Ahmed N Mahmoud1, Amr F Barakat2, Akram Y Elgendy2, Erik Schneibel2, Amgad Mentias2, Ahmed Abuzaid2, Islam Y Elgendy2. 1. From the Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville (A.N.M., A.Y.E., E.S., I.Y.E.); Department of Medicine, Cleveland Clinic Foundation, OH (A.F.B.); Division of Cardiovascular Medicine, Department of Medicine, University of Iowa Carver College of Medicine (A.M.); and Department of Cardiovascular Medicine, Sidney Kimmel Medical College at Thomas Jefferson University/Christiana Care Health System, Newark, DE (A.A.) islam.elgendy@medicine.ufl.edu. 2. From the Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville (A.N.M., A.Y.E., E.S., I.Y.E.); Department of Medicine, Cleveland Clinic Foundation, OH (A.F.B.); Division of Cardiovascular Medicine, Department of Medicine, University of Iowa Carver College of Medicine (A.M.); and Department of Cardiovascular Medicine, Sidney Kimmel Medical College at Thomas Jefferson University/Christiana Care Health System, Newark, DE (A.A.).
Abstract
BACKGROUND: Data regarding the long-term efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents are limited. This meta-analysis aimed to compare the long-term outcomes with both devices. METHODS AND RESULTS: Randomized trials reporting clinical outcomes beyond 1 year and comparing BVS with everolimus-eluting stents were included. Summary estimates risk ratios (RRs) were constructed. The primary efficacy outcome was target lesion failure, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization, and the primary safety outcome was definite or probable stent/scaffold thrombosis. Six trials with 5392 patients were included (mean follow-up, 25 months). BVS had a higher rate of target lesion failure (RR, 1.33; 95% confidence interval [CI], 1.11-1.58) driven by the higher rates of target vessel myocardial infarction (RR, 1.65; 95% CI, 1.26-2.17) and target lesion revascularization (RR, 1.39; 95% CI, 1.08-1.78). The risk of definite or probable stent/scaffold thrombosis (RR, 3.22; 95% CI, 1.89-5.49) and very late stent/scaffold thrombosis (>1 year; RR, 4.78; 95% CI, 1.66-13.8) was higher with BVS. The risk of cardiac and all-cause mortality was similar in both groups. CONCLUSIONS: Compared with everolimus-eluting stents, BVS is associated with increased risk of target lesion failure driven by the increased rates of target vessel myocardial infarction and ischemia-driven target lesion revascularization in these studies (mean follow-up, 25 months). The risk of definite or probable stent/scaffold thrombosis and very late stent/scaffold thrombosis seems to be higher with BVS. Further information from randomized trials is critical to evaluate clinical outcomes with BVS on complete resolution of the scaffold.
BACKGROUND: Data regarding the long-term efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents are limited. This meta-analysis aimed to compare the long-term outcomes with both devices. METHODS AND RESULTS: Randomized trials reporting clinical outcomes beyond 1 year and comparing BVS with everolimus-eluting stents were included. Summary estimates risk ratios (RRs) were constructed. The primary efficacy outcome was target lesion failure, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization, and the primary safety outcome was definite or probable stent/scaffold thrombosis. Six trials with 5392 patients were included (mean follow-up, 25 months). BVS had a higher rate of target lesion failure (RR, 1.33; 95% confidence interval [CI], 1.11-1.58) driven by the higher rates of target vessel myocardial infarction (RR, 1.65; 95% CI, 1.26-2.17) and target lesion revascularization (RR, 1.39; 95% CI, 1.08-1.78). The risk of definite or probable stent/scaffold thrombosis (RR, 3.22; 95% CI, 1.89-5.49) and very late stent/scaffold thrombosis (>1 year; RR, 4.78; 95% CI, 1.66-13.8) was higher with BVS. The risk of cardiac and all-cause mortality was similar in both groups. CONCLUSIONS: Compared with everolimus-eluting stents, BVS is associated with increased risk of target lesion failure driven by the increased rates of target vessel myocardial infarction and ischemia-driven target lesion revascularization in these studies (mean follow-up, 25 months). The risk of definite or probable stent/scaffold thrombosis and very late stent/scaffold thrombosis seems to be higher with BVS. Further information from randomized trials is critical to evaluate clinical outcomes with BVS on complete resolution of the scaffold.
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Authors: Cordula M Felix; Victor J van den Berg; Sanne E Hoeks; Jiang Ming Fam; Mattie Lenzen; Eric Boersma; Peter C Smits; Patrick W Serruys; Yoshinobu Onuma; Robert Jan M van Geuns Journal: PLoS One Date: 2018-05-09 Impact factor: 3.240
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