Randomized Multicenter Comparison of Conventional Anticoagulation Versus Antiplatelet Therapy in Unplanned and Elective Coronary Stenting

Abstract

Background —Dual therapy with ticlopidine and aspirin has been shown to be as effective as or more effective than conventional anticoagulation in patients with an optimal result after implantation of intracoronary metallic stents. However, the safety and efficacy of antiplatelet therapy alone in an unselected population has not been evaluated. Methods —Patients were randomized to conventional anticoagulation or to treatment with antiplatelet therapy alone. Indications for stenting were classified as elective (decided before the procedure) or unplanned (to salvage failed angioplasty or to optimize the results of balloon angioplasty). After stenting, patients received aspirin and either ticlopidine or conventional anticoagulation (heparin or oral anticoagulant). The primary end point was the occurrence of bleeding or peripheral vascular complications; secondary end points were cardiac events (death, infarction, or stent occlusion) and duration of hospitalization. Results —In 13 centers, 236 patients were randomized to anticoagulation and 249 to antiplatelet therapy. Stenting was elective in 58% of patients and unplanned in 42%. Stent implantation was successfully achieved in 99% of patients. A primary end point occurred in 33 patients (13.5%) in the antiplatelet group and 48 patients (21%) in the anticoagulation group (odds ratio=0.6 [95% CI 0.36 to 0.98], P =0.03). Major cardiac-related events in electively stented patients were less common (odds ratio=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 111, 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 after coronary stenting significantly reduced rates of bleeding and subacute stent occlusion compared with conventional anticoagulation.

Stent Thrombosis in the Modern Era

“…Prior registries 12,13 and several randomized trials 11,14,15,18 have shown the dramatic reduction in stent thrombosis afforded by the use of aspirin and ticlopidine after successful high-pressure stent implantation. The large sample size of our study allows a reliable estimate of the true stent thrombosis risk and analysis of the factors that may influence this risk.…”

Antithrombotic therapy for acute coronary syndrome: Past, present and future

“…▶ Figure 3 shows the key results of the ISAR trial. Further important studies like Stent Anticoagulation Restenosis Study (STARS) (26), Full Anticoagulation versus ASpirin and TIClopidine after stent implantation (FANTASTIC) (27) and Multicenter Aspirin and Ticlopidine Trial after Intracoronary Stenting (MAT-TIS) (28) followed and provided important confirmation of the ISAR trial results (25). In concert, these studies paved the way towards a widespread adoption of coronary stenting procedures being accompanied by a DAPT regimen.…”

The Effect of Tirofiban and Clopidogrel Pretreatment on Outcome of Old Saphenous Vein Graft Stenting in Patients with Acute Coronary Syndromes

“…Ticlopidine or clopidogrel is structurally related thienopyridine derivates and they exert their antiplatelet effects by inhibiting the adenosine diphosphate dependent pathway of platelet activation (Sharis et al 1998). Trials have shown the superiority of the combination antiplatelet regimen of aspirin and thienopyridines over aspirin alone, or aspirin plus oral anticoagulation with warfarin in preventing stent thrombosis, not only in patients with optimal stent deployment but also in patients who are at high risk of stent thrombosis (Schomig et al 1996;Schuhlen et al 1997;Bertrand et al 1998;Leon et al 1998;Urban et al 1998). Regardless of the stimulus for their activation, the aggregation of platelets that leads to thrombus formation is finally regulated through their membrane binding sites for fibrinogen in the glycoprotein IIb/IIIa receptor complex.…”