THE MUST TRIAL - ACUTE RESULTS AND 6-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 c omparison to balloon angioplasty in selected patients. However, subacu te thrombosis and vascular complications associated with conventional anticoagulant therapy (warfarin for one month, with 4-5 days of IV hep arin) remain of concern. By means of a prospective, multi-center regis try, we sought to demonstrate that the use of ticlopidine and aspirin as the sole post-stenting treatment was safe by reducing bleeding comp lications without increasing the risk of major cardiac events. A total of 260 patients with stable and unstable angina and a short, single d e novo lesion were enrolled in this registry. Successful stent deploym ent without ultrasound guidance was achieved in 259 patients. All pati ents were treated with aspirin greater than or equal to 100 mg daily f or 6 months and ticlopidine 250 to 500 mg daily according to body weig ht for 1 month. The primary endpoint was safety, defined by the occurr ence of death, myocardial infarction (MI), coronary bypass surgery (CA BG) or repeat angioplasty (PTCA) within 30 days of the procedure, in a ddition to subacute stent thrombosis and bleeding and vascular complic ations 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 r ate was 96.0%. Bleeding complications requiring blood transfusion or v ascular repair occurred in 2 patients. Treatment was discontinued in o ne patient because of mild reversible leucopenia. At 6 months, event-f ree 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 revasc ularization rate at 6 months was 6.2%. This study demonstrates that Pa lmaz-Schatz stenting of single de novo lesions with length < 15 mm, wi thout ultrasound guidance but With the routine use of high-pressure ba lloon dilatation, and with ticlopidine and aspirin as the sole treatme nt post intervention, is feasible and safe both in terms of clinical o utcome and hematologic adverse side-effects. This registry demonstrate s that six-month event-free survival exceeding 90% can be achieved.