How does XIENCE Sierra™ Stent differ from previous generations of XIENCE™ DES?

XIENCE Sierra™ Stent offers these features:³

• Increased post dilatation maximum expansion to 5.5 mm for 3.5 and 4.0 mm diameters
• No shortening at maximum post dilatation maximum at 5.5 mm
• Ultra-low stent profile of 0.0390" allows for easier crossing of difficult lesions
• Best in class deliverability while expending less force across lesions (e.g., 73% less force than Synergy^‡

The ultra-low crossing profile allows users to choose XIENCE™ Stent for the most challenging cases of coronary artery disease. XIENCE™ Stents, in addition to being the most studied stents, produce consistently low stent thrombosis (ST) rates.¹

What are the stent sizes and ordering information for XIENCE Sierra™ drug-eluting stents?

What are the unique properties of the XIENCE™ DES fluoropolymer?

The specific fluoropolymer used—based on years of research—plays a critical role in XIENCE™ Stent's superior outcomes. Abbott successfully identified a polymer that offers both mechanical integrity and scientific evidence of biocompatibility. Extensive research showed that polymers with a fluorinated surface were associated with “protective” attributes, such as the ability to tightly bind albumin to create a “protective cloak” around the stent.⁴ This results in the following characteristics, collectively known as fluoropassivation:

• Thromboresistance, referring to the preferential adsorption and retention of good protein (e.g., albumin) vs thrombogenic proteins (e.g., fibrinogen)—leading to less platelet adhesion and activation.
• Minimal inflammatory response,⁸ since the preferential adsorption of albumin minimizes platelet adhesion, leukocyte activation and leukocyte recruitment.
• Functional endothelialization, since preferential albumin adsorption elicits a cellular response conducive to healing, with rapid formation of functional endothelium and minimal chronic inflammation.⁵

Thus the XIENCE™ fluoropolymer was created to ensure long-term protection to the vessel and ultimately to the patient.

What is the dual antiplatelet therapy (DAPT) duration with XIENCE™ Stents?

With more than 24,000 XIENCE™ DES patients analyzed in DAPT studies,⁶ Abbott has received a 1-month DAPT CE indication for High Bleeding Risk patients.

In addition, the STOPDAPT, STOPDAPT 2, XIENCE 28 and XIENCE 90 trials reported consistently low ST rates when DAPT was discontinued after 1 or 3 months.⁷ (XIENCE 28, STOPDAPT, STOPDAPT 2 and XIENCE 90 results at 12 months). Learn more about DAPT.

* The effects of MRI on overlapped stents greater than 71 mm in length, or involving stents with fractured struts, are unknown.
 

References

1. Zanchin C, et al. JACC Cardiovasc Interv. 2019;12(17):1665-1675. Serruys P, et al. N Engl J Med. 2010;363:136-146. Shiomi H, et al. JACC Cardiovasc Interv. 2019;12:637-647. Kufner S, et al. Circulation. 2019:139(3):325-333. Palmerini T, et al. Lancet. 2013;379:1393-1402. Bangalore S, et al. Circulation. 2012;125:2873-2891. Bangalore S, et al. Circ Cardiovasc Interv. 2013;6(6):378-390. Pilgrim T, et al. Lancet. 2014;384:2111-2122. Pilgrim T, et al. Lancet. 2018;392:737-746. Data on file at Abbott.
2. Instructions for Use, XIENCE Sierra™ Stent.
3. Tests performed by and data on file at Abbott. Increased maximum expansion compared XIENCE Sierra™ Stent with XIENCE Alpine™ Stent. Shortening compared XIENCE Sierra™ Stent (4.0 x 18 mm, n=5), SYNERGY^‡ (4.0 x 20 mm, n=5), Resolute Onyx^‡ (4.5 x 18 mm, n=5). Crossing data showed that XIENCE Sierra™ stent performed better in crossability and was not statistically different in trackability and pushability compared to Resolute Onyx^‡ and SYNERGY^‡ stents. Bench test results may not necessarily be indicative of clinical performance. Testing performed on XIENCE Sierra™ Stent (3.0 x 18 mm, n=5), SYNERGY^‡ (3.0 x 20 mm, n=5), Resolute Onyx^‡ (3.0 x 18 mm, n=5). Catheter performance crossability test measures average force to cross a challenging lesion model.
4. Garfinkle AM, et al. Trans Am Soc Artif Intern Organs. 1984;30:432-439. Ao PY, et al. Eur J Vasc Endovasc Surg. 2000;20:241-249. Jinnouchi H, et al. EuroIntervention. 2020;10:EIJ-D-19-00938
5. Garfinkle AM, et al. Trans Am Soc Artif Intern Organs. 1984;30:432-439. Chinn JA, et al. J Biomed Mater Res. 1998;39:130-140. Généreux P, et al. Circ Cardiovasc Interv. 2015;8:e001362.
6. Généreux P, et al. Circ Cardiovasc Interv. 2015;8: e001362. Natsuaki M, et al. Cardiovasc Interv and Ther. 2016. 31:196–209. Watanabe H, et al. JAMA. 2019;321(24):2414-2427. Hahn J, et al. ACC 2019, SMART CHOICE. Valgimigli M, et al. Circulation. 2012;125:2015-2026. Gilard M, et al. J Am Coll Cardiol. 2015;65:777-786, Hong SJ, et al. JACC Cardiovasc Interv. 2016;9:1438–1446. Gwon HC, et al. ACC 2011, EXCELLENT. Mehran R, et al. TCT Connect 2020, XIENCE 28/90.
7. Natsuaki M, et al., Cardiovasc Interv and Ther. 2016. 31:196–209; Watanabe H, et al. JAMA. 2019;321(24):2414-2427. Mehran R, et al. TCT Connect 2020, XIENCE 28/90. Valgimigli M, et al. ACC 2021, XIENCE 28/90.
8. Jinnouchi H, et al. J Am Coll Cardiol. 2019;74:Suppl B - TCT-291.