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Boston Scientific Announces Clinical Data Supporting Safety and Efficacy of Platinum Chromium PROMUS Element™ Stent
Date:9/21/2010

chromium alloy."

The PLATINUM clinical program is evaluating the safety and efficacy of the PROMUS Element Stent in five multi-center studies totaling more than 1,800 patients, including a randomized controlled trial for workhorse lesions, as well as single-arm studies evaluating small vessels, long lesions and pharmacokinetics.  The prospective, single-arm PLATINUM QCA study enrolled 100 patients at 14 sites.  

The PLATINUM QCA primary endpoint of 30-day composite cardiac events was 1.0 percent, which included cardiac death (0.0 percent), myocardial infarction (0.0 percent), target lesion revascularization (TLR, 1.0 percent) and stent thrombosis (ARC (2) definite/probable, 1.0 percent).  Of the 100 patients studied, one patient experienced a peri-procedural stent thrombosis and TLR.  No additional major clinical events were reported from 31 days to nine months.

The study also met its pre-specified efficacy endpoint of in-stent late loss in workhorse lesions at nine months as measured by QCA compared to historical TAXUS® Express® Stent data.  The PROMUS Element nine-month in-stent late loss of 0.17 mm +/- 0.25 mm was superior to the performance goal of 0.44 mm (p<0.001) based on TAXUS Express historical data and similar to in-stent late loss reported for the PROMUS (Xience V®) Everolimus-Eluting Stent in the SPIRIT trials.  

The study met a second pre-specified efficacy endpoint of post-procedure incomplete stent apposition as measured by IVUS compared to PROMUS (Xience V) data from the SPIRIT III trial.  The PROMUS Element post-procedure incomplete stent apposition of 5.7 percent was significantly below the performance goal of 34.4 percent (p<0.001) based on PROMUS (Xience V) historical data.  The percent net volume obstruction at nine months as measured by IVUS was also low at 7.2 percent.

"These results demonstrate the successful transfer of drug and polymer from th
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SOURCE Boston Scientific Corporation
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