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Background: The optimal treatment for coronary calcified nodules (CNs) is still unclear. The aim of this study was to compare the modification of these lesions by coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA) using optical coherence tomography (OCT)., Methods: ROTA.shock was a 1:1 randomized, prospective, double-arm multi-center non-inferiority trial that compared the use of IVL and RA with percutaneous coronary intervention (PCI) in severely calcified lesions. In 19 of the patients out of this study CNs were detected by OCT in the target lesion and were treated by either IVL or RA., Results: The mean angle of CNs was significantly larger in final OCT scans than before RA (92 ± 17° vs. 68 ± 7°; p = 0.01) and IVL (89 ± 18° vs. 60 ± 10°; p = 0.03). The CNs were thinner upon final scans than in initial native scans (RA: 17.8 ± 7.8 mm vs. 38.6 ± 13.1 mm; p = 0.02; IVL: 16.5 ± 9.0 mm vs. 37.2 ± 14.3 mm; p = 0.02). Nodule volume did not differ significantly between native and final OCT scans (RA: 0.66 ± 0.12 mm 3 vs. 0.61 ± 0.33 mm 3 ; p = 0.68; IVL: 0.64 ± 0.19 mm 3 vs. 0.68 ± 0.22 mm 3 ; p = 0.74). Final stent eccentricity was high with 0.62 ± 0.10 after RA and 0.61 ± 0.09 after IVL., Conclusion: RA or IVL are unable to reduce the volume of the calcified plaque. CN modulation seems to be mainly induced by the stent implantation and not by RA or IVL., Competing Interests: Declaration of competing interest Tommaso Gori received grant support and speaker's honoraria from Abbott vascular and speaker's honoraria from Boston Scientific and Shockwave Medical. Luise Gaede received speaker's honoraria from Abbott vascular, Boston Scientific and Shockwave Medical. Maren Weferling has received speaker's honoraria from Boston Scientific and Shockwave Medical. Helge Möllmann received speaker's honoraria from Boston Scientific and Shockwave Medical. Holger Nef received grant support and speaker's honoraria from Abbott vascular and Shockwave Medical. All other authors report no relevant conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV)., Background: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI., Methods: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated., Results: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049)., Conclusions: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI., Competing Interests: Funding Support and Author Disclosures Dr Pagnesi has received personal fees from Abbott, AstraZeneca, Boehringer Ingelheim, and Vifor Pharma. Dr Kim is a proctor for Boston Scientific and Abbott Vascular; and has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and Meril outside the submitted work. Dr Barbanti has served as a consultant for Edwards Lifesciences. Dr De Marco has served as a proctor for Boston Scientific and Kardia. Dr Adamo has received speaker fees from Abbott Vascular and Medtronic. Dr Estévez-Loureiro has served as a consultant for Abbott Vascular and Boston Scientific; and is a proctor for Lifetech Scientific. Dr Conradi has served as an advisory board member for Abbott, Medtronic, JenaValve, and Neovasc; and has received personal fees from Edwards Lifesciences, Boston Scientific, and MicroInterventions. Dr Toggweiler is a proctor for Abbott Vascular, Boston Scientific, Medtronic, and Biosensors/NVT; and is a consultant for Boston Scientific, Medtronic, Biosensors/NVT, Medira, Shockwave, Teleflex, AtHeart, VeoSource, and Equity in Hi-D Imaging. Dr Mylotte is a proctor for Medtronic and Microport. Dr Veulemans has received lecture fees and travel support from Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic and SMT. Dr Wolf is a proctor for Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Pilgrim has received institutional research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received personal fees from Boston Scientific, Biotronik, Abbott, Medtronic, and HighLifeSAS outside the submitted work. Dr Montorfano serves as a proctor for Edwards Lifesciences, Abbott Vascular, and Kardia. Dr Hildick-Smith has served as an adviser or proctor for Edwards Lifesciences, Boston Scientific, and Medtronic. Dr Taramasso is a consultant for Boston Scientific, Abbott Vascular, 4Tech, and CoreMedic; and has received speaker fees from Edwards Lifesciences. Dr Sinning is a proctor for Medtronic and Boston Scientific; has received speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received research grants from Boston Scientific, Edwards Lifesciences, and Medtronic outside the submitted work. Dr Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi Sankyo; and has received advisory fees from Abbott Vascular, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi Sankyo. Dr Khogali is a proctor for Medtronic and Boston Scientific. Dr Wood has received grant support from Boston Scientific; and is a consultant for Medtronic. Dr MacCarthy is a proctor for Edwards Lifesciences. Dr Hamm has served on advisory boards for Medtronic. Dr Schäfer is a proctor for Boston Scientific and Medtronic; and has received lecture fees and travel support from both companies. Dr Zeus is a proctor for Medtronic; and has received speaker fees and financial scientific support from Medtronic and Edwards Lifesciences. Dr Naber has received lecture fees from Boston Scientific, Medtronic, and Abbott Vascular; and has served on advisory boards for Boston Scientific and Abbott Vascular. Dr Windecker has received institutional research and educational grants from Abbott Vascular, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave. Dr Siqueira is a proctor for Medtronic and Edwards Lifesciences. Dr Sedaghat has received travel grants and support from Medtronic. Dr Metra has received personal fees from Amgen, Vifor Pharma, AstraZeneca, Abbott Vascular, Bayer, Servier, Edwards Therapeutics, Actelion, LivaNova, and Windtree Therapeutics. Dr Latib has served on advisory boards or as a consultant for Medtronic, Boston Scientific, Philips, Edwards Lifesciences. and Abbott Vascular. Dr Mangieri has received an institutional research grant from Boston Scientific; has served on a medical advisory board for Boston Scientific; and has received speaker honoraria from Concept Medical and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr Kim has received personal fees from Abbott. Dr Colli is an unpaid consultant for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Elevated pulmonary vascular resistance (PVR) is broadly accepted as an imminent risk factor for mortality after heart transplantation (HTx). However, no current HTx recipient risk score includes PVR or other hemodynamic parameters. This study examined the utility of various hemodynamic parameters for risk stratification in a contemporary HTx population., Methods: Patients from seven German HTx centers undergoing HTx between 2011 and 2015 were included retrospectively. Established risk factors and complete hemodynamic datasets before HTx were analyzed. Outcome measures were overall all-cause mortality, 12-month mortality, and right heart failure (RHF) after HTx., Results: The final analysis included 333 patients (28% female) with a median age of 54 (IQR 46-60) years. The median mean pulmonary artery pressure was 30 (IQR 23-38) mm Hg, transpulmonary gradient 8 (IQR 5-10) mm Hg, and PVR 2.1 (IQR 1.5-2.9) Wood units. Overall mortality was 35.7%, 12-month mortality was 23.7%, and the incidence of early RHF was 22.8%, which was significantly associated with overall mortality (log-rank HR 4.11, 95% CI 2.47-6.84; log-rank p < .0001). Pulmonary arterial elastance (Ea) was associated with overall mortality (HR 1.74, 95% CI 1.25-2.30; p < .001) independent of other non-hemodynamic risk factors. Ea values below a calculated cutoff represented a significantly reduced mortality risk (HR 0.38, 95% CI 0.19-0.76; p < .0001). PVR with the established cutoff of 3.0 WU was not significant. Ea was also significantly associated with 12-month mortality and RHF., Conclusions: Ea showed a strong impact on post-transplant mortality and RHF and should become part of the routine hemodynamic evaluation in HTx candidates., (Copyright © 2022 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: The combination of riociguat and interventional balloon pulmonary angioplasty (BPA) is currently used to treat patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). The aim of the present study was to evaluate the impact of this combination therapy on the prognosis of inoperable CTEPH patients by comparing the long-term survival rates of patients undergoing combination therapy with riociguat and BPA with those of inoperable patients from the first international CTEPH registry who did not receive specific treatment., Methods: Between March 2014 and August 2019, 138 technically inoperable patients were included in the present prospective, observational cohort study when they were treated with riociguat and BPA at a single CTEPH referral center. Long-term survival of this cohort was compared using propensity score matching with that of inoperable patients recruited between 2007 and 2009 in the first international CTEPH registry. Kaplan-Meier methods were used to evaluate differences in outcomes., Results: Whereas the survival rate in the historical group was 84.6% in the first year, 76.6% in the second, 68.5% in the third, and 58.5% in the fifth year after diagnosis, implementation of riociguat/BPA led to survival rates of 100%, 96.7%, 92.9%, and 90% in the respective follow-up periods. In a comparison of 83 well-matched pairs from the 2 cohorts, survival was markedly better in the group treated with riociguat and BPA than in the historical cohort (HR = 0.145, 95% CI 0.05, 0.421)., Conclusion: The combination of riociguat and BPA for the treatment of inoperable CTEPH is associated with excellent 5-year survival