Clinical and angiographic outcomes with an everolimus-eluting stent in large coronary arteries: the SPIRIT III 4.0 mm registry.
OBJECTIVE
This study evaluates the safety and efficacy of the XIENCE V 4.0 mm stent for the treatment of de novo native coronary artery lesions.


BACKGROUND
In the SPIRIT III trial, the XIENCE V everolimus-eluting stent (EES), compared with the TAXUS EXPRESS(2) paclitaxel-eluting stent (PES) in 2.5-3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE).


METHODS
The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions <or=28 mm in length and reference vessel diameter 3.75-4.25 mm treated with a 4.0 mm EES. The primary endpoint was 8-month in-segment LL compared with the randomized PES arm.


RESULTS
In-segment LL was 0.17 +/- 0.38 mm in the 4.0 mm EES registry compared with 0.28 +/- 0.48 mm in the PES arm (P < 0.0001 for noninferiority). The 1-year rates of ischemia-driven TVF (cardiac death, myocardial infarction [MI], or target vessel revascularization) and MACE (cardiac death, MI, or target lesion revascularization [TLR]) were numerically, but not statistically, lower in the 4.0 mm EES patients compared with the randomized PES patients (5.9 vs. 11.3%, P = 0.27 and 5.9 vs. 10.3%, P = 0.36, respectively). There was no difference in 8-month LL or 1-year TVF or MACE between the 4.0 mm EES and randomized EES patients.


CONCLUSIONS
In large coronary arteries, the 4.0 mm EES results in low rates of LL at 8 months and adverse clinical events at 1 year.
Gordon
Paul C
PC
Division of Cardiology, The Miriam Hospital, Providence, Rhode Island 02906, USA. pgordon@lifespan.org
Applegate
Robert J
RJ
Hermiller
James B
JB
Weinsier
Steven B
SB
Doostzadeh
Julie
J
Cao
Sherry
S
Sudhir
Krishnankutty
K
Lansky
Alexandra J
AJ
Stone
Gregg W
GW
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D002317:Cardiovascular Agents; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus