US health care major Abbott Laboratories says that a subset analysis of diabetic patients in a clinical trial of its Xience V everolimus-eluting stent system showed nearly identical rates of in-stent late loss at six months in diabetic patients as those observed in the overall study patient population. The positive nine-month safety data from the SPIRIT II trial showed no additional occurrences of major adverse cardiac event or stent thrombosis between six and nine months.
Patrick Serruys, the trial's principal investigator, noted that diabetic patients present many challenges because of their higher rate of restenosis after treatment. "These subgroup results are highly encouraging for difficult-to-treat patients," he stated.
Overall six-month data from SPIRIT II, which demonstrated that the Xience V system is statistically superior to USA-based Boston Scientific's Taxus Paclitaxel-eluting coronary stent system, as measured by its primary endpoint of in-stent late loss, were presented last month at the World Congress of Cardiology, held in Barcelona, Spain. In-stent late loss in the recent diabetic subgroup analysis was 0.15mm for Xience V versus 0.39mm for Taxus. This is comparable to the overall six-month SPIRIT II study results, which showed late loss of 0.11mm vs 0.36 mm. Abbott hopes that the data will help differentiate Xience V for physicians with challening cases.
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