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Moderate fish consumption was associated with lower long-term cardiovascular disease (CVD) risk in high-risk individuals and those with existing vascular disease but not in the general population, according to a large pooled analysis.
In the largely CVD-naïve PURE study cohort, individuals who ate 350 g (or four servings of fish) a week were not better off than peers with little or no fish intake in terms of major CVD events (HR 0.95, 95% CI 0.86-1.04) or total mortality (HR 0.96, 95% CI 0.88-1.05) over a median 9.1 years of follow-up.
By contrast, moderate fish consumption at 175 g (two servings) per week was associated with reduced risk of major CVD (HR 0.84, 95% CI 0.73-0.96) and total mortality (HR 0.82, 95% CI 0.74-0.91) among the smaller ONTARGET, TRANSCEND, and ORIGIN cohorts of people with vascular disease or diabetes. Risk did not sink further with greater fish intake in this group.
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An FDA advisory committee turned thumbs down on Becton Dickinson s Lutonix 014 drug-coated balloon (DCB) for peripheral artery disease (PAD) during a virtual meeting on Wednesday.
Circulatory System Devices Panel members voted 14-3 (with one abstention) that the benefits of the investigational angioplasty catheter do not outweigh its risks as a treatment for patients with critical limb ischemia (CLI) who have obstructive de novo or non-stented restenotic lesions in below-the-knee (BTK) arteries.
Committee members were largely unconvinced that the Lutonix DCB was supported by adequate efficacy data.
In the pivotal Lutonix BTK IDE trial, the device showed a 10.5% absolute advantage in the primary efficacy endpoint (combined primary patency and limb salvage) at 6 months that was not significant under Bayesian analysis. Such improvement, if any, vanished by 12 months, and the endpoint started to favor the regular percutaneous transluminal angioplasty (PTA) arm by