Real world experience of GenXSync™ sirolimus eluting coronary stent system in patients with long coronary lesions: outcome of the GEL registry

Hiremath M. S.; C. N. Makhale; Abhishek Gorlawar; Ashish Indani; Poonam Bhutada; Murlidhar Bendale

doi:10.18203/2349-3933.ijam20163743

Authors

Hiremath M. S. Department of Cardiology, Ruby Hall Clinic, Pune, Maharashtra, India
C. N. Makhale Department of Cardiology, Ruby Hall Clinic, Pune, Maharashtra, India
Abhishek Gorlawar Department of Radiology, Ravi Imaging, Jupitor Scan Centre, Mumbai, Maharashtra, India
Ashish Indani SME Medical Devices, Medical Writing, Tata Consultancy Services, Mumbai, Maharashtra, India
Poonam Bhutada Department of Research Methodology, Krishnamugdha Insititute of Advanced Learning and Research, Maharashtra, India
Murlidhar Bendale MIV Therapeutics, Surat, Gujarat, India

DOI:

https://doi.org/10.18203/2349-3933.ijam20163743

Keywords:

Angioplasty, Complex PCI, Genxsync, Long stent, Long lesion PCI, MIV therapeutics, Hybrid design stent, Percuteneous coronary intervention, PCI, Sirolimus eluting stent, Tata consultancy services

Abstract

Background: The study aimed to assess the immediate (procedural outcome) and long- term clinical (Cumulative hierarchical MACE up to 2 years) and angiographic outcomes (late lumen loss at 8 months) in the patients undergoing angioplasty with at least one 40 mm GenXSync™ SES. (Indian Study Regulatory ID CTRI/2014/07/004783).

Methods: This single centre prospective study included 26 real-world coronary artery disease (CAD) patients with long and very long lesions (38 lesions, 48 stents). All patients were treated with one or more 40 mm GenxSync™ sirolimus eluting stent (SES). All the subjects were followed up for 2 years including angiographic follow-up at 8 months. Angiography data was evaluated and reported by an independent angiographic core-lab. Subset analyses were performed for all 40mm long stents and 40mm with small diameter stents.

Results: The procedural success was observed in 94%. The acute gain was 2.25±0.53mm in stent and 2.09±0.71mm in segment despite of long and complex lesions including CTO. At 2 years, there was only 1 (3.84%) MACE (binary restenosis at 8 months) and stent thrombosis. At 8 months late lumen loss was in-segment 0.15±0.30mm and in-stent 0.14±0.17mm (p = 0.06). The 40mm stents subset, revealed acute gain of 2.21±0.58mm in-stent and 2.01±0.74mm in-segment. The late loss was 0.16± 0.31mm and 0.13±0.17mm in-stent and in-segment respectively. In 40mm stent with small diameter subset, the acute gain was 2.19±0.42mm in-stent and 1.69 ± 0.59mm in-segment and late lumen loss was 0.10±0.18mm in-segment and 0.13± 0.33mm in-stent.

Conclusions: The results of real world long lesions PCI revealed efficacy, safety and procedural success observed with GenXSync™ stent comparable to other reported studies.

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