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.

Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial.

The combined use of a drug-eluting balloon (DEB) and a bare metal stent (BMS) for the treatment of de novo non-small vessel coronary artery diseases (CAD) remains to be evaluated. We investigated the efficacy of a sequential treatment using a DEB together with a BMS implantation in comparison to a zotarolimus-eluting stent (ZES). This study was a prospective, randomized, open-label study. We designed it to demonstrate the non-inferiority of a sequential treatment using a DEB first followed by a BMS (DEB + BMS) compared with the use of a ZES. The primary endpoint was in-segment late loss (LL) at 9 months measured by quantitative coronary angiography (QCA). A total of 180 patients were enrolled in the study. The 9-month follow-up angiography was performed in 72 patients with DEB + BMS and 74 patients with ZES. When comparing the DEB + BMS results with the ZES ones, LL was 0.50 ± 0.46 mm in DEB + BMS patients vs. 0.21 ± 0.44 mm in ZES patients (P < 0.001). The mean difference of the LL was 0.31 mm, which was larger than the prespecified non-inferiority margin of 0.19 mm, and the 2-sided 95% confidence interval was 0.15-0.48. The clinical outcomes were not significantly different. In conclusion, the DEB + BMS strategy is inferior to the ZES one in terms of the LL result at 9 months. The DEB strategy for de novo coronary artery lesions needs to be improved for it to become an alternative treatment option.

Impact of catheter size on reliability of quantitative coronary angiographic measurements (comparison of 4Fr and 6Fr catheters).

To evaluate the feasibility of catheter down sizing for QCA, the reliability of a 4Fr catheter as a calibration device was evaluated. Repeated coronary angiograms of 9 lesions were obtained using 4Fr and 6Fr catheters under otherwise identical conditions. The calibration factor was measured 10 times by 4Fr and 6Fr catheters. QCA measurements including minimal lumen diameter (MLD), interpolated normal reference (Int N), percent diameter stenosis (%DS), and lesion length (LL) were performed by two technicians twice with a 3-month interval. The intraobserver and interobserver variability of each parameter was evaluated using intraclass correlation coefficients (ICCs). Mean of mean SD of calibration factor was significantly larger in 4Fr than in 6Fr in 9 lesions. The mean of mean coefficient of variance was significantly larger in 4Fr catheters vs in 6Fr catheters. A 6Fr catheter showed excellent reliability for both intraobserver and interobserver variability in MLD, Int N, %DS, and LL. In contrast, 4Fr showed that reliability in intraobserver variability depended on the analyst. Although reliability of interobserver variability in Int N measured by the 4Fr catheter was >0.80, the value was less than that by the 6Fr catheter. Taking these results into consideration, 4Fr catheters are less reliable than 6Fr catheters when measuring QCA data especially for follow-up data that need most accurate measurements of MLD and %DS. It would be better to use a 6Fr catheter to evaluate QCA measurements such as acute gain, late loss, restenosis rate, and device size.

Association between cholesterol efflux capacity and coronary restenosis after successful stent implantation.

The measurement of high-density lipoprotein (HDL) functionality could be useful for identifying patients who have an increased risk of coronary restenosis after stent implantation. In the present study, we elucidates whether HDL functionality can predict restenosis. The participants included 48 consecutive patients who had stable angina and were successfully implanted with a drug-eluting stent (DES) or bare-metal stent. Follow-up coronary angiography was performed after 6-8 months of stenting. Cholesterol efflux and the anti-inflammatory capacity of HDL were measured before stenting (at baseline) and at follow-up. The mean age was 64 ± 11 years and the body mass index was 24 ± 3 kg/m(2). While HDL cholesterol (HDL-C) significantly increased from baseline to follow-up, there was no significant association between HDL-C level at baseline and in-stent late loss. Cholesterol efflux capacity was significantly increased from baseline to follow-up. The efflux capacity at baseline was negatively correlated with in-stent late loss, whereas the anti-oxidative activity of HDL at baseline was not associated with in-stent late loss. We analyzed the predictors of in-stent late loss using independent variables (efflux capacity and anti-oxidative capacity at baseline in addition to age, gender, HDL-C and low-density lipoprotein cholesterol at baseline, hypertension, diabetes mellitus, smoking, lesion length and DES implantation, history of myocardial infarction and prior percutaneous coronary intervention) by a multiple regression analysis. The efflux capacity at baseline was only independently associated with in-stent late loss. In conclusion, cholesterol efflux capacity at baseline could predict coronary restenosis in patients with successful stent implantation.

