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Marco Comeglio UO Diagnostica ed Interventistica del Cuore e dei Vasi USL 3 Pistoia Come gestire la terapia antiaggregante e anticoagulante nei pazienti.

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Presentazione sul tema: "Marco Comeglio UO Diagnostica ed Interventistica del Cuore e dei Vasi USL 3 Pistoia Come gestire la terapia antiaggregante e anticoagulante nei pazienti."— Transcript della presentazione:

1 Marco Comeglio UO Diagnostica ed Interventistica del Cuore e dei Vasi USL 3 Pistoia Come gestire la terapia antiaggregante e anticoagulante nei pazienti in attesa di chirurgia non cardiaca?

2 Risk Stratification for Perioperative TE in patients on OAT Mod from Douketis et al. Chest 2008

3 HEMORRHAGIC RISK IN NON CARDIAC SURGERY RISK BLOODTRANSFUSION TYPE OF SURGERY LOW INTERMEDIATE HIGH Usually not required Frequently required Possible bleeding in a closed space Skin, and general surgery Minor orthopedic, ORL Endoscopy Cataract, anterior eye Dental extr & surgery Visceral surgery CV surgery Major orthop, ORL, urologic Intracranial neurosurgery Spinal canal surgery Eye post chamber surgery Adapted Abualsaud et al, JACC Int 2010

4 Perioperative Management of OAT in Low- and High-Risk patients/procedures Low thromboembolic risk/low bleeding risk Continue anticoagulant therapy with INR in therapeutic range Low thromboembolic risk/high bleeding risk Discontinue anticoagulant therapy 5 days before the procedure Start LMWH prophylaxis once daily or UFH i.v. 1 day after acenocoumarol interruption, and 2 days after warfarin interruption. Administer the last dose of LMWH at least 12 h before the procedure or give UFH i.v. up to 4 h prior to surgery Resume LMWH or UFH at the pre-procedural dose 1-2 days (at least 12 h) after the procedure according to the haemostatic status. Resume anticoagulant therapy 1 to 2 days after surgery at the pre-procedural dose + 50% boost dose for 2 consecutive days according to the haemostatic status. LMWH/UFH until therapeutic INR is reached BRIDGING

5 High thromboembolic risk Discontinue anticoagulant therapy 5 days before the procedure Start therapeutic LMWH twice daily or UFH i.v. 1 day after acenocoumarol interruption, and 2 days after warfarin interruption. Administer the last dose of LMWH at least 12 h before the procedure or give UFH i.v. up to 4 h prior to surgery Resume LMWH or UFH at the pre-procedural dose 1-2 days (at least 12 h) after the procedure according to the haemostatic status. Resume anticoagulant therapy 1 to 2 days after surgery at the pre-procedural dose + 50% boost dose for 2 consecutive days according to the haemostatic status. LMWH or UHF is continued until the INR has returned to therapeutic levels Perioperative Management of OAT in Low- and High-Risk patients/procedures (2) BRIDGING

6 Circulation 2009; 119: 2920 Indication for OAT (n = 1,262) N (%)

7 Pengo et al, Circulation 2009 Anticoagulation Protocols According to Patient Thromboembolic Risk HIGH TE-RISK CRITERIA Mechanical mitral valve prostheses Monoleaflet aortic prostheses or bileaflet with AF or previous TE AF associated with previous TE or mitral valve disease Previous cardiogenic or unesplained systemic embolism Venous TE < 3 m N = 295 N = 967

8 Pengo et al, Circulation 2009 Types of Procedures According to the Bleeding Risk HIGH BLEEDING RISK (369) Abdominal Orthopedic Maxillofacial Urologic Vascular Gynecologic Ocular Mammary Neurosurgery LOW BLEEDING RISK (893) GI Endoscopy Cutaneous Surgery Cistoscopy Biopsies Hand surgery Angiography Ocular anterior ENT procedures Gyno procedures PM/ICD Hepatic procedures Arthroscopy Miscellaneous

9 Pengo et al, Circulation 2009 Thromboembolic Events 5 TE events: 3 venous and 2 arterial 1 fatal event All 5 events in HIGH TE-risk patients 3 events : LMWH not administered according to protocol 2 events : not bridget at all Hemorrhagic Events 15 major bleedings : none fatal 11 / 15 : surgical site bleeding 8 / 15 : protocol A ; 7 / 15 : protocol B 53 minor bleedings 27 /53 : at the procedure site Related to protocol (A > B) and procedure bleeding risk

10 EVENTIISCHEMICI EVENTIEMORRAGICI Come gestire la terapia antiaggregante nei pazienti in attesa di chirurgia non cardiaca? Prevenzione PrimariaPrevenzione Primaria Prevenzione SecondariaPrevenzione Secondaria Post-StentingPost-Stenting BMS/DESBMS/DES

11 Prevenzione Primaria Thrombosis and Haemostasis 2011;105 As the peri-operative use of aspirin is associated with increased blood loss and blood product use and as patients undergoing primary prophylaxis show no manifestation of any cardiovascular disease, this expert group suggests that aspirin given for primary prevention should be stopped 5–7 days before any type of surgery (46, 47). Further trials are required in order to confirm or refute this recommendation in the future.

