A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study)

Aims: Evaluation of safety and efficacy of ProNOVA XR, a new generation of polymer-free sirolimus eluting stents (SES), utilizing a pharmaceutical excipient for timed release of sirolimus from the XR platform. Methods and results: Safety and efficacy of ProNOVA XR coronary stent system was examined in EURONOVA prospective, single arm, multi-center registry of 50 patients with de novo native coronary lesions up to 28 mm in length in arteries between 2.25 and 4 mm. At 6-month, in-stent late lumen loss by QCA was 0.45 ± 0.41 mm and in-stent neointimal volume obstruction in the IVUS sub-study was 14 ± 11%. One-year clinical follow-up revealed a favorable safety profile, with 2% of in-hospital MACE and 6.4% of MACE from hospital discharge up to 12 months (including 1 cardiac death >30 days after stent implantation and 2 TLRs). According to the ARC definition, there was no definite or probable stent thrombosis and 1 possible stent thrombosis (2%) up to 12 months of clinical follow-up. Conclusions: In this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up

Facilitated percutaneous coronary intervention in patients with acute myocardial infarction transferred from remote hospitals

Two hundred patients with acute myocardial infarction admitted to hospitals. remote from a interventional center (transfer time >90 minutes) received IV bolus doses of heparin, half-dose alteplase, and abciximab, and were immediately transferred to the interventional center, with continued alteplase and abciximab infusions. Transfer was safe with no deaths. Seventy-one percent of the patients presented with TIMI grade 3 flow in the infarct-related artery at the diagnostic angiography, whereas percutaneous intervention facilitated by this lytic regimen resulted in a final TIMI 3 flow in 93% of patients and low mortality at 30 days (3.5%); however, there were frequent bleeding complications