danami 2 august 2003.ppt
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The DANAMI-2 TrialThe DANAMI-2 Trial
A Comparison of Coronary Angioplasty with Fibrinolytic Therapy in Acute Myocardial Infarction
Henning Rud Andersen et al for the DANAMI-2 investigators
N Engl J Med 2003; 349: 733-42
High-risk ST elevation MI patients (>4 mm elevation), Sx < 12 hrs5 PCI centers (n=443) and 22 referring hospitals (n=1,129), transfer in < 3 hrs
Lytic therapyFront-loaded tPA 100
mg
(n=782)
Death / MI / Stroke at 30 Days
DANAMI-2: Study DesignDANAMI-2: Study Design
Primary PCIwith transfer
(n=567)
Primary PCIwithout transfer
(n=223)
Stopped early by safety and efficacy committee
N Engl J Med 2003; 349: 733-42
13.7%
8.0%
0%
4%
8%
12%
16%
30 D
ay D
eath
/ M
I / S
trok
e (%
)
Lytic Primary PCI
P<0.001 P=0.002Combined Transfer Sites
P=0.05Non-Transfer Sites
DANAMI-2: Primary ResultsDANAMI-2: Primary Results
Lytic Primary PCI Lytic Primary PCI
14.2%
8.5%
0%
4%
8%
12%
16%
12.3%
6.7%
0%
4%
8%
12%
16%
N=27 N=15N=80 N=48
N Engl J Med 2003; 349: 733-42
N=107 N=63
2.0%
1.1%
0%
2%
4%
6%
8%
6.3%
1.6%
0%
2%
4%
6%
8%
7.8%
6.6%
0%
2%
4%
6%
8%
10%
Lytic Primary PCI
P=0.35Death
DANAMI-2: ResultsDANAMI-2: Results
Lytic Primary PCI
P=0.15Stroke
Lytic Primary PCI
P<0.001Recurrent MI
N Engl J Med 2003; 349: 733-42
DANAMI-2: Risk of Recurrent MI Largely Drives DANAMI-2: Risk of Recurrent MI Largely Drives Results of the Composite EndpointResults of the Composite Endpoint
The DANAMI 2 Investigators state that:
“Although the rates of death, clinical reinfarction, and stroke were all reduced with angioplasty, the better overall outcome after angioplasty was driven primarily by the reduction in the rate of reinfarction. Our finding of a higher 30-day mortality rate among patients with reinfarction accords with recent results by Gibson et al. and indicates that clinical reinfarction in our trial was a severe event.”
Recurrent MI During Index Hospitalization is Recurrent MI During Index Hospitalization is Associated with Higher Mortality at 2 YearsAssociated with Higher Mortality at 2 Years
Kaplan-Meier survival estimates, by early reinfarction
Years 0 0.5 1 1.5 2
0.5
0.75
1 No early reinfarction
10.1%, n=19,265
Early reinfarction19.6%, n=836
Log-rank p<0.0001
Gibson CM et al, J Am Coll Cardiol 2003;42:7–16.
Similar to DANAMI 2, A Lower Rate of Recurrent MI Following Similar to DANAMI 2, A Lower Rate of Recurrent MI Following PCI Drives the Benefit Observed in Many of the Recent Primary PCI Drives the Benefit Observed in Many of the Recent Primary
PCI vs Fibrinolytic TrialsPCI vs Fibrinolytic Trials
*Pre-hospital administration.*Pre-hospital administration.PP<0.05: ReMI;death (PCAT only); stroke (PCAT only).<0.05: ReMI;death (PCAT only); stroke (PCAT only).Grines C, et al. Grines C, et al. Am Heart J.Am Heart J. 2003;145:47-57. 2003;145:47-57.
