The MUST Trial: Acute Results and Six-Month Clinical Follow-up

Coronary stenting is now an established technique which is associated with improved acute and long-term results and prevents restenosis in comparison to balloon angioplasty in selected patients. However, subacute thrombosis and vascular complications associated with conventional anticoagulant therapy (warfarin for one month, with 4Ð5 days of IV heparin) remain of concern. By means of a prospective, multi-center registry, we sought to demonstrate that the use of ticlopidine and aspirin as the sole post-stenting treatment was safe by reducing bleeding complications without increasing the risk of major cardiac events. A total of 260 patients with stable and unstable angina and a short, single de novo lesion were enrolled in this registry. Successful stent deployment without ultrasound guidance was achieved in 259 patients. All patients were treated with aspirin ³ 100 mg daily for 6 months and ticlopidine 250 to 500 mg daily according to body weight for 1 month. The primary endpoint was safety, defined by the occurrence of death, myocardial infarction (MI), coronary bypass surgery (CABG) or repeat angioplasty (PTCA) within 30 days of the procedure, in addition to subacute stent thrombosis and bleeding and vascular complications within 30 days of the intervention. During hospital stay there were no deaths; 8 patients experienced MI, 1 patient underwent urgent CABG and 4 patients had repeat PTCA. Therefore, the clinical success rate was 96.0%. Bleeding complications requiring blood transfusion or vascular repair occurred in 2 patients. Treatment was discontinued in one patient because of mild reversible leucopenia. At 6 months, event-free survival was 90.3%. Major events involved CABG in 4 patients and a second PTCA at the same site in 14 patients. The target vessel revascularization rate at 6 months was 6.2%. This study demonstrates that Palmaz-Schatz stenting of single de novo lesions with length < 15 mm, without ultrasound guidance but with the routine use of high-pressure balloon dilatation, and with ticlopidine and aspirin as the sole treatment post intervention, is feasible and safe both in terms of clinical outcome and hematologic adverse side-effects. This registry demonstrates that six-month event-free survival exceeding 90% can be achieved.