Author + information
- Sameer Dani1,
- Keyur Parikh2,
- Prathap Kumar N. Pillai3,
- Ranjan Shetty4,
- Jagdish Hiremath5 and
- Dinesh Shah6
- 1Lifecare Institute of Medical Sciences and Research and Apollo Hospitals, Ahmedabad, India
- 2Care Institute of Medical Sciences, Ahmedabad, India
- 3Meditrina Hospital, Kollam, India
- 4Kasturba Medical College - Manipal, Mangalore, India
- 5Ruby Hall Clinic, Pune, Maharashtra, India
- 6William Beaumont Hospital, Troy, MI
Over past the decade, drug-coated balloons have emerged as an effective treatment for coronary stenosis with and advantage of delivering the anti-proliferative agent to the clogged vessel without any metallic implant. We sought to assess the world’s first sirolimus-coated balloon (SCB) -Magictouch (Concept Medical) in the treatment coronary atherosclerotic disease.
NANOLUTE is a multi-centre, prospective, and real-world study. The measured endpoint was MACE (major adverse cardiac events) at 1 year. MACE component encompassed target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI), and cardiac death. To derive the device performance in long run, we calculated MACE at extended follow-up at 2 years and 3 years.
Four hundred thirty-eight patients were included in the study, with a total of 516 PCI procedures on 465 lesions, all treated with SCB. Of the 465 lesions, 45.81% were in-stent restenotic lesions, and de-novo accounted for 54.19%. Among those de-novo lesions, 43.87% were located in small coronary vessels (RVD ≤ 2.75 mm). The event characteristics were depicted in Table 1. MACE rates were 4.33%, 5.1%, and 7.72% at 1 year, 2 years and 3 years, respectively. The follow-up for the rest of the patients is yet to come, as NANOLUTE is an ongoing registry. There was no increment in events at 2- and 3-year follow-up.
|N (%)||1 Year N=393∗||2 Years N=330∗||3 Years N=220∗|
*Number of patients completed follow-up through October 2017
The present study demonstrated that SCB is a valid revascularization strategy in an all-comers population of patients with coronary atherosclerotic disease with an acceptable rate of cardiac events up to 3 years of follow-up.