Carvedilol for Prevention of Restenosis After Directional Coronary Atherectomy - EUROCARE

Apr 20, 2004
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Date Published:
01/01/2000
Date Updated:
04/20/2004
Original Posted Date:
04/20/2004
References

Description:

The goal of this study was to assess the safety and efficacy of carvedilol in the prevention of coronary restenosis among patients with coronary artery disease (CAD) undergoing directional coronary atherectomy (DCA).

Hypothesis:

In addition to being a nonselective beta-adrenergic receptor antagonist and an alpha-1 receptor antagonist, carvedilol has been shown to be a direct inhibitor of myofibroblast migration as well as a potent antioxidant. Because of its various properties, it was hypothesized that carvedilol had the potential to prevent restenosis in patients after DCA.

Study Design

Study Design:

Patients Enrolled: 406
Mean Follow Up: Seven months
Mean Patient Age: Mean age 58.2 ± 9.8 years
Female: 12

Patient Populations:

Patients with angina (both stable and unstable except for Braunwald class 3 unstable angina) who were scheduled to undergo elective DCA of a single primary coronary artery stenosis in a native vessel were eligible.

Exclusions:

Exclusion criteria included: contraindications to carvedilol or to a discontinuation of existing beta-blocker therapy, ineligibility for DCA, planned stent implantation, documented myocardial infarction within five days preceding randomization, and intolerance to aspirin.

Primary Endpoints:

MLD as assessed by angiography at 26 ± 2 weeks after successful DCA

Secondary Endpoints:

Major adverse cardiac events at seven months, angiographic indices of absolute and relative loss in MLD, rate of restenosis, and adverse events were secondary endpoints.

Drug/Procedures Used:

Eligible patients were randomized to receive either a fixed dose of carvedilol (25 mg orally twice per day) or placebo. Prior to enrollment, participants were weaned off all previous vasoactive, antihypertensive, and antianginal medications, with the exception of nitrates. Carvedilol or placebo therapy was initiated at least 24 hours prior to the scheduled DCA and was continued for five months after the successful procedure.

Principal Findings:

No significant difference was observed between the placebo or carvedilol groups in the primary outcome of minimal luminal diameter (MLD) on angiographic follow-up (1.99 ± 0.73 mm vs. 2.00 ± 0.74 mm). Additionally, there were not significant differences in the rate of angiographic restenosis (23.4% vs. 23.9%), target lesion revascularization (15.5 % vs. 15.4%), or event-free survival (78.1% vs. 79.9%) between the placebo group and the carvedilol group. Finally, there was no significant difference in the incidence of adverse events between the placebo and carvedilol groups (47.5% vs. 50%).

Interpretation:

Among patients with CAD who undergo DCA, carvedilol therapy was not associated with a reduction in restenosis or an improvement in clinical outcomes. These findings suggest that, while carvedilol was not associated with an increase in adverse events, it is of no clinical value in the prevention of restenosis after successful DCA.

References:

Serruys PW, Foley DP, Hofling B, et al. Carvedilol for prevention of restenosis after directional coronary atherectomy: final results of the European carvedilol atherectomy restenosis (EUROCARE) trial. Circulation 2000;101:1512-8.

Keywords: Myofibroblasts, Follow-Up Studies, Atherectomy, Coronary, Coronary Restenosis, Disease-Free Survival, Propanolamines, Vasodilator Agents, Carbazoles, Adrenergic alpha-1 Receptor Antagonists, Nitrates, Receptors, Adrenergic, beta


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