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Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial Arroyo D; Togni M; Puricel S; Gerard B; Sonja L; Corpataux N; Villeneuve H; Boute E; Stauffer JC; Goy JJ; Cook STrials 2014[Jan]; 15 (ä): 9BACKGROUND: Second-generation everolimus-eluting stents (EES) and third generation biolimus-eluting stents (BES) have been shown to be superior to first-generation paclitaxel-eluting stents (PES) and second-generation sirolimus-eluting stents (SES). However, neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent (DES) implantation overall. The Absorb (Abbott Vascular, Abbott Park, IL, USA) is the first CE approved DES with a bioresorbable vascular scaffold (BVS) thought to reduce long-term complication rates. The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion. METHODS/DESIGN: The EVERBIO II trial is a single-center, assessor-blinded, randomized trial. The study population consists of all patients aged>/=18 years old undergoing percutaneous coronary intervention. Exclusion criterion is where the lesion cannot be treated with BVS (reference vessel diameter>4.0 mm). A total of 240 patients will be enrolled and randomly assigned into 3 groups of 80 with either BVS, EES or BES implantation. All patients will undergo a follow-up angiography study at 9 months. Clinical follow-up for up to 5 years will be conducted by telephone. The primary endpoint is in-segment late lumen loss at 9 months measured by quantitative coronary angiography. Secondary endpoints are patient-oriented major adverse cardiac event (MACE) (death, myocardial infarction and target-vessel revascularization), device-oriented MACE (cardiac death, myocardial infarction and target-lesion revascularization), stent thrombosis according to ARC and binary restenosis at follow-up 12 months angiography. DISCUSSION: EVERBIO II is an independent, randomized study, aiming to compare the clinical efficacy, angiographic outcomes and safety of BVS, EES and BES in all comer patients. TRIAL REGISTRATION: The trial listed in clinicaltrials.gov as NCT01711931.|*Absorbable Implants[MESH]|*Drug-Eluting Stents[MESH]|*Research Design[MESH]|*Tissue Scaffolds[MESH]|Cardiovascular Agents/*administration & dosage[MESH]|Clinical Protocols[MESH]|Coronary Angiography[MESH]|Coronary Artery Disease/diagnosis/mortality/*therapy[MESH]|Coronary Restenosis/etiology[MESH]|Coronary Thrombosis/etiology[MESH]|Everolimus[MESH]|Humans[MESH]|Myocardial Infarction/etiology[MESH]|Percutaneous Coronary Intervention/adverse effects/*instrumentation/mortality[MESH]|Prosthesis Design[MESH]|Sirolimus/administration & dosage/*analogs & derivatives[MESH]|Switzerland[MESH]|Time Factors[MESH]|Treatment Outcome[MESH] |
