Sabato Sorrentino1, Gennaro Giustino2, Roxana Mehran2, Anapoorna S Kini2, Samin K Sharma2, Michela Faggioni3, Serdar Farhan2, Birgit Vogel2, Ciro Indolfi4, George D Dangas5. 1. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Division of Cardiology, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy. 2. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 3. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Cardiothoracic Department, Division of Cardiology, University Hospital of Pisa, Pisa, Italy. 4. Division of Cardiology, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy; URT-CNR, Department of Medicine, Consiglio Nazionale delle Ricerche of IFC, Catanzaro, Italy. 5. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: george.dangas@mountsinai.org.
Abstract
BACKGROUND: Recent evidence suggests that bioresorbable vascular scaffolds (BVS) are associated with an excess of thrombotic complications compared with metallic everolimus-eluting stents (EES). OBJECTIVES: This study sought to investigate the comparative effectiveness of the Food and Drug Administration-approved BVS versus metallic EES in patients undergoing percutaneous coronary intervention at longest available follow-up. METHODS: The authors searched MEDLINE, Scopus, and web sources for randomized trials comparing BVS and EES. The primary efficacy and safety endpoints were target lesion failure and definite or probable stent thrombosis, respectively. RESULTS: Seven trials were included: in sum, 5,583 patients were randomized to receive either the study BVS (n = 3,261) or the EES (n = 2,322). Median time of follow-up was 2 years (range 2 to 3 years). Compared with metallic EES, risk of target lesion failure (9.6% vs. 7.2%; absolute risk difference: +2.4%; risk ratio: 1.32; 95% confidence interval: 1.10 to 1.59; number needed to harm: 41; p = 0.003; I2 = 0%) and stent thrombosis (2.4% vs. 0.7%; absolute risk difference: +1.7%; risk ratio: 3.15; 95% confidence interval: 1.87 to 5.30; number needed to harm: 60; p < 0.0001; I2 = 0%) were both significantly higher with BVS. There were no significant differences in all-cause or cardiovascular mortality between groups. The increased risk for ST associated with BVS was concordant across the early (<30 days), late (30 days to 1 year), and very late (>1 year) periods (pinteraction = 0.49). CONCLUSIONS: Compared with metallic EES, the BVS appears to be associated with both lower efficacy and higher thrombotic risk over time. (Bioresorbable vascular scaffold compare to everolimus stents in long term follow up; CRD42017059993).
BACKGROUND: Recent evidence suggests that bioresorbable vascular scaffolds (BVS) are associated with an excess of thrombotic complications compared with metallic everolimus-eluting stents (EES). OBJECTIVES: This study sought to investigate the comparative effectiveness of the Food and Drug Administration-approved BVS versus metallic EES in patients undergoing percutaneous coronary intervention at longest available follow-up. METHODS: The authors searched MEDLINE, Scopus, and web sources for randomized trials comparing BVS and EES. The primary efficacy and safety endpoints were target lesion failure and definite or probable stent thrombosis, respectively. RESULTS: Seven trials were included: in sum, 5,583 patients were randomized to receive either the study BVS (n = 3,261) or the EES (n = 2,322). Median time of follow-up was 2 years (range 2 to 3 years). Compared with metallic EES, risk of target lesion failure (9.6% vs. 7.2%; absolute risk difference: +2.4%; risk ratio: 1.32; 95% confidence interval: 1.10 to 1.59; number needed to harm: 41; p = 0.003; I2 = 0%) and stent thrombosis (2.4% vs. 0.7%; absolute risk difference: +1.7%; risk ratio: 3.15; 95% confidence interval: 1.87 to 5.30; number needed to harm: 60; p < 0.0001; I2 = 0%) were both significantly higher with BVS. There were no significant differences in all-cause or cardiovascular mortality between groups. The increased risk for ST associated with BVS was concordant across the early (<30 days), late (30 days to 1 year), and very late (>1 year) periods (pinteraction = 0.49). CONCLUSIONS: Compared with metallic EES, the BVS appears to be associated with both lower efficacy and higher thrombotic risk over time. (Bioresorbable vascular scaffold compare to everolimus stents in long term follow up; CRD42017059993).
Authors: Junedh M Amrute; Lambros S Athanasiou; Farhad Rikhtegar; José M de la Torre Hernández; Tamara García Camarero; Elazer R Edelman Journal: J Biomed Opt Date: 2018-03 Impact factor: 3.170
Authors: Aydin Huseynov; Stefan Baumann; Holger Nef; Thomas Riemer; Steffen Schneider; Thomas Pfannenbecker; Stephan Achenbach; Julinda Mehilli; Thomas Münzel; Tommaso Gori; Jochen Wöhrle; Ralf Zahn; Johannes Kastner; Axel Schmermund; Gert Richardt; Christian W Hamm; Ibrahim Akin Journal: Clin Res Cardiol Date: 2019-06-29 Impact factor: 5.460