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.
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).
Kastrati
A
A
1. Medizinische Klinik, Technische Universität München, Munich, Germany.
Schühlen
H
H
Hausleiter
J
J
Walter
H
H
Zitzmann-Roth
E
E
Hadamitzky
M
M
Elezi
S
S
Ulm
K
K
Dirschinger
J
J
Neumann
F J
FJ
Schömig
A
A
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
D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; D006493:Heparin; D013988:Ticlopidine; D010644:Phenprocoumon