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Calcified nodules (CNs) are among the most challenging lesions to treat in contemporary percutaneous coronary intervention. CNs may be divided into 2 subtypes, eruptive and noneruptive, which have distinct histopathological and prognostic features. An eruptive CN is a biologically active lesion with a disrupted fibrous cap and possibly adherent thrombus, whereas a noneruptive CN has an intact fibrous cap and no adherent thrombus. The use of intravascular imaging may allow differentiation between the 2 subtypes, thus potentially guiding treatment strategy. Compared with noneruptive CNs, eruptive CNs are more likely to be deformable, resulting in better stent expansion, but are paradoxically associated with worse clinical outcomes, in part because of their frequent initial presentation as an acute coronary syndrome and subsequent reprotrusion of the CN into the vessel lumen through the stent struts. Pending the results of ongoing studies, a tailored therapeutic approach based on the distinct features of the different CNs may be of value., Competing Interests: Funding Support and Author Disclosures Dr Galougahi has received speaking honoraria from Abbott. Dr Maehara has served as a consultant for Boston Scientific, Philips, and Shockwave Medical. Dr Spratt has received research grants from Shockwave Medical; and has received consultant fees from Shockwave Medical and Boston Scientific. Dr Collet has received research grants from Biosensor, Coroventis Research, Medis Medical Imaging, Pie Medical Imaging, CathWorks, Boston Scientific, Siemens, HeartFlow, and Abbott Vascular; and has received consultant fees from HeartFlow, OpSens, Abbott Vascular, and Philips Volcanumber. Dr Barbato has received speaker fees from Abbott Vascular, Boston Scientific, and GE. Dr Gonzalo has received research grant support from Abbott; and has received consultancy and speaker fees from Abbott, Boston Scientific, Philips, and Shockwave. Dr Mintz has served as a consultant for Boston Scientific, Abbott, Spectrawave, and Gentuity; and has received honoraria from Boston Scientific, Abbott, Spectrawave, and Gentuity. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant for Abbott, Daiichi-Sankyo, Ablative Solutions, CorFlow, Cardiomech, Robocath, Miracor, Vectorious, Apollo Therapeutics, Elucid Bio, Valfix, TherOx, HeartFlow, Neovasc, Ancora, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, HighLife, Elixir, Remote Cardiac Enablement, and Aria; and holds equity/options in Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. Dr Stone’s employer, Mount Sinai Hospital, has received research grants from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr E. Shlofmitz has served as a consultant to Abbott Vascular, Medtronic, and Opsens Medical. Dr R.A. Shlofmitz has served as a speaker for Shockwave Medical. Dr Jeremias has received institutional grants and consulting fees from Abbott Vascular and Philips/Volcano; and has received consultant fees from ACIST Medical and Boston Scientific. Dr Ali has received institutional grants from Abbott, Abiomed, ACIST Medical, Boston Scientific, Cardiovascular Systems Inc, Medtronic, Opsens Medical, Philips, and Shockwave Medical; has received personal fees from Amgen, AstraZeneca, and Boston Scientific; and holds equity in Elucid, Lifelink, Spectrawave, Shockwave, and Vital Connect. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Intravascular ultrasound (IVUS) studies show that one-quarter of left anterior descending (LAD) arteries have a myocardial bridge. An MB may be associated with stent failure when the stent extends into the MB., Objectives: The aim of this study was to investigate: 1) the association between an MB and chronic total occlusion (CTO) in any LAD lesions; and 2) the association between an MB and subsequent clinical outcomes after percutaneous coronary intervention in LAD CTOs., Methods: A total of 3,342 LAD lesions with IVUS-guided percutaneous coronary intervention (280 CTO and 3,062 non-CTO lesions) were included. The primary outcome was target lesion failure (cardiac death, target vessel myocardial infarction, definite stent thrombosis, and ischemic-driven target lesion revascularization)., Results: An MB by IVUS was significantly more prevalent in LAD CTOs than LAD non-CTOs (40.4% [113/280] vs 25.8% [789/3,062]; P < 0.0001). The discrepancy in CTO length between angiography and IVUS was greater in 113 LAD CTOs with an MB than 167 LAD CTOs without an MB (6.0 [Q1, Q3: 0.1, 12.2] mm vs 0.2 [Q1, Q3: -1.4, 8.4] mm; P < 0.0001). Overall, 48.7% (55/113) of LAD CTOs had a stent that extended into an MB after which target lesion failure was significantly higher compared to a stent that did not extend into an MB (26.3% vs 0%; P = 0.0004) or compared to an LAD CTO without an MB (26.3% vs 9.6%; P = 0.02)., Conclusions: An MB was more common in LAD CTO than non-CTO LAD lesions. If present, approximately one-half of LAD CTOs had a stent extending into an MB that, in turn, was associated with worse outcomes., Competing Interests: Funding Support and Author Disclosures Dr Karmpaliotis has received honoraria from Boston Scientific and Abbot Vascular; and holds equity in Saranas Soundbite and Traverse Vascular. Dr Matsumura is a consultant for Terumo Corporation and Boston Scientific. Dr Fall is a consultant for INFRAREDX and Boston Scientific. Dr Prasad is a consultant for CONAVI, Neovasc, Abbott Vascular, Cardinol, Chiesi, and Boehringer Ingelheim; and is on the Speakers Bureau for CONAVI, Neovasc, Abbott Vascular, Cardinol, Chiesi, and Boehringer Ingelheim. Dr Ng has received honoraria from Edwards Lifesciences and Medtronic. Dr Parikh has received research grants from Abbott, Boston Scientific, Medtronic, Phillips, Cordis, Jannsen; is a consultant for Inari, Penumbra, Terumo, and Canon; and holds equity in eFemoral, Advanced Nano Therapies, and Encompass Vascular. Dr Ali has received grants from Abbott Vascular and CSI; is a consultant for Amgen, AstraZeneca, and Boston Scientific; and holds equity for Shockwave. Dr Leon has received institutional clinical research grants from Abbott Vascular, Boston Scientific, and Medtronic. Dr McEntegart has received honoraria from Boston Scientific, Abbot Vascular, Shockwave Medical, Teleflex, and Biosensors. Dr Moses holds equity in Orchestra Biomed and Xenter. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, Siemens, Philips, ReCor Medical, and Neurotronic; has received institutional funding including fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content; is a consultant for IMDS; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Ochiai has received consulting fees from Abbott, Asahi Intecc, Boston Scientific, and Terumo. Dr Mintz has received honoraria from Boston Scientific, Philips, SpectraWave, and Gentuity. Dr Maehara has received research grants from Boston Scientific and Abbott Vascular; and is a consultant for Boston Scientific and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Low fractional flow reserve (FFR) after percutaneous coronary intervention (PCI) has been associated with adverse clinical outcomes. Hitherto, this assessment has been independent of the epicardial vessel interrogated., Objectives: This study sought to assess the predictive capacity of post-PCI FFR for target vessel failure (TVF) stratified by coronary artery., Methods: We performed a systematic review and individual patient-level data meta-analysis of randomized clinical trials and observational studies with protocol-recommended post-PCI FFR assessment. The difference in post-PCI FFR between left anterior descending (LAD) and non-LAD arteries was assessed using a random-effect models meta-analysis of mean differences. TVF was defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization., Results: Overall, 3,336 vessels (n = 2,760 patients) with post-PCI FFR measurements were included in 9 studies. The weighted mean post-PCI FFR was 0.89 (95% CI: 0.87-0.90) and differed significantly between coronary vessels (LAD = 0.86; 95% CI: 0.85 to 0.88 vs non-LAD = 0.93; 95% CI: 0.91-0.94; P < 0.001). Post-PCI FFR was an independent predictor of TVF, with its risk increasing by 52% for every reduction of 0.10 FFR units, and this was mainly driven by TVR. The predictive capacity for TVF was poor for LAD arteries (AUC: 0.52; 95% CI: 0.47-0.58) and moderate for non-LAD arteries (AUC: 0.66; 95% CI: 0.59-0.73; LAD vs non-LAD arteries, P = 0.005)., Conclusions: The LAD is associated with a lower post-PCI FFR than non-LAD arteries, emphasizing the importance of interpreting post-PCI FFR on a vessel-specific basis. Although a higher post-PCI FFR was associated with improved prognosis, its predictive capacity for events differs between the LAD and non-LAD arteries, being poor in the LAD and moderate in the non-LAD vessels., Competing Interests: Funding Support and Author Disclosures Dr Collet received research grants from Biosensors, HeartFlow Inc, Abbott Vascular, Insight Lifetech, GE Healthcare, Siemens and Shockwave Medical. Dr Johnson has received internal funding from the Weatherhead PET Center for Preventing and Reversing Atherosclerosis; has received significant institutional research support from St. Jude Medical (CONTRAST, NCT02184117) and Philips Volcano (DEFINE-FLOW, NCT02328820) for studies using intracoronary pressure and flow sensors; has an institutional licensing agreement with Boston Scientific for the smart-minimum FFR algorithm commercialized under 510(k) K191008; and has pending patents on diagnostic methods for quantifying aortic stenosis and TAVI physiology and also algorithms to correct pressure tracings from fluid-filled catheters. Dr Mizukami has received consultancy fees from Zeon Medical. Dr Fearon receives institutional research support from Abbott Vascular, Boston Scientific, Medtronic, and Edwards Lifesciences; he has a consulting relationship with CathWorks and Siemens; and he owns minor stock options in HeartFlow. Dr Berry receives research funding from the British Heart Foundation grant (RE/18/6134217); and is employed by the University of Glasgow, which holds consultancy and research agreements for his work with Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Causeway Therapeutics, Coroventis, Genentech, GlaxoSmithKline, HeartFlow, Menarini, Neovasc, Siemens Healthcare, and Valo Health. Dr Sonck is supported by a grant provided by the CardioPath PhD program. Dr Collison has received honoraria/speaker fees from Abbott. Dr Koo has received an institutional research grant from St. Jude Medical (Abbott Vascular) and Philips Volcano. Dr Meneveau has received consultancy and speaker fees from Abbott Vascular, Edwards Lifesciences, Terumo, Boston Scientific, Bayer Healthcare, BMS-Pfizer, Boehringer, and AstraZeneca. Dr Oldroyd is an employee of Biosensors International. Dr Leipsic is a consultant for and holds stock options in Circle CVI and HeartFlow; and has a research grant from GE Healthcare. Dr Taylor is an employee of HeartFlow Inc. Dr Ko has received consultancy fees from Abbott Vascular and Medtronic; and has received research support from Canon Medical. Dr Perera has received research grant support from Abbott Vascular, HeartFlow, and Philips. Dr Leone received consultant fees and honoraria for lectures in sponsored symposia with Abbott Vascular and Bracco Imaging/ACIST Medical. Dr Matsuo has received consultancy fees from Zeon Medical; and has received speaker fees from Abbott Vascular Japan, Philips, and Boston Scientific. Dr Amabile reports consulting/proctoring fees from Abbott Vascular, Boston Scientific, and Shockwave Medical; and has received an institutional research grant from Abbott Vascular and Boston Scientific. Dr Piróth has received consultancy and speaker fees from Abbott Vascular, Opsens, and Boston Scientific. Dr Toth has received consultancy fees and research support from Abbott, Biotronik, Medtronic, and Terumo. Dr Ihdayhid reports receiving consulting honorarium from Abbott Medical, Edwards Lifesciences, Boston Scientific, Artrya Pty Ltd (including equity interest). Dr West is an employee of Abbott Vascular. Dr Munhoz is supported with a PhD grant from CardioPath. Dr Barbato has received speaker fees from Abbott and Boston Scientific. Dr Engstrøm has received consultancy and speaker fees from Abbott Vascular, Novo Nordisk, and Bayer AS. Dr Escaned is supported by the Intensification of Research Activity project INT22/00088 from Spanish Instituto de Salud Carlos III, and served as speaker and advisory board member for Abbott and Philips. Dr Ali has received institutional grant support Abbott, Abiomed, ACIST Medical, Amgen, Boston Scientific, Cathworks, Canon, Conavi, Heartflow, Inari, Medtronic Inc, National Institute of Health, Nipro, Opsens Medical, Medis, Philips, Shockwave, Siemens, Spectrawave, Teleflex; and consulting fees from Abiomed, AstraZeneca, Boston Scientific, Cathworks, Opsens, Philips, Shockwave and equity in Elucid, Lifelink, Spectrawave, Shockwave, VitalConnect. Dr Kern has received speaker fees from Abbott, ACIST Medical, Boston Scientific, Opsens, and Philips. Dr Pijls has received research grants from Abbott and Hexacath and consultancy fees from Abbott, GE, Philips, and HeartFlow and have equity in GE, Philips, and Heartflow. Dr De Bruyne has received institutional consulting fees from Abbott Vascular, Boston Scientific, Siemens, and GE; has received institutional grant support from Abbott Vascular, Boston Scientific, Biotronic, CathWorks, Pie Medical, and HeartFlow; and holds minor equities in Philips, Siemens, GE, Bayer, HeartFlow, Edwards Lifesciences, and Ceyliad. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr E.S. Shlofmitz is a consultant for Abbott, Medtronic, Janssen Pharmaceuticals, OpSens Medical, Philips, and Shockwave. Dr R.A. Shlofmitz has received speaker fees from Shockwave Medical. Dr Jeremias has received institutional funding (unrestricted education grant) from Philips/Volcano; and is a consultant for Philips/Volcano, Abbott Vascular, ACIST Medical, and Boston Scientific. Dr Ali has received institutional research grants to St Francis Hospital from Abbott, Philips, Boston Scientific, Abiomed, ACIST Medical, Medtronic, Cardiovascular Systems Inc; is a consultant to Amgen, AstraZeneca, and Boston Scientific; and has equity in Shockwave Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Whether an eruptive or noneruptive target lesion calcified nodule (CN) portends worse acute and long-term clinical outcomes after stenting has not been established., Objectives: The authors sought to compare acute and long-term clinical outcomes in eruptive CN vs noneruptive CN morphology., Methods: Using optical coherence tomography, an eruptive CN was defined as an accumulation of small calcium fragments protruding and disrupting the overlying fibrous cap, typically with small amount of thrombus. A noneruptive CN was defined as an accumulation of small calcium fragments with a smooth intact fibrous cap without an overlying thrombus. The primary endpoint was target lesion failure (TLF) including cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization in patients with ≥6-month follow-up., Results: Among 3,231 patients with evaluable pre- and postintervention OCT, 236 patients had lesions with CNs (7.3%). After eliminating 4 secondary lesions and 6 patients without ≥6-month follow-up, 126 (54.8%) lesions with eruptive CNs and 104 (45.2%) lesions with noneruptive CNs formed the current report. Compared with noneruptive CNs, eruptive CNs were independently associated with greater stent expansion (89.2% ± 18.7% vs. 81.5% ± 18.9%; P = 0.003) after adjusting for morphologic and procedural factors. At 2 years, eruptive CNs trended toward more TLF compared with noneruptive CNs (Kaplan-Meier estimates, 19.8% vs 12.5%; P = 0.11) and significantly more target lesion revascularization (18.3% vs 9.6%; P = 0.04). In the adjusted model, eruptive CNs were independently associated with 2-year TLF (HR: 2.07; 95% CI: 1.01-4.50; P = 0.048)., Conclusions: Compared with noneruptive CN morphology, lesions with an eruptive CN appearance on optical coherence tomography had a worse poststent long-term clinical outcome despite better acute stent expansion., Competing Interests: Funding Support and Author Disclosures Dr Evan Shlofmitz has been a consultant to Abbott Vascular, Medtronic, and Opsens Medical. Dr Khalique has received speaker fees from Edwards Lifesciences. Dr Cohen has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic and has received a consulting income from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mintz has received honoraria from Boston Scientific/Philips. Dr Richard A. Shlofmitz has been a speaker for Shockwave Medical. Dr Jeremias has received institutional grants and consulting fees from Abbott Vascular and Philips/Volcano; and has received consultant fees from ACIST and Boston Scientific. Dr Ali has received institutional research grants for Columbia University from Abbott and Cardiovascular Systems Inc; and has served as a consultant for Abbott, Abiomed, AstraZeneca, and Shockwave Medical. Dr Maehara has received grant support from Abbott Vascular and Boston Scientific; has been a consultant for Abbott Vascular and Boston Scientific; and has received consultant fees from Conavi Medical Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Competing Interests: Funding Support and Author Disclosures Dr E. Shlofmitz is a consultant for Abbott, Medtronic, Janssen Pharmaceuticals, OpSens Medical, Philips, and Shockwave. Dr Jeremias has received institutional funding (unrestricted education grant) from Philips/Volcano; and is a consultant for Philips/Volcano, Abbott Vascular, ACIST Medical, and Boston Scientific. Dr R. Shlofmitz has received speaker fees from Shockwave Medical. Dr Ali has received institutional research grants to St. Francis Hospital from Abbott, Philips, Boston Scientific, Abiomed, ACIST Medical, Medtronic, and Cardiovascular Systems; is a consultant to Amgen, AstraZeneca, and Boston Scientific; and has equity in Shockwave Medical. Ms Chau has reported that she has no relationships relevant to the contents of this paper to disclose.

Background: Although the presence of severe stenosis in the left main coronary artery (LMCA) is a well-established predictor of mortality, whether this extends to nonobstructive atherosclerosis in the LMCA is unknown., Objectives: The aim of this study was to evaluate the association between LMCA disease by intravascular ultrasound (IVUS) and long-term mortality., Methods: Between 2005 and 2013, 3,239 patients with LMCA IVUS imaging without LMCA revascularization (either before angiography or scheduled based on index angiography or IVUS) were included. The primary and secondary endpoints were all-cause and cardiac mortality at a minimum of 5 years obtained from the National Death Index., Results: The IVUS-measured LMCA minimum lumen area (MLA) and plaque burden were 13.1 ± 5.0 mm 2 and 41.7% ± 15.6%, respectively. The median follow-up was 8.2 years. The Kaplan-Meier estimated 12-year all-cause and cardiac death rates were 37.5% and 17.0%, respectively. Greater plaque burden (unadjusted HR per 10%: 1.17; 95% CI: 1.12-1.22; P < 0.0001) and smaller IVUS MLA (unadjusted HR per 1 mm 2 : 0.98; 95% CI: 0.96-0.99; P = 0.0008) were associated with all-cause death. After adjusting for clinical, angiographic, and IVUS factors, plaque burden (adjusted HR per 10%: 1.12; 95% CI: 1.04-1.21; P = 0.003) but not MLA (adjusted HR per 1 mm 2 : 1.02; 95% CI: 0.99-1.04; P = 0.18) was associated with long-term all-cause death. These findings were also consistent for long-term cardiac mortality., Conclusions: In the present large-scale study with a 12-year follow-up, increasing LMCA plaque burden was associated with long-term all-cause and cardiac mortality in patients not undergoing LMCA revascularization, even when the lumen area was preserved., Competing Interests: Funding Support and Author Disclosures This work was supported in part by an unrestricted grant from Boston Scientific. Dr Matsumura is a consultant for Terumo Corporation. Dr Ali has received a grant from Abbott Vascular and Cardiovascular Systems Inc, is a consultant for Amgen, AstraZeneca, and Boston Scientific; and has equity in Shockwave. Dr Karmpaliotis has received honoraria from Boston Scientific and Abbott Vascular; has equity in Saranas Soundbite and Traverse Vascular. Dr Parikh has provided research for Abbott, Boston Scientific, Surmodics, TriReme, Shockwave, and Veryan Medical; is on the advisory board for Abbott, Boston Scientific, Cordis, Medtronic, Cardiovascular Systems Inc, and Philips; and is a consultant for Inari, Penumbra, Terumo, and Abiomed. Dr Leon has received institutional clinical research grants from Abbott Vascular, Boston Scientific, and Medtronic. Dr Stone is a speaker or has received other honoraria from Cook and Infraredx; is a consultant for Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Reva, MAIA Pharmaceuticals, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and MedFocus family of funds. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems Inc, Siemens, Philips, ReCor Medical, and Neurotronic; has received institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content; has received consulting fees from interventional Medical Device Solutions; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems Inc, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Mintz has received honoraria from Boston Scientific, Philips, Abiomed, and Medtronic. Dr Maehara has received research grants from Boston Scientific, Abbott Vascular, Consultant, Boston Scientific, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year., Objectives: This study reports the final 2-year results of the randomized Onyx ONE trial., Methods: The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y 12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years., Results: A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: -3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P = 0.54)., Conclusions: Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653)., Competing Interests: Funding Support and Author Disclosures The Onyx ONE trial was sponsored by Medtronic. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave; served as an unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, CardioValve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis but has not received personal payments by pharmaceutical companies or device manufacturers; and has served as a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Latib has received consulting fees from Medtronic, Abbott Vascular, and Boston Scientific. Dr Kedhi has received speaker honoraria and institutional grants from Medtronic and Abbott Vascular. Dr Kirtane has received institutional funding to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, and Neurotronic (in addition to research grants, institutional funding includes fees paid to Columbia University and/or the Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content); has served as a consultant for IMDS; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Kandzari has received institutional research or grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Orbus Neich, Medtronic, and Ablative Solutions; and has received personal consulting honoraria from Cardiovascular Systems, Magenta Medical, and Medtronic. Dr Mehran has received institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, and OrbusNeich; has received consulting fees from Abbott Laboratories, Boston Scientific, CardiaWave, Chiesi, Cine-Med Research, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, and Siemens Medical Solutions; has received consultant fees paid to the institution from Abbott Laboratories and Bristol Myers Squibb; has served on the advisory board, with funding paid to the institution, for Spectranetics/Philips/Volcano Corp; has a spouse who has served as a consultant for Abiomed, The Medicines Company, Merck; Equity <1% from Claret Medical, Elixir Medical, Applied Therapeutics, and STEL; has received Data Safety and Monitoring Board Membership fees paid to the institution from Watermark Research Partners; has served as a consultant (no fee) for Idorsia Pharmaceuticals and Regeneron Pharmaceuticals; and has served as an Associate Editor for the American College of Cardiology and the American Medical Association. Dr Price has received consulting fees and speaker honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Medtronic; and has received consulting fees from Acutus, Baylis Medical, and W.L. Gore. Dr Simon has received honoraria for serving as a course director (<$10,000) from Medtronic. Dr Worthley has received institutional grant or research support from Abbott and Biotronik. Dr Zaman has received consulting fees from Abbott, Boston Scientific, Medtronic, Meril, SMT, and Terumo. Dr Petrov has received consulting, proctor, or speaker fees from Medtronic, Edwards, Philips, Cardiatis, Boehringer Ingelheim, Servier, and Pfizer. Dr Mylotte has received consulting fees from Medtronic, Boston Scientific, and MicroPort. Dr Moreno has received lecture or consulting fees from Medtronic, Biosensors, Abbott Vascular, Boston Scientific, Terumo, and Braun. Dr Pasupati has received consulting, proctor, or speaker fees from Medtronic, Edwards, Boston Scientific, JenaValve, BioExcel, Boehringer Ingelheim, and Pfizer. Dr Kim has received research grants through Seoul National University Hospital from Abbott, Medtronic, Biotronik, B. Braun, and Daiichi-Sankyo; and has received lecture and consulting fees from Edwards Lifesciences, Medtronic, Novartis, Pfizer, Daiichi-Sankyo, AmGen, AstraZeneca, and Boehringer Ingelheim. Dr Tie has received speaker fees from Boehringer Ingelheim, outside the submitted work. Dr Hur has received research grants from Boston Scientific and Terumo. Dr Marx has received an honorarium for Clinical Events Committee membership from the Cardiovascular Research Foundation. Dr Ali has received institutional grant support from Abiomed, Acist Medical, Abbott, Boston Scientific, Cardiovascular Systems, Philips, and Opsens Medical; has received consulting or advisory fees from Amgen and Boston Scientific; has received speaker honoraria from AstraZeneca; and owns equity in Shockwave Medical. Ms. Parke and Dr Lung are employees of Medtronic. Dr Stone has received speaker honoraria from Cook, Infraredx, Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Reva, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and owns equity or options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and the MedFocus family of funds. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine correlates and consequences of contrast-associated acute kidney injury (CA-AKI) on clinical outcomes in patients with or without pre-existing chronic kidney disease (CKD)., Background: The incidence and impact of CA-AKI on clinical outcomes during contemporary percutaneous coronary intervention (PCI) are not fully defined., Methods: The ADAPT-DES (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents) study was a prospective, multicenter registry of 8,582 patients treated with ≥1 drug-eluting stent(s). CA-AKI was defined as a post-PCI increase in serum creatinine of >0.5 mg/dL or a relative increase of ≥25% compared with pre-PCI. CKD was defined as estimated glomerular filtration rate <60 mL/min/1.73 m 2 . The primary endpoint was the 2-year rate of net adverse clinical events (NACE): All-cause mortality, myocardial infarction (MI), definite or probable stent thrombosis, or major bleeding., Results: Of 7287 (85%) patients with evaluable data, 476 (6.5%) developed CA-AKI. In a multivariable model, older age, female sex, Caucasian race, congestive heart failure, diabetes, hypertension, CKD, presentation with ST-segment elevation MI, Killip class II to IV, radial access, intra-aortic balloon pump use, hypotension, and number of stents were independent predictors of CA-AKI. The 2-year NACE rate was higher in patients with CA-AKI (adjusted HR: 1.88; 95% CI: 1.42-2.49), as was each component of NACE (all-cause mortality, HR: 1.77; 95% CI: 1.22-2.55; MI, HR: 1.67; 95% CI: 1.18-2.36; definite/probable stent thrombosis, HR: 1.71; 95% CI: 1.10-2.65; and major bleeding, HR: 1.38; 95% CI: 1.06-1.80). Compared with the CA-AKI-/CKD- group, the CA-AKI+/CKD- (HR: 1.83; 95% CI: 1.33-2.52), CA-AKI-/CKD+ (HR: 1.56; 95% CI: 1.15-2.13), CA-AKI+/CKD+ (HR: 3.29; 95% CI: 1.92-5.67), and maintenance dialysis (HR: 2.67; 95% CI: 1.65-4.31) groups were at higher risk of NACE., Conclusions: CA-AKI was relatively common after contemporary PCI and was associated with increased 2-year rates of NACE. Patients with pre-existing CKD were at particularly high risk for NACE after CA-AKI., Competing Interests: Funding Support and Author Disclosures The ADAPT-DES study was sponsored by the Cardiovascular Research Foundation, with funding provided by Boston Scientific, Abbott Vascular, Medtronic, Cordis, Biosensors, The Medicines Company, Daiichi Sankyo, Eli Lilly, Volcano, and Accumetrics. Dr Chertow has received grant funding from the National Institute of Diabetes and Digestive and Kidney Diseases and National Institute of Allergy and Infectious Diseases; served as a consultant to Akebia, Ardelyx, AstraZeneca, Baxter, CloudCath, Cricket, Durect, Gilead, Miromatrix, Outset, Reata, Sanifit, Unicycive, and Vertex; and served on the Data Safety and Monitoring Board/Data Monitoring Committee for Angion, Bayer, National Institute of Diabetes and Digestive and Kidney Diseases, and ReCor. Dr Jeremias has received institutional funding (unrestricted education grant) and served as a consultant for Volcano/Philips and Abbott Vascular; and served as consultant to ACIST Medical and Boston Scientific. Dr Cohen has received research grant support and consulting income from Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Maehara has received grant support and served as a consultant for Abbott Vascular and Boston Scientific. Dr Mintz has received honoraria from Abiomed, Boston Scientific, Medtronic, and Philips. Dr Leon has received institutional research grants and served as a nonpaid advisor for Abbott, Boston Scientific, and Medtronic; and has served as a nonpaid advisor for Sinomed; and owns equity in Medinol. Dr Stuckey has served on the advisory board for Boston Scientific; and received speaker honoraria from Boston Scientific and Eli Lilly/Daiichi Sankyo. Dr Rinaldi has served on the advisory board for Boston Scientific; has taught courses for Abbott and Edwards Lifesciences; served as a consultant for Abbott, Boston Scientific, and Edwards Lifesciences; received research/grant support from Boston Scientific; and served as a proctor for Abbott and Edwards Lifesciences. Dr Weisz has received consulting fees from Filterlex, Intratech, and Magenta; and owns stock options in Filterlex, Intratech, Magenta, Medivizer, Trisol, and Vectorious. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical, and in addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting; served as a consultant for Neurotronic; and received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Mehran has received institutional research grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, and OrbusNeich; has received consultant fees from Abbott Laboratories, Boston Scientific, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, and Siemens Medical Solutions; has received consultant fees paid to the institution from Abbott Laboratories, Bristol Myers Squibb; has served on the advisory board for, with funding paid to the institution from Spectranetics/Philips/Volcano; has a spouse who has served as a consultant for Abiomed and The Medicines Company; owns equity <1% in Claret Medical, Elixir Medical; has received on the Data Safety and Monitoring Board Membership fees paid to the institution from Watermark Research Partners; has served as a consultant (no fee) for Idorsia Pharmaceuticals and Regeneron Pharmaceuticals; and has served as an Associate Editor for the American College of Cardiology and the American Medical Association. Dr Dangas has received research grant support from the The Medicines Company, Bristol Myers Squibb/Sanofi, and Eli Lilly and Company/Daiichi Sankyo; and served as a consultant for Abbott Vascular, AstraZeneca, Boston Scientific, Covidien, Janssen Pharmaceuticals, Regado Biosciences, Maya Medical, Merck and Co, and The Medicines Company. Dr Stone has received speaker and other honoraria from Cook, Terumo, Orchestra Biomed, and Qool Therapeutics; has served as a consultant to TherOx, Reva, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Matrizyme, Miracor, Neovasc, V-Wave, Abiomed, Shockwave, MAIA Pharmaceuticals, Cardiomech, SpectraWave, Valfix, Ancora, and Vectorious; and owns equity/options in Applied Therapeutics, Biostar family of funds, MedFocus family of funds, Aria, Cardiac Success, Cagent, SpectraWave, Valfix, Ancora, Orchestra Biomed, and Qool Therapeutics. Dr Ali has received institutional research grants from Abbott, Boston Scientific, Philips, Opsens Medical, Abiomed, ACIST Medical, Medtronic, and Cardiovascular Systems Inc; has served as a consultant for Amgen, AstraZeneca, and Boston Scientific; and owns equity in Shockwave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to identify the post-percutaneous coronary intervention (PCI) target value of instantaneous wave-free ratio (iFR) that would best discriminate clinical events at 1 year in the DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) study., Background: The impact of residual ischemia detected by iFR post-PCI on clinical and symptom-related outcomes is unknown., Methods: Blinded iFR pull back was performed after successful stent implantation in 500 patients. The primary endpoint was the rate of residual ischemia, defined as iFR ≤0.89, after operator-assessed angiographically successful PCI. Secondary endpoints included clinical events at 1 year and change in Seattle Angina Questionnaire angina frequency (SAQ-AF) score during follow-up., Results: As reported, 24.0% of patients had residual ischemia (iFR ≤0.89) after successful PCI, with 81.6% of cases attributable to angiographically inapparent focal lesions. Post-PCI iFR ≥0.95 (present in 182 cases [39%]) was associated with a significant reduction in the composite of cardiac death, spontaneous myocardial infarction, or clinically driven target vessel revascularization compared with post-PCI iFR <0.95 (1.8% vs 5.7%; P = 0.04). Baseline SAQ-AF score was 73.3 ± 22.8. For highly symptomatic patients (baseline SAQ-AF score ≤60), SAQ-AF score increased by ≥10 points more frequently in patients with versus without post-PCI iFR ≥0.95 (100.0% vs 88.5%; P = 0.01)., Conclusions: In DEFINE PCI, despite angiographically successful PCI, highly symptomatic patients at baseline without residual ischemia by post-PCI iFR had greater reductions in anginal symptoms at 1 year compared with patients with residual ischemia. Achieving post-PCI iFR ≥0.95 was also associated with improved 1-year event-free survival. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367)., Competing Interests: Funding Support and Author Disclosures This study was supported by funding from Philips/Volcano Corporation. The funding source was uninvolved with the design of the protocol and the analysis and interpretation of the study results. Dr Patel has received research grants from Bayer, Janssen, Amgen, Novartis, the National Heart, Lung, and Blood Institute, Phillips, and HeartFlow; and is an advisory board member for Bayer, Janssen, and HeartFlow. Dr Jeremias has received institutional funding (unrestricted education grant) from Philips/Volcano; and is a consultant for Philips/Volcano, Abbott Vascular, Acist Medical, and Boston Scientific. Dr Maehara has received institutional research grants from Boston Scientific and Abbott Vascular; and is a consultant for Boston Scientific and Philips, outside the submitted work. Dr Matsumura is a consultant for Terumo. Dr Shammas has received educational and research grants from Boston Scientific, Phillips, VentureMed Group, Angiodynamics, and Bard/BD; and is a member of the Speakers Bureau of Janssen, Eli Lilly, Esperion, and Boehringer Ingelheim. Dr Seto has received research grants from Phillips and Acist Medical; and has received honoraria from Terumo, General Electric, and Janssen. Dr Samady has received institutional grants from Medtronic; is a consultant to Abbott, Philips, Valo, and Vigilant Labs; and is a cofounder and equity holder of Covanos. Dr Sharp is a consultant to Medtronic, Recor