Francesco BurzottaFrancesco Burzotta

HOTLINE III, ESC Congress 2007HOTLINE III, ESC Congress 2007September 4th 2007, ViennaSeptember 4th 2007, Vienna

OPTIMIST: the Outcome of Pci OPTIMIST: the Outcome of Pci

for stent-ThrombosIs MultIcentre for stent-ThrombosIs MultIcentre

STudySTudy

Institute of Cardiology, Policlinico A. Gemelli –Institute of Cardiology, Policlinico A. Gemelli –Catholic University of the Sacred Heart (UCSC)Catholic University of the Sacred Heart (UCSC)

BACKGROUND AND RATIONALE FOR THE STUDY

Stent thrombosis occurs in 1-2% of the pts treated by PCI with stent implantation

Usage of drug-eluting stents (DES) in the real world practice might increase risk of stent thrombosis compared to bare metal stents (BMS)

The most common management of pts with stent thrombosis is re-PCI

There is lack of scientific data describing the angiographic and clinical outcome of PCI for stent thrombosis in the contemporary DES era

AIMS OF THE OPTIMIST STUDY

TO COMPARE THE CLINICAL AND ANGIOGRAPHIC CHARACTERISTICS OF DES VS BMS THROMBOSIS

TO EVALUATE THE EFFICACY OF THROMBECTOMY DEVICES DURING PCI FOR STENT THROMBOSIS

TO ASSESS THE CLINICAL OUTCOME OF PCI FOR STENT THROMBOSIS

THE OPTIMIST STUDY DESIGN

Non sponsored, multicentre registry

S.Pietro FBF (Dr Belloni)

S.Filippo Neri (Dr Pristipino)

Pol. Gemelli (Prof. Crea, Dr Trani, Dr Romagnoli)

S.Camillo (Dr Parma)

S.Spirito (Dr Danesi)

S.Eugenio (Dr Gioffrè)

Pol. Umberto I (Dr Sardella)Pertini (Dr Rigattieri)

Pol. Casilino (Dr Summaria)

S.Carlo (Dr Mazzarotto)

S.Giovanni (Dr. Manzoli)

Non sponsored, multicentre registry

Burzotta et al, Am Heart J 2007

Enrolling during two years (2005-2006) all patients undergoing urgent PCI for angiographically-confirmed stent thrombosis

The clinical outcome @ 30-day and @ 6-month (primary endpoints: death and MACCE)

The angiographic outcome of PCI by an independent core-lab: Rome Heart Research, Dr Prati(primary end-points: TIMI 3+MBG 2-3 and MBG 3)

TO ASSESS:

THE OPTIMIST STUDY DESIGN

RESULTS

PREVALENCE OF PCI FOR STENT THROMBOSIS

PREVALENCE OF PCI FOR STENT THROMBOSIS

12280* PCI with stenting

7318* PCI with DES (59.6%)

OPTIMIST centres

4962* PCI with BMS (40.4%)

*Official data of the Italian Society of Interventional Cardiology SICI-GISE

120 PCI for stent thrombosis in 110 patients

62 PCI for DES thrombosis

52 PCI for BMS thrombosis

== ==0.85%0.85% 1.05%1.05%P=0.24

2484* urgent (primary or

rescue) PCI for STEMI

89 (74%) STEMINSTEMIUA

==

3.6%3.6%

CHARACTERISTICS OF THE STUDY POPULATIONCHARACTERISTICS OF THE STUDY POPULATION

Characteristics

Males 70%

Age (yrs, mean+SD) 66+12

Diabetes 30%

Renal Failure 20%

Anti-PTL therapy withdrawal <15 days 10%

Symptoms-to-PCI time (hrs, mean+SD) 4+6

Cardiogenic Shock 17%

Type of thrombosed stentDES (SES, PES, other)BMSUnknown

50% (26%,14%,7%)

38%12%

Interval between PCI and stent thrombosis (days, mean+SD)

99+283

Left anterior descending artery (LAD) 50%

Pre-PCI TIMI 0-1 84%

DES vs BMS THROMBOSIS

RESULTS

Characteristics DES(n=55)

BMS(n=43)

P

Age (yrs+SD) 63+11 68+12 0.03

Diabetes 40% 19% 0.02

Anti-PLT therapy withdrawal <15 days

15% 2% 0.04

LAD 66% 37% <0.001

Bifurcation 27% 7% 0.01

Stent diameter 2.8+0.4 3.0+0.5

0.04

DES VS BMS: BASELINE CHARACTERISTICSDES VS BMS: BASELINE CHARACTERISTICS

Characteristics DES(n=55)

BMS(n=43)