rates., (Copyright © 2022 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objective: The present study was designed to investigate the dynamics of right atrial pressure (RAP) and mid-regional pro-atrial natriuretic peptide (MR-proANP) during physical exercise in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and to determine whether these parameters might serve as a tool to measure exercise-dependent atrial stress as an indicator of right heart failure., Methods: This prospective observational cohort study included 100 CTEPH patients who underwent right heart catheterization during physical exercise (eRHC). Blood samples for MR-proANP measurement were taken prior, during, and after eRHC. MR-proANP levels were correlated to RAP levels at rest, at peak exercise (eRAP), and during recovery. RAP at rest ≤7 mmHg was defined as normal and eRAP >15 mmHg as suggestive of right heart failure., Results: During eRHC mean RAP increased from 6 mmHg (standard deviation, SD 4) to 16 mmHg (SD 7; p < 0.001). MR-proANP levels and dynamics correlated with RAP at rest (r s  = 0.61; p < 0.001) and at peak exercise (r s  = 0.66; p < 0.001). Logistic regression analysis revealed the peak MR-proANP level (B = 0.058; p = 0.004) and the right atrial area (B = 0.389; p < 0.001) to be associated with eRAP dynamics. A peak MR-proANP level ≥139 pmol/L (AUC = 0.81) and recovery level ≥159 pmol/L (AUC = 0.82) predicted an eRAP >15 mmHg. Physical exercise unmasked right heart failure in 39% of patients with normal RAP at rest; these patients were also characterized by a more distinct increase in MR-proANP levels (p = 0.005) and higher peak (p < 0.001) and recovery levels (p < 0.001)., Conclusions: RAP and MR-proANP dynamics unmask manifest and latent right heart failure in CTEPH patients., (Copyright © 2022 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: There is a paucity of data regarding the safety and efficacy of different antiplatelet regimens according to standardized body mass index (BMI) categories., Objectives: The aim of this study was to investigate bleeding and ischemic outcomes according to BMI in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial., Methods: The TWILIGHT trial randomized high-risk patients to ticagrelor plus aspirin or ticagrelor plus placebo at 3 months after percutaneous coronary intervention. In this secondary analysis, patients were stratified by standard BMI categories, as recommended by the European Society of Cardiology Working Group on Thrombosis (normal weight [BMI 18.5-24.99 kg/m 2 ], overweight [BMI 25-29.99 kg/m 2 ], and obese [BMI ≥30 kg/m 2 ]) and by median BMI, as prespecified in the protocol., Results: Among 7,038 patients randomized and with available BMI, 1,807 (25.7%) were normal weight, 2,927 (41.6%) were overweight, and 2,304 (32.7%) were obese. In normal-weight, overweight, and obese patients, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced the primary endpoint of Bleeding Academic Research Consortium type 2, 3, or 5 bleeding (normal weight: HR: 0.48 [95% CI: 0.32-0.73]; overweight: HR: 0.57 [95% CI: 0.41-0.78]; obese: HR: 0.63 [95% CI: 0.44-0.91]; P for interaction = 0.627), without any increase in the composite ischemic endpoint of all-cause death, myocardial infarction, or stroke (normal weight: HR: 1.36 [95% CI: 0.84-2.19]; overweight: HR: 0.92 [95% CI: 0.63-1.35]; obese: HR: 0.84 [95% CI: 0.56-1.25]; P for interaction = 0.290). These findings were consistent with the prespecified analysis by median BMI., Conclusions: Among high-risk patients undergoing percutaneous coronary intervention, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced bleeding events without any increase in ischemic risk across different BMI categories., Competing Interests: Funding Support and Author Disclosures This research was supported by an investigator-initiated grant from AstraZeneca. Dr Baber has received honoraria from AstraZeneca and Boston Scientific. Dr Cohen has received grant support, paid to his institution, and consulting fees from AstraZeneca, Medtronic, and Abbott Vascular; and has received grant support, paid to his institution, from Boston Scientific. Dr Angiolillo has received consulting fees or honoraria from Abbott, Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; has received payments for participation in review activities from CeloNova and St. Jude Medical, outside the present work; and has received research grants to the institution from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry, Merck, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation. Dr Dangas has received consulting fees and advisory board fees from AstraZeneca; has received consulting fees from Biosensors; and previously held stock in Medtronic. Dr Escaned has received consulting and lecture fees from Abbott, Philips, Boston Scientific, and Medtronic; and has received lecture fees from Abiomed, Terumo, and Biosensors. Dr Gurbel has received grant support and consulting fees from Bayer, Medicure, US WorldMeds, and Merck; has received grant support from Instrumentation Laboratory, Haemonetics, Amgen, Idorsia, Janssen, and Ionis; and holds patent 9188597 on detection of restenosis risk in patients receiving stents by measuring the characteristics of blood clotting, including measurement of maximum thrombin-induced clot strength. Dr Hamm has received lecture and advisory board fees from AstraZeneca. Dr Huber has received lecture fees from AstraZeneca and Bayer. Dr Mehta has received grant support from and has served on an executive committee and as site investigator for AstraZeneca. Dr Ohman has received consulting fees from 3D Communications, ACI Clinical, Biotie, Cara Therapeutics, Cardinal Health, Faculty Connection, Imbria, Impulse Medical, Janssen Pharmaceuticals, Medscape, Milestone Pharmaceuticals, and XyloCor; has received grant support and consulting fees from Abiomed; and has received grant support from Chiesi and Portola. Dr Oldroyd has received grant support and lecture fees from AstraZeneca. Dr Steg has received grant support and fees for serving on a steering committee from Bayer/Janssen; has received grant support and lecture fees from Merck; has received grant support, fees for serving as co-chair of trials, consulting fees, and lecture fees from Sanofi; has received grant support, fees for serving on an executive steering committee, and consulting fees from Amarin; has received consulting and lecture fees from Amgen; has received consulting fees, lecture fees, and fees for serving on a critical event committee from Bristol Myers Squibb; has received fees for serving on an executive steering committee from Boehringer Ingelheim; has received fees for serving on a critical event committee from Pfizer; has received fees for serving on a steering committee and consulting fees from Novartis; has received consulting fees from Regeneron, Eli Lilly, and Novo Nordisk; has received consulting and lecture fees from AstraZeneca; has received grant support, fees for serving as chair of a data monitoring committee, and fees for serving as chair of a registry from Servier; and has received fees for serving on a steering committee from Idorsia. Dr. Gibson has received grant support and consulting fees from Angel Medical, Bayer, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson, and Portola Pharmaceuticals; has received consulting fees from The Medicines Company, Eli Lilly, Gilead Sciences, Novo Nordisk, WebMD, UpToDate Cardiovascular Medicine, Amarin Pharma, Amgen, Boehringer Ingelheim, Chiesi, Merck, PharmaMar, Sanofi, Somahlution, Verreseon, Boston Scientific, Impact Bio, MedImmume, Medtelligence, MicroPort, the PERT Consortium, and GE Healthcare; holds equity in Inference; serves as chief executive officer of the Baim Institute; and has received grant support, paid to the Baim Institute, from Bristol Myers Squibb and Astra Zeneca. Dr Mehran has received institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol Myers Squibb, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, Daiichi Sankyo, Insel Gruppe, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, and Zoll; has received personal fees from the American College of Cardiology, Boston Scientific, the California Institute for Regenerative Medicine, Cine-Med Research, Janssen, WebMD, and the Society for Cardiovascular Angiography and Interventions; has received consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, CardiaWave, CeloNova, Chiesi, Concept Medical, Daiichi Sankyo, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, and Philips; holds equity (<1%) in Applied Therapeutics, Elixir Medical, STEL, and CONTROLRAD (spouse); and is a scientific advisory board member for the American Medical Association and Biosensors (spouse). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Para-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases)., Methods: Patients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation., Results: Core-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV., Conclusions: This study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome., Objectives: The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV., Methods: Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91])., Results: Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm 2 vs 1.3 ± 0.8 cm 2 ; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176)., Conclusions: In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR., Competing Interests: Funding Support and Author Disclosures Dr Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr Kim is a proctor for and has received speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr Abdel-Wahab has received speaker honoraria and/or consultancy fees to the hospital on his behalf from Boston Scientific and Medtronic. Dr Barbanti is a consultant for Edwards Lifesciences; and is an advisory board member for Biotronik. Dr Søndergaard has received consulting fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr Redwood is a proctor for and has received lecture fees from Edwards Lifesciences. Dr Hamm is an advisory board member for Medtronic. Dr Sinning has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Sathananthan is a consultant to Edwards Lifesciences. Dr Schofer has received speaker fees and travel compensation from Boston Scientific; and has received travel compensation from Edwards Lifesciences and Abbott/St. Jude Medical. Dr Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr Castriota is a proctor for Medtronic and Boston Scientific. Dr Nazif is a consultant for or has received honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Biotrace, and Baylis Medical; and is a consultant for and holds equity in Venus Medtech. Dr Pilgrim has received research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received speaker fees from Boston Scientific and Biotronik. Dr Babaliaros is a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr Van Mieghem has received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi Sankyo, and PulseCath; and has received institutional research grant support from Edwards Lifesciences. Dr Latib has received institutional research and grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and has received personal consulting honoraria from Abbott, Edwards Lifesciences, and Medtronic. Dr Hildick-Smith is a proctor and adviser for Boston Scientific, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Background: Balloon pulmonary angioplasty (BPA) is an emerging interventional treatment for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) that targets subsegmental branches of the pulmonary artery. As the reported complication rates are high, the aim of the present study was to evaluate the effects of certain complications on the outcome after treatment., Methods: From March 2014 to December 2019, a total of 235 patients with inoperable CTEPH underwent BPA. Of these patients, 140 were included who completed a follow-up examination 6 months after the last intervention; another 2 patients deceased due to complications of BPA., Results: A high baseline pulmonary vascular resistance (PVR) >6.6 WU correlated with a higher rate of complications (mostly pulmonary artery perforations). Wire perforation during BPA did not correlate with worse outcome in terms of PVR reduction. The complication rate per intervention decreased from 21% to 14% during the 5 year period of the study., Conclusions: Complications are frequently observed in BPA, but the mortality rate is very low in expert centers. Importantly, the occurrence of complications does not portend a worse outcome., (Copyright © 2022 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Whether the access site influences the comparative efficacy and safety of ticagrelor and prasugrel in patients with acute coronary syndrome (ACS) undergoing invasive treatment strategy remains unstudied., Methods: This post-hoc analysis included ACS patients undergoing invasive treatment via radial or femoral access and randomized to either ticagrelor or prasugrel in the ISAR-REACT 5 trial. The primary efficacy endpoint was the composite of death, myocardial infarction (MI) or stroke, safety endpoint was BARC 3 to 5 bleeding. Outcomes were assessed out to 12 months after randomization., Results: Out of 4018 patients, 3984 underwent invasive treatment via radial or femoral access. 1479 had coronary angiography via radial access (ticagrelor, N = 748; prasugrel, N = 731) and 2505 via femoral access (ticagrelor, N = 1245; prasugrel, N = 1260). There was no interaction between access route and assignment to either ticagrelor or prasugrel regarding the primary efficacy or safety endpoints (P for interaction≥0.616). In the radial group, the primary efficacy endpoint (7.6% versus 5.8%, HR: 1.32 [0.88-1.97], P = 0.151) and the safety endpoint (4.3% versus 3.0%, HR: 1.36, [0.73-1.31], P = 0.300) were not statistically different in patients receiving either ticagrelor or prasugrel. In the femoral group, the primary efficacy endpoint occurred more frequently in patients assigned to ticagrelor as compared to prasugrel (10.3% versus 7.3%, HR: 1.44 [1.10-1.88], P = 0.006) without significant difference in terms of safety endpoint (6.4% versus 5.8%, HR: 1.14, [0.81-1.60], P = 0.470)., Conclusions: In patients with ACS undergoing an invasive treatment strategy, the access route does not influence the comparative efficacy and safety of ticagrelor and prasugrel., Clinical Trial Registration: NCT01944800., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: Malpositioning of transcatheter heart valves increases the risk of procedural failure. For the ACURATE system, inadvertent movement of the prosthesis to a varying extent is sometimes observed upon full release, but the incidence, mechanisms, and clinical impact of such valve micro-dislodgement (VMD) are poorly understood. The aim of the present study was to assess the incidence, predictors, and clinical outcomes of VMD in an all-comers population that underwent transcatheter aortic valve implantation (TAVI) with the ACURATE neo2 prosthesis (NEO2)., Methods: This was a retrospective analysis of 448 consecutive patients who underwent transfemoral TAVI with NEO2 at our institution. VMD was defined as displacement ≥2 mm between the initial position and immediately after valve release as measured on fluoroscopy at the non-coronary cusp. The initial valve position prior to step 2 was categorized using the radiopaque marker band (RMB) relative to the annular plane. In addition, further anatomical and procedural characteristics were assessed., Results: A total of 68 (15.2%) cases with VMD were identified. A larger cover index, higher RMB position, partial detachment of the lower crown, and severe parallax prior to deployment were independent predictors of VMD, whereas a position of the delivery system in the outer curvature was protective against VMD. Among patients with VMD, the rates of valvular malpositioning and thus technical failure (VARC-3) were higher, but mean transprosthetic gradients were lower., Conclusions: VMD occurs in a notable proportion of transfemoral TAVI cases with NEO2 and is associated with more frequent technical failure of the procedure., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Radial (RA) instead of femoral access (FA) for coronary interventions has become a European Society of Cardiology Class-IA guideline recommendation. But when the decision on the access site is left to the discretion of the operator, differences in adverse event rates mitigate., Methods: We compared the 30-day outcome for RA and FA in all patients recruited for the observational German Austrian ABSORB Registry (GABI-R) in regard to all-cause mortality, stroke, myocardial infarction (MI), TIMI major bleedings (TMB) and quality of life (QoL). All patients were treated with a bioresorbable vascular scaffold. Access site was left to the discretion of the operator., Results: In total, 3137 patients included by 92 centers received percutaneous coronary interventions (PCI) for acute MI in 51.5% and non-acute settings in 48.5%. RA was performed in 47.8% and had a higher median radiation exposure (3896 vs. 3082 cGycm 2 , p < 0.001). There was no difference in the amount of contrast used. There was also no difference in all-cause mortality (0.53% vs. 0.49%, p = 0.86), the combination of death, MI and stroke (1.87% vs. 1.83%, p = 0.94), but a trend towards more TMB (0.47% vs. 1.04%, p = 0.07) with FA. These outcomes were consistent across the subgroups of patients with ST-elevation MI, non-ST-elevation-ACS and stable coronary artery disease. Finally, QoL did not differ between RA and FA., Conclusions: In this contemporary GABI-R cohort, in which access site was left to the discretion of the operator, both access routes were safe and equal concerning QoL (ClinicalTrials.gov; NCT02066623)., Competing Interests: Declaration of competing interest, (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Despite excellent procedural results in a broad clinical population, certain anatomical or clinical conditions are still challenging for transcatheter aortic valve replacement (TAVI). Whether the adherence to the instructions for use (IFU) or the use of a clinically suitable device is a prerequisite for procedural success has not been well characterized., Aims: The anatomical and clinical suitability of new-generation transcatheter heart valves (THV) was evaluated in an all-comers population (n = 540) at a high-volume center., Methods: Conformity with anatomical IFU criteria was evaluated in each implanted THV. In addition, the suitability of the implanted THV was verified in each case according to clinical and anatomical criteria, which had been previously defined according to the results of an international survey including 20 renowned TAVI operators. Furthermore, criteria of clinical suitability and adherence to IFU of each THV were applied to the overall cohort to analyze the proportion of patients in whom the use of the respective THV would have been judged to be unsuitable or off-label., Results: An off-label use of THV based on anatomical considerations was found in 20% of all procedures, whereas the implantation of a THV deemed to be clinically unsuitable was noted in 16.3% of all procedures. Clinical suitability and conformity with IFU were present to a varying extent across the THV systems. Neither clinical suitability, nor conformity with IFU were associated with device failure or periprocedural mortality. On multivariable analysis, aortic tortuosity, mean transaortic gradient and ascending aorta diameter were identified as independent predictors of device failure (VARC-3)., Conclusions: Off-label TAVI and the use of clinically unsuitable THVs were common, but did not affect procedural outcomes. The variety of clinical and anatomical coverage of the different THV systems emphasizes the importance of an individualized THV selection., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objectives: The aim of this study was to evaluate if patients with prior myocardial infarction (MI) could benefit from ticagrelor monotherapy in terms of bleeding reduction without any compromise in ischemic event prevention., Background: Patients with history of MI who undergo percutaneous coronary intervention (PCI) remain at risk for recurrent ischemic events. The optimal antithrombotic strategy for this cohort remains debated., Methods: In this prespecified analysis of the randomized TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, the authors evaluated the impact of history of MI on treatment effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing PCI with drug-eluting stent with at least 1 clinical and 1 angiographic high-risk feature and free from adverse events at 3 months after index PCI. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, and the key secondary endpoint was the composite of all-cause death, MI, or stroke, both at 12 months after randomization., Results: A total of 1,937 patients (29.7%) with and 4,595 patients (70.3%) without prior MI were randomized to ticagrelor and placebo or ticagrelor and aspirin. At 1 year after randomization, patients with prior MI experienced higher rates of death, MI, or stroke (5.7% vs 3.2%; P < 0.001) but similar BARC types 2 to 5 bleeding (5.0% vs 5.5%; P = 0.677) compared with patients without prior MI. Ticagrelor monotherapy consistently reduced the risk for the primary bleeding outcome in patients with (3.4% vs 6.7%; HR: 0.50; 95% CI: 0.33-0.76) and without (4.2% vs 7.0%; HR: 0.58; 95% CI: 0.45-0.76; P interaction  = 0.54) prior MI. Rates of the key secondary ischemic outcome were not significantly different between treatment groups irrespective of history of MI (prior MI, 6.0% vs 5.5% [HR: 1.09; 95% CI: 0.75-1.58]; no prior MI, 3.1% vs 3.3% [HR: 0.92; 95% CI: 0.67-1.28]; P interaction  = 0.52)., Conclusions: Ticagrelor monotherapy is associated with significantly lower risk for bleeding events compared with ticagrelor plus aspirin, without any compromise in ischemic prevention, among high-risk patients with history of MI undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242)., Competing Interests: Funding Support and Author Disclosures This research was conducted with support from AstraZeneca Pharmaceuticals LP. Dr Baber has received honoraria from AstraZeneca and Boston Scientific. Dr Sharma has received Speakers Bureau fees from Abbott Vascular, Boston Scientific, and Cardiovascular Systems. Dr Dangas has received personal fees from Biosensors and Philips. Dr Angiolillo has received consulting fees or honoraria from Abbott, Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; has received payments for participation in review activities from CeloNova and St Jude Medical, outside the present work; and has received research grants to his institution from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry, Merck, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation. Dr Stefanini has received a research grant from Boston Scientific; and has received speaker and consulting fees from Bayer, Braun, Biosensors, Boston Scientific, Daiichi-Sankyo and GADA, outside the submitted work. Dr Gibson has received grants and personal fees from Johnson & Johnson, Janssen, and CSL Behring; has received personal fees from Bayer, AstraZeneca (during the conduct of the study), Angel Medical Corporation, The Medicines Company, the Boston Clinical Research Institute, the Cardiovascular Research Foundation, Gilead Sciences, WebMD, UpToDate in Cardiovascular Medicine, Boehringer Ingelheim, Somahlution, Vereseon, Boston Scientific, the Duke Clinical Research Institute, Medtelligence, Microport, PERT Consortium, Caladrius Biosciences, CeleCor Therapeutics, Thrombolytic Science, Eidos Therapeutics, Kiniksa Pharmaceuticals, Microdrop, MD Magazine, MJ Health, Samsung, the Society for Cardiovascular Angiography and Interventions, Revance Therapeutics, Pfizer, GenTech, CytoSorbents, AMAG Pharmaceuticals, Bristol Myers Squibb, Intercept Pharmaceuticals, Novartis, Syneos Health, and Amarin; has received other compensation from nference, Dyad Medical, and Absolutys, and PhaseBio; has received nonfinancial support from the Baim Institute; and has received grants from the SCAD Alliance, outside the submitted work. Dr Mehran has received institutional grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, Chiesi, CSL Behring, Daiichi-Sankyo Inc, Medtronic, Novartis Pharmaceuticals, and OrbusNeich; has received personal fees from Boston Scientific, Janssen, Scientific Affairs, Sanofi, and Siemens Medical Solutions; has received consulting fees paid to the institution from Abbott Laboratories and Bristol Myers Squibb; and is an advisory board member (funding paid to the institution) for Spectranetics/Philips/Volcano. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Compared with invasive fractional flow reserve (FFR), coronary CT angiography (cCTA) is limited in detecting hemodynamically relevant lesions. cCTA-based FFR (CT-FFR) is an approach to overcome this insufficiency by use of computational fluid dynamics. Applying recent innovations in computer science, a machine learning (ML) method for CT-FFR derivation was introduced and showed improved diagnostic performance compared to cCTA alone. We sought to investigate the influence of stenosis location in the coronary artery system on the performance of ML-CT-FFR in a large, multicenter cohort., Methods: Three hundred and thirty patients (75.2% male, median age 63 years) with 502 coronary artery stenoses were included in this substudy of the MACHINE (Machine Learning Based CT Angiography Derived FFR: A Multi-Center Registry) registry. Correlation of ML-CT-FFR with the invasive reference standard FFR was assessed and pooled diagnostic performance of ML-CT-FFR and cCTA was determined separately for the following stenosis locations: RCA, LAD, LCX, proximal, middle, and distal vessel segments., Results: ML-CT-FFR correlated well with invasive FFR across the different stenosis locations. Per-lesion analysis revealed improved diagnostic accuracy of ML-CT-FFR compared with conventional cCTA for stenoses in the RCA (71.8% [95% confidence interval, 63.0%-79.5%] vs. 54.8% [45.7%-63.8%]), LAD (79.3 [73.9-84.0] vs. 59.6 [53.5-65.6]), LCX (84.1 [76.0-90.3] vs. 63.7 [54.1-72.6]), proximal (81.5 [74.6-87.1] vs. 63.8 [55.9-71.2]), middle (81.2 [75.7-85.9] vs. 59.4 [53.0-65.6]) and distal stenosis location (67.4 [57.0-76.6] vs. 51.6 [41.1-62.0])., Conclusion: In a multicenter cohort with high disease prevalence, ML-CT-FFR offered improved diagnostic performance over cCTA for detecting hemodynamically relevant stenoses regardless of their location., Competing Interests: Declaration of competing interest Dr. Renker has received speaker fees from Abbott. Dr. Baumann has received consulting fees from Phillips Volcano. Dr. Tesche has received research support and honoraria for speaking from Siemens. Dr. Kim received proctor/speaker fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Meril. Dr. Nieman reports unrestricted institutional support from Siemens Healthineers, Bayer, GE, and Heartflow Inc., and consultancy honoraria from Siemens Medical Solutions USA. Dr. Persson reports on institutional support from Siemens Healthineers. Dr. Schoepf has received grants and/or personal fees from Bayer, Bracco, Elucid BioImaging, GE, Guerbet, HeartFlow Inc., Keya Medical, and Siemens. All other authors declare that they have no financial disclosures., (Copyright © 2021 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Background: Peripheral artery disease (PAD) is associated with an increased risk of ischemic events following percutaneous coronary intervention (PCI). More aggressive antiplatelet therapy may mitigate this risk. The present study evaluates the efficacy of cangrelor in patients with PAD undergoing PCI., Methods and Results: This is a pooled analysis from the CHAMPION PCI, CHAMPION PLATFORM, AND CHAMPION PHOENIX trials, evaluating cangrelor versus either clopidogrel or placebo in PCI patients. The occurrence of the primary endpoint of death, myocardial infarction, or ischemia-driven revascularization (IDR) was assessed in patients with and without PAD. GUSTO severe bleeding at 48 h was also evaluated. There were 1720 (7%) patients with PAD and 22,802 (93%) without PAD. After adjustment for differences in baseline variables, PAD patients, compared with those without PAD, experienced increased odds of the primary endpoint (OR [95% CI] = 1.27 [0.91, 1.77], P = 0.16) and GUSTO severe bleeding (OR [95% CI] = 3.24 [1.28, 8.21], P = 0.01). In PAD patients, the primary endpoint was 4.7% with cangrelor vs. 7.2% with clopidogrel (OR [95% CI] = 0.64 [0.42,0.96]); in patients without PAD the primary endpoint was 3.5% with cangrelor vs. 4.2% with clopidogrel (OR [95% CI] = 0.83 [0.72,0.95]), P-interaction 0.23. Among patients with or without PAD, there was no significant difference in the rate of GUSTO severe bleeding with cangrelor compared with control, P-interaction 0.86., Conclusions: In a pooled analysis of the CHAMPION studies, PAD was associated with increased rates of ischemic and bleeding complications. Cangrelor reduced the odds of ischemic events, without increasing GUSTO severe bleeding., Clinical Trial Registration: clinicaltrials.gov identifiers: CHAMPION PCI (NCT00305162), CHAMPION PLATFORM(NCT00385138), CHAMPION PHOENIX (NCT01156571)., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. J. Antonio