Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study.
BACKGROUND
Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions.


METHODS
The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed.


RESULTS
The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12).


CONCLUSIONS
The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley-Liss, Inc.
Onuma
Yoshinobu
Y
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Tanimoto
Shuzou
S
Ruygrok
Peter
P
Neuzner
Jörg
J
Piek
Jan J
JJ
Seth
Ashok
A
Schofer
Joachim J
JJ
Richardt
Gert
G
Wiemer
Marcus
M
Carrié
Didier
D
Thuesen
Leif
L
Dorange
Cecile
C
Miquel-Hebert
Karine
K
Veldhof
Susan
S
Serruys
Patrick W
PW
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000628:therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging / Q000209:etiology; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus; D005260:Female; D006801:Humans; D007194:India; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus