Χειρισμός Αντιθρομβωτικής Αγωγής σε μη Καρδιοχειρουργικές Επεμβάσεις

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1 Χειρισμός Αντιθρομβωτικής Αγωγής σε μη Καρδιοχειρουργικές Επεμβάσεις PeriklisA. Davlouros, Assistant Professor of Cardiology Invasive Cardiology & Congenital Heart Disease Patras University Hospital

2 No conflict to declare Patras University Hospital

3 Antithrombotic Therapy Antiplatelet agents (ASA, Clopidogrel, Prasugrel, Ticagrelor) Anticoagulant agents VKA (Coumadins) Parenteral (Heparins, etc.) NOACs (anti-xa, antithrombins)

4 Perioperative Antithrombotic Tx: Key Questions Patras University Hospital Is interruption of antithrombotic therapy in the perioperative period needed? In pts who are having a major surgical or other major invasive procedure, interruption required to minimize the risk for perioperative bleeding... In pts who are undergoing minor surgical or invasive procedure (eg, dental, skin, or cataract), interruption may not be required...

5 Risk Stratification for Bleeding High bleeding-risk surgeries/procedures include: Urologic surgery/procedures: TURP, bladder resection or tumor ablation, nephrectomy or kidney biopsy (untreated tissue damage after TURP and endogenous urokinase release) Colonic polyp resection, especially >1-2 cm sessile polyps (bleeding occurs at transected stalk after hemostatic plug release) Bowel resection (bleeding may occur at anastomosis site) Vascular organ surgery: thyroid, liver, spleen

6 Risk Stratification for Bleeding High bleeding-risk surgeries/procedures include: Major surgery involving considerable tissue injury: cancer surgery, joint arthroplasty, reconstructive plastic surgery Cardiac, intracranial, intraoccular, or spinal surgery (small bleeds can have serious clinical consequences) Pacemaker or ICD implantation (separation of infraclavicular fascia and no suturing of unopposed tissues may lead to hematoma) BRUISE CONTROL study less pocket cont. Warfarin, (3.5% versus 16%; relative risk 0.19; 95% CI )

7 Perioperative Antithrombotic Tx: Key Questions Patras University Hospital For intermediate bleeding risk surgery is interruption of antithrombotic Tx needed? If antithrombotic therapy is interrupted before surgery, is Bridging Anticoagulation needed? This depends on Thrombosis-Bleeding risk balance

8 Minimizing the Risk of Perioperative Bleeding Patras University Hospital If antithrombotic therapy should be stopped before surgery to minimize bleeding risk ~ hours for UFH/LMWH ~ 2-3 days for NOACs ~5 days for warfarin ~7-10 days for antiplatelet drugs

9 Minimizing the Risk of Perioperative Bleeding Patras University Hospital In resuming treatment after surgery, it takes: days for anticoagulant effect to begin after starting VKAs h for peak anticoagulant effect after starting LMWH - 2-3h for peak anticoagulant effect after starting NOACs - Mins for an antiplatelet effect to begin after starting ASA Hrs for an antiplatelet effect to begin after starting a maintenance dose of clop/pras/ticag

10 Minimizing the Risk of Perioperative Events Patras University Hospital Most surgery/procedures done out-of-hospital and potential TE or bleeding complications occur during the initial 2 wks after surgery while patient is at home - Close pt FU during early postop period allows early detection and treatment of complications

11 Perioperative Antithrombotic Tx: Thrombotic Risk Patras University Hospital Patients' estimated risk for thromboembolism (TE): High-risk pts: need to prevent TE will dominate management irrespective of bleeding risk; (the potential consequences of TE may justify bridging) Moderate-risk pts: a single perioperative strategy is not dominant and management will depend on individual patient risk assessment Low-risk pts: need to prevent TE will be less dominant; (bridging may be avoided)

12 Perioperative Antithrombotic Tx: Bridging Patras University Hospital Patients' estimated risk for thromboembolism (TE): In all patients, judicious use of postoperative bridging is needed to minimizing bleeding that would have the undesired effect of delaying resumption of antithrombotic therapy after surgery

13 Antiplatelet Therapy

14 Patients With ACS: Facts DAPT is mandatory for 1 year following an ACS Newer antiplatelet agents (NAPA) are more potent than clopidogrel in reducing ischemic end-points NAPA increase bleeding risk compared to clopidogrel Patients with increased ischemic risk also have increased bleeding risk