CAPTIM DANAMI-2 C-PORT PCAT
n 840 1,572 451 2,725PCI t-PA* PCI t-PA PCI t-PA PCI Lytic
Death 4.6% 3.7% 6.6% 7.6% 6.2% 7.1% 6.2% 8.2%
ReMI 1.7% 3.7% 1.6% 6.3% 5.3% 10.6% 4.8% 9.8%
Stroke 0% 1.0% 1.1% 2.0% 2.2% 4.0% 0.7% 1.9%
CM Gibson 2003CM Gibson 2003
If Recurrent MI Drives The Results of DANAMI 2 and Other If Recurrent MI Drives The Results of DANAMI 2 and Other Recent Trials, Can We Reduce The Risk of Recurrent MI Recent Trials, Can We Reduce The Risk of Recurrent MI
Following Fibrinolytic Administration?Following Fibrinolytic Administration?
• Yes.
• Performance of early rescue PCI (early PCI of a closed artery), adjunctive PCI (early PCI of an open artery) , and delayed PCI are collectively associated with a reduction in recurrent MI after fibrinolytic administration.
Gibson CM et al, J Am Coll Cardiol 2003;42:7–16.
Risk of Early Recurrent MI Following Thrombolysis in 20,101 Risk of Early Recurrent MI Following Thrombolysis in 20,101 PatientsPatients
4.5
1.6
0
1
2
3
4
5
No PCI PCI
% R
ecur
rent
MI
% R
ecur
rent
MI
Gibson CM et al, J Am Coll Cardiol 2003;42:7–16.
P< 0.001
Is Performance of Rescue / Adjunctive / Delayed PCI After Fibrinolytic Is Performance of Rescue / Adjunctive / Delayed PCI After Fibrinolytic Administration Associated With Improved Mortality at 2 Years?Administration Associated With Improved Mortality at 2 Years?
• Yes.
• Performance of early rescue PCI (early PCI of a closed artery), adjunctive PCI (early PCI of an open artery) , and delayed PCI are collectively associated with a reduction in mortality.
Gibson CM et al, J Am Coll Cardiol 2003;42:7–16.
2 Year Survival Following Rescue PCI2 Year Survival Following Rescue PCI
Gibson et al, Circulation 2002, 105:1909-1913
0.5
0.6
0.7
0.8
0.9
1
0 0.5 1 1.5 2
Log rank p=0.03
Survival was Improved in patients with 90 minute TIMI Grade 0/1 Flow who underwent rescue PCI
Years
Sur
viva
l
Rescue PCI
No Rescue PCI
2 Year Survival Associated with Adjunctive PCI in Patients with 2 Year Survival Associated with Adjunctive PCI in Patients with an Open Artery Following Thrombolytic Administrationan Open Artery Following Thrombolytic Administration
Gibson et al, Circulation 2002, 105:1909-1913
0.7
0.8
0.9
1
0 0.5 1 1.5 2
Survival tended to be improved in patients with an open artery at 90 minutes who underwent immediate adjunctive or delayed PCI
Years
p=0.11; after adjusting for stent use p=0.07 for adjunctive PCI
Immediate Adjunctive PCI
Delayed PCI
No PCI
Performance of Early PCI After Fibrinolysis is Associated with Improved Survival at 2 Years in 20,101 Patients
Years0 0.5 1 1.5 2
1
0.9
0.8
0.7
No PCI
PCI
Log rank p<0.0001
Surv
ival
Gibson CM et al, J Am Coll Cardiol 2003;42:7–16.
Are The Benefits of PCI After Fibrinolysis True for Both Low Risk and Are The Benefits of PCI After Fibrinolysis True for Both Low Risk and High Risk Patients?High Risk Patients?
• Yes.
• Similar relative risk reductions in survival following PCI have been observed among low, intermediate and high risk patients.
Gibson CM et al, J Am Coll Cardiol 2003;42:7–16.
