Key result
Valsartan treatment did not significantly reduce the primary composite endpoint of death, non-fatal MI, and target lesion revascularization at 18 months compared to non-ARB treatment (HR 0.84).
Why the study?
Does valsartan add-on treatment reduce the composite of all-cause death, non-fatal myocardial infarction, and target lesion revascularization in patients undergoing PCI with bare-metal stents?
RCT (n=191)
Open-label
Minimization method
Yes
Does valsartan add-on treatment reduce the composite of all-cause death, non-fatal myocardial infarction, and target lesion revascularization in patients undergoing PCI with bare-metal stents?
Valsartan add-on therapy did not significantly reduce the primary composite endpoint at 18 months after PCI with bare-metal stents, though it may reduce long-term target lesion revascularization.
Answers are grounded in this paper and cite their sources.
Valsartan add-on does not reduce ischemic events after bare-metal stent PCI; challenges routine ARB use and prior benefit assumptions.
BACKGROUND: Angiotensin II receptor blockers (ARB) have been shown to reduce cardiovascular events in patients at risk. The effect of valsartan on outcomes after percutaneous coronary interventions (PCI) with bare-metal stents (BMS) was investigated. METHODS AND RESULTS: The prospective, randomized study included 191 patients at 5 participating institutions, who were randomly assigned to either a 40-80 mg valsartan add-on or non-ARB treatment. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, and target lesion revascularization (TLR) at 18 months. Enrollment was stopped when the use of drug-eluting stents has been expanded in Japan. No significant differences existed between the groups in terms of primary endpoint (18.9% vs. 24.8%; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.61-1.14; P = 0.26). In the valsartan group, as compared with the non-ARB group, the secondary endpoint of TLR was significantly reduced at a median follow-up 4.4 years; the rate of TLR was from 27.8% to 14.5% (HR, 0.69; 95%CI, 0.49-0.96; P = 0.024). CONCLUSIONS: Valsartan treatment was not superior to non-ARB treatment in reducing the primary endpoint after PCI at 18 months. The pre-specified secondary endpoint of TLR was lower in the valsartan group, but this needs to be proved statistically with an adequate study sampling.
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Okada et al. (2011) conducted an RCT in Coronary artery disease requiring percutaneous coronary intervention with bare-metal stents (n=191). Valsartan vs. Non-ARB antihypertensives was evaluated on Composite of all-cause death, non-fatal myocardial infarction, and target lesion revascularization at 18 months (HR 0.84, 95% CI 0.61-1.14, p=0.26). Valsartan treatment did not significantly reduce the primary composite endpoint of death, non-fatal MI, and target lesion revascularization at 18 months compared to non-ARB treatment (HR 0.84).
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