PPCI in STEMI

Dr Hassan MhishDr Hassan MhishInterventional Cardiology Consultant

Cardiology Fellowship Program Directorgy p gPrince Salman Heart Center

King Fahd Medical CityRiyadh, KSA

ESC at the 22nd Annual Conference of the Saudi Heart Association

February 21th, 2011

Primary PCI vs Thrombolysis in STEMI: Q tit ti A l i (23 RCT * N 7739)Quantitative Analysis (23 RCTs*, N=7739)

25 Short-term outcomes

P<.0001 PCITh b l ti

15

20

y, %

outcomes(4–6 wk)

Thrombolytictherapy

P<.0001

10

15

Freq

uenc

y

P=.0002 P<.0001P=.032

5

F

P<.0001

0 Death NonfatalMI

RecurrentIschemia

Hemor-rhagicStroke

MajorBleed

Death, Nonfatal

Reinfarction,or Stroke

Keeley EC, et al. Lancet. 2003;361:13-20.

S*The criterion for time to treatment was 6 h or less in 9 of the trials, 12 h in 13 trials, and up to 36 h in the SHOCK trial.

Background:

2007 focused update of the ACC/AHA STEMI guidelines

Pathway: Triage and Transfer for PCI (in STEMI)STEMI patient who is aSTEMI patient who is acandidate for reperfusion

Initially seen at a PCIcapable facility

Initially seen at a non-PCIcapable facilitycapable facility

Send to Cath Lab for primary PCI

Transfer for primary PCI

Initial Treatmentwith fibrinolytictherapy (Class 1, LOE:A)

(Class I, LOE:A) (Class I, LOE:A)NOT HIGH RISK

Transfer to a PCI facility may be considered

HIGH RISKTransfer to a PCI facility is reasonable for At PCI

facilityPrep antithrombotic (anticoagulantplus antiplatelet) regimen

Diagnostic angio

considered (Class IIb, LOE:C), especially if ischemic symptoms

early diagnostic angio & possible PCI or CABG (Class IIa, LOE:B),

facility, evaluate for timing of diagnostic angioDiagnostic angio

Medicaltherapy only

PCI CABG

y ppersist and failure to reperfuse is suspected

High-risk patients as defined by 2007 STEMI Focused Update should

g

2009 STEMI Focused Update. Appendix 5

py y Update should undergo cath (Class 1: LOE B)

Clinical ImplicationsI t l ti d l t f i h th t t•Incremental time delays to reperfusion have the greatest

impact on myocardial salvage and survival in the first 2-3 hours and have much less impact after 3 hours.p

•Short DBT impact mortality most in pts presenting early whocan be reperfused within the 3 hour window of optimumcan be reperfused within the 3 hour window of optimumbenefit

Mortality Reduction %

100

60

80 Mortality Reduction %y %

0

20

40

60Myocardial Salvage %

Myocardial Salvage %0 3 6 9 12 24Hours

Gersh JAMA 2007

Mortality With Primary PCI vs Lysis b R l ti Ti iby Relative Timing

ath

(%)

15

P= 006nce

in D

e

10

Favors PCI

P=.006

62 min

sk D

iffer

en 5

0 Favors Lysis

solu

te R

is 0

-54040 8080 100100

PCI-Related Time Delay(Door-to-Balloon Minus Door-to-Needle), min

Abs 00 2020 4040 6060 8080 100100

Circle sizes=sample size of individual study; solid line=weighted meta-regression.For every 10-minute delay to PCI: 0.94% reduction in mortality difference vs lytics.Nallamothu et al. Am J Cardiol. 2003;92:824-826 (B).

Time vs. InTime vs. In--Hospital Mortality Hospital Mortality 3/43/4DoorDoor––toto––Balloon Time: NRMIBalloon Time: NRMI––3/43/4

6

8

ity %

5.75.7

7.47.4N = 29,222N = 29,222PP < 0.001< 0.001

4

6

al M

orta

li

3 03 0

4.24.2

2

-hos

pita 3.03.0

0<= 90 90 - 120 120 - 150 > 150

In

Door-to-Balloon (minutes)McNamara RL, et al. JACC. 2006;47:2180.

Interhospital Delay in Transfer Patients

15

p yDoor-to-Door Times

12.1

15

(%)

(%)

6.26.4

10

orta

lity

(or

talit

y (

3.25

MM

0< 30" 30 – 59" 60 – 89" > 90"

De Luca G, et al. Am J Cardiol. 2005;95:1361.

