<div><h4>Artificial Intelligence, Computational Simulations, and Extended Reality in Cardiovascular Interventions.</h4><i>Samant S, Bakhos JJ, Wu W, Zhao S, ... Dangas G, Chatzizisis YS</i><br /><AbstractText>Artificial intelligence, computational simulations, and extended reality, among other 21st century computational technologies, are changing the health care system. To collectively highlight the most recent advances and benefits of artificial intelligence, computational simulations, and extended reality in cardiovascular therapies, we coined the abbreviation AISER. The review particularly focuses on the following applications of AISER: 1) preprocedural planning and clinical decision making; 2) virtual clinical trials, and cardiovascular device research, development, and regulatory approval; and 3) education and training of interventional health care professionals and medical technology innovators. We also discuss the obstacles and constraints associated with the application of AISER technologies, as well as the proposed solutions. Interventional health care professionals, computer scientists, biomedical engineers, experts in bioinformatics and visualization, the device industry, ethics committees, and regulatory agencies are expected to streamline the use of AISER technologies in cardiovascular interventions and medicine in general.</AbstractText><br /><br />Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 23 Oct 2023; 16:2479-2497</small></div>

<div><h4>Dyspnea-Related Ticagrelor Discontinuation After Percutaneous Coronary Intervention.</h4><i>Angiolillo DJ, Cao D, Sartori S, Baber U, ... Pocock S, Mehran R</i><br /><b>Background</b><br />Nearly 20% of patients on ticagrelor experience dyspnea, which may lead to treatment discontinuation in up to one-third of cases.<br /><b>Objectives</b><br />The authors sought to evaluate the incidence, predictors, and outcomes of dyspnea-related ticagrelor discontinuation after percutaneous coronary intervention (PCI).<br /><b>Methods</b><br />In the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial, after 3 months of ticagrelor plus aspirin, patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. The occurrence of dyspnea associated with ticagrelor discontinuation was evaluated among all patients enrolled in the trial. A landmark analysis was performed at 3 months after PCI, that is, the time of randomization. Predictors of dyspnea-related ticagrelor discontinuation were obtained from multivariable Cox regression with stepwise selection of candidate variables.<br /><b>Results</b><br />The incidence of dyspnea-related ticagrelor discontinuation was 6.4% and 9.1% at 3 and 15 months after PCI, respectively. Independent predictors included Asian race (lower risk), smoking, prior PCI, hypercholesterolemia, prior coronary artery bypass, peripheral artery disease, obesity, and older age. Among 179 patients who discontinued ticagrelor because of dyspnea after randomization, ticagrelor monotherapy was not associated with a higher risk of subsequent ischemic events (composite of all-cause death, myocardial infarction, or stroke) compared with ticagrelor plus aspirin (5.0% vs 7.1%; P = 0.566).<br /><b>Conclusions</b><br />In the TWILIGHT trial, dyspnea-related ticagrelor discontinuation occurred in almost 1 in 10 patients and tended to occur earlier rather than late after PCI. Several demographic and clinical conditions predicted its occurrence, and their assessment may help identify subjects at risk for therapy nonadherence.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 23 Oct 2023; 16:2514-2524</small></div>

<div><h4>New Angiographic Difficulty Score for First-Attempt Chronic Total Occlusion in the 3 Major Coronary Arteries.</h4><i>Niizeki T, Tsuchikane E, Konta T, Kishi K, ... Yoshikawa R, Tanaka H</i><br /><b>Background</b><br />Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is still challenging due to complex lesion morphology. Success rates may vary among the 3 major coronary arteries, influenced by clinical and angiographic characteristics.<br /><b>Objectives</b><br />This study sought to evaluate the differences in the predictors of unsuccessful PCI in first-attempt CTO lesions of the 3 major coronary arteries compared with the J-CTO (Japanese CTO) score.<br /><b>Methods</b><br />This study assessed 6,408 first-attempt CTO patients from the Japanese CTO-PCI expert registry between January 2014 and December 2021, randomly assigned to derivation and validation sets. Difficulty scores for each artery were determined by assigning points to predictive unsuccessful factors.<br /><b>Results</b><br />The CTO lesions were distributed as follows: left anterior descending coronary artery: 2,245 (35%), left circumflex coronary artery: 1,131 (18%), and right coronary artery (RCA): 3,032 (47%). Regarding success rates, left circumflex coronary artery CTO had the lowest procedural success rate (90%) followed by RCA CTO (92%) and left anterior descending coronary artery CTO (94%). RCA CTO was significantly longer and more severely angulated, requiring more often the retrograde approach. A multivariate logistic analysis revealed that predictors of failed PCI were different in CTO lesions among the 3 major coronary arteries, respectively. Moreover, our difficulty score for RCA CTO was superior to the J-CTO score in predicting unsuccessful PCI.<br /><b>Conclusions</b><br />Clinical and angiographic differences might explain the discrepancies of success rates in CTO lesions among the 3 major coronary arteries. Our novel difficulty score was comparable to the J-CTO score in predicting unsuccessful CTO-PCI with a superior discriminatory capacity.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 23 Oct 2023; 16:2542-2551</small></div>

<div><h4>Safety and Efficacy Transcatheter Aortic Valve Replacement with a Pressure-Sensor and Pacing Guidewire: SAFE-TAVI Trial.</h4><i>Regueiro A, Alperi A, Vilalta V, Asmarats L, ... Pelletier-Beaumont E, Rodés-Cabau J</i><br /><b>Background</b><br />The SavvyWire™ (OpSens Inc., Quebec, Canada) is a 0.035\'\' preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring. The objective of the study was to determine the efficacy and safety of the guidewire during Transcatheter Aortic Valve Replacement (TAVR) procedures.<br /><b>Methods</b><br />This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mmHg). The safety outcome included the absence of major procedural complications related to the guidewire.<br /><b>Results</b><br />A total of 121 patients (mean age: 82.2±5.9 years, 50% of women) were included in the study and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6±11.3 mmHg. Hemodynamic assessment with the use of OptoMonitor™ 3 without additional catheter exchange, was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation were reported.<br /><b>Conclusions</b><br />The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision-making after THV deployment.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 18 Oct 2023; epub ahead of print</small></div>

<div><h4>Balloon-vs. Self-Expanding Transcatheter Valve for Failed Small Surgical Aortic Bioprostheses:1-Year Results of the LYTEN Trial.</h4><i>Nuche J, Abbas AE, Serra V, Vilalta V, ... Pibarot P, Rodés-Cabau J</i><br /><b>Background</b><br />Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies.<br /><b>Objective</b><br />To compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR.<br /><b>Methods</b><br />Patients with a failed small (≤ 23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler-echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria.<br /><b>Results</b><br />A total of 98 patients underwent ViV-TAVR (46-BEV, 52-SEV). Patients receiving a SEV had a lower peak and mean trans-aortic gradients (peak: 42±15 mmHg-BEV vs. 27±14 mmHg-SEV, p˂0.001; mean: 22±8 mmHg-BEV vs. 14±7 mmHg-SEV, p < 0.001), and a higher rate on intended valve hemodynamic performance (BEV:30%, SEV:76%, p < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA class > II, BEV: 7.3%, SEV:4.1%, p=0.505) or quality of life (KCCQ, BEV:77.9±21.2, SEV:81.8±14.8, p=0.334). No differences in all-cause mortality (BEV:6.5%, SEV:3.9%, p=0.495), heart failure hospitalization (BEV:6.5%, SEV:1.9%, p=0.214), stroke (BEV:0%, SEV:1.9%; p=0.369), myocardial infarction (BEV:0%, SEV:1.9%, p=0.347), or pacemaker implantation (BEV:2.2%, SEV:1.9%, p=0.898) were found.<br /><b>Conclusions</b><br />In patients who underwent ViV-TAVR for small failed aortic bioprostheses, a better hemodynamic profile was found after one year in patients receiving a SEV. Differences were not found between SEV and BEV in regard to functional status, quality of life, or clinical outcomes.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 18 Oct 2023; epub ahead of print</small></div>

<div><h4>Coronary Physiology Guidance vs. Conventional Angiography for Optimization of Percutaneous Coronary Intervention: the AQVA II Trial.</h4><i>Biscaglia S, Verardi FM, Erriquez A, Colaiori I, ... Versaci F, Campo G</i><br /><b>Background</b><br />The debate surrounding the efficacy of coronary physiology guidance, compared to conventional angiography, in achieving optimal post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) values persists.<br /><b>Objectives</b><br />First, demonstrating the superiority of physiology-guided PCI, using either angiography or microcatheter-derived FFR, over conventional angiography-based PCI in complex and high-risk procedures (CHIP). Second, establishing the non-inferiority of angiography-derived FFR guidance compared to microcatheter-derived FFR guidance.<br /><b>Methods</b><br />Patients showing obstructive coronary lesions and meeting CHIP criteria were randomized 2:1 to receive either a physiology- or angiography-based PCI. Those assigned to the former were randomly allocated to angiography- or microcatheter derived FFR guidance. CHIP criteria were long lesion (>28 mm), tandem lesions, severe calcifications, severe tortuosity, true bifurcation, in-stent restenosis, left main stem disease. The primary outcome was invasive post-PCI FFR value. Optimal post-PCI FFR value was defined as >0.86.<br /><b>Results</b><br />A total of 305 patients (331 study vessels) were enrolled in the study (101 undergoing conventional angiography-based PCI and 204 physiology-based PCI). Optimal post-PCI FFR values were more frequent in the physiology-based PCI group compared to the conventional angiography-based PCI group (77% vs. 54%; absolute difference 23%, relative difference 30%, p<0.0001). The occurrence of the primary outcome did not differ between the two physiology-based PCI subgroups, demonstrating the non-inferiority of angiography- vs. microcatheter-derived FFR (p<0.01).<br /><b>Conclusions</b><br />In CHIP patients, procedural planning and guidance based on physiology (either through angiography-or microcatheter-derived FFR) are superior to conventional angiography for achieving optimal post-PCI FFR values.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 18 Oct 2023; epub ahead of print</small></div>

<div><h4>Recurrent Revascularization at 10 Years after Percutaneous Treatment of Drug-Eluting Stent Restenosis.</h4><i>Koch T, Lenz T, Rheude T, Cassese S, ... Kastrati A, Kufner S</i><br /><b>Objectives</b><br />To investigate long-term incidence of recurrent revascularization events after percutaneous treatment of drug-eluting in-stent restenosis (DES-ISR).<br /><b>Background</b><br />Treatment of patients with recurrence of ISR remains particularly challenging with data and guideline recommendations for repeat PCI being scant.<br /><b>Methods</b><br />In this post-hoc analysis, 402 patients (500 lesions) being assigned to plain balloon (PB), drug-coated balloon (DCB) or drug-eluting stent (DES) in the randomized ISAR-DESIRE 3 trial were followed-up over a median of 10.3 years. Primary endpoint was total repeat target lesion revascularization (R-TLR) including all, first and recurrent events.<br /><b>Results</b><br />At the end of follow-up, first R-TLR was required in 204 lesions, 82 in PB, 70 in DCB and 52 in DES group. Total number of R-TLR was 373: 162 in PB, 124 in DCB and 87 in DES. During the first year of follow-up, the risk of total R-TLR was reduced by DCB (hazard ratio [HR] = 0.36 [95% confidence interval: 0.24-0.54]) and by DES (HR = 0.23 [0.14-0.38]) as compared with PB. After 1 year, the risk of total R-TLR was non-significantly reduced by DCB (HR = 0.77 [0.51-1.16]) and significantly reduced by DES (HR = 0.61 [0.39-0.95]) as compared with PB. Risk in DCB- versus DES-group was similar during (HR = 1.54 [0.89-2.69]) and after 1year (HR = 1.26 [0.82 - 1.92]).<br /><b>Conclusions</b><br />The total number of R-TLR over 10 years after treatment of DES-ISR is high. DCB and, particularly DES, are able to reduce the need of both first and recurrent revascularizations as compared with PB.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 18 Oct 2023; epub ahead of print</small></div>

<div><h4>1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study.</h4><i>von Bardeleben RS, Mahoney P, Morse MA, Price MJ, ... Asch FM, Rodriguez E</i><br /><b>Background</b><br />The fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated.<br /><b>Objectives</b><br />The aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system.<br /><b>Methods</b><br />EXPAND G4 is an ongoing prospective, multicenter, international, single-arm study that enrolled subjects with primary and secondary MR. One-year outcomes included MR severity (echocardiographic core laboratory assessed), heart failure hospitalization, all-cause mortality, functional capacity (NYHA functional class), and quality of life (Kansas City Cardiomyopathy Questionnaire).<br /><b>Results</b><br />A total of 1,164 subjects underwent M-TEER from 2020 to 2022. At 1 year, there was a durable reduction in MR to mild or less in 92.6% and to none or trace in 44.2% (P < 0.0001 vs baseline). Few subjects had major adverse events through 1 year (<2% for myocardial infarction, surgical reintervention, or single-leaflet device attachment). The 1-year Kaplan-Meier estimates for all-cause mortality and heart failure hospitalization were 12.3% and 16.9%. Significant improvements in functional capacity (NYHA functional class I or II in 82%; P < 0.0001 vs baseline) and quality of life (18.5-point Kansas City Cardiomyopathy Questionnaire overall summary score improvement; P < 0.0001) were observed.<br /><b>Conclusions</b><br />M-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to ≤1+ in more than 90% of patients and concomitant improvements in functional status and quality of life.<br /><br />Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 17 Oct 2023; epub ahead of print</small></div>

