Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial.
OBJECTIVE
In patients with acute myocardial infarction and ST-segment elevation (STEMI), primary angioplasty is frequently not available or performed beyond the recommended time limit. We designed a non-inferiority, randomized, controlled study to evaluate whether lytic-based early routine angioplasty represents a reasonable reperfusion option for victims of STEMI irrespective of geographic or logistical barriers.


RESULTS
A total of 212 STEMI patients were randomized to full tenecteplase followed by stenting within 3-12 h of randomization (early routine post-fibrinolysis angioplasty; 104 patients), or to undergo primary stenting with abciximab within 3 h of randomization (primary angioplasty; 108 patients). The primary endpoints were epicardial and myocardial reperfusion, and the extent of left ventricular myocardial damage, determined by means of the infarct size and 6-week left ventricular function. The secondary endpoints were the acute incidence of bleeding and the 6-month composite incidence of death, reinfarction, stroke, or revascularization. Early routine post-fibrinolysis angioplasty resulted in higher frequency (21 vs. 6%, P = 0.003) of complete epicardial and myocardial reperfusion (TIMI 3 epicardial flow and TIMI 3 myocardial perfusion and resolution of the initial sum of ST-segment elevation > or = 70%) following angioplasty. Both groups were similar regarding infarct size (area under the curve of CK-MB: 4613 +/- 3373 vs. 4649 +/- 3632 microg/L/h, P = 0.94); 6-week left ventricular function (ejection fraction: 59.0 +/- 11.6 vs. 56.2 +/- 13.2%, P = 0.11; endsystolic volume index: 27.2 +/- 12.8 vs. 29.7 +/- 13.6, P = 0.21); major bleeding (1.9 vs. 2.8%, P = 0.99) and 6-month cumulative incidence of the clinical endpoint (10 vs. 12%, P = 0.57; relative risk: 0.80; 95% confidence interval: 0.37-1.74).


CONCLUSIONS
Early routine post-fibrinolysis angioplasty safely results in better myocardial perfusion than primary angioplasty. Despite its later application, this approach seems to be equivalent to primary angioplasty in limiting infarct size and preserving left ventricular function.
Fernández-Avilés
Francisco
F
Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, C/ Doctor Esquerdo 46, 28007, Madrid, Spain. faviles@secardiologia.es
Alonso
Joaquín J
JJ
Peña
Gonzalo
G
Blanco
Jesús
J
Alonso-Briales
Juan
J
López-Mesa
Juan
J
Fernández-Vázquez
Felipe
F
Moreu
José
J
Hernández
Rosa A
RA
Castro-Beiras
Alfonso
A
Gabriel
Rafael
R
Gibson
C Michael
CM
Sánchez
Pedro L
PL
D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000925:Anticoagulants / Q000627:therapeutic use*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000473:pathology / Q000628:therapy*; D012008:Recurrence; D016879:Salvage Therapy / Q000379:methods; D015607:Stents; D000077785:Tenecteplase; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000209:etiology
D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase; D000077284:Abciximab