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Gro Egholm,1,2,* Morten Madsen,2,* Troels Thim,1 Morten Schmidt,2,3 Evald Høj Christiansen,1 Hans Erik Bøtker,1 Michael Maeng1 1Department of Cardiology, 2Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, 3Department of Internal Medicine, Regional Hospital of Randers, Denmark *These authors contributed equally to this work Background: Registry-based monitoring of the safety and efficacy of interventions in patients with ischemic heart disease requires validated algorithms.Objective: We aimed to evaluate algorithms to identify acute myocardial infarction (AMI) in the Danish National Patient Registry following percutaneous coronary intervention (PCI).Methods: Patients enrolled in clinical drug-eluting stent studies at the Department of Cardiology, Aarhus University Hospital, Denmark, from January 2006 to August 2012 were included. These patients were evaluated for ischemic events, including AMI, during follow-up using an end point committee adjudication of AMI as reference standard.Results: Of 5,719 included patients, 285 patients suffered AMI within a mean follow-up time of 3 years after stent implantation. An AMI discharge diagnosis (primary or secondary) from any acute or elective admission had a sensitivity of 95%, a specificity of 93%, and a positive predictive value of 42%. Restriction to acute admissions decreased the sensitivity to 94% but increased the specificity to 98% and the positive predictive value to 73%. Further restriction to include only AMI as primary diagnosis from acute admissions decreased the sensitivity further to 82%, but increased the specificity to 99% and the positive predictive value to 81%. Restriction to patients admitted to hospitals with a coronary angiography catheterization laboratory increased the positive predictive value to 87%.Conclusion: Algorithms utilizing additional information from the Danish National Patient Registry yield different sensitivities, specificities, and predictive values in registry-based detection of AMI following PCI. We were able to identify AMI following PCI with moderate-to-high validity. However, the choice of algorithm will depend on the specific study purpose. Keywords: Danish National Patient Registry, registry, percutaneous coronary intervention, validity, sensitivity, specificity

Leif Thuesen,1 Lisette Okkels Jensen,2 Hans Henrik Tilsted,3 Michael Mæng,1 Christian Terkelsen,1 Per Thayssen,2 Jan Ravkilde,3 Evald Høj Christiansen,1 Hans Erik Bøtker,1 Morten Madsen,4 Jens F Lassen1 1Department of Cardiology, Aarhus University Hospital, Skejby, Denmark; 2Department of Cardiology, Odense University Hospital, Odense, Denmark; 3Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark; 4Department of Clinical Epidemiology, Aarhus University Hospital, Skejby, Denmark Aim: To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials. Background: Randomized clinical trials often focus on short-term efficacy and safety in a controlled environment. Trial follow-up may be linked with study-related investigations and differ from routine clinical practice. Because treatment and control in randomized trials differ from daily practice, trial results may have reduced general applicability and may be of limited value in clinical decision-making. Further, it is economically very costly to conduct randomized clinical trials. Methods and results: Population-based health care databases collect data continuously and prospectively, and make it possible to monitor lifelong outcomes of cardiac interventions in large numbers of patients. This strengthens external validity by eliminating the effects of study-related monitoring or diagnostic tests. Further, follow-up data can be obtained at low expense. Importantly, data sources encompassing a complete population are likely to reflect clinical practice. Because population-based health care databases collect data for quality-control and administrative purposes unrelated to scientific investigations, certain biases, such as nonresponse bias, recall bias, and bias from losses to follow-up, can be avoided. Conclusion: Event detection using population-based health care databases is a new research tool in interventional cardiology that may allow large, low-cost, randomized clinical trials to reflect daily clinical practice, covering a broad range of patients and end points with complete lifelong follow-up. Keywords: clinical study, national registries, event detection, PCI, coronary stents

A 70-year-old male with a prior coronary artery bypass operation presented with increasing episodes of chest pain. Coronary angiography revealed severe disease of the left anterior descending artery (LAD), CX, and RCA. A left internal mammary artery to LAD was patent. A jump venous graft, with four distal anastomoses, had two significant stenoses. Percutaneous coronary intervention with distal protection, and direct stenting with a drug-eluting stent, was planned. A 3.00 x 16 mm TaxusExpress (Boston Scientific) was used. At an inflation pressure of 10 atm the stent balloon seemed to extend 20 mm proximally with a diameter of 4.5 mm, and the balloon ruptured. Angiography showed rupture of the vessel proximal to the implanted stent, and the patient developed severe hypotension. The rupture was treated with a covered stent and pericardiocentesis was performed with evacuation of 600 mL blood. However, it was not possible to resuscitate the patient, who died due to severe pump failure and incessant ventricular fibrillation. [ABSTRACT FROM AUTHOR]

The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients with diabetes with coronary artery disease were randomized to Cypher (n = 76) or Taxus (n = 77) stent implantation. All patients were followed for 8 months. The primary end point was 8-month angiographic in-stent late luminal loss. This primary end point was reduced in the Cypher group compared with the Taxus group (0.23 +/- 0.54 vs 0.44 +/- 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel-eluting Taxus stent. [ABSTRACT FROM AUTHOR]

Background: The benefit of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease and severe aortic stenosis who are undergoing transcatheter aortic-valve implantation (TAVI) remains unclear., Methods: In an international trial, we randomly assigned, in a 1:1 ratio, patients with severe symptomatic aortic stenosis and at least one coronary-artery stenosis with a fractional flow reserve of 0.80 or less or a diameter stenosis of at least 90% either to undergo PCI or to receive conservative treatment, with all patients also undergoing TAVI. The primary end point was a major adverse cardiac event, defined as a composite of death from any cause, myocardial infarction, or urgent revascularization. Safety, including bleeding events and procedural complications, was assessed., Results: A total of 455 patients underwent randomization: 227 to the PCI group and 228 to the conservative-treatment group. The median age of the patients was 82 years (interquartile range, 78 to 85), and the median Society of Thoracic Surgeons-Predicted Risk of Mortality score (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after the procedure) was 3% (interquartile range, 2 to 4). At a median follow-up of 2 years (interquartile range, 1 to 4), a major adverse cardiac event (primary end point) had occurred in 60 patients (26%) in the PCI group and in 81 (36%) in the conservative-treatment group (hazard ratio, 0.71; 95% confidence interval [CI], 0.51 to 0.99; P = 0.04). A bleeding event occurred in 64 patients (28%) in the PCI group and in 45 (20%) in the conservative-treatment group (hazard ratio, 1.51; 95% CI, 1.03 to 2.22). In the PCI group, 7 patients (3%) had PCI procedure-related complications., Conclusions: Among patients with coronary artery disease who were undergoing TAVI, PCI was associated with a lower risk of a composite of death from any cause, myocardial infarction, or urgent revascularization at a median follow-up of 2 years than conservative treatment. (Funded by Boston Scientific and the Danish Heart Foundation; NOTION-3 ClinicalTrials.gov number, NCT03058627.)., (Copyright © 2024 Massachusetts Medical Society.)

Successful percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in the coronary arteries in the left anterior descending (LAD) artery is associated with better outcome than unsuccessful PCI. Randomized data have not found invasive treatment of non-CTO LAD lesion to be associated with better outcome. This study aimed to investigate the prognostic impact of CTO revascularization stratified on target treated vessel compared with non-CTO LAD PCI. The hypothesis was that successful PCI of LAD CTO and non-LAD CTO and unsuccessful non-LAD CTO were associated with the same prognosis as non-CTO LAD lesions, whereas patients with unsuccessful LAD CTO were associated with a poorer prognosis. The study was a population-based cohort study, including consecutive patients who underwent PCI from 2009 to 2019 in the Central Denmark Region. Patients with acute myocardial infarction within 30 days were excluded. Patients with CTO were stratified by occluded vessel and procedural success. The primary end point was long-term all-cause mortality and was calculated as a hazard ratio with a 95% confidence interval. Secondary end points were myocardial infarction and target vessel revascularization. In total, 21,141 patients were screened, 4,518 had non-CTO LAD PCI, and 1,475 had CTO PCI. The median (interquartile range) follow-up was 5.8 years (3.6 to 8.8). In the successful CTO groups, the adjusted risk for all-cause mortality was equal to patients with non-CTO LAD (LAD CTO hazard ratio [95% confidence interval] 1.14 [0.90 to 1.44], non-LAD CTO 1.09 [0.95 to 1.27]). Patients with unsuccessful LAD CTO had a higher risk than patients with non-CTO LAD, whereas unsuccessful non-LAD CTO had not (unsuccessful LAD 1.88 [1.33 to 2.65], unsuccessful non-LAD 1.26 [0.97 to 1.63]). In conclusion, successful LAD and non-LAD CTO PCI had the same prognosis as non-CTO LAD PCI, whereas only unsuccessful LAD CTO PCI had a poorer prognosis. Patients with LAD CTO are a high-risk population, and dedicated CTO trials are needed to confirm this finding and establish guideline recommendations., Competing Interests: Declaration of competing interest Dr. Holck received institutional funds from Asahi Corp., Phillips Corp. and Orbus Neich Corp. EHC received institutional funds from Asahi Corp., Phillips Corp., Abbott Vascular, and Orbus Neich Corp. The remaining authors have no competing interests to declare., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Fractional flow reserve (FFR) or non-hyperaemic pressure ratios are recommended to assess functional relevance of intermediate coronary stenosis. Both diagnostic methods require the placement of a pressure wire in the coronary artery during invasive coronary angiography. Quantitative flow ratio (QFR) is an angiography-based computational method for the estimation of FFR that does not require the use of pressure wires. We aimed to investigate whether a QFR-based diagnostic strategy yields a non-inferior 12-month clinical outcome compared with an FFR-based strategy., Methods: FAVOR III Europe was a multicentre, randomised, open-label, non-inferiority trial comparing a QFR-based with an FFR-based diagnostic strategy for patients with intermediate coronary stenosis. Enrolment was performed in 34 centres across 11 European countries. Patients aged 18 years or older with either chronic coronary syndrome or stabilised acute coronary syndrome, and with at least one intermediate non-culprit stenosis (40-90% diameter stenosis by visual estimate; referred to here as a study lesion), were randomly assigned (1:1) to the QFR-guided or the FFR-guided group. Randomisation was done using a concealed web-based system and was stratified by diabetes and presence of a left anterior descending coronary artery study lesion. The primary endpoint was a composite of death, myocardial infarction, and unplanned revascularisation at 12 months. The predefined non-inferiority margin was 3·4% and the primary analysis was performed in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03729739) and long-term follow-up is ongoing., Findings: Between Nov 6, 2018, and July 21, 2023, 2000 patients were enrolled and randomly assigned to the QFR-guided strategy (1008 patients) or the FFR-guided strategy (992 patients). The median age was 67·3 years (IQR 59·9-74·7); 1538 (76·9%) patients were male and 462 (23·1%) were female. Median follow-up time was 365 days (IQR 365-365). At 12 months, a primary endpoint event had occurred in 67 (6·7%) patients in the QFR group, and in 41 (4·2%) patients in the FFR group (hazard ratio 1·63 [95% CI 1·11-2·41]). The event proportion difference was 2·5% (90% two-sided CI 0·9-4·2). The upper limit of the 90% CI exceeded the prespecified non-inferiority margin of 3·4%. Therefore, QFR did not meet non-inferiority to FFR. A total of 18 (1·8%) patients in each group experienced an adverse procedural event, the most frequent being procedure-related myocardial infarction, which occurred in ten (1·0%) patients in the QFR group and seven (0·7%) in the FFR group. One patient in the QFR group died in relation to the index procedure., Interpretation: The results of the FAVOR III Europe trial do not support the use of QFR if FFR is available to guide revascularisation decisions in patients with intermediate coronary stenosis. This finding could have implications for current clinical guidelines recommending QFR for this purpose., Funding: Medis Medical Imaging Systems and Aarhus University., Competing Interests: Declaration of interests BKA reports an institutional research grant from Medis Medical Imaging and free licences for the QFR application from Medis Medical Imaging during the trial. GCam reports institutional research grants from SMT, Medis Medical Imaging, Abbott Vascular, GADA, Siemens, and GE Healthcare outside the present work. TR reports consultant and proctoring honoraria from Boston Scientific, EPS Vascular, and Cardirad. BES is supported by the H H Sheikh Khalifa bin Hamad Al-Thani Research Programme; has received research grants to the institution from Boston Scientific, the B Braun Foundation, the German Center for Cardiovascular Research (DZHK), the German Heart Research Foundation, Edwards Lifesciences, the Iten-Kohaut Foundation, and the OPO Foundation; has received consulting and speaker fees from Abbott Vascular, Abiomed, and Boston Scientific; and received free licences for the QFR application from Medis Medical Imaging during the trial. LDS reports consulting fees from Abbott Vascular, Boston Scientific, and Philips outside the submitted work. JE reports serving as a speaker or advisory board member for Abbott, Boston Scientific, Medis Medical Imaging, and Philips. RL-P received a free licence for the QFR software from Medis Medical Imaging during the trial. UL reports research grants to the institution from Abbott, Amgen, Bayer, and Novartis. RSD reports an institutional research grant from Medis Medical Imaging and free licences for the QFR application from Medis Medical Imaging during the trial. HM-R reports consultancy fees from Medis Medical Imaging and speaker fees from Philips and Abbott. LK received free licences for the QFR application from Medis Medical Imaging during the trial. JA reports teaching grants from Biotronik and Medis Medical Imaging. YSA reports consulting fees from Boston Scientific and Shockwave. TL served as a Medis technical and research support consultant in Haga Hospital (The Hague, Netherlands) and performed beta testing of software from Medis Medical Imaging, neither of which was study related, and received a free licence for the QFR application from Medis Medical Imaging during the trial. KL received free licences for the QFR application from Medis Medical Imaging during the trial; speaker fees and travel support from BMS and Boston Scientific; speaker fees from DGK; and served as an advisory board member for BMS. GCas received a free licence for the QFR application from Medis Medical Imaging during the trial. SB reports institutional research grants from Medis Medical Imaging, SMT, Abbott, Siemens, Insight Lifetech, and Amgen; free licences for the QFR application from Medis Medical Imaging during the trial; speaker's fee from SMT, Medis Medical Imaging, Abbott, and Siemens; and advisory board activities for Siemens. NTO reports institutional research grants from Abbott and from Shockwave. RS reports an institutional research grant from Abbott; institutional research contract with Medis Medical Imaging; and speaker and consultation fees from Abbott and Fondazione Menarini. EHC reports institutional research grants from Abbott, Biosensors, Meril, and Medis Medical Imaging; and speaker fees from Abbott and EPS. NRH reports Institutional research grants from Abbott, B Braun, Biosensors, Boston Scientific, and Medis Medical Imaging; and speaker fees from Abbott and EPS. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background: The CTO-ARC (Chronic Total Occlusion Academic Research Consortium) recognized that a nonstandardized definition of chronic total occlusion (CTO) percutaneous coronary intervention approaches can bias the complications' attribution to each crossing strategy., Objectives: The study sought to describe the numbers, efficacy, and safety of each final CTO crossing strategy according to CTO-ARC recommendations., Methods: In this cross-sectional study, data were retrieved from the European Registry of Chronic Total Occlusions between 2021 and 2022., Results: Out of 8,673 patients, antegrade and retrograde approach were performed in 79.2% and 20.8% of cases, respectively. The antegrade approach included antegrade wiring and antegrade dissection and re-entry, both performed with or without retrograde contribution (antegrade wiring without retrograde contribution: n = 5,929 [68.4%]; antegrade wiring with retrograde contribution: n = 446 [5.1%]; antegrade dissection and re-entry without retrograde contribution: n = 353 [4.1%]; antegrade dissection and re-entry with retrograde contribution: n = 137 [1.6%]). The retrograde approach included retrograde wiring (n = 735 [8.4%]) and retrograde dissection and re-entry (n = 1,073 [12.4%]). Alternative antegrade crossing was associated with lower technical success (70% vs 86% vs 93.1%, respectively; P < 0.001) and higher complication rates (4.6% vs 2.9% vs 1%, respectively; P < 0.001) as compared with retrograde and true antegrade crossing. However, alternative antegrade crossing was applied mostly as a rescue strategy (96.1%)., Conclusions: The application of CTO-ARC definitions allowed the reclassification of 6.7% of procedures as alternative antegrade crossing with retrograde or antegrade contribution which showed higher MACCE and lower technical success rates, as compared with true antegrade and retrograde crossing., Competing Interests: Funding Support and Author Disclosures Dr Bufe has received speaker honoraria from Biotronik and Shockwave Medical. Dr Pyxaras has received consulting/speaker/proctorship honoraria from Abiomed, AstraZeneca, Asahi Intecc, Biotronik, Boston Scientific, and Terumo. Dr Ladwiniec has received consulting/speaker/proctoring honoraria from Abbott, Biotronik, Boston Scientific, Cordis, Shockwave Medical, and SMT. Dr Werner has received speaker honoraria from Abbott, Asahi Intecc, OrbusNeich, Philips, Siemens, and Terumo. Dr Mashayekhi has received consulting/speaker/proctoring honoraria from Abbott, Abiomed, Asahi Intecc, AstraZeneca, Biotronik, Boston Scientific, Cardinal Health, Daiichi-Sankyo, Medtronic, OrbusNeich, Shockwave Medical, Teleflex, and Terumo. Dr Ayoub has received consultant/proctor honoraria from Boston Scientific, Teleflex, Asahi Intecc, Cordis, Terumo, and SIS Medical. Dr Goktekin has received consulting/speaker/proctoring honoraria from Boston Scientific, Medtronik, MicroPort, and Asahi Inc. Dr Agostoni has received consulting honoraria from Abbott, Boston Scientific, Cordis, iVascular, Medtronic, Neovasc, Seven Sons, Teleflex, and Terumo. Dr Diletti has received consultant/proctoring honoraria from Asahi Intecc, Terumo, IMDS, Boston Scientific, Teleflex, and Philips. Dr Rathore has received honoraria for speaker and proctoring from Abbott Vascular and Translumina Therapeutics. Dr Bozinovic has served as a speaker or proctor and/or received honoraria from Orbus Neich and Medtronic. Dr Galassi has received consulting/speaker honoraria from Asahi Intecc and Ivascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

In-stent restenosis (ISR) still occurs after percutaneous coronary intervention (PCI). Few studies have compared the outcomes of PCI for de novo stenosis with those of PCI for ISR, and the results are conflicting. The present study aimed to conduct this comparison. Using patient-level data from the randomized all-comer SORT OUT studies III to X, we included all patients with previous PCI and either an ISR or a de novo lesion as the study target lesion. Outcomes of interest were major adverse cardiac events (MACE) and target lesion revascularization (TLR) after 5 years. Of the 2,928 patients with a previous PCI included in the SORT OUT studies, 491 (17%) were treated for ISR and 2,437 (83%) for a de novo stenosis. Baseline characteristics did not differ significantly. At 5 years, MACE occurred in 148 patients (32%) in the ISR group and 654 patients (28%) in the de novo stenosis group (crude and adjusted hazard ratio 1.16 [95% confidence interval (CI) 0.97 to 1.38] and 1.16 [95% CI 0.97 to 1.38]). The risk of TLR was higher in the ISR group compared with the de novo stenosis group (crude and adjusted hazard ratio 1.64 [95% CI 1.24 to 2.17] and 1.71 [95% CI 1.27 to 2.30]). In conclusion, the risk of MACE was similar between PCI for ISR and PCI for de novo lesions after 5 years. However, the risk of TLR was higher in the ISR group compared with the de novo stenosis group., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background and Aims: Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤75 years of age, including both tricuspid and bicuspid AS., Methods: The Nordic Aortic Valve Intervention (NOTION)-2 trial enrolled and 1:1 randomized low-risk patients aged ≤75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke, or rehospitalization (related to the procedure, valve, or heart failure) at 12 months., Results: A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group [absolute risk difference 3.1%; 95% confidence interval (CI), -2.7% to 8.8%; hazard ratio (HR) 1.4; 95% CI, 0.7-2.9; P = .3]. Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation, and moderate or greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0; 95% CI, 0.5-2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8; 95% CI, 0.8-18.5) treated with TAVI or surgery, respectively (P for interaction = .1)., Conclusions: Among low-risk patients aged ≤75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at 1 year was similar between TAVI and surgery. Transcatheter aortic valve implantation outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134)., Trial Registration Number: ClinicalTrials.gov NCT02825134., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Selection for invasive angiography is recommended to be based on pretest probabilities (PTPs), and physiological measures of hemodynamical impairment by, for example, fractional flow reserve (FFR) should guide revascularization. The risk factor-weighted clinical likelihood (RF-CL) and coronary artery calcium score-weighted clinical likelihood (CACS-CL) models show superior discrimination of patients with suspected obstructive coronary artery disease (CAD), but validation against hemodynamic impairment is warranted., Objectives: The aim of this study was to validate the RF-CL and CACS-CL models against hemodynamically obstructive CAD., Methods: Stable de novo chest pain patients (N = 4,371) underwent coronary computed tomography angiography and subsequently invasive coronary angiography with FFR measurements. Hemodynamically obstructive CAD was defined as invasive FFR ≤0.80 or high-grade stenosis by visual assessment (>90% diameter stenosis). For comparison, a guideline-endorsed basic PTP model was calculated based on age, sex, and symptom typicality. The RF-CL model additionally included the number of risk factors, and the CACS-CL model incorporated the coronary artery calcium score into the RF-CL., Results: In total, 447 of 4,371 (10.9%) patients had hemodynamically obstructive CAD. Both the RF-CL and CACS-CL models classified more patients with a very low clinical likelihood (≤5%) of obstructive CAD compared to the basic PTP model (33.0% and 53.7% vs 12.0%; P < 0.001) with a preserved low prevalence of hemodynamically obstructive CAD (<5% for all models). Against hemodynamically obstructive CAD, calibration and discrimination of the RF-CL and CACS-CL models were superior to the basic PTP model., Conclusions: The RF-CL and CACS-CL models are well calibrated and superior to a currently recommended basic PTP model to predict hemodynamically obstructive CAD. (Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease [Dan-NICAD]; NCT02264717; Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 2 [Dan-NICAD 2]; NCT03481712, Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 3 [Dan-NICAD 3]; NCT04707859)., Competing Interests: Funding Support and Author Disclosures Dr Rasmussen has received support in terms of a research grant (PD5Y-2023001-DCA) from the Danish Cardiovascular Academy, which is funded by the Novo Nordisk Foundation, grant number NNF20SA0067242 and The Danish Heart Foundation. Dr Knuuti has received consulting fees from GE Healthcare and Synektik; and has received speaker fees from Lundbeck, Bayer, Boehringer-Ingelheim, Pfizer, and Siemens Healthineers. Dr Schmidt has received a research grant from Acarix AB. Dr Holm has received institutional research grants from Abbott, Boston Scientific, and Medis Medical Imaging; and has received speaker fees from Abbott and Terumo. Dr Christiansen has received consulting fees from Abbott, Phillips, and Boston Scientific. Dr Bøttcher has served on the Advisory Boards for NOVO Nordisk, AstraZeneca, Pfizer, Boehringer Ingelheim, Bayer, Sanofi, Novartis, AMGEN, CLS-Behring, and Acarix. Dr Winther has received support from the Novo Nordisk Foundation Clinical Emerging Investigator grant (NNF21OC0066981). 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: Cardiac allograft vasculopathy is characterized by increased coronary intimal thickness and is a leading cause of death in heart transplant (HTx) recipients despite the routine use of statins. The experience with inhibitors of proprotein convertase subtilisin-kexin type 9 in HTx recipients is limited. Our hypothesis was that lowering cholesterol with the proprotein convertase subtilisin-kexin type 9inhibitor evolocumab would reduce coronary intimal thickness in these patients without compromising safety., Objectives: This double blind, randomized trial was conducted to test whether evolocumab reduces the burden of cardiac allograft vasculopathy., Methods: Patients who had received a cardiac allograft at 1 of the Nordic transplant centers within the prior 4 to 8 weeks were randomized to monthly subcutaneous injections of evolocumab 420 mg or matching placebo. The primary endpoint was the baseline-adjusted maximal intimal thickness as measured by intracoronary ultrasound after 12 months' treatment., Results: The trial enrolled 128 patients between June 2019 and May 2022. Matched pairs of coronary ultrasound images were available for 56 patients assigned to evolocumab and 54 patients assigned to placebo. At 12 months, the adjusted mean difference in the maximal intimal thickness between the 2 arms was 0.017 mm (95% CI: -0.006 to 0.040; P = 0.14). The mean reduction in low-density lipoprotein cholesterol with evolocumab compared with placebo was 1.11 mmol/L (95% CI: 0.86-1.37 mmol/L). The use of evolocumab was not associated with an increase in adverse events., Conclusions: Twelve months of treatment with evolocumab substantially reduced low-density lipoprotein cholesterol but did not reduce maximal coronary intimal thickness in HTx recipients. (Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients [EVOLVD]; NCT03734211)., Competing Interests: Funding Support and Author Disclosures This work was funded by Amgen, the South-Eastern Norway Regional Health Authority, and the Kardimmun foundation. Amgen provided the investigational medicinal products and an unrestricted grant. The funders had no role in the trial design or data collection, analysis, and interpretation. The funders had no role in the preparation or review of the manuscript, or in the decision to publish, but were allowed to read the manuscript for approval prior to publication. Dr Broch has received lecture fees from Amgen, AstraZeneca, Boehringer Ingelheim, Novartis, Novo Nordisk, Orion Pharma, Pfizer, Pharmacosmos, and Vifor Pharma. Dr Gullestad has received lecture fees from AstraZeneca, Boehringer Ingelheim, Novartis, and Amgen; and has been a member of local advisory board in AstraZeneca and Boehringer Ingelheim. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Diabetes mellitus is associated with higher risk of target lesion failure (TLF) after percutaneous coronary intervention. We studied the 5-year outcome in patients with diabetes mellitus treated with biodegradable polymer stents., Methods: The SORT OUT VII was a randomised trial comparing the ultrathin sirolimus-eluting Orsiro stent (O-SES) and the biolimus-eluting Nobori stent (N-BES) in an all-comer setting. Patients ( n = 2525) were randomised to receive O-SES ( n = 1261, diabetes: n = 236) or N-BES ( n = 1264, diabetes: n = 235). Endpoints were TLF (a composite of cardiac death, target-lesion myocardial infarction (MI), target lesion revascularization (TLR)), definite stent thrombosis and a patient related outcome (all-cause mortality, MI and revascularization) within 5 years., Results: Patients with diabetes mellitus had higher TLF (20.6% vs 11.0%, (Rate ratio (RR) 1.85 95% confidence interval (CI): (1.42-2.40) and patient related outcome (42.0% vs 31.0%, RR 1.43 95% CI: (1.19-1.71)) compared to patients without diabetes. Among patients with diabetes mellitus, TLF after 5 years did not differ between O-SES and N-BES (21.2% vs 20.0%), RR 1.05 95% CI: (0.70-1.58), p = 0.81). Cardiac death, MI, TLR, and definite stent thrombosis did not differ between the groups., Conclusion: In patients with diabetes mellitus, 5-year outcomes were similar among patients treated with biodegradable polymer O-SES or N-BES., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01879358., Competing Interests: Declaration of conflicting interestsThe author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: LOJ has received research grants from Biotronik and Biosensor to her institution, MKC has received both educational and research grants from Biotronik and Terumo. MM is supported by a grant from the Novo Nordisk Foundation (grant number NNF22OC0074083); has received lecture and/or advisory board fees from AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Novo Nordisk, has received a travel grant from Novo Nordisk, has received institutional research grants from Philips, Bayer and Novo Nordisk, has ongoing research contracts with Janssen, Novo Nordisk, and Philips, and equity in Novo Nordisk, Eli Lilly & Company, and Verve Therapeutics. JT, EHC, KNH, AE, LJ, MM, PF, RVJ, MN, JEG, NBS, JK and KTV declare they have no conflicts of interest.

Background and Aims: The microvascular resistance reserve (MRR) is a novel invasive index of the microcirculation, which is independent of epicardial stenoses, and MRR has both diagnostic and prognostic implications. This study investigates whether MRR is associated with health status outcomes by revascularization in patients with moderate coronary stenoses., Methods: Consecutive patients with stable chest pain and moderate (30-90% diameter) stenoses on invasive coronary angiography (n=222) underwent invasive physiology assessment. Revascularization was performed by guideline recommendations. At baseline and follow-up, health status and myocardial perfusion were assessed by Seattle Angina Questionnaire (SAQ) and positron emission tomography. The primary endpoint was freedom from angina at follow-up with secondary endpoints including changes in health status by SAQ domains and myocardial perfusion by MRR and revascularization status. Low MRR was defined as ≤3.0., Results: Freedom from angina occurred in 38/173 patients. In multivariate analyses, MRR was associated with freedom from angina at follow-up (odds ratio 0.860, 95% confidence interval 0.740-0.987). By MRR and revascularization groups, patients with normal MRR who did not undergo revascularization, and patients with abnormal MRR who underwent revascularization, improved health status of angina frequency (mean difference SAQ angina frequency score 8.5 [3.07-13.11] and 13.5 [2.82-23.16], respectively). For both groups, health status of physical limitation (mean difference in SAQ physical limitation score 9.7 [4.79-11.93] and 8.7 [0.53-13.88], respectively) and general health status (mean difference in SAQ summary score 9.3 [5.18-12.50] and 10.8 [2.51-17.28], respectively) also improved. Only patients with abnormal MRR who underwent revascularization improved myocardial perfusion., Conclusions: In patients with moderate coronary stenoses, MRR seems to predict symptomatic and perfusion benefit of revascularization., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Diffuse coronary artery disease affects the safety and efficacy of percutaneous coronary intervention (PCI). Pathophysiologic coronary artery disease patterns can be quantified using fractional flow reserve (FFR) pullbacks incorporating the pullback pressure gradient (PPG) calculation. This study aimed to establish the capacity of PPG to predict optimal revascularization and procedural outcomes., Methods: This prospective, investigator-initiated, single-arm, multicenter study enrolled patients with at least one epicardial lesion with an FFR ≤0.80 scheduled for PCI. Manual FFR pullbacks were used to calculate PPG. The primary outcome of optimal revascularization was defined as an FFR ≥0.88 after PCI., Results: A total of 993 patients with 1044 vessels were included. The mean FFR was 0.68±0.12, PPG 0.62±0.17, and the post-PCI FFR was 0.87±0.07. PPG was significantly correlated with the change in FFR after PCI (r=0.65 [95% CI, 0.61-0.69]; P <0.001) and demonstrated excellent predictive capacity for optimal revascularization (area under the receiver operating characteristic curve, 0.82 [95% CI, 0.79-0.84]; P <0.001). FFR alone did not predict revascularization outcomes (area under the receiver operating characteristic curve, 0.54 [95% CI, 0.50-0.57]). PPG influenced treatment decisions in 14% of patients, redirecting them from PCI to alternative treatment modalities. Periprocedural myocardial infarction occurred more frequently in patients with low PPG (<0.62) compared with those with focal disease (odds ratio, 1.71 [95% CI, 1.00-2.97])., Conclusions: Pathophysiologic coronary artery disease patterns distinctly affect the safety and effectiveness of PCI. PPG showed an excellent predictive capacity for optimal revascularization and demonstrated added value compared with an FFR measurement., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04789317., Competing Interests: Dr Collet reports receiving research grants from Biosensors, Coroventis Research, Medis Medical Imaging, Pie Medical Imaging, CathWorks, Boston Scientific, Siemens, HeartFlow, and Abbott Vascular; consultancy fees from HeartFlow, OpSens Medical, Abbott Vascular, and Philips Volcano; and has patents pending on diagnostic methods for coronary artery disease. Dr Munhoz reports a research grant provided by the CardioPath PhD programme and speaker fees from Abbott Vascular. Dr Mizukami reports receiving research grants from Boston Scientific and speaker fees from Abbott Vascular, CathWorks, and Boston Scientific. Dr Matsuo has received consulting fees from Kaneka and Zeon and speaker’s fees from Abbott Medical Japan, Boston Scientific, Philips, and Amgen. Dr Ko has received consulting fees from Canon Medical, Abbott, and Medtronic. Dr Biscaglia received research grants provided by Sahajanand Medical Technologies, Medis Medical Imaging, Eukon Srl, Siemens Healthineers, General Electric Healthcare, and Insight Lifetech. Dr Engstrøm reports speaker and advisory board fees from Abbott, Boston Scientific, and Novo Nordisk. Dr Leone reports receiving consultancy fees from Abbott and honoraria for sponsored symposia from Abbott, Medtronic, and Abiomed. Dr Fearon receives institutional research support from Abbott, Boston Scientific, and Medtronic and has consulting relationships with CathWorks and Siemens and stock options from HeartFlow. Dr Christiansen has received consulting fees from Abbott Medical Denmark A/S. Dr Yong has received minor honoraria from Abbott Vascular and research grants from Abbott Vascular and Philips. Dr Escaned is supported by the Intensification of Research Activity project INT22/00088 from the Spanish Instituto de Salud Carlos III and received speaker and advisory board member fees from Abbott and Philips. Dr Storozhenko reports a grant provided by the EAPCI Fellowship Programme. Dr West is an employee of Abbott Vascular. Dr De Potter is a paid consultant for Biosense Webster and receives grant support (institutional) and consultancy fees (institutional) from Abbott. Dr Berry receives research funding from the British Heart Foundation (grants RE/18/6134217, BHF/FS/17/26/32744, and PG/19/28/34310) and is employed by the University of Glasgow, which holds consultancy and research agreements for his work with Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Coroventis Research, GlaxoSmithKline, HeartFlow, Menarini, Novartis, Servier, Siemens Healthcare, and Valo Health. Dr Collison has received consulting fees from Abbott. Dr Johnson has received consultancy or speaker fees from Abbott Vascular, Boston Scientific, Medtronic, Shockwave, and Terumo, and research grants from Abbott Vascular. Dr Amano reports receiving lecture fees from Astellas Pharma, Astra Zeneca, Bayer, Daiichi Sankyo, and Bristol Myers Squibb. Dr Perera has received research grant support from Abbott Vascular, HeartFlow, and Philips. Dr Jeremias has received consulting fees from Canon Medical, Artrya Medical, and Boston Scientific. Dr Ali reports institutional grant support from Abbott, Abiomed, Acist, Amgen, Boston Scientific, CathWorks, Canon Medical, Conavi, HeartFlow, Inari, Medtronic, the US National Institutes of Health, Nipro, OpSens Medical, Medis, Philips, Shockwave, Siemens, SpectraWAVE, and Teleflex; consulting fees from Abiomed, Astra Zeneca, Boston Scientific, CathWorks, OpSens Medical, Philips, and Shockwave; and equity in Elucid, Lifelink, SpectraWAVE, Shockwave, and VitalConnect. Dr Pijls has received research grants from Abbott and Hexacath; consultancy fees from Abbott, GE, Philips, and HeartFlow; and has equity in General Electric, Philips, and HeartFlow. Dr De Bruyne reports receiving consultancy fees from Boston Scientific and Abbott and research grants from Coroventis Research, Pie Medical Imaging, CathWorks, Boston Scientific, Siemens, HeartFlow, and Abbott Vascular. Dr Johnson received internal funding from the Weatherhead PET Center for Preventing and Reversing Atherosclerosis; has received significant institutional research support from St Jude Medical (CONTRAST [Can Contrast Injection Better Approximate FFR Compared to Pure Resting Physiology?; URL: https://www.clinicaltrials.gov; Unique identifier: NCT02184117]) and Philips Volcano (DEFINE-FLOW [Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses; URL: https://www.clinicaltrials.gov; Unique identifier: NCT02328820]) for other studies using intracoronary pressure and flow sensors; has an institutional licensing agreement with Boston Scientific for the smart-minimum FFR algorithm (now commercialized under 510[k] K191008); and has patents pending on diagnostic methods for quantifying aortic stenosis and TAVI physiology and on methods to correct pressure tracings from fluid-filled catheters.

Introduction: Based on technical advancements and clinical evidence, transcatheter aortic valve implantation (TAVI) has been widely adopted. New generation TAVI valve platforms are continually being developed. Ideally, new valves should be superior or at least non-inferior regarding efficacy and safety, when compared to best-in-practice contemporary TAVI valves., Methods and Analysis: The Compare-TAVI trial (ClinicalTrials.gov NCT04443023) was launched in 2020, to perform a 1:1 randomized comparison of new vs contemporary TAVI valves, preferably in all comers. Consecutive cohorts will be launched with sample sizes depending on the choice of interim analyses, expected event rates, and chosen superiority or non-inferiority margins. Enrollment has just been finalized in cohort B, comparing the Sapien 3/Sapien 3 Ultra Transcatheter Heart Valve (THV) series (Edwards Lifesciences, Irvine, California, USA) and the Myval/Myval Octacor THV series (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India) balloon expandable valves. This non-inferiority study was aimed to include 1062 patients. The 1-year composite safety and efficacy endpoint comprises death, stroke, moderate-severe aortic regurgitation, and moderate-severe valve deterioration. Patients will be followed until withdrawal of consent, death, or completion of 10-year follow-up, whichever comes first. Secondary endpoints will be monitored at 30 days, 1, 3, 5, and 10 years., Summary: The Compare-TAVI organization will launch consecutive cohorts wherein patients scheduled for TAVI are randomized to one of two valves. The aim is to ensure that the short- and long-term performance and safety of new valves being introduced is benchmarked against what achieved by best-in-practice contemporary valves., Competing Interests: Declaration of competing interest Funding parties, including companies producing TAVI valves, will have no influence on study design or conduct. The ethical committees will be informed of any study support, and any contract regarding financial support must be approved by institutional legal departments. No honoraria will be given to the patients, or to the physicians or investigators responsible for the study. Grants will be used to conduct the study (eg, data handling, and salaries for study personnel) and to present the data., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Understanding the prognostic impact of percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) is crucial for patient management. Previous studies have primarily been studying prognostic impact of successful versus unsuccessful CTO PCI. This study investigated the prognostic impact of successful and unsuccessful percutaneous coronary intervention (PCI) of chronic total occluded coronary arteries (CTO) with non-CTO PCI as reference., Methods: Patients treated with PCI from 2009 to 2019 in the Central Region of Denmark were included in a population-based cohort study. We compared successful and unsuccessful CTO PCI with non-CTO PCI. Exclusion criteria was myocardial infarction within 30 days. Primary outcome was difference in a composite major adverse cardio- and cerebrovascular events (MACCE) encompassing all-cause death, any myocardial infarction, stroke, hospitalization for heart failure or revascularization tracked via nationwide registries., Results: Of 21,141 screened patients, 10,638 were enrolled: 9,065 underwent non-CTO PCI, 1,300 had successful CTO PCI, and 273 had unsuccessful CTO PCI. Median follow-up time was 5.9 [3.5;9.0] years and 4,750 MACCEs were recorded. Compared to non-CTO PCI, the adjusted MACCE rate for successful CTO PCI was equivalent (Hazard Ratio (HR): 0.98, 95% Confidence Interval (CI): 0.90-1.07, p = 0.71). In contrast, unsuccessful CTO PCI was associated with a higher MACCE rate (HR: 1.22, 95% CI: 1.04-1.43, p<0.01). HR was adjusted for age, body-mass index, previous revascularization, smoking, kidney disease, two or three-vessel disease, left ventricular ejection fraction, diabetes and comorbidities., Conclusions: The pre-specified hypothesis was accepted. Successful CTO PCI was associated with equivalent long-term outcomes as non-CTO PCI, and unsuccessful CTO PCI was identified as a high-risk group associated to worse outcomes., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: ENH: Received institutional funds from Asahi Corp., Orbus Neich Corp. and Phillips Corp. EHC: eceived institutional funds from Asahi Corp., Orbus Neich Corp., Phillips Corp. and Abbott Vascular., (Copyright: © 2024 Holck et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Finding patients with chronic coronary syndromes (CCS) whom revascularization could benefit, is complicated. Myocardial flow reserve (MFR), a measurement of myocardial perfusion, has proven prognostic value on survival and risk of major adverse cardiac events (MACE). We investigated if MFR identifies who may benefit from revascularization., Methods: Among 7462 patients from Danish hospitals examined with 82 Rb PET between January 2018 and August 2020, patients with ≥5% reversible perfusion defects were followed for MACE and all-cause mortality. Associations between revascularisation (within 90 days) and outcomes according to MFR (< and ≥ 2) was assessed by Cox regression adjusted by inverse probability weighting for demographics, cardiovascular risk factors, comorbidities, and 82 Rb PET variables., Results: Of 1806 patients with ≥5% reversible perfusion defect, 893 (49%) had MFR < 2 and 491 underwent revascularisation (36.6% in MFR < 2 versus 17.9% MFR ≥ 2, p < 0.001). During a median follow-up of 37.0 [31.0-45.8 IQR] months, 251 experienced a MACE and 173 died. Revascularisation was associated with lower adjusted risk of all-cause mortality (hazard ratio [HR], 0.51 [95% CI, 0.30-0.88], p = 0.015) and MACE (HR, 0.54 [0.33-0.87], p = 0.012) in patients with MFR < 2 but not MFR ≥ 2 for all-cause mortality (HR 1.33 [0.52-3.40], p = 0.542) and MACE (HR 1.50 [0.79-2.84], p = 0.211). MFR significantly modified the association between revascularisation and MACE, but not all-cause mortality (interaction p-value 0.021 and 0.094, respectively)., Conclusions: Revascularization was associated with improved prognosis among patients with impaired MFR. No association was seen in patients with normal MFR. In patients with regional ischemia, MFR may identify patients with a prognostic benefit from revascularization., Competing Interests: Declaration of competing interest The authors report no relationships that could be construed as a conflict of interest., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: The hyperaemic stenosis resistance (HSR) index was introduced to provide a more comprehensive indicator of the haemodynamic severity of a coronary lesion. HSR combines both the pressure drop across a lesion and the flow through it. As such, HSR overcomes the limitations of the more traditional fractional flow reserve (FFR) or coronary flow reserve (CFR) indices., Aims: We aimed to identify the diagnostic and prognostic value of HSR and evaluate the clinical implications., Methods: Patients with chronic coronary syndromes (CCS) and obstructive coronary artery disease were selected from the multicentre ILIAS Registry. For this study, only patients with combined Doppler flow and pressure measurements were included., Results: A total of 853 patients with 1,107 vessels were included. HSR more accurately identified the presence of inducible ischaemia compared to FFR and CFR (area under the curve 0.71 vs 0.66 and 0.62, respectively; p<0.005 for both). An abnormal HSR measurement was an independent and important predictor of target vessel failure at 5-year follow-up (hazard ratio 3.80, 95% confidence interval: 2.12-6.73; p<0.005). In vessels deferred from revascularisation, HSR seems to identify more accurately those vessels that may benefit from revascularisation rather than FFR and/or CFR., Conclusions: The present study affirms the theoretical advantages of the HSR index for the detection of ischaemia-Âinducing coronary lesions in a large CCS population. (Inclusive Invasive Physiological Assessment in Angina Syndromes Registry [ILIAS Registry], ClinicalTrials.gov: NCT04485234).

Background: Despite recent guideline recommendations, quantitative perfusion (QP) estimates of myocardial blood flow from cardiac magnetic resonance (CMR) have only been sparsely validated. Furthermore, the additional diagnostic value of utilizing QP in addition to the traditional visual expert interpretation of stress-perfusion CMR remains unknown. The aim was to investigate the correlation between myocardial blood flow measurements estimated by CMR, positron emission tomography, and invasive coronary thermodilution. The second aim is to investigate the diagnostic performance of CMR-QP to identify obstructive coronary artery disease (CAD)., Methods: Prospectively enrolled symptomatic patients with >50% diameter stenosis on computed tomography angiography underwent dual-bolus CMR and positron emission tomography with rest and adenosine-stress myocardial blood flow measurements. Subsequently, an invasive coronary angiography (ICA) with fractional flow reserve and thermodilution-based coronary flow reserve was performed. Obstructive CAD was defined as both anatomically severe (>70% diameter stenosis on quantitative coronary angiography) or hemodynamically obstructive (ICA with fractional flow reserve ≤0.80)., Results: About 359 patients completed all investigations. Myocardial blood flow and reserve measurements correlated weakly between estimates from CMR-QP, positron emission tomography, and ICA-coronary flow reserve (r<0.40 for all comparisons). In the diagnosis of anatomically severe CAD, the interpretation of CMR-QP by an expert reader improved the sensitivity in comparison to visual analysis alone (82% versus 88% [ P =0.03]) without compromising specificity (77% versus 74% [ P =0.28]). In the diagnosis of hemodynamically obstructive CAD, the accuracy was only moderate for a visual expert read and remained unchanged when additional CMR-QP measurements were interpreted., Conclusions: CMR-QP correlates weakly to myocardial blood flow measurements by other modalities but improves diagnosis of anatomically severe CAD., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03481712., Competing Interests: Disclosures Dr Rasmussen acknowledges support in terms of a research grant (PD5Y-2023001-DCA) from the Danish Cardiovascular Academy, which is funded by the Novo Nordisk Foundation, grant NNF20SA0067242, and The Danish Heart Foundation. Dr Winther acknowledges support from the Novo Nordisk Foundation Clinical Emerging Investigator grant (NNF21OC0066981). Dr Bøttcher is a previous employee and a shareholder of Circle Cardiovascular Imaging, Inc. S.E. Petersen provides consultancy to and was a previous stockowner of Circle Cardiovascular Imaging, Inc. Dr Bøttcher discloses advisory board participation for NOVO Nordisk, AstraZeneca, Pfizer, Boehringer Ingelheim, Bayer, Sanofi, Novartis, AMGEN, CLS-Behring, and Acarix. The other authors report no conflicts.

Background: Unintended deformation of implanted coronary stents can lead to loss of coronary access, stent thrombosis and coronary events during follow-up. The incidence, mechanisms and clinical outcomes of unintended stent deformations (USD) during complex bifurcation stenting are not well characterized., Objectives: In a prespecified analysis of the OCTOBER (European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction) trial, we aimed to: 1) determine the incidence and characterize mechanisms of USD identified by optical coherence tomography (OCT); and 2) evaluate physician's detection and correction of accidental abluminal rewiring and USD., Methods: OCT scans were analyzed for accidental abluminal rewiring and USD. When USD was identified, the plausible mechanism was determined by analysis of all procedural OCT scans and the corresponding angiograms., Results: USD was identified by the core lab in 9.3% (55/589) of OCT-guided cases. Accidental abluminal rewiring was the cause in 44% (24/55), and guide catheter collision was the cause in 40% (22/55) of cases. USD was found in 18.5% of all cases with left main bifurcation percutaneous coronary intervention. The total incidence of abluminal rewiring was 33 in 32 OCT-guided cases (5.4%) and was corrected by physicians in 18 of 33 appearances (54.5%). The 2-year major adverse cardiac event rate for patients with untreated USD (n = 30) was 23.3%, whereas patients with confirmed or possibly corrected USD (n = 25) had no events during follow-up., Conclusions: USD was associated with adverse procedural complications and cardiac events during follow-up when not identified and corrected. The predominant mechanisms were undetected abluminal rewiring and guide catheter collision. Left main bifurcation percutaneous coronary intervention was a particular risk with USD detected in 18.5% of cases., Competing Interests: Funding Support and Author Disclosures The OCTOBER main study was funded by Abbott Vascular and St. Jude Medical. Dr Neghabat has received speaker fees from Abbott. Dr Kumsars received speaker fees from AstraZeneca, Biotronik, Bayer, Novartis. Dr Bennett has received institutional grants from Abbott and Biotronik; and consultancy/speaker fees from Abbott, Boston Scientific, Medtronic, and Elixir. Dr Olsen has received institutional research support from Abbott and Shockwave. Dr Odenstedt has received compensation for lectures, proctoring, and serving on an advisory board; and has received an educational grant from Abbott. Dr Burzotta has received speaker fees from Abbott, Abiomed, Daiichi-Sankyo, Medtronic, and Terumo. Dr Johnson has received institutional research grants from Abbott; and consultancy/speaker fees from Abbott, Boston Scientific, Cordis, Medtronic, and Terumo. Dr O’Kane has received speaker fees from Abbott. Dr Christiansen has received institutional research grants from Abbott and Philips; and speaker fees from Abbott and Boston Scientific. Dr Holm received institutional research grants from Abbott, Biosensors, Boston Scientific, and Medis Medical Imaging; and speaker fees from Abbott and Terumo. 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: The microvascular resistance reserve (MRR) is an innovative index to assess the vasodilatory capacity of the coronary circulation while accounting for the presence of concomitant epicardial disease. The MRR has shown to be a valuable diagnostic and prognostic tool in the general coronary artery disease (CAD) population. However, considering the fundamental aspects of its assessment and the unique hemodynamic characteristics of women, it is crucial to provide additional considerations for evaluating the MRR specifically in women., Aim: The aim of this study was to assess the diagnostic and prognostic applicability of the MRR in women and assess the potential differences across different sexes., Methods: From the ILIAS Registry, we enrolled all patients with a stable indication for invasive coronary angiography, ensuring complete physiological and follow-up data. We analyzed the diagnostic value by comparing differences between sexes and evaluated the prognostic value of the MRR specifically in women, comparing it to that in men., Results: A total of 1494 patients were included of which 26% were women. The correlation between MRR and CFR was good and similar between women (r = 0.80, p < 0.005) and men (r = 0.81, p < 0.005). The MRR was an independent and important predictor of MACE in both women (HR 0.67, 0.47-0.96, p = 0.027) and men (HR 0.84, 0.74-0.95, p = 0.007). The optimal cut-off value for MRR in women was 2.8 and 3.2 in men. An abnormal MRR similarly predicted MACE at 5-year follow-up in both women and men., Conclusion: The MRR seems to be equally applicable in both women and men with stable coronary artery disease., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Diabetes may be associated with differential outcomes in patients undergoing left main coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The aim of this study was to investigate outcomes in patients with left main disease with and without diabetes randomized to PCI versus CABG., Methods: Individual patient data were pooled from 4 trials (SYNTAX [Synergy Between PCI With Taxus and Cardiac Surgery], PRECOMBAT [Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease], NOBLE [Nordic-Baltic-British Left Main Revascularisation Study], and EXCEL [Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization]) that randomized patients with left main disease to PCI or CABG. Patients were considered suitable for either approach. Patients were categorized by diabetes status. Kaplan-Meier event rates, Cox model hazard ratios, and interactions were assessed., Results: Among 4393 patients, 1104 (25.1%) had diabetes. Patients with diabetes experienced higher rates of 5-year death (158/1104 [Kaplan-Meier rate, 14.7%] versus 297/3289 [9.3%]; P <0.001), spontaneous myocardial infarction (MI; 67/1104 [6.7%] versus 114/3289 [3.7%]; P <0.001), and repeat revascularization (189/1104 [18.5%] versus 410/3289 [13.2%]; P <0.001). Rates of all-cause mortality did not differ after PCI versus CABG in those with (84/563 [15.3%] versus 74/541 [14.1%]; hazard ratio, 1.11 [95% CI, 0.82-1.52]) or without (155/1634 [9.7%] versus 142/1655 [8.9%]; hazard ratio, 1.08 [95% CI, 0.86-1.36; P intHR =0.87) diabetes. Rates of stroke within 1 year were lower with PCI versus CABG in the entire population, with no heterogeneity based on diabetes status ( P intHR =0.51). The 5-year rates of spontaneous MI and repeat coronary revascularization were higher after PCI regardless of diabetes status (spontaneous MI: 45/563 [8.9%] versus 22/541 [4.4%] in diabetes and 82/1634 [5.3%] versus 32/1655 [2.1%] in no diabetes, P intHR =0.47; repeat revascularization: 127/563 [24.5%] versus 62/541 [12.4%] in diabetes and 254/1634 [16.3%] versus 156/1655 [10.1%] in no diabetes, P intHR =0.18). For spontaneous MI and repeat revascularization, there were greater absolute risk differences beyond 1 year in patients with diabetes (4.9% and 9.9%) compared with those without (2.1% and 4.3%; P intARD =0.047 and 0.016)., Conclusions: In patients with left main disease considered equally suitable for PCI or CABG and with largely low to intermediate SYNTAX scores, diabetes was associated with higher rates of death and cardiovascular events through 5 years. Compared with CABG, PCI resulted in no difference in the risk of death and a lower risk of early stroke regardless of diabetes status, and a higher risk of spontaneous MI and repeat coronary revascularization, with larger late absolute excess risks in patients with diabetes., Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01205776, NCT0146651, NCT00422968, and NCT00114972., Competing Interests: Disclosures Dr Gaba, S.A. Murphy, and Drs Bellavia, Sabatine, and Bergmark are members of the TIMI Study Group, which has received grant support through Brigham and Women’s Hospital (Boston, MA) from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals, Daiichi-Sankyo, Eisai, Intarcia, Ionis, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Roche, Siemens Healthcare Diagnostics, The Medicines Company, and Zora Biosciences. Dr Sabik was the North American Surgical Principal Investigator in the EXCEL trial. Dr Serruys declares consultancy or personal fees from SMT, Novartis, Philips, Xeltis, and Merillife. Dr Kappetein is an employee of Medtronic. Dr S.-J. Park declares grants from Abbott Vascular, Daiichi-Sankyo, ChongKunDang Pharm, Daewoong Pharm, and Edwards, as well as personal fees from Abbott Vascular and Edwards, all outside the submitted work. Dr D.-W. Park declares grants from Daiichi-Sankyo, ChongKunDang Pharm, Daewoong Pharm, and Abbott Vascular, as well as personal fees from Edwards, Abbott Vascular, and Medtronic, all outside the submitted work. Dr Christiansen has received grant support from Biosensors and Abbott Vascular. Dr Holm declares institutional research grants from Abbott, Biosensors, Bbraun, Boston Scientific, and Reva Medical, as well as speaker fees from Abbott, Reva Medical, and Terumo. Dr Sabatine declares research grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Eisai, Intarcia, Ionis, The Medicines Company, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Saghmos Therapeutics, and Verve Therapeutics. Dr Sabatine has consulted for Althera, Amgen, Anthos Therapeutics, AstraZeneca, Beren Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, CVS Caremark, DalCor, Dr Reddy’s Laboratories, Fibrogen, IFM Therapeutics, Intarcia, MedImmune, Merck, Moderna, Novo Nordisk, Precision BioSciences, and Silence Therapeutics. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, and Abbott; has served as a consultant to Daiichi Sankyo, Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, Adona Medical, and Millennia Biopharma; has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; and his employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Bergmark declares research grants through Brigham and Women’s Hospital from Pfizer, Ionis, Quark, AstraZeneca/MedImmune, and Amgen, as well as consulting or personal fees from Philips, Abbott Vascular, CSI, Abiomed, Servier, Janssen, Quark, and Daiichi Sankyo. The other authors report no conflicts.

