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Angiography and Optical Coherence Tomography Assessment of the Drug-Coated Balloon ESSENTIAL for the Treatment of
Jose M de la Torre Hernández1, Tamara Garcia Camarero1, Fernando Lozano Ruiz-Poveda2
1Hospital Universitario Marques de Valdecilla, Dpt. of Interventional Cardiology, Santander, Spain.
Insights
The ESSENTIAL drug-coated balloon (DCB) effectively treated in-stent restenosis (ISR), demonstrating sustained efficacy in preventing recurrent restenosis. This study confirms DCB as a viable option for managing ISR.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Interventional Cardiology
Background:
- Drug-coated balloons (DCBs) are recognized treatments for in-stent restenosis (ISR).
- Clinical evidence supports DCB efficacy, but a class effect cannot be assumed.
- Individual evaluation of new DCB models is crucial.
Purpose of the Study:
- To evaluate the efficacy of the ESSENTIAL drug-coated balloon (DCB) for treating in-stent restenosis (ISR).
- To assess the safety and performance of the ESSENTIAL DCB in a prospective, multicenter clinical study.
Main Methods:
- Prospective, multicenter study involving patients treated with the ESSENTIAL DCB for ISR.
- Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) used for follow-up.
- Primary endpoint: OCT-derived in-segment maximal area stenosis; Secondary endpoints: QCA-derived late lumen loss (LLL) and target lesion failure (TLF) rates.
Main Results:
- 31 patients were treated; 26 completed 6-month angiographic follow-up.
- Mean in-segment maximal area stenosis was 51.4% (median 53%); in DES-ISR subgroup, 52.6% (median 55.2%).
- Late lumen loss (LLL) was 0.25 mm; binary restenosis rate was 7.7%. Target lesion failure (TLF) was 10% at 6 months, 13.3% at 12 and 24 months.
Conclusions:
- The ESSENTIAL DCB demonstrated sustained efficacy in preventing recurrent restenosis post-ISR treatment.
- The study supports the use of the ESSENTIAL DCB as an effective therapeutic option for ISR.
- Low rates of binary restenosis and manageable TLF indicate a favorable safety profile.
Objectives:
This study sought to assess the efficacy of the drug-coated balloon (DCB) ESSENTIAL for the treatment of in-stent restenosis (ISR).
Background:
DCBs have proven a valid therapeutic option for the management of ISR in several clinical trials, yet no class effect can be claimed. Accordingly, every new DCB model has to be individually evaluated through clinical studies.
Methods:
This is a prospective, multicenter study including consecutive patients undergoing percutaneous coronary intervention for ISR with the ESSENTIAL DCB. A 6-month quantitative coronary angiography (QCA)/optical coherence tomography (OCT) follow-up was scheduled. The primary endpoint was OCT-derived in-segment maximal area stenosis. Secondary endpoints included QCA-derived in-segment late lumen loss (LLL) and target lesion failure (TLF) rates at 6, 12, and 24 months. TLF was defined as the composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization.
Results:
A total of 31 patients were successfully treated with DCB, with 67% of ISR corresponding to drug-eluting stents (DES). At 6 months, 26 patients underwent the scheduled angiographic follow-up. The mean value for in-segment maximal area stenosis was 51.4 ± 13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, these parameters were 52.6 ± 10% and 55.2% (IQR 49.3-58.5), respectively. In-segment LLL was 0.25 ± 0.43 mm with only 2 (7.7%) patients showing binary restenosis (>50%). The incidence of TLF was 10% at 6 months, 13.3% at 12 months, and 13.3% at 24 months.
Conclusions:
In this study, the ESSENTIAL DCB showed sustained efficacy in the prevention of recurrent restenosis after treatment of ISR.
Summary:
We sought to assess the efficacy of the drug-coated balloon ESSENTIAL for the treatment of in-stent restenosis through a prospective, multicenter study including QCA and OCT assessment at 6-month follow-up. The primary endpoint was in-segment maximal area stenosis. Among the 31 patients successfully treated with the ESSENTIAL DCB, an angiographic follow-up was conducted in 26. Mean in-segment maximal area stenosis was 51.4 ± 13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, corresponding values were 52.6 ± 10% and 55.2% (IQR 49.3-58.5), respectively. The observed in-segment LLL was 0.25 ± 0.43 mm and binary restenosis rate was 7.7%. TLF was 10% at 6 months and 13.3% at 12 and 24 months.
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