Abstract

Background: CAMELOT Study showed that the administration of amlodipine to diabetic patients with coronary artery disease (CAD) resulted in reduced adverse cardiovascular events, especially repeat coronary revascularization. Objective: To compare the effects of amlodipine versus placebo on restenosis and clinical outcome after percutaneous coronary intervention (PCI) for diabetic patients. Methods: In a prospective, double-blind design, 540 patients with 659 denovo lesions were randomized to receive 5–10mg of amlodipine or placebo. Diabetic patients were enrolled in171 patients (32%). The primary angiographic endpoint was minimal lume diameter (MLD) at 6 month assessed by follow-up (FU) quantitative coronary angiography (QCA). Clinical end points were death, myocardial infarction, coronary bypass surgery and repeat any PCI at 12 months. Results: Angioplasty was performed in all patients without complications ;461 patients (85%) had received coronary stent implantation.FU QCA was obtained in all patients. The MLD at FU was significantly larger in the amlodipine group (1.50±0.52mm in the amlodipine group versus 1.42±0.52mm in the placebo group: p=0.035). The loss index was tendency to be lower in the amlodipine group (0.54±0.66 in the amlodipine group versus 0.61±0.56 in the placebo group: p=0.076). The binary restenosis (defined as >50% diameter stenosis at FU) rate was 22.6% in the amlodipine group versus 28.5% in the placebo group (p=0.078). The composite incidence of clinical events were occurred in 89 patients (32%) in the amlodipine group versus 102 patients (39%) in the placebo group (p=0.103). The composite incidence of clinical events in diabetic patients were occurred in 30 patients (37%) in the amlodipine group versus 51 patients (57%) in the placebo group (p=0.007). Conclusion: Administration of amlodipine in diabetic patients resulted in reduced adverse cardiovascular events after PCI.

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