Background: Shockwave intravascular lithotripsy (S-IVL) is widely used during percutaneous coronary intervention (PCI) of calcified coronary arteries. Ventricular capture beats during S-IVL are common but arrhythmias are rare., Case Presentation: A 75-year-old woman was scheduled for PCI to a short, heavily calcified chronic total occlusion of the right coronary artery. After wiring of the occlusion, S-IVL was used to predilated the calcified stenosis. During S-IVL, the patient developed ventricular fibrillation twice., Conclusion: To our knowledge, this is only the second reported case of VF during S-IVL. Although very rare, it is important to be aware of this potential and serious complication., (© 2024. The Author(s).)

Background: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear., Methods: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation., Results: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09)., Conclusions: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.)., (Copyright © 2024 Massachusetts Medical Society.)

Objectives: Left internal mammary artery (LIMA) graft stenoses detected at early coronary angiography may be reversible and consequently prompt unnecessary graft revision. We aim to investigate the frequency, natural course, and clinical significance of internal mammary artery graft stenosis upon early angiography in patients undergoing hybrid myocardial revascularization., Methods: In this retrospective sub-study of the Coronary Hybrid Revascularization Study, we compared graft appearance, ie, stenosis degree and flow, on early (in-hospital) and scheduled follow-up coronary angiography after 1 year. We assessed the change in graft patency using the Fitzgibbon classification (grade A: unimpaired runoff; grade B > 50% stenosis; grade O: occlusion), as well as graft association with adverse events (death, myocardial infarction, stroke, and repeat revascularization) at up to 5-year follow-up., Results: We report clinical follow-up data for all 131 patients included in the Coronary Hybrid Revascularization Study. Change in graft patency was analyzed in 86 patients with satisfactory visualization of the LIMA graft on early and follow-up coronary angiography. All LIMA grafts were patent at discharge and follow-up. Twenty-seven of 37 (73%) grade B graft stenoses at early angiography resolved to grade A during follow-up of median 12 months (range, 8-83 months) after surgery. Angiographically significant graft stenoses at early coronary angiography were not associated with adverse clinical outcome up to 5-year follow-up., Conclusions: Our results suggest that the majority of clinically silent LIMA graft stenoses resolve during follow-up and are not associated with adverse clinical outcomes.

Background: Previous meta-analyses have shown reduced risks of composite adverse events with intravascular imaging-guided percutaneous coronary intervention (PCI) compared with angiography guidance alone. However, these studies have been insufficiently powered to show whether all-cause death or all myocardial infarction are reduced with intravascular imaging guidance, and most previous intravascular imaging studies were done with intravascular ultrasound rather than optical coherence tomography (OCT), a newer imaging modality. We aimed to assess the comparative performance of intravascular imaging-guided PCI and angiography-guided PCI with drug-eluting stents., Methods: For this systematic review and updated meta-analysis, we searched the MEDLINE, Embase, and Cochrane databases from inception to Aug 30, 2023, for studies that randomly assigned patients undergoing PCI with drug-eluting stents either to intravascular ultrasound or OCT, or both, or to angiography alone to guide the intervention. The searches were done and study-level data were extracted independently by two investigators. The primary endpoint was target lesion failure, defined as the composite of cardiac death, target vessel-myocardial infarction (TV-MI), or target lesion revascularisation, assessed in patients randomly assigned to intravascular imaging guidance (intravascular ultrasound or OCT) versus angiography guidance. We did a standard frequentist meta-analysis to generate direct data, and a network meta-analysis to generate indirect data and overall treatment effects. Outcomes were expressed as relative risks (RRs) with 95% CIs at the longest reported follow-up duration. This study was registered with the international prospective register of systematic reviews (PROSPERO, number CRD42023455662)., Findings: 22 trials were identified in which 15 964 patients were randomised and followed for a weighted mean duration of 24·7 months (longest duration of follow-up in each study ranging from 6 to 60 months). Compared with angiography-guided PCI, intravascular imaging-guided PCI resulted in a decreased risk of target lesion failure (RR 0·71 [95% CI 0·63-0·80]; p<0·0001), driven by reductions in the risks of cardiac death (RR 0·55 [95% CI 0·41-0·75]; p=0·0001), TV-MI (RR 0·82 [95% CI 0·68-0·98]; p=0·030), and target lesion revascularisation (RR 0·72 [95% CI 0·60-0·86]; p=0·0002). Intravascular imaging guidance also reduced the risks of stent thrombosis (RR 0·52 [95% CI 0·34-0·81]; p=0·0036), all myocardial infarction (RR 0·83 [95% CI 0·71-0·99]; p=0·033), and all-cause death (RR 0·75 [95% CI 0·60-0·93]; p=0·0091). Outcomes were similar for OCT-guided and intravascular ultrasound-guided PCI., Interpretation: Compared with angiography guidance, intravascular imaging guidance of coronary stent implantation with OCT or intravascular ultrasound enhances both the safety and effectiveness of PCI, reducing the risks of death, myocardial infarction, repeat revascularisation, and stent thrombosis., Funding: Abbott., Competing Interests: Declaration of interests GWS has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant to Abbott, Daiichi Sankyo, Ablative Solutions, CorFlow, Apollo Therapeutics, Cardiomech, Gore, Robocath, Miracor, Vectorious, Abiomed, Valfix, TherOx, HeartFlow, Neovasc, Ancora, Elucid Bio, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, and HighLife; and has equity or options from Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. GWS's employer, Mount Sinai Hospital, receives research grants from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. EHC has received speaker honoraria from Abbott and receives research grants from Abbott, Asahi Intecc, Biosensors, Biotronik, Boston Scientific, OrbusNeich, and Philips. ZAA reports institutional grant support from Abbott, Abiomed, Acist Medical, Boston Scientific, Cardiovascular Systems, Medtronic, the National Institute of Health, Opsens Medical, Philips, and Teleflex; consulting fees from AstraZeneca, Philips, and Shockwave; and equity in Elucid, Spectrawave, Shockwave, and VitalConnect. AM has received speaker honoraria from Nipro and is a consultant for Boston Scientific. YA is a consultant for Cardiovascular Systems and Shockwave, and serves on the Medical Advisory Board of Boston Scientific. UL has received speaker or advisory honoraria from Abbott, Boston Scientific, Amgen, Bayer, NovoNordisc, Pfizer, and Sanofi. NRH has received institutional research grants from Abbott, Biosensors, Boston Scientific, Medis Medical Imaging, and Reva Medical, and speaker fees from Abbott, Cardirad, and Terumo. LNA declares no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)