title: Clinical experience in coronary stenting with the Vivant Z Stent.
abstract: This single centre study was designed to demonstrate feasibility, safety and efficacy of the Vivant Z stent (PFM AG, Cologne, Germany). Patients with de novo lesion were recruited. Coronary angioplasty was performed with either direct stenting or after balloon predilatation. Repeated angiogram was performed 6 months later or earlier if clinically indicated. Between January to June 2003, a total of 50 patients were recruited (mean age 55.8 +/- 9 years). A total of 52 lesions were stented successfully. Mean reference diameter was 2.77 mm (+/-0.59 SD, range 2.05-4.39 mm) with mean target lesion stenosis of 65.5% (+/-11.6 SD, range 50.1-93.3%). Forty-six lesions (88.5%) were American College of Cardiologist/American Heart Association class B/C types. Direct stenting was performed in 18 (34.6%) lesions. Mean stent diameter was 3.18 mm (+/-0.41 SD, range 2.5-4 mm), and mean stent length was 14.86 mm (+/-2.72 SD, range 9-18 mm). The procedure was complicated in only one case which involved the loss of side branch with no clinical sequelae. All treated lesions achieved Thrombolysis In Myocardial Infarction 3 flow. Mean residual diameter stenosis was 12.2% (+/-7.55 SD, range 0-22.6%) with acute gain of 1.72 mm (+/-0.50 SD, range 0.5-2.8). At 6 months, there was no major adverse cardiovascular event. Repeated angiography after 6 months showed a restenosis rate of 17% (defined as >50% diameter restenosis). Mean late loss was 0.96 mm (+/-0.48 SD) with loss index of 0.61 (+/-0.38 SD). The restenosis rate of those lesions less than 3.0 mm in diameter was 22.2% compared with 6.25% in those lesions more than 3.0 mm in diameter. The Vivant Z stent was shown to be safe and efficacious with low restenosis rate in de novo coronary artery lesion.
authors.affiliation: Cardiology Unit, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
authors.forename: K H
authors.initials: KH
authors.lastname: Chee
authors.forename: F S
authors.initials: FS
authors.lastname: Siaw
authors.forename: C G
authors.initials: CG
authors.lastname: Chan
authors.forename: W P
authors.initials: WP
authors.lastname: Chong
authors.forename: Z A
authors.initials: ZA
authors.lastname: Imran
authors.forename: H K
authors.initials: HK
authors.lastname: Haizal
authors.forename: W
authors.initials: W
authors.lastname: Azman
authors.forename: K H
authors.initials: KH
authors.lastname: Tan
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography / Q000379:methods; D023921:Coronary Stenosis / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015607:Stents