This document contains guidelines and proposals for operational models from GISE-ANMCO-SIAARTI on the topic of coronary stents and surgery. It includes a protocol, results from position papers, consensus documents, studies on risk stratification and perioperative management of antiplatelet therapy, as well as proposals for apps and regional guidelines. The key points are to maintain aspirin in most patients, postpone high risk surgery if possible, discontinue P2Y12 inhibitors after 6 months only for low risk PCI, and use bridging LMWH in selected high risk cases.

1. PROTOCOLLI E PROPOSTE DI MODELLI OPERATIVI
Protocollo GISE-ANMCO-SIAARTI:
risultati positivi?
Roberta Rossini
USC Cardiologia
AO Papa Giovanni XXIII
Bergamo, ITALY

2. Stent and Surgery
POSITION PAPER

3. DOCUMENTO DI POSIZIONE: Cosa Sospendere,Quando Sospendere,
Come sospendere
RISCHIO TROMBOTICO - Definito dal CARDIOLOGO
RISCHIO
BASSO
RISCHIO
INTERMEDIO RISCHIO ALTO
RISCHIO BASSO
RISCHIO
INTERMEDIO
????
RISCHIO ALTO
RISCHIOEMORRAGICO
DefinitodalCHIRURGO
?
?

4. Premature Discontinuation of Antiplatelet Therapy as Predictor of ST
OR=89.8
(29.9-270)
HR=19.2
(5.6-65.5)
OR=4.8
(2.0-11.1)
HR=13.7
(4.0-46.7)
Odds/HazardRatio
Iakovou et al
JAMA 2005
Park et al
Am J CARD 2006
Kuchulakanti et al
Circulation 2006
Airoldi et al
Circulation 2006

5. Aspirin multiplied baseline bleeding rate by a
factor of 1.5 (median, interquartile range: 1.0–2.5).
Mortalities, caused by bleeding, occurred only after
intracranial surgery and possibly transurethral
prostatectomy
Meta-analysis of 41 studies (12 observational retrospective, 19 observational prospective, 10
randomized), including 49 590 patients (14 981 on aspirin, 34 609 controls).
W. Burger, et al. Journal of Internal Medicine 2005; 257: 399–414
Cardiovascular risks after low-dose aspirin perioperative withdrawal
versus bleeding risks with its continuation

6. Eur Heart J. 2009;30:2769-812
What the Guidelines say (and don’t say)

7. Why we needed a Consensus Document
Risk of
thrombosis
Risk of
bleeding
?????

8. R. Rossini et al. EuroIntervention in press

9. R. Rossini et al. EuroIntervention in press

10. • Maintain aspirin in the vast majority of patients
• Postpone surgery, whenever possible, in patients at
high/intermediate thrombotic risk
• Discontinue P2Y12 inhibitor in selected patients after
6 month in low-risk PCI undergoing high
hemorrhagic risk surgery
• Use bridge therapy with GPI in selected patients
undergoing high hemorrhagic risk surgery
CONSENSUS DOCUMENT
KEY POINTS

11. EuroIntervention_May 2014, in press

13. A multicenter registry of consecutive patients undergoing
cardiac and noncardiac surgery or operative
endoscopic/endovascular procedures
after implantation of a coronary stent

14. Background
Optimal perioperative antiplatelet therapy in patients with coronary
stents undergoing surgery still remains poorly defined and remains a
matter of debate between cardiologists, surgeons, and
anesthesiologists.
Surgery represents one of the most common reasons for premature
antiplatelet therapy discontinuation, which is associated with a
significant increase in mortality and major adverse cardiac events, in
particular stent thrombosis.

15. Primary Objective
To describe the management strategies and adverse event rates in
patients with previous coronary stenting undergoing any kind of surgery
or operative endoscopic/endovascular procedures.
Secondary Objective
To assess the applicability of the Consensus Document on “stent
coronarico e chirurgia” issued by GISE and ANMCO

16. Primary End-point
The composite of death, myocardial infarction, probable/definite stent
thrombosis according the Academic Research Consortium definition
and bleeding events of Bleeding Academic Research Consortium
(BARC) Grade ≥3 during index surgical admission.
Secondary End-point
The composite of death, myocardial infarction and probable/definite
stent thrombosis at 30 days. The incidence of bleeding events of
Bleeding Academic Research Consortium (BARC) grade ≥3 within 30
days of index admission/procedure

