RANDOMIZED MULTICENTER COMPARISON OF CONVENTIONAL ANTICOAGULATION VERSUS ANTIPLATELET THERAPY IN UNPLANNED AND ELECTIVE CORONARY STENTING -THE FULL ANTICOAGULATION VERSUS ASPIRIN AND TICLOPIDINE (FANTASTIC) STUDY

Background-Dual therapy with ticlopidine and aspirin has been shown to be as effective as or more effective than conventional anticoagulatio n in patients with an optimal result after implantation of intracorona ry metallic stents. However, the safety and efficacy of antiplatelet t herapy alone in an unselected population has not been evaluated. Metho ds-Patients were randomized to conventional anticoagulation or to trea tment with antiplatelet therapy alone. Indications for stenting were c lassified as elective (decided before the procedure) or unplanned (to salvage failed angioplasty or to optimize the results of balloon angio plasty). After stenting, patients received aspirin and either ticlopid ine or conventional anticoagulation (heparin or oral anticoagulant). T he primary end point was the occurrence of bleeding or peripheral vasc ular complications; secondary end points were cardiac events (death, i nfarction, or stent occlusion) and duration of hospitalization. Result s-In 13 centers, 236 patients were randomized to anticoagulation and 2 49 to antiplatelet therapy. Stenting was elective in 58% of patients a nd unplanned in 42%. Stent implantation was successfully achieved in 9 9% of patients. A primary end point occurred in 33 patients (13.5%) in the antiplatelet group and 48 patients (21%) in the anticoagulation g roup (odds ratio=0.6 [95% CI 0.36 to 0.98], P=0.03). Major cardiac-rel ated events in electively stented patients were less common (odds rati o=0.23 [95% CI 0.05 to 0.91], P=0.01) in the antiplatelet group (3 of 123, 2.4%) than the anticoagulation group (11 of ill, 9.9%). Hospital stay was significantly shorter in the antiplatelet group (4.3 +/- 3.6 versus 6.4 +/- 3.7 days, P=0.0001). Conclusions-Antiplatelet therapy a fter coronary stenting significantly reduced rates of bleeding and sub acute stent occlusion compared with conventional anticoagulation.