Abstract

JACC

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TCTAP A-043

Long-Term Safety and Efficacy Outcomes after Treatment of Coronary Artery Lesions using Sirolimus Coated Balloons: Insights from Real-world All-comer Patients

By Sameer Dani

Presenter

Sameer Dani

Authors

Sameer Dani1

Affiliation

Apollo Hospitals, India1
View Study Report
TCTAP A-043
Drug-Eluting Balloons

Long-Term Safety and Efficacy Outcomes after Treatment of Coronary Artery Lesions using Sirolimus Coated Balloons: Insights from Real-world All-comer Patients

Sameer Dani1

Apollo Hospitals, India1

Background

Percutaneous coronary intervention (PCI) with Drug-coated balloons (DCBs) is the commonest procedure used in the invasive treatment of coronary artery disease (CAD). The effect of DCBs is based on the fast and homogenous transfer of antiproliferative drugs into the vessel wall during single balloon inflation. We investigated the performance of MagicTouch sirolimus coated balloon (SCB) (Concept Medical), up to 36-months clinical follow-up in real-world all-comer Patients.

Methods

NANOLUTE was a prospective, multicenter, and real-world study that enrolled real-world all-comers patients. The study evaluated 450 patients (479 lesions) treated with MagicTouch Sirolimus coated balloon. MACE was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), and target lesion/vessel revascularization (TLR/TVR) and it was investigated up to 36 months. 

Results

The mean patient age was 60 years, and 369 (82%) were male. Of 450 patients, 217 patients presented with acute coronary syndromes(48.2%), 26(12%) patients had non-ST-segment elevation myocardial infarction, and 52 (24%) patients had ST-segment elevation myocardial infarction. The main indication for SCB intervention was de-novo lesions (53%), whereas, in 64 (47%) patients, the SCB was applied for in-stent restenosis (ISR). MagicTouch SCB was deployed successfully in almost all the patients (99.6%) while there were dissections reported in two lesions.
Clinical follow-up was available for all patients up to 36 months. The primary endpoint, the incidence of MACE @ 6 months was reported as 3.3% mainly driven by TLR/TVR(2.9%) followed by TV-MI (0.2%) and cardiac death (0.2%). The cumulative incidence of MACE was reported as 6.7% mainly driven by TLR/TVR (4.7%) followed by TV-MI (0.5%) and cardiac death (1.6%) at 36 months. The results were equally promising in the high-risk subgroups like a small vessel (4.6%). ISR (10.0%) and DES-ISR (12%) at 36 months. 

Conclusion

Long-term clinical outcomes revealed lower MACE rates in the overall population as well as in complex subgroups. The results clinically prove the safety and efficacy of MagicTouch Sirolimus coated balloon in a real-world population. 

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