1

The GRACIA – 2 TrialThe GRACIA – 2 Trial ((GRGRupo de upo de AAnálisis de la nálisis de la CCardiopatía ardiopatía IIsquémica squémica AAguda)guda)

The GRACIA – 2 TrialThe GRACIA – 2 Trial ((GRGRupo de upo de AAnálisis de la nálisis de la CCardiopatía ardiopatía IIsquémica squémica AAguda)guda)

Randomised trial comparing Randomised trial comparing Primary PCI Primary PCI

versus versus Facilitated Intervention Facilitated Intervention

(TNK + Stenting) (TNK + Stenting) in patients with STEMI in patients with STEMI

Randomised trial comparing Randomised trial comparing Primary PCI Primary PCI

versus versus Facilitated Intervention Facilitated Intervention

(TNK + Stenting) (TNK + Stenting) in patients with STEMI in patients with STEMI

Francisco F. AvilésFrancisco F. Avilés(on behalf on the GRACIA group)(on behalf on the GRACIA group)

Francisco F. AvilésFrancisco F. Avilés(on behalf on the GRACIA group)(on behalf on the GRACIA group)

2

GRACIA – 2 GRACIA – 2

BACKGROUNDBACKGROUNDGRACIA – 2 GRACIA – 2

BACKGROUNDBACKGROUND

Thrombolysis is widely available and easily applicable, but Thrombolysis is widely available and easily applicable, but

strongly limited by reopening failure and reocclusion strongly limited by reopening failure and reocclusion

Thrombolysis is widely available and easily applicable, but Thrombolysis is widely available and easily applicable, but

strongly limited by reopening failure and reocclusion strongly limited by reopening failure and reocclusion

Less than 50% of pts with STEMI achieve optimal arterial Less than 50% of pts with STEMI achieve optimal arterial

reopening plus effective myocardial reperfusion because of reopening plus effective myocardial reperfusion because of

the still limited use, availability and efficacy of current the still limited use, availability and efficacy of current

therapies therapies

Less than 50% of pts with STEMI achieve optimal arterial Less than 50% of pts with STEMI achieve optimal arterial

reopening plus effective myocardial reperfusion because of reopening plus effective myocardial reperfusion because of

the still limited use, availability and efficacy of current the still limited use, availability and efficacy of current

therapies therapies

Primary PCI is highly effective, but available for less than Primary PCI is highly effective, but available for less than

20% of pts with STEMI in Europe (Euro Heart Survey ACS). 20% of pts with STEMI in Europe (Euro Heart Survey ACS).

Few pts receive primary PCI within 2 hours of onset (6% in Few pts receive primary PCI within 2 hours of onset (6% in

the PAMI trial) the PAMI trial)

Primary PCI is highly effective, but available for less than Primary PCI is highly effective, but available for less than

20% of pts with STEMI in Europe (Euro Heart Survey ACS). 20% of pts with STEMI in Europe (Euro Heart Survey ACS).

Few pts receive primary PCI within 2 hours of onset (6% in Few pts receive primary PCI within 2 hours of onset (6% in

the PAMI trial) the PAMI trial)

3

GRACIA – 2 GRACIA – 2

RATIONALE FOR FACILITATION RATIONALE FOR FACILITATION

(pharmacological reperfusion therapy + early planned PCI)(pharmacological reperfusion therapy + early planned PCI)

GRACIA – 2 GRACIA – 2

RATIONALE FOR FACILITATION RATIONALE FOR FACILITATION

(pharmacological reperfusion therapy + early planned PCI)(pharmacological reperfusion therapy + early planned PCI)

Pharmacological reopening prolongs time-window for Pharmacological reopening prolongs time-window for

definitive mechanical repair of the culprit artery (PCI more definitive mechanical repair of the culprit artery (PCI more

available) available)

Pharmacological reopening prolongs time-window for Pharmacological reopening prolongs time-window for

definitive mechanical repair of the culprit artery (PCI more definitive mechanical repair of the culprit artery (PCI more

available) available)

(1) Stone GW. Circulation 2001; (2) Lundergan CF. Am Heart J 2002; (3) Ross AM. JACC1999; (4) Hermann HC. JACC 2000; (4) Simoons ML. Lancet 1998; (6) Aviles FF. Eur Heart J 2003

Unlike in previous attemptsUnlike in previous attempts44, in the era of stents and modern , in the era of stents and modern

antiplatelets, early posthrombolysis PCI seems to be antiplatelets, early posthrombolysis PCI seems to be

feasible, feasible,

safe and beneficial (PACT safe and beneficial (PACT33, SPEED, SPEED55, GRACIA – 1, GRACIA – 166) )

Unlike in previous attemptsUnlike in previous attempts44, in the era of stents and modern , in the era of stents and modern

antiplatelets, early posthrombolysis PCI seems to be antiplatelets, early posthrombolysis PCI seems to be

feasible, feasible,

safe and beneficial (PACT safe and beneficial (PACT33, SPEED, SPEED55, GRACIA – 1, GRACIA – 166) )

TIMI 3 flow before primary PCI increases technical success TIMI 3 flow before primary PCI increases technical success

and benefits prognosis by enhancing myocardial salvage and benefits prognosis by enhancing myocardial salvage

and preserving LV function and preserving LV function11,2,3

TIMI 3 flow before primary PCI increases technical success TIMI 3 flow before primary PCI increases technical success

and benefits prognosis by enhancing myocardial salvage and benefits prognosis by enhancing myocardial salvage

and preserving LV function and preserving LV function11,2,3

4

HYPOTHESISHYPOTHESIS

In pts with STEMI, the strategy of performing In pts with STEMI, the strategy of performing immediate thrombolysis followed by routine immediate thrombolysis followed by routine early catheterization and appropriate early catheterization and appropriate intervention is as available as thrombolysis intervention is as available as thrombolysis and as effective as primary PCIand as effective as primary PCI

HYPOTHESISHYPOTHESIS

In pts with STEMI, the strategy of performing In pts with STEMI, the strategy of performing immediate thrombolysis followed by routine immediate thrombolysis followed by routine early catheterization and appropriate early catheterization and appropriate intervention is as available as thrombolysis intervention is as available as thrombolysis and as effective as primary PCIand as effective as primary PCI

GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2

5

PURPOSE PURPOSE

To compare the safety and efficacy of optimal To compare the safety and efficacy of optimal primary PCI versus a combined reperfusion primary PCI versus a combined reperfusion strategy designed to be easily applicable and strategy designed to be easily applicable and widely availablewidely available

PURPOSE PURPOSE

To compare the safety and efficacy of optimal To compare the safety and efficacy of optimal primary PCI versus a combined reperfusion primary PCI versus a combined reperfusion strategy designed to be easily applicable and strategy designed to be easily applicable and widely availablewidely available

GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2

6

““OPTIMALOPTIMALPRIMARY PCIPRIMARY PCI””

(N=108)(N=108)

DIRECT PTCA – IRA** (stent / abciximab)

< 180 min

GRACIA-2GRACIA-2

(*) Adequate revascularization: revascularization of culprit artery or non-culprit arteries with severe stenosis threatening large areas of myocardium (**) IRA: Infarct Related Artery

TNK + Enoxaparin

Immediately

ADEQUATE REVASCULARIZATION*(stent / CABG)

3 – 12 hours

““FACILITATEDFACILITATEDINTERVENTION”INTERVENTION”

(N=104)(N=104) AMI / ST+(<12 hours)

RANDOMISATION

CLINICAL AND ANGIOGRAPHIC CLINICAL AND ANGIOGRAPHIC FOLLOW- UP FOLLOW- UP

AT 6 WEEKS & 6 MONTHSAT 6 WEEKS & 6 MONTHS

3 deaths3 deaths 6 deaths6 deaths

N = 103N = 103 N = 102N = 102

7

GRACIA – 2 GRACIA – 2

CO – CO – PRIMARY PRIMARY ENDPOINTENDPOINTSS

Infarct sizeInfarct size (area under the CK-MB mass curve and cTnT (area under the CK-MB mass curve and cTnT release curve) release curve)

Myocardial reperfusion Myocardial reperfusion (% of pts with complete (% of pts with complete ∑∑STe resolution at STe resolution at 1, 3 and 6 hours) 1, 3 and 6 hours)

LV angiographic evolution at 6 weeksLV angiographic evolution at 6 weeks (volumes, LVEF, Wall Motion Index) (volumes, LVEF, Wall Motion Index)

CO – CO – PRIMARY PRIMARY ENDPOINTENDPOINTSS

Infarct sizeInfarct size (area under the CK-MB mass curve and cTnT (area under the CK-MB mass curve and cTnT release curve) release curve)

Myocardial reperfusion Myocardial reperfusion (% of pts with complete (% of pts with complete ∑∑STe resolution at STe resolution at 1, 3 and 6 hours) 1, 3 and 6 hours)

LV angiographic evolution at 6 weeksLV angiographic evolution at 6 weeks (volumes, LVEF, Wall Motion Index) (volumes, LVEF, Wall Motion Index)

8

GRACIA-2 GRACIA-2

SECONDARY ENDPOINTSSECONDARY ENDPOINTS

Combined incidence of death, non-fatal myocardial Combined incidence of death, non-fatal myocardial infarction, or ischaemia-driven revascularization infarction, or ischaemia-driven revascularization at 6 weeks and 6 months at 6 weeks and 6 months

Incidence of bleeding complications and non-cardiac Incidence of bleeding complications and non-cardiac events at 6 weeks and 6 months events at 6 weeks and 6 months

SECONDARY ENDPOINTSSECONDARY ENDPOINTS

Combined incidence of death, non-fatal myocardial Combined incidence of death, non-fatal myocardial infarction, or ischaemia-driven revascularization infarction, or ischaemia-driven revascularization at 6 weeks and 6 months at 6 weeks and 6 months

Incidence of bleeding complications and non-cardiac Incidence of bleeding complications and non-cardiac events at 6 weeks and 6 months events at 6 weeks and 6 months

9

GRACIA – 2GRACIA – 2 GRACIA – 2GRACIA – 2

212 patients212 patients

July 2002 – March 2003July 2002 – March 2003

15 Centres (Spain & Portugal)15 Centres (Spain & Portugal)

212 patients212 patients

July 2002 – March 2003July 2002 – March 2003

15 Centres (Spain & Portugal)15 Centres (Spain & Portugal)

H. Clínico-Universitario, Valladolid (FF Avilés)

H. P. Del Río Hortega, Valladolid (J Blanco, JJ Sanz)

H. Río Carrión, Palencia (J López Mesa)

H. Juan Canalejo, A Coruña (A Castro, N Vázquez)

H. Meixoeiro (MEDTEC), Vigo (J Golicolea)

H. Miguel Servet, Zaragoza (I Calvo)

Complejo Hospitalario, León (F Fernández V)

H. Clínico de San Carlos, Madrid (R A Hernández)

H. Virgen de la Salud, Toledo (J Moreu)

H. U. Virgen del Rocío, Sevilla (L Díaz de la Llera)

H. U. V. de la Victoria, Málaga (J Alonso B)

H. Rafael Méndez, Lorca-Murcia (S. Nicolás)

H. C. U. Valencia (J Sanchís)

H. Los Arcos, San Javier-Murcia (F.Martinez)

H. Fernando Fonseca, Amadora, Portugal (P. Abreu)

H. Clínico-Universitario, Valladolid (FF Avilés)

H. P. Del Río Hortega, Valladolid (J Blanco, JJ Sanz)

H. Río Carrión, Palencia (J López Mesa)

H. Juan Canalejo, A Coruña (A Castro, N Vázquez)

H. Meixoeiro (MEDTEC), Vigo (J Golicolea)

H. Miguel Servet, Zaragoza (I Calvo)

Complejo Hospitalario, León (F Fernández V)

H. Clínico de San Carlos, Madrid (R A Hernández)

H. Virgen de la Salud, Toledo (J Moreu)

H. U. Virgen del Rocío, Sevilla (L Díaz de la Llera)

H. U. V. de la Victoria, Málaga (J Alonso B)

H. Rafael Méndez, Lorca-Murcia (S. Nicolás)

H. C. U. Valencia (J Sanchís)

H. Los Arcos, San Javier-Murcia (F.Martinez)

H. Fernando Fonseca, Amadora, Portugal (P. Abreu)

RecruitmentRecruitment RecruitmentRecruitment

10

MAIN SPONSORSMAIN SPONSORS

Spanish Ministry of Health*Spanish Ministry of Health*

Guidant**Guidant**

Lilly**Lilly**

MAIN SPONSORSMAIN SPONSORS

Spanish Ministry of Health*Spanish Ministry of Health*

Guidant**Guidant**

Lilly**Lilly**

GRACIA – 2GRACIA – 2 GRACIA – 2GRACIA – 2

(*) Cooperative Network for Cardiovascular Research [Instituto de Salud Carlos III]; (**) Unrestricted grant

11

GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2

Primary PCI Primary PCI (108 pts)(108 pts)

