Relevantie verschillende generaties stents voor apotheker en duale antistolling
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1 Relevantie verschillende generaties stents voor apotheker en duale antistolling Pieter C. Smits MD, Ph.D, FESC Maasstad Hospital, Rotterdam, The Netherlands
2 DISCLOSURES I have received in the last 3 years lecture fees from Abbott Vascular and institutional research grants from Abbott Vascular, Terumo, and St. Jude
3 PCI (Percutane Coronair Interventie) aantallen in NL Totale PCI : NL inwoners 2013: PCI => PCI / milj Bronnen: BHN 25 juni 2015, CBS 21 juni 2015
4 PCI s per million inhabitants United States PCIs 1,060,502 Population 307 PCIs/mln 3,454 EU Country Detail Europe PCIs 1,132,000 Population 593 PCIs/mln 1,191 Country Total PCIs Population PCIs/million Switzerland 36, ,849 Germany 299, ,660 Austria 19, ,358 Italy 128, ,161 France 120, ,921 Spain 60, ,340 UK 77, ,273 China PCIs 254,000 Population 1,325 PCIs/mln 192 India PCIs 121,000 Population 1,140 PCIs/mln 106 Bron: J. Capek, CEO Abbott 2009 Japan PCIs 228,000 Population 128 PCIs/mln 1,785
5 PTCA behandeling ( dotter ) Force Exerted Breken van de plaque Oprekken van het bloedvat Comprimeren van de plaque
6 Restenosis: de achillishiel Recoil and remodeling Neointimal hyperplasia Focal short lesions 15 25% Small diameter lesions 30 40% Long lesions 37 50% Diabetes 26 46% Bifurcated lesions 40 60%
7 Restenosis: de achillishiel Recoil and remodeling de Stent: de oplossing!
8 Restenosis: de achillishiel Recoil and remodeling de Stent, de gedeeltelijke oplossing! Intima hyperplasie Litteken weefsel als reactie op de behandeling en stent Restenose (>50% DS) 20-40% Bij 15-20% van de patienten recidief AP Meestal binnen 6 maanden na de PCI
9 In-stent restenosis: intima hyperplasie
10 Mechanisms of Restenosis Thrombus (platelets) Arterial Injury Inflammation Growth factors & cytokines neutrophils monocytes macrophage lymphocytes Smooth muscle cell Receptor activation X Signal TOR Transduction Cell Cycle DES Drug Eluting Stents Matrix secretion X SMC Proliferation Migration
11 DES Technology: 3 Components Drug Polymer Stent Paclitaxel 1 µg/mm 2 Translute TM Express 2 Sirolimus 0.14 µg/mm 2 PEVA + PBMA Cypher TM select
12 DES stents 1 e generation (first available, durable polymer, stainless steel) Sirolimus eluting (Cypher) Paclitaxel eluting (Taxus Express / Liberté) CE marked / e generatie DES veel effectiever dan bare metal stents (DES) Re-stenose percentage daalde van 15-30% naar 1-5%
13 Incidence of ST with 1 e gen DES % annual increase Bern-Rotterdam registry, pts. Def. ST Wenaweser, P. et al. JACC 2008;52: Pooled SPIRIT II, II, IV & COMPARE pts, def/prob ST Planer/Smits et al. JACC. Int 2011
14 Pathophysiology of Very Late ST Eosinophilic Infiltrates Delayed Healing P< P< P= Cook et al. Circulation 2009 Vessel Remodeling Guagliumi et al. Circulation 2011 Neoatherosclerosis Cook et al. Circulation 2007 Nakazawa JACC 2011 Virmanu et al. Experts Review 2008:6:
15
16 DES stents 1 e generation (first available, durable polymer, stainless steel) Sirolimus eluting (Cypher) Paclitaxel eluting (Taxus Express / Liberté) 2 e generation (biocompatible durable polymer, CoChr/ PtChr, thin struts, improved deliverability) Zotarolimus eluting (Endeavor / Resolute) Everolimus eluting (Xience / Promus Element CE marked / /
17 COMPARE 1:1 randomization Single center All-comer Superiority design (delta 5%, Power 85%) Minimal in-exclusion criteria DAPT for 12 months No cardiogenic shock Life expectancy > 5 years 1e Gen. DES Taxus Liberté n = 903 pts PI: dr. P. C. Smits N = 1800 patients Single center 2e Gen. DES Xience-V n = 897 pts Clinical/MACE 30d 6mo Prim endpoint 12mo 2yr 3yr 4yr TCT yr Primary endpoint: All death, non fatal MI and TVR at 12 months Secondary endpoints: - Cardiac death, non fatal MI and ID-TLR - Stent thrombosis
18 Final 5-Year Results from COMPARE MACE (Cardiac Death, Myocard Infarct, re-pci) Cumulative incidence of events [%] Taxus Xience Taxus Xience RR = 0.68 ( ) P=0.023 RR = 0.66 ( ) P = (log-rank test) P= % RR = 0.67 ( ) P= % 9.1 % 12.3 % 9.0 % 6.2 % 2.9 % 4.7 % 6.1 % RR = 0.73 ( ) P= % 18.4 % 6.7 % Time after initial procedure [months] Kedhi et al. Lancet 2010; 365: Smits et al. JACC 2011; 58:11-8. Smits et al. JACC Intv 2015; 8:
