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Incidence of surgery after DES

Incidence of surgery after DES. 695 surgeries in 481 patients out of 12.794 with DES implantation (5.4%): Incidence as a function of time from intervention. Types of intervention. In 15 of 36 patients (42%) the event occurred right before or right after a surgical procedure

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Incidence of surgery after DES

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  1. Incidence of surgery after DES

  2. 695 surgeries in 481 patients out of 12.794 with DES implantation (5.4%): Incidence as a function of time from intervention

  3. Types of intervention

  4. In 15 of 36 patients (42%) the event occurred right before or right after a surgical procedure for which the 2 antiplatelet agents or Plavix alone was discontinued.

  5. Timing of noncardiac surgery in cardiac-stable/ asymptomatic patients with prior PCI 2009 ESC Guidelines on perioperative evaluation for noncardiac surgery

  6. Risk factors for stent thrombosis

  7. Additional risk factors for stent thrombosis

  8. October Early surgery after stent implantation: risk stratification for bleeding Colorectal surgery

  9. Risk factors for bleeding

  10. 21009 patients , 437 (2.1%) with stent thrombosis

  11. Risk of early surgery after stent implantation * *All MACEs were fatal

  12. Early surgery after stent implantation: High risk after discontinuation of dual antiplatelet therapy

  13. 550 patients undergoing non-cardiac surgery after stent implantation 35% 15% 13% 9% 6% MACE= death,MI,stent thrombosis,repeat revascularization

  14. Noncardiac surgery after stent implantation: Antiplatelet therapy and risk of bleeding 550 patients undergoing non-cardiac surgery after stent implantation Van Kuijk P. Am J Cardiol 2009;104:1229

  15. Early surgery after stent implantation: Decision making October

  16. Ospedali Niguarda e Legnano PROTOCOLLO PER LA SOSPENSIONE TEMPORANEA DI CLOPIDOGREL PER CHIRURGIA NON-CARDIACA INDIFFERIBILE IN PAZIENTI PORTATORI DI STENT CORONARICO

  17. Clopidogrel bridging protocol Inclusion criteria • Consecutive candidates for urgent major (CV or non-CV) surgery • or eye surgery in whom dual antiplatelet therapy could not be withdrawn as the time of surgery was within 6 months of the placement of any DES, or within one year of the placement of any DES under conditions considered to be at higher risk for stent thrombosis: • stent implantation due to an ACS, • diabetes, • renal insufficiency or • severe left ventricular dysfunction, • stents placed in LMCA, proximal LAD (or equivalent), bifurcation

  18. Phase 2 bridge study for urgent surgery early after DES Exclusion criteria Inclusion criteria • 12 months in the case of high-risk of ST: • stent implantation due to an ACS • diabetes • renal insufficiency • severe LV dysfunction • DES in LMCA, proximal LAD, bifurcation · Allergy to tirofiban – eptifibatide · Thrombocytopenia <100.000 · Stroke < 30 days or prior ICH · Intracranial disease · Uncontrolled hypertension · Unable to sign consent form Patients within 6-12 months of DES implantation + high-risk for surgical bleeding, “so that the surgeon would not operate on clopidogrel” surgery Stop Plavix Start bridge Stop bridge Resume Bridge** Resume Plavix 300+75 mg*** • Aspirin continued throughout • Low-dose LMWH for DVT prevention T Day -5 -4 -3 -2 -1 4h* 0 4h follow-up until discharge *8h in pts with eGFR <30 ml/min **if oral admin not possible *** as soon as oral admin possible Primary EP: the composite of Death, MI, stent thrombosis, haemostatic reoperation Savonitto S et al, Br J Anaesth. 2010 Jan 3. [Epub ahead of print]

  19. Antagonisti della Gp IIb/IIIa farmacocinetica 100 Tirofiban Abciximab 80 Eptifibatide 60 % aggregazione piastrinica 40 20 0 6 12 18 24 30 36 oredalla sospensione dell’infusione Mousa et al. Drugs Future 1996;21: 1141-54

  20. Initial experience : 30 patients-8 cardiac surgery, 6 urinary tract , 10 gastroenteric surgery, 5 other surgery- No MACE ( death, MI, stroke )- 1 TIMI major bleeding- 8 patients required blood transfusion ( 6 before surgery for anemia, 2 post-operatively for proctorrhagy ). Savonitto S et al, Br J Anaesth. 2010 Jan 3. [Epub ahead of print]

  21. Summaryof first 40 cases

  22. Delay from DES implantation to surgery Updated October 2, 2009 Median 3 months, range 12 days – 12 months Cardiovascular N= 13 Non Cardiovascular N= 27 12 months N° 10 17 20 28 29 30 34 36 37 38 39 40 <6 months N=30 6-12 months N=10

  23. Phase 2 bridge study For urgent surgery early after DES: current status PATIENTS ENROLLED 40 cardiac 13 urinary tract 6 gastrointestinal 14 mixed surgery 7 PRIMARY ENDPOINT* 0 (97.5% C.I. 0-8.81) BLEEDING** EVENTS major 1 minor 3 transf. 9 SEVERE§ THROMBOCITOPENIA 1 * The composite of death+MI+stent thrombosis+haemostatic reoperation **Bleeding according to TIMI criteria: major means Hb decrease >5 g/dL, minor means Hb decrease >3 but <5 g/dL, after correction for transfusion (1 g ofHb for each U transfused); § platelet count <20,000.

  24. 550 patients undergoing non-cardiac surgery after stent implantation 50% 14% 4% MACE= death,MI,stent thrombosis,repeat revascularization

  25. Combined events ( death,MI,stent thrombosis as a function of time )

  26. 695 surgeries in 481 patients out of 12.794 with DES implantation (5.4%): Incidence as a function of time from intervention Stent thrombosis Death , MI , stent thrombosis Events as stratified by time from PCI to surgery

  27. Early surgery after stent implantation: High risk after discontinuation of dual antiplatelet therapy October

  28. Early surgery after stent implantation: risk stratification for stent thrombosis

  29. Antagonisti della Gp IIb/IIIa tollerabilità Studio farmaco sanguinamenti maggiori (TIMI) p trattamento placebo <0,001NS 0,043 NS NS <0,001 EPIC EPILOG CAPTURE EPISTENT IMPACT II PURSUIT Abciximab Abciximab Abciximab Abciximab Eptifibatide Eptifibatide 14% 2,0% 3,8% 1,5% 5,1% 3,0% 6,6% 3,1% 1,9% 2,2% 4,8% 1,3% Lamifiban 0,5% 2,4% 0,4% 1,4% 1,5% 2,1% 0,4% 0,8% PARAGON NS NS NS NS RESTORE PRISM PRISM-PLUS Tirofiban Tirofiban Tirofiban adapted from Blankenship et al. Am Heart J Oct 1999; 138: S287-S296

  30. F.G. , woman , 77 years old • Type II diabetes, hypertension • October 08 , NSTE-ACS • Coronary arteriography : prox LAD 80% • PCI ( Cypher 3-18 ) • Discharged with ASA 75 mg, Plavix 75mg, Atorvastatin 20 mg, Metformin 1500 mg, Ramipril 10 mg.

  31. December 2008: recurrent fever, urine culture analysis positive for Escherichia Coli . Treated with antibiotics • January 2009 : hospitalized because of abdominal pain , colonoscopy : colo-vesical fistula . • Surgery needed ( colon resection, vesical suture ).

  32. Stent thrombosis is observed in about 2 per cent of patients after 1 year of implantation , but it results in death in more than 20% of cases and in death and MI in nearly 90% of cases.

  33. Problems : • Discontinuation of clopidogrel ? • Surgery on clopidogrel ?

  34. Problems : • Discontinuation of clopidogrel ? ( risk of stent thrombosis )

  35. BUT: 161 cases of late-very late definite stent thrombosis published in the literature

  36. 21009 patients , 437 (2.1%) with stent thrombosis

  37. Problems : • Discontinuation of clopidogrel ? ( risk of stent thrombosis ) • Surgery on clopidogrel ? ( surgeon’s objections: 1) risk of important bleeding 2) no absorption of the drug in the perioperative period.

  38. CF.V. 77 years old- Clopidogrel discontinued 5 days before surgery starting January 31st.- Tirofiban infusion ( dose used for NSTE-ACS no heparin )- February 5th: surgery ( colon resection, vesical suture ). Tirofiban resumed until intestinal canalization ( February 9th when clopidogrel LD 300 mg and aspirin were given and Tirofiban discontinued )- No clinical complications , no major bleeding . Pre-op Hb 10.3g/dl (Transfusion 2U) Hb post-op (February 9th) 10.2g/dl

  39. Protocollo Ospedale Niguarda

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