Eight Rivals to Jointly Study Clots in Stent Patients

In an unprecedented move, eight medical companies are collaborating to initiate a $100 million study to understand how to best protect heart patients from rare but dangerous clots following <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">heart stent implantation.  The study is intended to take four years and include 20,000 patients. Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages to restore blood flow and relieve chest pain.

The study will be looking at whether heart stent patients can safely be removed from aggressive blood-thinning treatment after one year, or if such patients would be better served by remaining on the medication for at least two and a-half years following implantation with a stent.  Today, guidelines mandate that those patients implanted with drug-coated stents remain on the medication for no less than one year.

There is some concern about this course of treatment because clots can form in the devices well over a year after they are implanted, with potentially lethal consequences.  Although a rare occurrence, the emergence of clots following stent implantation has concerned doctors and patients and has created issues over how long follow-up treatment should be prescribed. “It’s created a lot of anxiety in patients’ and physicians’ minds, not knowing the answer to the long-term safety question,” said Laura Mauri, a cardiologist at Brigham and Women’s Hospital—Boston, Massachusetts.  Mauri is also co-principal investigator for the study and chief scientific officer at Harvard Clinical Research Institute, which has been chosen by the companies to run the study.  The study follows a Food and Drug Administration (FDA) request for stent and drug makers to determine the optimal duration for blood thinning. “The results will lead to greater clarity of an extremely important problem,” said Bram Zuckerman, an FDA official who helped initiate study.

Dr. Mauri was among several researchers, as well as company and FDA officials who discussed the study Wednesday at the annual Transcatheter Cardiovascular Therapeutics conference.  Four of the companies are stent makers:  Boston Scientific Corporation, Johnson & Johnson, Medtronic Inc., and Abbott Laboratories Inc.  All four companies are long-established rivals fighting in the $5 billion global stent market.  Four drug companies will also be participating in the study: Bristol-Myers Squibb Company, Sanofi Aventis SA, Eli Lilly & Company, and Daiichi Sankyo of Japan.  There is competition among the drug makers as well.  Bristol-Myers Squibb Company and Sanofi Aventis SA co-market the anti-platelet drug Plavix, which, combined with aspirin, comprises the current regimen for most stent patients.  Eli Lilly & Company and Daiichi Sankyo of Japan are co-developing prasugrel, which is awaiting FDA approval and expected to draw fierce competition for the Bristol-Myers-Sanofi Aventis collaboration.

Separately, with one occurring at the annual Transcatheter Cardiovascular Therapeutics conference and another published at the same time, two new studies report that cardiac patients may fare better by receiving fewer artery-opening stents and that stents tend to be used arbitrarily.  Both studies focused on how to treat patients with clogged arteries, a condition known as ischemia, in which patients develop chest pains when blood flow to the heart’s muscle is blocked.

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