XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study (XIENCE V India)

• Stent thrombosis rates as defined by Academic Research Consortium (ARC) [ Time Frame: Annually through to 3 years ] [ Designated as safety issue: Yes ]
  
• Composite endpoint of cardiac death and myocardial infarction (MI) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
  

• Composite rate of cardiac death and any MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 2 and 3 years ] [ Designated as safety issue: Yes ]
  
• Composite rate of all death and any MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 2 and 3 years ] [ Designated as safety issue: Yes ]
  
• Composite rate of cardiac death , any MI (Q-wave and non Q-wave) attributed to the target vessel, and target lesion revascularization (PCI and CABG) [ Time Frame: at 30, 180 days and at 2 and 3 years ] [ Designated as safety issue: Yes ]
  
• Death (cardiac death, vascular death, and non-cardiovascular death) [ Time Frame: at 30, 180 days and at 2 and 3 years ] [ Designated as safety issue: Yes ]
  
• Any MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 2 and 3 years ] [ Designated as safety issue: Yes ]
  
• Major bleeding complications [ Time Frame: at 14, 30, 180 days and at 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
  
• Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: at 14, 30, 180 days and at 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
  
• Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG) [ Time Frame: at 30, 180 days and at 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
  
• Clinical device and procedural success [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
  
• Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire [ Time Frame: at baseline, 180 days, and 1 year ] [ Designated as safety issue: No ]
  
• Stent thrombosis [ Time Frame: 24 hours (acute) and 30 days (sub-acute) ] [ Designated as safety issue: Yes ]
  
• Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG) [ Time Frame: 30, 180 days and 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
  

Long term surveillance studies using a drug eluting stent (DES) may help elucidate mechanisms responsible for death, myocardial infarction, and late stent thrombosis risks not observed during controlled pre-market trials. This study will evaluate XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) performance in the "real world" when used by a broad group of physicians at a variety of health care facilities. Consequently, this protocol will include all consecutively enrolled patients in India who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.

Adjunctive anti-platelet therapy is a critical factor in optimizing long term DES safety. Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE V® EECSS India Post-marketing Single-Arm Study (XIENCE V® India) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval XIENCE V India study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the XIENCE V India study, from 5 years to after completion of the three year follow-up.