Boston Scientific Corp. (NYSE:BSX) enrolled its first patient in a worldwide trial examining the use of blood thinners in conjunction with drug-eluting stents, joining a trio of other industry giants and their pharmaceutical partners in the study.
Participating in the four-year DAPT Study are Natick, Mass.-based Boston Scientific, manufacturer of the Taxus and Promus stents, along with device makers Medtronic Inc. (NYSE:MDT), Abbott Laboratories (NYSE:ABT) and Cordis Corp., the stents arm of healthcare conglomerate Johnson & Johnson (NYSE:JNJ). Drug-makers Bristol-Myers Squibb Co. (NYSE:BMY), Sanofi Pharmaceuticals (NYSE:SNY), Eli Lilly & Co. (NYSE:LLY) and Daiichi-Sankyo Company Ltd. (TYO:4568) also have signed on for the study.
The Harvard Clinical Research Institute, an industry-supported facility based in Boston, enrolled the first of 20,000 individuals slated to participate in the trial in October, 2009. Boston Scientific said its participation will look at the Taxus Liberté stent, which elutes a drug called paclitaxel, and the use of aspirin and Effient, an anti-coagulant made by Eli Lilly and Daiichi Sankyo. The company said it plans to contribute data on the first 1,524 eligible patients from its post-approval study of the Taxus Liberté to the DAPT 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 more than 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.
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