17. Inclusion criteria
• Male and female patients > 18 years of age.
• Patients with previous coronary stenting undergoing any kind of
surgical or operative endoscopic procedure at the participating
Centers, irrespective of the distance in time between stenting and
surgery
• Both candidates to elective/urgent operations and those
undergoing emergency operations will be included in the SAS
registry, and will be considered as two separate cohorts

18. Exclusion criteria
• Unwilligness/inability to sign the Informed Consent Form
• There are no other selection criteria

19. eCRF SAS:
STEP n. 1:
ADD A NEW PATIENT

20. SCREENING:eCRF SAS:

21. eCRF SAS:
Pre-Procedure:
Previous and current Cardiac Status

22. eCRF SAS:
Pre-Procedure:
Previous Cardiac Status
Informations about implanted stents

23. Entering type of
procedure and
evaluating the
TROMBOTIC
RISK
Automatically get
HEMORRHAGIC
RISK

24. PREVIOUS AND CONCOMITANT MEDICATION

25. Antithrombotic therapy

26. Antithrombotic therapy:
STOP and RESTART informations

27. Study Endpoints:
 Death
 MI
 Stent thrombosis
 Bleeding

28. 1 Month FU:
 ECG
 Check of therapy

29. GISE-ANMCO National Registry
1. S.C. Cardiologia, Arcispedale S. Maria Nuova, IRCCS, Reggio Emilia, PI Stefano Savonitto
2. Dipartimento Cardiovascolare, AO Papa Giovanni XXIII Bergamo, PI Roberta Rossini-Giuseppe Musumeci
3. Divisione di Cardiologia, IRCCS Fondazione Policlinico S. Matteo, Pavia, PI Luigi Oltrona Visconti- Ezio
Bramucci
4. Dipartimento Cardiovascolare, Azienda Ospedaliera di Legnano, Legnano , PI Stefano De Servi
5. UO di Cardiologia 2, Ospedale di Circolo, Varese, PI Battistina Castiglioni
6. UO Cardiologia, Ospedale della Misericordia di Grosseto, PI Ugo Limbruno
7. Divisione di Cardiologia, Ospedale Carlo Poma, Mantova, PI Corrado Lettieri
8. Divisione di Cardiologia, Ospedale L.Sacco, Milano, PI Emanuela Piccaluga
9. Dipartimento di Scienze Cardiovascolari, Centro Cardiologico Monzino, PI Daniela Trabattoni
10. Istituto Clinico Humanitas, Rozzano, PI Maddalena Lettino
11. Dipartimento Cardiovascolare, Ospedale Niguarda, PI Paola Colombo-Antonio Mafrici
12. Dipartimento Cardiovascolare, Università di Padova, PI Giuseppe Tarantini
13. Dipartimento CardioToracico, Università di Pisa, PI Anna Sonia Petronio
14. UO Cardiologia, Azienda Ospedaliero-Universitaria di Parma, PI Alberto Menozzi
15. UO Cardiologia, Ospedale Galliera, Genova, PI Maria Molfese-Marco Falcidieno
16. UO Cardiologia Presidio Ospedaliero Sirai, Carbonia, PI Salvatore Ierna
17. UO Cardiologia, Ospedale Mauriziano, Torino, PI Maria Rosa Conte-Mauro De Benedictis
18. UO Cardiologia, Azienda Ospedaliera di Cosenza, PI Roberto Caporale
19. Dipartimento di Medicina e Chirurgia, Università di Salerno, PI Federico Piscione
20. UOC Cardiologia, Ospedale S. Pietro F.B.F, Roma, PI Roberto Serdoz
21. ASL Bologna, PI Stefano Urbinati
22. Azienda Ospedaliera G.Brotzu, Cagliari, PI Gianpaolo Scorcu

30. 417
72 of 417
(17%)

31. Rossini R et al. ESC 2013
Retrospective study: 720 pts OORR Bergamo, Mantova, Grosseto
Independent predictors of cardiac and bleeding events
within hospitalization for surgery
p<0.001
No discontinuation
Discontinuation
p<0.001
p<0.001
p<0.001
7.5
2.7
4
0.3 0.3 0
0
5
10
15
20
MACE Cardiac Death MI
Discontinuation
No discontinuation
%