15 DAPT duration for stable Clopidogrel 1-6 months depending on stent type I(A/B) < 6 mo if bleeding risk, > 6 mo if isch/ bl risk IIb(A/C)

16

17 Savonitto et al. Journal of Thromb and Haemost 2011 Incidence of surgery within 1 year of coronary stenting (5-8%)

18 Incidence of surgery within 1 year of coronary stenting

19 What Does the Surgeon Recommend if a Pt with a Recent Stent Needs Surgery? Fear of excessive bleeding leads to the generally accepted policy of discontinuing antiplatelet agents 7-10 days before surgery Not uncommonly surgeons recommend discontinuation for 14 days, or even 2-3 days!!!

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21

22 The Perfect Storm Patras University Hospital

23 Stent Thrombosis 839 pts from 4 studies p=0.35 MACEs 404 pts/6 studies p=0.04 Perioperative Stent Thrombosis in pts with DES as a function of the time elapsed since stent implantation Patras University Hospital Perioperative MACEs in pts with DES as a function of the time elapsed since stent implantation

24 Perioperative MACEs in pts with DES as a function of the time elapsed since stent implantation Patras University Hospital Savonitto et al. Journal of Thromb and Haemost 2011

25 839 pts from 4 studies p=0.35

26 DAPT may not be protective perioperatively Most urgent interventions performed in a proinflammatory and prothrombotic milieu, (cancer, trauma, and anemia) Operative trauma: hypercoagulable state... Increased PLTs, von Willebrand factor, fibrinogen, etc, impaired deformability of erythrocytes, decreased proteins that oppose formation of stable fibrin CABG: cardiopulmonary bypass circuit may also induce systemic prothrombotic state by activating tissue factor, kallikrein, and complement Clopidogrel: poorly absorbed and requires extensive metabolism, a process that is dramatically impaired in acutely ill pts because of splanchnic and liver hypoperfusion, and reduced gastric emptying resulting from the use of opioids for analgesia and sedation

27 Perioperative Events in Stented Pts Patras University Hospital The incidence of perioperative death, MI and ST decreases over time Particularly high (up to 30%) in the 1 st mo regardless of the type of implanted stent; 10 15% at 2-6 mos; and< 10% after 6 mos The indication for index stenting SAP vs. ACS is probably more important than the type of stent deployed, or even timing... The risk of cardiac adverse events in recent PCI does not seem to depend on ST alone, but on the more general coronary risk The first postoperative week is the most critical: in the EVENT Registry, the risk of death, MI or ST was 27-fold higher in the week following NCS than in any other week after stent implantation

28 Key Issues to be Addressed Whether continuing perioperative DAPT protects against cardiac ischemic events The extent to which it increases the risk of surgical bleeding How to balance the potential benefits and risks in individual patients This subject has been discussed by cardiovascular surgeons for 20 years with regard to aspirin, and for a few years with regard to clopidogrel added to aspirin

29 Patients With Coronary Stents Having Surgery Patras University Hospital Recommendation: In pts with a coronary stent who are receiving DAPT and require surgery, we recommend deferring surgery for at least 6 wks after placement of a BMS and for at least 6 mos after placement of a DES (Grade 1C) Recommendation: In pts who require surgery within 6 wks of placement of a BMS or 6 mos of placement of a DES, we suggest continuing DAPT around the time of surgery instead of stopping DAPT 7-10 days before surgery (Grade 2C)

30 What does ESC recommend? DAPT for at least 1 mo after BMS in stable CAD, 6 mo after ng-des, and up to 1 yr after ACS, irrespective of revascularization strategy A minimum of 1 (BMS) to 3 (ng-des) mo of DAPT might be acceptable, independently of the acuteness of CAD, in cases when surgery cannot be delayed for a longer period Such surgical procedures should be performed in hospitals where 24/7 catheterization laboratories are available

31 What does ESC recommend? Single anti-platelet therapy (preferably with ASA) should be continued

32 What does ESC recommend? Single anti-platelet therapy (preferably with ASA) should be continued

33 What does ESC recommend? In pts needing surgery within a few days

34 What does ESC recommend? Dual anti-platelet therapy should be resumed as soon as possible after surgery and, if possible, within 48 hours

35 What does ESC recommend? Platelet function tests for optimal timing of surgery not recommended Ideal platelet function assay or bleeding cut-off

36 Compared with the guidelines, this individualized approach reduced the pre-operative waiting period by about 50% Thrombelastography (TEG) to determine the timing of CABG in pts on clopidogrel was evaluated in the first prospective study, TARGET CABG which showed that pts non responsive by TEG had no greater chest tube output when operated within 24 hrs of last clopidogrel dose compared to clopidogrel naïve pts.

