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Randomized trial of occluded artery angioplasty after acute myocardial infarction - DECOPI
Description:
The goal of the DECOPI trial was to evaluate the efficacy of PCI compared with medical therapy in patients with an occluded artery 2-15 days post-MI.
Study Design
Study Design:
Patients Enrolled: 212
Mean Follow Up: Follow-up at 6 months and 2 years (mean 33-35 months)
Mean Patient Age: mean age 57 years
Female: 15
Mean Ejection Fraction: Baseline mean 37%
Patient Populations:
First Q-wave MI within 2-15 days; TIMI flow grade 0/1; proximal lesion; age 20-75 years
Exclusions:
Left main lesion; CABG needed; PCI not technically feasible
Primary Endpoints:
Composite endpoint of cardiac death, recurrent MI, ventricular tachyarrhythmia
Secondary Endpoints:
Primary endpoint + CHF; 6 month LVEF; 6 month patency; total mortality
Drug/Procedures Used:
Patients with an occluded artery 2-15 days post-MI were randomized to PCI (n=109) or medical therapy (n=103). Medical therapy consisted of aspirin, beta-blocker, and ACE-inhibitors when indicated. In the PCI arm, stents were recommended and use of glyocprotein IIb/IIIa inhibitors were left to the discretion of the investigator. Holter testing and LV grams were performed at 6 month follow-up, and clinical status was assessed through 2 years.
Principal Findings:
The trial was discontinued early due to slow enrollment. Median time from MI to PCI was 8 days. Single vessel disease was present in 62% of patients in the medical therapy arm and 71% of patients in the PCI arm. Stents were used in 80.4% and glyocprotein IIb/IIIa inhibitors in 9.4% of patients in the PCI arm. There was no difference in the primary endpoint of cardiac death, MI or ventricular tachyarrhythmia between the two treatment arms (8.7% in medical therapy vs 7.3% in PCI arm, p=0.68). Among the individual components of the composite endpoint, there were no ventricular tachyarrhythmia, and there was no difference in cardiac death (6.8% vs 5.5%, p=0.63) or recurrent MI (1.9% vs 2.7%, p=0.70). There was also no difference in the primary endpoint+CHF (12.6% vs 10.1%, p=0.56) or CHF alone (4.8% vs 2.7%, p=0.43). At 6 month angiographic follow-up, patency was present more frequently in the PCI arm (82.8% vs 34.2%, p<0.001), and LVEF was higher (median 59% vs 54%, p=0.013). Spontaneous recanilization within 6 months occurred in 25% of medical therapy patients. Total cost during follow-up was lower in the medical therapy arm (10,809 vs 13,484 Euro, p<0.0001) driven primarily by cost during the initial treatment (6,511 vs 9,266 Euro, p<0.0001).
Interpretation:
Among patients with an occluded artery 2-15 days post-MI, there was no difference in the primary endpoint of cardiac death, recurrent MI, or ventricular tachyarrhythmia between treatment with PCI or medical therapy. Given the discontinuation of the trial after only one-third of patients were enrolled, the trial was likely underpowered for the primary endpoint analysis. Despite the lack of benefit in the primary endpoint, patency and LVEF were higher at the 6 month follow-up. Previous trials of late PCI in occluded MI patients were very small and results varied. Patients in the present trial were relatively low risk. Results of the larger, ongoing 3,200 patient OAT trial will address the same question in a higher risk population.
References:
Steg PG, et al. DECOPI (DEsobstruction COronaire en Post-Infarctus): a randomized multi-centre trial of occluded artery angioplasty after acute myocardial infarction. EHJ 2004;25:2187–2194.
Presented by P.G. Steg at the European Society of Cardiology, Vienna, Austria, September 2003.
Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Stents, Tachycardia
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