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Novel Stentless Strategy With Perfusion and Drug-Coated Balloons for Treating Acute Coronary Syndrome
Ryota Fukuoka1, Tomohiro Kawasaki1, Kyoko Umeji1
1Cardiovascular Center, Shin-Koga Hospital, Kurume City, Japan.
Background:
The challenge with the stentless strategy is that the method of optimal predilatation, and predictors of success remain unknown. Studies involving the stentless strategy prior to predilatation are limited. This study aimed to evaluate the long-term efficacy and safety of a new stentless strategy for treating acute coronary syndrome (ACS) using gradual, prolonged predilation with a perfusion balloon combined with a drug-coated balloon (DCB).
Methods:
This was a single-center, prospective, single-arm study. A total of 30 patients with ACS underwent gradual, prolonged predilation using a perfusion balloon for 10 minutes, followed by additional dilation using a DCB. The primary end point was target vessel failure at 24 months. Secondary end points were a composite of acute end points, including stentless strategy success rate, procedural complications, final grade of coronary dissection, acute coronary occlusion, in-hospital major adverse cardiac events, and a chronic end point of target vessel failure at 24 months.
Results:
A successful stentless strategy was achieved in 24 patients (80%), and 2 (8.3%) patients required ischemic-driven target lesion revascularization in the chronic phase. Six (20%) patients required stent placement due to type C dissection or acute recoil. No acute occlusion and in-hospital major adverse cardiac events were reported.
Conclusions:
A novel stentless strategy using predilation with a perfusion balloon and DCB may be helpful for the revascularization of patients with ACS.
Insights
A new stentless strategy using prolonged predilation with a perfusion balloon and drug-coated balloon (DCB) shows promise for acute coronary syndrome (ACS) patients. This approach achieved an 80% success rate with no in-hospital major adverse cardiac events reported.
Area of Science:
- Interventional Cardiology
- Vascular Medicine
- Cardiovascular Research
Background:
- Optimal predilation methods and success predictors for stentless strategies remain unclear.
- Limited studies exist on stentless strategies prior to predilation.
- Acute coronary syndrome (ACS) treatment requires effective revascularization techniques.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of a novel stentless strategy for ACS.
- To assess a technique combining gradual, prolonged predilation with a perfusion balloon and a drug-coated balloon (DCB).
Main Methods:
- A single-center, prospective, single-arm study involving 30 ACS patients.
- Gradual, prolonged predilation using a perfusion balloon (10 minutes) followed by DCB dilation.
- Primary endpoint: target vessel failure at 24 months; secondary endpoints included procedural success, complications, and adverse events.
Main Results:
- Successful stentless strategy achieved in 80% of patients (24/30).
- No acute occlusion or in-hospital major adverse cardiac events were reported.
- 20% of patients required stent placement due to dissection or recoil; 8.3% needed revascularization in the chronic phase.
Conclusions:
- A novel stentless strategy utilizing perfusion balloon predilation and DCB shows potential for ACS revascularization.
- This approach appears safe and effective in the short-to-medium term.
- Further research is warranted to confirm long-term outcomes and optimize patient selection.
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