Is There a Role for BMS in 2016
Is There a Role for BMS in 2016? James Hermiller, MD, FACC, FSCAI St Vincent Medical Group St Vincent Heart Center of Indianapolis, IN
James Hermiller, MD, FACC, FSCAI Consulting Fees/Honoraria/Research Support • Medtronic • Edwards Lifesciences • Abbott Vascular • Boston Scientific • St Jude Medical
Outline • Introduction • Randomized studies • Registry results • Meta-Analyses • Summary/Conclusions
Early DES: Problems Very Late Stent Thrombosis Late Acquired Stent Malapposition Late Catch up Phenomenon SES PES Lagerqvist, et al. Circ Cardiovasc Intervent 2009 Rathore S et al. J Invasive Cardiol 2009; 21: 666– 667 Räber L et al. Circulation 2011; 123: 2819 -2828
Early DES: Problems Included Stent Design, Coating Technology, and Drug Selection Thick Strut Coating Increased risk of stent thrombosis and restenosis Thick strut- increase in foreign body, greater recirculation, stagnation of blood Kolandaivelu et al. Circulation. 2011; 123: 1400 -1409 • Non uniform polymer coating • Webbing and bonding • Delamination
Outline • Introduction • Randomized studies • Registry results • Meta-Analyses • Summary/Conclusions
CONCLUSION: DES-treated subjects have longterm rates of stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT 00977938) J Am Coll Cardiol Intv 2015; 8: 1552– 62
DES vs BMS in DAPT Trial Kereiakes, et al. J Am Coll Cardiol Intv 2015; 8: 1552– 62
DES vs BMS in DAPT Trial Kereiakes, et al. J Am Coll Cardiol Intv 2015; 8: 1552– 62
Stent Thrombosis- DES vs BMS: DAPT Trial Kereiakes, et al. J Am Coll Cardiol Intv 2015; 8: 1552– 62
MACCE - DES vs BMS: DAPT Trial Kereiakes, et al. J Am Coll Cardiol Intv 2015; 8: 1552– 62
MACCE - DES vs BMS: DAPT Trial Kereiakes, et al. J Am Coll Cardiol Intv 2015; 8: 1552– 62
EXAMINATION TRIAL: BMS vs DES in STEMI Conclusions The 2 -year follow-up of the EXAMINATION trial confirms the safety and efficacy of the EES compared with BMS in the setting of STEMI. Specifically, both rates of target lesion revascularization and stent thrombosis were reduced in recipients of EES without any signs of late attrition for either of these endpoints. J Am Coll Cardiol Intv 2014; 7: 64– 71
EXAMINATION TRIAL
Target Lesion Revascularization P=0. 009 5. 6% 2. 9% TLR & Def/prob Stent Thrombosis 2. 8% Vision p = 0. 04 1. 3% Xience V 0 0. 5 Acute 1 Subacute 1. 5 Late 2 2. 5 3 Very Late JACC Cardiovasc Interv 2014 Jan; 7(1): 64 -71 J Am Coll Cardiol Intv 2014; 7: 64– 71
5 Year EXAMINATION TRIAL: At 5 years, the EES (a durable polymer-based 2 nd gen DES) was associated to reductions of the patient-oriented and of the deviceoriented endpoints as compared to BMS implantation in STEMI patients undergoing primary intervention. The benefit of EES over BMS was mainly attributed to reductions in all-cause death and revascularization rates.
High Risk for Abbreviated DAPT Non-Compliant Needs Surgery
DES vs BMS – ZEUS Trial Valgimigli, et al. J Am Coll Cardiol 2015; 65: 805– 15 CONCLUSIONS: Compared with BMS, DES using a stent with Methods: 1, 606 randomized patients with implantation stable or unstable symptoms, and a biocompatible polymer and fast drugeluting characteristics, combined who on the basis of thrombotic bleeding or restenosis risk criteria, qualified with as an uncertain candidates for DES, to receive ZES orin BMS. DAPTrisk duration was on abbreviated, tailored DAPT regimen, resulted a lower of 1 -year MACE in the basis of patient for characteristics, rather than stent characteristics, Endeavor and uncertain candidates DES implantation. (Zotarolimus-eluting allowed personalized dual antiplatelet regimen. Sprint Stentfor in a. Uncertain DES 1 -month Candidates [ZEUS] Study; NCT 01385319)
DES vs BMS – ZEUS Trial Valgimigli, et al. J Am Coll Cardiol 2015; 65: 805– 15 High Risk Bleeding Characteristics and Days of DAPT Duration to First Discontinuation
DES vs BMS – ZEUS Trial Valgimigli, et al. J Am Coll Cardiol 2015; 65: 805– 15
DES vs BMS – ZEUS Trial Valgimigli, et al. J Am Coll Cardiol 2015; 65: 805– 15
DES vs BMS – ZEUS Trial Valgimigli, et al. J Am Coll Cardiol 2015; 65: 805– 15
Leaders Free Trial N Engl J Med 2015; 373: 2038 -47. CONCLUSIONS: Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1 -month course of dual antiplatelet therapy.
Leaders Free Trial N Engl J Med 2015; 373: 2038 -47. % 10 9 DCS 8. 9 BMS 8 7 6. 1 6 5 5. 3 Components of Safety Endpoint 4. 2 4 3 2. 0 2 2. 2 1 0 Cardiac death p = 0. 19 MI p = 0. 01 ST (def / prob) p = 0. 70
Leaders Free Trial N Engl J Med 2015; 373: 2038 -47. 94. 9% % 100 SAPT 80 DAPT During Follow-Up 60 40 9. 5% 20 DAPT 0 0 30 90 180 270 390 Day Since Randomization DAPT= dual antiplatelet treatment or clopidogrel alone + vitamin K antagonist during first 30 days
Outline • Introduction • Randomized studies • Registry results • Meta-Analyses • Summary/Conclusions
94 384 consecutive stent implantations Sarno et al. European Heart Journal (2012) 33, 606– 613 Conclusions: PCI with newer gen DES (n-DES) is associated with a 38% lower risk of restenosis, 43% lower definite ST, and a 23% lower risk of death compared with older gen DES (o-DES)
Outline • Introduction • Randomized studies • Registry results • Meta-Analysis • Summary/Conclusions
Network Meta-Anaysis BMS vs DES
Network Meta-Anaysis BMS vs DES
All-Cause Mortality Meta analysis of 126 RCTs and >258, 000 patient-years of follow-up BMS* DES RR (95% Cr. I) SES vs. BMS* 0. 86 (0. 73 -1. 03) PES vs. BMS* 0. 89 (0. 74 -1. 07) Co. Cr EES vs. BMS* 0. 72 (0. 58 -0. 90) Pt. Cr EES vs. BMS* 0. 72 (0. 48 -1. 09) ZES-E vs. BMS* 0. 87 (0. 67 -1. 16) ZES-R vs. BMS* 0. 69 (0. 47 -1. 08) BP-DES vs. BMS* 0. 81 (0. 63 -1. 06) 0 Bangalore et al. BMJ 2013; 347: f 6625 Risk 1 10 Ratio (95% Crl) *Composite of several BMS
Myocardial Infarction Meta analysis of 126 RCTs and >258, 000 patient-years of follow-up BMS* DES RR (95% Cr. I) SES vs. BMS* 0. 83 (0. 72 -0. 93) PES vs. BMS* 0. 98 (0. 86 -1. 10) Co. Cr EES vs. BMS* 0. 65 (0. 55 -0. 75) Pt. Cr EES vs. BMS* 0. 61 (0. 44 -0. 87) ZES-E vs. BMS* 0. 80 (0. 67 -0. 95) ZES-R vs. BMS* 0. 71 (0. 55 -0. 92) BP-DES vs. BMS* 0. 80 (0. 66 -0. 96) 0 Bangalore et al. BMJ 2013; 347: f 6625 1 10 Risk Ratio (95% Crl) *Composite of several BMS
Myocardial Infarction Relative Risk Reduction MI (% vs. BMS*) Risk Reduction vs. BMS* P <0. 05 Meta analysis of 76 RCTs with >117, 000 PY of follow up Bangalore et al. Circulation. 2012; 125: 2873 -2891 *Composite of several BMS
Definite Stent Thrombosis Meta analysis 126 RCTs and >258, 000 patient-years of follow-up BMS* DES RR (95% Cr. I) SES vs. BMS* 1. 01 (0. 76 -1. 33) PES vs. BMS* 1. 17 (0. 91 -1. 59) Co. Cr EES vs. BMS* 0. 35 (0. 21 -0. 53) Pt. Cr EES vs. BMS* 0. 50 (0. 21 -1. 13) ZES-E vs. BMS* 0. 79 (0. 51 -1. 32) ZES-R vs. BMS* 0. 88 (0. 37 -1. 91) BP-DES vs. BMS* 0. 71 (0. 48 -1. 05) 0 Bangalore et al. BMJ 2013; 347: f 6625 1 10 Risk Ratio (95% Crl) *Composite of several BMS
Relative platelet cell adhesion LDH Adsorbance for Stent formulation / ® LDH Adsorbance for MULTI-LINK VISION (81 µm) N Engl J Med 2015; 373: 2038 -47. 2 49% ; P<0. 001 1. 8 1. 6 Kolandaivelu et al. Circulation. 2011; 123: 1400 -1409 1. 4 1. 2 1. 0 24% ; P=0. 002 0. 8 0. 6 0. 4 0. 2 TS = thick strut 0. 0 MULTI-LINK VISION (81 µm) ® TS VISION (162 µm) XIENCE V (96. 6 µm) ® Contrary to popular perception, drug/polymer coatings do not inherently increase acute stent clotting; they reduce thrombosis
EES DES vs. Biodegradable Polymer Metallic DES in RCT Meta-analysis Biodegradable Polymer Metallic DES RCT Network Meta-Analysis 126 RCTs involving 106, 427 patients ARC Definite Stent Thrombosis 1 Comprehensive set of BP-DES included, such as Synergy. TM, Bio. Matrix Flex. TM, Orsiro. TM, and Nobori. TM Conclusion: “The utility of biodegradable polymer stents in the context of excellent clinical outcomes with newer generation durable polymer stents needs to be proven. ” – Bangalore S, et al. BMJ, Nov. 2013
Outline • Introduction • Randomized studies • Registry results • Meta-Analyses • Summary/Conclusions
Is There a Role for BMS in 2016? BMS No!
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