Incidence of surgery after DES
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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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Incidence of surgery after DES

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Incidence of surgery after des

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


Incidence of surgery after des

Types of intervention


Incidence of surgery after des

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.


Incidence of surgery after des

Timing of noncardiac surgery in cardiac-stable/

asymptomatic patients with prior PCI

2009 ESC Guidelines on perioperative evaluation for noncardiac surgery


Incidence of surgery after des

Risk factors for stent thrombosis


Incidence of surgery after des

Additional risk factors for stent thrombosis


Incidence of surgery after des

October

Early surgery after stent implantation:

risk stratification for bleeding

Colorectal surgery


Incidence of surgery after des

Risk factors for bleeding


Incidence of surgery after des

21009 patients , 437 (2.1%) with stent thrombosis


Incidence of surgery after des

Risk of early surgery after stent implantation

*

*All MACEs were fatal


Incidence of surgery after des

Early surgery after stent implantation:

High risk after discontinuation of dual antiplatelet therapy


Incidence of surgery after des

550 patients undergoing non-cardiac surgery after stent implantation

35%

15%

13%

9%

6%

MACE= death,MI,stent thrombosis,repeat revascularization


Incidence of surgery after des

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


Incidence of surgery after des

Early surgery after stent implantation: Decision making

October


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


Incidence of surgery after des

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


Incidence of surgery after des

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]


Incidence of surgery after des

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


Incidence of surgery after des

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]


Incidence of surgery after des

Summaryof first 40 cases


Incidence of surgery after des

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


Incidence of surgery after des

Phase 2 bridge study

For urgent surgery early after DES: current status

PATIENTS ENROLLED40

cardiac13

urinary tract 6

gastrointestinal14

mixed surgery 7

PRIMARY ENDPOINT*0 (97.5% C.I. 0-8.81)

BLEEDING** EVENTSmajor1

minor3

transf.9

SEVERE§ THROMBOCITOPENIA1

* 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.


Incidence of surgery after des

550 patients undergoing non-cardiac surgery after stent implantation

50%

14%

4%

MACE= death,MI,stent thrombosis,repeat revascularization


Incidence of surgery after des

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


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

Stent thrombosis

Death , MI , stent thrombosis

Events as stratified by time from PCI to surgery


Incidence of surgery after des

Early surgery after stent implantation:

High risk after discontinuation of dual antiplatelet therapy

October


Incidence of surgery after des

Early surgery after stent implantation:

risk stratification for stent thrombosis


Incidence of surgery after des

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


Incidence of surgery after des

  • 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.


Incidence of surgery after des

  • 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 ).


Incidence of surgery after des

  • 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.


Incidence of surgery after des

  • Problems :

  • Discontinuation of clopidogrel ?

  • Surgery on clopidogrel ?


Incidence of surgery after des

  • Problems :

  • Discontinuation of clopidogrel ? ( risk of stent thrombosis )


Incidence of surgery after des

BUT:

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


Incidence of surgery after des

21009 patients , 437 (2.1%) with stent thrombosis


Incidence of surgery after des

  • 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.


Incidence of surgery after des

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


Incidence of surgery after des

Protocollo Ospedale Niguarda


Incidence of surgery after des

Patient characteristics and bleedinggastroenteric surgery


Incidence of surgery after des

Patient characteristics and bleedingurinary tract surgery


Incidence of surgery after des

Patient characteristics and bleeding: Cardiac surgery


Incidence of surgery after des

Patient characteristics and bleedingmixed surgery


Incidence of surgery after des

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


Incidence of surgery after des

141 Patients 7.6 +3 months after DES implantation


Incidence of surgery after des

141 Patients 7.6 +3 months after DES implantation


Incidence of surgery after des

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.


Incidence of surgery after des

Early surgery after stent implantation:

risk stratification for stent thrombosis


Incidence of surgery after des

October

Early surgery after stent implantation:

risk stratification for consequences of stent thrombosis


Incidence of surgery after des

Early surgery after stent implantation:

Decision making


Incidence of surgery after des

Early surgery after stent implantation:

Prevention strategies


Incidence of surgery after des

Early surgery after stent implantation:

risk stratification for bleeding and thrombosis

Chassot PJ, BJA 2007


Incidence of surgery after des

Early surgery after stent implantation:

Continuation of antiplatelet therapy

Chassot PJ, BJA 2007


Incidence of surgery after des

Incidence of urgent surgery after DES


Incidence of surgery after des

Perioperative stent thrombosis


Incidence of surgery after des

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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