D2B Time And Mortality2300 Patients2300 Patients

High risk = Killip class 3 or 4 age >70 anterior MI

Brodie BR, JACC 2006;47:289

High risk = Killip class 3 or 4, age >70, anterior MI

Terkelsen et al, JAMA 2010

Background: Various delays Symptom

onset

Transportation

EMScall

Arrival atPCI centre

D2B

PPCI

Patient delay Transportationdelay

D2Bdelay

Health Care System delay

Field-triagedto a PCI centre

Treatment delay

T i

Arrival atPCI centre

PPCIArrival atlocal hospital

Departure fromlocal hospital

Patient delayTransportation

delayLocal hospital

delay

Health Care System delay

D2Bdelay

InterhospitaldelayTransferred

from local hospitals

Treatment delay

System delay and mortality

Kaplan-Meier failure estimatesKaplan-Meier Cumulative Mortality System delay

0.25

0.30

25 3

0

121-180 min.

181-360 min.

.15

0.20

0

0-60 min.

ality,

%15

20

61-120 min.

050.

100

Mor

ta5

10

1

0.00

0.

1 2 3 4 5 6F ll ( )

0

1 2 3 4 5 6Follow-up (years)Follow-up (years)

Terkelsen et al, JAMA 2010

MANAGEMENT OF STEMIMANAGEMENT OF STEMI“It is not enough that we do ourIt is not enough that we do our best; sometimes we have to do what is required”

Sir Winston Churchill

Th b l iThrombolysis • Golden time: the first 2 hours 

from symptoms onset• DOOR TO NEEDLE TIME LESS 

THAN 30 MINUTESTHAN 30 MINUTES

Any Role for Facilitated PCI ?

Meta-analysis of 17 Trials*Facilitated PCI

Event Facilitated PCI (%) PCI (%) P

Death 5.0 3.0 .04Reinfarction 3 0 2 0 006Reinfarction 3.0 2.0 .006

Urgent TVR 4.0 1.0 .010Major bleeding 7.0 5.0 .010Stroke 1.1 0.3 .0008

*Includes 9 GP IIb/IIIa inhibitor trials (n=1148); 6 thrombolytic therapy trials (n=2957); 2 combination therapy trials (n=399).

Keeley EC, et al. Lancet. 2006;367:579-588.

Primary PCI:Primary PCI:• Door to balloon time of 60-90

minutes is essentialminutes is essential• Is benefit related to time of

presentation ?• Is benefit related to the risk• Is benefit related to the risk

status ?• What are the risk factors ?

1. Time is Myocardium2. Infarct Size is

))

100100 Outcomedu

ctio

n (%

)du

ctio

n (%

)

DD8080

6060

CC

orta

lity

Red

orta

lity

Red

4040

BB AAExtent ofExtent ofMyocardial SalvageMyocardial Salvage

Mo

Mo 2020

00

00 44 88 1212 1616 2020 2424Time From Symptom Onset to Reperfusion Therapy, hTime From Symptom Onset to Reperfusion Therapy, h

Critical TimeCritical Time--dependent Perioddependent PeriodGoal: Myocardial SalvageGoal: Myocardial Salvage

TimeTime--independent Periodindependent PeriodGoal: Open InfarctGoal: Open Infarct Related ArteryRelated ArteryGoal: Myocardial SalvageGoal: Myocardial Salvage Goal: Open InfarctGoal: Open Infarct--Related ArteryRelated Artery

Gersh BJ, et al. Gersh BJ, et al. JAMAJAMA 2005;293:979.2005;293:979.

Cadillac Plus Horizons-AMI

CADILLACN= 2082

HORIZONS-AMIN = 3602

PCI PerformedN 2082

PCI PerformedN 3345

Door-to-Balloon Time Door-to-Balloon Time

N=2082 N = 3345

Data AvailableN = 1909

Data AvailableN = 2639

Total Study PopulationPCI Performed

and DBT Data AvailableN = 4548

Impact of Door-to-Balloon Time (90 min) O Y M t liton One Year Mortality

All Patients

DBT 90 i4.3%

DBT > 90 min3.1%

DBT < 90 min

Unadjusted HR 0.72 (0.52–0.99)j ( )p = 0.045

Impact of Door-to-Balloon Time on One Year Mortalityon One Year Mortality

Early (< 1.5 hrs) vs Late Presenters

Time to Presentation > 1.5 hoursTiTime to Presentation < 1.5 hours Time to Presentation > 1.5 hours