Gutierrez discloses the following – personal fees from Janssen Pharmaceuticals. Dr. Robert A. Harrington discloses the following relationships – personal fees from Amgen Inc., Daiichi-Lilly, GILEAD Sciences, Gilead Sciences Inc., Janssen R and D, Medtronic, Merk, Novartis Corporation, The Medicines Company, Vida Health, Vox Media, and WebMD; Grants from AstraZeneca, BMS, CSL Behring, GSK, Merk, Portola, Sanofi-aventis, and The Medicines Company; ownership in Element Science and Myokardia; Advisory role in Evidint and Scandu. Dr. Gregg W. Stone discloses personal fees from Boston Scientific, InspireMD, Atrium, Daiichi-Lilly, and Astra Zeneca. Dr. Ph Gabriel Steg discloses the following relationships – Institutional research grant from Merck, Sanofi, and Servier; speaking or consulting fees from Amarin, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers-Squibb, CSL-Behring, Daiichi-Sankyo, GlaxoSmithKline, Janssen, Lilly, Merck Novartis, Pfizer, Regeneron, Sanofi, Servier, and The Medicines Company. Dr. Charles Michael Gibson discloses personal fees from The Medicines Company. Dr. Christian W. Hamm discloses the following relationships – Advisory board and speaking fees from AstraZeneca, Boehringer Ingelheim; speaking fees from Bayer, Daiichi Sankyo, Lilly, and Sanofi Aventis. Dr. Matthew J. Price reports personal fees from The Medicines Company, during the conduct of the study, AstraZeneca, Merck & Co., Accriva Diagnostics, Boston Scientific, Medtronic, and Terumo. Dr. Renato D. Lopes discloses the following relationships - Institutional research grant and consulting fees from Bristol-Myers Squibb; institutional research grant from GlaxoSmithKline; consulting fees from Bayer, Boehringer Ingleheim, Pfizer, Merck, Portola. Dr. Sergio Leonardi discloses the following relationships - Advisory Board: The Medicine Company, AstraZeneca, and Eli Lilly. Dr. Jayne Prats discloses the following relationships — was an employee of the Medicines Company at the time of the study and is a consultant for Chiesi USA. Dr. Efthymios N. Deliagyris discloses the following relationships — was an employee of the Medicines Company. Dr. Mahaffey discloses personal fees from American College of Cardiology, grants from Amgen, personal fees from AstraZeneca, personal fees from Bayer, personal fees from Boehringer Ingelheim, personal fees from Bristol Myers Squibb, personal fees from Cubist, grants from Daiichi, personal fees from Eli Lilly, personal fees from Epson, personal fees from Forest, personal fees from Glaxo Smith Kline, grants and personal fees from Johnson & Johnson, grants and personal fees from Medtronic, personal fees from Merck, personal fees from Mt. Sinai, personal fees from Myokardia, personal fees from Omthera, personal fees from Portola, personal fees from Purdue Pharma, personal fees from Spring Publishing, grants from St. Jude, grants from Tenax, personal fees from Vindico, personal fees from WebMD, outside the submitted work. Dr. White discloses grants from Sanofi-Aventis, grants from Eli Lilly, grants from National Institute of Health, grants from GSK, grants from Merck Sharpe & Dohme, grants and personal fees from AstraZeneca, outside. Dr. Deepak L. Bhatt discloses the following relationships - Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Cleveland Clinic, Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi (including for serving as co-Chair and co-PI of the CHAMPION trials), Eisai, Ethicon, Forest Laboratories, Ironwood, Ischemix, Lilly, Medtronic, Pfizer, Roche, Sanofi Aventis, The Medicines Company (including for serving as co-Chair and co-PI of the CHAMPION trials); Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, St. Jude Medical (now Abbott); Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, PLx Pharma, Takeda., (© 2021 The Authors.)

Objectives: The aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR)., Background: Impaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences., Methods: In this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included., Results: Success rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P = 0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P = 0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P = 0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement., Conclusions: CA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality., Competing Interests: Funding Support and Author Disclosures Dr Kim has received proctor and speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, Medtronic, and Meril Lifesciences. Dr Ludwig has received travel compensation from Edwards Lifesciences. Dr Möllmann has received proctor fees and/or speaker honoraria from Abbott, Biotronik, Edwards Lifesciences, and Boston Scientific. Dr Leuschner has received speaker honoraria from Medtronic. Dr Amat-Santos is a proctor for Boston Scientific; Dr Dabrowski has received proctor fees from Boston Scientific; and has received speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr Rudolph has received proctor fees and/or lecture honoraria from Boston Scientific, Edwards Lifesciences, Medtronic, and Abbott. Dr Toggweiler is a consultant and/or proctor for New Valve Technology/Biosensors, Boston Scientific, Abbott, Medtronic, Carag, and Medira; has received institutional research grants from Boston Scientific and Fumedica; and holds equity in Hi-D Imaging. Dr Frank is a consultant for Edwards Lifesciences and Medtronic; and has received an institutional research grant from Edwards Lifesciences. Dr Webb is a consultant to Edwards Lifesciences; and has received research grants from Abbott, Boston Scientific, and Medtronic. Dr Barbanti is a consultant for Edwards Lifesciences; and an advisory board member for Medtronic. Dr Pilgrim has received research grants to the institution from Biotronik and Boston Scientific; has received speaker fees from Biotronik and Boston Scientific; is a consultant for HighLife SAS; and is a proctor for Medtronic and Boston Scientific. Dr Seiffert is a consultant for JenaValve and Boston Scientific; has received travel compensation from Abbott Vascular, Edwards Lifesciences, JenaValve, Boston Scientific, and Biotronik; and has received speaker honoraria from Medtronic. Dr Werner is a proctor for Medtronic; and has received speaker honoraria from Edwards Lifesciences, Boston Scientific, Medtronic. Dr Allali has received proctor and speaker fees from Boston Scientific. Dr Makkar has received consultant fees from Abbott; and has received research grants and consulting and speaker fees from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Leuschner has received speaker honoraria from Medtronic. Dr Nef has received proctor or speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Hamm is an advisory board member for Medtronic. Dr Sinning has received research grants from Boston Scientific, Edwards, and Medtronic; and has received speaker honoraria from Abbott, Abiomed, Boston Scientific, Edwards, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Pseudoaneurysm of the ascending aorta is a rare but potentially life-threatening complication of cardiothoracic surgery. Re-operation is associated with a high mortality risk; therefore, percutaneous endovascular closure techniques with different closure devices have been repeatedly reported over the last 15 years. Previous endovascular procedures were performed using a transfemoral or transbrachial approach. We report a case of transradial ascending aortic pseudoaneurysm closure in a patient deemed unsuitable for surgery., Competing Interests: Declaration of competing interest None., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: We introduce a novel approach that involves a single arterial access and low contrast agent volume (SLIM)., Background: Transcatheter aortic valve implantation (TAVI) is subject to an ongoing process of refinement and simplification., Methods: Between January 2019 and November 2020, a total 888 patients with severe aortic stenosis underwent transfemoral TAVI using balloon-expandable or specific self-expanding devices. The study cohort comprised patients with attempted SLIM approach (n = 291). A matched cohort of patients who were treated in a standard fashion served as control group (n = 291)., Results: The SLIM approach was successful in 92.4% of attempted cases. In the SLIM group, utilization of contrast agent (23 [19-37] vs. 75 [52-100] ml; p < 0.001), rates of any acute kidney injury (5.5% vs. 12.7%; p = 0.002), complications at the secondary access (0.3% vs. 3.1%; p = 0.011) and length of hospital stay (7 [5-8] vs. 7 [6-9]) days; p = 0.039) were significantly reduced. All other procedural outcomes were similar between groups., Conclusions: Initial results of this novel, minimalistic approach demonstrate its feasibility and potential beneficial effects without compromising procedural safety. Further refinement of this approach is warranted., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: The most common method of percutaneous closure in transfemoral transcatheter aortic valve implantation (TAVI) employs two obtusely oriented ProGlide devices. The aim of this study was to assess the feasibility and safety of using a single ProGlide system for primary access site closure in comparison with the double ProGlide approach in an all-comers TAVI population., Methods: Between March 2016 and December 2018, a total of 1105 patients underwent transfemoral TAVI for severe aortic stenosis at our center. Application of two ProGlide systems was standard until April 2017 (n = 432), whereas thereafter a single ProGlide system was used (n = 663). A 1:1 propensity score matching was performed to adjust for baseline differences between the two groups, resulting in 327 matched cases. Primary outcomes of interest were