Impact of abciximab on prognosis in diabetic patients undergoing primary percutaneous coronary intervention.

BACKGROUND: The impact of diabetes in patients with acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention (PCI) is unclear. The benefit of abciximab in this subset of patients remains controversial. METHODS AND RESULTS: Three hundred and twenty-seven consecutive and unselected patients with acute AMI treated with primary PCI were included in our single-center retrospective registry, 103 diabetic (31%) and 224 nondiabetic (69%). Abciximab was given at the physician's discretion. Diabetic patients were older (mean age 68.5±11 vs. 65±12 years; P=0.009), had an increased prevalence of hypertension (73 vs. 54%; P=0.001), a decreased prevalence of smoking (31 vs. 45%; P=0.02), a longer duration of symptoms before hospital admission (190 vs. 143 min; P=0.031), and a higher number of stents implanted (1.4 vs. 1.2; P=0.04). Other clinical and angiographic characteristics were comparable in the two groups. Diabetic patients had a higher incidence of the combined end-point of death and reinfarction rate at 30 days (18 vs. 10%; P=0.04) compared to nondiabetic patients. Abciximab treatment was associated with a lower in-hospital (23.8 vs. 5%; P=0.005) and 30-day (23.8 vs. 6.6%; P=0.012) mortality, and a lower incidence of death and reinfarction at 30 days (33.3 vs. 9.8%; P=0.003) in diabetic patients. In nondiabetic patients, abciximab was not associated with improved outcome measures. Advanced Killip class (III and IV) and abciximab were found to be independently associated with 30-day death or myocardial infarction [respectively, odds ratio (OR) 6.075, 95% confidence interval (CI) 1.59-23.218, P=0.008 and OR 0.177, 95% CI 0.034-0.938, P=0.042] in the propensity score-matched populations of diabetic patients. Advanced Killip class and thrombolysis in myocardial infarction score index were found to be independently associated with 30-day death or myocardial infarction (respectively, OR 6.607, 95% CI 1.5-29.106, P=0.013 and OR 1.094 95% CI 1.042-1.148, P<0.001) in the propensity score-matched populations of nondiabetic patients. CONCLUSIONS: In our registry diabetic patients treated with primary PCI for AMI had a worse in-hospital and 30-day outcome than nondiabetic patients. Adjunct pharmacologic treatment with abciximab was associated to a better prognosis only in diabetic patients.

[Lower is better: ENHANCE affair]. / Lower is better: la lezione del trial ENHANCE.

Ezetimibe lowers the intestinal absorption of cholesterol, being complementary to the effects of statin. To check its efficacy in lowering the carotid intima-media thickness, in 2002 a multicenter international trial called ENHANCE was started, in order to assess by ultrasound the regression of atherosclerotic plaques. The protocol tested the use of simvastatin 80 mg + placebo versus simvastatin 80 mg + ezetimibe 10 mg in 720 randomized patients. Both drugs were well tolerated. Combination therapy was associated with a larger reduction in LDL cholesterol, but there were no differences in the intima-media thickness measured at three sites in the carotid arteries, nor differences in cardiovascular events between the two groups in the trial. These results provoked disappointment of sponsors (Merck, Schering Plough) who, although the results of the trial were available since march 2007, delayed official communication of about 18 months. This led to speculations and rumors among media, American Government, cardiologic scientific associations, and consequences in the Ezetimibe market and at Wall Street. In particular, the American College of Cardiology didn't accept the communication of ENHANCE results to the Late Breaking Trial Session of the Chicago congress, diverting it to another secondary forum. In conclusion, the experience of the ENHANCE trial suggests to pharmaceutical companies, researchers, clinicians, scientific companies and media a deep meditation in order to avoid in the future similar problems in the management of results of medical research.