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Nisoldipine for Coronary Artery Disease in Leuven - NICOLE
Description:
Nisoldipine for the progression of minor coronary lesions at 3 years.
Hypothesis:
To evaluate the effect of nisoldipine on the progression of minor coronary lesions in nondilated segments of nonoccluded arteries at 3 years.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 826
Mean Follow Up: Ongoing
Patient Populations:
Under 75 years of age
Successful single-vessel or multivessel PTCA
Primary Endpoints:
Progression of minor coronary lesions at 3 years.
Secondary Endpoints:
Angiographic restenosis at 6 months
Drug/Procedures Used:
Nisoldipine 20 mg qd for 14 days, then 40 mg qd
Principal Findings:
Approximately 24% of nisoldipine patients needed a dose reduction, primarily because of edema.
Of the 826 patients enrolled, 772 were included in the intention-to-treat analysis, and 646 remained valid for the efficacy population. There were 308 patients in the nisoldipine group and 338 patients in the placebo group.
At the 6-month follow-up, no significant difference was found in the restenosis rate for the two groups. There were also no statistically significant differences in deaths and acute myocardial infarctions between the two groups. CABG was performed less often for the nisoldipine group, and the incidences of PTCA of nontarget lesions and repeat PTCA were lower in the nisoldipine group.
Interpretation:
Based on the 6-month follow-up data, the NICOLE investigators concluded that nisoldipine did not reduce the angiographic restenosis rate after PTCA. Nisoldipine did reduce the number of repeat revascularizations, however, probably due to its antianginal effect.
References:
1. Presented at XXth Congress of the European Society of Cardiology, Vienna, 1998. Preliminary results
Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Nisoldipine, Research Personnel, Intention to Treat Analysis, Edema, Calcium Channel Blockers, Disease Progression
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