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
| Autor: | John A. Ormiston, Stephan Windecker, Ton de Vries, Peter J. Fitzgerald, Stefan Verheye, Javaid Iqbal, Lynn Morrison, Sara Toyloy, Alexandre Abizaid, Patrick W. Serruys |
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| Přispěvatelé: | Cardiology, Cardio-vascular diseases, Clinical sciences |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.medical_treatment Coronary Disease 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Percutaneous Coronary Intervention Randomized controlled trial law Internal medicine Coronary stent Medicine Humans Zotarolimus 030212 general & internal medicine Myocardial infarction Prospective Studies Aged Sirolimus novolimus Everolimus business.industry Stent Percutaneous coronary intervention Drug-Eluting Stents Middle Aged medicine.disease Clinical trial zotarolimus Cardiology Female Macrolides Cardiology and Cardiovascular Medicine business medicine.drug Follow-Up Studies |
| Zdroj: | EuroIntervention, 12(11), e1336-e1342. EuroPCR |
| ISSN: | 1969-6213 1774-024X |
| DOI: | 10.4244/eijy15m10_04 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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