Risk of late-acquired incomplete stent apposition after drug-eluting stent versus bare-metal stent. A meta-analysis from 12 randomized trials.
BACKGROUND
Incomplete stent apposition (ISA) is an unusual finding of intravascular ultrasound (IVUS) that may occur both after drug-eluting stent (DES) or bare-metal stent (BMS) implantation and could be associated with late stent thrombosis. Controversy still remains about whether the risk of late-acquired ISA is increased after DES implantation. This meta-analysis aimed to clarify whether DES implantation is associated with an increased risk of late-acquired ISA.


METHODS
We performed a meta-analysis from 12 randomized trials that compared DES and BMS and included IVUS follow up: TAXUS II (n = 469), TAXUS IV (n = 187), TAXUS V (n = 213) and VI (n = 147), ASPECT (n = 81), DELIVER (n = 65), SIRIUS (n = 141), DIABETES (n = 140), ENDEAVOR II (n = 250), FUTURE I and II (n = 83), and SPIRIT-I (n = 58). In these trials, 1,834 patients (972 DES, and 862 BMS) underwent immediate and follow-up IVUS examination.


RESULTS
There was no heterogeneity among the trials (Q-test for heterogeneity: Chi2: 7.69; (p = 0.26), I2: 22%. Out of the 1,834 patients undergoing serial IVUS examination, 85 developed late-acquired ISA (4.6%). This incidence was significantly higher in DES compared with BMS (6.5% vs. 2.6%, respectively; odds ratio [OR] 2.48, 95% confidence interval [CI] 1.26 to 4.87; p = 0.008). That means that the risk of developing late-acquired ISA is 2.5 times higher after DES versus BMS implantation. No stent thrombosis occurred in the patients diagnosed with ISA over a period up to 12 months.


CONCLUSIONS
DES implantation could be associated with an increased risk of late ISA in comparison with BMS. The clinical implication of late ISA in the long term remains to be clarified.
Sanchez-Recalde
Angel
A
Sección de Hemodinámica y Cardiología Intervencionista (1 planta diagonal), Hospital Universitario La Paz, Paseo de la Castellana 261, 28046, Madrid, Spain. asanchezr.hulp@salud.madrid.org
Moreno
Raul
R
Barreales
Laura
L
Rivero
Fernando
F
Galeote
Guillermo
G
Jimenez-Valero
Santiago
S
Calvo
Luis
L
López de Sá
Esteban
E
López-Sendón
José L
JL
D015906:Angioplasty, Balloon, Coronary; D001672:Biocompatible Materials; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D006801:Humans; D008670:Metals; D011475:Prosthesis Failure; D016032:Randomized Controlled Trials as Topic; D015607:Stents / Q000009:adverse effects*; D013997:Time Factors; D018084:Ultrasonography, Interventional
D001672:Biocompatible Materials; D008670:Metals