1.7%
6.2%
15.0%
3.7%
10.3%
27.3%
0%
10%
20%
30%
PCI No PCI
p<0.001
Low RiskTRS 0-2
Mortality to 2 Years by In-Hospital PCI, Stratified by TIMI Risk Mortality to 2 Years by In-Hospital PCI, Stratified by TIMI Risk Score in 20,101 PatientsScore in 20,101 Patients
Mor
talit
y (%
)
p<0.001
Intermediate RiskTRS 3-4
High RiskTRS >5
p<0.001
PCI No PCI PCI No PCI
Gibson CM et al, J Am Coll Cardiol 2003;42:7–16.
Are the There Recent Randomized Trials to Support PCI Are the There Recent Randomized Trials to Support PCI Following Fibrinolytic Administration?Following Fibrinolytic Administration?
• Yes.
• In August of 2003, the SIAM 3 and ALKK study were published contemporaneously with the DANAMI 2 Trial.
CM Gibson 2003CM Gibson 2003
61.5%56.4%
0%
20%
40%
60%
SIAM III TrialSIAM III Trial
J Am Coll Cardiol 2003;42:634-41
rPA + Delayed PCIrPA + Early PCI
EF at 6 monthsp=0.018
25.6%
50.6%
0%
20%
40%
60%
Death/reMI/ischemicevents/TLR at 6 months
p=0.001
rPA + Delayed PCIrPA + Early PCI
Randomized trial of thrombolysis (rPA) with transfer for early PCI (within 6 hours; n=82) or thrombolysis with delayed angiography at 2 weeks (n=81) in patients with acute MI presenting at community hospitals
90%82%
0%
20%
40%
60%
80%
100%
ALKK TrialALKK Trial
Circulation. 2003;108:1324-1328
Medical TherapyPTCA
Event-free* Survival at 1 Yearp=0.06
96%89%
0%
20%
40%
60%
80%
100%
Survival at Long-term (mean 56 months)
follow-up p=0.02
Randomized trial of angioplasty (n=149) or medical therapy (n=151) in stable patients 8-42 days post acute MI
Medical TherapyPTCA* Survival free of reinfarction, ischemia-driven (re) PTCA, CABG, or rehospitalization for severe angina
If PCI After Fibrinolysis is Associated with Benefit, was PCI If PCI After Fibrinolysis is Associated with Benefit, was PCI Frequently Performed After Fibrinolysis in DANAMI 2?Frequently Performed After Fibrinolysis in DANAMI 2?
No.
As stated by the authors:“The frequency of rescue angioplasty was low.”
Rescue angioplasty was performed infrequently (15 cases, 1.9% of patients)
If PCI After Fibrinolysis is Associated with Benefit, Could the Results in the If PCI After Fibrinolysis is Associated with Benefit, Could the Results in the Fibrinolytic Arm Have Been Improved in DANAMI 2?Fibrinolytic Arm Have Been Improved in DANAMI 2?
Observational and randomized trial data from other trials presented above suggest that outcomes may have been improved if PCI had been performed more frequently after fibrinolysis, but this cannot be ascertained from the data at hand in DANAMI 2.
CM Gibson 2003CM Gibson 2003
Are Prolonged Door to Balloon Times Associated With Higher Are Prolonged Door to Balloon Times Associated With Higher Mortality?Mortality?
• Yes.
• Door to balloon delays beyond 90 minutes are associated with a rise in mortality.
4.2 4.6 5.16.7
8.5 7.9
0
2
4
6
8
10
0-60 61-90 91-120 121-150 151-180 >180
Mor
talit
y (%
)
N=27,080P < 0.00001
NRMI-2: Primary PCI Door-to-Balloon time vs. Mortality
Door-to-Balloon Time (minutes) JAMA 2000; 283:2941-7.
Primary PCI for STEMIPrimary PCI for STEMITime to Reperfusion and 30-Day MortalityTime to Reperfusion and 30-Day Mortality
Time to Reperfusion (h)Time to Reperfusion (h)
Brodie BR, et al. Brodie BR, et al. J Am Coll Cardiol.J Am Coll Cardiol. 2003;41(suppl A):368A. De Luca G, et al. 2003;41(suppl A):368A. De Luca G, et al. J Am Coll Cardiol.J Am Coll Cardiol. 2003;41(suppl A):368A. 2003;41(suppl A):368A.
00
Mor
talit
y (%
)M
orta
lity
(%)
11
22
33
55
66
44
<3<3 3-63-6
0.9
2.3 2.2
>6>6
Time to Reperfusion (h)Time to Reperfusion (h)
00
22
44
66
1010
1212
88
<2<2 2-42-4
2.5
5.6
4-64-6
9.6
P=0.04 ( 3h v 3h) P<0.001
n=1,7911994-2001
n=2,002
3.1
>6>6
CADILLAC Zwolle
Was the Door to Balloon Delay in Performing PCI 3 Hours in Was the Door to Balloon Delay in Performing PCI 3 Hours in DANAMI 2?DANAMI 2?
• No.
• It was actually much quicker at 90 to 110 minutes.
• Are door to balloon times among transfer patients this quick in the United States?
• No.
• Currently, the median delay in the US is 185 minutes, only 4.8% of arteries are opened in under 90 minutes as suggested by the ACC/AHA guidelines.
CM Gibson 2003CM Gibson 2003
DANAMI vs US AMI: DANAMI vs US AMI: Are We As Quick in the US?Are We As Quick in the US?
Pinto D, et al. Pinto D, et al. Cardiovascular Reviews and Report.Cardiovascular Reviews and Report. 2003;24:267-276. 2003;24:267-276.
0
Med
ian
Tim
e (m
in)
DANAMIOn-Site Primary PCI
DANAMITransfer Primary PCI
US AMITransfer Primary PCI
90
110
185
50
100
150
200
225
25
75
125
175
Is There A Time Dependence of the Potential Advantage of PCI Is There A Time Dependence of the Potential Advantage of PCI Over Fibrinolysis?Over Fibrinolysis?
• Yes.
• Delays in door to balloon times of over 60 minutes beyond that of a center’s door to needle time may nullify the benefits of primary PCI.
Benefits of PCI vs Lysis: The Importance of Timing
Kent DM et al Eff Clin Pract 4: 214, 2001
Are There Potential Benefits of Even Quicker Fibrinolytic Are There Potential Benefits of Even Quicker Fibrinolytic Administration Such as Pre Hospital Fibrinolytic Therapy?Administration Such as Pre Hospital Fibrinolytic Therapy?
• Yes.
• A recent meta analysis of 6 trials suggests a relative risk reduction in mortality of 16%
• The CAPTIM trial suggests that pre hospital therapy administered to those patients with a short duration of symptoms (< 2 hours) may be associated with improved clinical outcomes over primary PCI.
Favors Favors No. of Quality Pre-hospital In-hospital
Study Patients Score OR (95% CI) Thrombolysis Thrombolysis
Results of Randomized Trials of Results of Randomized Trials of Pre-hospital Thrombolysis on Hospital MortalityPre-hospital Thrombolysis on Hospital Mortality
All TrialsAll Trials
Morrison LE, et al. Morrison LE, et al. JAMA.JAMA. 2000;283:2686-2691. 2000;283:2686-2691.
MITI, 1993 360 0.91 0.69 (0.30-1.57)
EMIP, 1993 5469 0.85 0.86 (0.72-1.03)
GREAT, 1991 311 0.78 0.56 (0.25-1.23)
Roth et al, 1990 116 0.65 0.80 (0.17-3.77)
Schofer et al, 1990 78 0.63 0.46 (0.04-5.31)
Castaigne et al, 1989 100 0.48 0.74 (0.14-3.56)
Overall 6434 0.83 (0.70-0.98)
CAPTIM 1-Year ResultsCAPTIM 1-Year Results
Touboul P. Presented at: The 18th International Symposium on Thrombolysis and Interventional Therapy in Acute Myocardial Infarction - Touboul P. Presented at: The 18th International Symposium on Thrombolysis and Interventional Therapy in Acute Myocardial Infarction - George Washington University Symposium; November 16, 2002; Chicago, Ill. George Washington University Symposium; November 16, 2002; Chicago, Ill.
Sx Sx 2 h 2 h
0.0
DeathSx Sx 2 h 2 h
5.0
7.5
2.5
Pre-hospital Lysis Primary PCI
2.2
5.7
DeathP=0.057
0.0
7.5
10.0
2.5
Pre-hospital Lysis Primary PCI
5.9
3.7
DeathP=0.47
5.0
Perc
ent
CAPTIM 1-Year ResultsCAPTIM 1-Year Results
DeathSx Sx 2 h 2 h
Touboul P. Presented at: The 18th International Symposium on Thrombolysis and Interventional Therapy in Acute Myocardial Infarction - Touboul P. Presented at: The 18th International Symposium on Thrombolysis and Interventional Therapy in Acute Myocardial Infarction - George Washington University Symposium; November 16, 2002; Chicago, Ill. George Washington University Symposium; November 16, 2002; Chicago, Ill.
Sx Sx 2 h 2 h
0.0
5.0
7.5
2.5
Pre-hospital Lysis Primary PCI
1.3
5.3
Shock Randomization to DCP=0.032
0.0
7.5
2.5
Pre-hospital Lysis Primary PCI
0.0
3.6
Shock Randomization to AdmP=0.0007
5.0
Perc
ent
Is Restoration of Epicardial Blood Flow Before PCI Associated Is Restoration of Epicardial Blood Flow Before PCI Associated with Improved Clinical Outcomes in STEMI?with Improved Clinical Outcomes in STEMI?
• Yes
0.5 1.0 1.5 2.0
0.5 1.0 1.5 2.0
Facilitated PCI in STEMI: Pre-PCI Angiographic Findings and MortalityFacilitated PCI in STEMI: Pre-PCI Angiographic Findings and Mortality
In both primary PCI and adjunctive/In both primary PCI and adjunctive/rescue PCI, TIMI flow grade before PCI rescue PCI, TIMI flow grade before PCI is associated with long-term mortalityis associated with long-term mortality
In adjunctive/rescue PCI, TIMI myocardial In adjunctive/rescue PCI, TIMI myocardial perfusion before PCI is associated with perfusion before PCI is associated with long-term mortalitylong-term mortality
Stone GW, et al. Stone GW, et al. Circulation.Circulation. 2001;104:636-641. 2001;104:636-641.
0.8
0.9
1.0
00.7
3- way log-rank3- way log-rankPP=0.0013=0.0013
TFG 0/1TFG 0/1
TFG 2TFG 2TFG 3TFG 3
Surv
ival
Surv
ival
0.8
0.9
1.0
00.7
Log-rankLog-rankPP=0.03=0.03
Surv
ival
Surv
ival
TMPG 2/3TMPG 2/3TMPG 0/1TMPG 0/1
1 2 4 6
94
98
100
090
Log-rank Log-rank PP for trendfor trendPP=0.009=0.009
Surv
ival
(%)
Surv
ival
(%)
TIMI 0/1 (1,657)TIMI 0/1 (1,657)
TIMI 3 (n=375)TIMI 3 (n=375)TIMI 2 (n=295)TIMI 2 (n=295)
MonthsMonths
92
96 4.4%4.4%
0.5%0.5%
2.8%2.8%
3 5
Gibson CM, et al. Gibson CM, et al. Circulation.Circulation. 2002;105:1909-1913. 2002;105:1909-1913.
62.457.9 54.7
0
20
40
60
80
TIMI 3 on cath lab arrival TIMI 3 after leaving cath lab Never had TIMI 3
Adapted from Ross AM, et al. J Am Coll Cardiol. 1999;34:1954-1962.