DBT > 90 min4.6%

3 8%

HR 0.49 (0.26-0.93)p = 0.029

DBT > 904.6%

HR 0.86 (0.58-1.28)p = 0.47

DBT < 90 min

DBT > 90 minDBT > 90

DBT < 90

3.8%

1.9%

DBT > 90

DBT < 90 4.0%

DBT < 90

Impact of Door-to-Balloon Time in Early Presenters:Comparison of High and Low Risk GroupsComparison of High and Low Risk Groups

(TIMI Risk < 2 vs > 2)

High Risk Low Risk

Time to Presentation < 1.5 hrs

DBT > 907.0%

g Low Risk

HR 0 52 (0 14-1 89)

DBT < 90 3.7%

HR 0 52 (0 24 1 08) DBT > 90 1.5%

HR 0.52 (0.14 1.89)p = 0.32

HR 0.52 (0.24-1.08)p = 0.08

DBT 90

DBT < 90 0.8%

TRANSFER-AMI

Study of pharmacoinvasive strategyStudy of pharmacoinvasive strategy 1059 patients with STEMI

non-PCI-capable hospitals within 12 hrs of symptom onsetwithin 12 hrs of symptom onset

with ≥ 1 high-risk feature

Cantor et al. N Eng J Med 2009;360:26.

Recommendations for Triage and Transfer for PCI: *High Risk Definition

Defined in TRANSFER AMI as >2 mm ST• Defined in TRANSFER-AMI as >2 mm ST-segment elevation in 2 anterior leads or ST elevation at least 1 mm in inferior leads

ith t l t f th f ll iwith at least one of the following: – systolic blood pressure <100 mm Hg – heart rate >100 beats per minute p– Killip Class II-III – >2 mm of ST-segment depression in the

anterior leadsanterior leads – >1mm of ST elevation in right-sided lead V4

indicative of right ventricular involvement

Cantor et al. N Eng J Med 2009;360:26.

TRANSFER-AMI--Designg• All patients received standard-dose tenecteplase

(TNK), ASA, and either UFH or enoxaparin.( ), , p– a pharmaco-invasive strategy (immediate

transfer for PCI within 6 hours of fibrinolytic therapy) or totherapy) or to

– standard treatment after fibrinolytic therapy (included rescue PCI as required for ongoing chest pain and less than 50% resolution of STchest pain and less than 50% resolution of ST-elevation at 60-90 minutes or hemodynamic instability).St d d t t t ti t h did t i– Standard treatment patients who did not require rescue PCI remained at the initial hospital for at least 24 hours and coronary angiography within

fthe first 2 weeks encouraged

Cantor et al. N Eng J Med 2009;360:26.

TRANSFER-AMI--Design (cont.)g ( )

• Clopidogrel loading (300 mg for patients < 75• Clopidogrel loading (300 mg for patients < 75 years of age, and 75 mg >75 years of age) strongly encouraged in all study patients

• GP IIb/IIIa receptor antagonists administered at the PCI-capable hospitals according to institutions’ standard practiceinstitutions standard practice

Cantor et al. N Eng J Med 2009;360:26.

TRANSFER-AMI: ResultsProceduresProcedures

Pharmaco-invasive vs. Standard Treatment

Median time to TNK administration from symptom onset

Approximately 2 hrs in both groups

symptom onset

Median time from TNK to

2.8 hrs vs. 32.5 hrsTNK to catheterizationCoronary 98.5% vs. 88.7%yangiography

PCI performed 84.9% vs. 67.4%

Cantor et al. N Engl J Med 2009;360:26.

TRANSFER-AMI: Efficacy Kaplan Meier Curves for Primary Endpoint

primary end point: composite of death, reinfarction, recurrent ischemia, newor worsening CHF, or shock within 30 days pharmaco-invasive group=11 0% vs standard treatment group=17 2%

17.2%

pharmaco-invasive group=11.0% vs. standard treatment group=17.2%

11.0%

Cum

ulative Incidence

p=0.004

Days

RR= 0.64, 95 CI% (0.47-0.87)Cantor et al. N Engl J Med 2009;360:26

TRANSFER-AMI--Safety Resultsy

• Incidence of TIMI major and minor bleeding andIncidence of TIMI major and minor bleeding and GUSTO moderate and severe bleeding was not different between groups

• There was higher incidence of GUSTO mild bleeding in the pharmaco-invasive group (13.0% compared to 9.0% in the standard treatmentcompared to 9.0% in the standard treatment group, p=0.036).

