19 research outputs found
TCT-515 Multi-Center, Post-marketing Evaluation of the Elixir DESolve® Novolimus Eluting Bioresorbable Coronary Stent System: 6-month Results from the DESolve PMCF Study
TCT-37 Prospective, Multi-Center Evaluation of the DESolve Nx Novolimus-Eluting Bioresorbable Coronary Scaffold: First Report of One Year Clinical and Imaging Outcomes
TCT-17 Prospective, Multi-Center Evaluation of the DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold: Imaging Outcomes and 3-Year Clinical and Imaging Results
MULTICENTER, PROSPECTIVE, RANDOMIZED, SINGLE BLIND, CONSECUTIVE ENROLLMENT EVALUATION A NOVOLIMUS-ELUTING CORONARY STENT SYSTEM WITH BIOABSORBABLE POLYMER COMPARED TO A ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM: 6-MONTH ANGIOGRAPHIC AND IVUS RESULTS AND 24- MONTH CLINICAL: THE EXCELLA BD STUDY
TCT-515 Multi-Center, Post-marketing Evaluation of the Elixir DESolve® Novolimus Eluting Bioresorbable Coronary Stent System: 6-month Results from the DESolve PMCF Study
CRT-63 Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation A Novolimus-eluting Coronary Stent System With Bioabsorbable Polymer Compared To a Zotarolimus-eluting Coronary Stent System: 12- Month Clinical And 6-month Angiographic and IVUS Results: The Excella BD Study
DESyne novolimus-eluting coronary stent is superior to Endeavor zotarolimus-eluting coronary stent at five-year follow-up: final results of the multicentre EXCELLA II randomised controlled trial
AIMS
Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES. Current-generation DES have zotarolimus, everolimus or biolimus as antiproliferative drugs. Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load. We report the final five-year outcomes of the EXCELLA II trial comparing a zotarolimus-eluting stent (ZES) with a novolimus-eluting stent (NES).
METHODS AND RESULTS
EXCELLA II is a prospective, multicentre, single-blind, non-inferiority clinical trial. Patients (n=210) with a maximum of two de novo lesions in two different epicardial vessels were randomised (2:1) to treatment with either NES (n=139) or ZES (n=71). At five-year follow-up, patients in the NES group had a significantly lower incidence of the patient-oriented (HR 0.53, 95% CI: 0.32-0.87, p=0.013) and device-oriented (HR 0.38, 95% CI: 0.17-0.83, p=0.011) composite endpoints. There was no difference in cardiac death and definite/probable stent thrombosis between the two groups; however, there was a trend towards reduction in myocardial infarction and repeat revascularisation in the NES group at five-year follow-up.
CONCLUSIONS
At five-year follow-up, the incidence of device- and patient-oriented events was significantly lower in the NES group. Further studies, adequately powered for clinical outcomes, are warranted.
TRIAL REGISTRATION
ClinicalTrials.gov number NCT00792753