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13 Prevenzione Secondaria Thrombosis and Haemostasis 2011;105 In summary, there is likely a favourable peri-operative benefit-to risk profile for antiplatelet monotherapy (aspirin or clopidogrel) in secondary prevention with the exception of specific types of surgery and situations where the additional bleeding implies an important risk to the patient. This expert group therefore recommends the continuation of aspirin (or clopidogrel) monotherapy for secondary prevention during most types of surgery. Only in patients undergoing surgical procedures in areas of closed space (e.g. intracranial neurosurgery, posterior chamber of the eye, medullary canal etc.) or when major bleeding complications are to be expected, stopping monotherapy with aspirin or clopidogrel 5–7 days pre operatively should be evaluated on a case by case basis. Further clinical trials are warranted.

14 Antiaggreganti Piastrinici dopo Angioplastica Coronarica

15 Shomig et al NEJM, 1996

16 The main complication of BMS is In-stent-restenosis

17 …a stent with optimal deliverability and scaffolding which is also impervious to intimal hyperplasia A KEYSTONE of Interventional Cardiology will be….. N = 238 patients de novo, native de novo, native coronary artery coronary artery N = 238 patients de novo, native de novo, native coronary artery coronary artery Randomized Sirolimus-coated Sirolimus-coated Bx Velocity TM Stent Bx Velocity TM Stent n = 120 Sirolimus-coated Sirolimus-coated Bx Velocity TM Stent Bx Velocity TM Stent n = 120 Uncoated Bx Velocity TM Stent Bx Velocity TM Stent n = 118 Uncoated Bx Velocity TM Stent Bx Velocity TM Stent n = 118 Primary Endpoint Late Loss measured by quantitative angiographic analysis at 6 months RAVEL trial NEJM ; 23

18 RAVEL – Event-Free Survival (Death, MI, CABG, Re-PTCA) 94.0% 70.7% P (FE) < P (LR) = Patients Without Event(%) Time (Days) 0 Sirolimus Control N Engl J M ; 23

19 DES use must be cautious in patients with ASA/Clopidogrel intolerance or allergy Surgery candidates Haemorrhagic diseases Lancet 2004

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21 VLST in DES

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25 Daemen et al, Lancet 2007 First Generation DES Occurrence and Frequency of ST over time VLST

26 DES and VLST Bern-Rotterdam Cohort 4 Years 8,146 consecutive patients treated with 1 st gen DES Wenaveser et al, JACC 2008 Risk of VLST 0.4 – 0.5 % per year

27 % Mortality in Patients with Stent Thrombosis (38/2974 – 1.27%) Kuchulakanti et al, Circ % 19% 31% 0 1 M 6 M F-UP Acute5 Sub-acute ± 8.5 d Late (>30d) ± 100 d Lack of CLOPI Rx was the strongest ST predictor p =

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29 Iakovou et al, JAMA, 2005 PREDICTORS OF THROMBOSIS AFTER SUCCESSFUL IMPLANTATION OF DES

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31 Factors identified with premature discontinuation of APT Not receiving discharge instructions for medication useNot receiving discharge instructions for medication use Not being referred for a cardiac rehabilitation programNot being referred for a cardiac rehabilitation program Older ageOlder age Low cultural levelLow cultural level Not being marriedNot being married Economical issuesEconomical issues Pre-existing anemiaPre-existing anemia Invasive proceduresInvasive procedures SurgerySurgery Berger et al JACC Int 2010 Days after hospital discharge Freedom from Major Surgery 0.5% per month after the first 2 months 5% EVENT Registry Major Non-Cardiac Surgery After DES 206/4,367

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34 RESTENOSIS STENT THROMBOSIS Sarno G, ESC ,773 12,153 6,425

35 Raber et al, ESC 2011 Bern-Rotterdam Cohort Study EES N = 4212 PES N = 4308 SES N = 3819

36 Raber et al, ESC 2011 Bern-Rotterdam Cohort Study

37 Valgimigli, ESC, 2011

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41 Kastrati, ESC, 2011

42 Novel Antiplatelets PRASUGREL Oral Thienopyridine Pro-drug metabolized via cit P450 Selective and irreversible binding More rapid, potent and consistent platelet inhibition More effective than Clopidogrel in ACS but with more bleedings Peri-operative use maight be limited because of increased risk of bleeding Potentially useful soon after surgery

43 Novel Antiplatelets TICAGRELOR Oral ADP P2Y12 receptor antagonist Non thienopyridine ADP analog Binds directly and reversibly to the P2Y12 without metabolic activation Achieves greater platelet aggregation inhibition than Clopidogrel Short half-life (6-12 h) Rapid onset of action (2-4 h) Reversibility Patients with stents would discontinue TICAGRELOR only 1 day before surgery and resume it soon after surgery, reducing the risk of both ST and Hemorrhage

44 Novel Antiplatelets CANGRELOR Intravenous ADP P2Y12 receptor antagonist Non thienopyridine ADP analog Binds directly and reversibly to the P2Y12 without metabolic activation Very short half-life (3 min) Rapid onset of action Reversibility Could be used as a Bridging Therapy in the perioperative setting: stopped minutes before surgery and resumed sooner than other APT post-operatively The BRIDGE trial ongoing

