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Published on: February 18, 2020
A randomized controlled clinical trial of prolonged balloon inflation during stent deployment strategy in primary
Min Ma1,2, Ling Wang3, Kai-Yue Diao4
1Department of Cardiology, West China Hospital, Sichuan University, No. 37 GuoXueXiang, Chengdu, 610041, China.
Insights
Prolonged balloon inflation during primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) significantly reduces the no-reflow phenomenon. This strategy also improved myocardial microcirculation perfusion compared to conventional methods.
Area of Science:
- Cardiology
- Interventional Cardiology
- Myocardial Infarction Research
Background:
- Primary percutaneous coronary intervention (PPCI) is standard for ST-segment elevation myocardial infarction (STEMI) reperfusion.
- The no-reflow phenomenon remains a common complication of PPCI, leading to adverse outcomes.
Purpose of the Study:
- To evaluate if prolonged balloon inflation during stent deployment in PPCI can reduce the incidence of the no-reflow phenomenon.
- To compare this strategy against the conventional rapid inflation/deflation technique.
Main Methods:
- A randomized controlled trial comparing prolonged balloon inflation in stent deployment group (PBSG) with conventional deployment strategy group (CDSG).
- Patients were assigned in a 1:1 ratio.
- Cardiac magnetic resonance (CMR) imaging was used to assess a subset of patients.
Main Results:
- The PBSG showed significantly higher Thrombolysis in MI (TIMI) flow grade 3 (96.7% vs 63.3%) and reduced no-reflow (0% vs 30%) compared to CDSG.
- Improved ST-segment resolution, corrected TIMI frame count, and myocardial blush grade were observed in the PBSG.
- Cardiac magnetic resonance revealed significantly lower microvascular obstruction (MVO) in the PBSG (6.7% vs 50%).
Conclusions:
- Prolonged balloon inflation during stent deployment in PPCI is an effective strategy to reduce the no-reflow phenomenon in STEMI patients.
- This technique improves myocardial microcirculation perfusion and may reduce adverse cardiovascular events.
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).
