Comparison of two antiplatelet regimens (aspirin alone versus aspirin + ticlopidine or clopidogrel) after intracoronary implantation of a carbofilm-coated stent.
Stent thrombosis (ST) is an infrequent (0.5% to 1.5%) complication of intracoronary stenting, with severe clinical consequences. This multicenter, randomized study evaluated the clinical outcome in 479 patients (598 lesions treated) who underwent elective coronary stenting with a Carbofilm-coated stent (CarboStent) who met prespecified eligibility criteria and were randomly assigned to receive aspirin alone (n = 235) or aspirin plus a thienopyridine antiplatelet regimen (n = 244). Clinical, angiographic, and procedural characteristics were similar between groups. The primary end point was the incidence of 30-day ST; secondary end points included major vascular or bleeding complications within 30 days and death, acute myocardial infarction, and target vessel revascularization at 6 months. ST occurred in 4 patients (1.4%) in the aspirin-only group and in 1 patient (0.3%) in the aspirin-plus-thienopyridine group (relative risk 0.23, 95% confidence interval 0.03 to 2.08, p = NS). After careful review of cases, 89 patients (19%) with protocol deviations were identified. When they were excluded from the analysis, no ST was observed in either group. Secondary end points were reached by 4% of the aspirin-alone group and 8% of the aspirin-plus-thienopyridine group (relative risk 2.35, 95% confidence interval 0.94 to 5.85, p = NS). In conclusion, after optimal intracoronary implantation of the CarboStent, antiplatelet therapy with aspirin alone was safe and provided efficacy comparable to aspirin plus a thienopyridine in the prevention of ST.
Bartorelli
Antonio Luca
AL
Institute of Cardiology, University of Milan, Centro Cardiologico Monzino, IRCCS, Milan, Italy. antonio.bartorelli@ccfm.it
Tamburino
Corrado
C
Trabattoni
Daniela
D
Galassi
Alfredo
A
Serdoz
Roberto
R
Sheiban
Imad
I
Piovaccari
Giancarlo
G
Zimarino
Marco
M
Benassi
Alberto
A
Di Mario
Carlo
C
Sangiorgio
Pietro
P
Chierchia
Sergio
S
Reimers
Bernhard
B
D001241:Aspirin / Q000008:administration & dosage / Q000627:therapeutic use*; D002244:Carbon; D002423:Cause of Death; D000077144:Clopidogrel; D020099:Coated Materials, Biocompatible; D003327:Coronary Disease / Q000601:surgery*; D023903:Coronary Restenosis / Q000209:etiology; D003328:Coronary Thrombosis / Q000209:etiology; D004338:Drug Combinations; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019106:Postoperative Hemorrhage / Q000209:etiology; D011446:Prospective Studies; D012086:Reoperation; D015607:Stents; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D004338:Drug Combinations; D010975:Platelet Aggregation Inhibitors; D002244:Carbon; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin