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SPIRIT - SPIRIT
Description:
The goal of the SPIRIT study was to evaluate the safety and efficacy of an everolimus-eluting cobalt chromium coronary stent among patients with a single de novo coronary lesion.
Study Design
Patients Enrolled: 60
Mean Follow Up: 12 months
Mean Patient Age: Mean age 63 years
Female: 27
Patient Populations:
Single de novo coronary lesion; stable angina; target vessel reference diameter 2.8-3.2 mm, lesion length ≤12 mm, and stenosis ≥50%
Exclusions:
Lesion located within 2 mm of the origin of the left anterior descending artery or left circumflex or within 2 mm of a bifurcation; other significant lesions (≥40% stenosis) in the same vessel as the target lesion; within 3 days of MI; ejection fraction ≤30%; history of unstable arrhythmias; organ transplant candidate or recipient; known immunosuppressive disease; chronic anticoagulation therapy; drug-eluting stent implantation within the prior year
Primary Endpoints:
In-stent late loss at 6 month angiographic follow-up
Secondary Endpoints:
Binary restenosis and percent diameter stenosis at 6 months; in-stent percent volume obstruction; in-stent late loss at 1 year; acute success; MACE at 6 and 12 months, defined as death, MI or clinically driven target lesion revascularizations
Drug/Procedures Used:
Patients were randomized to bare metal stent or everolimus-eluting cobalt chromium coronary stent. Follow-up angiographic and intravascular ultrasound (IVUS) were performed at 6 months and 1 year.
Principal Findings:
Baseline and angiographic characteristics were generally well-balanced between the groups, with an LAD lesion in 43% and type B1 or B2 lesions in 95% of patients. Procedural and device success was high in both groups (>95%).
The primary endpoint of in-stent late lumen loss was lower in the everolimus-eluting stent group compared with the bare metal stent group (0.10 mm vs 0.84 mm, p<0.0001). the="" proximal="" and="" distal="" late="" loss="" in="" the="" everolimus-eluting="" stent="" group="" was="" 0.10="" mm="" and="" 0.07="" mm,="" respectively.="" there="" were="" no="" cases="" of="" binary="" restenosis="" in="" the="" everolimus-eluting="" stent="" group.="" neointimal="" volume="" on="" ivus="" was="" smaller="" in="" the="" everolimus-eluting="" stent="" group="" versus="" the="" bare="" metal="" stent="" group.="" mace="" at="" 6="" months="" was="" lower="" in="" the="" everolimus-eluting="" stent="" group="" (7.7%="" vs="" 21%);="" none="" of="" the="" mace="" events="" in="" the="" everolimus-eluting="" stent="" group="" occurred="" after="" 30="" days.="" the="" proximal="" and="" distal="" late="" loss="" in="" the="" everolimus-eluting="" stent="" group="" was="" 0.10="" mm="" and="" 0.07="" mm,="" respectively.="" there="" were="" no="" cases="" of="" binary="" restenosis="" in="" the="" everolimus-eluting="" stent="" group.="" neointimal="" volume="" on="" ivus="" was="" smaller="" in="" the="" everolimus-eluting="" stent="" group="" versus="" the="" bare="" metal="" stent="" group.="" mace="" at="" 6="" months="" was="" lower="" in="" the="" everolimus-eluting="" stent="" group="" (7.7%="" vs="" 21%);="" none="" of="" the="" mace="" events="" in="" the="" everolimus-eluting="" stent="" group="" occurred="" after="" 30="">
Interpretation:
Among patients with a single de novo coronary lesion, use of an everolimus-eluting cobalt chromium coronary stent was associated with a reduction in late lumen loss compared with a bare metal stent at 6 month angiographic follow-up. Results of the present SPIRIT study are similar to results seen in the FUTURE I and FUTURE II trials, which also evaluated an everolimus-eluting stent compared with bare metal stent. However, the trials differ in the stent used for the elution, which in the FUTURE trials was a stainless steel stent and the SPIRIT trial was a cobalt chromium stent with thinner struts. Everolimus is a novel anti-proliferation agent developed for the prevention of graft rejection in organ transplantation.
References:
Presented at the 2005 Cardiovascular Research Therapeutics Sessions, Washington, DC.
Keywords: Follow-Up Studies, Stainless Steel, Angina, Stable, Cobalt, Graft Rejection, Drug-Eluting Stents, Immunosuppressive Agents, Chromium, Constriction, Pathologic, Sirolimus, Stents
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