Medical, Boston Scientific, and Philips. Dr Ali has received institutional grants from Abbott and Cardiovascular Systems; has received personal fees from Amgen, AstraZeneca, and Boston Scientific; and holds equity in Shockwave Medical, outside the submitted work. Dr Mintz has received honoraria from Boston Scientific, Philips, Medtronic, and Abiomed. Dr Davies is a consultant for Volcano-Philips; and has patents pertaining to iFR technology licensed by Imperial College to Volcano-Philips. Dr Stone has received speaker or other honoraria from Cook and Terumo; is a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, CardioMech, Elucid Bio, and Occlutech; and holds equity or options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, the MedFocus family of funds, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Objectives: The aim of this study was to evaluate various stent expansion indexes to determine the best predictor of clinical outcomes., Background: Numerous intravascular ultrasound (IVUS) studies have shown minimum stent area (MSA) to be the most powerful predictor of future events., Methods: ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of 8,582 patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents. Native coronary artery lesions treated with IVUS-guided PCI with final analyzable IVUS were included. Ten stent expansion indexes (MSA, MSA/vessel area at MSA site, conventional stent expansion [MSA/average of proximal and distal reference luminal area], minimum stent expansion using Huo-Kassab or linear model accounting for vessel tapering, stent asymmetry [minimum/maximum stent diameter within the entire stent], stent eccentricity [smallest minimum/maximum stent diameter at a single slice within the stent], IVUS-XPL [Impact of intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions] criteria, ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions] criteria, and ILUMIEN IV criteria) were evaluated for their associations with lesion-specific 2-year clinically driven target lesion revascularization (TLR) or definite stent thrombosis., Results: Overall, 2,140 lesions in 1,831 patients were included; final MSA measured 6.2 ± 2.4 mm 2 . Among the 10 stent expansion indexes, only MSA/vessel area at the MSA site was independently associated with 2-year clinically driven TLR or definite stent thrombosis (hazard ratio: 0.77; 95% confidence interval: 0.59-0.99; P = 0.04) after adjusting for morphologic and procedural parameters., Conclusions: In this IVUS-guided PCI cohort with excellent final MSA overall, stent/vessel area at the MSA site, an index of relative stent expansion, was superior to absolute MSA and other expansion indexes in predicting 2-year clinically driven TLR or definite stent thrombosis., Competing Interests: Funding Support and Author Disclosures The ADAPT-DES study was sponsored by the Cardiovascular Research Foundation, with funding provided by Boston Scientific, Abbott Vascular, Medtronic, Cordis, Biosensors, The Medicines Company, Daiichi-Sankyo, Eli Lilly, Volcano, and Accumetrics. Dr Matsumura is a consultant for Terumo. Dr. Metzger has received symposium honoraria from Abbott Vascular and Boston Scientific. Dr Rinaldi is an advisory board member for Abbott, Boston Scientific, Cordis, and 4C Medical; has taught courses for Abbott and Edwards Lifesciences; is a consultant for Abbott, Boston Scientific, Edwards Lifesciences, and Cordis; and has received research and grant support from Boston Scientific. Dr Duffy is a consultant and speaker for Philips Medical/Volcano. Dr Weisz has received consulting fees from Filterlex, Intratech, and Magenta; holds stock options in Filterlex, Intratech, Magenta, Medivizer, Trisol, and Vectorious; and has received honoraria from Cardiovascular Systems. Dr Stuckey is an advisory board member for Boston Scientific; and has received speaker honoraria from Boston Scientific and Eli Lilly/Daiichi-Sankyo. Dr Ali has received institutional research grants to Columbia University from Abbott, Cardiovascular Systems; is a consultant for Amgen, AstraZeneca, and Boston Scientific; and holds equity in Shockwave Medical. Dr. Mintz has received honoraria from Boston Scientific, Philips, Terumo, and Medtronic. Dr Stone has received speaker or other honoraria from Cook, Terumo, Qool Therapeutics, and Orchestra Biomed; is a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, CardioMech; and holds equity or options in Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, the MedFocus family of funds, and Valfix. Dr Maehara has received grant support from and is a consultant for Abbott Vascular and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL)., Background: The clinical outcomes of IVL to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in 4 prospective studies (Disrupt CAD I [NCT02650128], Disrupt CAD II [NCT03328949], Disrupt CAD III [NCT03595176], and Disrupt CAD IV [NCT04151628])., Methods: Patient data were pooled from the Disrupt CAD studies, which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from major adverse cardiovascular events (composite of cardiac death, all myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis ≤30% by quantitative coronary angiography without in-hospital major adverse cardiovascular events. Secondary outcomes included serious angiographic complications, target lesion failure, cardiac death, and stent thrombosis at 30 days., Results: Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 ± 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of target lesion failure, cardiac death, and stent thrombosis were 7.2%, 0.5%, and 0.8%. Rates of post-IVL and final serious angiographic complications were 2.1% and 0.3%, with no IVL-associated perforations, abrupt closure, or episodes of no reflow., Conclusions: In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success., Competing Interests: Funding Support and Author Disclosures Dr. Kereiakes is a consultant for SINO Medical Sciences Technologies, Boston Scientific, Elixir Medical, Svelte Medical Systems, Caliber Therapeutics/Orchestra BioMed, and Shockwave Medical; and is a stockholder in Ablative Solutions. Dr. Riley has received honoraria from Boston Scientific, Asahi Intecc, and Medtronic. Dr. Di Mario has received research grants from Amgen, Behring, Chiesi, Daiichi-Sanyo, Edwards Lifesciences, Medtronic, Shockwave, and Volcano Philips. Dr. Shlofmitz is a speaker for Shockwave Medical. Dr. Saito is a consultant for Terumo and Japan Lifeline. Dr. Ali has received grants from the National Heart, Lung, and Blood Institute, Abbott Vascular, and Cardiovascular Systems; has received personal fees from Amgen, AstraZeneca, and Boston Scientific; and holds equity in Shockwave Medical. Dr. Price has received consulting and speaker honoraria from Abbott Vascular, Boston Scientific, Biosense Webster, Medtronic, Shockwave Medical, and W.L. Gore. Dr. Hill has received fees and grant support from Abbott Vascular, Boston Scientific, Abiomed, and Shockwave Medical; and is a stockholder in Shockwave Medical. Dr. Stone has received speaker honoraria from Cook Medical and Terumo; is a consultant for Valfix Medical, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, and CardioMech; and has equity and options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, the BioStar family of funds, SpectraWave, Orchestra BioMed, Aria, Cardiac Success, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

A significant proportion of lesions treated with transcatheter interventions in the coronary and peripheral vascular beds exhibit moderate to severe calcific plaques known to portend lower procedural success rates, increased peri-procedural adverse events, and unfavorable clinical outcomes compared with noncalcific plaques. Adapted from lithotripsy technology used for treatment of ureterorenal calculi, intravascular lithotripsy (IVL) is a novel technique for the treatment of severely calcific plaque lesions that uses acoustic shockwaves in a balloon-based delivery system. Shockwaves induce calcium fractures, which facilitate stent expansion and luminal gain. In this review, the authors summarize the physics, preclinical and clinical data on IVL use in the coronary and peripheral vasculature, and future directions of IVL in transcatheter cardiovascular therapies., Competing Interests: Funding Support and Author Disclosures Dr. Kereiakes is a consultant for SINO Medical Sciences Technologies, Boston Scientific, Elixir Medical, Svelte Medical Systems, Caliber Therapeutics/Orchestra Biomed, and Shockwave Medical; and is a stockholder in Ablative Solutions. Dr. Virmani has received grant, research, and clinical trial support from the National Institutes of Health, the Leducq Foundation, 480 Biomedical, 4C Medical, 4Tech, Abbott, Accumedical, Amgen, Biosensors, Boston Scientific, Canon USA, Cardiac Implants, Celonova, Claret Medical, Concept Medical, Cook, CSI, DuNing, Edwards Lifesciences, Emboline, Endotronix, Envision Scientific, Lutonix/Bard, Gateway, Lifetech, Limflo, MedAlliance, Medtronic, Mercator, Merrill, Microport Medical, Microvention, Mitralign, MitrAssist, NAMSA, Nanova, Neovasc, NIPRO, Novogate, Occulotech, OrbusNeich Medical, Phenox, Profusa, Protembis, Qool, ReCor Medical, Senseonics, Shockwave, Sinomed, Spectranetics, Surmodies, Terumo, Vesper, W.L. Gore, and Xeltis; and is a consultant for Abbott Vascular, Boston Scientific, Celenova, Cook Medical, CSI, Edwards Lifesciences, Bard BD, Medtronic, OrbusNeich Medical, ReCor Medical, SinoMedical Technology, Surmodics, Terumo, W.L. Gore, and Xeltis. Dr. Hokama is an employee of Shockwave Medical. Dr. Illindala is an employee of Shockwave Medical. Dr. Mena-Hurtado is a consultant for Abbott, Boston Scientific, Cook, Medtronic, Cardinal Health, and Optum Labs. Dr. Holden is a clinical investigator and medical advisory board member for Shockwave Medical. Dr. Hill reports fees and grant support from Abbott Vascular, Boston Scientific, Abiomed, and Shockwave Medical; and is a stockholder in Shockwave Medical. Dr. Lyden is a consultant to Boston Scientific, Abbott, Medtronic, Shockwave Medical, PQ Bypass, Intact, and Penumbra. Dr. Ali has received grants from the National Institutes of Health/National Heart, Lung, and Blood Institute, Abbott Vascular, and Cardiovascular Systems; has received personal fees from Amgen, AstraZeneca, and Boston Scientific; and holds equity in Shockwave Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the long-term impact of coronary artery calcification (CAC) on outcomes after percutaneous coronary intervention and the respective performance of first- and second-generation drug-eluting stents (DES)., Background: Whether contemporary DES have improved the long-term prognosis after percutaneous coronary intervention in lesions with severe CAC is unknown., Methods: Individual patient data were pooled from 18 randomized trials evaluating DES, categorized according to the presence of angiography core laboratory-confirmed moderate or severe CAC. Major endpoints were the patient-oriented composite endpoint (death, myocardial infarction [MI], or any revascularization) and the device-oriented composite endpoint of target lesion failure (cardiac death, target vessel MI, or ischemia-driven target lesion revascularization). Multivariate Cox proportional regression with study as a random effect was used to assess 5-year outcomes., Results: A total of 19,833 patients were included. Moderate or severe CAC was present in 1 or more target lesions in 6,211 patients (31.3%) and was associated with increased 5-year risk for the patient-oriented composite endpoint (adjusted hazard ratio [adjHR]: 1.12; 95% confidence interval [CI]: 1.05 to 1.20) and target lesion failure (adjHR: 1.21; 95% CI: 1.09 to 1.34), as well as death, MI, and ischemia-driven target lesion revascularization. In patients with CAC, use of second-generation DES compared with first-generation DES was associated with reductions in the 5-year risk for the patient-oriented composite endpoint (adjHR: 0.88; 95% CI: 0.78 to 1.00) and target lesion failure (adjHR: 0.73; 95% CI: 0.61 to 0.87), as well as death or MI, ischemia-driven target lesion revascularization, and stent thrombosis. The relative treatment effects of second-generation compared with first-generation DES were consistent in patients with and without moderate or severe CAC, although outcomes were consistently better with contemporary devices., Conclusions: In this large-scale study, percutaneous coronary intervention of target lesion moderate or severe CAC was associated with adverse patient-oriented and device-oriented adverse outcomes at 5 years. These detrimental effects were mitigated with second-generation DES., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to examine the use of saphenous vein grafts (SVGs) for retrograde crossing during chronic total occlusion (CTO) percutaneous coronary intervention (PCI)., Background: The use of SVGs for retrograde crossing during CTO PCI has received limited study., Methods: A total of 1,615 retrograde CTO PCIs performed between 2012 and 2019 at 25 centers were examined. Clinical, angiographic, and technical characteristics and procedural outcomes were compared among retrograde cases via SVGs (SVG group) versus other collateral vessels (non-SVG group)., Results: Retrograde CTO PCI via SVGs was performed in 189 cases (12%). Patients in the SVG group were older (mean age 70 ± 9 years vs. 64 ± 10 years; p < 0.01) and had higher rates of prior myocardial infarction (62% vs. 51%; p < 0.01) and prior PCI (81% vs. 70%; p < 0.01). They were more likely to have moderate or severe calcification (81% vs. 65%; p < 0.01) and moderate or severe tortuosity (53% vs. 44%; p = 0.02) and had similar J-CTO (Multicenter CTO Registry in Japan) scores (3.2 ± 1.0 vs. 3.1 ± 1.1; p = 0.13) but higher PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores (4.7 ± 1.7 vs. 3.1 ± 1.1; p < 0.01). Technical (85% vs. 78%; p = 0.04) and procedural (81% vs. 74%; p = 0.04) success rates were higher in the SVG group, with no difference in in-hospital major adverse events (6.4% vs. 4.4%; p = 0.22). Contrast volume was lower in the SVG group (225 ml [173 to 325 ml] vs. 292 ml [202 to 400 ml]; p < 0.01)., Conclusions: Use of SVGs for retrograde crossing is associated with higher rates of technical and procedural success and similar rates of in-hospital major adverse cardiac events compared with retrograde CTO PCI via other collateral vessels., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

