Results of a randomised trial in this week's issue of THE LANCET suggest that a more aggressive approach involving coronary angioplasty soon after anti-clotting medical therapy is safe and could offer a better prognosis than more conservative treatment for patients who have had heart attack.
Medical therapy to reduce blood clotting (fibrinolysis) is widely used to treat people after heart attack. Coronary angioplasty is also effective for patients with heart attack, although the time taken to transfer patients to cardiac centres limits its use. Current guidelines do not recommend angioplasty soon after medical therapy because of concerns about increased risk of bleeding and other cardiovascular problems.
Investigators in the GRACIA-1 trial assessed whether, in an era of more sophisticated angioplasty materials and newer anti-clotting agents, coronary angioplasty within 24 hours of medical therapy could improve the outcome for heart-attack patients compared with those treated conservatively (medical therapy and subsequent angioplasty if indicated by ischaemia). 500 patients from Spain and Portugal who had a heart attack accompanied by a change in ECG profile known as STEMI (ST segment elevation myocardial infharction) were randomly assigned to either type of treatment.
The primary endpoint of the study--the combined rate of death, reinfarction, or revascularisation at 12 months--was more than halved among patients given angioplasty soon after medical therapy compared with those treated conservatively (9% compared with 21%). At 30 days both groups had a similar incidence of cardiac events. In-hospital incidence of revascularisation induced by spontaneous recurrence of ischaemia was higher in patients in the conservative group than in those in the invasive group.
Investigator Francisco Fernandez-Avilés (Hospital Universitario de Valladolid, Spain) comments: "Some practical conclusions can be drawn from the GRACIA-1 trial. First, the results reinforce recent evidence about the benefit of early intervention over a conservative approach for patients with acute coronary syndromes in the era of modern antiplatelets and stenting. According to our results, the benefit of early intervention not only applies to patients with acute coronary syndromes without ST-segment elevation but also to patients with STEMI treated with thrombolytics. The importance of this finding for clinical practice relates to the fact that, unlike primary angioplasty, the strategy of stenting hours after intravenous thrombolysis is applicable to the entire population with acute myocardial infarction, and represents a good alternative for the still high proportion of patients with STEMI for whom primary angioplasty is not available".
In an accompanying commentary (p 1014), Freek Verheugt (University Medical Center St Radboud, Nijmegen, Netherlands) concludes: "The major advantages of an elective intervention (mean 17 hours after lysis) in GRACIA are the day-time logistics for transport and catheterisation, and the absence of bleeding induced by lytic-therapy angioplasty. The grace of this strategy is, of course, not only attractive to patients but also for the catheterisation and ambulance teams…However, both GRACIA and ALKK [a similar trial from Germany} are too small to be conclusive about long-term mortality, the only hard endpoint in trials with an open design."
Contact: Professor Francisco Fernandez-Avilés, Instituto de Ciencias del Corazón ICICOR, Hospital Universitario de Valladolid, Ramón y Cajal 3, 47005, Valladolid, Spain;
T) 34-98-342-0026;
faviles@secardiologia.es
Professor Freek W A Verheugt, Department of Cardiology, University Medical Centre, Heartcenter 540 Cardiology, PO Box 9101, 6500 HB Nijmegen, Netherlands ;
T) 31-24-361-4220 ;
f.verheugt@cardio.umcn.nl
Journal
The Lancet