TY - JOUR JO - EuroIntervention TI - Safety and performance of a resorbable magnesium scaffold under real-world conditions: 12-month outcomes of the first 400 patients enrolled in the BIOSOLVE-IV registry AB - <p class="ximage author-picture"><img class="Bloc-graphique-standard" src="https://files.eurointervention.com/issues/ahead_of_print/jaa.png" width="56" height="70" /></p> <p class="intertitre1"> </p> <p class="text-1er-paragraph"><span class="abstracts-titres">Aims:</span> We aimed to assess the safety and performance of the Magmaris bioresorbable magnesium scaffold in a large patient population.<br /><br /><span class="abstracts-titres">Methods and results:</span> BIOSOLVE-IV is an international, single arm, multi-center registry. This is the pre-defined report on 12-month outcomes of the first 400 out of 2054 patients planned. Mean patient age was 62.0&plusmn;11.0 years and 15.8% (n=63) had non-ST-elevation myocardial infarction. Lesions (n=425) were 3.3&plusmn;0.3 mm in diameter and 14.5&plusmn;4.1 mm long. The primary endpoint, target lesion failure at 12 months, occurred in 4.3% [95%CI:2.7;6.9], consisting of 4.3% target lesion revascularizations, 0% cardiac death, and 0.8% target-vessel myocardial infarction. One definite scaffold thrombosis occurred on post-procedure day 10 after cessation of dual antiplatelet therapy.<br /><br /><span class="abstracts-titres">Conclusions: </span>The preliminary analysis of the first 400 patients enrolled in BIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in clinical routine.</p> AU - Verheye Stefan AU - Wlodarczak Adrian AU - Montorsi Piero AU - Bennett Johan AU - Torzewski Jan AU - Haude Michael AU - Vrolix Mathias AU - Buck Thomas AU - Aminian Adel AU - van der Schaaf J. René AU - Nuruddin Arrif Amin AU - Lee K.Y. Michael VL - IS - Y1 - 22/01/2019 Y1 - 2019 DOI - 10.4244/EIJ-D-18-01058 SP - KW - nstemi KW - stable angina KW - bioresorbable scaffolds KW - myocardial infarction KW - stent thrombosis PB - Europa Digital & Publishing UR - https://eurointervention.pcronline.com/article/safety-and-performance-of-a-resorbable-magnesium-scaffold-under-real-world-conditions-12-month-outcomes-of-the-first-400-patients-enrolled-in-the-biosolve-iv-registry SN - 1774-024X ER -