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

BACKGROUND Reperfusion 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 RESULTS A 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. CONCLUSIONS This 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. REGISTRATION URL: http://www.chictr.org.cn . Unique identifier: ChiCTR00052856