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Coronary Artery Disease: HELP
Articles by Dean J. Kereiakes
Based on 60 articles published since 2010
(Why 60 articles?)
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Between 2010 and 2020, Dean Kereiakes wrote the following 60 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Editorial More Data Than Options for the "No-Option" Refractory Angina Patient in the United States. 2019

Riley, Robert F / Kereiakes, Dean J / Henry, Timothy D. ·From the Christ Hospital Heart and Vascular Center / The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, OH. ·Circ Res · Pubmed #31170056.

ABSTRACT: -- No abstract --

2 Editorial The TWENTE Trial in Perspective: Stents and Stent Trials in Evolution. 2017

Kereiakes, Dean J. ·The Christ Hospital Heart and Vascular Center, Cincinnati, Ohio2The Lindner Center for Research and Education, Cincinnati, Ohio. ·JAMA Cardiol · Pubmed #28114677.

ABSTRACT: -- No abstract --

3 Editorial Dual Antiplatelet Therapy Duration Following Coronary Stenting. [Corrected]. 2015

Yeh, Robert W / Mauri, Laura / Kereiakes, Dean J. ·Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. · Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. · The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, Ohio. Electronic address: lindner@thechristhospital.com. ·J Am Coll Cardiol · Pubmed #25720621.

ABSTRACT: -- No abstract --

4 Editorial Complete revascularization: a quality-performance metric? 2013

Kereiakes, Dean J. ·Christ Hospital Heart and Vascular Center, The Lindner Research Center, Cincinnati, Ohio. Electronic address: Lindner@thechristhospital.com. ·J Am Coll Cardiol · Pubmed #23747771.

ABSTRACT: -- No abstract --

5 Review Evolution of the SYNERGY bioresorbable polymer metallic coronary stent. 2018

Shreenivas, Satya S / Kereiakes, Dean J. ·The Christ Hospital Heart & Vascular Center/The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital, 2123 Auburn Avenue, Suite 424, Cincinnati 45219, OH, USA. ·Future Cardiol · Pubmed #29926758.

ABSTRACT: The SYNERGY stent is composed of thin, platinum-chromium metal alloy struts and an ultrathin, bioabsorbable poly-DL-lactide-co-glycolide polymer limited to the abluminal strut surface which elutes everolimus prior to complete resorption within 3-4 months. SYNERGY was designed to reduce inflammation and facilitate stent healing compared with permanent polymer drug eluting stents. This review summarizes the preclinical and clinical development of SYNERGY, its integration into clinical practice and future directions.

6 Review 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. 2017

Ali, Ziad A / Serruys, Patrick W / Kimura, Takeshi / Gao, Runlin / Ellis, Stephen G / Kereiakes, Dean J / Onuma, Yoshinobu / Simonton, Charles / Zhang, Zhen / Stone, Gregg W. ·New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY, USA. · International Centre for Cardiovascular Health, Imperial College, London, London, UK. · Kyoto University Hospital, Kyoto, Japan. · Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. · Cleveland Clinic, Cleveland, OH, USA. · The Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, OH, USA. · Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands. · Abbott Vascular, Santa Clara, CA, USA. · New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY, USA. Electronic address: gs2184@columbia.edu. ·Lancet · Pubmed #28732815.

ABSTRACT: BACKGROUND: Bioresorbable vascular scaffolds (BVS) offer the potential to improve long-term outcomes of percutaneous coronary intervention after their complete bioresorption. Randomised trials have shown non-inferiority between BVS and metallic drug-eluting stents at 1 year in composite safety and effectiveness outcomes, although some increases in rates of target vessel-related myocardial infarction and device thrombosis were identified. Outcomes of BVS following the first year after implantation are unknown. We sought to ascertain whether BVS are as safe and effective as drug-eluting stents within 2 years after implantation and between 1 and 2 years. METHODS: We did a systematic review and meta-analysis of randomised trials in which patients were randomly assigned to everolimus-eluting Absorb BVS or metallic everolimus-eluting stents (EES) and followed up for at least 2 years. We searched MEDLINE, the Cochrane database, TCTMD, ClinicalTrials.gov, Clinical Trial Results, CardioSource, and abstracts and presentations from major cardiovascular meetings up to April 1, 2017, to identify relevant studies. The primary efficacy outcome measure was the device-oriented composite endpoint (cardiac mortality, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation) and the primary safety outcome measure was definite or probable device thrombosis. Individual patient data from the four ABSORB trials were used for landmark and subgroup analysis and multivariable modelling. FINDINGS: We identified seven randomised trials in which 5583 patients were randomly assigned to Absorb BVS (n=3261) or metallic EES (n=2322) and followed up for 2 years. BVS had higher 2-year relative risks of the device-oriented composite endpoint than did EES (9·4% [304 of 3217] vs 7·4% [169 of 2299]; relative risk [RR] 1·29 [95% CI 1·08-1·56], p=0·0059). These differences were driven by increased rates of target vessel-related myocardial infarction (5·8% [187 of 3218] vs 3·2% [74 of 2299]; RR 1·68 [95% CI 1·29-2·19], p=0·0003) and ischaemia-driven target lesion revascularisation (5·3% [169 of 3217] vs 3·9% [90 of 2300]; 1·40 [1·09-1·80], p=0·0090) with BVS, with non-significant differences in cardiac mortality. The cumulative 2-year incidence of device thrombosis was higher with BVS than with EES (2·3% [73 of 3187] vs 0·7% [16 of 2281]; RR 3·35 [95% CI 1·96-5·72], p<0·0001). Landmark analysis between 1 and 2 years also showed higher rates of the device-oriented composite endpoint (3·3% [69 of 2100] vs 1·9% [23 of 1193]; RR 1·64 [95% CI 1·03-2·61], p=0·0376) and device thrombosis (0·5% [11 of 2085] vs none [0 of 1183], p<0·0001) in BVS-treated patients than in EES-treated patients. INTERPRETATION: BVS was associated with increased rates of composite device-oriented adverse events and device thrombosis cumulatively at 2 years and between 1 and 2 years of follow-up compared with EES. FUNDING: Abbott Vascular.

7 Review Bioresorbable vascular scaffolds for the treatment of coronary artery disease: what have we learned from randomized-controlled clinical trials? 2017

Rizik, David G / Hermiller, James B / Simonton, Charles A / Klassen, Kevin J / Kereiakes, Dean J. ·aHonorHealth and the Scottsdale-Lincoln Health Network bHonorHealth, Scottsdale Shea Medical Center, Scottsdale, Arizona cSt Vincent Heart Center, Indianapolis, Indiana dAbbott Vascular, Santa Clara, California eThe Christ Hospital, Heart and Vascular Center and The Lindner Research Center, Cincinnati, Ohio, USA. ·Coron Artery Dis · Pubmed #27561169.

ABSTRACT: Although current everolimus-eluting coronary stents have shown improved event-free survival within the first year following implantation compared with bare-metal stents or earlier generation drug-eluting stents, they remain associated with an ongoing risk for adverse outcomes (thrombosis, myocardial infarction, and restenosis) beyond 1 year at rates similar to those observed following bare-metal stent deployment. This ongoing very late hazard has been attributed to the permanent presence of the metal frame and/or polymer in these stents. The Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) has been developed to provide mechanical support and drug-delivery functions similar to metallic drug-eluting stents, followed by complete resorption with recovery of more normal vascular structure and function, thus avoiding the limitations associated with permanent metallic endovascular prostheses. Absorb BVS has shown safety and efficacy in the dedicated clinical trial development program of Abbott Vascular and in an array of investigator-sponsored studies involving a broad spectrum of clinical (patient) as well as coronary anatomic complexity. Longer-term evidence, largely limited to single-arm studies, appears to reflect durable safety and efficacy and suggests Absorb BVS to be an attractive therapeutic option. Interim evidence from a series of randomized-clinical trials (RCTs) comparing Absorb BVS with the Xience cobalt-chromium metallic everolimus-eluting stent has shown noninferiority of Absorb BVS with respect to target lesion failure (composite occurrence of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization) beyond the first year, with no statistically significant differences in other safety/efficacy measures. However, concerns do exist in terms of increased rates of scaffold thrombosis, the risk for which may be mitigated by improved patient and lesion selection, procedural technique, and device iteration. We provide an overview of the evolution of percutaneous coronary intervention, in-vivo characterization of Absorb BVS resorption, and a summary with a critical evaluation of available evidence from RCTs, pooled analyses, and meta-analyses of RCTs for the safety and efficacy of Absorb BVS obtained primarily following the treatment of noncomplex coronary lesions in patients with stable ischemic heart disease and/or stabilized acute coronary syndromes.

8 Review Bioresorbable vascular scaffolds for the treatment of coronary artery disease: Clinical outcomes from randomized controlled trials. 2016

Rizik, David G / Hermiller, James B / Kereiakes, Dean J. ·Director of Structural and Coronary Intervention, HonorHealth and the Scottsdale-Lincoln Health Network, Scottsdale, Arizona. davidrizik@aol.com. · Director of Interventional Cardiology and Director of Interventional Cardiology Fellowship, St. Vincent Heart Center of Indiana, Indianapolis, Indiana. · The Christ Hospital Heart and Vascular Center, The Lindner Research Center, Cincinnati, Ohio. ·Catheter Cardiovasc Interv · Pubmed #27797464.

ABSTRACT: The permanent metal prosthesis common to bare metal stents (BMS) as well as both first- and second-generation drug-eluting stents (DES) following treatment of coronary artery disease represents a long-lasting substrate for late adverse coronary events including restenosis, thrombosis, and neoatherosclerosis. Following resorbtion, bioresorbable scaffolds (BRS) may eliminate this nidus and improve late outcomes through restoration of the vessel to more normal vascular structure and function. BRS represents a single platform which incorporates the mechanical features of metallic stents to provide safe and effective revascularization, suppression of restenosis and prevention of constrictive remodeling with long-term restoration of the treated vessel to a more natural state. The landscape of BRS is rapidly evolving with new materials which target various performance goals for the duration of vascular support and polymer resorption time. The Absorb bioresorbable vascular scaffold (Absorb BVS), recently approved by United States Food and Drug Administration, has extensive clinical evidence to date in support of its clinical efficacy and safety. Recently published data from well-executed randomized clinical trials (RCTs) as part of the ABSORB Clinical development program along with other investigator-initiated trials provide insights into the safety and performance of this device in patients with de novo coronary lesions as well in the setting of ST-segment elevation myocardial infarction (STEMI). This review provides a comprehensive, outcomes based understanding of the available evidence from RCTs that offer head-to-head comparisons of Absorb BVS with metallic everolimus-eluting stents (EES). © 2016 Wiley Periodicals, Inc.

9 Review The ABSORB bioresorbable vascular scaffold: A novel, fully resorbable drug-eluting stent: Current concepts and overview of clinical evidence. 2015

Rizik, David G / Hermiller, James B / Kereiakes, Dean J. ·Director of Structural & Coronary Interventions, HonorHealth and Scottsdale Healthcare Hospital, Scottsdale, Arizona. · Director of Interventional Cardiology and Director of Interventional Cardiology Fellowship, St. Vincent Heart Center of Indiana, Indianapolis, Indiana. · Medical Director of The Christ Hospital Heart and Vascular Center, Cincinnati, Ohio. · The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio. ·Catheter Cardiovasc Interv · Pubmed #26386235.

ABSTRACT: The advent of fully bioresorbable stent technology and specifically the ABSORB™, a bioresorbable vascular scaffold (BVS) stent, is heralded as breakthrough technology in the current era of percutaneous coronary interventions. This article reviews the current understanding of this technology along with the clinical evidence from trials and registries of ABSORB BVS that included patients with both simple as well as more complex "real-world" coronary lesions. In addition, considering the current limitations of this device-mostly associated with the mechanical properties of the polymeric scaffold structure-a review of guidelines on successful implantation of the ABSORB BVS is presented. Although expert feedback suggests extensive use of this device in routine clinical practice outside the United States despite a paucity of data on long-term safety in this setting, attention to procedural details and implantation technique is obligatory to achieve optimal clinical outcomes.

10 Review Reassessing the importance of complete versus incomplete coronary revascularization. 2014

Kereiakes, Dean J. ·The Lindner Research Center, The Christ Hospital Heart and Vascular Center, Cincinnati, OH. ·Rev Cardiovasc Med · Pubmed #24762463.

ABSTRACT: Coronary revascularization may be performed for relief of anginal symptoms or, in specific patient subgroups, to reduce the incidence of myocardial infarction and mortality. Achieving complete revascularization of all significantly obstructed coronary segments has been an established goal of coronary bypass graft surgery (CABG) and more recent data demonstrate a salutary effect of complete revascularization following percutaneous coronary intervention (PCI) on long-term clinical outcomes as well. Incomplete coronary revascularization is associated with increased mortality following both CABG and PCI, as well as with an increased incidence of myocardial infarction, repeat revascularization, and major adverse cardiovascular or cerebrovascular events following PCI. The relationship between completeness of revascularization and late adverse clinical outcomes is both qualitative and quantitative as reflected by the residual SYNTAX score (angiographic lesion complexity) following PCI. Thus, complete revascularization has evolved as an important objective for either CABG or PCI and the ability to achieve complete revascularization should enter into the decision algorithm for choice of revascularization modality.

11 Review Safety of drug-eluting stents. 2010

Kereiakes, Dean J. ·The Christ Hospital Heart and Vascular Center, The Lindner Research Center, Cincinnati, OH, USA. ·Rev Cardiovasc Med · Pubmed #21389909.

ABSTRACT: Significant evolution in catheter-based technologies for percutaneous coronary intervention has occurred since the introduction of coronary balloon angioplasty by Andreas Grüntzig in 1977. As balloon angioplasty was supplanted by bare metal stents and subsequently drug-eluting stents (DES), randomized comparative clinical trials have demonstrated a progressive decline in both angiographic and clinical restenosis with each technologic iteration. Following widespread clinical use of DES, multiple safety issues have been identified in late follow-up that have prompted efforts toward development of bioresorbable polymers and polymer-free metal platforms, as well as completely resorbable DES platforms. The ultimate goal of these efforts is to provide safe and durable coronary patency. The promise of bioresorbable DES platforms includes the additional benefits of recovery in normal autoregulatory as well as microvascular function, the capacity for late luminal enlargement/expansive remodeling, and the potential for reducing the requirement for prolonged dual antiplatelet therapy.

12 Review Ticagrelor for the treatment of arterial thrombosis. 2010

Gurbel, Paul A / Kereiakes, Dean J / Tantry, Udaya S. ·Sinai Hospital of Baltimore, Sinai Center for Thrombosis Research, Cardiac Catheterization Laboratory, 2401 W. Belvedere Ave, Baltimore, MD 21215, USA. pgurbel@lifebridgehealth.org ·Expert Opin Pharmacother · Pubmed #20707759.

ABSTRACT: IMPORTANCE OF THE FIELD: High platelet reactivity has been linked to recurrent ischemic events in patients treated with conventional dual antiplatelet therapy, in patients with arterial diseases and particularly in patients treated with coronary artery stenting. The limitations of clopidogrel have served as a major rationale for the development of new P2Y(12) blockers that have superior pharmacodynamic profiles uninfluenced by concomitant therapies or specific genotypes. Ticagrelor is the first direct-acting reversibly binding oral P2Y(12) receptor antagonist. Extensive Phase II investigations have addressed the pharmacokinetic, pharmacodynamic and safety-related properties of ticagrelor compared with clopidogrel. The recently completed PLATO trial demonstrated promise for ticagrelor as a major treatment strategy for a wide spectrum of patients with acute coronary syndromes. Ticagrelor is now being reviewed by the FDA as a P2Y(12) receptor blocker to treat patients with coronary artery disease and, once accepted, will be in widespread use as an antiplatelet agent. Thus, it is both appropriate and timely to review available data and provide a comprehensive review of ticagrelor. AREAS COVERED IN THIS REVIEW: We discuss the rationale for the development of ticagrelor, a reversible and potent P2Y(12) receptor blocker. The data regarding ticagrelor based on preclinical and clinical studies are examined. We researched articles about 'AZD6140' and 'ticagrelor' in PubMed from 2006 to 2010 and also reviewed data presented at recent cardiology meetings. WHAT THE READER WILL GAIN: This is an updated and comprehensive review of ticagrelor. The advantages and disadvantages of ticagrelor and available P2Y(12) receptor blockers such as clopidogrel and prasugrel are discussed, thus providing a clear picture to readers. TAKE HOME MESSAGE: Ticagrelor has an important role as an antiplatelet agent in the settings of acute coronary syndrome and percutaneous coronary intervention and once accepted will be in widespread use.

13 Clinical Trial Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial. 2018

Stone, Gregg W / Ellis, Stephen G / Gori, Tommaso / Metzger, D Christopher / Stein, Bernardo / Erickson, Matthew / Torzewski, Jan / Williams, Jerome / Lawson, William / Broderick, Thomas M / Kabour, Ameer / Piegari, Guy / Cavendish, Jeffrey / Bertolet, Barry / Choi, James W / Marx, Steven O / Généreux, Philippe / Kereiakes, Dean J / Anonymous3660963. ·NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA. Electronic address: gs2184@columbia.edu. · Cleveland Clinic, Cleveland, OH, USA. · Kardiologie I University Medical Center and Deutsches Zentrum für Herz-Kreislaufforschung, Rhein-Main, Mainz, Germany. · Ballad Health Systems CVA Heart Institute, Kingsport, TN, USA. · Morton Plant Hospital, Clearwater, FL, USA. · Royal Perth Hospital, Perth, WA, Australia. · Kliniken Oberallgäu, Immenstadt, Germany. · Presbyterian Hospital, Charlotte, NC, USA. · Stony Brook University Medical Center, Stony Brook, NY, USA. · The Carl and Edyth Lindner Research Center at The Christ Hospital, Cincinnati, OH, USA. · Mercy St Vincent Medical Center, Toledo, OH, USA. · St Joseph Medical Center, Wyomissing, PA, USA. · Scripps Memorial Hospital La Jolla, La Jolla, CA, USA. · North Mississippi Medical Center, Tupelo, MS, USA. · Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas, TX, USA. · NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA. · Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ, USA; Hôpital du Sacré-Coeur de Montréal, Montreal, QC, Canada. ·Lancet · Pubmed #30266412.

ABSTRACT: BACKGROUND: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. METHODS: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. FINDINGS: Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0%) patients assigned to BVS and 48 (3·7%) patients assigned to EES (difference 1·3%, upper 97·5% confidence limit 2·89; one-sided p INTERPRETATION: Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. FUNDING: Abbott Vascular.

14 Clinical Trial Evaluation of a fully bioresorbable vascular scaffold in patients with coronary artery disease: design of and rationale for the ABSORB III randomized trial. 2015

Kereiakes, Dean J / Ellis, Stephen G / Popma, Jeffrey J / Fitzgerald, Peter J / Samady, Habib / Jones-McMeans, Jennifer / Zhang, Zhen / Cheong, Wai-Fung / Su, Xiaolu / Ben-Yehuda, Ori / Stone, Gregg W. ·The Christ Hospital Heart and Vascular Center, and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, OH. · Cleveland Clinic Foundation, Cleveland, OH. · Beth Israel Deaconess Medical Center, Boston, MA. · Stanford University School of Medicine, Stanford, CA. · Emory University Hospital, Atlanta, GA. · Abbott Vascular, Santa Clara, CA. · Columbia University Medical Center, New York Presbyterian Hospital and The Cardiovascular Research Foundation, New York, NY. · Columbia University Medical Center, New York Presbyterian Hospital and The Cardiovascular Research Foundation, New York, NY. Electronic address: gs2184@columbia.edu. ·Am Heart J · Pubmed #26386787.

ABSTRACT: BACKGROUND: Randomized trials have demonstrated progressive improvements in clinical and angiographic measures of restenosis with technologic iterations from balloon angioplasty to bare-metal stents and subsequently to drug-eluting stents (DES). However, the permanent presence of a metal stent prevents coronary vasomotion, autoregulation, and adaptive coronary remodeling. The limitations imposed by a permanent metal implant may be overcome with a bioresorbable scaffold. ABSORB III is a large-scale, multicenter, randomized trial designed to support US premarket approval of the ABSORB BVS platform and is the first study with sufficient size to allow valid examination of the relative clinical outcomes between metallic DES and bioresorbable scaffold. DESIGN: ABSORB III (ClincalTrials.gov NCT01751906) will register approximately 2,262 patients and includes a lead-in phase (n = 50), the primary randomized analysis group (n = 2,000), an imaging cohort (n = 200), and a pharmacokinetic substudy (n = 12). In the primary analysis group, approximately 2,000 patients with up to 2 de novo native coronary artery lesions in separate epicardial vessels will be prospectively assigned in a 2:1 ratio to ABSORB BVS versus XIENCE everolimus-eluting stents (EES). The primary end point is target lesion failure (the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year, powered for noninferiority of ABSORB BVS compared to XIENCE EES. Clinical follow-up will continue for 5 years. Enrollment has been completed, and the principal results will be available in the fall of 2015. CONCLUSIONS: The large-scale ABSORB III randomized trial will evaluate the safety and effectiveness of ABSORB BVS compared to XIENCE EES in the treatment of patients with coronary artery disease.

15 Clinical Trial Procedural effectiveness of a novel 1.20 mm diameter angioplasty catheter: clinical and angiographic outcomes. 2013

Kandzari, David E / Teirstein, Paul S / Kereiakes, Dean J / Cannon, Louis A / Hearne, Steven E / Kuo, Hai-Chien / Ying, Shih-Wa / Cheong, Wai-Fung / Popma, Jeffrey J. ·Piedmont Heart Institute, Suite 300, 275 Collier Road, Atlanta, GA 30309, USA. david.kandzari@piedmont.org ·J Interv Cardiol · Pubmed #23369084.

ABSTRACT: OBJECTIVE: To evaluate clinical and angiographic outcomes using a 1.20 mm diameter angioplasty catheter as part of a predilation strategy for coronary lesion treatment. BACKGROUND: Development of an angioplasty catheter with low crossing profile and small balloon diameter represents an opportunity to facilitate percutaneous revascularization of complex coronary disease. METHODS: Clinical and angiographic outcomes were evaluated following a predilation treatment strategy using a low profile, 1.20 mm angioplasty catheter. The primary end-point of procedural success was defined as successful device delivery, performance and lesion treatment without occurrence of perforation, flow-limiting dissection, reduction in baseline TIMI grade, or clinically significant arrhythmias, and with final achievement of TIMI 3 flow. In-hospital major adverse events were also determined. RESULTS: Among 71 patients (83 lesions), angiographic characteristics included: de novo lesion, 75.9%; saphenous vein graft 9.6%; lesion length (mean ± standard deviation), 12.27 ± 5.96 mm; reference vessel diameter, 2.61 ± 0.57 mm; lesion classification B2/C, 59.0%; baseline TIMI 0/1 flow, 4.8%. Procedural success was achieved for 98.5% (66/67) of patients. Catheter delivery to the target lesion was achieved in all patients, and the rate of device success with luminal improvement after predilation was 96.2% (75/78). No acute procedural complications were observed, and in-hospital target lesion failure occurred in 6 patients (8.5%) related to peri-procedural non-Q wave myocardial infarction. CONCLUSIONS: Coronary lesion predilation with a low profile, 1.20 mm angioplasty catheter is associated with favorable procedural safety and efficacy and may represent an effective treatment for complex coronary anatomy.

16 Clinical Trial The XIENCE nano everolimus eluting coronary stent system for the treatment of small coronary arteries: the SPIRIT Small Vessel trial. 2012

Cannon, Louis A / Simon, Daniel I / Kereiakes, Dean / Jones, Jennifer / Mehran, Roxana / Kusano, Hajime / Zhang, Zhen / Lombardi, William / James Fleischhauer, F / Costa, Marco A. ·Northern Michigan Regional Hospital Heart and Vascular Institute, Petoskey, Michigan, USA. ·Catheter Cardiovasc Interv · Pubmed #22121027.

ABSTRACT: OBJECTIVES: The SPIRIT Small Vessel (SV) was designed to evaluate the safety and effectiveness of the 2.25-mm XIENCE V everolimus eluting coronary stent system (EECSS), known as the XIENCE nano EECSS, in subjects with SVs and ischemic heart disease. BACKGROUND: The core sizes of XIENCE V EECSS are associated with low rates of restenosis and thrombosis in the general population, but the XIENCE nano EECSS has not been tested in the United States. METHODS: This prospective, single-arm, open-label study was conducted at 33 centers and in 150 patients in the United States. The primary endpoint was the target lesion failure (TLF) rate at 1 year, required to meet the prespecified performance goal (PG) of 20.4%, derived from historical data. RESULTS: The mean patient age was 63 years, 38% were women, 39.2% were diabetic, 49.3% had multivessel disease, and the reference vessel diameter was 2.13 ± 0.23 mm. The 1-year TLF rate was 8.1% in with an upper limit of the one-sided 95% confidence interval of 13.0%, which met the PG of 20.4% (P < 0.0001). At 1 year, the rate of cardiac death was 1.5%, the target vessel myocardial infarction rate was 1.5%, and clinically indicated target lesion revascularization rate was 5.1%. The 8-month angiographic in-stent late loss was 0.2 ± 0.4 mm, respectively. The 1-year academic research consortium defined definite/probable stent thrombosis rate was 1.5%. CONCLUSIONS: Based on the 1-year clinical and 8-month angiographic SPIRIT SV data, the XIENCE nano EECSS is considered safe and effective in the treatment of SVs.

17 Clinical Trial A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: the PERSEUS Small Vessel trial. 2011

Cannon, Louis A / Kereiakes, Dean J / Mann, Tift / Popma, Jeffrey J / Mooney, Michael R / Mishkel, Gregory J / Lee, Tommy C / Wilson, B Hadley / Stuckey, Thomas D / Orlow, Steven / McGarry, Thomas / Ring, Michael E / Kellett, Mirle A / Underwood, Paul / Dawkins, Keith D. ·Cardiac and Vascular Research Center of Northern Michigan, Northern Michigan Regional Hospital, Petoskey, MI, USA. ·EuroIntervention · Pubmed #21330238.

ABSTRACT: AIMS: Small reference vessel diameter predicts adverse outcomes following coronary stenting. TAXUS Express and TAXUS Liberté paclitaxel-eluting stents (PES) reduce restenosis compared to bare metal stents (BMS) in small diameter vessels. TAXUS Element is a novel thin-strut, platinum chromium stent designed to enhance visibility, conformability, and drug delivery in small diameter vessels. METHODS AND RESULTS: The PERSEUS Small Vessel (SV) prospective, single-arm, superiority trial evaluates the TAXUS Element PES in 224 subjects with target lesion length≤20 mm and vessel diameter≥2.25 to <2.75 mm, compared to 125 lesion-matched historical Express BMS control subjects from the TAXUS V trial. The primary endpoint was nine-month in-stent late loss. The secondary endpoint was 12-month target lesion failure (TLF) compared to a pre-specified performance goal (PG). Outcomes were analysed with and without propensity-score adjustment. TAXUS Element was superior to the Express BMS for late loss (0.38±0.51 versus 0.80±0.53 mm respectively; P<0.001), and TLF (7.3%) was significantly less than the 19.5% PG (P<0.001). No differences in mortality, myocardial infarction, or stent thrombosis were observed through 12 months. Results were similar after adjustment. CONCLUSIONS: PERSEUS SV supports the efficacy and safety of the platinum chromium, thin-strut TAXUS Element stent in small coronary vessels.

18 Article Interruption of Dual Antiplatelet Therapy Within Six Months After Coronary Stents (from the Dual Antiplatelet Therapy Study). 2019

Stefanescu Schmidt, Ada C / Steg, Philippe Gabriel / Yeh, Robert W / Kereiakes, Dean J / Tanguay, Jean-Francois / Hsieh, Wen-Hua / Massaro, Joseph M / Mauri, Laura / Cutlip, Donald E / Anonymous3351150. ·Baim Institute for Clinical Research, Boston, Massachusetts; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. · Hôpital Bichat, AP-HP, Paris, France; Université Paris-Diderot, Paris, France; INSERM U-1148, Paris, France; Royal Brompton Hospital, Imperial College, London, United Kingdom. · Baim Institute for Clinical Research, Boston, Massachusetts; Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. · The Christ Hospital, Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio. · Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada. · Baim Institute for Clinical Research, Boston, Massachusetts. · Medtronic, Minneapolis, Minnesota. · Baim Institute for Clinical Research, Boston, Massachusetts; Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: dcutlip@bidmc.harvard.edu. ·Am J Cardiol · Pubmed #31653353.

ABSTRACT: The risk of major adverse cardiac and cerebrovascular events (MACCE) in subjects who interrupt temporarily or permanently thienopyridine therapy in the first 6 months after percutaneous coronary intervention (PCI) remains uncertain. In the dual antiplatelet therapy (DAPT) study subjects were enrolled within 72 hours of PCI and treated with aspirin and a thienopyridine for 12 months before being randomized to continued thienopyridine versus placebo. This analysis focuses on the 12-month period before randomization. Thienopyridine interruptions of greater than 24 hours, occurring in the first 6 months after PCI were evaluated. The incidence of MACCE and moderate or severe bleeding occurring within 12 months after PCI were compared between subjects with and without interruptions. Among 23,002 subjects, the incidence of interruption of thienopyridine was 5.1% (n = 1,173). Compared with subjects who adhered to treatment, subjects with an interruption had a higher incidence of MACCE (6.1% vs 4.3%, p = 0.005), death (2.2% vs 1.4%, p = 0.02), myocardial infarction (3.8% vs 2.7%, p = 0.03), and bleeding (3.1% vs 2.2%, p = 0.04) at 12 months. After adjusting for baseline characteristics, interruptions were associated with MACCE (adjusted odds ratio 1.3, 95% confidence interval 1.0, 1.7, p = 0.04) and had a borderline association with subsequent bleeding (adjusted odds ratio 1.4, 95% confidence interval 1.0, 2.0, p = 0.05). In conclusion, interruption of thienopyridine in the first 6 months after PCI occurs not infrequently and is associated with an increased risk of MACCE and subsequent bleeding between the time of interruption and 12 months after PCI.

19 Article Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial. 2019

Kereiakes, Dean J / Ellis, Stephen G / Metzger, D Christopher / Caputo, Ronald P / Rizik, David G / Teirstein, Paul S / Litt, Marc R / Kini, Annapoorna / Kabour, Ameer / Marx, Steven O / Popma, Jeffrey J / Tan, Siok Hwee / Ediebah, Divine E / Simonton, Charles / Stone, Gregg W / Anonymous4691005. ·The Christ Hospital Heart and Vascular Center, Lindner Research Center, Cincinnati, OH (D.J.K.). · Cleveland Clinic, OH (S.G.E.). · Wellmont Holston Valley Medical Center, Kingsport, TN (D.C.M.). · St. Joseph's Hospital Health Center, Liverpool, NY (R.P.C.). · Scottsdale Healthcare, AZ (D.G.R.). · Scripps Clinic, La Jolla, CA (P.S.T.). · Baptist Medical Center, Jacksonville, FL (M.R.L.). · Mount Sinai Medical Center, New York (A. Kini). · Mercy St. Vincent's Medical Center, Toledo, OH (A. Kabour). · New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation (S.O.M., G.W.S.). · Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.). · Abbott Vascular, Santa Clara, CA (S.H.T., D.E.E., C.S.). ·Circulation · Pubmed #31553222.

ABSTRACT: BACKGROUND: The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption. METHODS: Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years. RESULTS: Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55-1.24] versus 1.35 [95% CI, 1.02-1.78]; CONCLUSIONS: In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01751906.

20 Article The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale. 2019

Mauri, Laura / Doros, Gheorghe / Rao, Sunil V / Cohen, David J / Yakubov, Steven / Lasala, John / Wong, S Chiu / Zidar, James / Kereiakes, Dean J. ·Harvard Medical School. · Baim Institute for Clinical Research; Department of Biostatistics, Boston University. · The Duke Clinical Research Institute. · Saint Luke's Mid America Heart Institute, Kansas City, MO. · OhioHealth Riverside Methodist Hospital. · Washington University School of Medicine in St. Louis. · Weil Cornell Medicine. · University of North Carolina. · The Christ Hospital and Lindner Research Center. Electronic address: Lindner@thechristhospital.com. ·Am Heart J · Pubmed #31415994.

ABSTRACT: Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.

21 Article Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women. 2018

Berry, Natalia C / Kereiakes, Dean J / Yeh, Robert W / Steg, P Gabriel / Cutlip, Donald E / Jacobs, Alice K / Abbott, J Dawn / Hsieh, Wen-Hua / Massaro, Joseph M / Mauri, Laura / Anonymous3030966. ·Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (N.C.B., L.M.). · Harvard Medical School, Boston, MA (N.C.B., L.M., D.E.C., R.W.Y.). · Baim Institute for Clinical Research, Boston, MA (N.C.B., L.M., D.E.C., R.W.Y., W.-H.H., J.M.M.). · The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K). · The Smith Center for Outcomes Research in Cardiology (R.W.Y.), Beth Israel Deaconess Medical Center, Boston, MA. · Université Paris-Diderot, Sorbonne Paris Cité, INSERM Unité-1148, Département Hospitalo-Universitaire Fibrosis Inflammation Remodeling, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.). · National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, United Kingdom (P.G.S.). · Division of Cardiology, Department of Medicine (D.E.C.). · Boston University School of Medicine, Boston, MA (A.K.J.). · Rhode Island Hospital, Brown University School of Medicine (J.D.A.). · Boston University School of Public Health, MA (J.M.M.). ·Circ Cardiovasc Interv · Pubmed #30354781.

ABSTRACT: BACKGROUND: Women may derive differential benefit from prolonged DAPT (dual antiplatelet therapy) after coronary stenting than men. We assessed whether the risks/benefits of prolonged DAPT differ between women and men. METHODS AND RESULTS: The DAPT study was a randomized double-blind, placebo-controlled trial comparing continued thienopyridine versus placebo beyond 12 months after coronary stenting. We compared rates of myocardial infarction, stent thrombosis, major adverse cardiovascular and cerebrovascular events, and bleeding by sex and randomized treatment. Of 11 648 patients, women (N=2925) were older, with higher prevalence of diabetes mellitus and lower rates of acute coronary syndrome than men. At 12 to 30 months, women had similar adjusted ischemic and bleeding events as men. The effects of continued thienopyridine therapy did not differ significantly by sex for stent thrombosis (women: hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.22-1.36; men: HR, 0.26; 95% CI, 0.15-0.44; interaction P=0.17), myocardial infarction (women: HR, 0.75; 95% CI, 0.50-1.14; men: HR, 0.46; 95% CI, 0.36-0.60; interaction P=0.052), major adverse cardiovascular and cerebrovascular events (women: HR, 0.87; 95% CI, 0.62-1.22; men: HR, 0.70; 95% CI, 0.58-0.85; interaction P=0.26), and bleeding (women: HR, 1.45; 95% CI, 0.88-2.40; men: HR, 1.78; 95% CI, 1.28-2.49; interaction P=0.50). CONCLUSIONS: Women had similar late risks of ischemia and bleeding as men after coronary stent procedures. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00977938.

22 Article Rationale and design of the EVOLVE Short DAPT Study to assess 3-month dual antiplatelet therapy in subjects at high risk for bleeding undergoing percutaneous coronary intervention. 2018

Mauri, Laura / Kirtane, Ajay J / Windecker, Stephan / Yeh, Robert W / Dauerman, Harold L / Price, Matthew J / Christen, Thomas / Allocco, Dominic J / Meredith, Ian T / Kereiakes, Dean J. ·Division of Cardiovascular Medicine/Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: laura.mauri@gmail.com. · Division of Cardiology, Columbia University/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA. · Bern University Hospital, Bern, Switzerland. · Beth Israel Deaconess Medical Center, Boston, MA, USA. · University of Vermont Larner College of Medicine, Burlington, VT, USA. · Scripps Clinic, La Jolla, CA, USA. · Boston Scientific Corporation, Marlborough, MA, USA. · The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH, USA. Electronic address: lindner@thechristhospital.com. ·Am Heart J · Pubmed #30218844.

ABSTRACT: BACKGROUND: While extended dual antiplatelet therapy (DAPT) with aspirin and a platelet (P2Y TRIAL DESIGN: EVOLVE Short DAPT is a prospective, single-arm, international study that enrolled 2009 high risk bleeding subjects (defined as age ≥75 years, chronic anticoagulation, major bleeding within 12 months, history of stroke, renal insufficiency/failure, or thrombocytopenia) who underwent PCI with the SYNERGY stent. Subjects presenting with acute MI or complex lesions were excluded. After 3 months treatment with DAPT (except those on anticoagulant in whom aspirin is optional), subjects free from stroke, MI, revascularization or ST will be eligible to discontinue P2Y CONCLUSION: The EVOLVE Short DAPT study will prospectively define the safety of DAPT discontinuation at 3 months in high bleeding risk patients treated with the SYNERGY stent.

23 Article Efficacy and safety of alirocumab in patients with or without prior coronary revascularization: Pooled analysis of eight ODYSSEY phase 3 trials. 2018

Kereiakes, Dean J / Lepor, Norman E / Gerber, Robert / Veronica Lee, L / Elassal, Joe / Thompson, Desmond / Michael Gibson, C. ·The Christ Hospital, Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH, USA. Electronic address: Lindner@thechristhospital.com. · Cedars-Sinai Medical Center/Westside Medical Associates of Los Angeles, Beverly Hills, CA, USA. · Department of Cardiology, East Sussex Healthcare NHS Trust, Hastings, UK. · Sanofi, Bridgewater, NJ, USA. · Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA. · Beth Israel Deaconess Medical Center, Boston, MA, USA. ·Atherosclerosis · Pubmed #30025648.

ABSTRACT: BACKGROUND AND AIMS: Patients with atherosclerotic cardiovascular disease (ASCVD) and prior revascularization are at high risk of further cardiovascular events and may require additional lipid-lowering therapies beyond maximally tolerated statin therapy. We assessed the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in patients with ASCVD, with or without prior coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]). METHODS: Data from eight controlled (placebo/ezetimibe) phase 3 ODYSSEY trials were pooled and stratified by trial design: alirocumab 150 mg or 75 mg with possible dose increase to 150 mg (75/150 mg) every 2 weeks (Q2W) versus placebo, and alirocumab 75/150 mg Q2W versus ezetimibe. Most patients received background maximally tolerated statin therapy. RESULTS: Among 4629 randomized patients with hypercholesterolemia, 3382 had ASCVD including 2191 with prior revascularization. Although baseline characteristics were comparable between alirocumab and control groups, revascularized patients were more likely to be male, have had prior myocardial infarction/stroke, have higher lipoprotein (a) and PCSK9 levels, and were more often treated with high-intensity statin therapy. Alirocumab significantly reduced low-density lipoprotein cholesterol (LDL-C; primary endpoint; p < 0.0001), lipoprotein (a), non-high-density lipoprotein cholesterol, and apolipoprotein B levels from baseline to week 24 (vs. control), regardless of stratified treatment group or revascularization status. On-treatment LDL-C levels with alirocumab ranged from 45.6 to 64.8 mg/dL. Alirocumab had a similar safety profile regardless of revascularization status, and higher rates of injection-site reactions versus controls. CONCLUSIONS: Alirocumab is generally well-tolerated and effective with a similar safety profile in high-risk patients with or without prior revascularization (PCI/CABG).