Facilitated PCIFacilitated PCI(104 pts)(104 pts) pp

Age Age 6363++1313 6262++12 12 0.30.3

Male Male 82%82% 78%78% 0.60.6

Prior AnginaPrior Angina 25%25% 15%15% 0.10.1

Prior PCIPrior PCI 9%9% 2%2% 0.060.06

DiabetesDiabetes

HypertensionHypertension

HyperlipidaemiaHyperlipidaemia

SmokingSmokingFamily historyFamily history

27%27%

39%39%

40%40%

45%45%

18%18%

23%23%

34%34%

41%41%

50%50%

15%15%

0.490.49

0.750.75

0.410.41

0.480.48

0.510.51

Anterior MIAnterior MI 50%50% 45%45% 0.470.47

Baseline Clinical Baseline Clinical Baseline Clinical Baseline Clinical

12

GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2

85%89%

75%79%

66% 68%

91%97%

87%

Adjunctive medical treatmentAdjunctive medical treatmentAdjunctive medical treatmentAdjunctive medical treatment

64%67%

23%

Thienopyridines Aspirin ACE Inh. Statins AbciximabB - Blockers

p = 0.001

Primary Primary FacilitatedFacilitated

13

GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2

Time intervals (mean)Time intervals (mean)Time intervals (mean)Time intervals (mean)

PrimaryPrimary FacilitatedFacilitated

0

3

6

9

12

Onset torandomisation

Randomisation toCatheterisation

Onset toCatheterisation

Ho

urs

3.18+1.9 hh 3.20+2.05 hh

1.08+3.7 hh

5.89+3.7 hh4.19+9.06 hh

9.06+4.19 hh

p = 0.82

p = 0.001

p = 0.001

14

GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2

Baseline culprit artery flowBaseline culprit artery flowTIMI flow grade (TFG) & Corrected TIMI Frame Count (CTFC)TIMI flow grade (TFG) & Corrected TIMI Frame Count (CTFC)11

Baseline culprit artery flowBaseline culprit artery flowTIMI flow grade (TFG) & Corrected TIMI Frame Count (CTFC)TIMI flow grade (TFG) & Corrected TIMI Frame Count (CTFC)11

Primary (4.2Primary (4.2++9.1 hh from onset)9.1 hh from onset)

TFG 3 TFG 2 TFG 1/0 Mean CTFC (only TFG 2/3)

p=0.005

p=0.047

p=0.008

p=0.034

20.920.9++13.013.0

30.630.6++20.520.5

14%14% 15%15%23%23%

73%73%

8%8%

59%59%

FacilitatedFacilitated (9.1 (9.1++4.2 hh from onset)4.2 hh from onset)

(1) Gibson CM et al. Circulation 1996

15

IRA locationIRA location

LAD RCA CX LMCA

47%47%44%44%

44%44%

45%45%

5%5%

11%11%

2%2%0%0%

CAD extensionCAD extension(vessels with (vessels with >>50% QCA50% QCA stenosis)stenosis)

GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2

Baseline AngiographyBaseline AngiographyBaseline AngiographyBaseline Angiography

PrimaryPrimary FacilitatedFacilitated

56,0%

28,0%

14,0%

2,0%

55%

30%

3%

11%

1 vessel 2 vessel 3 vessel 0 vessel

(P=0.82)

(P=0.37)

(P=0.08)(P=0.01)

16

GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2

Angiography (culprit lesion)Angiography (culprit lesion)Angiography (culprit lesion)Angiography (culprit lesion)

PRIMARYPRIMARY(4.19+9.1 hh from onset)(4.19+9.1 hh from onset)

FACILITATEDFACILITATED (4.19+9.1 hh from onset)(4.19+9.1 hh from onset)

pp

Reference PreReference Pre 2.582.58++0.9 mm0.9 mm 2.672.67++0.82 mm 0.82 mm 0.520.52

MLD pre MLD pre 0.440.44++0.67 mm0.67 mm 1.061.06++0.660.66 <0.001<0.001

% stenosis Pre% stenosis Pre 84.884.8++59.7%59.7% 59.759.7++23.8%23.8% <0.01<0.01

Lesion Length Lesion Length 8.28.2++3.7 mm 3.7 mm 7.97.9++3.4 mm3.4 mm 0.680.68

CalcificationCalcification 6%6% 2%2% 0.480.48

ThrombusThrombus 70%70% 43%43% 0.0010.001

Success (angio)Success (angio) 85%85% 89%89% 0.600.60

Reference PostReference Post 3.093.09++0.62 mm0.62 mm 3.373.37++2.03 mm2.03 mm 0.240.24

