XIENCE Sierra: Setting the standard for safety

XIENCE: Most Studied, Most Implanted Stent in the World

You Can't Beat Zero: XIENCE Stent Thrombosis Data

One of the key factors in safety with stents is stent thrombosis. XIENCE consistently results in zero stent thrombosis. This best-in-class safety is demonstrated in several clinical trials with real-world patient populations, including complex patients and patients who have discontinued dual antiplatelet therapy (DAPT).

XIENCE: Most Studied Stent in Patients With Reduced Dual Antiplatelet Therapy (DAPT)

DAPT duration often depends on the patient — and it may depend on the stent as well.

Notably, the XIENCE everolimus-eluting stent (EES) has been associated with the lowest rates of early, late and very late stent thrombosis (ST).8-11 Therefore researchers have examined safety outcomes with a reduced DAPT duration following XIENCE implantation.3

AP2945979-WBU Rev. B

* 10,000,000 implants number is based on data of DES implants through Q1 2017. Data on file at Abbott.

  1. Chevalier B et al. "Four-year follow-up of the randomised comparison between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II Trial). EuroIntervention January 2018."
  2. Gao R, et al. "ABSORB China: Two-Year Clinical Results" TCT 2016.
  3. Natsuaki M, et al. One-year outcome of a prospective trial stopping dual antiplatelet therapy at 3 months after everolimus-eluting cobalt-chromium stent implantation: ShortT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent (STOPDAPT) trial. Cardiovasc Interv Ther. 2016;31:196–209. doi: 10.1007/s12928-015-0366-9. ARC Definite Stent Thrombosis definition used for STOPDAPT.
  4. Thienopyridine was discontinued within 4 months in 94.7% of patients in the STOPDAPT trial. There are several important limitations in the current study. First, and most importantly, this study was not a randomized controlled trial, but a single-arm study comparing with a historical control group. We couldnot draw any definitive conclusions from a single-arm study. The current study was designed as a pilot study to investigate the safety of 3-month DAPT in patients receiving G2-DES, because the study sponsor had planned a large randomized controlled trial comparing 3 months versus longer DAPT duration after G2-DES implantation. Second, selection bias toward inclusion of patients with lower ischemic risk should be considered when interpreting the result of this study. Multivariable analysis could not fully adjust the measured and unmeasured confounders. Third, detailed information of PCI such as final balloon size, balloon dilatation pressure and intravascular ultrasound use was not collected in this study. Finally, we could not exclude the possibility of underreporting of the clinical events in this investigator-driven study. However, the method of follow-up data collection was exactly the same in the STOPDAPT as in the RESET.
  5. von Birgelen C, et al. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting XIENCE V stents in real-world patients: The TWENTE Trial. JACC. 2012;59(15):1350-1361. doi: 10.1016/j.jacc.2012.01.008. ARC Definite Stent Thrombosis definition used for TWENTE.
  6. Fajadet J, et al. PLATINUM PLUS 30-day Poster. TCT 2012. ARC Definite/Probable Stent Thrombosis definition used for PLATINUM PLUS.
  7. 7. SPIRIT II (n=223), SPIRIT III (n=669), SPIRIT IV (n=2,458), SPIRIT V (n=1,662), SPIRIT Women (n=1,506), XIENCE V USA (n=6,516), XIENCE V India (n=931), COMPARE (n=897), STOPDAPT (n=1,525).
  8. Baber U, et al. Impact of the everolimus-eluting stent on stent thrombosis: a meta-analysis of 13 randomized trials. JACC. 2011;58:1569–1577. doi:10.1016/j.jacc.2011.06.049.
  9. Palmerini T, et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis Lancet. 2012;379:1393–1402. doi: 10.1016/S0140-6736(12)60324-9.
  10. Palmerini T, et al. Stent thrombosis with everolimus-eluting stents: meta-analysis of comparative randomized controlled trials. Circ Cardiovasc Interv. 2012;5:357–364. doi: 10.1161/CIRCINTERVENTIONS.111.967083.
  11. Räber L, et al. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: A prospective cohort study. Circulation. 2012;125:1110–1121. doi: 10.1161/CIRCULATIONAHA.111.058560.
  12. Levine GN, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2016;68(10): 1082-1115. doi: 10.1016/j.jacc.2016.03.513.

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