<div><h4>A Prospective Randomized Trial Comparing Sirolimus-Coated Balloon With Paclitaxel-Coated Balloon in De Novo Small Vessels.</h4><i>Ninomiya K, Serruys PW, Colombo A, Reimers B, ... Cortese B, Onuma Y</i><br /><b>Background</b><br />There are no data comparing sirolimus-coated balloons (SCBs [MagicTouch, Concept Medical]) to paclitaxel-coated balloons (PCBs [SeQuent Please Neo, B. Braun]) for the treatment of de novo small vessel disease (SVD).<br /><b>Objectives</b><br />This study sought to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo SVD with a PCB or SCB.<br /><b>Methods</b><br />This prospective, multicenter, noninferiority trial randomized 121 patients (129 SVD lesions) to treatment with an SCB or PCB, with balloon sizing determined using optical coherence tomography. The primary endpoint was noninferiority for the 6-month angiographic net lumen gain.<br /><b>Results</b><br />Angiographic follow-up was completed in 109 (90.1%) patients in the per-protocol analysis. The mean ± SD angiographic net gains were 0.25 ± 0.40 mm with SCBs vs 0.48 ± 0.37 mm with PCBs, resulting in SCBs failing to meet the 0.30 mm criterion for noninferiority (P<sub>noninferiority</sub> = 0.173), with an absolute difference of -0.23 mm (95% CI: -0.37 to -0.09) secondary to a smaller late loss (mean ± SD: 0.00 ± 0.32 vs 0.32 ± 0.47 mm; P < 0.001) and more frequent late lumen enlargement (53.7% vs 30.0%; OR: 2.60; 95% CI: 1.22 to 5.67; P = 0.014) with PCBs. Binary restenosis rates were 32.8% and 12.5% following treatment with SCBs and PCBs, respectively (OR: 3.41; 95% CI: 1.36-9.44; P = 0.012). The mean ± SD angiography-derived fractional flow ratio at follow-up was 0.86 ± 0.15 following treatment with SCBs and 0.91 ± 0.09 following PCBs (P = 0.026); a fractional flow ratio ≤0.80 occurred in 13 and 5 vessels after treatment with SCBs and PCBs, respectively.<br /><b>Conclusions</b><br />The SCB MagicTouch failed to demonstrate noninferiority for angiographic net lumen gain at 6 months compared to the PCB SeQuent Please Neo.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 17 Oct 2023; epub ahead of print</small></div>

<div><h4>One-year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation Patients.</h4><i>Smith RL, Lim DS, Gillam LD, Zahr F, ... Hausleiter J, CLASP IID Pivotal Trial Investigators</i><br /><b>Background</b><br />Favorable six-month outcomes from the CLASP IID Registry demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy.<br /><b>Objectives</b><br />To assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry.<br /><b>Methods</b><br />Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality of life outcomes were assessed at one year. Study oversight included a central screening committee, echocardiographic core laboratory and clinical events committee.<br /><b>Results</b><br />Ninety-eight patients were enrolled. One-year Kaplan-Meier estimates of freedom from composite major adverse events, all-cause mortality and heart failure hospitalization were 83.5%, 89.3% and 91.5%, respectively. Significant MR reduction was achieved at 1 year (p<0.001 vs. baseline) including 93.2% at MR≤2+ and 57.6% at MR≤1+ with improvements in related echocardiographic measures. New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (p<0.001 vs. baseline).<br /><b>Conclusions</b><br />At one year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 16 Oct 2023; epub ahead of print</small></div>

<div><h4>1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results.</h4><i>Zahr F, Song HK, Chadderdon S, Gada H, ... Mack M, Leon MB</i><br /><b>Background</b><br />High surgical risk may preclude mitral valve replacement in many patients. Transcatheter Mitral Valve Replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients.<br /><b>Objective</b><br />This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study (EFS) in patients with ≥ moderate-severe MR.<br /><b>Methods</b><br />The EFS is a multi-center, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to MVARC criteria.<br /><b>Results</b><br />Thirty-three patients, enrolled at 9 U.S. sites between February 2020-August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean STS-PROM for MV replacement was 5.3%. Thirty-one patients were successfully implanted (93.9%). Median post-procedural hospitalization length of stay was 5 days and 87.9% of patients were discharged to home. At 30 days there were no deaths or strokes; 8 patients had major vascular complications (24.2%) none required surgical intervention; there were 4 cases of venous thromboembolism all successfully treated without sequelae; and 1 patient had MV re-intervention for severe LVOT obstruction. At 1-year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, no/trace paravalvular leak in all patients, median (Q1, Q3) mitral valve mean gradient was 4.6 (3.9, 5.3) mmHg, and 91.7% of survivors were in NYHA Class I/II with a median 11.4-point improvement in KCCQ overall summary scores.<br /><b>Conclusion</b><br />The early benefits of the Intrepid Transfemoral Transseptal TMVR System were maintained up to 1 year with low mortality, low re-intervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 10 Oct 2023; epub ahead of print</small></div>

<div><h4>Impact of Post-PCI FFR Stratified by Coronary Artery.</h4><i>Collet C, Johnson NP, Mizukami T, Fearon WF, ... Jüni P, De Bruyne B</i><br /><b>Background</b><br />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.<br /><b>Objectives</b><br />This study sought to assess the predictive capacity of post-PCI FFR for target vessel failure (TVF) stratified by coronary artery.<br /><b>Methods</b><br />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.<br /><b>Results</b><br />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).<br /><b>Conclusions</b><br />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.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 09 Oct 2023; 16:2396-2408</small></div>

<div><h4>Everolimus-Eluting Stents or Bypass Surgery for Multivessel Disease in Diabetics: The BEST Extended Follow-Up Study.</h4><i>Kim H, Kang DY, Ahn JM, Lee J, ... Park SJ, BEST Extended Follow-Up Study Investigators</i><br /><b>Background</b><br />Diabetes mellitus is associated with more complex coronary artery diseases. Coronary artery bypass grafting (CABG) is a preferred revascularization strategy over percutaneous coronary intervention (PCI) in diabetics with multivessel coronary artery disease (MVD).<br /><b>Objectives</b><br />This study sought to examine the different prognostic effects of revascularization strategies according to the diabetes status from the randomized BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial.<br /><b>Methods</b><br />Patients (n = 880) with MVD were randomly assigned to undergo PCI with an everolimus-eluting stent vs CABG stratified by diabetics (n = 363) and nondiabetics (n = 517). The primary endpoint was the composite of death, myocardial infarction, or target vessel revascularization during a median follow-up of 11.8 years (IQR: 10.6-12.5 years).<br /><b>Results</b><br />In diabetics, the primary endpoint rate was significantly higher in the PCI group than in the CABG group (43% and 32%; HR: 1.53; 95% CI: 1.12-2.08; P = 0.008). However, in nondiabetics, no significant difference was found between the groups (PCI group, 29%; CABG group, 29%; HR: 0.97; 95% CI: 0.67-1.39; P = 0.86; P<sub>interaction</sub>= 0.009). Irrespective of the presence of diabetes, no significant between-group differences were found in the rate of a safety composite of death, myocardial infarction, or stroke and mortality rate. However, the rate of any repeat revascularization was significantly higher in the PCI group than in the CABG group.<br /><b>Conclusions</b><br />In diabetics with MVD, CABG was associated with better clinical outcomes than PCI. However, the mortality rate was similar between PCI and CABG irrespective of diabetes status during an extended follow-up. (Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST Extended], NCT05125367; Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST], NCT00997828).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 09 Oct 2023; 16:2412-2422</small></div>

<div><h4>Trends and Outcomes of Antegrade Dissection and Re-Entry in Chronic Total Occlusion Percutaneous Coronary Intervention.</h4><i>Rempakos A, Alexandrou M, Simsek B, Kostantinis S, ... Burke MN, Brilakis ES</i><br /><b>Background</b><br />The contemporary frequency and outcomes of antegrade dissection and re-entry (ADR) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have received limited study.<br /><b>Objectives</b><br />The aim of this study was to determine the frequency and outcomes of ADR use in a large multicenter CTO PCI registry.<br /><b>Methods</b><br />The characteristics and outcomes of ADR were examined among 12,568 patients who underwent 12,841 CTO PCIs at 46 U.S. and non-U.S. centers between 2012 and 2023.<br /><b>Results</b><br />ADR was used in 2,385 of the procedures (18.6%). ADR use declined from 37.9% in 2012 to 14.5% in 2022 (P < 0.001). Patients in whom ADR was used had a high prevalence of comorbidities. Compared with cases that did not use ADR, ADR cases had more complex angiographic characteristics, higher mean J-CTO (Multicenter CTO Registry in Japan) score (2.94 ± 1.11 vs 2.23 ± 1.26; P < 0.001), lower technical success (77.0% vs 89.3%; P < 0.001), and higher in-hospital major adverse cardiac events (3.7% vs 1.6%; P < 0.001). The use of the CrossBoss declined from 71% in 2012 to 1.4% in 2022 and was associated with higher technical success (87%) compared with wire-based techniques (73%). The Stingray device displayed higher technical success (86%) compared with subintimal tracking and re-entry (STAR) (74%) and limited antegrade subintimal tracking (78%); however, its use has been decreasing, with STAR becoming the most used re-entry technique in 2022 (44% STAR vs 38% Stingray).<br /><b>Conclusions</b><br />The use of ADR has been decreasing. ADR was used in more complex lesions and was associated with lower technical success and higher major adverse cardiac events compared with non-ADR cases. There has been a decrease in Stingray use and an increase in the use of STAR for re-entry.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 09 Oct 2023; epub ahead of print</small></div>

<div><h4>Complete Percutaneous Coronary Revascularization in Acute Coronary Syndromes With Multivessel Coronary Disease: A Systematic Review.</h4><i>Faro DC, Laudani C, Agnello FG, Ammirabile N, ... Greco A, Capodanno D</i><br /><AbstractText>Multivessel disease (MVD) affects approximately 50% of patients with acute coronary syndromes (ACS) and is significantly burdened by poor outcomes and high mortality. It represents a clinical challenge in patient management and decision making and subtends an evolving research area related to the pathophysiology of unstable plaques and local or systemic inflammation. The benefits of complete revascularization are established in hemodynamically stable ACS patients with MVD, and guidelines provide some reference points to inform clinical practice, based on an evidence level that is solid for ST-segment elevation myocardial infarction and less robust for non-ST-segment elevation myocardial infarction and cardiogenic shock. However, several areas of uncertainty remain, such as the optimal timing for complete revascularization or the best guiding strategy for intermediate stenoses. We performed a systematic review of current evidence in the field of percutaneous revascularization in ACS and MVD, also including future perspectives from ongoing trials that will directly compare different timing strategies and investigate the role of invasive and noninvasive guidance techniques. (Complete percutaneous coronary revascularization in patients with acute myocardial infarction and multivessel disease; CRD42022383123).</AbstractText><br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 09 Oct 2023; 16:2347-2364</small></div>

<div><h4>QFR Assessment and Prognosis After Nonculprit PCI in Patients With Acute Myocardial Infarction.</h4><i>Lee SH, Hong D, Shin D, Kim HK, ... Lee JM, FRAME-AMI Investigators</i><br /><b>Background</b><br />Complete revascularization using either angiography-guided or fractional flow reserve (FFR)-guided strategy can improve clinical outcomes in patients with acute myocardial infarction (AMI) and multivessel disease. However, there is concern that angiography-guided percutaneous coronary intervention (PCI) may result in un-necessary PCI of the non-infarct-related artery (non-IRA), and its long-term prognosis is still unclear.<br /><b>Objectives</b><br />This study sought to evaluate clinical outcomes after non-IRA PCI according to the quantitative flow ratio (QFR).<br /><b>Methods</b><br />We performed post hoc QFR analysis of non-IRA lesions of AMI patients enrolled in the FRAME-AMI (FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease) trial, which randomly allocated 562 patients into either FFR-guided PCI (FFR ≤0.80) or angiography-guided PCI (diameter stenosis >50%) for non-IRA lesions. Patients were classified by non-IRA QFR values into the QFR ≤0.80 and QFR >0.80 groups. The primary outcome was a major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, and repeat revascularization.<br /><b>Results</b><br />A total of 443 patients (552 lesions) were eligible for QFR analysis. Of 209 patients in the angiography-guided PCI group, 30.0% (n = 60) underwent non-IRA PCI despite having QFR >0.80 in the non-IRA. Conversely, only 2.7% (n = 4) among 209 patients in the FFR-guided PCI group had QFR >0.80 in the non-IRA. At a median follow-up of 3.5 years, the rate of MACEs was significantly higher among patients with non-IRA PCI despite QFR >0.80 than in patients with deferred PCI for non-IRA lesions (12.9% vs 3.1%; HR: 4.13; 95% CI: 1.10-15.57; P = 0.036). Non-IRA PCI despite QFR >0.80 was associated with a higher risk of non-IRA MACEs than patients with deferred PCI for non-IRA lesions (12.9% vs 2.1%; HR: 5.44; 95% CI: 1.13-26.19; P = 0.035).<br /><b>Conclusions</b><br />In AMI patients with multivessel disease, 30.0% of angiography-guided PCI resulted in un-necessary PCI for the non-IRA with QFR >0.80, which was significantly associated with an increased risk of MACEs than in those with deferred PCI for non-IRA lesions. (FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease [FRAME-AMI] ClinicalTrials.gov number; NCT02715518).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 09 Oct 2023; 16:2365-2379</small></div>

<div><h4>The Index of Microcirculatory Resistance After Primary PCI: A Pooled Analysis of Individual Patient Data.</h4><i>El Farissi M, Zimmermann FM, De Maria GL, van Royen N, ... Berry C, Fearon WF</i><br /><b>Background</b><br />Despite treatment with primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI), the risk of heart failure and late death remains high. Microvascular dysfunction, as assessed by the index of microcirculatory resistance (IMR), after primary PCI for STEMI has been associated with worse outcomes. It is unclear whether IMR after primary PCI predicts cardiac death.<br /><b>Objectives</b><br />The aims of this analysis were: 1) to determine if IMR is an independent predictor of cardiac death; 2) to assess the optimal cutoff value of IMR after STEMI; and 3) to compare IMR with several cardiac magnetic resonance parameters, including infarct size.<br /><b>Methods</b><br />In a collaborative, pooled analysis of individual patient data from 6 cohorts that measured IMR directly after primary PCI, cardiac mortality up to 5 years was estimated using Kaplan-Meier analyses. The primary endpoint was cardiac death using the predefined IMR cutoff value of 40.<br /><b>Results</b><br />In total, 1,265 patients were included in this study with a median follow-up of 2.8 years (IQR: 1.2-5.0 years). Cardiac death at 5 years occurred in 2.2% and 4.9% of patients (HR: 2.81; 95% CI: 1.34-5.88; P = 0.006) in the IMR ≤40 and IMR >40 groups, respectively. The composite of cardiac death or hospitalization for heart failure occurred in 4.9% and 8.9% (HR: 1.98; 95% CI: 1.20-3.29; P = 0.008) in the IMR ≤40 and IMR >40 groups, respectively. IMR was an independent predictor of cardiac death, whereas coronary flow reserve was not. The optimal cutoff value of IMR for the prediction of cardiac death in this cohort was 70 (HR: 4.73; 95% CI: 2.27-9.83; P < 0.001). Infarct size was 17.6% ± 13.3% and 23.9% ± 14.6% of the left ventricular mass in the IMR ≤40 and IMR >40 groups, respectively (P < 0.001). Microvascular obstruction and intramyocardial hemorrhage occurred more frequently in the IMR >40 group than in the IMR ≤40 group.<br /><b>Conclusions</b><br />In this large, pooled analysis of individual patient data, IMR measured directly after primary PCI in STEMI was an independent predictor of cardiac death. IMR may be used as a tool to identify patients at the time of primary PCI who are at highest risk for late cardiac mortality and who might benefit most from additional cardioprotective therapies and monitoring.<br /><br />Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 09 Oct 2023; 16:2383-2392</small></div>

<div><h4>Efficacy and Safety of Anticoagulation, Catheter-Directed Thrombolysis, or Systemic Thrombolysis in Acute Pulmonary Embolism.</h4><i>Zhang RS, Maqsood MH, Sharp ASP, Postelnicu R, ... Alviar C, Bangalore S</i><br /><b>Background</b><br />The optimal treatment strategy of patients with pulmonary embolism (PE) (especially those with intermediate risk) continues to evolve and remains controversial.<br /><b>Objectives</b><br />The study sought to compare the efficacy and safety of anticoagulation (AC) alone, catheter-directed thrombolysis (CDT), and systemic thrombolysis (ST) in patients with acute PE.<br /><b>Methods</b><br />PubMed and EMBASE were searched for randomized controlled trials or observational studies which compared outcomes of AC alone, CDT, and ST in acute PE. Efficacy outcome was all-cause mortality. Safety outcomes were major bleeding and intracranial hemorrhage (ICH).<br /><b>Results</b><br />We identified 45 studies (17 randomized controlled trials, 2 prospective nonrandomized trials, and 26 retrospective observational trials), which included 81,705 patients. When compared with AC alone, CDT had lower mortality (OR: 0.55; 95% CI: 0.39-0.80) but higher major bleeding (OR: 1.84; 95% CI: 1.10-3.08) and numerically higher ICH (OR: 1.51; 95% CI: 0.75-3.04). ST was associated with no difference in mortality but higher major bleeding (OR: 2.16; 95% CI: 1.38-3.38) and ICH (OR: 2.26; 95% CI: 1.14-4.48) when compared with AC alone. The risk of mortality (OR: 2.05; 95% CI: 1.46-2.89) and ICH (OR: 1.50; 95% CI: 1.13-1.99) was higher with ST when compared with CDT. Findings were similar when analysis was restricted to trials of intermediate risk PE.<br /><b>Conclusions</b><br />In patients with acute PE, when compared with AC alone, CDT was associated with a lower mortality but higher risk of bleeding. CDT had an enhanced safety profile when compared with ST.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 27 Sep 2023; epub ahead of print</small></div>

<div><h4>Diagnosis, Classification, and Management Strategies for Mitral Annular Calcification: A Heart Valve Collaboratory Position Statement.</h4><i>Guerrero ME, Grayburn P, Smith RL, Sorajja P, ... Leon MB, George I</i><br /><AbstractText>Mitral annular calcium (MAC) with severe mitral valvular dysfunction presents a complex problem, as valve replacement, either surgical or transcatheter, is challenging because of anatomy, technical considerations, concomitant comorbidities, and advanced age. The authors review the clinical and anatomical features of MAC that are favorable (green light), challenging (yellow light), or prohibitive (red light) for surgical or transcatheter mitral valve interventions. Under the auspices of the Heart Valve Collaboratory, an expert working group of cardiac surgeons, interventional cardiologists, and interventional imaging cardiologists was formed to develop recommendations regarding treatment options for patients with MAC as well as a proposed grading and staging system using both anatomical and clinical features.</AbstractText><br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 25 Sep 2023; 16:2195-2210</small></div>

<div><h4>5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results.</h4><i>Guerrero ME, Eleid MF, Wang DD, Pursnani A, ... O\'Neill W, Rihal C</i><br /><b>Background</b><br />The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve-in-mitral annular calcification (ViMAC).<br /><b>Objectives</b><br />The aim of this study was to evaluate 5-year outcomes among these patients.<br /><b>Methods</b><br />A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories.<br /><b>Results</b><br />A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled.<br /><b>Conclusions</b><br />MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 25 Sep 2023; 16:2211-2227</small></div>

