a pharmaco-invasive reperfusion strategy with immediate percutaneous coronary intervention is safe...
TRANSCRIPT
A Pharmaco-invasive Reperfusion Strategy with Immediate Percutaneous
Coronary Intervention is Safe and Effective in ST-Elevation Myocardial
Infarction Patients with Expected Delays Due to Long Distance Transfer
David M. Larson, Chris Solie,Scott Sharkey,Sue Duval, Steven Mulder, Joan Krikava, Timothy Dirks, Peter Stokman, James Madison,Barbara Unger, James Harris, Robert Westin, Debra
Nyquist, Timothy Henry
Background
• Primary PCI is the preferred reperfusion strategy for STEMI patients if it can be done in a timely manner
• Only 25% of hospitals in the US are capable of Primary PCI
• 82% of STEMI patients transferred from non-PCI hospitals for Primary PCI have Door to Balloon times > 120 minutes (ACC/NCDR) Chakrabarti, JACC 2008
Reperfusion Options for Patients with Expected Delays1) Full-dose fibrinolytic, admission to non-PCI
hospital with ischemia guided transfer for rescue PCI
2) Full-dose fibrinolytic, routine transfer to PCI hospital with aggressive rescue PCI
3) Primary PCI (no matter how long it takes)
4) Full or reduced dose fibrinolytic with transfer for immediate PCI (Pharmaco-invasive strategy)
5) Any of the above depending on the PCI facility and Cardiologist on call
Current Guidelines for STEMI Patients With
Expected Delays to PCI
Fibrinolysis Recommended if:
ACC/AHA ESC
First Medical Contact (Door) to balloon
> 90 minutes > 120 minutes
Unresolved Issues
• Timing of PCI following fibrinolysis
• Optimal pharmacologic regimen
Study Objective
• Assess the safety and efficacy of a pharmaco-invasive approach utilizing half dose fibrinolytic, Clopidogrel (600mg), UFH and ASA combined with transfer for immediate PCI in patients transferred from rural hospitals located long distances from a PCI center
• Prospective registry data from the “Level 1 MI” program of the Minneapolis Heart Institute at Abbott Northwestern Hospital (ANW)
• Included all STEMI patients from 4/03 to 12/08, presenting directly to the PCI hospital (ANW) or transferred from 30 community hospitals
• No exclusions for age, cardiac arrest or cardiogenic shock
Methods
PPCI
Ph-Inv
Primary PCI protocol (Zone 1 < 60 miles)
Aspirin 324mgClopidogrel 600mgUFH 60/kg load, 12/kg/hr infusionMetoprolol 25mg PO
Ph-Inv PCI protocol (Zone 2: 60-210 miles)
Aspirin 324mg POClopidogrel 600mg POUFH 60/kg load, 12/kg/hr infusionMetoprolol 25mg PO½ dose Fibrinolytic
Total STEMIN=2,262
PCI HospN=496
Zone 1 HospN=1,031
Zone 2 HospN=735
PPCIN=496
PPCIN=1,005
Ph-InvN=26
Ph-InvN=580
PPCIN=155
PPCIN=1,501
Ph-InvN=606
Baseline characteristicsPPCI PPCI Ph-InvPh-Inv P value
Age62.1 ± 14.7 63.3 ± 13.6 0.083
Patients ≥ 75394 (23.8) 147 (24.3) 0.82
Male1176 (71.0) 446 (73.6) 0.23
Hyperlipidemia861 (54.0) 314 (54.0) 0.99
Hypertension945 (57.6) 332 (54.9) 0.26
Diabetes250 (15.2) 99 (16.4) 0.50
Current Smoking620 (37.8) 247 (41.0) 0.17
History of MI315 (19.1) 114 (18.8) 0.88
History of CABG115 (7.0) 34 (5.6) 0.25
History of PCI333 (20.2) 111 (18.3) 0.32
Clinical characteristicsPPCIPPCI Ph-InvPh-Inv P value
Cardiogenic shock
before PCI
166 (10.0) 47 (7.8) 0.10
Cardiac arrest
before PCI
154 (9.3) 42 (6.9) 0.076
Out of hosp cardiac
arrest
96 (5.8) 23 (3.8) 0.059
Anterior MI558 (34.4) 211 (35.3) 0.71
Killip Class 2-4233 (14.1) 82 (13.5) 0.74
LBBB57 (3.5) 14 (2.3) 0.16
TIMI Risk score4.2 ± 2.4 4.2 ± 2.5 0.94
PCI HospPPCIPPCIN=496
Zone 1 (<60)PPCIPPCIN=1,005
Zone 2 (60-210)Ph-InvPh-InvN=606
P valuePCI Hosp vs. Zone 2
D2B time 64 (44,84) 95 (81,117) 123 (102,151) <0.0001
Mortality hospital
5.0% 4.4% 5.5% 0.76
Mortality 30 day
5.7% 5.2% 5.8% 0.93
Reischemia30 days
3.0% 0.9% 1.0% 0.014
Major Bleeding
1.4% 0.7% 1.2% 0.71
Stroke 30 days
1.2% 0.5% 1.0% 0.73
Results
ICH in Pharmaco-invasive patients
• 3 Intracranial hemorrhage (0.5%) 74 yr old male – survived 82 yr old female – survived 57 yr old male – survived
Kaplan-Meier Survival
0.00
0.25
0.50
0.75
1.00
Su
rviv
al p
rob
ab
ility
0 100 200 300 400Days since presentation
PPCI
PI
One-Year Survival
PPCIPh-Inv
Pre-PCI Patency
47.1
72.7
0
10
20
30
40
50
60
70
80
TIMI 2/3
Per
cent
age
of p
atie
nts
P<0.001
PPCI
Ph-Inv
Summary• Pharmacologic Regimen: ½ dose Fibrinolytic, Clopidogrel
600mg, UFH, ASA combined with transfer for immediate PCI• All patients included unless contraindication to fibrinolytic
Cardiogenic shock – 8% Elderly – 24% ≥ 75yrs
• Timing: Median D2B time – 123 minutes• Safety: No differences in major bleeding or stroke• Efficacy:
Increased pre-PCI patency Mortality similar to non-transfer PPCI patients Reduced re-ischemia compared to non-transfer PPCI
patients
A pharmaco-invasive approach utilizing a reduced dose fibrinolytic combined with immediate transfer for PCI is a safe and effective reperfusion strategy for STEMI patients with expected delays due to long distances to a PCI center
Conclusion
Thank you