CLINICAL AND ANGIOGRAPHIC RESULTS WITH THE MULTI-LINK(TM) CORONARY STENT SYSTEM - THE WEST-EUROPEAN STENT TRIAL (WEST)

Background. The objectives for the West European Stent Trial (WEST) we re to assess the safety and efficacy of the new ACS Multi-Link(TM) cor onary stent system with regards to bleedings and vascular complication s and incidence of major adverse cardiac events during 12 months follo w-up. Methods and Results. The balloon-expandable Multi-Link stent is made from a single hypotube and is composed of 316 L stainless steel. In an open, non-randomized, multicenter registry, 102 patients with an gina pectoris to be treated with this stent mere recruited from 7 Euro pean centers. Following stent implantation, patients were given hepari n infusion and oral coumadin treatment was maintained for 3 months. Pr ocedural success was achieved in 100 of the 102 patients (98%). One pa tient had subacute stent thrombosis and 6 patients lad major bleeds du ring the hospital stay. All patients were alive at 12 months and 85% w ere free of angina pectoris. Nineteen patients (19%) reached a primary clinical endpoint; four patients underwent bypass surgery (two in con nection with the stent procedure), four patients suffered an acute myo cardial infarction and 11 had a repeat angioplasty of the target vesse l. Quantitative angiography showed that the minimum lumen diameter had decreased from 2.66 +/- 0.34 mm after stent deployment to 2.02 +/- 0. 58 mm at 6 months and the percent diameter stenosis had increased from 18 +/- 7% to 33 +/- 16%. The in-stent restenosis rate was 12% and app earance of a stenosis in the target vessel outside the stent occurred in an additional 5%. Conclusion. The WEST study has demonstrated a hig h degree of safety and efficacy of the Multi-Link stent with a low inc idence of complications and clinical events during follow-up. The resu lts compare favorably with data from other stents.