Incidence and predictors of early and late target lesion revascularization after everolimus-eluting stent implantation in unselected patients in japan.

OBJECTIVE: The objective of this study was to clarify the incidence and predictors of early and late target lesion revascularization (TLR) after everolimus-eluting stent (EES) implantation in actual clinical practice. BACKGROUND: Several clinical studies have reported the incidence and predictors of TLR after EES implantation. However, detailed features of early and late TLR are unknown. METHODS: We analyzed the clinical data of patients who underwent EES implantation between January 2010 and December 2011 at 22 institutions in Japan (Tokyo-MD PCI study). Patients who underwent ischemia-driven TLR (ID-TLR) were grouped according to the number of years elapsed since stent placement, and incidence and correlations between clinical factors were analyzed. RESULTS: Statistical analysis was performed for 1,899 patients and 2,305 lesions. The mean age was 70.0 ± 9.9 years, and the median follow-up period was 1,281 days (IQR: 762-1,440 days). The incidence of ID-TLR was 2.7% at 1 year and 5.4% at 4 years. After 2 years, the ID-TLR rates plateaued. The independent predictors of ID-TLR occurring within 2 years were hemodialysis, triple vessel disease, restenotic lesion, and ostial lesions. The independent predictors of ID-TLR between 2 and 4 years were diabetes mellitus and peripheral artery disease. CONCLUSION: The ID-TLR rates leveled off after 2 years. Furthermore, the predictors of ID-TLR that occurred within 2 years of EES implantation differed from those that occurred later than 2 years. © 2017 Wiley Periodicals, Inc.

Initial and late efficacy of everolimus-eluting stents for small and non-small coronary lesions from evaluating delayed late loss study.

The aim of the present study was to evaluate the long-term outcomes at 2 years in patients in whom everolimus-eluting stents (EESs) were implanted in small and non-small vessels. A small vessel is an important risk factor for restenosis with BMSs, even in the first generation DESs. The 690 patients with 690 lesions implanted with an EES were enrolled and divided into two groups by vessel reference diameter (RD): >2.5 mm for non-small vessels (Non-S-group) and ≤2.5 mm for small vessels (S-group). Two years later, the 365 patients with no restenosis at 8 months who underwent angiography were enrolled into the late catch-up study. At the initial 8-month follow-up, the rates of restenosis and target lesion revascularization (TLR) of both groups were not significantly different (restenosis 3.9 vs 6.5%, p = 0.17; TLR 3.9 vs 6.5%, p = 0.17). At the late 2-year follow-up, there were no significant differences in the late loss (0.36 ± 0.66 vs 0.34 ± 0.50 mm, p = 0.14), net gain (1.50 ± 0.75 vs 1.26 ± 0.60 mm, p = 0.39), late catch-up restenosis rate (5.1 vs 3.4%, p = 0.38), TLR (4.9 vs 2.7%, p = 0.40), and delayed late loss (0.14 ± 0.58 vs 0.15 ± 0.49 mm, p = 0.10) between both groups. There is no correlation between delayed late loss and RD in all patients(r = -0.009) and in AMI patients (r = -0.004). These results demonstrate that the initial and late catch-up restenosis rates of small coronary vessels with EES placement were excellent, the same as for non-small coronary vessels. We suggest that involvement of small coronary arteries may not be a risk factor for restenosis and results of stenting for small coronary arteries with EES placement were excellent.

A serial 3- and 9-year optical coherence tomography assessment of vascular healing response to sirolimus- and paclitaxel-eluting stents.

Early-generation drug-eluting stents (DES) have been demonstrated to delay vascular healing. Limited optical coherence tomography (OCT) data on the very long-term neointimal response after DES implantation are available. The aim of this study was a serial OCT assessment of neointimal thickness, stent strut coverage, malapposition, and protrusion as markers of neointimal response at 3 and 9 years after implantation of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). In this single-centre, longitudinal study consecutive patients undergoing elective PCI with SES or PES were included. OCT analysis was performed after 3 and 9 years by the independent core laboratory. A total of 22 subjects (8 SES and 14 PES) underwent an OCT assessment at 3 and 9 years post index procedure. The lumen, neointimal and malapposition area and the neointimal thickness (SES ∆50 µm, p = 0.195, PES ∆10 µm, p = 0.951) did not change significantly over the 6 year follow-up. No differences in the incidence of uncovered, malapposed or protruding struts were found in each type of stent. At 3 and 9 years after PCI, implantation of early-generation SES and PES may be associated with similar neointimal thickness, strut coverage, malapposition and protrusion, as assessed by serial OCT examination among patients with uneventful follow-up at 3 years post procedure. The small size of the study warrants judicious interpretation of our results and confirmation in larger multimodality imaging studies, including patients treated with contemporary stent platforms.

Incidence and predictors of the late catch-up phenomenon after drug-eluting stent implantation.

BACKGROUND: Although clinical restenosis within 1 year after percutaneous coronary intervention has been remarkably reduced with the advent of drug-eluting stents (DES), the late catch-up (LCU) phenomenon remains an issue despite medical advances. The aim of this study was to investigate the incidence and predictive factors of the LCU phenomenon in an unselected population treated with first-generation DES. METHODS: A total of 923 patients treated with DES between June 2004 and August 2008 were analyzed. The LCU phenomenon was defined as secondary revascularization 1 year after index stenting. Retreatment for very late stent thrombosis was considered as part of the LCU phenomenon. RESULTS: Incidence of the LCU phenomenon was seen in 33 patients (3.6%). Very late stent thrombosis was observed in 5 patients (0.6%) and very late in-stent restenosis was observed in 28 patients (3.0%). At the 12-month landmark analysis, the cumulative rate of cardiac death was significantly higher in patients with the LCU phenomenon than in those without any target lesion revascularization (9.0% vs. 0.9%, p<0.001). In the multivariate analysis, hemodialysis [odds ratio (OR) 6.07, p=0.003], number of stents (OR 1.58, p=0.02), and coronary bifurcation lesions (OR 2.06, p=0.048) were identified as independent predictors of the LCU phenomenon. CONCLUSION: The LCU phenomenon is associated with serious consequences and adverse events and remains an important issue in modern practice, despite medical advances. DES should be deployed with a minimum number of stents, and special consideration must be given to patients on hemodialysis and those with coronary bifurcation lesions.