Long‐term follow‐up after sirolimus‐coated balloon use for coronary artery disease. Final results of the Nanolutè study

Abstract

Objectives To test the long‐term efficacy of a sirolimus‐coated balloon (SCB). Background Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in‐stent restenosis (ISR). We here present the 24 months clinical data. Methods All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel‐myocardial infarction (MI). Results A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow‐up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%). Conclusion The Nanoluté prospective registry is the first long‐term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.

Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry

“…Of note, 47% of patients underwent PCI for ISR, and procedural success was achieved in all patients. El-Mokdad et al have shown the longest follow-up of patients treated with SCBs to date [ 16 ]. They included 408 patients, of which 45% had diabetes mellitus, and in 47% of cases, ACS was the indication to coronary angiography, with unstable angina accounting for 64.4% of all ACS.…”

First-in-human experience with the sirolimus-coated balloon in ischemic peripheral arterial disease and occlusion of the common femoral artery

“…Sirolimus is less lipophilic than paclitaxel, but exerts only cytostatic and not cytotoxic effects. The Nanolutè registry 2 confirmed the safety and efficacy of this device in a broad population of patients with coronary artery disease with a long-term follow-up. However, unknown remains regarding the performance of Sirolimus-Coated Balloon (SCB) in peripheral arterial disease (PAD).…”

Duration of Dual Antiplatelet Therapy After Implantation of Drug-Coated Balloon

“…The MACE and TLR rates were similar between the two groups, and only one stent thrombosis occurred in the PCB group. Two other large prospective trials that enrolled a real-world, all-comer patient population also showed the safety and efficacy of SCB, both in patients with ISR or de novo lesions (75,76). The Nanolutè study evaluated the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of ISR and de novo coronary lesions.…”

“…The Nanolutè study evaluated the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of ISR and de novo coronary lesions. Dual antiplatelet therapy was recommended for 3–12 months in this trial ( 75 ). The MACE rate was 4.2% with 3.2% TLR at 2 years.…”