A randomized controlled clinical trial of prolonged balloon inflation during stent deployment strategy in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a pilot study

Abstract

Background: Primary percutaneous coronary intervention (PPCI) is the standard procedure for reperfusion for ST-segment elevation myocardial infarction (STEMI), but the occurrence of the no-reflow phenomenon remains common and is associated with adverse outcomes. Aims: This study aimed to evaluate whether prolonged balloon inflation in stent deployment would lessen the occurrence of the no-reflow phenomenon in PPCI compared with conventional rapid inflation/deflation strategy. Methods: Patients were randomly assigned to either the prolonged balloon inflation in stent deployment group (PBSG) or conventional deployment strategy group (CDSG) in a 1:1 ratio. A subset of patients was included in the cardiac magnetic resonance (CMR) assessment. Results: Thrombolysis in MI (TIMI) flow grade 3 was found in 96.7% and 63.3% of the patients of the PBSG and CDSG, respectively (P = 0.005). The results of the PBSG and CDSG are respectively shown as follows: 0% versus 30% no-reflow or slow flow (P = 0.002); 90% versus 66.7% ST-segment resolution ≥ 50% (P = 0.028); 35.6 ± 14.5 frames versus 49.18 ± 25.2 frames on corrected TIMI frame count (P = 0.014); and 60% versus 20% myocardial blush grade 3 (P = 0.001). At 1 month, the major cardiovascular adverse event (cardiovascular mortality) rate was 3.3% in both groups; at 1 year, the rate was 3.3% and 6.7% for the PBSG and CDSG, respectively (P = 1.00). In the CMR subset of cases, the presence of microvascular obstruction (MVO) was detected in 6.7% and 50% of the patients in the PBSG and CDSG, respectively (P = 0.023). Conclusion: In our pilot trial, prolonged balloon inflation during stent deployment strategy in PPCI reduces the occurrence of the no-reflow phenomenon in patients with STEMI and improved the myocardial microcirculation perfusion (ClinicalTrials.gov number: NCT03199014; registered: 26/June/2017).