Sameer Dani

A novel nanocarrier sirolimus-coated balloon for coronary interventions: 12-Month data from the Nanoluté Registry

BACKGROUNDnThe aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions.nnnMETHODSnAll patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12u202fmonths post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12u202fmonths. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction.nnnRESULTSnA total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (averageu202f±u202fSD) were 21.83u202f±u202f6.70u202fmm and 2.69u202f±u202f0.45u202fmm respectively. All patients with 1u202fyear follow-up were included. Overall DOCE rate was 4.2% (nu202f=u202f14) which included death 0.3% (nu202f=u202f1), TLR 3.6% (nu202f=u202f12) and myocardial infarction 0.3% (nu202f=u202f1).nnnCONCLUSIONnThe Nanoluté prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions.

TCT-486 Clinical outcomes of a novel abluminal coated sirolimus eluting stent: 2 years results from en-ABL e-Registry

nos: 487 499

TCT-388 Sirolimus Coated balloon in the treatment of Acute Coronary Syndrome: Results from the Nanolutè Registry

nos: 387 396 TCT-387 Sirolimus Coated Balloons for the Prevention of Vascular Restenosis in small vessel disease: Insights from the Nanoluté

TCT-390 Influence of Diabetes on the Safety and Efficacy of Sirolimus Coated Balloon in a Real-World Multi-Centre Nanolutè Registry.

myocardial infarction (11.83%). Most coronary lesions were located in LAD (46.96%). Bail-out stenting was required in 6.51% patients. In most cases SCB alone therapy was employed (93.49%). In 6 months follow-up was available for 94.67% patients. The overall incidence of TLR/TVR and TV-MI were 4.38% and 0.63% respectively. Total 83.43% patients completed 12 months follow-up and the reported MACE was 6.38%, mainly driven by TLR/TVR (5.67%) followed by TV-MI (0.71%).