32. Rossini R et al. ESC 2013
OUTCOME OR 95% LCL 95% UCL P value
MACCE* 7.3 2.7 19.5 <0.001
Cardiac death* 8.5 1.0 69.1 0.045
Myocardial infarction* - - - -
Stroke* - - - -
ACS leading to
re-hospitalization*
2.5 0.8 8.0 0.12
Heart failure* - - - -
OUTCOME OR 95% LCL 95% UCL P value
BARC 1 bleeding, n (%)** 0.5 0.1 2.5 0.43
BARC 2 bleeding, n (%)** - - - -
BARC 3 bleeding, n (%)** 1.4 0.8 2.4 0.12
BARC 4 bleeding, n (%)** 0.9 0.3 3.1 0.87
BARC 5 bleeding, n (%)** 0.6 0.1 5.8 0.69
Adjusted thirty-day risk for any antiplatelet discontinuation

33. LMWH
(N=179)
No LMWH
(N=179)
P value
Cardiac
death
3 (1.7) 0 (0) 0.25
MI 9 (5.0) 0 (0) 0.004
Recurrent
ACS
2 (1.1) 1 (0.6) 1.00
Stroke 2 (1.1) 0 (0) 0.50
ARC ST 2 (1.1) 0 (0) 0.50
Data expressed as n (%)
P = 0.001
Rossini R et al. ESC 2013
"Bridging therapy" with low molecular weight heparin
in patients with stent undergoing surgery
30-day MACCE-Matched cohort
RETROSPECTIVE STUDY
STENT AND SURGERY SUBSTUDY

34. LMWH
(N=179)
No LMWH
(N=179)
P value
BARC 1 4 (2.2) 2 (1.1) 0.69
BARC 2 0 (0) 1 (.6) 1.00
BARC 3 39 (21.8) 23 (12.8) 0.025
BARC 4 NA NA NA
BARC 5 1 (0.6) 0 (0) 1.00
Data expressed as n (%)
P = 0.027
Rossini R et al. ESC 2013
"Bridging therapy" with low molecular weight heparin
in patients with stent undergoing surgery
30-day BARC ≥2-Matched cohort
RETROSPECTIVE STUDY
STENT AND SURGERY SUBSTUDY

36. Linee Guida Aziendali

37. Linee Guida Aziendali

38. Linee Guida Aziendali

39. 180W GreenLight XPS (GL-XPS)

40. Eur Urol. 2013 Jul;64(1):101-5

41. “Stent and Surgery”
Apple-Android Application

42. App Download
06 Marzo 2014: 6755 downloads

43. “Drugs don’t work in patients who don’t take them”
C. Everett Koop, MD

44. 10-
8-
6-
4-
2-
0-
Austrian
Vicenzi MN
BJA 2006
Cleveland
Anwaruddin S
JACC Intv 2009
3.8%
5.0%
8.6%
New Zealand
To ACY
Circ CV Intv 2009
Noncardiac
Cardiac (20%)
+ Noncardiac
Noncardiac
4.4%
Scottish
Cruden N
Circ CV Int 2010
Noncardiac
4.4%
major
EVENT
REGISTRY
Berger PB
JACC Intv 2010
Noncardiac
2.0%
minor
S.Savonitto et al. Journal of Thrombosis and Haemostasis, 2011; 9: 2133–2142
Incidence of surgery within 1 year after coronary stenting

45. Anwaruddin S. et al. J Am Coll Cardiol Intv 2009;2:542–9
0
5
10
15
20
25
30
Stent Thrombosis Combined Endpoint
< 1 mos 1-6 mos 6-12 mos > 12 mos
Events
p=0.04 p=0.0001
%
Events as stratified by time from PCI to surgery

46. 0
5
10
15
20
25
1-45 days 46-180 days 181-365 days 366-730 days 2-10 years
BMS
DES
ANY STENT
%
RCRI ≥ 4: 9.7%
RCRI 3 : 6.3%
RCRI 2: 3%
RCRI 1: 1.1%
Wijeysundera D N et al. Circulation 2012;126:1355-1362
MACE at 30 days in patients with coronary stent
undergoing elective surgery

47. P. Albaladejo et al Heart 2011;97:1566-1572
High risk surgery Low risk surgery
% %
X2; p=0.085 X2; p=0.119
No discontinuation or
≤ 5 days
No discontinuation or
≤ 5 days
> 5 days > 5 days
MACCE in stented patients
undergoing high- and low-risk surgery