Initial Single Centre Experience of a Novel Polymer-free Drug Eluting Stent (DES) (Cre-8) in a Real World All-Comer Patient Population

Abstract

Cre-8 is a carbofilm coated cobalt-chromium amphilimus (sirolimus + organic acid) eluting stent using polymer free abluminal reservoir technology, configuration allowing increased sirolimus cellular dosing. We examined the efficacy, deliverability, deployability of Cre-8, 30- and 60-day MACCE (death, stroke, bleeding events, TLR, and rehospitalisation) in treated all-comer patients 52 consecutive patients were treated with Cre-8 stent over a 5-month period (November 2016 to March 2017) (71 vessels and 80 lesions: 50% were ACC/AHA type C, 16.3% were CTO), over half with ACS presentation (55.8%). All received dual antiplatelets and heparin. Patients had either single (n = 37, 71.2%) or multi-vessel stenting (double: 21.2%, triple 7.7%) (65 vessels stented, 6 ballooned only). 81 Cre-8 stents were deployed. Reference vessel size (mean) was 3.5 mm, longest stented length was 120 mm (mean length 30 mm). Procedural success was 100% with all stents being delivered and deployed. 1 case of acute stent thrombosis (ST) occurred due to patient factors (inadequate antiplatelet loading, antiphospholipid syndrome) and inadequate stent sizing (confirmed by IVUS). Post-dilatation performed (100%) with post-dilatation balloon greater than (74.1%) or equal to stent diameter (25.9%). Apart from 1 acute ST, all patients had no MACCE at 1 month (100%) and 2 months follow-up (73.1%). Cre-8 is safe and efficacious in our initial experience. Excellent deliverability and visibility with stent-edge markers were helpful in stent positioning. Large clinical trials are currently underway directly comparing efficacy with current DES. More data is needed.