A novel reperfusion method in patients with acute ST elevation myocardial infarction during primary percutaneous coronary intervention: A randomized control trial

Abstract

AbstractBACKGROUNDReperfusion injury is associated with larger infarct size and drawback of long-term outcome in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Volume-Controlled Reperfusion (VCR) is our original reperfusion method combined with accurate gentle reperfusion and active protection for unstable plaque. A single center, prospective, randomized clinical trial was conducted to demonstrate the feasibility, clinical safety, and potential effects of VCR in STEMI patients during PPCI.METHODS AND RESULTSA total of 60 patients with STEMI presenting within 12 h of symptom onset undergoing PPCI were randomized enrolled to VCR group (n=30) or control group (n=30). Patients in VCR group recanalized with VCR followed by routine PCI. Patients in control group recanalized with routine PCI procedure only. The primary endpoint was all-cause death and major adverse cardiac events (MACE) during hospitalization and followed up, the main second endpoints were MVO extent measured 5-7 days post PPCI and left ventricular function. Baseline characteristics were well matched between two groups. No MACE from in-hospital to 1 year followed up in VCR group. In-hospital echocardiography based left ventricular eject fraction (LVEF) in VCR group compared with control group was (57.6 ± 6.2) % vs (52.9 ± 8.5) %, p = 0.018; especially in anterior STEMI VCR subgroup (55.1 ± 6.3) % v (s 48.6 ± 6.4) %, p = 0.003. There was no significant difference in infarct size, MVO mass or MVO mass/infarct mass ratio by late gadolinium enhancement-cardiac magnetic resonance imaging (LGE-CMR). In hospital CMR based LVEF in anterior STEMI VCR subgroup was (50.55 ± 7.55) % vs (40.53 ± 7.39) %, p = 0.002. Follow up echocardiography based LVEF were (64.12 ± 6.35) % vs (59.44 ± 8.20) %, p = 0.025 between two groups and (62.07 ± 7.06) % vs (55.94 ± 6.70) %, p = 0.016 between anterior STEMI subgroups.CONCLUSIONSThis is the pilot RCT study demonstrated that VCR method was feasibility and clinical safe among patients with acute STEMI during PPCI to 12-month follow-up, indicated potential attenuate effect in reperfusion injury as well. Staged II RCT is needed to verify clinical benefit.REGISTRATIONURL:http://www.chictr.org.cn. Unique identifier: ChiCTR00052856