Multicenter randomized trial of facilitated percutaneous coronary intervention with low-dose tenecteplase in patients with acute myocardial infarction: the Athens PCI trial.
OBJECTIVE
To examine the safety and efficacy of low-dose tenecteplase, administered before facilitated percutaneous coronary intervention (PCI) to restore Thrombolysis In Myocardial Infarction (TIMI) grade 2 or 3 blood flow in the infarct related artery (IRA) in patients with ST elevation myocardial infarction (STEMI) scheduled to undergo PCI with a shortest anticipated delay of 30 min.


BACKGROUND
PCI preceded by administration of glycoprotein IIb/IIIa inhibitors, full-dose thrombolytics, or both, is associated with no benefit or a higher incidence of adverse events than PCI alone.


METHODS
Patients with STEMI < 6 hr in duration were randomly assigned to PCI preceded by tenecteplase, 10 mg (facilitated PCI group, n = 143) versus standard PCI (control group, n = 141). All patients received aspirin and unfractionated heparin (70 IU/kg bolus) at time of randomization. Both groups received IIb/IIIa inhibitors in the catheterization laboratory and for at least 20 hr after PCI.


RESULTS
The median door-to-balloon time was 122 min (91-175) in the facilitated PCI versus 120 min (89-175) in the control group. IRA patency on arrival in the catheterization laboratory was 59.5% in the facilitated PCI (24% TIMI-2, 35% TIMI-3), versus 37% in the control (8% TIMI-2, 29% TIMI-3) group (P = 0.0001). During hospitalization, 9 patients (6%) died in the facilitated PCI versus 5 patients (3.5%) in the control group (P = 0.572). A single patient in the facilitated PCI group suffered a non-fatal ischemic stroke.


CONCLUSIONS
Facilitated PCI with low-dose tenecteplase in patients presenting with STEMI was associated with a high IRA patency rate before PCI.
Kanakakis
John
J
Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece.
Nanas
John N
JN
Tsagalou
Eleftheria P
EP
Maroulidis
George D
GD
Drakos
Stavros G
SG
Ntalianis
Argirios S
AS
Tzoumele
Panagiotis
P
Skoumbourdis
Emmanuel
E
Charbis
Panagiotis
P
Rokas
Stylianos
S
Anastasiou-Nana
Maria
M
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000401:mortality; D000925:Anticoagulants / Q000008:administration & dosage; D001241:Aspirin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D003326:Coronary Circulation; D004334:Drug Administration Schedule; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006115:Greece; D006493:Heparin / Q000008:administration & dosage; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D010360:Patient Transfer; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D000077785:Tenecteplase; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000401:mortality; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014654:Vascular Patency
D000925:Anticoagulants; D005343:Fibrinolytic Agents; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D006493:Heparin; D010959:Tissue Plasminogen Activator; D001241:Aspirin; D000077785:Tenecteplase