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BACK
XIENCE 28 & XIENCE 90 Trial Results

XIENCE 28 showed that XIENCE™ Stent with 1-month DAPT had no increase in ischemic events and a significantly lower rate of severe bleeding (BARC 3-5) compared with 6-month DAPT. These data were used to support the CE Mark for a 1-month DAPT indication in High Bleeding Risk Patients.

XIENCE™ Stent is proven safe with 1-month and 3-month DAPT in HBR patients.1

XIENCE 28 Results1

XIENCE 28: All Death and All MI

XIENCE™ Stent with 1-month DAPT showed no increase in ischemic events versus 6-month DAPT — all death or MI.1

XIENCE 28 met its primary non-inferiority endpoint and included over 1600 high-bleeding risk patients.1

XIENCE 28: BARC 3-5 Bleeding

XIENCE™ Stent with 1-month DAPT had a significantly lower rate of severe bleeding versus 6-month DAPT. (BARC 3-5).1

For BARC 2-5 — XIENCE™ Stent with 1-month DAPT showed numerically lower bleeding rate versus 6-month DAPT.1

Note: PS stratified analysis for BARC 3-5 bleeding was not pre-specified.
Note: BARC 2-5 was a powered secondary endpoint.

XIENCE™ Stent shows low ST rate and is significantly more thromboresistant than other DES.1,2

XIENCE 28: Stent Thrombosis

XIENCE™ Stent with 1-month DAPT showed no increase in ST versus 6-month DAPT.1

XIENCE™ Stent with 1-month DAPT had a low rate of Definite/Probable stent thrombosis of 0.3% for the 1-month DAPT group.1

XIENCE™ Stent is significantly more thromboresistant than other DES.2

XIENCE Stent fluoropolymer

XIENCE™ Stent's fluoropolymer is significantly more thromboresistant than other DES2

XIENCE™ Stent shows significantly (p<0.01) less platelet adhesion vs. other DES.2

XIENCE 90 Results1

XIENCE 90: All Death and All MI

XIENCE™ Stent with 3-month DAPT showed no increase in ischemic events versus 12-month DAPT — all death or MI.1

XIENCE 90 met its primary non-inferiority endpoint and included over 2000 high-bleeding risk patients.1

XIENCE 90: BARC 3-5 Bleeding

XIENCE™ Stent with 3-month DAPT had a significantly lower rate of severe bleeding versus 12-month DAPT. (BARC 3-5).1

For BARC 2-5 -- XIENCE with 3-month DAPT showed numerically lower bleeding rate versus 12-month DAPT.1

Note: PS stratified analysis for BARC 3-5 bleeding was not pre-specified.
Note: BARC 2-5 was a powered secondary endpoint.

XIENCE 90: Stent Thrombosis

XIENCE™ Stent with 3-month DAPT met its performance goal for ST.1

XIENCE 90 met its performance goal for ST and showed a low rate of Definite/Probable stent thrombosis of 0.2% for the 3-month DAPT group.1

References

  1. XIENCE Skypoint - Instructions for Use. Mehran R, et al. J Am Coll Cardio Intv. 2021;14:1870-1883
  2. Sato Y, et al. Int J Caridol. 2021;338:42-49.
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