Gestione peri-operatoria della terapia antitrombotica

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Battista Nanni
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1 Gestione peri-operatoria della terapia antitrombotica Matteo Nicola Dario Di Minno Centro di Coordinamento Regionale per le Emocoagulopatie AOUP Federico II Napoli

2 Antithrombotic Drugs Anti-coagulant drugs Anti-platelet drugs

3 Patologie vascolari nelle quali è dimostrata l efficacia dell ASPIRINA Patologia Dose efficace (mg/die) Uomini ad elevato rischio cardiovascolare 75 Ipertensione/diabete (prevenzione primaria) Angina stabile 75 Angina instabile* 75 Infarto miocardico acuto 160 TIA ed ictus ischemico* 50 Stenosi carotidee severe* 75 Ictus ischemico acuto* 160 Ritardo di crescita fetale/abortività 100 *dosaggi superiori testati in altri trials non hanno dimostrato efficacia superiore Patrono C, et al. CHEST 2004; 126: 234S, modified

4 CREDO STUDY ogni anno 2 MILIONI di pazienti vengono sottoposti a rivascolarizzazioni coronariche (PCIs) 1.5 MILIONI dei quali (80%) ricevono impianto di STENT (antiaggregazione obbligatoria) 100,000 dei quali (5%) saranno sottoposti ad interventi di chirurgia non-cardiaca entro 1 anno STEINHUBL SR. JAMA 2002, 288, ; VICENZI ML, BR J. ANESTH 2006, 96,

5 Come gestire un paziente che dopo una recente PCI assume aspirina e/o clopidogrel e che deve essere sottoposto a procedure chirurgiche STEINHUBL SR. JAMA 2002, 288, ; VICENZI ML, BR J. ANESTH 2006, 96,

6 PERIOPERATIVE ANTIPLATELET TREATMENT Patients NOT at high risk for cardiac events: we suggest stopping antiplatelet agent 7 to 10 days before the surgery procedure Patients at high risk of cardiac events PCI continue aspirin. continue clopidogrel. Non-cardiac surgery continue aspirin stop clopidogrel (if present) 5-10 d prior to surgery CABG continue aspirin stop clopidogrel 5-10 d prior to surgery.

7 PERIOPERATIVE ANTIPLATELET TREATMENT Differenti livelli di rischio vascolare Differenti tipi di interventi chirurgici Differenti livelli di rischio emorragico

8 Rischio emorragico intra-operatorio in pazienti che assumono ASA Burger W, J. Int. Med. 257, 399, 2005 META-ANALISI DI 474 STUDI Anestesiologia Dermatologia Gastroenterologia Chirurgia oculistica Chirurgia ortopedica ORL Urologia Chirurgia vascolare

9 Rischio emorragico intra-operatorio in pazienti che assumono ASA Burger W, J. Int. Med. 257, 399, 2005 META-ANALISI DI 474 STUDI NO DIFFERENCE IN SURGICAL COMPLICATIONS/OUTCOME IN DENTAL (BLEEDING PREVENTED BY LOCAL HAEMOSTASIS) OPHTALMOLOGIC (BLEEDING THREATNING VISION PREVENTED BY LOCAL HAEMOSTASIS) VISCERAL/MINOR GENERAL ENDOSCOPY BIOPSY DIALYSIS/CATHETER INSERTION

10 Rischio emorragico intra-operatorio in pazienti che assumono ASA RISK INCREASED BY 2.0 FOLD (MODEST RISE IN BLEEDING RATE) NO INCREASE IN SURGICAL MORTALITY AND MORBIDITY INTRACRANIAL NEUROSURGERY HIGH RISK OF POST-OPERATIVE INTRACEREBRAL HAEMATOMA CONTRIBUTING FACTOR TO FATAL OUTCOME (32%) Palmer JD Neurosurgery , 1994

