Key result
Prolonged balloon inflation eliminates no-reflow in STEMI compared to ~30% with conventional rapid inflation.
Why the study?
The no-reflow phenomenon remains common and associated with adverse outcomes during PPCI for STEMI, and it was unknown whether prolonged balloon inflation during stent deployment could lessen its occurrence.
Does prolonged balloon inflation during stent deployment reduce the occurrence of the no-reflow phenomenon in patients with STEMI undergoing primary PCI?
RCT (n=120)
Single-blind
Simple random sampling
No
Does prolonged balloon inflation during stent deployment reduce the occurrence of the no-reflow phenomenon in patients with STEMI undergoing primary PCI?
Absolute Event Rate: 0% vs 30%
p-value: p=0.002
Prolonged balloon inflation during stent deployment in primary PCI for STEMI significantly reduces the no-reflow phenomenon and improves myocardial microcirculation perfusion compared to conventional rapid inflation/deflation.
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).
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Ma et al. (2022) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=120). Prolonged balloon inflation during stent deployment vs. Conventional deployment strategy (inflation time < 10 seconds) was evaluated on Incidence of no-reflow phenomenon (TIMI flow grade < 3 and myocardial blushing grade < 2) (p=0.002). Prolonged balloon inflation during stent deployment reduced the incidence of no-reflow phenomenon to 0% compared to 30% with conventional rapid inflation in patients with STEMI.
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