John C Wang1, Didier Carrié2, Monica Masotti3, Andrejs Erglis4, David Mego5, Matthew W Watkins6, Paul Underwood7, Dominic J Allocco8, Christian W Hamm9. 1. MedStar Union Memorial Hospital, Baltimore MD, USA. Electronic address: john.wang@medstar.net. 2. Centre Hôpital Universitaire Rangueil, Toulouse, France. Electronic address: carrie.didier@chu-toulouse.fr. 3. Hospital Clinic, University of Barcelona, Spain. Electronic address: MASOTTI@clinic.ub.es. 4. Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia. Electronic address: a.a.erglis@stradini.lv. 5. Arkansas Heart Hospital, Little Rock, AR. Electronic address: David.Mego@arheart.com. 6. University of Vermont Medical Center, Burlington VT, USA. Electronic address: Matthew.Watkins@vtmednet.org. 7. Boston Scientific, Marlborough MA USA. Electronic address: Paul.underwood@bsci.com. 8. Boston Scientific, Marlborough MA USA. Electronic address: Dominic.allocco@bsci.com. 9. Kerckhoff Heart and Thoraxcenter, Bad Nauheim, Germany. Electronic address: C.Hamm@kerckhoff-klinik.de.
Abstract
BACKGROUND/ PURPOSE: Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms. METHODS/MATERIALS: OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery lesions (≤28 mm long; diameter ≥2.25 mm to ≤4.50mm). The primary endpoint was 9-month target lesion failure (TLF: cardiac death, target vessel-related MI, target lesion revascularization [TLR]) compared to a prespecified performance goal (PG) based on prior generation BMS. All major cardiac events were independently adjudicated. DAPT was required for a minimum of 1 month post procedure. RESULTS: In the OMEGA study, the mean age was 65; 17% had diabetes mellitus. The primary endpoint was met; 9 month TLF rate was 11.5%, and the upper 1-sided 95% confidence bound of 14.79% was less than the prespecified PG of 21.2% (p<0.0001). One-year event rates were low including a TLF rate of 12.8% and an ST rate of 0.6% at 12 months. CONCLUSIONS: One-year outcomes of OMEGA show low rates of TLF, revascularization and ST. This supports safety and efficacy of the OMEGA BMS for the treatment of coronary artery disease.
BACKGROUND/ PURPOSE: Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms. METHODS/MATERIALS: OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery lesions (≤28 mm long; diameter ≥2.25 mm to ≤4.50mm). The primary endpoint was 9-month target lesion failure (TLF: cardiac death, target vessel-related MI, target lesion revascularization [TLR]) compared to a prespecified performance goal (PG) based on prior generation BMS. All major cardiac events were independently adjudicated. DAPT was required for a minimum of 1 month post procedure. RESULTS: In the OMEGA study, the mean age was 65; 17% had diabetes mellitus. The primary endpoint was met; 9 month TLF rate was 11.5%, and the upper 1-sided 95% confidence bound of 14.79% was less than the prespecified PG of 21.2% (p<0.0001). One-year event rates were low including a TLF rate of 12.8% and an ST rate of 0.6% at 12 months. CONCLUSIONS: One-year outcomes of OMEGA show low rates of TLF, revascularization and ST. This supports safety and efficacy of the OMEGA BMS for the treatment of coronary artery disease.