Honton B, Motreff P, Mallet JS
… +19 more, Hovasse T, Godin M, Malclès G, Brunet J, Meneveau N, Deharo P, Lattuca B, Bressollette E, Angioi M, Benamer H, Gerbaud E, Pereira B, Cesario V, Poinas A, Laperche C, Sauguet A, Souteyrand G, Amabile N, Combaret N
EuroIntervention
· 2026 May · PMID 42200665
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BACKGROUND: The management of calcified coronary lesions remains challenging. Although several devices for advanced plaque modification are available, their relative efficacy is debated. AIMS: We aimed to compare intrava...BACKGROUND: The management of calcified coronary lesions remains challenging. Although several devices for advanced plaque modification are available, their relative efficacy is debated. AIMS: We aimed to compare intravascular lithotripsy (IVL)- and rotational atherectomy (RA)-based strategies for calcified plaque preparation during percutaneous coronary interventions (PCI). METHODS: This multicentre, prospective, randomised non-inferiority trial compared IVL with RA for plaque preparation in moderate-to-severe stable calcified coronary lesions. All interventions were guided by optical frequency domain imaging. A non-inferiority margin of 0.75 mm was prospectively defined based on prior intracoronary imaging studies, and the sample size calculation was based on a standard deviation of 1.9 mm, a one-sided alpha risk of 5%, and a power of 80%, under the assumption of no true difference between groups. The primary endpoint was the minimal stent area (MSA) following stent implantation. The target lesion failure (TLF) rate was analysed after 12 months. RESULTS: A total of 169 patients (RA: n=86, IVL: n=83; 81.1% male; median age 71.8±8.2 years) were included in the final analysis. The baseline characteristics of each group were balanced. Calcified nodules were identified in 48% of the patients. IVL was not inferior to RA for the primary endpoint (6.0±2.3 mm vs 5.9±2.2 mm, respectively; p for non-inferiority <0.05). Adequate geometrical stent expansion was similar in both groups (RA: 65.1%, IVL: 65.1%; p=0.994), whereas major strut malapposition were more frequently observed in the RA group (RA: 80.2% vs IVL: 57.8%; p=0.002). There was no difference between groups in terms of periprocedural complications. The TLF rates between groups after 12 months were equivalent (RA: 1.2%, IVL: 2.4%; p=0.61). CONCLUSIONS: In this trial, the IVL strategy was non-inferior to the RA strategy regarding MSA for PCI in moderate-to-severe calcified coronary lesions, with a comparable safety profile and equivalent clinical outcomes.
Volleberg RHJA, Mol JQ, Versteeg GAA
… +21 more, van der Zande J, Belkacemi A, Hermanides RS, Meuwissen M, Protopopov AV, Laanmets P, Krestyaninov OV, Laclé CF, Oemrawsingh RM, van Kuijk JP, Arkenbout K, van der Heijden DJ, Rasoul S, Lipsic E, Camaro C, Damman P, Roleder T, Kedhi E, van Leeuwen MAH, van Geuns RM, van Royen N
EuroIntervention
· 2026 May · PMID 42200638
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BACKGROUND: High-risk plaques (HRP) in non-flow limiting, deferred non-culprit lesions have been associated with adverse short-term cardiovascular outcome after myocardial infarction (MI). However, the long-term prognost...BACKGROUND: High-risk plaques (HRP) in non-flow limiting, deferred non-culprit lesions have been associated with adverse short-term cardiovascular outcome after myocardial infarction (MI). However, the long-term prognostic implications remain largely unknown. AIMS: This study sought to evaluate the long-term association between HRP and clinical outcome after MI. METHODS: In the prospective, observational PECTUS-obs study, 438 patients with recent MI underwent optical coherence tomography (OCT) of all fractional flow reserve-negative non-culprit lesions. Patients were grouped according to the presence or absence of at least one OCT-identified HRP. The current study evaluates the final long-term outcome. The primary patient-level endpoint was defined as major adverse cardiovascular events (MACE), a composite of cardiac death, nonfatal MI or unplanned revascularization, excluding all periprocedural, indeterminate and all stent failure-related events. RESULTS: After a median follow-up of 1828 days (IQR1821-1842), presence of at least one HRP was associated with MACE (HR 1.87, 95% CI 1.11-3.14, p=0.017). Among the individual endpoint components, non-fatal MI (HR 4.07, 95% CI 1.23-13.52, p=0.013) and unplanned revascularization (HR 1.97, 95% CI 1.07-3.64, p=0.027) occurred more frequently in patients with at least one HRP. In an exploratory landmark analysis, the risk associated with presence of HRP was observed only during the first two years of follow-up. The lesion-level incidence of target lesion failure did not differ significantly between groups (HR 1.65, 95% CI 0.91-2.96, p=0.097). CONCLUSIONS: Non-flow limiting but high-risk non-culprit plaques are associated with adverse patient-level clinical outcome during long-term follow-up after MI, potentially with a more pronounced short-term risk. Clinical Trial Registration NCT03857971.
Yosofi B, Woelders ECI, Peeters DAM
… +13 more, von Birgelen C, van Rees JB, Heestermans AACM, Claessen BEPM, van den Oord SCH, Dirksen MT, van Vliet D, Konijnenberg LSF, Cetinyurek-Yavuz A, van Royen N, van Geuns RM, Nijveldt R, Damman P
EuroIntervention
· 2026 May · PMID 42200636
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BACKGROUND: Ticagrelor monotherapy after a short period of dual antiplatelet therapy (DAPT) has shown to be safe and effective after percutaneous coronary intervention (PCI), including primary PCI in ST-elevation myocard...BACKGROUND: Ticagrelor monotherapy after a short period of dual antiplatelet therapy (DAPT) has shown to be safe and effective after percutaneous coronary intervention (PCI), including primary PCI in ST-elevation myocardial infarction (STEMI). However, direct omission of aspirin could further reduce bleeding risk. AIMS: We aimed to assess the impact of ticagrelor monotherapy directly after primary PCI regarding ischemic events, and to investigate the effect on clinical bleeding events. METHODS: In this multicentre open-label pilot study, 200 STEMI patients were 1:1 randomised to ticagrelor monotherapy versus ticagrelor plus aspirin, directly after primary PCI. Major adverse cardiac and cerebral events (MACCE) and bleeding were assessed at 13 months. Incidence of intramyocardial haemorrhage (IMH) was compared. RESULTS: In the ticagrelor monotherapy group (n=98) and DAPT group (n=101), MACCE occurred in 4.1% versus 4.0% (HR:1.04, 95%CI: 0.26-4.17). Clinically relevant bleeding was observed in 4.1% versus 10.9% (HR: 0.37, 95%CI: 0.12-1.17), and clinically relevant non-access site bleeding in 2.0% versus 9.9% (HR:0.20, 95%CI: 0.04-0.92). CONCLUSIONS: While no significant difference in ischemic events was observed between ticagrelor monotherapy and DAPT in the first thirteen months after primary PCI, this pilot study is underpowered to confirm efficacy. In addition, non-access site bleeding events were significantly reduced and all clinical bleeding events tended to be reduced. Incidence of IMH was similar between groups.
Casenghi M, De Backer O, De Biase C
… +36 more, Paolisso P, Gallinoro E, Kobari Y, Khokhar A, Scotti A, Adams AA, Testa L, Millin A, Giordano A, Corcione N, Vanderheyden M, Corradetti S, Esposito G, Oreglia J, Montalto C, Barbanti M, Costa G, Cannata S, Gandolfo C, De Marco F, Dipietro E, Ussia GP, Mangiacapra F, Toth G, Di Lenarda F, De Felice F, Cesario V, Nicolini E, Piva T, Leone A, Berni A, Belmonte M, Tchetche D, Latib A, Bedogni F, Barbato E
EuroIntervention
· 2026 May · PMID 42200635
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BACKGROUND: Contemporary self-expanding transcatheter heart valves (THVs) differ in leaflet position and frame architecture. Comparative data between new-generation intra-annular (IA) and supra-annular (SA) platforms rem...BACKGROUND: Contemporary self-expanding transcatheter heart valves (THVs) differ in leaflet position and frame architecture. Comparative data between new-generation intra-annular (IA) and supra-annular (SA) platforms remain limited. AIMS: We sought to compare 30-day and 1-year clinical and haemodynamic outcomes between contemporary intra-annular and supra-annular self-expanding THVs in a large multicentre real-world cohort. METHODS: Consecutive patients undergoing transfemoral transcatheter aortic valve implantation with a Navitor/Navitor Vision (IA self-expanding valve [SEV]) or Evolut FX/FX+ (SA-SEV) between June 2021 and April 2025 were included. The primary endpoint was the composite of all-cause death, disabling stroke, or heart failure hospitalisation at 1 year. Propensity score matching (PSM) was performed to adjust for baseline differences. RESULTS: Among 2,607 patients (IA-SEV: 1,604; SA-SEV: 1,003), PSM yielded 892 well-balanced pairs. Valve Academic Research Consortium 3 device success was achieved in 91.1% of IA-SEV patients and 90.9% of SA-SEV patients (p=0.868). Permanent pacemaker implantation was more frequent with IA-SEVs (22.1% vs 16.3%; p=0.007), whereas major or life-threatening bleeding was more common with SA-SEVs (4.2% vs 2.6%; p<0.001). At 1 year, the primary endpoint occurred in 12.6% of IA-SEV patients and 11.3% of SA-SEV patients (p=0.422) with no difference between groups in the time-to-event analysis (hazard ratio [HR] 1.01, 95% confidence interval [CI]: 0.77-1.33; p=0.916). The mean transvalvular gradients and rates of moderate or severe paravalvular leak remained low and similar between the two groups at 1 year. Findings were consistent in the unmatched cohort (HR 1.02, 95% CI: 0.81-1.31; p=0.835). CONCLUSIONS: In this large real-world registry, contemporary IA-SEVs and SA-SEVs demonstrated overall similar clinical outcomes and sustained haemodynamic performance at 1-year follow-up, despite differences in procedure-related endpoints between the groups.
Prado GFA, de PB, Dias SG
… +28 more, Franken M, Guimaraes PO, Assis C, Pitta FG, Teixeira FM, Bandeira WC, Sanali M, Lamas SR, Monfardini F, de LC, Rocha RC, Mangione F, Pazolini VA, Bertolin AJ, Antunes M, Silveira FS, Nascimento BR, Ohe LN, Ferreira E, Sampaio FBA, Sarmento-Leite R, Wainstein MV, Bezerra CG, Arruda JA, Almeida BO, Paradies V, Junior JM, Lemos PA
EuroIntervention
· 2026 May · PMID 42200630
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BACKGROUND: Whether the anatomical complexity of percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS) influences the effects of antiplatelet therapy remains unknown. AIMS: We aimed to evaluate the i...BACKGROUND: Whether the anatomical complexity of percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS) influences the effects of antiplatelet therapy remains unknown. AIMS: We aimed to evaluate the impact of coronary anatomical complexity on clinical outcomes in patients receiving potent P2Y inhibitor monotherapy or dual antiplatelet therapy (DAPT). METHODS: In the NEO-MINDSET trial, patients with ACS were randomised after successful PCI to 12-month ticagrelor- or prasugrel-based monotherapy or DAPT initiated within the first 4 days of hospitalisation. The coprimary endpoints were (i) a composite of death, myocardial infarction, urgent target vessel revascularisation, or stroke; and (ii) Bleeding Academic Research Consortium (BARC) Type 2, 3, or 5 bleeding. Complex PCI was defined by one or more of the following criteria: three-vessel PCI, ≥3 treated lesions, ≥3 stents implanted, total stent length >60 mm, two-stent bifurcation, or stenting in the left main coronary artery, in a bypass graft, or in a chronic total occlusion lesion. RESULTS: Of the 3,408 randomised patients with available procedural data, 791 (23.2%) underwent complex PCI. Compared with the non-complex PCI group, patients in the complex PCI group were older (mean age 60.63±10.52 years vs 59.33±10.83 years; p=0.005) and had a higher prevalence of hypertension (67.9% vs 62.9%; p=0.010). Among patients undergoing complex PCI, 1, 2, or ≥3 complexity criteria were present in 45.5% (n=360), 22.5% (n=178), and 32.0% (n=253), respectively. PCI complexity did not significantly modify the treatment effects of monotherapy versus DAPT on the ischaemic coprimary endpoint (p-interaction=0.68). Likewise, PCI complexity did not have an effect on the comparative risk of BARC Type 2, 3, or 5 bleedings between monotherapy versus DAPT. CONCLUSIONS: In this post hoc analysis of the NEO-MINDSET trial, PCI complexity did not significantly modify the treatment effects of potent P2Y inhibitor monotherapy versus DAPT on the coprimary ischaemic or bleeding outcomes. CLINICALTRIALS: gov: NCT04360720.
