We investigated the performance of MagicTouch sirolimus-coated balloon (SCB) (Concept Medical), on the immediate performance and the long-term clinical outcome, including target lesion revascularization (TLR) and major adverse cardiac event (MACE), in patients with a broad spectrum of coronary artery disease.

We evaluated the entire Nanolutè population of 450consecutive patients (479 lesions) undergoing Sirolimus coated balloon angioplasty for in-stent restenotic and de-novo lesions in coronary arteries. MACE rate, which included cardiac death, target vessel myocardial infarction(TV-MI) and target lesion revascularization (TLR) were investigated at 2 and3-years.

The mean patient age was 60 years, and 369 (82%) were male. Of the enrolled patients, 217 patients presented with acute coronary syndromes (48.2%), 26 patients (12%) had non-ST-segment elevation myocardial infarction, and 52 patients (24%) 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 ISR. MagicTouch SCB was deployed successfully in almost all the patients (99.6%). Follow-up at 2 year was available for 441 (98%) of the 450 patients. MACE occurred in 22 (5.6%) patients which was composite of 18 (4.6%) TLR, 2 (0.5%) TV-MI and 2(0.5%) cardiac death. Three-year follow-up is still ongoing. At the moment of drafting of the current abstract it was available for 390 (86.7%) patients and the incidence of MACE was 6.7%. The final follow-up of the study will be available by December 2020.

Inconclusion, the long-term results of the Nanolutè study suggest that MagicTouch SCB is associated with good clinical outcome in a real-world all-comer population of patients with coronary atherosclerosis.