Publication:

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

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.