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Update on the everolimus-eluting coronary stent system: results and implications from the SPIRIT clinical trial
R Michael Kirchner1, J Dawn Abbott
1Department of Cardiology, Rhode Island Hospital, Brown Medical School, Providence, RI 02903, USA.
Insights
Drug-eluting stents (DES) significantly reduce restenosis compared to bare metal stents. The Xience V stent demonstrated efficacy and safety in the SPIRIT trial program, offering improved outcomes in interventional cardiology.
Area of Science:
- Interventional Cardiology
- Biomedical Engineering
- Clinical Trials
Background:
- Drug-eluting stents (DES) have revolutionized interventional cardiology by reducing restenosis and target vessel revascularization compared to bare metal stents.
- Several DES are available, including first-generation sirolimus-eluting and paclitaxel-eluting stents, and second-generation everolimus-eluting and zotarolimus-eluting stents.
Purpose of the Study:
- To provide a comprehensive assessment of the Xience V everolimus-eluting stent.
- To review data from pre- and post-approval randomized controlled trials and registry studies within the SPIRIT clinical trial program.
- To discuss the implications of mid-term outcomes for interventional practice.
Main Methods:
- Analysis of data from the SPIRIT clinical trial program, including randomized controlled trials and registry studies.
- Assessment of pre- and post-approval data for the Xience V stent.
- Review of recently published mid-term outcomes.
Main Results:
- The Xience V stent was approved based on clinical efficacy and safety data from the SPIRIT trials.
- In the SPIRIT trials, Xience V was superior to the Vision bare metal stent for target vessel failure at 9 months.
- Xience V was noninferior to the paclitaxel-eluting stent for target vessel failure at 9 months.
Conclusions:
- The Xience V stent has demonstrated significant clinical efficacy and safety.
- Data from the SPIRIT clinical trial program support the use of Xience V in interventional cardiology.
- Mid-term outcomes continue to support the role of Xience V in improving patient care.
Abstract:
Drug-eluting stents (DES) have had a major impact in interventional cardiology. Compared to bare metal stents, they significantly reduce restenosis and the need for target vessel revascularization. Four DES are available in the US, the first-generation sirolimus-eluting (Cypher((R))) and paclitaxel-eluting (Taxus((R))) stents and later approved second-generation everolimus-eluting (Xience V((R))) and zotarolimus-eluting (Endeavor((R))) stents. The Xience V stent was approved on the basis of clinical efficacy and safety data from 3 studies in the SPIRIT clinical trial program. Within this trial series, the Xience V was superior to its bare metal stent counterpart, the Vision(R) stent, and noninferior to the paclitaxel-eluting stent for target vessel failure at 9 months. This review provides a comprehensive assessment of the data derived from both the pre- and post-approval randomized controlled trials and registry studies of Xience V that comprise the SPIRIT clinical trial program including recently published mid-term outcomes. The implications of the results in terms of interventional practice will be discussed.
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