main access site-related vascular complications., Results: The mean number of ProGlide devices used per patient was 1.03 (SD 0.2) in the single-ProGlide group versus 2.01 (SD 0.14) in the double-ProGlide group. An additional vascular closure device was required to obtain full hemostasis in 23.2% versus 9.5% of patients (p < 0.001) in the two groups, respectively. Technical success of ProGlide usage was similar (94.3% versus 92.1%, p = 0.163). In the matched cohorts, the rates of main access site-related major vascular complications were similar (4.0% vs. 6.4%, p = 0.217)., Conclusion: The single-ProGlide technique is feasible, with rates of technical success similar to those of the double-ProGlide technique. Use of this method did not lead to more frequent access site-related complications but was more cost effective than the double-ProGlide approach., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background and Aims: Oral anticoagulation is effective for stroke prevention in atrial fibrillation (AF). However, strokes may still occur in high-risk individuals. We conducted a prospective trial to assess the association between adipocytokine serum levels and surrogate parameters for thromboembolic events., Methods and Results: In this cross-sectional multicenter trial, we enrolled 189 patients with AF who were on oral anticoagulation. The primary endpoint was defined as either the presence of spontaneous echo contrast (SEC), a left atrial appendage (LAA), or a left atrial (LA) thrombus on transesophageal echocardiography. We investigated the association of adipocytokine serum levels with the combined endpoint using logistic regression analysis. Forty-eight individuals (25%) were assigned to group 1 (G1) due to the occurrence of at least one of the components of the combined endpoint (41 [21.7%] SEC, 3 [1.6%] LA thrombus, 13 [6.9%] LAA thrombus), whereas the remaining patients formed group 2 (G2). The BMI, logarithmized (log e ) leptin (G1: 2.0 ± 1.3 μg/ml, G2: 2.0 ± 1.1 μg/ml, p = 0.746) and visfatin serum levels (G1: 3.4 ± 0.3 ng/ml, G2: 3.4 ± 0.5 ng/ml, p = 0.900) did not significantly differ between the groups. Conversely, logarithmized adiponectin (G1: 3.3 ± 0.6 ng/ml, G2: 3.1 ± 0.7 ng/ml, p = 0.036) and resistin levels (G1: 1.8 ± 0.5 ng/ml, G2: 1.6 ± 0.5 ng/ml, p = 0.009) were higher in patients with the primary endpoint. Multivariate logistic regression analysis using a score that combined the individual adiponectin and resistin values in each patient corroborated this association., Conclusions: Our results suggest that adiponectin and resistin may act as potential biomarkers to identify individuals with AF who are at high thromboembolic risk., Competing Interests: Declaration of competing interest None declared., (Copyright © 2020 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Background: Despite the overall neutral results of the GLOBAL-LEADERS trial, results from a prespecified subgroup analysis showed that patients from Western Europe had a significantly lower rate of the primary endpoint when treated with ticagrelor monotherapy. Therefore, we aimed to examine the regional disparities in patients' baseline characteristics and their response to ticagrelor monotherapy., Methods: Patients' baseline characteristics and the treatment effects of ticagrelor combined with aspirin for 1 month, followed by ticagrelor monotherapy for 23-months versus 12-months of standard dual antiplatelet therapy (DAPT) were compared according to participating countries. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at two years., Results: Significant variances in patients' baseline characteristics were found between participating countries. The primary endpoint varied significantly according to the country (P interaction  = 0.027). Patients from France (1.6% versus 5.2%, HR: 0.31, 95%CI: 0.13-0.73) and The Netherlands (2.4% versus 4.8%, HR, 0.50, 95%CI: 0.26-0.94) had lower rates of the primary endpoint when allocated to ticagrelor monotherapy, compared with the standard DAPT regimen. Of the 26 baseline and post-randomization factors explored, variance in the rate of complex PCI between countries was identified as the top contributor to this regional interaction., Conclusions: Patients' baseline characteristics varied between participating countries in the GLOBAL-LEADERS trial. There is a significant regional variance in the treatment effect of ticagrelor monotherapy, which could partly be explained by the differences in complex PCI being performed., Clinical Trial Registration: ClinicalTrials.gov (NCT01813435)., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding., Methods: Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days., Results: In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; P interaction  = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; P interaction  = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant., Conclusions: Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Backgrounds: Data on optimal antiplatelet therapy in patients undergoing stenting of the proximal left anterior descending artery (LAD) are limited., Methods: This is a post-hoc analysis of the GLOBAL LEADERS trial, a prospective, multi-center, randomized controlled trial, comparing the experimental strategy (1-month dual anti-platelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) with the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in relation to stenting of the proximal LAD. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction (MI) and key secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years., Results: Among 15,845 patients included in the analysis, 3823 (23.9%) patients underwent stenting of the proximal LAD, while 12,022 (75.2%) did not. In the proximal LAD stenting group, there was no significant difference in the risk of the primary endpoint between the two antiplatelet strategies (3.38% vs. 3.93%; hazard ratio [HR]:0.86; 95% CI:0.62-1.20; P interaction  = 0.951). However, the risk of any MI (2.63% vs. 3.88%; HR:0.68; 95% CI:0.47-0.97; P interaction  = 0.015) and any revascularization (7.84% vs. 9.94%; HR:0.78; 95% CI:0.63-0.97; P interaction  = 0.058) was significantly lower in the experimental strategy group, while demonstrating a similar risk of BARC type 3 or 5 bleeding between the two antiplatelet strategies (1.93% vs. 1.99%; HR:0.98; 95% CI:0.62-1.54; P interaction  = 0.981)., Conclusions: The present study showed patients having stenting to the proximal LAD could potentially benefit from the experimental strategy with lower ischaemic events without a trade-off in major bleeding at two years., Competing Interests: Declaration of Competing Interest Dr. Hara reports grant from Japanese Circulation Society and Fukuda Foundation for Medical Technology, outside the submitted work; Dr. de Winter reports unrestricted educational research grant from Astra Zeneca for Acadamic Medical Center, University of Amsterdam, the Netherlands, outside the submitted work; Dr. Hamm reports personal fees from AstraZeneca, outside the submitted work; Dr. Steg reports grants and personal fees from Bayer/Janssen, grants and personal fees from Merck, grants and personal fees from Sanofi, grants and personal fees from Amarin, personal fees from Amgen, personal fees from Bristol Myers Squibb, personal fees from Boehringer-Ingelheim, personal fees from Pfizer, personal fees from Novartis, personal fees from Regeneron, personal fees from Lilly, personal fees from AstraZeneca, grants and personal fees from Servier, outside the submitted work; Dr. Windecker reports research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson& Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, Sinomed, outside the submitted work. He serves as unpaid member of the steering/excecutive group of trials funded by Abbott, Abiomed, Amgen, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Polares, Sinomed, V-Wave and Xeltis, but has not received personal payments by any pharmaceutical company or device manufacturer. He is also member of the steering/excecutive committee group of several investigated-initiated trials that receive funding by industry without impact on his personal remuneration. Dr. Vranckx reports personal fees from Astra Zeneca, personal fees from The Medicines Company, during the conduct of the study; personal fees from Bayer Health Care, personal fees from Daiichi Sankyo, personal fees from Terumo, personal fees from CLS Bhering, outside the submitted work; Dr. Valgimigli reports grants and personal fees from Abbott, personal fees from Chiesi, personal fees from Bayer, personal fees from Daiichi Sankyo, personal fees from Amgen, grants and personal fees from Terumo, personal fees from Alvimedica, grants from Medicure, grants and personal fees from Astrazeneca, personal fees from Biosensors, personal fees from Idorsia, outside the submitted work; Dr. Serruys reports personal fees from Abbott Laboratories, personal fees from AstraZeneca, personal fees from Biotrinik, personal fees from GLG Research, personal fees from Medtronic, personal fees from Sino Medical Sciences Technology, personal fees from Société Europa Digital Publishing, personal fees from Stentys France, personal fees from Svelte Medical Systems, personal fees from Philips/Volcano, personal fees from Qualimed, personal fees from Xeltis, outside the submitted work; All other authors declare no competing interests., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: This study sought to compare patient characteristics, procedural outcomes, and valve hemodynamics of surgical aortic valve replacement (SAVR) with current-generation rapid-deployment valves (RDVs) versus transcatheter aortic valve replacement (TAVR) with current-generation transcatheter heart valves (THVs)., Background: The patient population currently treated