title: Heparin-coated Palmaz-Schatz stents in human coronary arteries. Early outcome of the Benestent-II Pilot Study.
abstract: BACKGROUND
  The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs.
  
  
  RESULTS
  The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin-coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase I to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-I study (80%; relative risk, 0.68 [0.45 to 1.04]).
  
  
  CONCLUSIONS
  The implantation of stents coated with polyamine and end-point-attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis, and results in a favorable event-free survival after 6 months.
authors.affiliation: Thoraxcenter, Department of Interventional Cardiology, Erasmus University, Rotterdam, Netherlands.
authors.forename: P W
authors.initials: PW
authors.lastname: Serruys
authors.forename: H
authors.initials: H
authors.lastname: Emanuelsson
authors.forename: W
authors.initials: W
authors.lastname: van der Giessen
authors.forename: A C
authors.initials: AC
authors.lastname: Lunn
authors.forename: F
authors.initials: F
authors.lastname: Kiemeney
authors.forename: C
authors.initials: C
authors.lastname: Macaya
authors.forename: W
authors.initials: W
authors.lastname: Rutsch
authors.forename: G
authors.initials: G
authors.lastname: Heyndrickx
authors.forename: H
authors.initials: H
authors.lastname: Suryapranata
authors.forename: V
authors.initials: V
authors.lastname: Legrand
authors.forename: J J
authors.initials: JJ
authors.lastname: Goy
authors.forename: P
authors.initials: P
authors.lastname: Materne
authors.forename: H
authors.initials: H
authors.lastname: Bonnier
authors.forename: M C
authors.initials: MC
authors.lastname: Morice
authors.forename: J
authors.initials: J
authors.lastname: Fajadet
authors.forename: J
authors.initials: J
authors.lastname: Belardi
authors.forename: A
authors.initials: A
authors.lastname: Colombo
authors.forename: E
authors.initials: E
authors.lastname: Garcia
authors.forename: P
authors.initials: P
authors.lastname: Ruygrok
authors.forename: P
authors.initials: P
authors.lastname: de Jaegere
authors.forename: M A
authors.initials: MA
authors.lastname: Morel
mesh_terms: D001241:Aspirin / Q000008:administration & dosage; D017023:Coronary Angiography; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D003331:Coronary Vessels; D018572:Disease-Free Survival; D004867:Equipment Design; D005080:Exercise Test; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012449:Safety; D015607:Stents / Q000009:adverse effects; D013988:Ticlopidine / Q000008:administration & dosage; D016896:Treatment Outcome; D014859:Warfarin / Q000008:administration & dosage
chemical_list: D014859:Warfarin; D006493:Heparin; D013988:Ticlopidine; D001241:Aspirin