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Invasive Approach Best for Cocaine-Linked NSTEMI, but DAPT Is Key

March 16, 2021
Patients with a history of cocaine use who present with non-ST-segment elevation myocardial infarction have a lower risk of future major adverse cardiovascular events if treated invasively rather than with a more-conservative approach, according to a new retrospective study.
Overall, invasive management, which included coronary angiography followed by PCI or CABG if needed, lowered the risk of MACE at 6 months by 28% compared with a noninvasive strategy.
The results, however, point to one of the major challenges in treating patients with cocaine-associated NSTEMI, namely their ability to adhere to posttreatment dual antiplatelet therapy (DAPT). While there was no greater risk of emergent revascularization in the overall cohort, that risk was significantly elevated among patients deemed nonadherent to medical therapy who’d been treated with a drug-eluting stent, report researchers. ....

El Paso , United States , Mehdi Shishehbor , Shilpkumar Arora , Debabrata Mukherjee , L Kristin Newby , Richard Lange , Md Texas Tech University Health Sciences Center , American Heart Association , American College Of Cardiology , Md Duke Clinical Research Institute , Case Western Reserve University School , Cardiovascular Interventions , Treatment Best , American College , Nationwide Readmissions Database , Duke Clinical Research Institute , Texas Tech University Health Sciences Center , எல் பாசோ , ஒன்றுபட்டது மாநிலங்களில் , தேவப்ரதா முகர்ஜி , ல் கிறிஸ்டின் புதியவர் , ரிச்சர்ட் லாங்கே , ம்ட் டெக்சாஸ் தொழில்நுட்பம் பல்கலைக்கழகம் ஆரோக்கியம் அறிவியல் மையம் , அமெரிக்கன் இதயம் சங்கம் , அமெரிக்கன் கல்லூரி ஆஃப் இருதயவியல் ,

FDA Advisors Unconvinced by Lutonix BTK Drug-Coated Balloon

February 18, 2021
Despite having no significant safety concerns, an advisory panel to the US Food and Drug Administration said yesterday that it could not find enough evidence of efficacy and benefit to recommend premarket approval (PMA) of a below-the-knee drug-coated balloon (DCB) for the treatment of PAD.
After a full day of discussion, the Circulatory Devices Panel of the Medical Devices Advisory Committee
voted 15-2 (with one member abstaining) that reasonable assurance of safety was demonstrated for the DCB, made by Lutonix, a subsidiary of Becton, Dickinson and Company (BD).
On the question of reasonable assurance of efficacy, however, the vote was the same 15-2 (with one member abstaining) that efficacy was not demonstrated. Similarly, on the question of whether the panel believed that the benefits outweighed the risks, the vote was 14-3 (with one member abstaining) that they did not. ....

United States , University Of Pennsylvania , El Paso , John Hirshfeld , Bernard Gersh , Edwin Gravereaux , Joaquine Cigarroa , Michael Miller , Richard Lange , Haraldur Bjarnason , Md Mayo Clinical College Of Medicine , Md Texas Tech University Health Sciences Center , Do Miller Care Group , Md University Of Pennsylvania School Medicine , Drug Administration , Md Oregon Health Science University , Circulatory Devices Panel , Medical Devices Advisory Committeevoted , Major Deficiency Letter , Not Approvable , Texas Tech University Health Sciences Center , Oregon Health , Science University , New Technologies , Mayo Clinical College , Miller Care Group ,