Trimaille A, Morel O, Alperi A
… +31 more, Veiga-Fernandez G, Nombela-Franco L, Vilalta V, Munoz-Garcia A, Nuche J, Franzone A, Urena M, Asmarats L, Regueiro A, Del Trigo M, Auffret V, Del Val D, Serra V, Carmona A, Avanzas P, Fradejas-Sastre V, Sanchez I, Trichilo M, Maneiro N, Molaro MI, Fischer Q, Arzamendi D, Flores-Umanzor E, Oteo JF, Nolf M, Alfonso F, Pockels PD, Elkadiri C, Cepas-Guillén P, Avvedimento M, Rodés-Cabau J
EuroIntervention
· 2026 May · PMID 42186872
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BACKGROUND: Early haemodynamic valve deterioration (HVD) was associated with worse clinical outcomes and bioprosthetic durability after transcatheter aortic valve implantation (TAVI) in a single-centre study. AIMS: The a...BACKGROUND: Early haemodynamic valve deterioration (HVD) was associated with worse clinical outcomes and bioprosthetic durability after transcatheter aortic valve implantation (TAVI) in a single-centre study. AIMS: The aim of this study was to evaluate the incidence, predictors, and prognostic impact of early HVD in a large-scale TAVI population. METHODS: We analysed the data from an international, multicentre registry including consecutive patients from 16 centres undergoing TAVI. Early HVD was defined as an increase of at least 10 mmHg in the mean transaortic gradient on echocardiography performed within the first three months after TAVI, compared with the discharge echocardiography. The primary endpoint was the valve-related long-term clinical efficacy according to the Valve Academic Research Consortium 3. RESULTS: Among 7,392 patients, early HVD was observed in 231 patients (3.1%). Body mass index (adjusted odds ratio [aOR] per 5 kg/m increase 1.15, 95% confidence interval [CI]: 1.02-1.30), prosthesis size <26 mm (aOR 1.96, 95% CI: 1.43-2.70), valve-in-valve procedure (aOR 2.76, 95% CI: 1.83-4.08), and the absence of anticoagulation at discharge (aOR 1.64, 95% CI: 1.22-2.22) were independent predictors of early HVD. After a median follow-up of 4 years (interquartile range 2-5), early HVD was independently associated with a lower valve-related long-term clinical efficacy (subdistribution hazard ratio [sHR] 0.42, 95% CI: 0.32-0.56), and a higher risk of stroke (sHR 2.32, 95% CI: 1.51-3.57), stage 2 or 3 (sHR 2.74, 95% CI: 2.10-3.57) or stage 3 bioprosthetic valve dysfunction (sHR 3.53, 95% CI: 2.15-5.79), and bioprosthetic valve failure (sHR 3.04, 95% CI: 2.06-4.52). Consistent findings were observed in a propensity score-matched cohort and in different sensitivity analyses. CONCLUSIONS: Early HVD was observed in 3.1% of patients and was associated with adverse clinical and haemodynamic outcomes after TAVI. These findings validate the clinical relevance of detecting early HVD and the necessity for further research to guide optimal management of these patients.
