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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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slide2
695 surgeries in 481 patients out of 12.794 with DES implantation (5.4%):

Incidence as a function of time from intervention

slide4

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.

slide5

Timing of noncardiac surgery in cardiac-stable/

asymptomatic patients with prior PCI

2009 ESC Guidelines on perioperative evaluation for noncardiac surgery

slide9

October

Early surgery after stent implantation:

risk stratification for bleeding

Colorectal surgery

slide14

Early surgery after stent implantation:

High risk after discontinuation of dual antiplatelet therapy

slide15

550 patients undergoing non-cardiac surgery after stent implantation

35%

15%

13%

9%

6%

MACE= death,MI,stent thrombosis,repeat revascularization

slide16

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

ospedali niguarda e legnano
Ospedali Niguarda e Legnano

PROTOCOLLO PER LA SOSPENSIONE TEMPORANEA DI CLOPIDOGREL PER CHIRURGIA NON-CARDIACA INDIFFERIBILE IN PAZIENTI PORTATORI DI STENT CORONARICO

slide23

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  • or eye surgery in whom dual antiplatelet therapy could not be withdrawn as the time of surgery was within 6 months of the placement of any DES, or within one year of the placement of any DES under conditions considered to be at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
slide24

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]

slide25

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

slide26

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]

slide28

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

slide29

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.

slide31

550 patients undergoing non-cardiac surgery after stent implantation

50%

14%

4%

MACE= death,MI,stent thrombosis,repeat revascularization

slide35

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

slide36

Early surgery after stent implantation:

High risk after discontinuation of dual antiplatelet therapy

October

slide37

Early surgery after stent implantation:

risk stratification for stent thrombosis

slide38

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

slide39
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.

slide40
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 ).
slide41
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.
slide42
Problems :
  • Discontinuation of clopidogrel ?
  • Surgery on clopidogrel ?
slide43
Problems :
  • Discontinuation of clopidogrel ? ( risk of stent thrombosis )
slide44
BUT:

161 cases of late-very late definite stent thrombosis published in the literature

slide47
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.

slide48

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

slide58

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

Cumulative N° 10 17 20 28 29 30 34 36 37 38 39 40

<6 months N=30

6-12 months N=10

Savonitto S. Br J Anaesth , in press

slide61

Clopidogrel bridging protocol

Exclusion criteria

· Pazienti con nota allergia a precedente somministrazione di tirofiban

· Piastrinopenia <100.000 x 10-9/L

· storia di ictus nei 30 giorni precedenti o anamnesi di ictus emorragico;

· anamnesi positiva per patologie intracraniche (neoplasie, malformazioni arterovenose, aneurismi);

· storia di diatesi emorragica;

· ipertensione grave (PAS > 200 mm Hg o PAD > 110 mm Hg nonostante il trattamento antiipertensivo);

· Pazienti non consenzienti o non in grado di firmare il consenso informato.

slide62

Early surgery after stent implantation:

risk stratification for stent thrombosis

slide63

October

Early surgery after stent implantation:

risk stratification for consequences of stent thrombosis

slide66

Early surgery after stent implantation:

risk stratification for bleeding and thrombosis

Chassot PJ, BJA 2007

slide67

Early surgery after stent implantation:

Continuation of antiplatelet therapy

Chassot PJ, BJA 2007

slide74

437 stent thrombosis (152 DES Mean follow-up 30.9 months)

N=140 (32%)

N=180 (41%)

N=36 (8%)

N=22 (5%)

N=59 (14%)

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