title: Intravascular ultrasound analysis of small vessel lesions treated with the Sparrow coronary stent system: results of the CARE II trial.
abstract: OBJECTIVE
  The aim of this study was to evaluate the Sparrow sirolimus-eluting stent (Sparrow-SES) against the Sparrow bare-metal stent (Sparrow-BMS) and conventional balloon-expandable bare-metal stent (BMS: Driver/Micro-Driver stent, Medtronic Vascular, Santa Rosa, CA).
  
  
  BACKGROUND
  The Sparrow stent (Biosensors International, Singapore) consists of a guide wire-based, self-expandable, ultra-thin nitinol stent. The performance of this device with sirolimus in a fully biodegradable polymer has not been determined.
  
  
  METHODS
  A total of 74 patients were included in this intravascular ultrasound (IVUS) sub-study of the CARE II trial, which was a prospective, randomized, multicenter trial in the treatment of single de novo native coronary artery lesions in vessels ranging from 2.0 mm to 2.75 mm in diameter (Sparrow-SES: n = 31, Sparrow-BMS: n = 22, BMS: n = 21).
  
  
  RESULTS
  Stent volume index (VI) was significantly increased 8-month later in Sparrow-SES and Sparrow-BMS, but not in BMS (4.0 ± 1.0 to 4.6 ± 1.0 mm(3) /mm, p<0.0001, 4.0 ± 0.6 to 4.4 ± 0.8 mm(3) /mm, p<0.05, and 5.2 ± 1.0 to 5.1 ± 0.9 mm(3) /mm, p=0.421, respectively). % neointimal obstruction in Sparrow-SES was significantly smaller than those in Sparrow-BMS and BMS at follow-up (17.6 ± 9.4 vs. 36.2 ± 13.8 and 39.9 ± 11.1%, p<0.001). Sparrow-SES showed a mean 15% stent expansion and good suppression of neointimal proliferation, resulting in a significantly lower percentage of change in lumen VI during follow-up period (Sparrow-SES: -6.2 ± 16.2%, Sparrow-BMS: -30.4 ± 11.6%, BMS: -40.4 ± 10.0%, p<0.001).
  
  
  CONCLUSIONS
  The self-expanding Sparrow-SES demonstrated chronic stent expansion, good suppression of neointimal proliferation and resulted in a more preserved lumen in stented small vessels compared with the Sparrow-BMS and conventional balloon expandable BMS.
authors: Division of Cardiovascular Medicine, Stanford University Medical Center, Stanford, California, USA.
authors: Teruyoshi
authors: T
authors: Kume
authors: Katsuhisa
authors: K
authors: Waseda
authors: Bon-Kwon
authors: BK
authors: Koo
authors: Paul G
authors: PG
authors: Yock
authors: Roberto
authors: R
authors: Botelho
authors: Stefan
authors: S
authors: Verheye
authors: Robert
authors: R
authors: Whitbourn
authors: Ian
authors: I
authors: Meredith
authors: Stephen
authors: S
authors: Worthley
authors: Koh Tian
authors: KT
authors: Hai
authors: Yasuhiro
authors: Y
authors: Honda
authors: Alexandre
authors: A
authors: Abizaid
authors: Peter J
authors: PJ
authors: Fitzgerald
mesh_terms: D000368:Aged; D000497:Alloys; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D049109:Cell Proliferation; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D000497:Alloys; D002317:Cardiovascular Agents; C013616:nitinol; D020123:Sirolimus
keywords: coronary; drug-eluting stent; percutaneous coronary intervention; small vessel disease