Cantor et al. N Eng J M 2009;360:26.

TRANSFER-AMISt d C l iStudy Conclusion

• Following treatment with fibrinolyticFollowing treatment with fibrinolytic therapy in high risk STEMI pts presenting to hospitals without PCI-presenting to hospitals without PCI-capability, transfer to a PCI center to undergo coronary angiography and PCIundergo coronary angiography and PCI should be initiated immediately without waiting to determine whetherwaiting to determine whether reperfusion has occurred.

Cantor et al. N Eng J M 2009;360:26.

CARESS-IN-AMI:CARESS IN AMI:inclusion Criteria

• STEMI patients presenting within 12 hours from symptom onset with one or y pmore of the following high-risk criteria:

• summation of ST-segment elevationsummation of ST segment elevation ≥15 mm in all 12 ECG leads,

• new left bundle branch block previous• new left bundle branch block, previous MI, Killip class II or III, and left ventricular ejection fraction <35%ventricular ejection fraction <35%

CARESS-IN-AMI: Primary Outcomeprimary outcome (composite of all cause mortality reinfarction & refractory MI within 30 days)primary outcome (composite of all cause mortality, reinfarction, & refractory MI within 30 days) occurred significantly less often in the immediate PCI group vs. standard care/rescue PCI group

10 7%10.7%

4 4%4.4%

HR=0.40 (0.21-0.76)

Di Mario et al. Lancet 2008;371.

Adj t M di l ThAdjuvant Medical Therapy

ASA 300 PO• ASA 300 mg PO• Heparin 5000 IV bolus• Plavix 300-600 mg PO• GpIIb-IIIa inhibitors ?GpIIb IIIa inhibitors ?

MetaMeta--analysis of Clopidogrel analysis of Clopidogrel Pretreatment in PCIPretreatment in PCI

MetaMeta--analysis of Clopidogrel analysis of Clopidogrel Pretreatment in PCIPretreatment in PCIPretreatment in PCIPretreatment in PCIPretreatment in PCIPretreatment in PCI

No. (%)No. (%)SourceSource ClopidogrelClopidogrel PlaceboPlacebo OR (95% CI)OR (95% CI)MI Before PCIMI Before PCI

PCIPCI--CURE 2001 CURE 2001 47/1313 (3.6)47/1313 (3.6) 68/1345 (5.1)68/1345 (5.1)CREDO 2002CREDO 2002 —— ——PCIPCI--CLARITY CLARITY 37/933 (4.0)37/933 (4.0) 57/930 (6.1)57/930 (6.1)OverallOverall 84/2246 (3.7)84/2246 (3.7) 125/2275 (5.5)125/2275 (5.5)

CV Death or MI After PCI to 30 DaysCV Death or MI After PCI to 30 DaysPP=.005=.005

yyPCIPCI--CURE 2001 CURE 2001 38/1313 (2.9)38/1313 (2.9) 59/1345 (4.4)59/1345 (4.4)CREDO 2002CREDO 2002 54/9000 (6.0)54/9000 (6.0) 65/915 (7.1)65/915 (7.1)PCIPCI--CLARITY CLARITY 31/933 (3.3)31/933 (3.3) 50/930 (5.4)50/930 (5.4)PCIPCI CLARITY CLARITY 31/933 (3.3)31/933 (3.3) 50/930 (5.4)50/930 (5.4)OverallOverall 123/3146 (3.9)123/3146 (3.9) 174/3190 (5.5)174/3190 (5.5)

0 0.25 0.5 0.75 1 1.25

PP=.004=.004

Favors Favors PretreatmentPretreatment

Favors No Favors No PretreatmentPretreatment

Sabatine et al. JAMA. 2005;294:1224-1232 (A).