Inter- and intra-core laboratory variability in the quantitative coronary angiography analysis for drug-eluting stent treatment and follow up.

AIM: To evaluate inter-core laboratory variability of quantitative coronary angiography (QCA) parameters in comparison with intra-core laboratory variability in a randomized controlled trial evaluating drug-eluting stents. METHODS: A total of 50 patients with 62 coronary lesions were analyzed by four analysis experts belonging to an Angiographic Core Laboratory (ACL: 1 expert) and a Cardiovascular Imaging Core Laboratory (CICL: 3 experts). QCA was based on the same standard operating procedure, but selections of projection and cine frames were at the discretion of each analyst. Inter- and intra-core laboratory variabilities were evaluated by accuracy, precision, Bland Altman analysis, and coefficient of variation. RESULTS: Pre-MLD (minimal lumen diameter) was significantly smaller in results from ACL than those from all CICL experts. Number of analyzed projections did not affect pre-MLD results. Acute gain was larger in ACL than in CICL2. No significant difference was observed in late loss and loss index between inter-core laboratories. Agreement between core labs in the Bland-Altman analysis for each QCA parameter was as follows (mean difference, 95% limits of agreement): pre-MLD (-0.32, -0.74 to 0.10), stent MLD (0.08, -0.28 to 0.44), acute gain (0.22, -0.44 to 0.88), and late loss (-0.07, -0.69 to 0.55). Agreement between analysts in CICL (mean difference, 95% limits of agreement) was: pre MLD (-0.03, -0.37 to 0.31), stent MLD (0.15, -0.15 to 0.45), acute gain (0.05, -0.45 to 0.55), and late loss (0.04, -0.52 to 0.60). The widest limits of agreement among three analyses were shown in both analyses. Width of limited agreement in the intra-core laboratory analysis tended to be smaller than the inter-core laboratory analysis with these parameters. Coefficient of variation tended to be larger in lesion length (LL), acute gain, late loss, and loss index in inter- and in intra- core laboratory comparisons. CONCLUSION: Inter-core laboratory QCA variability in late loss and loss index analysis could be similar to intra-core laboratory variability, but more strict alignment between core laboratories would be necessary for initial procedural data analysis.

Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial.

OBJECTIVES: The aim of the present study was to evaluate the angiographic efficacy, clinical safety, and effectiveness of the Restore paclitaxel-coated balloon in a randomized trial designed to enable the approval of the new device in China. BACKGROUND: Drug-coated balloon (DCB) angioplasty offers an effective treatment for in-stent restenosis. Restore is a new DCB with a SAFEPAX shellac-ammonium salt excipient that can avoid drug washing off during catheter delivery to the target lesion site. METHODS: In the noninferiority RESTORE ISR China (Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis) trial, eligible patients with first occurrence of drug-eluting stent ISR were randomized to the Restore DCB or SeQuent Please DCB in a 1:1 ratio stratified by diabetes. Angiographic and clinical follow-up was planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment late loss. RESULTS: Between May 2016 and July 2017, a total of 240 subjects at 12 sites were randomized to either the Restore group (n = 120) or the SeQuent Please group (n = 120). Nine-month in-segment late loss was 0.38 ± 0.50 mm with Restore versus 0.35 ± 0.47 mm with SeQuent Please; the 1-sided 97.5% upper confidence limit of the difference was 0.17 mm, achieving noninferiority of Restore compared with SeQuent Please (p for noninferiority = 0.02). Both DCBs had similar 1-year rates of target lesion failure (13.3% vs. 12.6%; p = 0.87). CONCLUSIONS: In this head-to-head randomized trial, the Restore DCB was noninferior to the SeQuent Please DCB for the primary endpoint of 9-month in-segment late loss. (Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis; NCT02944890).