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Results from a late-stage clinical trial, called ABSORB III, showed Abbott's (NYSE:ABT) fully dissolving Absorb heart stent was non-inferior (no worse than) to its top-selling XIENCE metallic drug-eluting stent. The results, presented today at the 27th Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation, were used to support a regulatory application in the U.S.
- The data from ABSORB III demonstrated that there was no statistically significant difference in the two devices after one year. Specifically, the target lesion failure rate (the primary endpoint) for Absorb and XIENCE was 7.8% and 6.1%, respectively (non-inferiority p<0.007). All other pre-specified secondary endpoints were not statistically different, including the rate of definite and/or probable stent thrombosis (blood clot).
- During the meeting, Abbott also presented results from ABSORB China, a 480-subject study comparing Absorb to XIENCE that was conducted to support regulatory approval there. The primary endpoint, non-inferiority defined by in-segment late loss at one year, was also met (non-inferiority p=0.01).
- Absorb is currently cleared in over 100 countries. The company's regulatory application has been filed in the U.S. and will be filed in China in the near future.