A pilot randomized controlled trial of novel reperfusion method in patients of acute st elevation myocardial infarction during primary percutaneous coronary intervention

Abstract

Abstract Objectives This study was conducted to explore the feasibility, clinical safety and potential effects of a novel reperfusion method, Volume-Controlled Reperfusion (VCR) in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Background Reperfusion injury is associated with larger infarct size (IS) and drawback of long-term overcome. Microvascular obstruction (MVO) as detected on late gadolinium-enhanced cardiovascular magnetic resonance (LGE-CMR) is the most used index for assessment of reperfusion injury. To date, there is no feasible gradual reperfusion method in primary PCI setting. VCR is an original reperfusion method feasible in primary PCI for both accurate gradual reperfusion and intermittent flow. Methods A total of 60 patients with STEMI presenting within 12 h of symptom onset undergoing PPCI were randomized enrolled, 30 patients in VCR group and 30 patients in control group with routine PCI only. VCR was performed with the dual catheter technique, 10ml of artery blood diluted with10ml of heparin saline infused via manual aspiration catheter at speed of 20ml/min for 10 rounds after suspending the antegrade flow using a prophylactic inflated balloon. Then, routine PCI procedure as usual. The primary endpoint was major adverse cardiac events (MACE) during hospitalization, the main second endpoint was the MVO extent difference measured on day 5-7 post-procedure. Results Baseline characteristics were well matched between two groups. No major adverse cardiac events (MACE) found in-hospital or 30 days followed up. There were no complications associated with VCR procedure. 43 patients had LGE-CMR exam (22 in Control group, 21 in VCR group, among them, 14/22 were anterior wall control and 14/21 VCR). There was no significant difference in infarct size, MVO or CMR-LVEF in total patients between VCR and control. However, significant difference in CMR-LVEF was noted between control and VCR anterior wall subgroup (40.53 ± 7.39 vs50.55 ± 7.55; P=0.002), the average of MVO and MVO of infarct size were smaller in VCR group while no significant difference. Conclusions This is the pilot RCT study showed VCR method was feasibility and clinical safe among patients with acute STEMI during PPCI and 30 days followed up, indicated potential attenuate effect in reperfusion injury as well. Staged II study is needed to verify clinical benefit.VCR illustrationLGE-CMR figure