Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents.

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).

[1]  Hiroki Shiomi,et al.  Very Late Scaffold Thrombosis of Bioresorbable Vascular Scaffold: Systematic Review and a Meta-Analysis. , 2017, JACC. Cardiovascular interventions.

[2]  M. Togni,et al.  Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds. , 2015, Journal of the American College of Cardiology.

[3]  Gary S Mintz,et al.  In-stent restenosis in the drug-eluting stent era. , 2010, Journal of the American College of Cardiology.

[4]  P. Serruys,et al.  Safety and Efficacy of New-Generation Drug-Eluting Stents in Women Undergoing Complex Percutaneous Coronary Artery Revascularization: From the WIN-DES Collaborative Patient-Level Pooled Analysis. , 2016, JACC. Cardiovascular interventions.

[5]  Jonathan A C Sterne,et al.  Systematic reviews in health care: Investigating and dealing with publication and other biases in meta-analysis. , 2001, BMJ.

[6]  P. Serruys,et al.  A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial , 2015, The Lancet.

[7]  P. Serruys,et al.  Bioresorbable Vascular Scaffolds for Coronary Revascularization. , 2016, Circulation.

[8]  P Hall,et al.  Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. , 1995, Circulation.

[9]  Heribert Schunkert,et al.  Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials , 2016, The Lancet.

[10]  P. Serruys,et al.  Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: A Patient-Level Pooled Analysis of Randomized Controlled Trials. , 2016, JACC. Cardiovascular interventions.

[11]  R. Virmani,et al.  Acute Thrombogenicity of a Durable Polymer Everolimus-Eluting Stent Relative to Contemporary Drug-Eluting Stents With Biodegradable Polymer Coatings Assessed Ex Vivo in a Swine Shunt Model. , 2015, JACC. Cardiovascular interventions.

[12]  C. Indolfi,et al.  Bioresorbable vascular scaffolds — basic concepts and clinical outcome , 2016, Nature Reviews Cardiology.

[13]  R. Piccolo,et al.  Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. , 2017, The New England journal of medicine.

[14]  P. Serruys,et al.  TCT-49 Two-year clinical outcome of Everolimus-eluting bioresorbable scaffold vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial. , 2016, Journal of the American College of Cardiology.

[15]  P. Serruys,et al.  Early, late and very late incidence of bioresorbable scaffold thrombosis: a systematic review and meta-analysis of randomized clinical trials and observational studies. , 2017, Minerva cardioangiologica.

[16]  Hak Seung Lee,et al.  Stent Thrombosis With Drug-Eluting Stents and Bioresorbable Scaffolds: Evidence From a Network Meta-Analysis of 147 Trials. , 2016, JACC. Cardiovascular interventions.

[17]  D. Moher,et al.  Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement , 2009, BMJ.

[18]  D. Altman,et al.  Measuring inconsistency in meta-analyses , 2003, BMJ : British Medical Journal.

[19]  C. Bias.  The Cochrane Collaboration's tool for assessing risk of bias in randomised trials , 2011 .

[20]  C. Indolfi,et al.  The duration of balloon inflation affects the luminal diameter of coronary segments after bioresorbable vascular scaffolds deployment , 2015, BMC Cardiovascular Disorders.

[21]  J. Sterne,et al.  The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials , 2011, BMJ : British Medical Journal.

[22]  Bernard Chevalier,et al.  Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial , 2016, The Lancet.

[23]  P. Teirstein,et al.  Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. , 2015, The New England journal of medicine.

[24]  P. Serruys,et al.  Impact of Clinical Presentation (Stable Angina Pectoris vs Unstable Angina Pectoris or Non-ST-Elevation Myocardial Infarction vs ST-Elevation Myocardial Infarction) on Long-Term Outcomes in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents. , 2015, The American journal of cardiology.

[25]  P. Serruys,et al.  Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions ) , 2009 .

[26]  Hiroki Shiomi,et al.  Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial. , 2016, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[27]  D. Gavaghan,et al.  Pooling data for Number Needed to Treat: no problems for apples , 2002, BMC medical research methodology.

[28]  David Moher,et al.  An international registry of systematic-review protocols , 2011, The Lancet.

[29]  F. Eberli,et al.  Very Late Scaffold Thrombosis: Intracoronary Imaging and Histopathological and Spectroscopic Findings. , 2015, Journal of the American College of Cardiology.

[30]  P. Serruys,et al.  Safety and Efficacy of New-Generation Drug-Eluting Stents in Women at High Risk for Atherothrombosis: From the Women in Innovation and Drug-Eluting Stents Collaborative Patient-Level Pooled Analysis , 2016, Circulation. Cardiovascular interventions.

[31]  W. Little,et al.  Incidence of coronary stent thrombosis based on academic research consortium definitions. , 2008, The American journal of cardiology.

[32]  C. Indolfi,et al.  Neointimal proliferation is associated with clinical restenosis 2 years after fully bioresorbable vascular scaffold implantation. , 2014, Circulation. Cardiovascular imaging.

[33]  Deepak L. Bhatt,et al.  Outcomes with bioabsorbable vascular scaffolds versus everolimus eluting stents: Insights from randomized trials. , 2016, International journal of cardiology.