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Angiotensin II receptor blocker candesartan cilexetil on intimal hyperplasia after coronary stent implantation - AACHEN
Description:
The goal of the trial was to evaluate the effect of treatment with the angiotensin II receptor blocker (ARB) candesartan cilexetil on intimal hyperplasia after coronary stent implantation.
Study Design
Study Design:
Patients Enrolled: 120
Mean Follow Up: 24 weeks
Mean Patient Age: Mean age 61 years
Female: 17
Patient Populations:
Age ≥18 years, angina and/or target vessel–related ischemia documented by noninvasive stress testing, angiographically documented coronary stenosis in native vessels, type A/B de novo lesions, coronary stenosis elegible for elective stent implantation, suitability for emergency coronary bypass grafting, and suitability for therapy with an angiotensin II receptor antagonist
Exclusions:
Severe organic risk factors; type 1 diabetes mellitus; unstable angina pectoris; acute MI <4 weeks before randomization; clinically relevant hypotension <100 mm Hg; left ventricular ejection fraction <30%; implantation of coil stents or self-expandable stents; lesion length >20 mm; contraindication for candesartan cilexetil, aspirin, or clopidogrel; therapy with angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonist; increased risk for bleeding, thrombocytopenia, thrombocytopathy; aggressive diuretic therapy; reasons that make follow-up angiography unlikely or impossible; or known or expected poor compliance
Primary Endpoints:
Difference in neointimal area between groups evaluated by IVUS
Secondary Endpoints:
Differences in angiographic parameters, including restenosis rate, and incidence of MACE
Drug/Procedures Used:
Patients were randomized in a double-blind manner to candesartan cilexetil (32 mg; n = 63) or placebo (n = 57) starting 7-14 days before elective coronary stent implantation. Patients were to undergo repeat angiography and intravascular ultrasound (IVUS) at 24-week follow-up.
Principal Findings:
Lesion location was the left anterior descending (LAD) artery in 43% of patients. Mean stent diameter was 3.1 mm and length was 14.8 mm. Hypertension was present in 78% of patients and diabetes in 23%.
The primary endpoint of neointimal area on IVUS at 24-week follow-up did not differ between the treatment groups (2.1 mm2 each, p = 1.0). There was also no difference in angiographic parameters of late lumen loss (0.7 mm for candesartan vs. 0.6 mm for placebo, p = 0.39) or percent diameter stenosis (41% vs. 34%, p = 0.09). Binary restenosis occurred in 31% of the candesartan group and 21% of the placebo group (p = 0.35).
Major adverse cardiac events (MACE) did not differ by treatment group (8% for candesartan vs. 11% for placebo, p = 0.75), nor did myocardial infarction (MI) (2% vs. 4%, p = 0.60) or target lesion revascularization (8% vs. 7%, p = 0.74). There were no deaths in the trial.
Interpretation:
Among patients undergoing elective stent implantation, treatment with candesartan was not associated with a difference in neointimal area at 24-week IVUS follow-up compared with placebo.
Findings from the present study differ from two other recent studies of ARBs in stented patients, which showed improvements in neointima proliferation associated with ARB use. The study was designed based on the pathophysiologic concept that the renin-angiotensin system contributes to neointima formation. Despite this rationale, no difference was observed in neointimal area on IVUS, angiographic restenosis, or clinical events.
References:
Radke PW, Figulla HR, Drexler H, et al. A double-blind, randomized, placebo-controlled multicenter clinical trial to evaluate the effects of the angiotensin II receptor blocker candesartan cilexetil on intimal hyperplasia after coronary stent implantation. Am Heart J 2006;152:761.e1-6.
Keywords: Neointima, Angiotensin Receptor Antagonists, Myocardial Infarction, Renin-Angiotensin System, Constriction, Pathologic, Hyperplasia, Tetrazoles, Stents, Biphenyl Compounds, Coronary Stenosis, Benzimidazoles, Hypertension, Diabetes Mellitus
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