% C
onva
lesc
ent L
VEF
Convalescent LV Function by Patency Group: Global Ejection Convalescent LV Function by Patency Group: Global Ejection FractionFraction
P=0.004
Probability of Regional LV Dysfunction (Abnormal Chords) Increases as Time to Probability of Regional LV Dysfunction (Abnormal Chords) Increases as Time to Achieve Reperfusion IncreasesAchieve Reperfusion Increases
Lundergan CF, et al. Lundergan CF, et al. Am J Heart.Am J Heart. 2002;144:456-462. 2002;144:456-462.
PACT Substudy: Time to Reperfusion and LV Function in MIPACT Substudy: Time to Reperfusion and LV Function in MI
Time (h)Time (h)
0.600.60
Prob
abili
tyPr
obab
ility
0.650.65
0.700.70
0.750.75
0.900.90
0.950.95
0.800.80
22 66 1010Odds RatioOdds Ratio
00 11 22 33
0.850.85
44 88 44
30
Time Delay(min)
60
90
120
Door-to-Thrombolysis in Myocardial Infarction (TIMI) Time and MortalityDoor-to-Thrombolysis in Myocardial Infarction (TIMI) Time and Mortality
Juliard J-M, et al. Juliard J-M, et al. Am J Cardiol.Am J Cardiol. 2003;91:1401-1405. 2003;91:1401-1405.
After linear logistic regression, After linear logistic regression, only age, gender, and door-to-only age, gender, and door-to-TIMI grade 3 time (OR 1.27/ TIMI grade 3 time (OR 1.27/ 15 min) were independently 15 min) were independently correlated with in-hospital correlated with in-hospital mortalitymortality
Similar to the OR of Similar to the OR of 1.6/ 25 min in GUSTO IIb trial 1.6/ 25 min in GUSTO IIb trial (Berger PB et al, (Berger PB et al, CirculationCirculation 1999;100:14-20)1999;100:14-20)
00 1 h1 h > 1 h> 1 h
22
44
66
P<0.05
n=105n=105
1.8
6.7
n=394n=394
Mor
talit
y (%
)M
orta
lity
(%)
88
11
33
55
77
Can Glycoprotein IIbIIIa Inhibition Be Administered Safely Can Glycoprotein IIbIIIa Inhibition Be Administered Safely Following Fibrinolysis in the Cath Lab?Following Fibrinolysis in the Cath Lab?
• Yes.
• Non-randomized trial data suggests that this is not only safe but tends to be associated with reduced mortality.
GP IIb/IIIa Inhibitor Use With Early PCI After Full-Dose Fibrinolytic Therapy: Clinical GP IIb/IIIa Inhibitor Use With Early PCI After Full-Dose Fibrinolytic Therapy: Clinical Outcomes and Bleeding ComplicationsOutcomes and Bleeding Complications
GP IIb/IIIa Inhibitor (n=1,032)
No GP IIb/IIIa Inhibitor (n=2,386)
Odds Ratio* 95% CI
Mortality (%) 4.6 6.6 0.71 0.49-1.01 CHF (%) 6.8 6.5 1.23 0.87-1.74Re-infarction (%) 1.8 1.5 1.07 0.56-2.03Re-PCI (%) 2.1 3.3 1.27 0.75-2.16CABG (%) 1.6 2.8 0.64 0.36-1.15ICH (%) 0.4 0.9 0.60 0.19-1.90Severe Bleeding (%) 2.2 1.7 1.64 0.93-2.88Moderate Bleeding (%) 7.1 6.5 1.47 1.07-2.02Mod-Severe Bleeding (%) 10.2 8.1 1.64 1.24-2.16
Odds Ratio represents odds of the event for patients receiving GP IIb/IIIa inhibitors. Bleeding reported by GUSTO scale categories. Odds Ratio represents odds of the event for patients receiving GP IIb/IIIa inhibitors. Bleeding reported by GUSTO scale categories. Adapted with permission from Roe MT, et al. Safety of adjunctive glycoprotein IIb/IIIa blockade during rescue/early percutaneous Adapted with permission from Roe MT, et al. Safety of adjunctive glycoprotein IIb/IIIa blockade during rescue/early percutaneous coronary intervention following full-dose fibrinolytic therapy for acute myocardial infarction. Poster presented at the American College of coronary intervention following full-dose fibrinolytic therapy for acute myocardial infarction. Poster presented at the American College of Cardiology 52nd Annual Scientific Session; March 30-April 2, 2003; Chicago, Il.Cardiology 52nd Annual Scientific Session; March 30-April 2, 2003; Chicago, Il.
