View source for EBQ:A Comparison of Coronary Angioplasty with Fibrinolytic Therapy in Acute Myocardial Infarction

{{JC info
| title= A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction
| abbreviation= 
| expansion=
| published= 2003 Aug 21
| author= Andersen H
| journal= NEJM
| year= 2003
| volume= 349
| issue=8
| pages= 733-42
| pmid= 12930925
| fulltexturl= http://www.nejm.org/doi/full/10.1056/NEJMoa025142
| pdfurl=http://www.nejm.org/doi/pdf/10.1056/NEJMoa025142
|status =Under Review
}}
==Clinical Question==
In hospitals without PCA is transfer to centers with PCA superior to on site fibrinolytic therapy for STEMI?

==Conclusion==
Transfer of patients to treatment centers with PCA for reperfusion is superior to fibrinolytic therapy, given that the transfer take 2 hours or less.

==Major Points==
*The composite endpoint favors angioplasty over fibrinolysis.  Both referral centers and invasive centers show significant decrease in composite endpoints of the angioplasty group.
**The decrease in composite endpoint is mainly driven by a decrease in re-infarction rates.  Re-infarction is associated with a significant increase in 30 day mortality.
*Enrollment in the study was stopped after a third interim analysis that showed angioplasty was favorable to fibrinolysis in referral center subgroup
*Most patient's received intervention 2 hours after randomization, including referral center group
**Ability for quick intervention 
**Likely similar to Western countries

==Study Design==
*Cohort study of Danish patients with MI: Angioplasty vs. Fibrinolysis
**Subgroup analysis
***24 referral hospitals without PCA capability
***5 intervention centers with PCA capability

==Population==
*N= 1572
**Referral hospitals
***Fibrinolysis N=562
****Median time of onset of symptoms to treatment: 169 min
***Angioplasty N=567
****Median time of onset of symptoms to treatment: 224 min
**Invasive centers
***Fibrinolysis N=220
****Median time of onset of symptoms to treatment: 160 min
***Angioplasty N=223
****Median time of onset of symptoms to treatment: 188 min
===Patient Demographics===
*Demographics such as age, sex, comorbidities, and medications were analyzed.
**No statistical difference between groups
*Angiographic features were recorded but not analyzed between referral and invasive centers

===Inclusion Criteria===
*Age 18 yrs or older
*Symptoms for 30 min to 12 hrs
*ST segment elevation of 4 mm in at least 2 contiguous leads
 
===Exclusion Criteria===
*Contraindication to fibrinolysis
*LBBB
*Acute MI and fibrinolytic treatment within previous 30 days
*Pulseless femoral arteries
*Previous coronary bypass surgery
*Serum CR >2.83
*Use of metformin
*Non-ischemic heart disease
*Life expectancy <1 yr due to non-cardiac causes
*High risk during transportation
**Cardiogenic shock/severe CHF (sustained SBP<65)
**Persistent life threatening arrhythmia
**Mechanical ventilation

==Interventions==
*'''Fibrinolysis'''
**300 mg ASA PO
**IV BB 
**TPA (Ateplase)
***bolus 15 mg
***0.75 mg/kg over 30 min followed by 0.5 mg/kg over 60 min
**Unfractionated heparin
***bolus 5000U
***48 hr infusion to maintain PTT 70-90 sec 
*'''Angioplasty'''
**300 mg ASA IV
**IV BB (same as fibrinolytic group)
**Unfractionated heparin 10,000 U
***Additional heparin to achieve a goal activated clotting time of 350-450 sec
**IIb/IIIa blockers at discretion of physician
**Stenting
***Total occlusion, 30% stenosis culprit lesion, or <TIMI 3 flow
***Vessels <2mm diameter excluded
**Ticlopidine or Clopidogrel x 1 month post stenting

*Failure: No resolution of or recurrent ST elevation
**Repeat fibrinolysis prior to rescue angioplasty (fibrinolysis group)
**Repeat angioplasty (angioplasty group)

==Outcomes==
*Analysis with intention to treat principle

===Primary Outcome===
*Composite endpoint of death, clinical re-infarction, or disabling stroke at 30 days

*'''Death'''
**All hosptials
***Fibrinolysis: 7.8%
***Angioplasty: 6.6%
:p value = 0.35
 
*'''Re-infarction'''
**All hosptials
***Fibrinolysis: 6.3%
***Angioplasty: 1.6%
:p value = <0.001

*'''Disabling Stroke'''
**All hosptials
***Fibrinolysis: 2.0%
***Angioplasty: 1.1%
:p value = 0.15

*'''Compositie Endpoint'''
**All hosptials
***Fibrinolysis: 13.7%
***Angioplasty: 8.0%
:p value = <0.001

===Secondary Outcomes=== 
 
 

===Subgroup analysis===
*'''Death'''
**Referral hospitals
***Fibrinolysis: 8.5%
***Angioplasty: 6.5%
:p value = 0.20
**Invasive centers
***Fibrinolysis: 5.9%
***Angioplasty: 6.7%
:p value = 0.72
 
*'''Re-infarction'''
**Referral hospitals
***Fibrinolysis: 6.2%
***Angioplasty: 1.9%
:p value = <0.001
**Invasive centers
***Fibrinolysis: 6.4%
***Angioplasty: 0.9%
:p value = 0.002

*'''Composite Endpoint'''
**Referral hospitals
***Fibrinolysis: 14.2%
***Angioplasty: 8.5%
:p value = 0.02
**Invasive centers
***Fibrinolysis: 12.3%
***Angioplasty: 6.7%
:p value = 0.05

==Criticisms & Further Discussion==
*3 out of 5 intervention centers did not offer PCA as routine treatment prior to implementation of the study
*Significance of composite endpoint decrease and therefor favorability of angioplasty was driven by re-infarction rates
**There was no significant difference in the rate of death or disabling stroke at 30 days
*Timing of onset of symptoms to various endpoints are noted.  However, it is unclear how timing effects the endpoints.  The author comments that most patients have a time of <2 hours from randomization to treatment.  
**It is unclear where "randomization" falls into the typical patient visit. 
**The suggested threshold of <2 hours is unclear
**There is no mention of meaningfulness of symptom onset

==Funding==
Danish Heart Foundation, the Danish Medical Research Council, AstraZeneca, Bristol-Myers Squibb, Cordis, Pfizer, Pharmacia–Upjohn, Boehringer Ingelheim, and Guerbet.

==References==
<references/>

[[Category:EBQ]]
[[Category:Cardiology]]