Relocation of minimal luminal diameter after bare metal and drug‐eluting stent implantation: Incidence and impact on angiographic late loss

Abstract

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.

Impact of Acute Gain on Clinical Outcomes of Patients Treated With Sirolimus-Eluting Stent - A Sub-Analysis Study From the STLLR Trial -

“…Interpolated reference diameter and minimal lumen diameter were calculated in 2 orthogonal angiographic views using an automated contour detection algorithm (CAAS II; Pie Medical BV, Maastricht, The Netherlands). 10 Clinical follow-ups were scheduled at 1, 6, or 12 months after the procedure, and all adverse events were adjudicated independently by a clinical events committee also blinded to the angiographic GM assignments. The primary endpoint was the incidence of target lesion revascularization (TLR) 12 months after the procedure.…”

Letter by Agostini et al Regarding Article, “Stent Thrombosis Late After Implantation of First-Generation Drug-Eluting Stents: A Cause for Concern”

“…In conclusion, we already doubt the reliability of late loss as a surrogate for restenosis, [3][4][5] mainly when differences between devices are small (0.1 to 0.3 mm). Additionally, we believe that late loss should not be used as a surrogate for stent endothelialization and for late stent thrombosis in the absence of stronger than currently available evidence favoring this theory.…”

“…Even more important, each minimal lumen diameter can be measured in a different location of the coronary segment considered; minimal lumen diameter relocation, occurring between the measure performed immediately after stent deployment and at follow-up, is a frequent event and casts a light of caution on the value of late loss as surrogate end point. 5 Although we share with the authors concerns related to the long-term data on drug-eluting stents, we should also bear in mind that the 2 most commonly studied drug-eluting stents, sirolimus-and paclitaxel-eluting stents, have shown similar rates of stent thrombosis but significant differences in late loss, with paclitaxel-eluting stents showing constantly greater late loss that sirolimus-eluting stents.In conclusion, we already doubt the reliability of late loss as a surrogate for restenosis, 3-5 mainly when differences between devices are small (0.1 to 0.3 mm). Additionally, we believe that late loss should not be used as a surrogate for stent endothelialization and for late stent thrombosis in the absence of stronger than currently available evidence favoring this theory.…”

Strategies for drug‐eluting stent treatment of bifurcation coronary artery disease in the United States: Insights from the e‐Cypher S.T.L.L.R.Trial

“…Quantitative coronary analysis (QCA) was performed for both branches: from main trunk to MB and SB at preprocedural and final angiogram by an independent core laboratory [24]. Interpolated reference vessel diameter, minimal lumen diameter, and lesion length were calculated in best orthogonal angiographic views for both branches using an automated contour detection algorithm (Cardiovascular Angiography Analysis System II, PIE Medical imaging, Maastricht, The Netherlands).…”