The Experts below are selected from a list of 1419 Experts worldwide ranked by ideXlab platform
Patrick W Serruys - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of the absorb everolimus eluting bioresorbable scaffold for treatment of patients with diabetes mellitus results of the absorb diabetic substudy
2017Co-Authors: Dean J Kereiakes, Stephen G Ellis, Yoshinobu Onuma, Bernard Chevalier, Weiying Zhao, Takeshi Kimura, Alexandre Abizaid, Susan Veldhof, Zhen Zhang, Patrick W SerruysAbstract:Abstract Objectives The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable Vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus. Background Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population. Methods In a pre-specified, powered analysis, patients with diabetes who received ≥1 Absorb were pooled from the ABSORB II, III, and JAPAN randomized trials and from the single arm ABSORB EXTEND registry. The study composite primary endpoint was target lesion failure (TLF) at 1 year following Absorb BVS compared with a performance goal of 12.7%. Results Among 754 diabetic patients included in analysis (27.3% insulin treated), the 1-year TLF rate was 8.3% (upper 1-sided 95% confidence limit: 10.1%; p = 0.0001 vs. performance goal). Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF. Conclusions The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.
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what have we learned from meta analysis of 1 year outcomes with the absorb bioresorbable scaffold in patients with coronary artery disease
2017Co-Authors: Yohei Sotomi, Stephen G Ellis, Carlos Collet, Dean J Kereiakes, Yoshinobu Onuma, Gregg W Stone, Patrick W Serruys, Takeshi Kimura, Runlin GaoAbstract:The Absorb BVSs (Abbott Vascular, Santa Clara, CA; hereafter referred to as BVSs) is a 150 µm thick bioresorbable poly(l-lactide) scaffold with a conformal bioresorbable poly(d, l-lactide) coating (total thickness 7 µm) that elutes everolimus. Randomized trials comparing this device to the XIENCE cobalt-chromium everolimus-eluting stent (CoCr-EESs; Abbott Vascular) were done to support regulatory approval in Europe, Asia, and the United States, and have only recently been reported. These studies were designed to show the noninferiority of the BVSs compared with the CoCr-EESs for 1-year clinical and angiographic outcomes, since improved results with the BVSs compared with drug-eluting stents are not expected to become evident until 3-5 years after implantation. However, none of these trials were powered to exclude small differences in composite adverse event rates between devices, or to detect differences in rarely occurring safety endpoints, and their outcomes according to specific patient and lesion characteristics. Currently, several meta-analyses have been published [1-7]. In this chapter, we present the summary of what we have learned from these meta-analyses.
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tct 49 two year clinical outcome of everolimus eluting bioresorbable scaffold vs durable polymer everolimus eluting metallic stent in patients with st segment elevation myocardial infarction results of the randomized absorb st segment elevation myocardial infarction trofi ii trial
2016Co-Authors: Stephan Windecker, Yoshinobu Onuma, Manel Sabate, Taku Asano, Lorenz Raber, Salvatore Brugaletta, Patrick W SerruysAbstract:In the TROFI II randomized trial, it was demonstrated that stenting of culprit lesions with bioresorbable Vascular scaffolds (Absorb [Abbott Vascular, Santa Clara, CA, USA]) in the setting of ST-segment elevation myocardial infarction (STEMI) resulted in a nearly complete arterial healing and low
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the nidus for possible thrombus formation insight from the microenvironment of bioresorbable Vascular scaffold
2016Co-Authors: Erhan Tenekecioglu, Christos Bourantas, Carlos Collet, Yoshinobu Onuma, Ryo Torii, Eric K W Poon, Vikas Thondapu, Yaping Zeng, Andrew Ooi, Patrick W SerruysAbstract:A 3.0 × 18 mm Absorb bioresorbable Vascular scaffold (Abbott Vascular, Santa Clara, California) was implanted in the midsegment of the left anterior descending coronary artery of a patient with stable angina pectoris. Optical coherence tomography was performed following scaffold implantation (
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first report of the three year clinical and multi modality imaging results of the absorb trial evaluating the absorb everolimus eluting bioresorbable Vascular scaffold in the treatment of patients with de novo native coronary artery lesions
2013Co-Authors: Patrick W SerruysAbstract:The fully bioresorbable Absorb BVS (Abbott Vascular, Santa Clara) tested in the ABSORB Cohort A study in 30 patients demonstrated a 6 month in–scaffold late loss (Late Loss) of 0.44, a 11.8% reduction of the scaffold area and a 24.3% decrease in minimal luminal area by IVUS. The 5 year clinical
Yoshinobu Onuma - One of the best experts on this subject based on the ideXlab platform.
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Strut protrusion and shape impact on endothelial shear stress: insights from pre-clinical study comparing Mirage and Absorb bioresorbable scaffolds
2017Co-Authors: Erhan Tenekecioglu, Christos Bourantas, Solomon Su, Tom Crake, Carlos Collet, Yoshinobu Onuma, Yosuke Miyazaki, Yohei Sotomi, Ryo Torii, Patrick W.j.c. SerruysAbstract:Protrusion of scaffold struts is related with local coronary flow dynamics that can promote scaffold restenosis and thrombosis. That fact has prompted us to investigate in vivo the protrusion status of different types of scaffolds and their relationship with endothelial shear stress (ESS) distributions. Six Absorb everolimus-eluting Bioresorbable Vascular Scaffolds (Absorb, Abbott Vascular) and 11 Mirage sirolimus-eluting Bioresorbable Microfiber Scaffolds (Mirage, Manli Cardiology) were implanted in coronaries of eight mini pigs. Optical coherence tomography (OCT) was performed post-scaffold implantation and obtained images were fused with angiographic data to reconstruct the three dimensional coronary anatomy. Blood flow simulation was performed and ESS distribution was estimated for each scaffold. Protrusion distance was estimated using a dedicated software. Correlation between OCT-derived protrusion and ESS distribution was assessed for both scaffold groups. A significant difference was observed in the protrusion distances (156 ± 137 µm for Absorb, 139 ± 153 µm for Mirage; p = 0.035), whereas difference remained after adjusting the protrusion distances according to the luminal areas. Strut protrusion of Absorb is inversely correlated with ESS (r = −0.369, p
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does acute coronary syndrome impact on the incidence of thrombosis after the implantation of an absorb bioresorbable Vascular scaffold
2017Co-Authors: Yohei Sotomi, Carlos Collet, Yosuke Miyazaki, Pannipa Suwannasom, Taku Asano, Jan G P Tijssen, Robbert J De Winter, Ron Waksman, Michael J Lipinski, Yoshinobu OnumaAbstract:Aims: In the drug-eluting stent (DES) era, patients with acute coronary syndrome (ACS) had a higher risk of early stent thrombosis compared with stable patients. The present study aimed to evaluate whether the same is true for the bioresorbable Vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA). Methods and results: We assessed the relationship between the incidence of definite/probable scaffold thrombosis (ScT) (overall ScT and early ScT) and ACS percentage with the latest publications, including the most recent large randomised controlled trials. Out of a total study population of 13,708 devices in 45 trials, overall ScT was observed in 185 devices (1.35%) at a weighted mean follow-up period of 9.4 months, while early ScT was reported in 125 devices (0.97%) out of 12,896 devices in 44 trials. Meta-regression analysis demonstrated no significant correlation between overall/early ScT and the percentage of patients with ACS (overall ScT: R2=0.030, p=0.255; early ScT: R2=0.067, p=0.090). Conclusions: ACS appeared to have little impact on the incidence of ScT after the implantation of BVS. Further clinical study is warranted to investigate the predictors of ScT using multivariate analysis with sufficient statistical power.
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efficacy and safety of the absorb everolimus eluting bioresorbable scaffold for treatment of patients with diabetes mellitus results of the absorb diabetic substudy
2017Co-Authors: Dean J Kereiakes, Stephen G Ellis, Yoshinobu Onuma, Bernard Chevalier, Weiying Zhao, Takeshi Kimura, Alexandre Abizaid, Susan Veldhof, Zhen Zhang, Patrick W SerruysAbstract:Abstract Objectives The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable Vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus. Background Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population. Methods In a pre-specified, powered analysis, patients with diabetes who received ≥1 Absorb were pooled from the ABSORB II, III, and JAPAN randomized trials and from the single arm ABSORB EXTEND registry. The study composite primary endpoint was target lesion failure (TLF) at 1 year following Absorb BVS compared with a performance goal of 12.7%. Results Among 754 diabetic patients included in analysis (27.3% insulin treated), the 1-year TLF rate was 8.3% (upper 1-sided 95% confidence limit: 10.1%; p = 0.0001 vs. performance goal). Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF. Conclusions The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.
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what have we learned from meta analysis of 1 year outcomes with the absorb bioresorbable scaffold in patients with coronary artery disease
2017Co-Authors: Yohei Sotomi, Stephen G Ellis, Carlos Collet, Dean J Kereiakes, Yoshinobu Onuma, Gregg W Stone, Patrick W Serruys, Takeshi Kimura, Runlin GaoAbstract:The Absorb BVSs (Abbott Vascular, Santa Clara, CA; hereafter referred to as BVSs) is a 150 µm thick bioresorbable poly(l-lactide) scaffold with a conformal bioresorbable poly(d, l-lactide) coating (total thickness 7 µm) that elutes everolimus. Randomized trials comparing this device to the XIENCE cobalt-chromium everolimus-eluting stent (CoCr-EESs; Abbott Vascular) were done to support regulatory approval in Europe, Asia, and the United States, and have only recently been reported. These studies were designed to show the noninferiority of the BVSs compared with the CoCr-EESs for 1-year clinical and angiographic outcomes, since improved results with the BVSs compared with drug-eluting stents are not expected to become evident until 3-5 years after implantation. However, none of these trials were powered to exclude small differences in composite adverse event rates between devices, or to detect differences in rarely occurring safety endpoints, and their outcomes according to specific patient and lesion characteristics. Currently, several meta-analyses have been published [1-7]. In this chapter, we present the summary of what we have learned from these meta-analyses.
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tct 49 two year clinical outcome of everolimus eluting bioresorbable scaffold vs durable polymer everolimus eluting metallic stent in patients with st segment elevation myocardial infarction results of the randomized absorb st segment elevation myocardial infarction trofi ii trial
2016Co-Authors: Stephan Windecker, Yoshinobu Onuma, Manel Sabate, Taku Asano, Lorenz Raber, Salvatore Brugaletta, Patrick W SerruysAbstract:In the TROFI II randomized trial, it was demonstrated that stenting of culprit lesions with bioresorbable Vascular scaffolds (Absorb [Abbott Vascular, Santa Clara, CA, USA]) in the setting of ST-segment elevation myocardial infarction (STEMI) resulted in a nearly complete arterial healing and low
Bernard Chevalier - One of the best experts on this subject based on the ideXlab platform.
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four year follow up of the randomised comparison between an everolimus eluting bioresorbable scaffold and an everolimus eluting metallic stent for the treatment of coronary artery stenosis absorb ii trial
2018Co-Authors: Bernard Chevalier, Didier Carrié, Dariusz Dudek, Angel Cequier, Michael Haude, Manel Sabate, Stephan Windecker, Sebastian Reith, Manuel De Sousa Almeida, Gianluca CampoAbstract:AIMS No randomised comparison data are available beyond the resorption of the everolimus-eluting bioresorbable scaffold. Absorb is expected to be completely resorbed by 3 years. The purpose of this report is to provide the 4 year results of a randomised, single blind, multicentre evaluation of Absorb versus the metallic stent Xience (Abbott Vascular, Santa Clara, CA, USA). METHODS AND RESULTS Three-year follow-up has been previously published. Patients re-consented for additional follow-up up through to 5 years; 86% (N=289) and 84% (N=139) of whom underwent a 4 year follow-up visit. TLF was noted in 11.5% in the Absorb arm and 6.0% in the Xience arm (p=0.063) at 4 years, with 1.0% and 0.7% absolute difference respectively between 3 and 4 years. No new very late definite/probable scaffold/stent thrombosis was reported between 3 and 4 years, with a 4-year rate of 3.0% versus 0.0% (p=0.035) and a slight decrease in DAPT prescription in both arms at 4 years (25.9% versus 21.1%, p=NS). CONCLUSIONS A downturn of events was recorded beyond the expected resorption time. Further long-term evaluation in larger randomised studies is necessary to confirm this observation.
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efficacy and safety of the absorb everolimus eluting bioresorbable scaffold for treatment of patients with diabetes mellitus results of the absorb diabetic substudy
2017Co-Authors: Dean J Kereiakes, Stephen G Ellis, Yoshinobu Onuma, Bernard Chevalier, Weiying Zhao, Takeshi Kimura, Alexandre Abizaid, Susan Veldhof, Zhen Zhang, Patrick W SerruysAbstract:Abstract Objectives The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable Vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus. Background Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population. Methods In a pre-specified, powered analysis, patients with diabetes who received ≥1 Absorb were pooled from the ABSORB II, III, and JAPAN randomized trials and from the single arm ABSORB EXTEND registry. The study composite primary endpoint was target lesion failure (TLF) at 1 year following Absorb BVS compared with a performance goal of 12.7%. Results Among 754 diabetic patients included in analysis (27.3% insulin treated), the 1-year TLF rate was 8.3% (upper 1-sided 95% confidence limit: 10.1%; p = 0.0001 vs. performance goal). Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF. Conclusions The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.
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comparison of an everolimus eluting bioresorbable scaffold with an everolimus eluting metallic stent for the treatment of coronary artery stenosis absorb ii a 3 year randomised controlled single blind multicentre clinical trial
2016Co-Authors: Bernard Chevalier, Didier Carrié, Dariusz Dudek, Angel Cequier, Jan J Piek, Ad J Van Boven, Marcello Dominici, Dougal MccleanAbstract:Summary Background No medium-term data are available on the random comparison between everolimus-eluting bioresorbable Vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a result of recovered vasomotion of the scaffolded vessel. Methods The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. We enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of 0·14 mm. The trial is registered at ClinicalTrials.gov, number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years was not statistically different (Absorb group 0·047 mm [SD 0·109] vs Xience group 0·056 mm [0·117]; p superiority =0·49), whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm [0·45] vs 0·25 mm [0·25]; p non-inferiority =0·78). This difference in luminal dimension was confirmed by intraVascular ultrasound assessment of the minimum lumen area (4·32 mm 2 [SD 1·48] vs 5·38 mm 2 [1·51]; p vs 5%, hazard ratio 2·17 [95% CI 1·01–4·70]; log-rank test p=0·0425), mainly driven by target vessel myocardial infarction (6% vs 1%; p=0·0108), including peri-procedural myocardial infarction (4% vs 1%; p=0·16). Interpretation The trial did not meet its co-primary endpoints of superior vasomotor reactivity and non-inferior late luminal loss for the Absorb bioresorbable scaffold with respect to the metallic stent, which was found to have significantly lower late luminal loss than the Absorb scaffold. A higher rate of device-oriented composite endpoint due to target vessel myocardial infarction, including peri-procedural myocardial infarction, was observed in the Absorb group. The patient-oriented composite endpoint, anginal status, and exercise testing, were not statistically different between both devices at 3 years. Future studies should investigate the clinical impact of accurate intraVascular imaging in sizing the device and in optimising the scaffold implantation. The benefit and need for prolonged dual antiplatelet therapy after bioresorbable scaffold implantation could also become a topic for future clinical research. Funding Abbott Vascular.
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randomised comparison of a bioresorbable everolimus eluting scaffold with a metallic everolimus eluting stent for ischaemic heart disease caused by de novo native coronary artery lesions the 2 year clinical outcomes of the absorb ii trial
2016Co-Authors: Bernard Chevalier, Pieter C Smits, Jan J Piek, Manel Sabate, Ad J Van Boven, Steffen Helqvist, Andreas Baumbach, Ravindra Kumar, Luc WasunguAbstract:AIMS The one-year randomised data of the ABSORB II trial showed that the everolimus-eluting bioresorbable scaffold and the everolimus-eluting metallic stent were comparable for the composite secondary clinical outcomes of patient-oriented composite endpoint (PoCE) and device-oriented composite endpoint (DoCE)/target lesion failure (TLF), MACE and TVF. This report describes the two-year clinical outcomes of the ABSORB II trial. METHODS AND RESULTS Patients were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (XIENCE; Abbott Vascular). The trial enrolled 501 patients. Clinical follow-up at two years was available in 320 patients in the Absorb BVS arm and 160 patients in the XIENCE arm. At two years, the PoCE for the Absorb and XIENCE arms was 11.6% and 12.8% (p=0.70) and the DoCE/TLF was 7.0% and 3.0% (p=0.07), respectively. The hierarchical ID-MACE rate was 7.6% vs. 4.3% (p=0.16) and the rate of TVF was 8.5% vs. 6.7% (p=0.48). The definite/probable thrombosis rate was 1.5% in the Absorb arm vs. 0% in the XIENCE arm (p=0.17). Thirty-six percent and 34% of patients remained on DAPT at two years, respectively. Ninety-two percent of patients in both arms remained on aspirin. CONCLUSIONS Two-year clinical results demonstrate sustained low rates of PoCE, MACE, DoCE and TVF with the Absorb BVS as compared to the XIENCE stent.
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a bioresorbable everolimus eluting scaffold versus a metallic everolimus eluting stent for ischaemic heart disease caused by de novo native coronary artery lesions absorb ii an interim 1 year analysis of clinical and procedural secondary outcomes fro
2015Co-Authors: Bernard Chevalier, Didier Carrié, Dariusz Dudek, Angel Cequier, Marcello Dominici, Michael Haude, Andres Iniguez, Rene J Van Der Schaaf, Luc WasunguAbstract:Summary Background Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up. Methods In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intraVascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary reVascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov, number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p 2 vs 3·60 mm 2 , p vs 50 [30%] in the metallic stent group, p=0·04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients [5%] vs five patients [3%], p=0·35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases [4%] vs two cases [1%], respectively) and clinically indicated target-lesion reVascularisation (four cases [1%] vs three cases [2%], respectively). Interpretation The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent. Funding Abbott Vascular.
Dariusz Dudek - One of the best experts on this subject based on the ideXlab platform.
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four year follow up of the randomised comparison between an everolimus eluting bioresorbable scaffold and an everolimus eluting metallic stent for the treatment of coronary artery stenosis absorb ii trial
2018Co-Authors: Bernard Chevalier, Didier Carrié, Dariusz Dudek, Angel Cequier, Michael Haude, Manel Sabate, Stephan Windecker, Sebastian Reith, Manuel De Sousa Almeida, Gianluca CampoAbstract:AIMS No randomised comparison data are available beyond the resorption of the everolimus-eluting bioresorbable scaffold. Absorb is expected to be completely resorbed by 3 years. The purpose of this report is to provide the 4 year results of a randomised, single blind, multicentre evaluation of Absorb versus the metallic stent Xience (Abbott Vascular, Santa Clara, CA, USA). METHODS AND RESULTS Three-year follow-up has been previously published. Patients re-consented for additional follow-up up through to 5 years; 86% (N=289) and 84% (N=139) of whom underwent a 4 year follow-up visit. TLF was noted in 11.5% in the Absorb arm and 6.0% in the Xience arm (p=0.063) at 4 years, with 1.0% and 0.7% absolute difference respectively between 3 and 4 years. No new very late definite/probable scaffold/stent thrombosis was reported between 3 and 4 years, with a 4-year rate of 3.0% versus 0.0% (p=0.035) and a slight decrease in DAPT prescription in both arms at 4 years (25.9% versus 21.1%, p=NS). CONCLUSIONS A downturn of events was recorded beyond the expected resorption time. Further long-term evaluation in larger randomised studies is necessary to confirm this observation.
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comparison of an everolimus eluting bioresorbable scaffold with an everolimus eluting metallic stent for the treatment of coronary artery stenosis absorb ii a 3 year randomised controlled single blind multicentre clinical trial
2016Co-Authors: Bernard Chevalier, Didier Carrié, Dariusz Dudek, Angel Cequier, Jan J Piek, Ad J Van Boven, Marcello Dominici, Dougal MccleanAbstract:Summary Background No medium-term data are available on the random comparison between everolimus-eluting bioresorbable Vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a result of recovered vasomotion of the scaffolded vessel. Methods The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. We enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of 0·14 mm. The trial is registered at ClinicalTrials.gov, number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years was not statistically different (Absorb group 0·047 mm [SD 0·109] vs Xience group 0·056 mm [0·117]; p superiority =0·49), whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm [0·45] vs 0·25 mm [0·25]; p non-inferiority =0·78). This difference in luminal dimension was confirmed by intraVascular ultrasound assessment of the minimum lumen area (4·32 mm 2 [SD 1·48] vs 5·38 mm 2 [1·51]; p vs 5%, hazard ratio 2·17 [95% CI 1·01–4·70]; log-rank test p=0·0425), mainly driven by target vessel myocardial infarction (6% vs 1%; p=0·0108), including peri-procedural myocardial infarction (4% vs 1%; p=0·16). Interpretation The trial did not meet its co-primary endpoints of superior vasomotor reactivity and non-inferior late luminal loss for the Absorb bioresorbable scaffold with respect to the metallic stent, which was found to have significantly lower late luminal loss than the Absorb scaffold. A higher rate of device-oriented composite endpoint due to target vessel myocardial infarction, including peri-procedural myocardial infarction, was observed in the Absorb group. The patient-oriented composite endpoint, anginal status, and exercise testing, were not statistically different between both devices at 3 years. Future studies should investigate the clinical impact of accurate intraVascular imaging in sizing the device and in optimising the scaffold implantation. The benefit and need for prolonged dual antiplatelet therapy after bioresorbable scaffold implantation could also become a topic for future clinical research. Funding Abbott Vascular.
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a bioresorbable everolimus eluting scaffold versus a metallic everolimus eluting stent for ischaemic heart disease caused by de novo native coronary artery lesions absorb ii an interim 1 year analysis of clinical and procedural secondary outcomes fro
2015Co-Authors: Bernard Chevalier, Didier Carrié, Dariusz Dudek, Angel Cequier, Marcello Dominici, Michael Haude, Andres Iniguez, Rene J Van Der Schaaf, Luc WasunguAbstract:Summary Background Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up. Methods In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intraVascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary reVascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov, number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p 2 vs 3·60 mm 2 , p vs 50 [30%] in the metallic stent group, p=0·04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients [5%] vs five patients [3%], p=0·35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases [4%] vs two cases [1%], respectively) and clinically indicated target-lesion reVascularisation (four cases [1%] vs three cases [2%], respectively). Interpretation The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent. Funding Abbott Vascular.
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four year clinical follow up of the absorb everolimus eluting bioresorbable Vascular scaffold in patients with de novo coronary artery disease the absorb trial
2012Co-Authors: Dariusz Dudek, Yoshinobu Onuma, Leif Thuesen, John A Ormiston, Karine Miquelhebert, Patrick W SerruysAbstract:textabstractAims: The first-in-man ABSORB Cohort A trial demonstrated the bioresorption of the ABSORB BVS (Abbott Vascular, Santa Clara, CA, USA) at two years. This report describes the 4-year clinical outcomes. Methods and results: The ABSORB Cohort A trial enrolled 30 patients with a single de novo native coronary artery lesion. Clinical follow-up was available in 29 patients since one patient withdrew consent after the six month follow-up. At four years, the hierarchical ID-MACE of 3.4% remained unchanged. Clopidogrel therapy had been discontinued in all patients. Conclusions: Four-year clinical results demonstrate a sustained low MACE rate (3.4%) without any late complications such as stent thrombosis.
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comparison of in vivo acute stent recoil between the bioresorbable everolimus eluting coronary scaffolds revision 1 0 and 1 1 and the metallic everolimus eluting stent
2011Co-Authors: Yoshinobu Onuma, Bernard Chevalier, Dariusz Dudek, Dougal Mcclean, Patrick W Serruys, Josep Gomez, Bernard De Bruyne, Leif Thuesen, Peter Smits, Jacques J KoolenAbstract:The ABSORB cohort A trial using the bioresorbable everolimus-eluting scaffold (BVS revision 1.0, Abbott Vascular) demonstrated a slightly higher acute recoil with BVS than with metallic stents. To reinforce the mechanical strength of the scaffold, the new BVS scaffold (revision 1.1) with modified strut design was developed and tested in the ABSORB cohort B trial. This study sought to evaluate and compare the in vivo acute scaffold recoil of the BVS revision 1.0 in ABSORB cohort A and the BVS revision 1.1 in ABSORB cohort B with the historical recoil of the XIENCE V® everolimus-eluting metal stent (EES, SPIRIT I and II).
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four year follow up of the randomised comparison between an everolimus eluting bioresorbable scaffold and an everolimus eluting metallic stent for the treatment of coronary artery stenosis absorb ii trial
2018Co-Authors: Bernard Chevalier, Didier Carrié, Dariusz Dudek, Angel Cequier, Michael Haude, Manel Sabate, Stephan Windecker, Sebastian Reith, Manuel De Sousa Almeida, Gianluca CampoAbstract:AIMS No randomised comparison data are available beyond the resorption of the everolimus-eluting bioresorbable scaffold. Absorb is expected to be completely resorbed by 3 years. The purpose of this report is to provide the 4 year results of a randomised, single blind, multicentre evaluation of Absorb versus the metallic stent Xience (Abbott Vascular, Santa Clara, CA, USA). METHODS AND RESULTS Three-year follow-up has been previously published. Patients re-consented for additional follow-up up through to 5 years; 86% (N=289) and 84% (N=139) of whom underwent a 4 year follow-up visit. TLF was noted in 11.5% in the Absorb arm and 6.0% in the Xience arm (p=0.063) at 4 years, with 1.0% and 0.7% absolute difference respectively between 3 and 4 years. No new very late definite/probable scaffold/stent thrombosis was reported between 3 and 4 years, with a 4-year rate of 3.0% versus 0.0% (p=0.035) and a slight decrease in DAPT prescription in both arms at 4 years (25.9% versus 21.1%, p=NS). CONCLUSIONS A downturn of events was recorded beyond the expected resorption time. Further long-term evaluation in larger randomised studies is necessary to confirm this observation.
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tct 49 two year clinical outcome of everolimus eluting bioresorbable scaffold vs durable polymer everolimus eluting metallic stent in patients with st segment elevation myocardial infarction results of the randomized absorb st segment elevation myocardial infarction trofi ii trial
2016Co-Authors: Stephan Windecker, Yoshinobu Onuma, Manel Sabate, Taku Asano, Lorenz Raber, Salvatore Brugaletta, Patrick W SerruysAbstract:In the TROFI II randomized trial, it was demonstrated that stenting of culprit lesions with bioresorbable Vascular scaffolds (Absorb [Abbott Vascular, Santa Clara, CA, USA]) in the setting of ST-segment elevation myocardial infarction (STEMI) resulted in a nearly complete arterial healing and low
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randomised comparison of a bioresorbable everolimus eluting scaffold with a metallic everolimus eluting stent for ischaemic heart disease caused by de novo native coronary artery lesions the 2 year clinical outcomes of the absorb ii trial
2016Co-Authors: Bernard Chevalier, Pieter C Smits, Jan J Piek, Manel Sabate, Ad J Van Boven, Steffen Helqvist, Andreas Baumbach, Ravindra Kumar, Luc WasunguAbstract:AIMS The one-year randomised data of the ABSORB II trial showed that the everolimus-eluting bioresorbable scaffold and the everolimus-eluting metallic stent were comparable for the composite secondary clinical outcomes of patient-oriented composite endpoint (PoCE) and device-oriented composite endpoint (DoCE)/target lesion failure (TLF), MACE and TVF. This report describes the two-year clinical outcomes of the ABSORB II trial. METHODS AND RESULTS Patients were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (XIENCE; Abbott Vascular). The trial enrolled 501 patients. Clinical follow-up at two years was available in 320 patients in the Absorb BVS arm and 160 patients in the XIENCE arm. At two years, the PoCE for the Absorb and XIENCE arms was 11.6% and 12.8% (p=0.70) and the DoCE/TLF was 7.0% and 3.0% (p=0.07), respectively. The hierarchical ID-MACE rate was 7.6% vs. 4.3% (p=0.16) and the rate of TVF was 8.5% vs. 6.7% (p=0.48). The definite/probable thrombosis rate was 1.5% in the Absorb arm vs. 0% in the XIENCE arm (p=0.17). Thirty-six percent and 34% of patients remained on DAPT at two years, respectively. Ninety-two percent of patients in both arms remained on aspirin. CONCLUSIONS Two-year clinical results demonstrate sustained low rates of PoCE, MACE, DoCE and TVF with the Absorb BVS as compared to the XIENCE stent.
