GRACIA: Old news supports more recent facilitated PCI studies

Shelley Wood

September 16, 2004

London, UK - More than two years after the 30-day findings were presented at the 2002 European Society of Cardiology (ESC) meeting, the full Grup de Analisis de la Cardiopatia Isquemica Aguda (GRACIA) resultsshowing early catheterization after thrombolysis to be preferable to conservative managementhave been published in the September 18, 2004 issue of the Lancet[1]. Indeed, the promising results from GRACIA formed the basis for GRACIA-2, comparing facilitated PCI with PCI alone, presented the following year at the ESC.

Now, as the full results from GRACIA appear in print for the first time, the investigators, led by Dr Francisco Fernandez-Avilés (Hospital Universitario de Valladoid, Spain), say, "These results show the feasibility and safety of postthrombolysis stenting and could be regarded as a basis for further studies aimed at assessing the effectiveness of combined pharmacomechanical reperfusion strategies widely applicable in the earliest phase of STEMI."

Proponents of the facilitated angioplasty approach are also looking ahead to the results of ASSENT 4, expected for 2005. Until then, Dr Frans Van de Werf (Gasthuisberg University Hospital, Leuven, Belgium) commented when GRACIA-2 was presented at the ESC 2003 meeting, "Pharmacological therapy before PCI should still be considered as an experimental treatment."

GRACIA results

The original GRACIA study enrolled 500 patients who had undergone thrombolysis for STEMI with recombinant tPA. They were then randomized to angiography and intervention if indicated within 24 hours of thrombolysis or ischemia-guided conservative management.

At 30 days, there were no differences in the rate of the combination of death, reinfarction, or revascularization between the two groups, although the rate of revascularization was, as expected, higher in the conservative group. At 12 months, patients in the invasive group had a lower rate of death, reinfarction, or revascularization, the primary end point of the study, and trended toward reduced death or reinfarction.

There were no significant differences in major bleeding or vascular complications.

GRACIA: 12-month outcomes

End point

Invasive

Conservative

p

Death, reinfarction, or revascularization (%)

9 21 0.0008

Death, reinfarction (%)

7 12 0.07

In a Comment accompanying the GRACIA results, Dr Freek WA Verheugt (University Medical Centre, Nijmegen, the Netherlands) observes that the results support a strategy of "lyse now, stent later [2]."

"The grace of this strategy is, of course, not only attractive to patients but also for the catheterization and ambulance teams, who might see more effective use of their servicesand more undisturbed night shifts."

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