Objectives: This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI)., Background: Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant., Methods: DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR <0.90. The causes of impaired iFR were categorized as stent related, untreated proximal or distal focal stenosis, or diffuse atherosclerosis., Results: An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR., Conclusions: Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study examined the frequency and outcomes of radial access for chronic total occlusion (CTO) percutaneous coronary intervention (PCI)., Background: Radial access improves the safety of PCI, but its role in CTO PCI remains controversial., Methods: We compared the clinical, angiographic, and procedural characteristics of 3,790 CTO interventions performed between 2012 and 2018 via radial-only access (RA) (n = 747) radial-femoral access (RFA) (n = 844) and femoral-only access (n = 2,199) access at 23 centers in the United States, Europe, and Russia., Results: Patients' mean age was 65 ± 10 years, and 85% were men. Transradial access (RA and RFA) was used in 42% of CTO interventions and significantly increased over time from 11% in 2012 to 67% in 2018 (p < 0.001). RA patients were younger (age 62 ± 10 years vs. 64 ± 10 years and 65 ± 10 years; p < 0.001), less likely to have undergone prior coronary artery bypass graft surgery (18% vs. 39% and 35%; p < 0.001), and less likely to have undergone prior PCI (60% vs. 63% and 66%; p = 0.005) compared with those who underwent RFA and femoral-only access PCI. RA CTO PCI lesions had lower J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 1.4 vs. 2.6 ± 1.3 and 2.5 ± 1.3; p < 0.001) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) complication (2.3 ± 1.9 vs. 3.2 ± 2.0 and 3.2 ± 1.9; p < 0.001) scores. The mean sheath size was significantly smaller in the RA group (6.6 ± 0.7 vs. 7.0 ± 0.6 and 7.3 ± 0.8; p < 0.0001), although it increased with lesion complexity. Antegrade dissection re-entry (20% vs. 33% and 32%; p < 0.001) was less commonly used with RA, whereas use of retrograde techniques was highest with RFA (47%). The overall rates of technical success (89% vs. 88% vs. 86%; p = 0.061), procedural success (86% vs. 85% vs. 85%; p = 0.528), and in-hospital major complication (2.47% vs. 3.40% vs. 2.18%; p = 0.830) were similar in all 3 groups, whereas major bleeding was lower in the RA group (0.55% vs. 1.94% and 0.88%; p = 0.013)., Conclusions: Transradial access is increasingly being used for CTO PCI and is associated with similar technical and procedural success and lower major bleeding rates compared with femoral-only access interventions. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine the techniques and outcomes of hybrid chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a diverse group of patients and operators on 2 continents., Background: CTO PCI has been evolving with constant improvement of equipment and techniques., Methods: Contemporary outcomes of CTO PCI were examined by analyzing the clinical, angiographic, and procedural characteristics of 3,122 CTO interventions performed in 3,055 patients at 20 centers in the United States, Europe, and Russia., Results: The mean age was 65 ± 10 years, and 85% of the patients were men, with high prevalence of diabetes (43%), prior myocardial infarction (46%), prior coronary artery bypass graft surgery (33%), and prior PCI (65%). The CTO target vessels were the right coronary artery (55%), left anterior descending coronary artery (24%), and left circumflex coronary artery (20%). The mean J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores were 2.4 ± 1.3 and 1.3 ± 1.0, respectively. The overall technical and procedural success rate was 87% and 85%, respectively, and the rate of in-hospital major complications was 3.0%. The final successful crossing strategy was antegrade wire escalation in 52.0%, retrograde in 27.1%, and antegrade dissection re-entry in 20.9%; >1 crossing strategy was required in 40.9%. Median contrast volume, air kerma radiation dose, and procedure and fluoroscopy time were 270 ml (interquartile range: 200 to 360 ml), 2.9 Gy (interquartile range: 1.7 to 4.7 Gy), 123 min (interquartile range: 81 to 188 min) and 47 min (interquartile range: 29 to 77 min), respectively., Conclusions: CTO PCI is currently being performed with high success and acceptable complication rates among various experienced centers in the United States, Europe, and Russia. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436)., (Copyright © 2018 American College of Cardiology Foundation. All rights reserved.)

The advent of intravascular imaging has been a significant advancement in visualization of coronary arteries, particularly with optical coherence tomography (OCT) that allows for high-resolution imaging of intraluminal and transmural coronary structures. Accumulating data support a clinical role for OCT in a multitude of clinical scenarios, including assessing the natural history of atherosclerosis and modulating effects of therapies, mechanisms of acute coronary syndromes, mechanistic insights into the effects of novel interventional devices, and optimization of percutaneous coronary intervention. In this state-of-the-art review, we provide an overview of the published data on the clinical utility of OCT, highlighting the areas that need further investigation and the current barriers for further adoption of OCT in interventional cardiology practice., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Using intravascular ultrasound (IVUS), the authors compared outcomes by observed wire position (intraplaque vs. subintimal) achieved during successful chronic total occlusion (CTO) lesion treatment., Background: Recent successes in CTO percutaneous coronary intervention (PCI) have used both intraluminal and subintimal wire tracking to improve procedural success. IVUS may be used to determine the course of wire tracking after crossing a CTO., Methods: From March 2014 to March 2016, data were collected into a single-center database from 219 patients undergoing CTO PCI with concomitant IVUS imaging. IVUS-visualized wire tracking patterns were then retrospectively examined. Clinical outcomes with a composite in-hospital cardiovascular endpoint of all-cause death, periprocedural myocardial infarction, and in-hospital target lesion revascularization were analyzed along with IVUS-detected vascular injury., Results: Of the 524 lesions assessed, 219 patients with successfully recanalized CTO lesions had adequate IVUS imaging and were included. Subintimal tracking was detected in 52.1% of overall cases (86.7% dissection re-entry, 27.9% wire escalation). Minimal stent area of the CTO segment and prevalence of significant edge dissection were similar in the 2 groups. In the subintimal tracking group, there was a higher rate of the composite endpoint, mostly driven by periprocedural myocardial infarction. Subintimal tracking was associated with significantly greater IVUS-detected vascular injury, angiographic dye staining/extravasation, and branch occlusion., Conclusions: IVUS-detected subintimal tracking is observed in approximately one-half of all successful CTO PCI cases and is associated with an expected higher, yet acceptable, event rate with no difference in minimal stent area or edge dissection among patients undergoing contemporary hybrid CTO PCI., (Copyright © 2017. Published by Elsevier Inc.)