37 Need for non-cabg surgery 68-year-old DM, mild CRF, and colorectal cancer diagnosed following bleeding on DAPT, needs surgery 5 months DES in LAD bifurcation Best approach?

38 Interrupting DAPT: Thrombotic Risk Clinical Factors ACS Low EF Diabetes CRF Cancer Surgery Angiographic/Technical Factors BMS < 1 mo DES < 6-12 mo (New generation DES ) DES > 12 mo and Long lesions, Multiple stents, Small vessels, Bifurcations, LM disease, Last remaining vessel

39 Bridging: ESC recommendation For patients with a very high risk of ST, bridging with IV, reversible GPIs, should be considered Cangrelor, is not yet available... The use of LMWH for bridging in these pts should be avoided.

40 Urgent surgery in pts with a recently implanted DES: a phase II study of bridging antiplatelet therapy with tirofiban during temporary withdrawal of clopidogrel Patras University Hospital Savonitto et al. BJA pts with a mean age (range) of 65 (25 80) yr There were no adverse cardiac events during the index hospitalization, and no patient required surgical re-exploration because of bleeding: Point estimate of the primary endpoint rate was 0% (one-tailed 97.5% CI %) No patient experienced any major or minor TIMI bleeding during the preoperative phase, although one received 2 U of RBCs due to preexisting anaemia

41 ASA continued throughout Surgery Stop Prasugrel Stop Clopidogrel Ticagrelor Start Small molecule GPI (Tirof/Eptif) Stop Small molecule GPI (Tirof/Eptif) Resume Small molecule GPI (Tirof/Eptif) Resume Clopidogrel Day hrs hrs FU until discharge Tirofiban 0.1 mcg/kg/min Eptifibatide 2 mcg/kg/mi If CrCl < 50 ml/min half dose mg LD ASAP

42 The main findings of our study are that, in patients undergoing major surgery after DES implantation requiring interruption of thienopyridine administration, preoperative administration of a glycoprotein IIb/IIIa inhibitor (a)may not prevent postoperative stent thrombosis, and (b)may be associated with high risk for thrombocytopenia and bleeding

43 Cangrelor Intravenous ADP P2Y 12 receptor antagonist Rapid acting: quick onset, quick offset Plasma half-life of 3 6 minutes 60 minutes for return to normal platelet function HN S 4Na + N N O O O P Cl Cl O P O O P O O O HO O N OH N S CF 3

44 The Safety and Efficacy Of Cangrelor, a Short Acting, IV, Reversible, Platelet P2Y 12 Inhibitor In Patients Awaiting Cardiac Surgery: Results Of the BRIDGE Trial Dominick J. Angiolillo MD, PhD, Michael S. Firstenberg MD, Matthew J. Price MD, Pradyumna E. Tummala MD, Martin Hutyra MD, Ian J. Welsby MD, Michele D. Voeltz MD, Harish Chandna MD, Chandrashekhar Ramaiah MD, Miroslav Brtko MD, PhD, Louis Cannon MD, Cornelius Dyke MD Tiepu Liu MD, PhD, Gilles Montalescot MD, Steven V. Manoukian MD, Jayne Prats PhD, Eric J. Topol MD for the BRIDGE Investigators Patras University Hospital 44

45 PRU Trial design: Stage II Randomized, Double-Blind, Placebo-Controlled Bridge Stage II: Demonstration of Effective Cangrelor Infusion Dose Clopidogrel or prasugrel Demonstrate that cangrelor infusion of maintains PRU< 240 Cangrelor/Placebo Infusion Dose Determined in Stage I : 0.75 µg/kg/min (CABG rule-in) Elapsed Days CABG Treat per Standard of Care Thru Hospital Discharge Patients with an ACS or treated with a coronary stent (BMS or DES) on a thienopyridine (ticlopidine, clopidogrel or prasugrel) awaiting CABG. After thienopyridine discontinuation (<72 hours), patients were administered cangrelor/placebo for at least 48 hours and up to 7 days, which was discontinued 1-6 hours prior to CABG. Objective: demonstrate that cangrelor would maintain levels of platelet reactivity <240 P2Y12 Reaction Units (PRU) throughout the pre-operative period as measured by the VerifyNow P2Y12 test. 45 Patras University Hospital