19 First Definite Stent 5 yr Definite ST according to ARC Taxus Xience Taxus Xience P = 0.03 (log-rank test) Cumulative incidence of events [%] RR = 0.22 ( ) P = RR = 0.29 ( ) P = % 1.9 % 2.7 % 2.0 % 0.4 % 0.8 % RR = 0.31 ( ) P = % 3.5 % 1.1 % RR = 0.56 ( ) P = % 4.0 % 2.2 % Time after initial procedure [months] Kedhi et al. Lancet 2010; 365: Smits et al. JACC 2011; 58:11-8. Smits et al. JACC Intv 2015; 8:
20 DES stents 1 e generation (first available, durable polymer, stainless steel) Sirolimus eluting (Cypher) Paclitaxel eluting (Taxus Express / Liberté) 2 e generation (biocompatible durable polymer, CoChr/ PtChr, thin struts, improved deliverability) Zotarolimus eluting (Endeavor / Resolute) Everolimus eluting (Xience / Promus - Element 3 e generation (biodegradable polymer or polymer free, abluminal drug release) Biolimus eluting (Biomatrix / Nobori & Biofreedom) Sirolimus eluting (Orsiro / Supralimus / Ultimaster/ Excel / Firehawk / Noya/ Mistent & Yukon / Cre8) Everolimus eluting (Synergy) Novolimus eluting (DESyneBD CE marked / /
21 Biodegradable polymers (PLLA or PLGA)
22 COMPARE II 2:1 randomization Multicenter All-comer Non-inferiority design (delta 4%, Power 90%) Minimal in-exclusion criteria Vessel diameter: mm No cardiogenic shock Life expectancy > 5 years 3e Gen. DES Nobori stent n = 1800 pts Clinical/MACE 30d 6mo PI: dr. P. C. Smits N = 2700 patients 12 sites Europe (NL, Sp, Gr, Sw) Prim endpoint 12mo 2yr 2e Gen. DES Control EES stent n = 900 pts 3yr 4yr 5yr Primary endpoint: Composite of safety (cardiac death and non-fatal myocardial infarction) and efficacy (target vessel revascularization) at 1 year
23 3-Year Results from COMPARE II TVF (cardiac death, myocard infarct and re-pci) BES EES RR: 1.04 ( ) P = % Cumulative incidence (%) RR: 1.07 ( ) P = % 10.7 % % P logrank = Days since initial procedure Smits et al. Lancet 2013; 381: Vlachojannis et al. EuroIntervention 2015;11: 272-9
24 3-Year Results from COMPARE II Definite ST according to ARC 14 BES EES 12 Cumulative incidence (%) RR: 1.7 ( ) P = % 0.4 % P logrank = 0.33 RR: 1.52 ( ) P = % 0.8 % Days since initial procedure Smits et al. Lancet 2013; 381: Vlachojannis et al. EuroIntervention 2015;11: 272-9
25 4 e Generatie: Bioresorbable Stents (Scaffolds) Polylactide (PLA) => CO 2 + H 2 O (Igaki-Tamai, BVS-Abbott; DESolve-Elixir A.R.T-ART; Avatar-SV3; XINSORB-Weite) Tyrosine polycarbonaat => CO 2, Amino acids, Ethanol (ReZolve-REVA) Poly salicylaat => Salicylic acid (Xenogenics) Mg => Mg(OH) 2 + H 2 (Biosolve-Biotronic)
26 Everolimus-Eluting BVS
27 OCT Histology 28 days 100 % struts visible, No resorption 2 year 60 % struts visible, Voids filles with proteoglycanen 3 year 28 % struts visible, Voids filled with connective tissue 4 year Onuma Y, Serruys P W Circulation 2011;123: % struts visible Scaffold not traceable with histology
28 Mechanisme Anti-Plaatjes therapie Ticagrelor
29 The therapeutic target for thienopyridines and CPTPs is the platelet P2Y 12 receptor Esterification and 2-step oxidation to active metabolite Prasugrel 1-step oxidation to active metabolite Ticagrelor Active metabolite CPTP - Cyclo-pentyl-triazolo-pyrimidine
30
31 PCI for Stable Angina
32 PCI for Acute Coronary Syndrome
33 Impact of Therapies on Outcomes Ischemic events: Stent Thrombosis Bleeding
34 Does bleeding matter? Increased Mortality after Bleeding in patients with ACS 34,146 Pts in the OASIS-1/2 and CURE Mortality (%) P< First 30 days Bleeding No bleeding 12.8% 2.5% Days No. at Risk No bleeding Bleeding Mortality (%) Landmark analysis, 1-6 mo P=0.002 Days Bleeding No bleeding 4.6% 2.9% Adj. HR [95%CI] = 5.37 [3.97, 7.26] P< Adj. HR [95%CI] = 1.54 [1.02, 2.36] P=0.047 Eikelboom JW. Circulation 2006;114:
35 Bleeding does matter! Link to Mortality Major Bleeding Hypotension Cessation of ASA/Clop Transfusion Ischemia Stent Thrombosis Inflammation Mortality Bhatt DL. In Braunwald EB, Harrison s Online
36 How to prevent bleedings? Peri-procedural: Medication: Bivalirudin, IIbIIIa, Heparin Access site Stent choice Post procedure: Duration of DAPT New strategies
37 Bleeding matters, how to prevent Periprocedural: Medication: Bivalirudin? (mixed outcomes), UFH still a good option Access site: Radial Stent choice: 2 e - 3 e Generatie DES of BMS Postprocedure: Duration of DAPT: Shorter for high-risk bleeding patients. Longer for High-risk MI + low-risk bleeding New strategies: Global Leaders. 24 months DAPT vs 1 months DAPT + 23 months Mono Ticagrelor.
