title: Restenosis after coronary stent placement and randomization to a 4-week combined antiplatelet or anticoagulant therapy: six-month angiographic follow-up of the Intracoronary Stenting and Antithrombotic Regimen (ISAR) Trial.
abstract: BACKGROUND
  Platelets and mural thrombus at the lesion site may play a key role in initiating the restenosis process after coronary interventions. The ISAR Trial provides a comparison of the outcomes of patients randomized to two different antithrombotic regimens administered for 4 weeks after successful coronary stent placement: combined antiplatelet therapy (aspirin plus ticlopidine) or a conventional anticoagulant regimen (phenprocoumon with initial overlapping heparin plus aspirin). Within the first 4 weeks after stent placement, combined antiplatelet therapy has been associated with a significant reduction of ischemic complications. In the present study, we examined whether combined antiplatelet therapy administered for 4 weeks after stent placement is able to reduce the process of restenosis at 6 months.
  
  
  RESULTS
  Of 517 patients initially randomized, 496 were eligible for 6-month angiographic follow-up. Scheduled angiography was performed in 432 of the eligible patients (87.1%), 216 in each group. In a comparison of the two groups, there were no significant differences in clinical and procedural variables or in qualitative and quantitative lesion characteristics before and after stenting. At 6 months, minimal luminal diameter was 1.95+/-0.86 mm in the group with initial combined antiplatelet therapy and 1.90+/-0.87 mm in the group with initial anticoagulant therapy (P=.55). Late lumen loss was 1.10+/-0.81 and 1.15+/-0.75 mm (P=.54), and the restenosis rate was 26.8% and 28.9%, respectively (P=.70). Target lesion revascularization rate was 14.6% in the antiplatelet therapy group and 15.6% in the anticoagulant therapy group (P=.85).
  
  
  CONCLUSIONS
  This study shows that combined antiplatelet therapy (aspirin plus ticlopidine) administered for 4 weeks after coronary Palmaz-Schatz stent placement does not result in a detectable benefit for the prevention of restenosis compared with conventional anticoagulant therapy (phenprocoumon with initial overlapping heparin plus aspirin).
authors.affiliation: 1. Medizinische Klinik, Technische Universität München, Munich, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Kastrati
authors.forename: H
authors.initials: H
authors.lastname: Schühlen
authors.forename: J
authors.initials: J
authors.lastname: Hausleiter
authors.forename: H
authors.initials: H
authors.lastname: Walter
authors.forename: E
authors.initials: E
authors.lastname: Zitzmann-Roth
authors.forename: M
authors.initials: M
authors.lastname: Hadamitzky
authors.forename: S
authors.initials: S
authors.lastname: Elezi
authors.forename: K
authors.initials: K
authors.lastname: Ulm
authors.forename: J
authors.initials: J
authors.lastname: Dirschinger
authors.forename: F J
authors.initials: FJ
authors.lastname: Neumann
authors.forename: A
authors.initials: A
authors.lastname: Schömig
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000800:Angioplasty, Balloon; D000925:Anticoagulants / Q000008:administration & dosage*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000628:therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010644:Phenprocoumon / Q000008:administration & dosage; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D012008:Recurrence; D015607:Stents; D013988:Ticlopidine / Q000008:administration & dosage
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; D006493:Heparin; D013988:Ticlopidine; D010644:Phenprocoumon