Takao Shimohama

SPIRIT III JAPAN Versus SPIRIT III USA: A Comparative Intravascular Ultrasound Analysis of the Everolimus-Eluting Stent

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.

Incidence of diffuse and focal chronic stent recoil after implantation of current generation bare-metal and drug-eluting stents

Abstract Background The incidence of chronic stent recoil of currently available stents is not well known. Methods The incidence and degree of both diffuse and focal stent recoil during 6xa0months follow-up were evaluated in 52 Cypher, 64 Taxus, 61 Endeavor and 50 Driver stents using 3 dimensional intravascular ultrasound (IVUS) data. Results The overall incidence of diffuse and focal stent recoil was 3.5% and 1.8%, respectively. No difference was found in the incidence of stent recoil among all stents evaluated. The degree of recoil was not correlated with the amount of neointima. Conclusions Analysis of serial IVUS volumetric data revealed a low incidence of chronic stent recoil among current generation stents.

Intravascular Ultrasound Results From the NEVO ResElution-I Trial A Randomized, Blinded Comparison of Sirolimus-Eluting NEVO Stents With Paclitaxel-Eluting Taxus Liberté Stents in De Novo Native Coronary Artery Lesions

Background— The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberté PES) in human native coronary lesions using intravascular ultrasound (IVUS). Methods and Results— The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P=0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberté PES(0.04±0.04 mm versus 0.10±0.07 mm, P<0.0001). TAXUS Liberté PES showed significantly greater positive vessel remodeling than the NEVO SES (&Dgr;vessel volume index: 1.30±1.36 mm3/mm versus 0.36±0.63 mm3/mm, respectively, P=0.003). Conclusions— The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberté PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00714883.Background— The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberte PES) in human native coronary lesions using intravascular ultrasound (IVUS).nnMethods and Results— The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P =0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberte PES(0.04±0.04 mm versus 0.10±0.07 mm, P <0.0001). TAXUS Liberte PES showed significantly greater positive vessel remodeling than the NEVO SES (Δvessel volume index: 1.30±1.36 mm3/mm versus 0.36±0.63 mm3/mm, respectively, P =0.003).nnConclusions— The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberte PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins.nnClinical Trial Registration— URL: . Unique identifier: [NCT00714883][1].nn [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00714883&atom=%2Fcirccvint%2F4%2F2%2F146.atom

Comparison of everolimus- versus paclitaxel-eluting stents implanted in patients with diabetes mellitus as evaluated by three-dimensional intravascular ultrasound analysis.

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.

Intravascular Ultrasound Results From the NEVO ResElution-I Trial

Background— The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberté PES) in human native coronary lesions using intravascular ultrasound (IVUS). Methods and Results— The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P=0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberté PES(0.04±0.04 mm versus 0.10±0.07 mm, P<0.0001). TAXUS Liberté PES showed significantly greater positive vessel remodeling than the NEVO SES (&Dgr;vessel volume index: 1.30±1.36 mm3/mm versus 0.36±0.63 mm3/mm, respectively, P=0.003). Conclusions— The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberté PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00714883.Background— The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberte PES) in human native coronary lesions using intravascular ultrasound (IVUS).nnMethods and Results— The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P =0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberte PES(0.04±0.04 mm versus 0.10±0.07 mm, P <0.0001). TAXUS Liberte PES showed significantly greater positive vessel remodeling than the NEVO SES (Δvessel volume index: 1.30±1.36 mm3/mm versus 0.36±0.63 mm3/mm, respectively, P =0.003).nnConclusions— The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberte PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins.nnClinical Trial Registration— URL: . Unique identifier: [NCT00714883][1].nn [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00714883&atom=%2Fcirccvint%2F4%2F2%2F146.atom

Comparison of vascular response to the everolimus-eluting stent versus the paclitaxel-eluting stent: intravascular ultrasound results from the SPIRIT III trial.

AIMSnThe 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).nnnMETHODS AND RESULTSnData 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.nnnCONCLUSIONSnDetailed 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.

Novel drug eluting stent system for customised treatment of coronary lesions: CUSTOM I feasibility trial 24 month results.

