spirit v: a clinical evaluation of the xience v® everolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (diabetic sub-study)

Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Summary: the purpose of this clinical evaluation is a continuation in the assessment of the performance of the xience v® everolimus eluting coronary stent system (xience v® eecss) in the treatment of patients with de novo coronary artery lesions in patients (diabetic sub-study).

the spirit v clinical evaluation consists of two concurrent studies,the diabetic sub-study and the registry. the spirit v diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the xience v® eecss to the taxus® liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. approximately 300 patients will be randomized (2:1) against the taxus® liberté™ coronary stent system. these patients will be recruited in up to 40 selected sites. 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 spirit v 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 spirit v diabetic study after 1 year.

Eligibility criteria:
inclusion criteria: * at least 18 years * able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the xience v® eecss and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate medical ethics committee of the respective clinical site * diagnosed with diabetes, as documented by medical history. * evidence of myocardial ischemia * acceptable candidate for coronary artery bypass grafting (cabg) surgery * agree to undergo all clinical investigation plan (cip)-required follow-up examinations * artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents * maximum of one, de novo, target lesion per native major epicardial vessel or side branch * target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate * target lesion ≤ 28 mm in length by visual estimate * target lesion must be in a major artery or branch with a visually estimated stenosis of \> 50% and \ 1 exclusion criteria: * known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure * current unstable arrhythmias * left ventricular ejection fraction \< 30% * received a heart or any other organ transplant or is on a waiting list for any organ transplant * receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure. * receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease * known hypersensitivity or contraindication to specific agents * elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel * platelet count limits, white blood cell limits or documented or suspected liver disease * renal insufficiency * history of bleeding diathesis or coagulopathy or will refuse blood transfusions * cerebrovascular accident or transient ischemic attack within the past 6 months * significant gi or urinary bleed within the past 6 months * history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the cip, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year) target lesion meets any of the following criteria: * in-stent restenotic * aorto-ostial location (within 3 mm) * left main location * located within 2 mm of the origin of the left anterior descending artery (lad) or left circumflex artery (lcx) * located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and \> 20% stenosed lesion by visual estimation) * lesion involving a side branch ≥ 2.5 mm in diameter * lesion involving a side branch with \> 50% stenosis by visual estimation lesion involving a side branch requiring predilatation * located in a major epicardial vessel that has been previously treated with brachytherapy * located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), \< 9 months prior to the index procedure * total occlusion (timi flow 0), prior to wire crossing * excessive tortuosity proximal to or within the lesion * extreme angulation (≥ 90%) proximal to or within the lesion * heavy calcification the target vessel contains visible thrombus patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy) patient has additional clinically significant lesion(s) (\> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required

Keywords: drug eluting stents stents angioplasty coronary artery disease total coronary occlusion coronary artery restenosis stent thrombosis vascular disease myocardial ischemia coronary artery stenosis