Update on the everolimus-eluting coronary stent system: results and implications from the SPIRIT clinical trial program.
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.
Kirchner
R Michael
RM
Department of Cardiology, Rhode Island Hospital, Brown Medical School, Providence, RI 02903, USA.
Abbott
J Dawn
JD
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus