.9-14.0), P = 0.062 and P = 0.160, respectively, vs. CONTROL: MVO (% LVM, median, IQR) was similar across groups (1.0, 0.0-3.7, P = 0.205 and 0.6, 0.0-2.4, P = 0.244 for adenosine and SNP, respectively, vs. control 0.3, 0.0-2.8). On per-protocol analysis, infarct size (%LV mass, 12.0 vs. 8.3, P = 0.031), major adverse cardiac events (hazard ratio, HR, 5.39 1.18-24.60, P = 0.04) at 30 days and 6 months (HR 6.53 1.46-29.2, P = 0.01) were increased and ejection fraction reduced (42.5 ± 7.2% vs. 45.7 ± 8.0%, P = 0.027) in adenosine-treated patients compared with control. CONCLUSIONS: High-dose IC adenosine and SNP during PPCI did not reduce infarct size or MVO measured by CMR. Furthermore, adenosine may adversely affect mid-term clinical outcome. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01747174; https://clinicaltrials.gov/ct2/show/NCT01747174.
Nazir et al. (Wed,) conducted a rct in ST-segment elevation myocardial infarction (STEMI) (n=247). Intra-coronary high-dose adenosine or sodium nitroprusside (SNP) vs. Standard PPCI was evaluated on Infarct size % LV mass (%LVM) on CMR undertaken 24-96 h after PPCI (p=0.062). Intra-coronary adenosine or SNP during primary PCI did not reduce infarct size vs control (10.1% and 10.0% vs 8.3%; P=0.062 and P=0.160), while adenosine increased 6-month MACE.
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