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ESC Congress 2003: Reopening the closed artery after an acute myocardial infarction: is it useful? Results from a French randomized multicenter trial: DECOPI

September 01, 2003

IMPORTANT: This press release accompanies both a presentation and an ESC press conference given at the ESC Congress 2003. Written by the investigator himself/herself, this press release does not necessarily reflect the opinion of the European Society of Cardiology

ESC Congress 2003: Hot Line II - Acute coronary syndromes / percutaneous coronary intervention

Acute myocardial infarction is typically caused by abrupt blockage of a coronary artery. Timely reopening of the artery by clot dissolving agents (thrombolysis) or by angioplasty may salvage myocardium, preserve myocardial function and reduce mortality. However, for this treatment to be effective, it must be implemented within the first 12 hours after the onset of symptoms and patients often seek medical attention too late. When patients are seen later, there is controversy whether or not it is beneficial to reopen the closed vessel by angioplasty. On one hand, it is hoped that reopening the vessel, even late, may preserve the function of the heart, reduce the risk of arrythmia and provide a rescue channel for blood to flow in the event that another coronary artery develops a blockage. On the other hand, it is too late to salvage myocardium and there are risks and costs to the procedure of angioplasty.

While seeing patients too late for providing timely reperfusion is a frequent situation (occurring in up to 30% of patients with acute myocardial infarction), there is currently no agreement on the best strategy for these patients.

We therefore set up a french randomized clinical trial, called DECOPI, supported by public funding from the Programme Hospitalier de Recherche Clinique from the french Ministry of Health, by the Fondation pour la Recherche Médicale, and the Caisse Nationale d'Assurance Maladie des Travailleurs Salariés from France. The trial compared angioplasty to conventional medical therapy in patients with a complete occlusion of a large coronary artery 2 to 15 days after an acute myocardial infarction. 212 patients were enrolled in 34 hospitals (33 in France, one in Belgium) between 1998 and 2001 and randomly assigned to angioplasty of the closed infarct artery or medical therapy. The primary criterion to compare treatments was the occurrence of cardiovascular death, myocardial infarction or ventricular arrythmia. The comparison between the 2 groups at baseline showed no major difference in baseline characteristics. After an average of 34 months of follow up, the comparison between the two strategies shows no difference in the primary endpoint (8.7% in the medical group, 7.3% in the PCI group, p=0.64). There were also no differences between groups in the rates of death, myocardial infarction, ventricular arrythmias, admission for heart failure, admissions for cardiac causes, revascularizations or ischemia on a 6-month stress test.

Due to spontaneous recanalization on one hand and reocclusions on the other, at 6 month, patency of the infarct artery was seen in 39.7% of the patients in the medical arm and 82.7% of patients in the angioplasty arm (p<0.0001). Importantly, there was a 47.1% restenosis rate in the angioplasty arm. At 6 months, angiographic left ventricular ejection fraction was superior by approximately 3.5% in the angioplasty arm (p=0.025). Functional status at the end of the trial (dyspnea and angina) was comparable between groups. Costs were higher in the angioplasty arm (13484 EUR vs 12468 EUR, p < 0.0001).

Overall, the event rates in this population were low and there was no obvious clinical benefit to systematic angioplasty of the infarct related vessel. Although it was associated with a higher left ventricular ejection fraction at 6 months and a higher patency, this did not translate into statistically significant differences in outcomes, but did result in higher costs.

In conclusion, these results suggest that indiscriminate late reopening of the infarct vessel after acute myocardial infarction is probably associated more with costs than with clinical benefits. Because these results were observed in a small population at relatively low risk, care should be exercised before drawing too general conclusions. Whether a strategy of angioplasty would be beneficial in a higher risk population is currently being tested in a large scale international trial: the OAT study.

Philippe Gabriel Steg
Hôpital Bichat, Service de Cardiologie, Paris,
France

European Society of Cardiology (ESC)