BRAVE 3: Study designBRAVE 3: Study design

TREATMENT PCI t t t ith l id l (600TREATMENT: pre-PCI treatment with clopidogrel (600 mg), followed by abciximab vs. placebo

INCLUSION: suspected acute MI (ST change or LBBB) INCLUSION: suspected acute MI (ST change or LBBB) within 24 h of symptom onset

EXCLUSION: high risk for bleeding, prior stroke,shock,trauma, thrombolytics, hypertension,relevant hematologic deviations

1° OUTCOMES i f t i d th t k t1° OUTCOMES: infarct size, death, stroke, urgentrevascularization of affected artery

Mehilli et al. Circ. 2009;119:1933-1940

Effects of Abciximab

P= 0 47

P= 0.40

P 0.47

No significant difference in infarct size or major bleeding

Mehilli et al. Circ. 2009;119:1933-1940

Use of Glycoprotein IIb/IIIa Receptor Antagonists in STEMIAntagonists in STEMI

Modified

It is reasonable to start treatment with glycoprotein

Recommendation

g y pIIb/IIIa receptor antagonists at the time of primary PCI (with or without stenting) in selected patients with STEMI:III IIIIII IIbIIbIIb IIIIIIIIIIII IIIIII IIbIIbIIb IIIIIIIIIIII IIIIII IIbIIbIIb IIIIIIIIIIIIIII IIbIIbIIb IIIIIIIII with STEMI:

abciximab

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

tirofiban and eptifibatide

CONCLUSIONS:CONCLUSIONS:• STEMI patients who present to hospitals with requisite

f iliti d ti PPCI i th f d t tfacilities and expertise, PPCI is the preferred strategy. • Fibrinolysis without delay may provide maximal

advantage in younger patients at low risk of hemorrhage g y g p gand mortality presenting earlier (only if the delay to PPCI is beyond the acceptable time frame for that patient),

• High risk STEMI patients except very early STEMI• High-risk STEMI patients, except very early STEMI patients without Q waves on the admission ECG, might benefit from PPCI, even when longer delays are

id blunavoidable. • Routine but non-emergent invasive strategy after

fibrinolytic therapy is not only safe and effective but also y py ythe preferred approach.

AMI: special Groups

• Cardiogenic Shock • Large thrombotic burdenLarge thrombotic burden• Late presentation 12-24 hours

Randomized Studies in Cardiogenic Shock

Trial n/N n/NRelative Risk95% CI

Relative Risk95% CIFollow-up

Revascularization (PCI/CABG)SHOCKSMASH

76/15222/32

103/184

83/14918/23

11 /1 2

0.80 (0.66;0.98)0.87 (0.66;1.29)0 82 (0 70 0 98)

1-year30 days

Total 103/184 117/172 0.82 (0.70;0.98)

Early revascularization better

Medical treatmentbetter

Norepinephrine0.75 (0.55;0.93)64/145 50/13528 days

Dopamine

CatecholaminesSOAP II (CS Subgroup)

Norepinephrinebetter

Dopamine better

In-hospital 15/40 13/40 1.15 (0.59;2.27)Up-stream Abciximabbetter

Standard treatmentbetter

Glycoprotein IIb/IIIa-InhibitorsPRAGUE-7

30 days 97/201 76/180 1 14 (0 91;1 45)NO Synthase InhibitorsTRIUMPH 30 days

30 days30 days

97/20124/59

4/15125/275

76/1807/20

10/1593/215

1.14 (0.91;1.45)1.16 (0.59;2.69)0.40 (0.13;1.05)1.05 (0.85;1.29)

NO Synthase inhibitionbetter

Placebobetter

SHOCK-2Cotter et alTotal

IABPIABP SHOCK I 30 days 7/19 6/21

IABPbetter

Standard treatmentbetter

1.28 (0.45;3.72)IABP-SHOCK I

30 days30 days30 days

9/219/196/13

9/205/146/13

0.95 (0.48;1.90)1.33 (0.57-3.10)1 00 (0 44 2 29)

LVADThiele et alBurkhoff et alSeyfarth et al

0 0.5 1 2 30.75 1.5 2.50.25

30 days 6/1324/53

6/1320/47

1.00 (0.44-2.29)1.06 (0.68-1.66)

LVADbetter

IABPbetter

Seyfarth et alTotal

Thiele et al. Eur Heart J 2010;31:1828-1835

TAPAS: 1-Year ResultsT i l d i P ti t ith ST l ti di l i f ti d i d tTrial design: Patients with ST-elevation myocardial infarction were randomized to thrombus aspiration prior to PCI (n = 535) or standard PCI without aspiration (n = 536) and followed for 1 year.

