More Implants Than Any Other Drug Eluting Stent (DES)
Dual Antiplatelet Therapy DAPT Study
XIENCE provides confidence with the largest body of DAPT data
Current guidelines recommend that patients receive dual antiplatelet therapy (DAPT) for at least 6 months, if subjects have stable ischemic heart disease and are not at high risk of bleeding. These guidelines recommend at least 3 months of DAPT if subjects are at high bleeding risk.
*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)
4. Généreux, P. Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the Everolimus Stent Family trials. TCT 2012.
5. Including patients with no DAPT Interruption except possibly after Stent Thrombosis though 365 days. DAPT was considered to be interrupted if aspirin or a thienopyridine was not taken for at least 24 hours during the 2-year follow-up period for any reason. This is a post-hoc pooled analysis. Patients who require early discontinuation of antiplatelet therapy should be monitored carefully for cardiac events. At the discretion of the treating physician, the antiplatelet therapy should be restarted as soon as possible per patient needs. Ultimately the DAPT regimen is up to the discretion of the treating physician.
6. Philippe Genereux, et. al, Circ Cardiovasc Interv. 2015;8:e001362. DOI: 10.1161/CIRCINTERVENTIONS.114.001362. This is a post-hoc pooled analysis. Comparisons are between permanent discontinuation vs no permanent discontinuation (which includes no discontinuation at any time or temporary interruption). Permanent DAPT discontinuation was considered if DAPT was never resumed after discontinuation or never resumed before a ST event (if a ST occurred after DAPT discontinuation). Patients who experience early discontinuation of antiplatelet therapy should be monitored carefully for cardiac events. At the discretion of the treating physician, the antiplatelet therapy should be restarted as soon as possible per patient needs. Ultimately the DAPT regimen is up to the discretion of the treating physician.
Fluoropolymer Drug Eluting Stent
It Stays to Protect.
- The XIENCE fluoropolymer is durable, highly elastic, and smooth7
- Free of the coating defects seen with BP-DES8
- Reduced risk of thrombosis and elevated inflammation9
SEM images from in vitro bench test*
7. Lo et al.; U.S. Patent 3,178,399. Lilenfeld et al.; U.S. Patent 4,564,013. Mentions of coating technology and polymer include application processing with multi-layer coating over a primer. All data are from preclinical studies.
8. In vivo coating and degradation study. Photos and data on file at Abbott Vascular. Max deployment in in-vitro degradation solution. Vacuum dried for minimum of 5 hours.
9. Paton et al.; U.S. Patent 5,356,668. Garfinkle AM, Hoffman AS. Ratner BD, Reynolds LO, Hanson LR: Effects of a tetrafluoroethylene glow discharge on patency of small diameter Dacron vascular grafts. Trans. Am. Soc. Artif. Organs 1984;30: 432-439. Szott LM, Irvin C, Trollsas M, Hossainy S, and Ratner B.: Blood compatibility assessment of polymers used in drug eluting stent coating. Biointerphases, Vol. 11, No. 2, June 2016.
- Network meta-analysis comparing the safety and efficacy between DES and BMS*
- Analyzed data across only RCTs
- Note that as with any meta-analysis, the underlying studies may have differences in design, enrollment criteria and endpoints; and these results would share the same limitations as the original underlying studies
Source: Palmerini, et al. The Lancet. 379:9824, 14-20 April 2012, pp. 1393-1402.
"Meta-analyses should be regarded as hypothesis-generating and the findings of Palmerini and colleagues suggest that a randomized trial of CoCr EES and BMS is desirable." Ormiston, The Lancet, April 2012.
*The BMS comparator is a composite of several bare metal stents as a representation of the BMS category.
†An odds ratio is a method of comparing the odds of an event between two groups. The XIENCE system's clinical outcomes result from its components, including: a thin-strut, flexible ring and link design, with favorable strut apposition, no metal-to-metal touch points, and low strain upon expansion; the novel Everolimus compound; and the multi-layer coating and primer technologies, using a fluorinated polymer class known for cardiovascular implants, and known for having excellent mechanical properties.
Lower Stent Thrombosis
Significantly Lower 30 Day Stent Thrombosis Rates with XIENCE
Xience vs. Resolute™
Xience vs. Promus Element™
10. Serruys, PW et al. RESOLUTE All-Comers Trial, NEJM 2010. Published online June 16, 2010.
11. Fajadet J. PLATINUM PLUS 30-Day Poster, TCT 2012.