46 VerifyNow PRU Patras University Hospital Platelet reactivity by day 400 Cangrelor Placebo n=86 n=76 n=73 n=57 n=34 n=24 n=14 n=2 n=84 n=75 n= n= n=80 n=70 n=55 n=33 Baseline Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Last Pre-CABG on-infusion sample sample Time Point n=7 n=6 n=1 n=84 N indicates number of patients with valid samples in the intention to treat population; PRU= P2Y12 reaction units; Data expressed as mean±sd

47 Bleeding endpoint Excessive CABG-related bleeding (primary safety endpoint)* 15% 10% Excessive CABG-related bleeding 11,8% P= ,4% 5% 0% Cangrelor Placebo *Excessive CABG-related bleeding is defined as the occurrence of one or more of the following 3 components during the CABG procedure or post-operative hospitalization: Surgical reexploration, 24 hour CT output > 1.5 liters, Incidence of PRBC transfusion > 4 units.

48 Summary results When used as a bridging strategy to CABG after thienopyridine discontinuation, cangrelor (at 0.75 µg/kg/min) achieves levels of platelet inhibition known to be associated with a low risk of thrombotic events: Without increased risk of bleeding before or during CABG, although with a numerical increase in minor pre-cabg bleeding Independent of prior thienopyridine dose & time of discontinuation Consistent pharmaocdynamic effect during IV infusion Rapid offset after IV discontinuation prior to surgery No increased incidence of adverse events (e.g. dyspnea) or laboratory abnormalities despite extended dosing. Patras University Hospital

49 ASA continued throughout Surgery Start Cangrelor Stop Prasugrel Stop Clopidogrel Ticagrelor Stop Cangrelor Resume Cangrelor Resume Clopidogrel Day hrs hrs FU until discharge Within 72 hrs 0.75 μg/kg/min for a min 48 hrs and max 7 ds mg LD ASAP

50

51

52 Bridging strategy: Limitations Requires prolonged hospitalization Carries increased risk for bleeding Is costly Does not address the risk during the immediate postoperative period, when the ST risk is highest Unknown if it could reduce MACES

53

54 Carefully balance Bleeding risk (intracranial/spine/abdominal/prostate/etc) Ischemic risk (recent ACS, stent type, lesion type) ASA should be continued (especially if DES < 12 mo) If Low Thrombotic Risk Stop Prasugrel 7 days before surgery Stop Clopidogrel-Ticagrelor 5 days before surgery Stop clopidogrel 5 days before surgery, or less, if a validated platelet function testing method shows a poor response to clopidogrel Start Clopidogrel (LD), (or Ticagrelor?) ASAP Prasugrel contraindicated immediately postoperatively If High thrombotic risk pts bridging may be considered

55 Anticoagulation Therapy Patras University Hospital

56 Suggested Risk Stratification: Mechanical Heart Valves Patras University Hospital High Risk Any mitral valve prosthesis Older (caged-ball or tilting disc) aortic valve prosthesis Recent (within 6 months) stroke or TIA Moderate Risk Bileaflet aortic valve and at least one of: Afib, or CHADS 1 Low Risk Bileaflet aortic valve without AF and no other RFs for stroke

57 Suggested Risk Stratification: Afib Patras University Hospital High Risk Rheumatic valvular heart disease Recent (within 3 months) stroke or TIA CHADS 2 score = 5-6 Moderate Risk CHADS 2 score = 3-4 Low Risk CHADS 2 score = 0-2 and no prior stroke or TIA N.B. Individual pt characteristics (eg, prior embolic stroke or perioperative stroke/tia) may override suggested risk stratification

58 Suggested Risk Stratification: VTE Patras University Hospital High Risk Recent VTE (<3 months ago) Severe thrombophilia (eg, antiphospholipid antibodies) Moderate Risk VTE within the past 3-12 months Recurrent VTE Nonsevere thrombophilia (eg, heterozygous factor V) Active cancer (treated within 6 months or palliative) Low Risk Prior VTE >12 months ago and no other risk factors