AIMSnThe Custom NX 36 Drug Eluting Stent (DES) System is designed to treat coronary lesions via in situ stent length customisation. The stent evaluated in this study consists of nine interdigitated stent segments, each 4 mm in length, coated with a biodegradable formulation of Biolimus A9 and Poly-Lactic-Acid, a biodegradable drug carrier, and loaded into a unique sheath protected, integrated balloon delivery system.nnnMETHODS AND RESULTSnThe objective of this non-randomised prospective multicentre CUSTOM I Trial was to demonstrate the safety of in situ stent length customisation in 30 consecutive patients. Angiographic (QCA) and intravascular ultrasound (IVUS) follow-up was performed at two cohort time intervals: four (n=10) or eight (n=20) months. Mean lesion length and reference vessel diameters were 17.7 +/- 9.6 mm and 2.6 +/- 0.3 mm, respectively. Procedural success was 93%. There were three MACEs in the study population from enrollment through to twenty-four month follow-up. The in-hospital MACE rate was 2/30, with non-Q-wave myocardial infarctions events in two patients who recovered without further sequelae. At five months, one patient who had crossed over initially to PTCA required CABG surgery. Results from QCA and IVUS assessments at four and eight months showed no binary restenosis, mean in-stent late luminal loss of 0.25 +/- 0.23 mm and 0.26 +/- 0.23 mm.nnnCONCLUSIONSnThis first evaluation of the new customisable Biolimus A9-eluting Custom NX stent suggests safety and efficacy through twenty-four month follow-up. Further evaluations are warranted to confirm the overall favourable outcomes.

Intravascular ultrasound insights from the Cobalt Chromium Stent With Antiproliferative for Restenosis II (COSTAR II) trial comparing CoStar and Taxus paclitaxel-eluting stents

BACKGROUNDnDedicated 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.nnnMETHODS AND MATERIALSnAmong 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.nnnRESULTSnIn 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.nnnCONCLUSIONSnThe 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.

Intrastent Thrombus:– What You See Is What You Get? –

In this issue, Ichikawa et al2 analyze 55 patients with intracoronary angioscopy, including genotyping of CYP2C19, a marker for clopidogrel metabolism. Among the 55 patients, there were 6 cases of intrastent mural thrombus as assessed by angioscopy. The authors found that the presence of intrastent thrombus was associated with sirolimus-eluting stent (SES) implantation, poor clopidogrel metabolism genotype, and instent yellow plaque. Although there would have been a significant risk of selection bias because of the number of intrastent thrombus patients being only 6, the study provides evidence that the poor-metabolizer genotype could be associated with local thrombus formation. These results are consistent with a previous optical coherence tomography (OCT) study showing high intrastent thrombus formation among patients with CYP2C19*2 allele carrier status.3 tent thrombosis following drug-eluting stent (DES) implantation is an uncommon but serious complication. Multiple factors such as stent thrombogenicity, patient/ lesion factors, and procedural factors are considered to be involved in its development.1 Dual antiplatelet therapy (DAPT) has been the cornerstone of prevention of this life-threatening event. However, clopidogrel, the most frequently prescribed thienopyridine, has to be processed twice by the CYP2C19 enzyme to become the active metabolite. Therefore, when clopidogrel is used as a DAPT agent, there has always been a concern over possible reduced efficacy in patients with the poor-metabolizer CYP2C19 genotype.

Intravascular Ultrasound Results From the NEVO ResElution-I TrialClinical Perspective

Background— The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberté PES) in human native coronary lesions using intravascular ultrasound (IVUS). Methods and Results— The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P=0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberté PES(0.04±0.04 mm versus 0.10±0.07 mm, P<0.0001). TAXUS Liberté PES showed significantly greater positive vessel remodeling than the NEVO SES (&Dgr;vessel volume index: 1.30±1.36 mm3/mm versus 0.36±0.63 mm3/mm, respectively, P=0.003). Conclusions— The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberté PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00714883.Background— The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberte PES) in human native coronary lesions using intravascular ultrasound (IVUS).nnMethods and Results— The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P =0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberte PES(0.04±0.04 mm versus 0.10±0.07 mm, P <0.0001). TAXUS Liberte PES showed significantly greater positive vessel remodeling than the NEVO SES (Δvessel volume index: 1.30±1.36 mm3/mm versus 0.36±0.63 mm3/mm, respectively, P =0.003).nnConclusions— The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberte PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins.nnClinical Trial Registration— URL: . Unique identifier: [NCT00714883][1].nn [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00714883&atom=%2Fcirccvint%2F4%2F2%2F146.atom