45 Jaffer AK. Clev Clin J 2009 CHECKLIST Preoperative evaluation of patients with stents Determine type of stent: BMS or DES ? Determine type of stent: BMS or DES ? In case of DES: 1 st or 2 ° generation DES ? In case of DES: 1 st or 2 ° generation DES ? Determine how long ago each stent was implanted Determine how long ago each stent was implanted Determine location of each stent & tecnique (eg, crush) Determine location of each stent & tecnique (eg, crush) How complicated was the revascularisation? Were there any complications (eg, underexpansion, malapposition)? How complicated was the revascularisation? Were there any complications (eg, underexpansion, malapposition)? Is there any prior history of stent thrombosis? Is there any prior history of stent thrombosis? What APT regimen is being used? What APT regimen is being used? Determine patients comorbidities to further ascertain risk level (EF, diabetes, renal insufficiency) Determine patients comorbidities to further ascertain risk level (EF, diabetes, renal insufficiency) What is the recommended duration of DAPT? What is the recommended duration of DAPT? What is the surgery bleeding risk? What is the surgery bleeding risk?

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47 ExpertsRecommendations Korte et al, Thromb Haemost, 2011

48 May et al, Thromb Haemost 2008 Perioperative Antiplatelet Management in Patients with Recently Implanted Coronary Stents BRIDGING

49 Prevenzione SecondariaPrevenzione Primaria Valutazione del Rischio Emorragico Valutazione Collegiale del Rapporto R/B Stop APT ASA : 7 gg prima int elett TPD : 15 gg prima int elett ASA : 75 mg/die + PPI Da 7 gg prima dellint elettivo nei pazienti trattati con ASA Da 15 gg prima dellint elettivo nei pazienti trattati con TPD NO SI IntermedioElevato Pregresso IMA, CAD, Ictus, PAOD, Stent Riprendere ASA asap Profilassi TE dopo intervento * Basso * Protocollo Peri-Operatorio ASA o TPD

50 Protocollo Peri-Operatorio ASA + TPD Elevato Rischio TRBasso Rischio TR Chirurgia Differibile? Operare in DAPT NO Riprendere DAPT asap Profilassi TE dopo intervento * SI Differire NO SI Continua ASAContinua ASA Stop TPD 5 gg primaStop TPD 5 gg prima * Bridge Therapy Valutazione Collegiale del Rapporto R/B Rischio di sanguinamento non controllabile chirurgicamente?

51 STENT/APT e Chirurgia non Cardiaca DAPT in PCI = Obiettivo da perseguire DAPT in PCI = Obiettivo da perseguire Almeno 1 mese BMS; 6 mesi DES. In considerazione della gravità della ST e della incidenza di sanguinamenti relativamente bassa Valutazione collegiale : Chirurgo – Cardiologo – Anestesista Valutazione collegiale : Chirurgo – Cardiologo – Anestesista Controindicazioni ai DES : in alcune situazioni cliniche prevenire la necessità di DAPT prolungata è preferibile rispetto a curare le complicanze emorragiche o trombotiche Controindicazioni ai DES : in alcune situazioni cliniche prevenire la necessità di DAPT prolungata è preferibile rispetto a curare le complicanze emorragiche o trombotiche Rischio emorragico elevato : il trattamento con sola ASA è gravato da una incidenza di ST relativamente bassa Rischio emorragico elevato : il trattamento con sola ASA è gravato da una incidenza di ST relativamente bassa Completa sospensione dell APT : raramente necessaria, in tal caso è opportuno adottare terapie bridging Completa sospensione dell APT : raramente necessaria, in tal caso è opportuno adottare terapie bridging DES di nuova generazione : migliore profilo di sicurezza DES di nuova generazione : migliore profilo di sicurezza Nuovi farmaci antipiastrinici : posso facilitare la gestione peri- operatoria Nuovi farmaci antipiastrinici : posso facilitare la gestione peri- operatoria TakeHomeMessage

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54 Predictors of ARC Definite or Probable 2-Year Stent Thrombosis : EES Stent Discontinuation Hazard RatioP of Thienopyridine (95% CI)VALUE Before 6 months YES vs. NEVER After 6 months YES vs. NEVER 8.06 (1.79, 36.22) SPIRIT IV 1.06 (0.24, 4.73)

55 HEMORRHAGIC RISK IN NON CARDIAC SURGERY RISK BLOODTRANSFUSION TYPE OF SURGERY LOW INTERMEDIATE HIGH Usually not required Frequently required Possible bleeding in a closed space Skin, and general surgery Biopsies Minor orthopedic, ORL Endoscopy Cataract, anterior eye Dental extr & surgery Visceral surgery CV surgery Major orthop, ORL, urologic Intracranial neurosurgery Spinal canal surgery Eye post chamber surgery Adapted Abualsaud et al, JACC Int 2010

56 SURGICAL RISK ESTIMATE Risk of MI and Cardiac Death within 30 days after Surgery


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