Relocation of minimal luminal diameter after bare metal and drug-eluting stent implantation: incidence and impact on angiographic late loss.
Late loss (LL) has been a fundamental angiographic end-point in drug-eluting stents (DES) clinical trials. However, calculation of LL may be affected by a mismatch between post-procedure (PO) and follow-up (FU) sites of the minimal lumen diameter (MLD). Our aims were to investigate the incidence and methodological implications of the relocation of MLD after bare metal (BMS), sirolimus-eluting (SES), and paclitaxel-eluting (PES) stent implantation. Data from DIABETES I and II trials, which involved diabetic patients treated with BMS, SES, and PES, were analyzed. Angiographic data with matched projections between PO and 9-month angiographic FU were included. In-stent, in-lesion, and in-segment analyses included conventional and customized sub-segmental (5-mm/subsegment) methodology. MLD relocation was considered when the sites of MLD shifted a distance >> the intrinsic variability of the method. Conventional LL, site matched LL, maximal LL (MaxLL), and average LL (AvgLL) were calculated. Relationships between various LL and 1-year target lesion revascularization (TLR) were investigated. Post MLD was located distally, outside the stent, in > or =65% of the analyses. At FU, MLD relocation occurred in 70.5% (BMS), 40% (SES), and 35% (PES). MLD shifted > or =11 mm on average, mainly towards the stented segment. MLD relocation still occurred in 42.8% (BMS), 33.7% (SES), and 36.4% (PES), when analysis was restricted to in-stent segment. Among LL measurements, MaxLL showed the best association with TLR rates. Relocation of the MLD is a frequent phenomenon after both BMS and DES, and should be taken into account when calculating LL. Comprehensive LL analyses, including MaxLL and AvgLL, provides a better appraisal of the biological and clinical effectiveness of DES.
Costa
Marco A
MA
Division of Cardiology and Cardiovascular Imaging Core Laboratories, University of Florida Shands Jacksonville, Jacksonville, Florida 32209, USA. marco.costa@jax.ufl.edu
Sabaté
Manel
M
Angiolillo
Dominick J
DJ
Hu
Paula
P
Jimenez-Quevedo
Pilar
P
Corros
Cecilia
C
Alfonso
Fernando
F
Hernandez-Antolin
Rosana
R
Macaya
Carlos
C
Bass
Theodore A
TA
D000368:Aged; D000704:Analysis of Variance; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000188:drug therapy* / Q000209:etiology; D048909:Diabetes Complications / Q000000981:diagnostic imaging / Q000188:drug therapy; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D012372:ROC Curve; D020123:Sirolimus / Q000008:administration & dosage; D015607:Stents; D016896:Treatment Outcome
D017239:Paclitaxel; D020123:Sirolimus