24 Article Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. 2018

Ali, Ziad A / Gao, Runlin / Kimura, Takeshi / Onuma, Yoshinobu / Kereiakes, Dean J / Ellis, Stephen G / Chevalier, Bernard / Vu, Minh-Thien / Zhang, Zhen / Simonton, Charles A / Serruys, Patrick W / Stone, Gregg W. ·New York-Presbyterian Hospital/Columbia University Medical Center, New York (Z.A.A., G.W.S.). · Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.A.A., G.W.S.). · Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China (R.G.). · Kyoto University Hospital, Japan (T.K.). · Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O.). · The Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, OH (D.J.K.). · Cleveland Clinic, OH (S.G.E.). · Institut Cardiovasculaire Paris Sud, Massy, France (B.C.). · Abbott Vascular, Santa Clara, CA (M.-t.V., Z.Z., C.A.S.). · International Centre for Cardiovascular Health, Imperial College, London, UK (P.W.S.). · New York-Presbyterian Hospital/Columbia University Medical Center, New York (Z.A.A., G.W.S.) gs2184@columbia.edu. ·Circulation · Pubmed #29089314.

ABSTRACT: BACKGROUND: The Absorb bioresorbable vascular scaffold (BVS) completely resorbs within 3 years after coronary artery implantation. The safety and effectiveness of BVS through this critical 3-year period have not been characterized. METHODS: We performed an individual-patient-data pooled meta-analysis of the 4 randomized ABSORB trials in which 3389 patients with coronary artery disease were randomly assigned to everolimus-eluting Absorb BVS (n=2164) or cobalt-chromium everolimus-eluting stents (n=1225). The primary efficacy outcome measure was target lesion failure (cardiac mortality, target vessel myocardial infarction, or ischemia-driven target lesion revascularization), and the primary safety outcome measure was device thrombosis. RESULTS: BVS compared with cobalt-chromium everolimus-eluting stents resulted in higher 3-year rates of target lesion failure (11.7% versus 8.1%; risk ratio [RR], 1.38; 95% confidence interval [CI], 1.10-1.73; CONCLUSIONS: In the present individual-patient-data pooled meta-analysis of the ABSORB trials, BVS was associated with increased rates of target lesion failure and device thrombosis between 1 and 3 years and cumulatively through 3 years of follow-up compared with everolimus-eluting stents. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

25 Article Effect of Technique on Outcomes Following Bioresorbable Vascular Scaffold Implantation: Analysis From the ABSORB Trials. 2017

Stone, Gregg W / Abizaid, Alexandre / Onuma, Yoshinobu / Seth, Ashok / Gao, Runlin / Ormiston, John / Kimura, Takeshi / Chevalier, Bernard / Ben-Yehuda, Ori / Dressler, Ovidiu / McAndrew, Tom / Ellis, Stephen G / Kereiakes, Dean J / Serruys, Patrick W. ·New York Presbyterian Hospital, Columbia University Medical Center, New York, New York; The Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu. · Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. · Thoraxcenter, Erasmus Medical Center and Cardialysis, Rotterdam, the Netherlands. · Fortis Escorts Heart Institute, New Delhi, India. · Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. · University of Auckland School of Medicine, Auckland, New Zealand. · Kyoto University Hospital, Kyoto, Japan. · Institut Cardiovasculaire Paris Sud, Massy, France. · New York Presbyterian Hospital, Columbia University Medical Center, New York, New York; The Cardiovascular Research Foundation, New York, New York. · The Cardiovascular Research Foundation, New York, New York. · Cleveland Clinic, Cleveland, Ohio. · The Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, Ohio. · International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom. ·J Am Coll Cardiol · Pubmed #29100704.

ABSTRACT: BACKGROUND: Procedural technique may affect clinical outcomes after bioresorbable vascular scaffold (BVS) implantation. Prior studies suggesting such a relationship have not adjusted for baseline patient and lesion characteristics that may have influenced operator choice of technique and outcomes. OBJECTIVES: This study sought to determine whether target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) and scaffold thrombosis (ScT) rates within 3 years of BVS implantation are affected by operator technique (vessel size selection and pre- and post-dilation parameters). METHODS: TLF and ScT rates were determined in 2,973 patients with 3,149 BVS-treated coronary artery lesions from 5 prospective studies (ABSORB II, ABSORB China, ABSORB Japan, ABSORB III, and ABSORB Extend). Outcomes through 3 years (and between 0 to 1 and 1 to 3 years) were assessed according to pre-specified definitions of optimal technique (pre-dilation, vessel sizing, and post-dilation). Multivariable analysis was used to adjust for differences in up to 18 patient and lesion characteristics. RESULTS: Optimal pre-dilation (balloon to core laboratory-derived reference vessel diameter ratio ≥1:1), vessel size selection (reference vessel diameter ≥2.25 mm and ≤3.75 mm), and post-dilation (with a noncompliant balloon at ≥18 atm and larger than the nominal scaffold diameter, but not by >0.5 mm larger) in all BVS-treated lesions were performed in 59.2%, 81.6%, and 12.4% of patients, respectively. BVS implantation in properly sized vessels was an independent predictor of freedom from TLF through 1 year (hazard ratio [HR]: 0.67; p = 0.01) and through 3 years (HR: 0.72; p = 0.01), and of freedom from ScT through 1 year (HR: 0.36; p = 0.004). Aggressive pre-dilation was an independent predictor of freedom from ScT between 1 and 3 years (HR: 0.44; p = 0.03), and optimal post-dilation was an independent predictor of freedom from TLF between 1 and 3 years (HR: 0.55; p = 0.05). CONCLUSIONS: In the present large-scale analysis from the major ABSORB studies, after multivariable adjustment for baseline patient and lesion characteristics, vessel sizing and operator technique were strongly associated with BVS-related outcomes during 3-year follow-up. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281; ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906; A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population-ABSORB CHINA Randomized Controlled Trial [RCT] [ABSORB CHINA]; NCT01923740; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND]; NCT01023789; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284).

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