Bioresorbable polymer drug-eluting stents in PCI

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1 EARN 3 FREE CPD POINTS CARDIOVASCULAR Leader in digital CPD for Southern African healthcare professionals The BIOFLOW-V trial, using the Orsiro ultrathin strut stent with biodegradable polymer, showed a 30% reduction in target lesion failure compared to a durable polymer everolimus-eluting stent. Dr Tony Dalby, 2017 ESC Congress report Bioresorbable polymer drug-eluting stents in PCI the BIOFLOW-V trial Introduction The use of new-generation drug-eluting stents (DESs) is the standard of care for patients undergoing percutaneous coronary intervention (PCI), with both the European (2014 ESC/EACTS guidelines) and American guidelines recommending unrestricted use of these devices for all patients and lesion subsets. 1 The main shortcoming of early generations of DESs and permanent polymerbased DESs was delayed healing and inflammatory response, which resulted in an increase in late thrombotic events. Newer-generation, biocompatible or biodegradable polymer stents offer a lower risk of restenosis and need for repeat revascularisation. They also offer improved safety with a lower risk of stent-related complications such as myocardial infarction (MI), incomplete healing and stent thrombosis. Until recently, these potential benefits specific to bioresorbable polymer DESs with thinner struts were intuitive. The BIOFLOW-V international prospective randomised trial provides data on the clinical outcomes using a bioresorbable polymer sirolimuseluting stent compared to a durable polymer everolimus-eluting stent in a broad patient population. This report was made possible by an unrestricted educational grant from Biotronik. The content of the report is independent of the sponsor. February 2018 I 1

2 Characteristics of the ultrathin, bioresorbable polymer DES and first evidence of efficacy and non-inferiority to durable stents Orsiro is a novel ultrathin-strut cobaltchromium sirolimus-eluting stent with biodegradable polymer which is completely absorbed within 24 months. It has a unique hybrid concept with passive and active coatings designed to enhance tissue biocompatibility. A recent optical coherence tomography study of neointimal morphology and strut coverage of this device has shown complete coverage of the majority of stent struts within three months of implantation. 2 A homogeneous pattern of neointima was demonstrated in 59 of the 60 patients examined using this technology, with lipid-rich neointima seen at 12 months in only one patient who subsequently required target vessel revascularisation. Four randomised trials: BIOFLOW-II (n=452) 3 ; BIOFLOW-IV (n=579) 4 ; BIOSCIENCE (n=2119) 5 and BIO- RESORT (n=3490) 6 have shown that the ultrathin strut, bioresorbable polymer sirolimus-eluting stents achieved similar clinical safety and efficacy outcomes to durable polymer everolimus-eluting stents in these trials undertaken to show non-inferiority. The BIOFLOW-V randomised study was undertaken to assess clinical outcomes in patients who underwent coronary revascularisation using the Orsiro bioresorbable polymer sirolimus-eluting stent relative to a commonly used durable polymer everolimus-eluting stent (Xience). 7 Patient outcomes from this trial were added to the two independent investigator-initiated trials (BIOFLOW-II and -IV) to provide a total of patient outcomes for Bayesian analysis. The consistency and validity of pooled events were controlled by the BIOFLOW-V committee. Clinical relevance of BIOFLOW-V 8 BIOFLOW-V was a prospective, multicentre, 2:1 randomised controlled, all-comers trial to assess the safety and effectiveness of Orsiro in the treatment of patients with up to three de novo or restenotic lesions. Study design is summarised in Figure 1. The primary endpoint was target lesion failure at 12 months, defined as a composite of cardiovascular death, target-vessel related MI or any clinically driven target lesion revascularisation patients randomised across 91 centres in the USA, Canada, Europe, Israel, Australia and New Zealand Orsiro n = 884 2:1 Xience n = 450 Earn free CPD Points Join our CPD community at and start to earn today! 1-6-month clinical follow-up 12-month clinical follow-up Annual clinical follow-up up to five years Figure 1. BIOFLOW-V trial design 2 I February 2018

3 Pre-specified secondary endpoints are summarised in Table 1. Table 1. Pre-specified secondary endpoints Components of the primary endpoint Target vessel failure and its individual components Death MI and/or cardiac death Stent thrombosis (all, definite/probable, probable, possible) Success rates (device, lesion and procedure) The clinical and angiographic characteristics of the patients included in the trial are summarised in Table 2 and Table 3 respectively. Table 2. Clinical characteristics of patients included in the BIOFLOW-V trial Clinical characteristics BP SES (n=884) DP EES (n=450) Age, years 64.5 ± ± 10.7 Female 25.3% 27.1% Hypertension 79.7% 80.5% Hyperlipidaemia 78.9% 82.4% Diabetes mellitus 34.0% 37.0% Prior MI 27.4% 25.9% Prior PCI 36.8% 33.0% Prior CABG 7.1% 5.2% Current smoking 23.6% 22.7% Clinical presentation Stable angina 48.4% 47.4% Acute coronary syndrome 51.4% 49.6% February 2018 I 3

4 Table 3. Angiographic characteristics Angiographic characteristics BP SES (n=1051 lesions) DP EES (n=561 lesions) Target lesion vessel Left anterior descending 41.0% 41.2% Left circumflex 26.6% 26.0% Right coronary artery 32.4% 32.8% Thrombus 1.0% 0.9% Bifurcation lesion 14.8% 15.0% Moderate/severe calcification 24.0% 26.7% Moderate/severe tortuosity 58.8% 61.5% ACC/AHA lesion class B2/C 72.6% 75.9% Table 4. BIOFLOW-V procedural outcomes BP SES DP EES p value Lesion success* 1102/1107 (99.5%) 579/583 (99.3%) Device success 1082/1107 (97.7%) 566/.583 (97.1%) Procedure success 827/881 (93.9%) 401/445 (90.1%) *Lesion success defined as attainment of <30% residual stenosis of the target lesion using any percutaneous method. Device success defined as attainment of <30% residual stenosis of the target lesion using the assigned study stent only. Procedure success defined as attainment of <30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-q-wave MI, and any clinical-driven TLR). Earn free CPD Points Join our CPD community at and start to earn today! The procedural success rate was statistically significantly higher using the bioresorbable polymer sirolimus-eluting stent as compared to the durable polymer everolimus-eluting stent (Table 4). 4 I February 2018

5 Clinical results Clinical results showing primary and secondary endpoints in Figure 2 and Figure p-value = 0.04 p-value = % [%] % 4.7% 8.3% 0.1% 0.7% 2.0% 2.4% TLF TV-MI CD cd-tlr DP SES DP EES Figure 2. Clinical results. Primary endpoint and composites at 12 months % p-value = 0.05 Stent thrombus [%] % 0.3% 0.2% 0.1% 0.9% 0 Any ARC Early Late DP SES DP EES Figure 3. Stent thrombosis. Secondary endpoint 12-month Academic Research Consortium stent thrombosis 2 Conclusions The BIOFLOW-V trial using Orsiro showed statistically significantly lower target lesion failure rates compared to Xience at 12 months (absolute difference of 3.4%). Procedure success was higher with Orsiro driven mainly by a lower rate of MI, which was observed early but persisted through to 12 months in this landmark analysis (Figure 4). Target lesion failure in the pooled Bayesian analysis showed an absolute rate difference at 12 months of -2.6%, favouring Orsiro. February 2018 I 5

6 The results of this large randomised trial offers improved outcomes over durable polymer everolimus-eluting stents Cumulative Incidence TV MI 9% 6% 3% 0% Kaplan-Meier estimate 0.4% BP SES vs. 1.1% DP EES, p = % 0.4% Time after Initial Procedure (days) DP SES DP EES Earn free CPD Points Are you a member of Southern Africa s leading digital Continuing Professional Development website earning FREE CPD points with access to best practice content? Only a few clicks and you can register to start earning today Visit For all Southern African healthcare professionals Find us at DeNovo No. at Risk DP EES BP SES Figure 4. BIOFLOW-V landmark analysis: Target-vessel MI, 30 days to 12 months The results of this large randomised trial are of clinical interest and relevance, providing some evidence that this bioresorbable polymer sirolimus-eluting stent, offers improved outcomes over durable polymer everolimus-eluting stents, representing a new standard for DES comparisons. References 1. Costa F, Ariotti S, Valgimigli M, et al. Perspectives on the 2014 ESC/EACTS guidelines on myocardial revascularization. J Cardiovasc Transl Res 2015; 8(4): Legutko J, Gil RJ, Buszman PE, et al. An optical coherence tomography study of neointimal morphology and strut coverage at different time intervals from implantation of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv 2017 Oct 13. DOI: / ccd Windecker S, Haude M, Neumann FJ, et al. Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomised BIOFLOW-II trial. Circ Cardiovasc Interv 2015; 8(2): e DOI: / CIRCINTERVENTIONS BIOFLOW-IV study, presented at the Japan Circulation Congress, March Zbinden R, Piccolo R, Heg D, et al. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable-polymer everolimus-eluting stent for This report was written by Julia Aalbers, BSc(Hons), for denovo Medica. In summary, the overall findings from this international prospective, randomised trial endorse the safety and effectiveness of the ultrathin strut, bioresorbable polymer sirolimus-eluting stent in a complex PCI population and perhaps advance the standard for the comparison of new DESs. percutaneous coronary revascularization: 2-year results of the BIOSCIENCE trial. J Am Heart Assoc 2016; 5: e doi.org/ /jaha von Birgelen C, Kok MM, van der Heijden LC, et al. Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial. Lancet 2016; 388(10060): Doros G, Massaro JM, Kandzari DE, et al. Rationale of a novel study design for the BIOFLOW-V study, a prospective, randomised multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent, using a Bayesian approach. Am Heart J 2017; 193: DOI: /j.ahj Kandzari D, Mauri L, Koolen JJ, et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW-V): a randomised trial. Lancet 2017; 390: Disclaimer The views and opinions expressed in the article are those of the presenters and do not necessarily reflect those of the publisher or its sponsor. In all clinical instances, medical practitioners are referred to the product insert documentation as approved by relevant control authorities. Published by denovo Medica Reg: 2012/216456/07 70 Arlington Street, Everglen, Cape Town, 7550 Tel: (021) I info@denovomedica.com 6 I February 2018

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