Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial.

AIMS 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. METHODS AND 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). CONCLUSION 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.