Search

Aims: The purpose of this study was to investigate the vascular response of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) using serial intravascular ultrasound (IVUS)., Methods and Results: Data were obtained from the SPIRIT III trial, a multicentre, 2:1 randomised, controlled study comparing EES and PES in de novo native coronary artery lesions. IVUS images were eligible for volumetric analysis at eight-month follow-up in 158 lesions (EES: 113, PES: 45). At eight months, EES had a smaller neointimal volume index (VI: mm3/mm) (EES: 0.4±0.4 vs. PES: 0.8±0.8 mm3/mm, p=0.002) and also a smaller % neointimal obstruction (EES: 7.1±6.7% vs. PES: 11.1±10.5%, p=0.005) compared with PES. While there was no significant change in vessel VI with EES, there was a significant increase in vessel VI in PES during eight-month follow-up (EES: 0.1±1.2 vs. PES: 1.2±0.8 mm3/mm, p=0.001). There were no statistical differences in the frequency of edge dissection or incomplete stent apposition between the two groups., Conclusions: Detailed IVUS analysis confirmed significantly less neointimal hyperplasia with EES compared with PES. While there was no increase in vessel volume with EES during the eight-month follow-up period, vessel enlargement was seen at the stented segment in PES.

Background: Dedicated IVUS analyses of the second CObalt chromium STent with Antiproliferative for Restenosis (COSTAR II) trial have not been documented. We aim to compare IVUS findings between CoStar paclitaxel-eluting stent (PES) and Taxus PES in patients enrolled in the COSTAR II trial. We also attempted to examine the possible regional impact of multiple stenting., Methods and Materials: Among the 1700 patients enrolled, 238 were assigned to an IVUS cohort including 168 patients treated by provisional multiple stenting. At 9 months, qualitative and quantitative IVUS observations including incomplete stent apposition (ISA) and neointimal proliferation (neointimal obstruction: neointimal volume/stent volume ×100) were compared between CoStar and Taxus PESs., Results: In qualitative analysis, late-acquired ISA was observed in 1 patient treated by Taxus PES. Impaired strut continuity suggestive of stent fracture was observed in 2 out of 33 patients treated by multiple CoStar, and 4 out of 21 patients treated by multiple Taxus (P=.14). No such findings were found in single-stented patients in either stent subset. Quantitative analysis showed greater neointimal obstruction in CoStar (19.7%±13.4%, n=52) than in Taxus (10.7%±9.9%, n=38), whereas no significant difference in neointimal obstruction was found between single and multiple stenting in either CoStar or Taxus PES., Conclusions: The CoStar PES exhibits greater neointimal proliferation compared with Taxus PES at 9 months but with similar qualitative outcomes including late-acquired ISA. IVUS findings suggestive of stent fracture were found only in multiple-stenting cases irrespective of the stent used., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: There has been no detailed intravascular ultrasound (IVUS) analysis to evaluate the degree to which stent underexpansion or reference vessel/stent size mismatch contributes to the occurrence of post-procedural incomplete stent apposition (post-ISA)., Methods: We evaluated 238 lesions treated with everolimus-eluting stents (n = 110) or paclitaxel-eluting stents (n = 128). Reference lumen/stent area ratio was defined as the ratio of lumen area adjacent to the stent edge in the reference segment to stent area at the stent edge or at stent body ISA site., Results: Post-ISA was observed in 36 of the 238 cases (15%) at the proximal stent edge, 15 of the 238 cases (6%) at the distal stent edge and 14 of the 238 cases (6%) at stent body. Reference lumen/stent area ratio was significantly greater in the ISA group compared with non-ISA in proximal edge (127 ± 20 vs. 99 ± 10%; P<.001), and greater reference lumen/stent area ratio (118 ± 18 vs. 94 ± 11%; P<.001) and higher presence of calcification (60 vs. 29%; P<0.001) were observed in distal edge ISA group compared with non-ISA. At the stent body, presence of calcification was more frequently observed in the ISA compared with the non-ISA group (86 vs. 42%; P=.002)., Conclusions: Post-ISA at the stent edge was significantly associated with vessel/stent mismatch rather than stent underexpansion. IVUS-guided appropriate stent or balloon sizing might be useful to prevent post-ISA and optimize initial stent deployment.

Previous reports have shown the advantage of paclitaxel compared to limus-derivative drugs for the treatment of diabetics. A total of 109 diabetics (115 lesions) treated with everolimus-eluting stents (EESs, n = 58) or paclitaxel-eluting stents (PESs, n = 55) undergoing 8 to 9 months of follow-up 3-dimensional intravascular ultrasound examinations were enrolled. In addition to the standard intravascular ultrasound parameters, the percentage of neointimal volume (neointimal volume/stent volume) and maximum percentage of cross-sectional narrowing (neointimal area/stent area) was calculated. EESs showed a lower percentage of neointimal volume (7.2 +/- 7.1% vs 11.7 +/- 11.0%; p = 0.01) and maximum percentage of cross-sectional narrowing (22.5 +/- 16.3% vs 29.4 +/- 19.2%; p = 0.04) than PESs. One case of severe narrowing (lesions with maximum percentage of cross-sectional narrowing >60%) in the EES group developed and 6 cases in the PESs group (p = 0.05). The EESs showed no serial changes for vessel or peri-stent plaque during the follow-up period, and PESs showed significant increases in vessel and peri-stent plaque. PESs showed significantly greater peri-stent plaque increase, with a tendency toward greater vessel enlargement than EESs. Late acquired incomplete stent apposition was observed in 2 PES cases. The major adverse cardiac event rate was comparable < or =2 years. In conclusion, EESs showed greater neointimal suppression without significant vessel expansion than PESs in diabetic patients. In this small cohort, no significant differences were observed in the major adverse cardiac event rate < or =2 years.

The aim of this study was to evaluate the vascular response after everolimus-eluting stent (EES) implantation in the SPIRIT III Japan Registry (JAPAN) compared to EES implantation in the SPIRIT III United States (USA) trial using serial intravascular ultrasound (IVUS) analysis. Data were obtained from the JAPAN and the randomized EES arm of the USA trial. Serial (postprocedure and 8-month follow-up) IVUS analysis was available in 199 lesions (JAPAN 82, USA 117) of 183 patients (JAPAN 73, USA 110). Although no difference was observed in vessel size in the reference segment between the 2 groups, postprocedure minimum lumen area and stent volume index were significantly greater in the JAPAN arm (minimum lumen area 5.8 +/- 2.2 vs 5.1 +/- 1.5 mm(2), p = 0.03; stent volume index 7.0 +/- 2.4 vs 6.3 +/- 1.7 mm(3)/mm, p = 0.03). Postprocedure incomplete stent apposition (ISA) was less frequently observed in the JAPAN arm (15.9% vs 33.3%, p = 0.006), possibly related to higher maximum balloon pressure and/or more postdilatation without excess tissue prolapse or edge dissection. In the JAPAN arm, percent neointimal obstruction and maximum percent cross-sectional narrowing were significantly lower at 8-month follow-up (percent neointimal obstruction 3.5 +/- 4.2% vs 6.8 +/- 6.4%, p = 0.0004). Late acquired ISA was infrequent in the 2 arms. In conclusion, comparative IVUS analysis between the JAPAN and USA arms showed more optimal stent deployment in the JAPAN arm as evidenced by the lower incidence of postprocedure ISA and larger minimum lumen area after the procedure. Moreover, there was less neointimal hyperplasia in patients with EES implants from the JAPAN arm compared to the USA arm., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)

Background: Overlapping drug-eluting stents might be associated with an adverse vessel response because of increased drug/polymer toxicity and lesion rigidity., Methods and Results: Lesions treated with overlapping everolimus- (EES=36) or paclitaxel-eluting stents (PES=38) were analyzed for 8-9-months by 3-dimensional intravascular ultrasound. EES were associated with significantly greater neointimal suppression in the single-strut regions than PES, with a similar trend in the overlap region. PES had significant vessel expansion in all regions, whereas there were no changes with EES. Neither stent fracture nor late incomplete stent apposition (LISA) in the overlap region was observed., Conclusions: Overlapping EES appears to be effective without vessel expansion, stent fracture or LISA for up to 8-9 months.

Background: Preprocedual C-reactive protein (CRP) has been reported to correlate with in-stent restenosis following bare-metal stent implantation. The aim of this study was to investigate the impact of preprocedural inflammation on neointimal hyperplasia assessed by intravascular ultrasound (IVUS) following everolimus-eluting stent (EES) implantation., Methods: We identified 134 patients meeting the following criteria: 1) patients treated with EES; 2) those with stable or unstable angina; and 3) patients available for high-sensitivity (hs)-CRP before the procedure and volumetric IVUS analysis at follow up. We divided the patients into two groups on the basis of hs-CRP levels (< 3 or > or = 3 mg/L) before the procedure and compared IVUS parameters. Volume index (volume/length) was calculated for vessel (VVI), plaque (PVI), neointima (NIV), stent (SVI), and lumen (LVI). Percent neointimal volume (%NIV) was calculated as (NIV/SVI) x 100. Cross-sectional narrowing (CSN) was defined as neointimal area divided by stent area (%)., Results: There was no significant difference in VVI, PVI, or LVI at either baseline or 8-month follow up between the two groups. At 8-month follow up, there was also no significant difference in %NIV (4.93 +/- 5.66% vs. 4.98 +/- 5.25% p = 0.959) and maximum %CSN (16.81 +/- 13.62% vs. 18.14 +/- 13.91%; p = 0.608) as well as VVI, PVI, and LVI between the two groups. Furthermore, hs-CRP did not correlate with %NIV (r = 0.044; p = 0.610) and maximum %CSN (r = 0.086, p = 0.321) at follow up. There was no significant difference in incidence of late-acquired incomplete stent apposition between the two groups (1.2% vs. 0%; p = 0.512)., Conclusion: Our results suggest that preprocedural inflammation does not affect neointimal hyperplasia following EES implantation.

