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Published on: October 14, 2016
Clinical Impact of Perfusion Balloon for ST-Segment Elevated Myocardial Infarction: RYUSEI Study
Masami Nishino1, Yasuyuki Egami1, Hitoshi Nakamura1
1Division of Cardiology, Osaka Rosai Hospital, Nagasonecho, Kita-ku, Sakai, Osaka, Japan.
Insights
Perfusion balloons (PBs) before stenting improve outcomes for ST-segment elevation myocardial infarction (STEMI) patients by reducing slow-flow/no-reflow and improving coronary flow. This approach offers better clinical results compared to conventional stenting.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomedical Engineering
Background:
- Drug-eluting stents have reduced STEMI mortality but slow-flow/no-reflow and restenosis remain issues.
- Perfusion balloons (PBs) offer potential advantages by compressing thrombi and delivering agents like nitroprusside.
- The efficacy of PBs as a pre-stenting strategy for STEMI requires further investigation.
Purpose of the Study:
- To evaluate the effectiveness of perfusion balloons (PBs) used before stenting compared to conventional percutaneous coronary intervention (CP) in ST-segment elevation myocardial infarction (STEMI) patients.
- To assess the impact of PBs on slow-flow/no-reflow phenomenon (SFNR) and in-stent restenosis.
- To compare optical coherence tomography (OCT) findings and clinical outcomes between the PB and CP groups.
Main Methods:
- The Reduction of risk bY perfUsion balloon for ST-segment Elevated myocardial Infarction (RYUSEI) study enrolled STEMI patients undergoing OCT-guided PCI.
- Patients were divided into a PB group (treated with PBs before stenting) and a conventional percutaneous coronary intervention (CP) group.
- Propensity score-matching was used to compare clinical and OCT findings between the groups.
Main Results:
- In the propensity score-matched cohort (23 patients per group), the PB group showed significantly lower SFNR (p=0.047) and maximum protrusion area on OCT (p=0.019).
- Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 was significantly higher in the PB group (p=0.022).
- Kaplan-Meier analysis revealed significantly better clinical outcomes in the PB group compared to the CP group (p=0.038).
Conclusions:
- Pre-stent lesion modification with nitroprusside infusion using perfusion balloons (PBs) is beneficial for STEMI patients.
- PBs can lead to improved coronary flow and reduced adverse events compared to conventional stenting.
- The RYUSEI study suggests PBs are a valuable tool for enhancing clinical courses in STEMI management.
Abstract:
Drug-eluting stents have significantly contributed to reducing mortality in patients with ST-segment elevation myocardial infarctions (STEMIs), but slow-flow/no-reflow phenomenon (SFNR) and in-stent restenosis are still clinical problems. In contrast, perfusion balloons (PBs) can compress thrombi and ruptured plaque for long inflation without ischemia and can be used as a delivery device for infusion of nitroprusside to distal risk area during ballooning. We conducted a Reduction of risk bY perfUsion balloon for ST-segment Elevated myocardial Infarction (RYUSEI) study to evaluate whether PBs before stenting are more effective than conventional stenting for STEMIs. We divided consecutive patients with STEMIs who underwent optical coherence tomography (OCT)-guided percutaneous coronary intervention into PB group who were treated with PBs (Ryusei; Kaneka Medix Corporation, Osaka, Japan) before stenting and the conventional percutaneous coronary intervention (CP) group. We compared clinical results including SFNR, OCT findings, and clinical events between the 2 groups. We finally analyzed 34 patients in PB group and 90 in CP group. After propensity score-matching, PB and CP groups consisted of 23 patients, respectively. In the propensity score-matched cohort, SFNR and maximum protrusion area detected by OCT were significantly lower (p = 0.047 and p = 0.019), and thrombolysis in myocardial infarction flow grade 3 was higher (p = 0.022) in the PB group than CP group. Kaplan-Meier analysis revealed a significantly better clinical outcome in PB group than CP group (p = 0.038). In conclusion, the RYUSEI study revealed a pre-stent lesion modification in addition to nitroprusside infusion using PB is useful to achieve better clinical courses in STEMI patients.
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