with RDVs may have potential similarities with the current TAVR population, but comparative studies in a large patient population remain scarce., Methods: A total of 16,473 patients who underwent isolated SAVR using current-generation RDVs or isolated transfemoral TAVR with current-generation THVs between 2011 and 2017 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for RDVs and THVs before and after 1:1 propensity score matching. Furthermore, RDVs and THVs with similar design characteristics were compared with each other., Results: A total of 1,743 patients received SAVR with an RDV, whereas 14,730 patients were treated with transfemoral TAVR. Patients treated with TAVR were significantly older and had higher surgical risk scores. Following valve replacement, patients treated with an RDV had a significantly higher rate of disabling stroke (1.7% vs. 1.1%; p = 0.03), need for transfusion of >4 red blood cell units (8.5% vs. 1.4%; p < 0.001), and new onset renal replacement therapy (1.9% vs. 1.2%; p = 0.01), whereas the need for a new permanent pacemaker was lower (8.4% vs. 14.9%; p < 0.001). In-hospital mortality was similar (1.6% vs. 1.8%; p = 0.62). These findings persisted after 1:1 propensity score matching, but in-hospital mortality was significantly higher after RDVs (1.7% vs. 0.6%; p = 0.003). Balloon-expandable (BE) RDVs had significantly lower residual gradients compared with BE-THVs, while self-expanding (SE)-RDVs had significantly higher residual gradients compared with SE-THVs., Conclusions: In a large all-comers' registry, TAVR with current-generation THVs was associated with improved in-hospital outcomes compared with SAVR with current-generation RDVs. The pacemaker rate is significantly higher with TAVR. Post-procedural hemodynamic function varied between individual RDVs and THVs., Competing Interests: Author Relationship With Industry The responsible body of the registry is a nonprofit organization named Deutsches Aortenklappenregister gGmbH founded by the German Cardiac Society and the German Society for Thoracic and Cardiovascular Surgery. The registry receives financial support by unrestricted grants from medical device companies (Edwards Lifesciences, Medtronic, Abbott, Boston Scientific) and donations from the Dr. Rolf M. Schwiete Foundation, and is funded by the German Center for Cardiovascular Research (DZHK) and the German Ministry of Health. Dr. Frerker has received travel support and speaker honoraria from Medtronic, Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Biotronik. Dr. Bleiziffer has served as a proctor and consultant for Medtronic and as a proctor for Boston Scientific, JenaValve, and Highlife. Dr. Hamm has served on the advisory board of Medtronic and as an advisor for Abbott. Dr. Borger has received speaker honoraria and/or consulting fees from Edwards Lifesciences, Medtronic, Abbott, and CryoLife. Dr. Ensminger has received travel support and speaker honoraria from Medtronic, Edwards Lifesciences, Novartis, and B. Braun. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess the efficacy and safety of ticagrelor versus prasugrel in patients with diabetes mellitus (DM) presenting with acute coronary syndromes (ACS) in whom invasive therapy was planned., Background: The efficacy and safety of ticagrelor versus prasugrel in patients with ACS with DM undergoing invasive treatment remain unknown., Methods: This pre-specified analysis of the ISAR-REACT (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) 5 trial included 892 patients with ACS with DM and 3,124 patients with ACS without DM randomized to prasugrel or ticagrelor. The primary endpoint was a composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding (both assessed 12 months after randomization)., Results: The primary endpoint occurred in 51 patients (11.2%) in the ticagrelor group and 55 patients (13.0%) in the prasugrel group in the DM cohort (hazard ratio: 0.84; 95% confidence interval: 0.58 to 1.24; p = 0.383) and in 132 patients (8.6%) in the ticagrelor group and 81 patients (5.2%) in the prasugrel group in the non-DM cohort (hazard ratio: 1.70; 95% confidence interval: 1.29 to 2.24; p < 0.001). There was a significant treatment arm-by-diabetic status interaction (p int  = 0.0035). Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 27 patients (6.9%) in the ticagrelor group and 19 patients (5.5%) in the prasugrel group (p = 0.425) in the DM cohort and in 68 patients (5.2%) in the ticagrelor group and 60 patients (4.6%) in the prasugrel group in the non-DM cohort (p = 0.500)., Conclusions: DM seems to affect the efficacy of ticagrelor and prasugrel in patients with ACS. In patients with DM, the efficacy of ticagrelor was comparable with that of prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome [ISAR-REACT 5]; NCT01944800)., (Copyright © 2020. Published by Elsevier Inc.)

Background: Bioresorbable scaffolds (BRS) have been shown to be inferior to drug-eluting stents in randomized trials. Nevertheless, patients treated during daily routine differ from those treated within randomized trials and thus need further long-term evaluation. The present investigation aims to address this lack., Methods: Consecutive patients with coronary artery disease treated with implantation of everolimus-eluting BRS at 5 centers in Germany were included. Clinical follow-up was assessed up to 3 years. Analysis of clinical outcomes was performed by pooling of the individual patient data sets of each center. The major clinical endpoints of interest was target lesion failure (TLF) a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization. Furthermore occurrence of definite scaffold thrombosis was evaluated. A multivariable Cox regression analysis was applied to identify independent predictors of TLF., Results: A total of 1614 patients treated with BRS were analyzed (mean age 64.0 ± 10.9 years, 75.8% male, 28.3% diabetics). A total 1817 lesions were treated with BRS and 56.0% were considered to be complex. At 3 years, the rate of TLF was 17.1% and definite scaffold thrombosis was noted in 2.6%. Independent predictors of TLF were a higher age, diabetes, bifurcation, complex lesions and the use of small BRS., Conclusions: In this large-scale analysis of patients undergoing BRS implantation in daily routine, event rates were high, but in line with randomized studies. Predictors of TLF were identified which may optimize patient and lesion selection for BRS., Competing Interests: Declaration of competing interest Robert A. Byrne reports receiving lecture fees from B. Braun Melsungen AG, Biotronik, Boston Scientific and Micell, and institutional research grants from Boston Scientific and Celonova Biosciences. Holger Nef received research grants (institutional) and speaker honoraria from Abbott Vascular. All other authors did not report any potential conflict of interest., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background and Aims: The prognostic impact of pre-procedure heart rate (PHR) following percutaneous coronary intervention (PCI) has not yet been fully investigated. This post-hoc analysis sought to assess the impact of PHR on medium-term outcomes among patients having PCI, who were enrolled in the "all-comers" GLOBAL LEADERS trial., Methods and Results: The primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5) were assessed at 2 years. PHR was available in 15,855 patients, and when evaluated as a continuous variable (5 bpm increase) and following adjustment using multivariate Cox regression, it significantly correlated with the primary endpoint (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03-1.09, p < 0.001). Using dichotomous cut-off criteria, a PHR>67 bpm was associated with increased all-cause mortality (HR 1.38, 95%CI 1.13-1.69, p = 0.002) and more frequent new Q-wave MI (HR 1.41, 95%CI 1.02-1.93, p = 0.037). No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099). There was no interaction with the primary (p-inter = 0.236) or secondary endpoint (p-inter = 0.154) when high and low PHR was analyzed according to different antiplatelet strategies., Conclusions: Elevated PHR was an independent predictor of all-cause mortality at 2 years following PCI in the "all-comer" GLOBAL LEADERS trial. The prognostic value of increased PHR on outcomes was not affected by the different antiplatelet strategies in this trial., Competing Interests: Declaration of competing interest Dr. Chichareon reports research grant from Biosensors, outside the submitted work. Dr. Modolo received research grant form Biosensors and SMT. Dr. Eeckhout reports research grant from Biosensors. Dr. Hamm received advisory board fees from AstraZeneca. Dr. Jüni received grants from Canadian Institutes of Health Research (CIHR), during the conduct of the study, grants from Astra Zeneca, grants from Biotronik, grants from Biosensors International, grants from Eli Lilly, grants from The Medicines Company, outside the submitted work; and Peter Jüni serves as unpaid member of the steering group of trials funded by Astra Zeneca, Biotronik, Biosensors, St. Jude Medical and The Medicines Company. Dr. Vranckx received personal fees from Astra Zeneca, personal fees from Bayer Health Care, personal fees from Daiichi Sankio, personal fees from Terumo, personal fees from CLS Behring, outside the submitted work. Dr. Windecker reports research and educational grants to the institution from Amgen, Abbott, Biotronik, Boston Scientific, Bayer, BMS, CSL Behring, Edwards Lifesciences, Medtronic, Polares and Sinomed. Dr. van Geuns received speakers fee from Abbott Vascular and Boston Scientific. Dr. Serruys reports personal fees from Biosensors, personal fees from Cardialysis, personal fees from Medtronic, personal fees from Micel Technologies, personal fees from Sinomedical Sciences Technology, personal fees from