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Cardiol Res. 2018 Dec;9(6):350-357. doi: 10.14740/cr795. Epub 2018 Dec 7.

Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions.

Author information

1
KLE Academy of Higher Education and Research Centre (KLE University), Belgaum, Karnataka, 590010, India.
2
KIMS Hospital, Hyderabad, Telangana, 500003, India.
3
Fortis Escorts Heart Centre, Raipur, Chhattisgarh, 492001, India.
4
Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru, Karnataka, 560069, India.
5
Sri Jayadeva Institute of Cardiovascular Sciences and Research K.R. Hospital Campus, Mysore, Karnataka, 570016, India.
6
SUT Hospital Pattom, Trivandrum, Kerala, 695004, India.
7
Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, 396191, India.
8
U.N. Mehta Institute of Cardiology, Civil Hospital, Ahmedabad, Gujarat, 380016, India.

Abstract

Background:

When coronary lesions involve segments > 48 mm, the only treatment possibility is stent overlapping which is associated with higher neointimal proliferation that lead to more restenosis. Furthermore, tapering of coronary arteries is a major challenge observed with long diffuse coronary lesions. This study attempted to assess the safety and performance of world's first commercialised long-tapered (60 mm) sirolimus-eluting coronary stent (SES) system for the treatment of long diffused de novo coronary lesions in real world scenario.

Methods:

This was a retrospective, non-randomised, multicentre study which included 362 consecutive patients implanted with long-tapered BioMime™ Morph SES system for the treatment of long diffused de novo coronary lesions. Safety endpoint was major adverse cardiac events (MACE), which was defined as composite of cardiac death, myocardial infarction (MI) and ischemic-driven target lesion revascularization (ID-TLR), at 12-month follow-up.

Results:

Out of 362 patients included, 170 (47.0%) were diabetic and 159 (43.9%) were hypertensive. The mean age of all patients was 61.09 ± 9.04 years. A total of 625 lesions were identified; out of which 402 lesions were intervened successfully using BioMime Morph. The cumulative incidence of MACE was 7 (2.0%) at 12-month follow-up which included four (1.1%) cardiac deaths, one (0.3%) case of MI and two (0.6%) ID-TLR. Acute stent thrombosis was reported in one (0.3%) patient.

Conclusions:

The present study confirms the safety and performance of BioMime Morph, and hence, can be considered as a treatment of choice for long diffused tapered de novo coronary lesions in routine clinical practice.

KEYWORDS:

De novo; Long diffused lesions; Major adverse cardiac events; Tapered coronary stent system

Conflict of interest statement

Dr. Ashok S. Thakkar, Prakash Kumar Turiya, and Priyanka J. Desai are full-time employee of Meril Life Science, Pvt. Ltd., India. The other authors have no potential conflict of interest to declare.

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