Cynergy: the CYPHER-NEVO Registry (CYNERGY)

• Non-inferiority comparison of Target Lesion Failure (TLF) in the NEVO group to the CYPHER group in subjects with acute STEMI, diabetes mellitus or multi vessel disease. [ Time Frame: 12 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
  TLF: composite clinical endpoint of cardiac death (death that cannot be attributed to a non-cardiac cause), target vessel-related MI and clinically-driven target lesion revascularization in the NEVO group compared to the CYPHER group.
  
  

• TLF in the NEVO and the CYPHER group [ Time Frame: Discharge, 1, 6, and 24 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
  TLF: composite clinical endpoint of cardiac death (death that cannot be attributed to a non-cardiac cause), target vessel-related MI and clinically driven target lesion revascularization
  
  
• Prescription and compliance patterns and impact of dual antiplatelet therapy (DAPT) duration on the incidence of the composite endpoint of all death, all MI and all revascularization, its individual components,stent thrombosis (ST) and major bleeding. [ Time Frame: Duration throughout the study ] [ Designated as safety issue: No ]
  
• Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
  
• Clinically driven Target Vessel Revascularization (TVR) defined as repeat PCI or CABG to the target vessel [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
  
• Composite endpoint of all death, all MI, all revascularization and its individual components [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
  
• Incidence of ARC (Academic Research Consortium) defined (definite, probably, possible and the composite of definite and probable) early and late and very late stent thrombosis [ Time Frame: Hospital discharge, 1,6, 12 and 24 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
  
• Major bleeding complications [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure. ] [ Designated as safety issue: Yes ]
  
• Stroke that persists >24 hours [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure. ] [ Designated as safety issue: Yes ]
  Stroke (cerebrovascular accident or CVA) defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists >24 hours
  
  

The CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES) is a balloon-expandable intracoronary 316L stainless steel stent with a coating that consists of a blend of Sirolimus and polymers.

Sirolimus is a potent immunosuppressive agent which has been proven to prolong graft survival in many animal models of transplantation. Sirolimus prevents both proliferation and migration of smooth muscle cells (in vivo and in vitro) in graft and balloon injury models. Furthermore, Sirolimus has been shown to be effective in reducing restenosis and the need for repeat revascularization while demonstrating superior efficacy measures such as angiographic late loss and binary restenosis.

The NEVO™ Sirolimus-eluting Coronary Stent is a cobalt-chromium alloy stent platform that incorporates two unique features: reservoir technology, and a bioresorbable polymer which prevents initial contact between the polymer and the vessel wall and chronic polymer exposure. This design minimized initial tissue exposure to polymer, and also enables polymer resorption within approximately three months.