Four of the world’s largest manufacturers of drug-eluting stents and their pharmaceutical partners are teaming in a new research study to determine whether patients receiving the stents would benefit from extended treatment with blood thinners.
The Harvard Clinical Research Institute, an industry-supported facility based in Boston, said Friday it had enrolled the first of 20,000 individuals slated to participate in the trial. Participating in the four-year study are Natick, Mass.-based Boston Scientific Corp., manufacturer of the Taxus and Promus stents, along with device-makers Medtronic Inc., Abbott Laboratories and Cordis Corp., the stents arm of healthcare conglomerate Johnson & Johnson. Drug-makers Bristol-Myers Squibb Co., Sanofi Pharmaceuticals, Eli Lilly & Co., and Daiichi-Sankyo Company Limited also have signed on for the study.
Current medical guidelines call for patients receiving drug-eluting stents to use blood thinners during the first year following their procedures to guard against the effects of possible artery lesions. Some doctors, however, continue to prescribe anti-platelet drugs after more than 12 months. The HCRI study hopes to determine if the extra medication significantly reduces the risk of stroke, heart attacks or other problems.
The double-blind trial is expected to enroll over 15,000 subjects being treated with a drug-eluting stents at over 200 locations around the world as well as 5,000 subjects treated with a bare metal stents. All patients will receive anti-platelet drugs during the first 12 months in addition to their daily aspirin regimen. After the first year, all of the patients who do not show signs of abnormal bleeding will be split into equal groups — half of whom will get a placebo and the other half receiving blood thinners during the next 18 months.
All patients also will continue to use small doses of aspirin every day and will be monitored during a three-month post-trial period.
“This study is the first post-market investigation in which the FDA brought together industry competitors who put aside competition and achieved an unprecedented level of cooperation with regulators and academia to answer a major public health question,” said Margaret A. Hamburg, commissioner of the U.S. Food and Drug Administration.