EuroIntervention
· 2026 May · PMID 42137921
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BACKGROUND: Despite the growing demand for transcatheter aortic valve implantation (TAVI), there is no strategy to prevent its most common complication: cardiac conduction disturbances (CCD). These disturbances often nec...BACKGROUND: Despite the growing demand for transcatheter aortic valve implantation (TAVI), there is no strategy to prevent its most common complication: cardiac conduction disturbances (CCD). These disturbances often necessitate permanent pacemaker implantation (PPI), leading to high morbidity and costs. Post-TAVI CCD may be transient, resulting from inflammation. AIMS: We aimed to evaluate the feasibility, safety, and preliminary efficacy of glucocorticoids in preventing PPI in patients undergoing TAVI. METHODS: This pilot study followed a Prospective Randomised Open-label Blinded Endpoint (PROBE) design. One hundred TAVI patients were randomised 1:1 to standard care or methylprednisolone (7 mg/kg administered 1 hour preprocedure), followed by prednisone (15 mg every 12 hours for 5 days). Electrocardiograms and inflammatory biomarkers were assessed pre- and post-intervention, and at 1 month and 1 year. The primary efficacy endpoint was the 1-month incidence of PPI. Secondary outcomes included 1-year PPI, new left bundle branch block (LBBB), LBBB and PPI, other CCD, mortality, and procedural complications. RESULTS: The primary efficacy outcome occurred in 16% of the control group and 8% of the intervention group, reflecting a 50% relative risk (RR) reduction in PPI (RR 0.50, 95% confidence interval [CI]: 0.16-1.55; p=0.23). There was no significant difference in 1-year PPI (RR 0.67, 95% CI: 0.26-1.73; p=0.41) or new LBBB (RR 1.12, 95% CI: 0.66-1.89; p=0.66). The intervention was safe, without differences in complications, mortality (4% vs 12%; p=0.27), or adverse events (n=3). CONCLUSIONS: Glucocorticoids in TAVI are feasible and safe. The observed numerical difference in PPI did not reach statistical significance. Large-scale trials are needed to confirm the results of this pilot study.
EuroIntervention
· 2026 May · PMID 42137920
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BACKGROUND: Dedicated randomised studies on intravascular imaging guidance in unprotected left main coronary artery (LMCA) disease are lacking. AIMS: We aimed to investigate the clinical feasibility of optical coherence...BACKGROUND: Dedicated randomised studies on intravascular imaging guidance in unprotected left main coronary artery (LMCA) disease are lacking. AIMS: We aimed to investigate the clinical feasibility of optical coherence tomography (OCT) guidance in percutaneous coronary intervention (PCI) of true LMCA bifurcation lesions and to evaluate its prognostic impact compared with angiographic guidance. METHODS: Patients with true LMCA bifurcation lesions who were randomised to either OCT or angiographic guidance in the OCTOBER Trial were included. The feasibility of OCT guidance was assessed as the proportion of patients with successful and analysable OCT pullbacks before, during, and after stenting. Clinical outcomes between the two groups were compared based on the incidence of a composite of major adverse cardiac events (MACE), comprising cardiac death, any myocardial infarction, or target lesion revascularisation. RESULTS: In total, 227 patients were included (OCT: 111, angiography: 116). OCT guidance was successful, with 98% of cases having a pre-stenting pullback performed and 96% a final pullback, as per protocol. The proximal LMCA stent edge was analysable in 43% of patients, and in the remaining 57%, only 5% were limited by insufficient image quality. No statistically significant difference in MACE was observed between the two groups (OCT: 14.4% vs angiography: 18.4%, hazard ratio 0.78, 95% confidence interval: 0.39-1.51). CONCLUSIONS: OCT-guided PCI in true LMCA bifurcation lesions was clinically feasible, but visibility of the LMCA ostium was limited by short pullbacks, insufficient clearance, or guide catheter shadowing. OCT guidance was associated with a non-significant reduction in MACE, consistent with the effect estimate in the main trial.
