Key result
Primary PCI vs fibrinolysis increased the risk of clinical reinfarction in diabetic patients (RR 2.57; 95% CI 1.48-4.46; P<0.001) but decreased it in nondiabetics (RR 0.52; 95% CI 0.36-0.74; P<0.001).
Why the study?
Does primary percutaneous coronary intervention improve long-term clinical outcomes in patients with ST-elevation myocardial infarction and diabetes mellitus compared with fibrinolysis?
RCT (n=1,572)
randomized
Does primary percutaneous coronary intervention improve long-term clinical outcomes in patients with ST-elevation myocardial infarction and diabetes mellitus compared with fibrinolysis?
In a substudy of the DANAMI-2 trial, primary PCI was associated with an increased risk of clinical reinfarction compared to fibrinolysis in patients with diabetes, contrasting with the significant benefit observed in nondiabetic patients.
Answers are grounded in this paper and cite their sources.
Alerts to heightened reinfarction risk with primary PCI in diabetic STEMI; challenges uniform PCI superiority and supports diabetes-specific trials.
Little is known about the effect of diabetes mellitus on long-term clinical outcome after primary percutaneous coronary intervention (pPCI) compared with fibrinolysis in patients who have acute ST-elevation myocardial infarction. We analyzed 3-year clinical outcome in diabetic patients and nondiabetic patients who had been randomized to fibrinolysis or pPCI in the DANAMI-2 trial to compare long-term clinical outcome. The primary end point was a composite of death, clinical reinfarction, or disabling stroke. Median follow-up was 3.8 years. Among 1,572 consecutive patients who had ST-elevation myocardial infarction and were randomized to pPCI or fibrinolysis, 173 (11.0%) had diabetes mellitus; 60 of these patients received metformin treatment and were excluded. After 3 years no difference was found between diabetic patients who underwent pPCI versus fibrinolysis (combined event p=0.37, reinfarction p=0.06 in favor of fibrinolysis), whereas pPCI was superior to fibrinolysis in nondiabetic patients (combined event p=0.002, clinical reinfarction p<0.001). Three-year incidence of clinical reinfarction analyzed with Cox's regression showed that pPCI compared with fibrinolysis increased the relative risk of clinical reinfarction in diabetic patients (relative risk 2.57, 95% confidence interval 1.48 to 4.46, p <0.001) but decreased the risk in nondiabetic patients (relative risk 0.52, 95% confidence interval 0.36 to 0.74, p<0.001). In conclusion, from the DANAMI-2 trial we hypothesize that diabetes may abolish the beneficial effect of pPCI on long-term risk of clinical reinfarction.
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Madsen et al. (2005) conducted an RCT in Acute ST-elevation myocardial infarction (n=1,572). Primary percutaneous coronary intervention (pPCI) vs. Fibrinolysis was evaluated on Composite of death, clinical reinfarction, or disabling stroke (p=0.37 (diabetics), 0.002 (nondiabetics)). Primary PCI vs fibrinolysis increased the risk of clinical reinfarction in diabetic patients (RR 2.57; 95% CI 1.48-4.46; P<0.001) but decreased it in nondiabetics (RR 0.52; 95% CI 0.36-0.74; P<0.001).
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