Stents Linked to More Strokes Than Surgery

<"http://www.yourlawyer.com/topics/overview/drug_coated_stents">Stents, tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages, could be linked to increased risk of stroke or death versus surgery, according to researchers. Implanting a stent in neck arteries can increase the risk of stroke or death; however, carotid endarterectomy, a procedure meant to clear these blockages, cold lead to nerve damage or heart attack, said Reuters, citing the research.

The research looked at 13 clinical trials comparing both options, a matter of debate for some time now. “Both therapeutic procedures are effective,” Dr. Louis Caplan of Beth Israel Deaconess Medical Center and Dr. Thomas Brott of the Mayo Clinic, said in a commentary in the Archives of Neurology, quoted Reuters. “Surgery is superior concerning some outcomes; stenting seems to have advantages in others,” he added.

Carotid endarterectomy has been the traditional method in which to remove fatty deposits from neck arteries, often a precursor to stroke, noted Reuters. Which also explained that the procedure involves opening the neck and scraping the arteries. Meanwhile, the newer approach—carotid artery stenting—involves a wire mesh coil (the stent) threaded in the neck artery to broaden the blocked area and remove any dislodged plaque before it can move to the brain, a cause of stroke, said Reuters.

In a comparison of both treatments in over 7,000 patients, Dr. Sripal Bangalore of New York University School of Medicine and Harvard Clinical Research Institute, found that those receiving the stent experienced a 19 percent increased risk of stroke or death versus those who underwent surgery, said Reuters. Of note, those who underwent the stent procedure experienced a 55 percent decreased risk of heart attack and an 85 percent decreased risk of cranial nerve injury versus surgery, said Reuters.

“Strategies are urgently needed to identify patients who are best served by carotid artery stenting versus carotid endarterectomy,” the team wrote in the Archives of Neurology.

For now, it seems, the choice is patient dependent. Dr. Chris White, president-elect of the Society for Cardiovascular Angiography and Interventions, a group for doctors who perform stent procedures, the choice is a matter of what works best for the individual, wrote Reuters. “Basically, the message that I’ve taken from the last year from all of the trials has been that overall … there are patients who will do better with stenting and some who will better with carotid endarterectomy,” White told Reuters. “Who those patients are will be difficult to sort out.”

We have long written about the controversy surrounding cardiac stents. Most recently, Reuters reported that diabetics diagnosed with stable heart disease may not need invasive stent implantation, angioplasty, or bypass surgery. Reuters pointed out that that research might add to stent maker woes, including falling sales after prior studies revealed stents offered no better option over medication in stemming death and heart attacks in heart patients.

In a previous Reuters article citing the Occluded Artery Trial (OAT), findings indicated that one year following stent implantation, patients were as unable to climb stairs as those not implanted, they spent substantially more on the procedures, and their quality of life was shorter after two years over those treated with medications only.

Of the more than 800,000 angioplasties conducted last year for a total of $10 billion, Duke University concluded that about half could have received comparable treatment via drugs, diet, and exercise, with less risk of re-clogging, reported Bloomberg News earlier this year, citing the prior studies. Stent makers include Boston Scientific, Abbott Laboratories, Johnson & Johnson, and Medtronic Inc.

This entry was posted in Defective Medical Devices. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.