59 Patients Requiring Minor Procedures Patras University Hospital Recommendation: Minor dental surgery, either continue VKA with co-administration of an oral prohemostatic agent or stop VKAs 2-3 days before the procedure (Grade 2C) Recommendation: Minor skin procedures, continue VKAs and optimize local hemostasis (Grade 2C) Recommendation: Cataract surgery, continue VKAs (Grade 2C)

60 Pts at High Risk for TE having Major Surgery Patras University Hospital Recommendation: In pts who require temporary interruption of a VKA before surgery, we recommend stopping VKAs approximately 5 days before surgery (Grade 1C) Recommendation: In pts who require temporary interruption of a VKA before surgery, we recommend resuming VKAs approximately hrs after surgery (evening of or next morning) when there is adequate hemostasis (Grade 2C)

61 Pts at High Risk for TE having Major Surgery Patras University Hospital Recommendation: In pts with a mechanical heart valve, Afib or VTE at high risk for TE, we suggest bridging anticoagulation (Grade 2C)

62 Pts at Low Risk for TE Having Major Surgery Patras University Hospital Recommendation: In pts with a mechanical heart valve, Afib or VTE at low-risk for TE, we suggest no bridging (Grade 2C) N.B. In pts at moderate-risk for TE, the bridging or no bridging approach chosen is, as in the higher and lower risk pts, based on an assessment of individual patient- and surgery-related factors

63 Perioperative Administration of Bridging Recommendation: In pts who are receiving bridging anticoagulation with therapeutic-dose SC LMWH, we suggest administering the last preoperative dose approximately 24 h before surgery instead of 12 h before surgery (Grade 2C) Recommendation: In pts who are receiving bridging anticoagulation with therapeutic-dose SC LMWH and are undergoing high bleeding-risk surgery, we suggest resuming therapeutic-dose LMWH h after surgery instead of resuming LMWH within 24 h after surgery (Grade 2C) Patras University Hospital

64 What does ESC recommend? Stop VKA 3 5 days before surgery (depending on the type of VKA),with daily INR measurements, until 1.5 is reached, and that LMWH or UFH therapy be started one day after discontinuation of VKA or later, as soon as the INR is 2.0 The last dose of LMWH should be administered no later than 12 hrs before the procedure

65 What does ESC recommend? LMWH or UFH is resumed at the pre-procedural dose 1 2 days after surgery, depending on the patient s haemostatic status, but at least 12 hours after the procedure VKAs should be resumed on day 1 or 2 after surgery depending on adequate haemostasis with the preoperative maintenance dose plus a boosting dose of 50% for two consecutive days

66 NOACs: ESC guidelines In pts treated with the NOACs, all of which have a well-defined on and off action, bridging to surgery is in most cases unnecessary, due to their short biological half-lives

67

68 NOACs: ESC guidelines Stop NOACs for times their respective biological half-lives prior to surgery in surgical interventions with normal bleeding risk 4 5 times the biological half-lives before surgery in surgical interventions with high bleeding risk...

69 NOACs: ESC guidelines Because of the fast on -effect of NOACs, resumption of treatment after surgery should be delayed for 1 2 (in some cases 3 5) days, until post-surgical bleeding tendency is diminished

70 Ευχαριστώ

71 Reversal of anticoagulant therapy VKAs: low-dose ( mg) IV or oral vitamin K Effect on INR will first be apparent after 6 12 hs More immediate reversal: fresh-frozen plasma or prothrombin complex concentrate (PCC), in addition to low-dose vitamin K

72 Reversal of anticoagulant therapy UFH (IV): coagulation is usually normal 4 hours after cessation UFH (SC): anticoagulant effect more prolonged Immediate reversal: protamine sulphate, dose calculated by assessment of the amount of heparin received in the previous 2 hrs... 1 U per 1 U of heparin sodium...

73 Reversal of anticoagulant therapy LMWHs: anticoagulant effect reversed within 8 hours of the last dose Immediate reversal: IV protamine sulphate can be used, but anti-xa activity is never completely neutralized (maximum 50%)

74 Symptomatic treatment Lack of specific antidotes Potential benefit for PCC or apcc Haemodialysis (dabigatran)

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