MLD PostMLD Post 2.992.99++2.9 mm2.9 mm 2.962.96++1.671.67 0.940.94

% Stenosis Post% Stenosis Post 16.316.3++19.8%19.8% 11.411.4++5.7%5.7% 0.0340.034

17

GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2

Final treatmentFinal treatmentFinal treatmentFinal treatment

(*) Conservative treatment due to non-significant CAD or CAD unsuitable for revascularization

PrimaryPrimary

FacilitatedFacilitated

3%1%

8%16%

89%83%

9%

20%

CABG CULPRITPCI

ASSOCIATEDNON-CULPRIT PCI

NOMECHANICAL

INTERVENTION*

p = 0.64

p = 0.07p = 0.02

p = 0.19

18

GRACIA – 2GRACIA – 2GRACIA – 2GRACIA – 2

ST – Segment Elevation RecoveryST – Segment Elevation RecoveryST – Segment Elevation RecoveryST – Segment Elevation Recovery

Percentage of pts with “Complete”Percentage of pts with “Complete”** ∑STe Recovery ∑STe RecoveryPercentage of pts with “Complete”Percentage of pts with “Complete”** ∑STe Recovery ∑STe Recovery

24%

47%43%

15%

46%

61%

0%

20%

40%

60%

80%

1 hour 3 hours 6 hours

P= 0.19

P= 0.83

P= 0.03

PrimaryPrimary FacilitatedFacilitated

(*) [Schroeder R. JACC 1994]: (*) [Schroeder R. JACC 1994]: >> 70% reduction of the pre-reperfusion total deviation (∑STe) 70% reduction of the pre-reperfusion total deviation (∑STe)(*) [Schroeder R. JACC 1994]: (*) [Schroeder R. JACC 1994]: >> 70% reduction of the pre-reperfusion total deviation (∑STe) 70% reduction of the pre-reperfusion total deviation (∑STe)

19

GRACIA – 2GRACIA – 2GRACIA – 2GRACIA – 2Infarct sizeInfarct sizeInfarct sizeInfarct size

0,190,59

4,15

3,19 3,36

4,17

2,98

2,61

4,5

ng

/dl

0.0

3,06

2,23

Primary

Facilitated

days

0 1 2 3 4

cTnT releasecTnT release CK-MB massCK-MB mass

253,92

171,91

106,11

17,62

211,06

27,57 12,42

20,0834,62

58,56

229,12

91,68

160,87

15,5121,96

35,03

56,96

229,94

Primary

Facilitated

300

0 hours

0 12 24 48

Area under the curveArea under the curve PRIMARYPRIMARY FACILITATEDFACILITATED pp

cTnTcTnT 275.5275.5++211.4211.4 241.8241.8++155.5 155.5 0.520.52

CK-MB mass CK-MB mass 4768.304768.30++3734.03734.0 4602.014602.01++3371.23371.2 0.760.76

20

GRACIA – 2GRACIA – 2

LV evolution at 6 weeksLV evolution at 6 weeksGRACIA – 2GRACIA – 2

LV evolution at 6 weeksLV evolution at 6 weeks

PRIMARYPRIMARY FACILITATEDFACILITATED PP

LVEFLVEFBaseline Baseline

6-week FU 6-week FU ∆∆

52.552.5++14.3%14.3%

55.655.6++13.4%13.4%

3.23.2++11.811.8

53.453.4++9.9%9.9%

56.156.1++12.4%12.4%

3.43.4++11.811.8

0.70.7

0.90.9

0.90.9

Wall Motion Index (SD/chord)Wall Motion Index (SD/chord) Baseline Baseline

6-week FU6-week FU∆∆

-1.50-1.50++0.40.4

-1.10-1.10++0.60.6

0.420.42++0.670.67

-1.47-1.47++0.40.4

-1.24-1.24++0.460.46

0.240.24++0.500.50

0.70.7

0.10.1

0.090.09

EDLV volume index EDLV volume index ((ml/mml/m22)) Baseline Baseline

6-week FU 6-week FU ∆∆

126.5126.5++4141

139.8139.8++57.957.9

11.2111.21++37.7637.76

122.01122.01++4747

129.8129.8++54.054.0

13.2313.23++11.811.8

0.400.40

0.350.35

0.690.69

ESLV volume index ESLV volume index ((ml/mml/m22)) Baseline Baseline

6-week FU 6-week FU ∆∆

56.4356.43++25.0225.02

62.3262.32++35.735.7

5.285.28++21.08721.087

57.6257.62++25.8725.87

56.2356.23++31.9131.91

-2.07-2.07++28.3028.30

0.920.92

0.350.35

0.160.16

21

GRACIA – 2GRACIA – 26-week clinical outcome6-week clinical outcomeGRACIA – 2GRACIA – 26-week clinical outcome6-week clinical outcome