Objectives: The aim of this study was to compare the vessel response between zotarolimus-eluting stents (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound., Background: The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial was a randomized controlled study of zotarolimus-eluting, phosphorylcholine-coated, cobalt-alloy stents for the treatment of de novo coronary lesions compared with using PES for the same treatment., Methods: Data were obtained from patients with serial (baseline and 8-months follow-up) intravascular ultrasound analysis available (n = 198). Volumetric analysis was performed for vessel, lumen, plaque, stent, and neointima. Cross-sectional narrowing (given as percentage) was defined as neointimal area divided by stent area. Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. Subsegment analysis was performed at every matched 1-mm subsegment throughout the stent., Results: At follow-up, the ZES group showed significantly greater percentage of neointimal obstruction (16.6 +/- 12.0% vs. 9.9 +/- 8.9%, p < 0.01) and maximum cross-sectional narrowing (31.8 +/- 16.1% vs. 25.2 +/- 14.9%, p < 0.01) with smaller minimum lumen area than the PES group did. However, the incidence of maximum cross-sectional narrowing >50% was similar in the 2 groups. Neointima-free frame ratio was significantly lower in the ZES group. In overall analysis, whereas the PES group showed positive remodeling during follow-up (13.7 +/- 4.2 mm(3)/mm to 14.3 +/- 4.3 mm(3)/mm), the ZES group showed no significant difference (12.7 +/- 3.6 mm(3)/mm to 12.9 +/- 3.5 mm(3)/mm). In subsegment analysis, significant focal positive vessel remodeling was observed in 5% of ZES and 25% of PES cases (p < 0.05)., Conclusions: There were different global and focal vessel responses for ZES and PES. Both drug-eluting stents showed a similar incidence of lesions with severe narrowing despite ZES having a moderate increase in neointimal hyperplasia compared with neointimal hyperplasia in PES. There was a relatively lower neointima-free frame ratio in ZES, suggesting a greater extent of neointimal coverage. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Background: Diabetes has been reported as an independent predictor of restenosis after drug-eluting stent implantation. The purpose of this study was to assess the long-term impact of increased drug dose in sirolimus-eluting stents (SES) on neointimal hyperplasia (NIH) in diabetic patients using volumetric intravascular ultrasound analysis., Methods: The 3D trial is a multicenter, prospective, randomized, feasibility study of double-dose (280 microg/cm2) or conventional single-dose (140 microg/cm2) SES for the treatment of de novo coronary lesions in diabetic patients. To evaluate long-term efficacy, complete serial volumetric analyses (baseline, 6-month and 2-year follow up) were performed in 39 diabetic patients (17 single-dose, 22 double-dose). Each volume was divided by stent length to acquire volume index, expressed as mm3/mm. Percent neointimal volume was calculated as (neointimal volume/stent volume) x 100 at follow up., Results: Volumetric analysis showed similar results over time between the 2 stent groups (p = NS for all). At 2-year follow up, minimal increases in NIH area and percent NIH were observed in both groups, which translated into a decrease in lumen volume index compared to baseline (p < 0.05 for all). No late-acquired incomplete stent apposition was observed in either group., Conclusions: The current single dose of sirolimus in SES is effective in inhibiting NIH in diabetic patients up to 2 years. In this patient subset, double-dose SES did not confer additional NIH suppression at 2-year follow up compared to conventional single-dose SES.

Background: Percutaneous coronary intervention (PCI) is associated with increased clinical and angiographic restenosis in diabetic patients. Stent-based elution of paclitaxel from a biostable polymer reduces restenosis and major adverse cardiovascular events (MACE) when compared with bare-metal stent deployment. The safety and efficacy of paclitaxel elution from a bioresorbable polymer has not been studied in diabetic patients., Methods: Patients (n = 1700) with single- or multivessel coronary disease were randomized (3:2) to receive the CoStar or Taxus stent. All patients had glycolated hemoglobin (HbA1c) obtained at enrollment., Results: Medically-treated diabetes was present in 469 patients (117 insulin-treated) and 77 patients had elevated HbA1c > 6.5% in the absence of previously diagnosed diabetes. MACE were increased in diabetics and were greatest in those requiring insulin. Elevated HbA1c, in the absence of diagnosed diabetes, was not associated with adverse outcomes. MACE (8 months) in the diabetic cohort trended lower with Taxus versus CoStar (10.9 vs. 14.4%, respectively; p = 0.271) due to a reduction in target vessel revascularization. Late lumen loss in-segment (9 months) was reduced by Taxus compared to CoStar (0.20 vs. 0.52 mm, respectively; p < 0.05)., Conclusion: Diabetes is associated with adverse outcomes following stent deployment. Taxus stents improved angiographic outcomes with a trend toward improved clinical outcomes when compared with CoStar stents following PCI in diabetic patients. As a measure of preprocedural glycemic control, the HbA1c level was weakly correlated with outcomes.