<div><h4>Cardiac Death After Transcatheter Aortic Valve Replacement With Contemporary Devices.</h4><i>Mesnier J, Ternacle J, Cheema AN, Campelo-Parada F, ... Modine T, Rodés-Cabau J</i><br /><b>Background</b><br />The burden of cardiac death after transcatheter aortic valve replacement (TAVR), particularly from advanced heart failure (HF) and sudden cardiac death (SCD), remains largely unknown.<br /><b>Objectives</b><br />This study sought to evaluate the incidence and predictors of SCD and HF-related death in TAVR recipients treated with newer-generation devices.<br /><b>Methods</b><br />This study included a total of 5,421 consecutive patients who underwent TAVR with newer-generation devices using balloon (75.7%) or self-expandable (24.3%) valves.<br /><b>Results</b><br />After a median follow-up of 2 (IQR: 1-3) years, 976 (18.0%) patients had died, 50.8% from cardiovascular causes. Advanced HF and SCD accounted for 11.6% and 7.5% of deaths, respectively. Independent predictors of HF-related death were atrial fibrillation (HR: 2.17; 95% CI: 1.47-3.22; P < 0.001), prior pacemaker (HR: 1.79; 95% CI: 1.10-2.92; P = 0.01), reduced left ventricular ejection fraction (HR: 1.08 per 5% decrease; 95% CI: 1.01-1.14; P = 0.02), transthoracic approach (HR: 2.50; 95% CI: 1.37-4.55; P = 0.003), and new-onset persistent left bundle branch block (HR: 1.85; 95% CI: 1.14-3.02; P = 0.01). Two baseline characteristics (diabetes, HR: 1.81; 95% CI: 1.13-2.89; P = 0.01; and chronic kidney disease, HR: 1.72; 95% CI: 1.02-2.90; P = 0.04) and 3 procedural findings (valve in valve, HR: 2.17; 95% CI: 1.01-4.64; P = 0.04; transarterial nontransfemoral approach, HR: 2.23; 95% CI: 1.23-4.48; P = 0.01; and periprocedural ventricular arrhythmia, HR: 7.19; 95% CI: 2.61-19.76; P < 0.001) were associated with an increased risk of SCD after TAVR.<br /><b>Conclusions</b><br />Advanced HF and SCD accounted for a fifth of deaths after TAVR in contemporary practice. Potentially treatable factors leading to increased risk of HF deaths and SCD were identified, such as arrhythmia/dyssynchrony factors for HF and valve-in-valve TAVR or periprocedural ventricular arrhythmias for SCD.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 25 Sep 2023; 16:2277-2290</small></div>

<div><h4>Contemporary Methods for Predicting Acute Kidney Injury After Coronary Intervention.</h4><i>Uzendu A, Kennedy K, Chertow G, Amin AP, ... Curtis JP, Spertus JA</i><br /><b>Background</b><br />Acute kidney injury (AKI) is the most common complication after percutaneous coronary intervention (PCI). Accurately estimating patients\' risks not only creates a means of benchmarking performance but can also be used prospectively to inform practice.<br /><b>Objectives</b><br />The authors sought to update the 2014 National Cardiovascular Data Registry (NCDR) AKI risk model to provide contemporary estimates of AKI risk after PCI to further improve care.<br /><b>Methods</b><br />Using the NCDR CathPCI Registry, we identified all 2020 PCIs, excluding those on dialysis or lacking postprocedural creatinine. The cohort was randomly split into a 70% derivation cohort and a 30% validation cohort, and logistic regression models were built to predict AKI (an absolute increase of 0.3 mg/dL in creatinine or a 50% increase from preprocedure baseline) and AKI requiring dialysis. Bedside risk scores were created to facilitate prospective use in clinical care, along with threshold contrast doses to reduce AKI. We tested model calibration and discrimination in the validation cohort.<br /><b>Results</b><br />Among 455,806 PCI procedures, the median age was 67 years (IQR: 58.0-75.0 years), 68.8% were men, and 86.8% were White. The incidence of AKI and new dialysis was 7.2% and 0.7%, respectively. Baseline renal function and variables associated with clinical instability were the strongest predictors of AKI. The final AKI model included 13 variables, with a C-statistic of 0.798 and excellent calibration (intercept = -0.03 and slope = 0.97) in the validation cohort.<br /><b>Conclusions</b><br />The updated NCDR AKI risk model further refines AKI prediction after PCI, facilitating enhanced clinical care, benchmarking, and quality improvement.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 25 Sep 2023; 16:2294-2305</small></div>

<div><h4>Implications of a Race Term in GFR Estimates Used to Predict AKI After Coronary Intervention.</h4><i>Uzendu A, Kennedy K, Chertow G, Amin AP, ... Anderson C, Spertus JA</i><br /><b>Background</b><br />The prediction of mortality, bleeding, and acute kidney injury (AKI) after percutaneous coronary intervention (PCI) traditionally relied on race-based estimates of the glomerular filtration rate (GFR). Recently, race agnostic equations were developed to advance equity.<br /><b>Objectives</b><br />The authors aimed to compare the accuracy and implications of various GFR equations when used to predict AKI after PCI.<br /><b>Methods</b><br />Using the National Cardiovascular Data Registry (NCDR) CathPCI data set, we identified patients undergoing PCI in 2020 and calculated their AKI risk using the 2014 NCDR AKI risk model. We created 4 AKI models per patient for each estimate of baseline renal function: the traditional GFR equation with a race term, 2 GFR equations without a race term, and serum creatinine alone. We then compared each model\'s performance predicting AKI.<br /><b>Results</b><br />Among 455,806 PCI encounters, the median age was 67 years, 32.2% were women, and 8.5% were Black. In Black patients, risk models without a race term were better calibrated than models incorporating an equation with a race term (intercept: -0.01 vs 0.15). Race-agnostic models reclassified 6% of Black patients into higher-risk categories, potentially prompting appropriate mitigation efforts. However, even with a race-agnostic model, AKI occurred in Black patients 18% more often than expected, which was not explained by captured patient or procedural characteristics.<br /><b>Conclusions</b><br />Incorporating a GFR estimate without a Black race term into the NCDR AKI risk prediction model yielded more accurate prediction of AKI risk for Black patients, which has important implications for reducing disparities and benchmarking.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 25 Sep 2023; 16:2309-2320</small></div>

<div><h4>1- or 3-Month DAPT in Patients With HBR With or Without Oral Anticoagulant Therapy After PCI.</h4><i>Valgimigli M, Spirito A, Sartori S, Angiolillo DJ, ... Windecker S, Mehran R</i><br /><b>Background</b><br />The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients on long-term oral anticoagulation (OAC) therapy is still uncertain.<br /><b>Objectives</b><br />The aim of this analysis was to assess the effects of 1- vs 3-month DAPT in patients with and those without concomitant OAC included in the XIENCE Short DAPT program.<br /><b>Methods</b><br />The XIENCE Short DAPT program enrolled patients with high bleeding risk who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. DAPT was discontinued at 1 or 3 months in patients free from ischemic events and adherent to treatment. The effect of 1- vs 3-month DAPT was compared in patients with and those without OAC using propensity score stratification. The primary endpoint was all-cause death or any myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding. Outcomes were assessed from 1 to 12 months after index PCI.<br /><b>Results</b><br />Among 3,364 event-free patients, 1,462 (43%) were on OAC. Among OAC patients, the risk for death or MI was similar between 1- and 3-month DAPT (7.4% vs 8.8%; adjusted HR: 0.74; 95% CI: 0.49-1.11; P = 0.139), whereas BARC types 2 to 5 bleeding was lower with 1-month DAPT (adjusted HR: 0.71; 95% CI: 0.51-0.99; P = 0.046). These effects were consistent in patients with and those without OAC (P for interaction = NS).<br /><b>Conclusions</b><br />Between 1 and 12 months after PCI, 1-month compared with 3-month DAPT was associated with similar rates of all-cause death or MI and a reduced rate of BARC types 2 to 5 bleeding, irrespective of OAC treatment.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 16 Sep 2023; epub ahead of print</small></div>

<div><h4>Low-Dose vs High-Dose Drug-Coated Balloon for Symptomatic Femoropopliteal Artery Disease: PROSPECT MONSTER Study Outcomes.</h4><i>Nakama T, Takahara M, Iwata Y, Suzuki K, ... Ohki T, PROSPECT MONSTER Study Investigators</i><br /><b>Background</b><br />Randomized trials have shown comparable outcomes between second-generation low-dose drug-coated balloons (LD-DCBs) and first-generation high-dose drug-coated balloons (HD-DCBs); but the trial patients had low clinical complexity, and there were no comparisons in medically complex populations.<br /><b>Objectives</b><br />The aim of this study was to compare outcomes between an LD-DCB (Ranger; 2.0 μg/mm<sup>2</sup>) and an HD-DCB (IN.PACT; 3.5 μg/mm<sup>2</sup>) in patients with symptomatic femoropopliteal artery disease.<br /><b>Methods</b><br />PROSPECT MONSTER (Prospective Comparison of Second-Generation Low-Dose Drug-Coated Balloon With High-Dose Drug-Coated Balloon) was a prospective, multicenter, nonrandomized trial that prospectively collected data from 581 patients who underwent endovascular therapy with the LD-DCB (n = 370) or the HD-DCB (n = 211) for symptomatic femoropopliteal artery disease (Rutherford classes 2-5). The primary outcome was the 1-year primary patency of the LD-DCB in comparison with that of the HD-DCB, as evaluated using propensity score matching. The incidence of impaired flow after drug-coated balloon application was also evaluated.<br /><b>Results</b><br />Propensity score matching extracted 163 pairs (358 and 163 patients in the LD-DCB and HD-DCB groups, respectively), with no significant intergroup difference in baseline characteristics. The 1-year primary patency rates in the matched population were similar between the LD-DCB and HD-DCB groups (87.0% [82.5%-91.7%] vs 81.3% [74.8%-88.5%]; HR: 0.93; 95% CI: 0.55-1.59; P = 0.79), as was the incidence of impaired flow (13.6% vs 9.8%; OR: 1.46; 95% CI: 0.78-2.73; P = 0.24). No baseline characteristics had any significant interaction effects on the association of the LD-DCB vs the HD-DCB and 1-year restenosis risk.<br /><b>Conclusions</b><br />LD-DCBs demonstrate efficacy and safety comparable with HD-DCBs in patients with complex clinical backgrounds, suggesting that drug-coated balloon treatment using a lower dose may be possible.<br /><br />Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 11 Sep 2023; epub ahead of print</small></div>

<div><h4>CTO and Bifurcation Lesions: An Expert Consensus From the European Bifurcation Club and EuroCTO Club.</h4><i>Lefèvre T, Pan M, Stankovic G, Ojeda S, ... Mashayekhi K, Werner GS</i><br /><AbstractText>Knowledge in the field of bifurcation lesions and chronic total occlusions (CTOs) has progressively improved over the past 20 years. Therefore, the European Bifurcation Club and the EuroCTO Club have decided to write a joint consensus statement to share general knowledge and practical approaches in this complex field. When percutaneously treating CTOs, bifurcation lesions with relevant side branches (SBs) are found in approximately one-third of cases (35% at the proximal cap, 38% at the distal cap, and 27% within the CTO body). Occlusion of a relevant SB is not rare and has been shown to be associated with procedural complications and adverse outcomes. Simple bifurcation rules are very useful to prevent SB occlusion, and provisional SB stenting is the recommended approach in the majority of cases: protect the SB as soon as possible by wiring it, respect the fractal anatomy of the bifurcation by using the 3-diameter rule, and avoid using dissection and re-entry techniques. A systematic 2-stent approach can be used if needed or sometimes to connect both branches of the bifurcation. The retrograde approach can be very useful to save a relevant SB, especially in the case of a bifurcation at the distal cap or within the CTO body. Intravascular ultrasound is also a very important tool to address the difficulties with bifurcations at the proximal or distal cap and sometimes also within the CTO segment. Double-lumen microcatheters and angulated microcatheters are crucial tools to resolve access difficulties to the SB or the main branch.</AbstractText><br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 11 Sep 2023; 16:2065-2082</small></div>

<div><h4>Histology, OCT, and Micro-CT Evaluation of Coronary Calcification Treated With Intravascular Lithotripsy: Atherosclerotic Cadaver Study.</h4><i>Kawai K, Sato Y, Hokama JY, Kawakami R, ... Virmani R, Finn AV</i><br /><b>Background</b><br />Although intravascular lithotripsy (IVL) has been an emerging novel option to treat vascular calcification, the specific effects on histology have not been systematically examined.<br /><b>Objectives</b><br />The authors examined the histologic effects of IVL on coronary calcified lesions from human autopsy hearts and evaluated the diagnostic ability of optical coherence tomography (OCT) and micro-computed tomography (CT) to detect calcium fracture as identified by the gold standard histology.<br /><b>Methods</b><br />Eight coronary lesions were treated with IVL, and 7 lesions were treated with 10 atm inflation using an IVL catheter balloon without lithotripsy pulses (plain old balloon angioplasty [POBA]). OCT and micro-CT imaging were performed before and after treatment, and the presence of calcium fracture was assessed. The frequency and size of fractures were measured and compared with the corresponding histology.<br /><b>Results</b><br />All 15 treated lesions were diagnosed as sheet calcium by histology. Histological evidence of calcium fracture was significantly greater in the IVL group compared with the POBA group (62.5% vs 0.0%; P = 0.01). Calcified lesions with fracture had a larger maximum arc degree of calcification (median 145.6 [IQR: 134.4-300.4] degrees vs 107.0 [IQR: 88.9-129.1] degrees; P = 0.01). Micro-CT and histology showed an excellent correlation for fracture depth (R<sup>2</sup> = 0.83; P < 0.0001), whereas OCT showed less correlation (R<sup>2</sup> = 0.37; P = 0.11). The depth of fractures measured by OCT were significantly shorter than with those measured by histology (0.49 [IQR: 0.29-0.77] mm vs 0.88 [IQR: 0.64-1.07] mm; P = 0.008).<br /><b>Conclusions</b><br />IVL demonstrated a histologically superior fracturing effect on coronary calcified lesions compared with POBA. OCT failed to identify the presence of some calcium fractures and underestimated the depth of fracture when compared with micro-CT.<br /><br />Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 11 Sep 2023; 16:2097-2108</small></div>

<div><h4>Outcomes Based on Angiographic vs Functional Significance of Complex 3-Vessel Coronary Disease: FAME 3 Trial.</h4><i>Kobayashi Y, Takahashi T, Zimmermann FM, Otsuki H, ... Fearon WF, FAME 3 Trial Investigators</i><br /><b>Background</b><br />The functional SYNTAX score (FSS), which incorporates functional information as assessed by fractional flow reserve (FFR), is a better predictor of outcome after percutaneous coronary intervention (PCI) in patients with less complex coronary artery disease (CAD).<br /><b>Objectives</b><br />This study sought to test the prognostic value of the FSS in patients with complex CAD eligible for coronary artery bypass grafting (CABG).<br /><b>Methods</b><br />The FAME 3 (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3) trial compared FFR-guided PCI with CABG in patients with angiographic 3-vessel CAD. In this prespecified substudy, the angiographic core laboratory calculated the SYNTAX score (SS) and then the FSS by eliminating lesions that were not significant based on FFR. Outcomes in the PCI patients based on the FSS and the SS were compared to each other and to the patients treated with CABG.<br /><b>Results</b><br />The FSS reclassified more than one-quarter of patients from an SS >22 to an FSS ≤22. In the 50% of PCI patients who had an FSS ≤22, the primary endpoint occurred at a similar rate to patients treated with CABG (P = 0.77). The primary endpoint in patients without functionally significant 3-vessel CAD was similar to the CABG group (P = 0.97). The rate of myocardial infarction and revascularization among all deferred lesions was 0.5% and 3.2%, respectively.<br /><b>Conclusions</b><br />By measuring the FSS, one can identify 50% of patients who have a similar outcome at 1 year with PCI compared with CABG. Lesions deferred from PCI based on FFR have a low event rate.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 11 Sep 2023; 16:2112-2119</small></div>

<div><h4>Direct Comparison of Rotational vs Orbital Atherectomy for Calcified Lesions Guided by Optical Coherence Tomography.</h4><i>Okamoto N, Egami Y, Nohara H, Kawanami S, ... Nishino M, Tanouchi J</i><br /><b>Background</b><br />There are several retrospective studies comparing rotational atherectomy (RA) and orbital atherectomy (OA), but all percutaneous coronary interventions (PCIs) in those studies were not performed under intracoronary imaging guidance.<br /><b>Objectives</b><br />This study sought to compare the efficacy and safety of optical coherence tomography (OCT)-guided PCI with RA vs OA.<br /><b>Methods</b><br />The DIRO (To directly compare RA and OA for calcified lesions, a prospective randomized trial) trial was conducted. We enrolled patients with de novo calcified lesions (arc >180°) assessed by OCT or angiographically moderate or severe calcifications if the OCT catheter could not cross the lesion before any intervention. Eligible patients were randomly 1:1 allocated to lesion preparation with RA vs OA. Stent expansion was defined as the minimum stent area divided by the distal reference area multiplied by 100. Tissue modification was assessed using preatherectomy and postatherectomy OCT images. Procedural outcomes including periprocedural myocardial infarctions were evaluated. Furthermore, clinical events and vascular healing evaluated by OCT at 8 months postprocedure were assessed.<br /><b>Results</b><br />The stent expansion was significantly greater in the RA group vs the OA group (99.5% vs 90.6%; P = 0.02). The maximum atherectomy area was significantly larger in the RA group than in the OA group (1.34 [IQR: 1.02-1.89] mm<sup>2</sup> vs 0.83 [IQR: 0.59-1.11] mm<sup>2</sup>; P = 0.004). The procedural outcomes and clinical events at 8 months did not differ between the groups. The vascular healing was sufficient in both groups.<br /><b>Conclusions</b><br />The prospective randomized DIRO trial revealed that RA could produce a more favorable tissue modification, which may lead to a larger stent expansion than OA in heavily calcified lesions.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 11 Sep 2023; 16:2125-2136</small></div>

<div><h4>Late Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention in the Workup Pre-TAVR.</h4><i>Avvedimento M, Campelo-Parada F, Munoz-Garcia E, Nombela-Franco L, ... Faroux L, Rodés-Cabau J</i><br /><b>Background</b><br />In patients undergoing percutaneous coronary intervention (PCI) in the work-up pre-transcatheter aortic valve replacement (TAVR), the incidence and clinical impact of late bleeding events (LBEs) remain largely unknown.<br /><b>Objectives</b><br />This study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of LBEs in patients undergoing PCI in the work-up pre-TAVR.<br /><b>Methods</b><br />This was a multicenter study including 1,457 consecutive patients (mean age 81 ± 7 years; 41.5% women) who underwent TAVR and survived beyond 30 days. LBEs (>30 days post-TAVR) were defined according to the Valve Academic Research Consortium-2 criteria.<br /><b>Results</b><br />LBEs occurred in 116 (7.9%) patients after a median follow-up of 23 (IQR: 12-40) months. Late bleeding was minor, major, and life-threatening or disabling in 21 (18.1%), 63 (54.3%), and 32 (27.6%) patients, respectively. Periprocedural (<30 days post-TAVR) major bleeding and the combination of antiplatelet and anticoagulation therapy at discharge were independent factors associated with LBEs (P ≤ 0.02 for all). LBEs conveyed an increased mortality risk at 4-year follow-up compared with no bleeding (43.9% vs 36.0; P = 0.034). Also, LBE was identified as an independent predictor of all-cause mortality after TAVR (HR: 1.39; 95% CI: 1.05-1.83; P = 0.020).<br /><b>Conclusions</b><br />In TAVR candidates with concomitant significant coronary artery disease requiring percutaneous treatment, LBEs after TAVR were frequent and associated with increased mortality. Combining antiplatelet and anticoagulation regimens and the occurrence of periprocedural bleeding determined an increased risk of LBEs. Preventive strategies should be pursued for preventing late bleeding after TAVR, and further studies are needed to provide more solid evidence on the most safe and effective antithrombotic regimen post-TAVR in this challenging group of patients.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 11 Sep 2023; 16:2153-2164</small></div>