38 Trial Population Stent Evidence DAPT [2014] All-comer BMS, 1e-2e Gen DES Lower rates of MACE, ST and MI with longer DAPT Lower rates of major bleeding with shorter DAPT Higher all-cause mortality with longer DAPT PEGASUS [2015] Stable CAD with 1-3 yrs MI prior + 1 add risk factor NA Lower rates of CV death, MI or stroke Ticagrelor increased the risk of TIMI major bleeding, but not fatal bleeding or ICH Death from any cause showed no difference GLOBAL LEADERS [2018] All-comer 3e Gen. DES ASA 1 month + 24 months Tica Versus ASA lifelong + 12 months Tica 37
39 DAPT duration studies post PCI Short (3-6 months) & Extended (>12 months) BMJ Apr 16;350:h1618.
40
41 Co-Primary Effectiveness End Point MACCE Cumulative Incidence of Death, Myocardial Infarction or Stroke 10% 8% 6% 4% 2% 0% Thienopyridine Placebo Months After Enrollment Primary Analysis Period Months: HR 0.71 ( ) 4.3% vs. 5.9% P<0.001 # At Risk Thienopyridine Placebo
42
43 DAPT study: Bleeding P = P = 0.04 P = 0.15
44 Bleeding score models NCDR bleeding model Variable ACS type STEMI NSTEMI Shock Female CHF History of stroke Age >85 egfr Points (per 10 unit decrease) CHF indicates congestive heart failure Bleeding (%) /1 2/3 4/5 6/7 8/9 10/11 12/1 14/15 16/17 18/19 20/21 22/23 > Bleeding risk score Mehran bleeding model Variable Points Age >80 Female sex ACS type STEMI NSTEMI Anaemia WBC Creatinine Bivalirudin use WBC white blood cells Risk of non-cabg MB 30-days (per 1 unit increase) 1 (per 0.2 unit increase) Bleeding risk score Crusade bleeding model Variable SBP Female CHF History of stroke Anaemia egfr Diabetes Heart rate SBP systolic blood pressure Major bleeding (%) Points Very low Low Moderate High Very High Risk of bleeding
45 Predictors of Ischemic vs. Bleeding Events Ischemic Complications STEMI presentation NSTEMI presentation Age Female Gender Renal Insufficiency PAD Bleeding Complications STEMI presentation Low weight/bsa Age Female Gender Renal Insufficiency PAD Diabetes Prior CABG or PCI Implications: Challenging to identify individual patients who are likely to derive benefit or harm Salisbury A, et al. ACC 2010
46 HASBLED bloedingsscore (AF populatie)
47 Conclusies Nieuwe generatie DES (2 e & 3 e Gen.) zijn superieur in uitkomst in vergelijking met BMS en 1 e Gen. DES en derhalve eerste keus Volledig oplosbare stents (scaffolds) komen eraan Huidige richtlijnen schrijven DAPT (ASA+ Clopidogrel) voor 6 maanden post PCI (DES) bij stabiele angina en minstens 12 maanden DAPT (ASA + P2Y 12 ) by acute coronaire syndromen
48 Conclusies vervolg Majeure bloedingen na PCI zijn prognostisch net zo erg als ischemische events De rol van ASA als hoeksteen van post PCI beleid staat ter discussie Individuele aanpak van duale anti-platelet therapie na PCI (of ACS) lijkt logisch, maar is moeilijk Individueel post PCI beleid obv risico scores is nog niet onderzocht
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