Device profile of the XIENCE V and XIENCE Sierra stents for the treatment of coronary artery disease: an overview of safety and efficacy

ABSTRACT

Introduction: Coronary angioplasty with the use of stents transformed the percutaneous treatment of coronary artery disease. First-generation drug-eluting stents reduced the risk of restenosis but carried a threat of late stent thrombosis. Second-generation drug-eluting stents resolved these issues and have proven so far very good safety and efficacy performance.

Areas covered: This article aims to describe the new XIENCE® Sierra everolimus-eluting coronary stent system, to analyze the available data so far with regards to the safety, the effectiveness, and the overall clinical performance of the device and to seek future perspectives.

Expert opinion: XIENCE® Sierra everolimus-eluting coronary stent carries all the positive features of the precursor stents of the XIENCE® family and brings an ultra-low crossing profile which further increases deliverability and flexibility. CoCr-everolimus-eluting stents are among if not the most extensively investigated coronary stents and have demonstrated over the years a consistently remarkable low risk of acute, subacute, late, and very late stent thrombosis and are considered a trustworthy device in the interventional management of complex coronary artery disease.

KEYWORDS:

• Drug-eluting stent
• everolimus
• in-stent restenosis
• stent thrombosis
• XIENCE
• sirolimus
• paclitaxel
• biodegradable polymer

Article highlights

• The evolution of coronary stents has revolutionized the percutaneous management of coronary artery disease.

• The development of new generation DESs, with innovation in-stent platforms, polymers, and anti-proliferative drugs, achieved to demonstrate superiority against the BMSs and first-generation DESs.

• A large body of evidence supports the use of EES in complex cases with good acute and long-term outcomes supported by large-randomized trial, metanalysis, and registries.

• The XIENCE® Sierra carries all the successful features of its predecessors in the XIENCE® family, a well-studied Co-Cr EES, that have one of the lowest rates of stent thrombosis mainly based on the thromboresistant nature of the fluoropolymer and the more rapid endothelialization.

• The new XIENCE® Sierra appears to have a better performance with a very low profile (0.0390”) in terms of deliverability, flexibility, radial strength, and maximum expansion compared to other DESs.

• One of the unanswered questions in the new DES era is still the DAPT duration and many ongoing trials are aiming at addressing this issue.

Declaration of interest

Marco Valgimigli reports personal fees from Astra Zeneca, grants and personal fees from Terumo, personal fees from Alvimedica/CID, personal fees from Abbott Vascular, personal fees from Daiichi Sankyo, personal fees from Opsens, personal fees from Bayer, personal fees from CoreFLOW, personal fees from IDORSIA PHARMACEUTICALS LTD, personal fees from Universität Basel | Dept. Klinische Forschung, personal fees from Vifor, personal fees from Bristol Myers Squib SA, personal fees from iVascular. Andreas Mitsis has received a training grant from Medtronic. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.