Emilsson OL, Mohammad MA, van der Pals J
… +7 more, Braun O, Angerås O, Jernberg T, Zhou M, von Koch S, Erlinge D, Koul S
EuroIntervention
· 2026 May · PMID 42137919
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BACKGROUND: In patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) and who are treated with direct oral anticoagulants (DOACs), dual antithrombotic treatment without aspirin is...BACKGROUND: In patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) and who are treated with direct oral anticoagulants (DOACs), dual antithrombotic treatment without aspirin is recommended. Evidence comparing P2Y inhibitor strategies in this setting is limited. AIMS: This study aimed to compare outcomes with ticagrelor versus clopidogrel as part of dual antithrombotic treatment in ACS patients undergoing PCI. METHODS: Using data from the SWEDEHEART registry, we conducted a cohort study including patients on dual antithrombotic treatment with ACS undergoing PCI between January 2014 and February 2022. Outcomes within one year were analysed using multivariate Cox regression to obtain adjusted hazard ratios (aHR) with 95% confidence intervals (CI) for major adverse cardiovascular events (MACE; including mortality, myocardial infarction [MI], and stroke), all-cause mortality, clinically relevant bleeding, and MI. RESULTS: A total of 3,708 patients were included (median age 76 years; 69% males; 40% ST-segment elevation myocardial infarction). At discharge, 1,170 (32%) received ticagrelor and 2,538 (68%) clopidogrel. For MACE, the unadjusted event rate was 16.7% in the ticagrelor group and 16.6% in the clopidogrel group (aHR 1.02, 95% CI: 0.84-1.23). Mortality occurred in 6.6% of patients treated with ticagrelor and 6.2% of those treated with clopidogrel (aHR 1.24, 95% CI: 0.91-1.69). Bleeding was 4.9% in the ticagrelor group compared with 3.7% in the clopidogrel group (aHR 1.53, 95% CI: 1.06-2.22). MI occurred in 10.4% of patients on ticagrelor and 11.2% of those on clopidogrel (aHR 0.90, 95% CI: 0.71-1.13). CONCLUSIONS: In ACS patients on DOACs undergoing PCI, ticagrelor was associated with an increased risk of bleeding compared with clopidogrel, with no differences in MACE, mortality, or MI.
Feistritzer HJ, Lauten P, Rudolph TK
… +24 more, Rudolph V, Geisler T, Massberg S, Adam M, Baldus S, Sossalla S, Joner M, Moellmann H, Wolf A, Kim WK, Borger MA, Noack T, Boening A, Bleiziffer S, Hohenstein S, Hoesler N, Buske M, Majunke N, Lankisch N, Roeder MV, Desch S, Thiele H, Abdel-Wahab M, Of The Double-Choice Investigators OB
EuroIntervention
· 2026 May · PMID 42137918
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BACKGROUND: Although withdrawn from the market, the specific design of the ACURATE neo2 valve might influence the design of future transcatheter aortic valve platforms. AIMS: We aimed to evaluate the safety and efficacy...BACKGROUND: Although withdrawn from the market, the specific design of the ACURATE neo2 valve might influence the design of future transcatheter aortic valve platforms. AIMS: We aimed to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) using the ACURATE neo2 valve compared with the Evolut platform in selected anatomies. METHODS: In this investigator-initiated, 2x2 factorial, open-label, randomised, multicentre, non-inferiority trial, patients with symptomatic, severe aortic stenosis were randomised to the ACURATE neo2 or an Evolut PRO/PRO+/FX valve. The primary endpoint was a composite of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days. Non-inferiority of the ACURATE neo2 to an Evolut valve was tested in the intention-to-treat population (absolute non-inferiority margin of -6%, α of 0.05). RESULTS: At 10 sites in Germany, 835 patients were randomised. Within 30 days, the primary endpoint occurred in 60/389 patients (15.4%) in the ACURATE neo2 group and in 120/395 patients (30.4%) in the Evolut group (rate difference 15.0%, lower boundary of the 1-sided 95% confidence interval [CI]: 10.1%; p for non-inferiority<0.001, 2-sided 95% CI: 9.1-20.7; p for difference<0.001). A permanent pacemaker was implanted in 42/374 patients (11.2%) in the ACURATE neo2 group and in 101/381 patients (26.5%) in the Evolut group (p for difference <0.001). Rates of moderate/severe prosthetic valve regurgitation were low for both valves (1.3% vs 1.7%; p for difference=0.6). CONCLUSIONS: In selected anatomies, TAVI with the ACURATE neo2 was non-inferior to TAVI with an Evolut valve, with significantly lower rates of the primary endpoint, driven by lower permanent pacemaker implantation at 30 days.