Author + information
- John C. Wang1,
- Didier Carrié2,
- Monica Masotti3,
- Andrejs Erglis4,
- David Mego5,
- Matthew Watkins6,
- Paul Underwood7,
- Dominic J. Allocco7 and
- Christian W. Hamm8
Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) to drug-eluting stents (DES). DES lower rates of repeat revascularization compared to BMS, but may have higher rates of late and very late stent thrombosis (ST). This is potentially due to impaired endothelialization which requires longer dual anti-platelet therapy (DAPT) compared with BMS.
The OMEGA study is a prospective, multicenter, single-arm study enrolling 328 patients at 37 investigative sites in the US and EU. Patients received the OMEGA stent (also known as REBEL; a bare platinum chromium Element stent) for the treatment of de novo native coronary artery lesions (≤28 mm long; diameter ≥2.25 mm to ≤4.50 mm). 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.
In the OMEGA study, the mean age was 65; 17% had diabetes mellitus. Approximately 29% had previous PCI, 5% had previous CABG (Table). The primary endpoint was met; the 9 month TLF rate was 11.5% and the upper 1-sided 95% confidence bound of 14.84% was less than the prespecified PG of 21.2% (p<0.0001). Event rates were low including a ST rate of 0.6% at 9 months (Table). Through 9 months, the MI rate was 3.7% (12/326); all of the MIs were non-Q wave MIs most occurring within 1 day of the procedure (10/12).
Nine-month outcomes of OMEGA show a low rate of TLF, revascularization and ST events. This supports safety and efficacy of the novel, platinum chromium OMEGA/REBEL BMS for the treatment of coronary artery disease.
|Baseline Clinical Characteristics|
|Male, %||67.7% (222/328)||Stable Angina, %||49.7% (163/328)|
|Age, years||65.46±11.23 (328)||Unstable Angina, %||31.1% (102/328)|
|Diabetes*, %||17.4% (57/328)||Hyperlipidemia*, %||70.8% (230/324)|
|Smoking (ever), %||66.1% (211/319)||Hypertension*, %||75.0% (243/324)|
|History of Bleeding Disorder, %||2.5% (8/326)||Prior MI, %||29.0% (94/324)|
|History of TIA or CVA, %||7.7% (25/326)||Prior PCI, %||28.8% (94/326)|
|History of PVD, %||6.4% (21/326)||Prior CABG, %||4.6% (15/327)|
|Baseline Lesion Characteristics|
|RVD, mm||2.77±0.53 (327)||% DS||67.41±11.34 (327)|
|MLD, mm||0.90±0.38 (327)||Lesion Length (mm)||12.49±5.15 (327)|
|9-Month Outcomes (Intent-to-treat)|
|TLF||11.4% (37/324)||TVR||8.6% (28/326)|
|Cardiac Death||1.2% (4/326)||TLR||7.4% (24/326)|
|MI**||3.7% (12/326)||Stent Thrombosis (ARC ST; Definite/Probable)||0.6% (2/320)|
TIA: Transient Ischemic Attack; CVA: Cerebrovascular Accident; PVD: peripheral vascular disease; RVD: Reference Vessel Diameter; MLD: Minimum Lumen Diameter; %DS: Percent Diameter Stenosis; PCI: Percutaneous Coronary Intervention; CABG: Coronary Artery Bypass Graft surgery; TLF: cardiac death, myocardial infarction (MI) related to the target vessel, and target lesion revascularization (TLR); *Requiring medication; **All were non-Q-Wave MI defined as elevation of post-procedure CK-MB levels to >3.0 times ULN without new Q-waves.