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PRimary Angioplasty in patients transferred from General community hospitals to specialized PTCA Units with or without Emergency thrombolysis - PRAGUE
Description:
The PRAGUE trial compared clinical outcomes using three strategies of reperfusion for acute myocardial infarction (AMI): 1) on-site fibrinolytic therapy in community hospitals, 2) fibrinolytic therapy during transfer to a tertiary center for angioplasty, and 3) immediate transportation for primary angioplasty without pretreatment with a fibrinolytic agent.
Hypothesis:
Transfer of patients from community hospitals to tertiary care angioplasty centers would be feasible and safe, and would be associated with a reduced incidence of death, reinfarction, and stroke at 30 days.
Study Design
Study Design:
Patients Screened: 1,588
Patients Enrolled: 300
Mean Follow Up: 30 days
Mean Patient Age: mean 62
Female: 30
Patient Populations:
AMI (ST elevations >1 mm in at least two leads or a new bundle branch block on the initial electrocardiogram) <6 hours after onset of symptoms, time to angioplasty centre <60 minutes (distance was <75 km in all participating hospitals), feasibility to begin the transport to the centre within 30 minutes of randomization, and signed written informed consent
Exclusions:
Contraindication to fibrinolytic therapy and absence of bilateral femoral artery pulsations
Primary Endpoints:
Composite at 30 days of death, reinfarction, and stroke
Secondary Endpoints:
Individual components of the composite primary endpoint; procedural success; and procedural complications
Drug/Procedures Used:
Three arms:
1) On-site fibrinolytic therapy: streptokinase 1.5 ml/U over 45-60 minutes, lysin salicylate 900 mg intravenously (IV), and fraxiparin 0.8 ml/s for three days.
2) Fibrinolytic therapy during transfer: transport for percutaneous coronary intervention (PCI) immediately after starting the above fibrinolytic regimen and adjunctive medications. Following PCI, patients were given ticlodipine 500 mg for one month.
3) Immediate transfer for primary percutaneous transluminal coronary angioplasty (PTCA): transport to tertiary center for PCI immediately, lysine salicylate 900 mg IV, heparin 10,000 units IV (and additional as needed during PCI), fraxiparin 0.8 ml/s for three days, and ticlodipine 500 mg for one month. Stents were used if anatomically suitable.
Concomitant Medications:
As stated above
Principal Findings:
Three hundred of 1,588 patients presenting to participating community hospitals without catheterization laboratories were enrolled in the trial and randomized. There were two episodes of ventricular fibrillation (successfully treated) and no deaths in the groups of patients transported to tertiary centers. Transport times were <40 minutes, with a door-initiation of fibrinolytic time of 22 minutes in the fibrinolytic arm, door-balloon time of 95 minutes in the immediate transfer arm, and door-balloon time of 108 minutes in the fibrinolytic/transfer arm.
There were higher rates of TIMI 3 flow on angiography prior to PCI in patients receiving fibrinolytic therapy during transfer compared to patients transferred immediately (30% vs. 12%). The incidence of the combined endpoint of death/reinfarction/stroke was lower in patients transported for PCI (23% in the fibrinolytic only arm, 15% in the fibrinolytic/transfer arm, and 8% in the immediate transfer arm, p<0.02), driven largely by a reduction in reinfarction.
Interpretation:
The <40 minute transfer time is notable, and the overall door-balloon time of 95 minutes (including transfer) make this study less generalizable to systems of care in which transfer times and door-to-balloon times are greater. The PRAGUE-1 study used streptokinase as a fibrinolytic.
Among patients with AMI enrolled in this European trial based in the Czech Republic, transferring patients with AMI for PCI was safe and feasible, and was associated with a reduction in 30-day death, MI, or stroke. It is unclear how other fibrinolytic agents associated with more rapid arterial patency would compare.
References:
Widimsky P, Groch L, Zelizko M, Aschermann M, Bednar F, Suryapranata H. Multicentre randomized trial comparing transport to primary angioplasty vs immediate thrombolysis vs combined strategy for patients with acute myocardial infarction presenting to a community hospital without a catheterization laboratory. The PRAGUE study. Eur Heart J 2000;21:823-31.
Keywords: Thrombolytic Therapy, Salicylates, Myocardial Infarction, Stroke, Ventricular Fibrillation, Fibrinolytic Agents, Electrocardiography, Lysine, Angioplasty, Balloon, Coronary, Stents, Streptokinase, Mucoproteins, Catheterization, Bundle-Branch Block, Nadroparin
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