Cardiac EventsCardiac EventsCardiac EventsCardiac Events

PrimaryPrimary PrimaryPrimary FacilitatedFacilitatedFacilitatedFacilitated

12%

6%

1% 1%

6%

9%9%

3%2%

1%

7%

11%

0%

5%

10%

15%

CombinedCombinedclinical clinical

endpoint*endpoint*(10.5%)(10.5%)

CombinedCombinedclinical clinical

endpoint*endpoint*(10.5%)(10.5%)

SurgerySurgery(1%)(1%)

SurgerySurgery(1%)(1%)

IschaemiaIschaemiadriven PCIdriven PCI

(6.5%)(6.5%)

IschaemiaIschaemiadriven PCIdriven PCI

(6.5%)(6.5%)

Re-admissionRe-admission(4.5%)(4.5%)

Re-admissionRe-admission(4.5%)(4.5%)

DeathDeath((4.5%)4.5%)DeathDeath((4.5%)4.5%)

********

********

********

********

** p = NS** p = NS** p = NS** p = NS********

********

Re-infarctionRe-infarction(1(1.5.5%)%)

Re-infarctionRe-infarction(1(1.5.5%)%)

(*) Combined clinical EP: death, nonfatal MI, or ischemia-driven revascularization(*) Combined clinical EP: death, nonfatal MI, or ischemia-driven revascularization(*) Combined clinical EP: death, nonfatal MI, or ischemia-driven revascularization(*) Combined clinical EP: death, nonfatal MI, or ischemia-driven revascularization

22

GRACIA – 2GRACIA – 26-week clinical outcome6-week clinical outcomeGRACIA – 2GRACIA – 26-week clinical outcome6-week clinical outcome

Bleeding & vascular complicationsBleeding & vascular complicationsBleeding & vascular complicationsBleeding & vascular complications

(*) Major bleeding or vascular complication: intracranial haemorrhage, or any complications that prolonged stay or needed (*) Major bleeding or vascular complication: intracranial haemorrhage, or any complications that prolonged stay or needed surgery / transfusion surgery / transfusion

(*) Major bleeding or vascular complication: intracranial haemorrhage, or any complications that prolonged stay or needed (*) Major bleeding or vascular complication: intracranial haemorrhage, or any complications that prolonged stay or needed surgery / transfusion surgery / transfusion

PrimaryPrimary PrimaryPrimary FacilitatedFacilitatedFacilitatedFacilitated

AnyComplication

6.7%

3.0%

0.0%

10.3%

2.0%1.0%

0%

5%

10%

MajorComplications (ICH included)*

IntracranialHaemorrhage

(ICH)

p=0.45

p=0.97

p=0.99

23

Catheterization plus adequate revascularization within Catheterization plus adequate revascularization within 3 – 12 hours of immediate facilitation with TNK seems to be 3 – 12 hours of immediate facilitation with TNK seems to be as safe as optimal primary PCI (stent & GP IIb/IIIa inhibitors) as safe as optimal primary PCI (stent & GP IIb/IIIa inhibitors)

GRACIA – 2GRACIA – 2GRACIA – 2GRACIA – 2

CONCLUSIONSCONCLUSIONSCONCLUSIONSCONCLUSIONS

These results suggest that both strategies are similarly These results suggest that both strategies are similarly effective in restoring myocardial perfusion, preserving left effective in restoring myocardial perfusion, preserving left ventricular size & function and beneficing clinical outcome ventricular size & function and beneficing clinical outcome

If this equivalence is confirmed in large studies clinically If this equivalence is confirmed in large studies clinically focused, the proportion of patients with STEAMI who focused, the proportion of patients with STEAMI who can benefit from early PCI could increase dramatically can benefit from early PCI could increase dramatically

24

GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2

Hospital stayHospital stayHospital stayHospital stay

0

2

4

6

8

10

PRIMARY FACILITATED

Da

ys

7.4±5.6

p = 0.22

6.4±3.3