P=0.06
CM Gibson 2003CM Gibson 2003
GP 2b3a Inhibition After Full Dose LysisGP 2b3a Inhibition After Full Dose Lysis
Assess risk of ICH: High Risk: elderly female, low body weight,
elevated blood pressure, elevated Cr, inferior MI
Low Risk: young male, large, normotensive, normal Cr, anterior MI
Assess Fibrinogen Depletion:Stat fibrinogen on pt. arrival, ? above 100TNK does not deplete fibrinogen, drug of choice for
combination with PCItPA drops near 100 for 18-24 hrsrPA often dips below 100 for 18-24 hrs
CM Gibson 2003CM Gibson 2003
ConclusionsConclusions
• Time is muscle irrespective of the reperfusion strategy (drug or device)
• Benefits of PCI over fibrinolytic therapy are explained at least in part by a reduction in recurrent MI among patients treated with PCI
• In the modern era of interventional cardiology (stents, thienopyridines, GP 2b3a inhibition), the performance of PCI after fibrinolytic administration may reduce the risk of recurrent MI and may be associated with reduced long term mortality compared to fibrinolysis alone
CM Gibson 2003CM Gibson 2003
ConclusionsConclusions
• Safety and efficacy of full dose fibrinolytic monotherapy is well characterized while half dose fibrinolytic monotherapy is not well characterized
• Half dose fibrinolysis with simultaneous full dose GP 2b3a inhibition (“combination therapy”) is equal in clinical efficacy to fibrinolytic monotherapy but is associated with more major bleeding (GUSTO V, ASSENT 3)
• This is in contrast to full dose fibrinolytic monotherapy followed by full dose GP2b3a inhibition in the cardiac catheterization laboratory (hours later) which in non-randomized data tends to be associated with lower mortality (4.6% vs 6.6%, p=0.06) yet with a slight rise in moderate (7.1% vs 6.5%) and severe (2.2% vs 1.7%) bleeding
CM Gibson 2003CM Gibson 2003
ConclusionsConclusions
• Future prospective randomized trials will assess the efficacy of a variety of fibrinolytic and other pharmacologic agents before PCI and the concept of “facilitated PCI”
CM Gibson 2003CM Gibson 2003
Designs of Upcoming Facilitated PCI TrialsDesigns of Upcoming Facilitated PCI Trials
ASSENT 4 TNK Heparin/ASAADVANCE TNK +
IntegrilinIntegrilin
TITAN Integrilin in ER
Integrilin in cath lab
FINESSE r-PA r-PA + abciximab in ER vs CCL
CM Gibson 2003CM Gibson 2003
Selection of the Optimal Reperfusion Options for the STEMI Patient: 2003Selection of the Optimal Reperfusion Options for the STEMI Patient: 2003
Full Dose Fibrinolytic Monotherapy •Door to balloon (D-B)
> 90 min•Lack of access to skilled PCI center•(D-B) – (D-N) > 1 h•< 1 h from symptom onset
Invasive Strategy • Cardiogenic shock (age < 75)• Bleeding risk• Diagnosis in doubt
(pericarditis/aneurysm)• Door to balloon < 90 min• Skilled PCI center available, defined
by:– Operator experience > 75 cases/yr– Team experience > 36 primary PCI/yr
• Age > 75• Symptoms > 2-3 hCM Gibson 2003CM Gibson 2003