Coronary AngioPlasty Amlodipine REStenosis Study - CAPARES

Feb 24, 2004
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Date Presented:
01/01/2000
Date Published:
01/01/2000
Date Updated:
02/24/2004
Original Posted Date:
02/24/2004
References

Description:

The Coronary AngioPlasty Amlodipine REStenosis Study (CAPARES) was a multicenter randomized clinical trial designed to investigate the effect of amlodipine on restenosis and clinical outcomes in patients undergoing percutaneous transluminal coronary angioplasty (PTCA).

Hypothesis:

Compared to placebo, treatment with amlodipine would be associated with reduced rates of lumen loss and restenosis at four-month angiographic follow-up.

Study Design

Study Design:

Patients Enrolled: 635
Mean Follow Up: Mean duration of 132 days
Mean Patient Age: Mean 56 years
Female: 18%
Mean Ejection Fraction: Mean of 72%

Patient Populations:

Patients with stable angina pectoris and de novo lesions in native coronary arteries suitable for elective PTCA

Exclusions:

Reference segment diameter <2 mm, total occlusions

Primary Endpoints:

Mean loss in MLD

Secondary Endpoints:

Restenosis rate defined as ≥50% diameter stenosis at angiographic follow-up, death, MI, and repeat revascularization

Drug/Procedures Used:

Amlodipine 5 mg once daily for one week and then 10 mg once daily thereafter versus placebo control

Concomitant Medications:

Patients in the placebo arm received nifedipine periprocedurally during PTCA; patients in the amlodipine group received placebo nifedipine. All patients received aspirin and heparin. Stents were used in bail-out situations or for unsatisfactory PTCA results.

Principal Findings:

A total of 635 patients with stable angina pectoris and de novo lesions in native coronary arteries were randomized in a double-blind, placebo-controlled study design. The baseline clinical and angiographic characteristics of both study groups were similar.

PTCA was performed in 92.1% of patients, with stents implanted in 15.6% of patients. Both groups achieved similar acute gains in lumen diameter. There were no differences in loss of minimum lumen diameter (MLD) (0.30 mm in the amlodipine group vs. 0.29 mm in the placebo group, p=NS) or in restenosis rates (28.1% vs. 28.4%, p=NS) among groups at follow-up.

The rates of repeat PTCA and the composite of death, myocardial infarction (MI), coronary artery bypass graft (CABG), and repeat PTCA were lower among patients treated with amlodipine (3.1% vs. 7.3% for repeat PTCA, p=0.02; 9.4% vs. 14.5% for the composite endpoint, p=0.049).

Interpretation:

In this randomized, double-blinded, placebo-controlled multicenter trial, treatment with amlodipine was not associated with a reduction in angiographic restenosis, but was associated with lower rates of repeat PTCA. The reduction seen in the composite of repeat PTCA, CABG, MI, and death was largely driven by the reduction in repeat, largely symptom-driven PTCA. These results are attributable to the known anti-ischemic effects of amlodipine, and do not support the routine use of this medication in the prevention of restenosis after PTCA.

References:

Jorgensen B, Simonsen S, Endresen K, et al. Restenosis and clinical outcome in patients treated with amlodipine after angioplasty: results from the Coronary AngioPlasty Amlodipine REStenosis Study (CAPARES). J Am Coll Cardiol 2000;35:592-9.

Keywords: Myocardial Infarction, Coronary Restenosis, Angina, Stable, Amlodipine, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Calcium Channel Blockers, Stents


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