P

Age (yrs+SD) 63+11 68+12 0.03

Diabetes 40% 19% 0.02

Anti-PLT therapy withdrawal <15 days

15% 2% 0.04

LAD 66% 37% <0.001

Bifurcation 27% 7% 0.01

Stent diameter 2.8+0.4 3.0+0.5

0.04

DES VS BMS: BASELINE CHARACTERISTICSDES VS BMS: BASELINE CHARACTERISTICS

1-30 days0-24 hrs > 1 year31-365 days

ACUTE SUBACUTE LATE VERY LATE

12

55

24

9

23

63

95

0

20

40

60

80

100% DESBMS

DES VS BMS: TYPES OF THROMBOSISDES VS BMS: TYPES OF THROMBOSIS

67

33

86

14

0

20

40

60

80

100 DESBMS

<30 days > 30 days

LATE or VERY LATE

%P=0.03P=0.03

ACUTE or SUBACUTE

DES VS BMS: TYPES OF THROMBOSISDES VS BMS: TYPES OF THROMBOSIS

OUTCOME OF PCI FOR STENT THROMBOSIS

RESULTS

PROCEDURAL CHARACTERISTICS PROCEDURAL CHARACTERISTICS

PCI STRATEGY

Balloon dilation 95%

Thrombectomy 30%

Stent implantation-DES-BMS

45%20%25%

ANGIOGRAPHIC OUTCOME

TIMI 3TIMI 2TIMI 0-1

73%15%12%

Residual Stenosis (mean+SD) 18+26%

MBG 3MBG 2MBG 0-1

49%27%24%

PCI FOR STENT THROMBOSIS: CLINICAL OUTCOMEPCI FOR STENT THROMBOSIS: CLINICAL OUTCOME

30-day 6-month

Death 12% 16%

Non-fatal Mycardial infarction

7% 11%

Target Lesion Revasc. 13% 17%

Stroke 1% 1%

MACCE 21% 29%

DES VS BMS: OUTCOME AFTER THROMBOSISDES VS BMS: OUTCOME AFTER THROMBOSIS

DESBMS

no death

no MACCE

%

0

20

40

60

80

100

1 mo. 6 mo. 12 mo.

OR (95%CI) for 6-month mortality in MULTIVARIATE analysis

PREDICTORS OF OUTCOME IN PCI FOR STENT THROMBOSISPREDICTORS OF OUTCOME IN PCI FOR STENT THROMBOSIS

VERY LATE THROMBOSISVERY LATE THROMBOSIS10.0 (1.2-85.7)10.0 (1.2-85.7)

OTHER IMPLANTEDOTHER IMPLANTEDSTENT DURING PCISTENT DURING PCI

5.4 (1.3-22.8)5.4 (1.3-22.8)

POST-PCI MBG 2-3POST-PCI MBG 2-30.3 (0.1-0.9)0.3 (0.1-0.9)

210 43 65 87 9 1110

increased mortality

THROMBECTOMY DURING PCI FOR STENT THROMBOSIS

RESULTS

BY INTENTION TO TREAT

PCI FOR STENT THROMBOSIS: USE OF THROMBECTOMYPCI FOR STENT THROMBOSIS: USE OF THROMBECTOMY

Selection of devices according to the operator’s preference

STANDARD PCI in 83 pts

(75%)

THROMBECTOMY in 27 PTS

(25%)

> Longer time-to-treatment

> Females

> STEMI

> Inotropic drugs pre-PCI

pre-PCI risk features

> Large vessels

0%

20%

40%

60%

80%

100%AngiojetAngiojet (7,5%)

Diver CEDiver CE (48.1%)

ExportExport (44.4%)

ANGIOGRAPHIC RESULTS OF THROMBECTOMYANGIOGRAPHIC RESULTS OF THROMBECTOMY

TIMI 3 + MBG 2/3 MBG 3 ThrombectomyThrombectomy

Standard PCIStandard PCI

0

20

40

60

80

100%

76%61% 52% 46%

Pts without Shock (n=81)

0

20

40

60

80

100%

89%

61% 61%46%

P=0.027P=0.027

P=0.18P=0.18

CONCLUSIONS

1. Urgent PCI is needed for both DES and BMS thrombosis and represents 3.6% of the urgent PCI for STEMI

2. PCI for stent thrombosis is associated with a high rate of major adverse events, especially in pts with very late thrombosis3. DES thrombosis, compared to BMS, shows different clinical features (late or very late presentation, association with anti-PLT therapy withdrawal) but similar long term outcome

4. During PCI for stent thrombosis, implantation of other stents should be avoided. Mechanical thrombectomy is feasible and should be reserved to pts without haemodynamic instability

In the contemporary DES era…

Thank you for your attention

Thank you for your attention