Recent developments of interest in cardiovascular medicine
The FDA posted materials ahead of its June 19-20 advisory committee meeting on mortality risk of paclitaxel-coated stents and balloons for peripheral use; an Investor's Business Daily analyst said they suggest the agency won't pull the devices from the market but could call for more studies. Watch for MedPage Today's coverage onsite next week.
Meanwhile, Britain's FDA equivalent, the MHRA, is discouraging routine use of paclitaxel-eluting devices for intermittent claudication but says the benefits for critical limb ischemia may outweigh potential mortality risk. (MedTech Dive)
PCSK9 inhibitor evolocumab (Repatha) is now cost effective, after the 60% price drop announced last fall, researchers reported in JAMA Cardiology.
Fellow PCSK9 inhibitor alirocumab (Praluent)proved effective in lowering LDL atop statins for type 2 diabetes patients without interfering with glucose-lowering medications -- including insulin -- or glycemic control in the ODYSSEY DM-INSULIN and ODYSSEY DM-DYSLIPIDEMIA trials presented at the American Diabetes Association meeting in San Diego. (AJMC.com)
ICU admission for ST-segment elevation MI (STEMI) was associated with a 6 percentage-point mortality advantage at 30 days among patients with marginal ICU needs, according to research in The BMJ.
Novel partial adenosine A1 receptor agonist neladenoson didn't help exercise capacity for heart failure with preserved ejection fraction patients in the phase IIb PANACHE trial. (JAMA)
The American Heart Association and the Heart Failure Society of America pulled together their recommendations for management of diabetes and heart failure into a single scientific statement. (Circulation)
A circulating biomarker of visceral fat may flag whose metabolism won't benefit as much from endurance exercise training. (JAMA Cardiology)
A patient describes living with complete heart block in JAMA Cardiology.
For survivors of stroke at ages 18-49, mortality risk persisted up to 15 years afterward in a Dutch population-based study. (JAMA)
The FDA cleared the ReStore soft exo-suit system for stroke rehabilitation. (Mass Device)
The Cardioform ASD occluder was also cleared for closing ostium secundum atrial septal defects. (BioWorld MedTech)
European regulators cleared the Aperio hybrid stent retriever for treating ischemic stroke from large intracranial vascular occlusions. (FDANews)
The large-scale BIO-LIBRA trial of implanted cardiovascular devices for non-ischemic cardiomyopathy will comprise at least 40% women, Biotronik announced.
Read the original article on Medpage Today: Paclitaxel Device Prognosis; PCSK9 Now Cost Effective; ICU Benefit in STEMI?