Philips/Volcano, personal fees from Xeltis, personal fees from HeartFlow, outside the submitted work., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: We evaluated the association of pulse pressure (PP) and different antiplatelet regimes with clinical and safety outcomes in an all-comers percutaneous coronary intervention (PCI) population., Methods: In this analysis of GLOBAL LEADERS (n = 15,936) we compared the experimental therapy of 23 months of ticagrelor after 1 month of dual-antiplatelet therapy (DAPT) vs standard DAPT for 12 months followed by aspirin monotherapy in subjects who underwent PCI and were divided into 2 groups according to the median PP (60 mm Hg). The primary end point (all-cause death or new Q-wave myocardial infarction) and the composite end points: patient-oriented composite end points (POCE), Bleeding Academic Research Consortium (BARC) 3 or 5, and net adverse clinical events (NACE) were evaluated., Results: At 2 years, subjects in the high-PP group (n = 7971) had similar rates of the primary end point (4.3% vs 3.9%; P = 0.058), POCE (14.9% vs 12.7%; P = 0.051), and BARC 3 or 5 (2.5% vs 1.7%; P = 0.355) and higher rates of NACE (16.4% vs 13.7%; P = 0.037) compared with the low-PP group (n = 7965). Among patients with PP < 60 mm Hg, the primary end point (3.4% vs 4.4%, adjusted hazard ratio [aHR] 0.77, 95% confidence interval [CI] 0.61-0.96), POCE (11.8% vs 13.5%, aHR 0.86, 95% CI 0.76-0.98), NACE (12.8% vs 14.7%, aHR 0.85, 95% CI 0.76-0.96), and BARC 3 or 5 (1.4% vs 2.1%, aHR 0.69, 95% CI 0.49-0.97) were lower with ticagrelor monotherapy compared with DAPT. The only significant interaction was for BARC 3 or 5 (P = 0.008)., Conclusions: After contemporary PCI, subjects with high PP levels experienced high rates of NACE at 2 years. In those with low PP, ticagrelor monotherapy led to a lower risk of bleeding events compared with standard DAPT., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Myocardial infarction (MI) not only defines acute MI with obstructed coronary arteries (T1MI) but also myocardial necrosis caused by myocardial oxygen supply/demand mismatch as type 2 MI (T2MI); only T1MI patients benefit from an early invasive management. Myeloid-related protein(MRP)-8/14 is a biomarker described in various inflammatory diseases and in MI patients. Here we evaluate the potential of MRP-8/14 and high-sensitivity troponin I (hs-cTnI) to differentiate T2MI from T1MI. Patients with final diagnosis NSTEMI (n = 254; 33.1% female) enrolled in a prospective biomarker registry between 08/2011 and 10/2016 were analysed. Median baseline MRP-8/14 levels were higher in T2MI (n = 55; 3.37(1.88-6.48)μg/mL) than in T1MI (n = 199; 2.4 [1.4-3.79]μg/mL) (p = .013) patients, in contrast to hs-cTnI (T2MI:52[11.65-321.4]ng/L vs. T1MI:436.5 [61.25-1973.8]ng/L; p < .001). To detect the strength of this association odds ratios(OR) were calculated with MRP-8/14 yielding 2.13(1.16-3.92; p = .015) to predict T2MI and 0.47(0.26-0.87; p = .015) for T1MI. As expected, hs-cTnI yielded an OR of to predict T2MI 0.34(0.17-0.65; p = .001) and 2.98(1.53-5.81; p = .001) for T1MI. Both markers show comparable and independent results if adjust to hs-cTnI/MRP-8/14, TIMI risk score and CRP. T2MI is associated with higher MRP-8/14 and lower hs-cTnI concentrations than T1MI. Our data suggest that MRP-8/14 as a marker of inflammation might provide usable discriminatory information complementing hs-cTnI in a diagnostic procedure evaluating the type of MI directly upon hospital admission., Competing Interests: Declaration of competing interest C.W.H. received lecture or consulting honoraria from Astra Zeneca, Bayer, Boehringer Ingelheim, GSK, Daiichi-Sankyo and Pfizer-Bristol-Myers Squibb; speaker fees and honoraria from Abbott Vascular. H.N. received Speaker's fees from Abbott Vascular and Elixir Medical and institutional research grants from Abbott Vascular and Elixir Medical. C.L. received lecture or consulting honoraria from Abbott, Astra Zeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Daiichi-Sankyo and Pfizer-Bristol-Myers Squibb. T.K. received speaker fees from Abbott and ThermoFischer and consulting honoraria from Roche and BRAHMS. All other authors have nothing to declare., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: This study assessed the ability of the dual-antiplatelet therapy (DAPT) score in stratifying ischemic and bleeding risk in a contemporary percutaneous coronary intervention (PCI) population., Background: The DAPT score is recommended by guidelines as a tool to stratify ischemic and bleeding risk. Its utility in contemporary PCI is unknown., Methods: The study studied patients in GLOBAL LEADERS (A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) who were free of major ischemic and bleeding events and adhered to antiplatelet strategy during the first year after PCI. The primary ischemic endpoint was the composite of myocardial infarction or stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5. Outcomes from 12 to 24 months after PCI were compared according to the DAPT score., Results: Of 11,289 patients that were event-free after the first year, 6,882 and 4,407 patients had low (<2) and high (≥2) DAPT scores, respectively. Compared with a low DAPT score, patients with a high DAPT score had a higher rate of the composites of myocardial infarction or stent thrombosis (0.70% vs. 1.55%; p < 0.0001). The rate of Bleeding Academic Research Consortium type 3 or 5 bleeding was 0.54% and 0.30% in the low and high DAPT score groups, respectively (p = 0.058). The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups., Conclusions: The DAPT score can stratify ischemic but not bleeding risk in a contemporary PCI population during the second year. The score did not provide additional value for selection of antiplatelet strategy beyond the first year., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

Background and Aims: Diabetes has been well recognized as a strong predictor for adverse outcomes after percutaneous coronary intervention (PCI), however, studies in the era of drug-eluting stent and potent P2Y12 inhibitors have shown conflicting results. We aimed to assess ischemic and bleeding outcomes after contemporary PCI according to diabetic status., Methods: We studied 15,957 patients undergoing PCI for stable or acute coronary syndrome in the GLOBAL LEADERS study with known baseline diabetic status. The primary endpoint was all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was major bleeding defined as bleeding academic research consortium (BARC) type 3 or 5., Results: A quarter of the study cohort were diabetic (4038/15,957), and these patients had a significantly higher risk of primary endpoint at 2 years compared to non-diabetics (adjusted hazard ratio [HR] 1.38; 95% confidence interval [CI] 1.17-1.63). The difference was driven by a significantly higher risk of all-cause mortality at 2 years in diabetics (adjusted HR 1.47, 95% CI 1.22-1.78). The risk of BARC 3 or 5 bleeding was comparable between the two groups (adjusted HR 1.09, 95% CI 0.86-1.39). The antiplatelet strategy (experimental versus reference strategy) had no significant effect on the rates of primary endpoint and secondary safety endpoint at 2 years in patients with and without diabetes., Conclusions: Diabetic patients had higher risk of ischemic events after PCI than non-diabetic patients, whilst bleeding risk was comparable. The outcomes of diabetic patients following PCI were not affected by the two different antiplatelet strategies., Competing Interests: Declaration of competing interest Dr. Chichareon reports research grant from Biosensors, outside the submitted work. Dr. Modolo reports research grant from Biosensors, outside the submitted work. Dr. Kőszegi have received personal fees from AstraZeneca, Terumo Europe, MSD, Boehringer Ingelheim, Pfizer and Servier outside the submitted work during the last 36 months. Dr. Piek reports non-financial support from Abbott Vascular, personal fees and non-financial support from Philips/Volcano, outside the submitted work. Dr. Hamm reports advisory Board and Speaker fees from AstraZeneca. Dr. Steg reports grants and personal fees from Bayer/Janssen, grants and personal fees from Merck, grants and personal fees from Sanofi, grants and personal fees from Amarin, personal fees from Amgen, personal fees from Bristol Myers Squibb, personal fees from Boehringer-Ingelheim, personal fees from Pfizer, personal fees from Novartis, personal fees from Regeneron, personal fees from Lilly, personal fees from AstraZeneca, grants and personal fees from Servier, outside the submitted work. Dr. Vranckx reports personal fees from Astra Zeneca, personal fees from The Medicines Company, during the conduct of the study; personal fees from Daiichi Sankyo, personal fees from Bayer Health Care, personal fees from CLS Bhering, personal fees from Terumo, outside the submitted work. Dr. Valgimigli reports grants and personal fees from Abbott, personal fees from Chiesi, personal fees from Bayer, personal fees from Daiichi Sankyo, personal fees from Amgen, grants and personal fees from Terumo, personal fees from Alvimedica, grants from Medicure, grants and personal fees from Astrazeneca, personal fees from Biosensors, personal fees from Idorsia, outside the submitted work. Dr. Windecker reported research and institutional grants to the institution from Abbott, Amgen, Bayer, BMS, Boston Scientific, Biotronik, CSL Behring, Edwards, Medtronic, Polares, Sinomed. Dr. Onuma reports being a member of the advisory board of Abbott Vascular. Dr. Serruys reports personal fees from Sino Medical Sciences Technology, personal fees from Philips/Volcano, personal fees from Xeltis, outside the submitted work. All other authors have no disclosures., (Copyright © 2020 Elsevier B.V. All rights reserved.)