Lots of interesting abstracts and cases were submitted for TCTAP 2022. Below are the accepted ones after a thorough review by our official reviewers. Don’t miss the opportunity to expand your knowledge and interact with authors as well as virtual participants by sharing your opinion in the comment section!
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.
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.
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.