• All-cause mortality: 4.7% vs. 7.6% (p = 0.042), respectively

• Cardiac death: 3 6% vs 6 7% (p = 0 02)

Results

(p = 0.042) (p = 0.05)

8

• Cardiac death: 3.6% vs. 6.7% (p = 0.02), respectively

• Reinfarction: 2.2% vs. 4.3% (p = 0.05), respectively

% 2.2 4.3

4.7 7.6

0

4

Conclusions• In earlier presentation of TAPAS, thrombus

aspiration during acute MI improvedR i f tiAll-cause mortality Re-infarction aspiration during acute MI improved reperfusion

• Extended follow-up to 1 year demonstrates that this strategy reduces death and MIThrombus

aspirationStandard PCI

All-cause mortality Reinfarction

Vlaar PJ, et al. Lancet 2008;371:1915-20

aspiration

FINESSE: Study designFINESSE: Study design

Pre-PCI treatment with ½ -dose lytic plus Treatment

y pabciximab, pre-PCI abciximab alone, and abciximab at time of PCI

Inclusion Suspected acute MI (ST change or LBBB) within 6 h of symptom onset

Exclusion Low risk (<60 yo, localized inferior infarct) high risk for bleeding

1° OUTCOMES Death, VF after 48 hours, shock, CHF within 90 days

51

Ellis et al. N Eng J Med. 2008;358:2205-2217.

Primary, secondary, and bleeding end Primary, secondary, and bleeding end points in FINESSEEnd point Primary

PCI (%)Abciximab-facilitated

Combination (abciximab/

p, combination-facilitated vs

p, combination-

End point Primary PCI (%)

Abciximab-facilitated

Combination (abciximab/

p, combination-facilitated vs

p, combination-PCI (%) facilitated

(%)(abciximab/reteplase)-facilitated (%)

facilitated vsprimary PCI

combination-facilitated vsabciximab-facilitated

PCI (%) facilitated (%)

(abciximab/reteplase)-facilitated (%)

facilitated vsprimary PCI

combination-facilitated vsabciximab-facilitated

Primary end point* at 90 days

10.7 10.5 9.8 NS NS

>70% ST segment resolution within

31.0 33.1 43.9 0.003 0.01

Primary end point* at 90 days

10.7 10.5 9.8 NS NS

>70% ST segment resolution within

31.0 33.1 43.9 0.003 0.01

60–90 minTIMI major or minor bleeding through discharge

6.9 10.1 14.5 <0.001 0.00860–90 minTIMI major or minor bleeding through discharge

6.9 10.1 14.5 <0.001 0.008

through discharge or day 7through discharge or day 7*All-cause mortality; rehospitalization or emergency department treatment for CHF; resuscitated ventricular fibrillation occurring >48 hours after randomization; cardiogenic shock

52

Ellis et al. N Eng J Med. 2008;358:2205-2217

OnTIME 2: Study design

Acute myocardial infarctionAcute myocardial infarctiondiagnosed in ambulance or referral centerdiagnosed in ambulance or referral center

ASA+600 mg ASA+600 mg ClopidogrelClopidogrel

Tirofiban *Tirofiban *PlaceboPlacebo

TransportationTransportation

AngiogramAngiogramPCI centrePCI centreAngiogramAngiogram

TirofibanTirofiban TirofibanTirofibanPCIPCI

53

TirofibanTirofibanprovisionalprovisional

TirofibanTirofibancont’dcont’d

PCIPCI

van’t Hof et al. Lancet 2008;372:537-46.

OnTIME 2: endpoints

Primary• Residual ST segment deviation (>3mm) 1 hour after

PCI

li i l dKey Clinical Secondary• Combined occurrence of death, recurrent MI, urgent

TVR or thrombotic bailout at 30 days follow-upTVR or thrombotic bailout at 30 days follow-up

• Safety (major bleeding)

• Death at 1 year follow-up

54

y p

On-TIME 2: ResultsResidual ST Deviation after PCI

55van’t Hof et al. Lancet 2008;372:537-46

p=0.003 3.6± 4.6mm 4.8± 6.3mm

On-TIME 2: Results

Event-free Survival at 30 daysEvent-free Survival at 30 days

Clinical outcome Placebo tirofiban P-value

Death/recurrent MI or urgent TVR

39/477 (8 2%)

33/473 (7 0%)

0.485or urgent TVR (8.2%) (7.0%)

56van’t Hof et al. Lancet 2008;372:537-46.