Abstract
BackgroundMicrovascular 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 resultsREFLO-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.ConclusionsHigh-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 registrationClinicalTrials.gov Identifier: NCT01747174; https://clinicaltrials.gov/ct2/show/NCT01747174
Highlights
Primary percutaneous coronary intervention (PPCI) is the default reperfusion therapy for ST-segment elevation myocardial infarction (STEMI).[1]
REFLO-STEMI, a prospective, open-label, multi-centre trial with blinded endpoints, randomized (1:1:1) 247 STEMI paand results tients with single vessel disease presenting within 6 h of symptom onset to IC adenosine (2–3 mg total) or sodium nitroprusside (SNP) (500 mg total) immediately following thrombectomy and again following stenting, or to standard PPCI
Ten patients did not complete the cardiovascular magnetic resonance (CMR) so that the primary outcome of infarct size was assessed in 197 patients (80% of those randomized)
Summary
Primary percutaneous coronary intervention (PPCI) is the default reperfusion therapy for ST-segment elevation myocardial infarction (STEMI).[1]. Previous clinical trials with these agents varied in their design and they mostly lacked a sensitive method to detect MVO, which may have contributed to the multiple conflicting results seen.[7,8,9,12,16,17] Uncertainty remains regarding the potential therapeutic impact of these agents.[1]
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