title: ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design.
abstract: BACKGROUND
  Currently, no data are available on the direct comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) and conventional metallic drug-eluting stents.
  
  
  METHODS
  The ABSORB II study is a randomized, active-controlled, single-blinded, multicenter clinical trial aiming to compare the second-generation Absorb BVS with the XIENCE everolimus-eluting metallic stent. Approximately 501 subjects will be enrolled on a 2:1 randomization basis (Absorb BVS/XIENCE stent) in approximately 40 investigational sites across Europe and New Zealand. Treated lesions will be up to 2 de novo native coronary artery lesions, each located in different major epicardial vessels, all with an angiographic maximal luminal diameter between 2.25 and 3.8 mm as estimated by online quantitative coronary angiography (QCA) and a lesion length of ≤48 mm. Clinical follow-up is planned at 30 and 180 days and at 1, 2, and 3 years. All subjects will undergo coronary angiography, intravascular ultrasound (IVUS) and IVUS-virtual histology at baseline (pre-device and post-device implantation) and at 2-year angiographic follow-up. The primary end point is superiority of the Absorb BVS vs XIENCE stent in terms of vasomotor reactivity of the treated segment at 2 years, defined as the QCA quantified change in the mean lumen diameter prenitrate and postnitrate administration. The coprimary end point is the noninferiority (reflex to superiority) of the QCA-derived minimum lumen diameter at 2 years postnitrate minus minimum lumen diameter postprocedure postnitrate by QCA. In addition, all subjects allocated to the Absorb BVS group will undergo multislice computed tomography imaging at 3 years.
  
  
  CONCLUSIONS
  The ABSORB II randomized controlled trial (ClinicalTrials.gov NCT01425281) is designed to compare the safety, efficacy, and performance of Absorb BVS against the XIENCE everolimus-eluting stent in the treatment of de novo native coronary artery lesions.
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Roberto
authors.initials: R
authors.lastname: Diletti
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Vasim
authors.initials: V
authors.lastname: Farooq
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
authors.forename: Cecile
authors.initials: C
authors.lastname: Dorange
authors.forename: Karine
authors.initials: K
authors.lastname: Miquel-Hebert
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.forename: Richard
authors.initials: R
authors.lastname: Rapoza
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects; D000328:Adult; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000150:complications* / Q000175:diagnosis; D003328:Coronary Thrombosis / Q000209:etiology / Q000517:prevention & control; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005060:Europe; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000188:drug therapy / Q000209:etiology / Q000601:surgery / Q000628:therapy*; D009520:New Zealand; D010879:Piperazines / Q000008:administration & dosage; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D000068799:Prasugrel Hydrochloride; D012107:Research Design; D018401:Sample Size; D016037:Single-Blind Method; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019265:Spectroscopy, Near-Infrared; D013876:Thiophenes / Q000008:administration & dosage; D054457:Tissue Scaffolds / Q000009:adverse effects; D014057:Tomography, X-Ray Computed; D018084:Ultrasonography, Interventional
chemical_list: D007166:Immunosuppressive Agents; D010879:Piperazines; D010975:Platelet Aggregation Inhibitors; D013876:Thiophenes; D000068338:Everolimus; D000068799:Prasugrel Hydrochloride; D001241:Aspirin; D020123:Sirolimus