11 Rischio emorragico intra-operatorio in TYPE OF SURGERY TRANSFUSION RATE (%) COMMENTS pazienti che assumono ASA+CLOPIDOGREL Non-cardiac surgery CASES CONTROLS VASCULAR SIMILAR SURGICAL OUTCOME ORTHOPAEDIC AND OPERATIVE MORTALITY GENERAL Crit. Care Med., 29, 2271, 2001 ORAL/DENTISTRY TRANS-BRONCHIAL 0 0 BLEEDING RATE: 89% vs 3.4% BIOPSY HANDLED BY ENDOSCOPIC ROUTE JAMA 297, 159, 2007 NEUROSURGERY FATAL ICH DURING PROCEDURES (+ ANTI GP IBb/IIIa!) STROKE 33,1916, 2002

12 SURGICAL HAEMORRAGIC RISK LOW INTERMEDIATE HIGH Transfusion seldom required General surgery Plastic surgery Minor orthopaedic Endoscopy Biopsies Eye anterior chamber Dental extraction Transfusion often required Visceral surgery Cardiovascular surgery Major Orthopaedic Reconstructive surgery Endoscopic urology Possible bleeding in a closed space Intracranial Spinal canal Eye posterior chamber

13 Sospensione precoce di ASA in pazienti a rischio cardiovascolare moderato/severo Meta-analisi Biondi-Zoccai, Eur Heart J. 27, 2667, patients from six (out of 612) studies pts on adherence to aspirin in the secondary prevention of CAD 2594 pts on aspirin discontinuation in acute CAD pts on adherence to aspirin before or shortly after CABG 2229 pts on aspirin discontinuation among pts undergoing DES

14 Sospensione precoce di ASA in pazienti a rischio cardiovascolare moderato/severo Meta-analisi Biondi-Zoccai, Eur Heart J. 27, 2667, 2006

15 Sospensione precoce di CLOPIDOGREL dopo impianto di bar metal stents (BMS) o drug-eluting stents (DES) BASKET TRIAL, JACC 48, 2584, 2006 Consecutive series of 746 non-selected pts with 1,133 stented lesions surviving 6 mo without major events followed for 1 yr after clopidogrel withdrawal 7-18 MO AFTER CLOPIDOGREL CESSATION DES% BMS% p MI AND DEATH * LATE STENT THROMBOSIS * 38% higer at 12 mo (DES vs BMS) HR: 2.2 In 88% of cases, thrombosis-related events were MI or death

17 SURGICAL HAEMORRAGIC RISK LOW INTERMEDIATE HIGH Transfusion seldom required General surgery Plastic surgery Minor orthopaedic Endoscopy Biopsies Eye anterior chamber Dental extraction Transfusion often required Visceral surgery Cardiovascular surgery Major Orthopaedic Reconstructive surgery Endoscopic urology Possible bleeding in a closed space Intracranial Spinal canal Eye posterior chamber

18 WITHDRAWING ANTIPLATELET AGENTS STRATIFYING THE CARDIO- CEREBRO-VASCULAR RISK IN PTS ON ANTIPLATELET THERAPY LOW INTERMEDIATE HIGH 6 mo after MI, PCI, BMS, CABG, stroke > 12 mo if complications 6-24 wks after MI, PCI + BMS CAGB, or stroke; > 12 mo after DES; high risk stents (long, proximal, multilple, overlapping small vessels, bifurcation); low FE, diabetes < 6 wks after MI, PCI, BMS, CAGB; < 6 mo after same if complicated; < 12 mo after high risk DES; < 2 wks after stroke MI: myocardial infarction; CABG: coronary artery bypass graft, DES: drug eluting stent; PCI: percutaneous coronary intervention; BMS: bare metal stent EF: ejetion fraction

Patients with aspirin (75-150 mg/day) Patients with aspirin (75-150 mg/day) + Clopidogrel 75 mg/day Primary prevention Secondary prevention After MI, ACS, stent, Stroke, PAD High risk situations: < 6

19 Patients with aspirin ( mg/day) Patients with aspirin ( mg/day) + Clopidogrel 75 mg/day Primary prevention Secondary prevention After MI, ACS, stent, Stroke, PAD High risk situations: < 6 weeks after MI, PCI, BMS, Ictus < 12 months after DES High-risk stents Low-risk situations Intracranial neurosurgery All surgery Only vital surgery All surgery Stop 7 days Before operation As needed ACS: acute coronary syndrome PAD: peripheral arterial disease Operation under continuous treatment Risk of bleeding in closed space Stop clopidogrel mantain aspirin

20 1134 patients with coronary stents undergoing surgery Heart 2011;97:1566e1572.

Heart 2011;97:1566e1572. 1134 patients with coronary stents undergoing surgery Outcome: Cardiac and cerebrovascular events (MACCEs) and major or minor bleeding complications MACCE: 124 (10.

21 Heart 2011;97:1566e patients with coronary stents undergoing surgery Outcome: Cardiac and cerebrovascular events (MACCEs) and major or minor bleeding complications MACCE: 124 (10.9%) Haemorrhagic complications 108 (9.5%) Predictors of MACCE: complete OAT interruption, pre-op haemoglobin <10 g/dl, creatinine clearance <30ml/min emergency/high-risk surgery Predictors of bleeding complications: pre-op haemoglobin <10g/dl, creatinine clearance 30-60ml/min, stent implantation from <3 months high-risk surgery (Lee classification)

22 52 low-cv risk patients treated with low-dose ASA undergoing elective general surgery recruited. Randomization: continuous use of ASA or discontinuation of ASA (5 days before until 5 days after surgery). 1 in the ASA continuation group required re-operation due to post-operative hemorrhage. No thromboembolic events reported in the ASA continuation and the ASA discontinuation group.

$vascular disease Median ejection fraction 55% (range 35 68) 16 cancer 5 DES left main coronary artery 17 left anterior descending artery 14 multiple stents 20 stented during ACS 9 cardiovascular$

23 30 subjects DES within the previous 6-12 months (median 4 months) Candidates for urgent major surgery or eye surgery 14 hypertensives 5 diabetics 3 chronic kidney dysfunction 4 overt peripheral vascular disease Median ejection fraction 55% (range 35 68) 16 cancer 5 DES left main coronary artery 17 left anterior descending artery 14 multiple stents 20 stented during ACS 9 cardiovascular surgery 10 gastrointestinal surgery 6 urinary tract surgery 5 general surgery

24 Maintenance of aspirin Protocol Discontinuation of clopidogrel 5 days before surgery Short-acting GPIIb/IIIa-blocker (i.v.) in the perioperative period Resumption of dual oral antiplatelet therapy as soon as possible after surgery Strict cardiological monitoring

25 Cardiological monitoring Continuous 12-lead monitoring during the CCU/ICU stay 12-lead ECG Every morning In the case of ischaemic symptoms CK-MB determinations Every morning before and after surgery 6 h after any suspicious symptoms or ECG signs of ischaemia

26 Efficacy NO adverse cardiac events during the index hospitalization Primary endpoint rate was 0%

27 Safety Postoperative phase 1 patient (hemicolotomy for cancer): Major bleeding (proctorrhagia) on the 7 th postoperative day, 4 days after resuming clopidogrel Transfused 4 U RBCs and bleeding from the enterocolic anastomosis was stopped by placing 2 clips Clopidogrel and Aspirin stopped for 1 day 1 patient: Minor bleeding Transfusion (also pre-existing anaemia) 1 patient: (severe renal insufficiency and renal cancer) Rectal bleeding on the 6 th postoperative day, 4 days after resuming clopidogrel. Haemoglobin: from 11.9 to 9.2 g/dl, dyspnoea, ST depression 3 U PRBCs: ECG returned to normal. No increase in cardiac markers 2 patients Mild anaemia at baseline without bleeding 2 and 1 U of GRCs 1 patient: Mild thrombocytopenia (plt ) on the 2 nd postoperative day

28 Perspectives Di Minno MN et al. Ann Med 2011

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