BACKGROUND: In women with severe aortic stenosis, there are limited data regarding outcome differences following transcatheter (TAVR) vs surgical aortic valve replacement (SAVR). OBJECTIVES: The authors sought to examine outcomes of TAVR vs SAVR in a patient-level pooled analysis of women in the RHEIA and PARTNER 3 trials. METHODS: Patients in both trials were randomly allocated to a balloon-expandable SAPIEN 3/Ultra valve or to surgical bioprostheses. Individual patient data of female participants in the 2 trials were pooled. The primary endpoint was all-cause mortality, all stroke, or rehospitalization at 1 year. RESULTS: A total of 376 women were randomized to TAVR and 336 to SAVR. The mean age was ∼73 years, and the mean Society of Thoracic Surgeons (STS) score was 2.1%. Kaplan-Meier estimates of event rates at 1 year with TAVR vs SAVR were 8.5% vs 16.8% for the composite of all-cause mortality, all stroke, or rehospitalization (absolute difference -8.2%; 95% CI: -13.1% to -3.3%; P < 0.001), 1.1% vs 2.1% (P = 0.27) for all-cause mortality, 2.7% vs 3.9% (P = 0.35) for all stroke, and 5.4% vs 11.9% (P = 0.002) for rehospitalization. The composite endpoint of all-cause death or stroke was similar between the 2 treatment groups: 3.5% vs 5.4% (absolute difference -1.9%; 95% CI: -5.0% to 1.1%; P = 0.21). CONCLUSIONS: Among women with symptomatic severe aortic stenosis, TAVR led to a reduction in the rate of the combined endpoint of all-cause mortality, stroke, or rehospitalization at 1-year follow-up, largely due to a significant reduction in the rate of rehospitalization.

• MeSH
• Aortic Valve * surgery   physiopathology   diagnostic imaging   MeSH
• Aortic Valve Stenosis * mortality   surgery   physiopathology   diagnostic imaging   MeSH
• Bioprosthesis MeSH
• Time Factors MeSH
• Stroke mortality   etiology   therapy   MeSH
• Heart Valve Prosthesis Implantation * adverse effects   mortality   instrumentation   MeSH
• Risk Assessment MeSH
• Humans MeSH
• Prosthesis Design MeSH
• Randomized Controlled Trials as Topic MeSH
• Risk Factors MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Sex Factors MeSH
• Heart Valve Prosthesis MeSH
• Severity of Illness Index MeSH
• Transcatheter Aortic Valve Replacement * adverse effects   mortality   instrumentation   MeSH
• Treatment Outcome MeSH
• Patient Readmission MeSH
• Check Tag
• Humans MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Comparative Study MeSH

BACKGROUND AND AIMS: Although women with severe symptomatic aortic stenosis have more complications than men when undergoing surgical valve replacement, they are under-represented in clinical trials. The Randomized researcH in womEn all comers wIth Aortic stenosis (RHEIA) trial investigates the balance of benefits and risks of transcatheter aortic valve implantation (TAVI) vs. surgery in women. METHODS: Women were randomized 1:1 to transfemoral TAVI with a balloon-expandable valve or surgery. The primary composite endpoint was death, stroke, or (valve, procedure or heart failure related) rehospitalization at 1 year. Non-inferiority testing with a pre-specified 6% margin and superiority testing were performed in the as-treated population. RESULTS: At 48 European centres, 443 women underwent randomization, and 420 were treated as randomized. Mean age was 73 years, and the mean estimated surgical risk of death was 2.1% (Society of Thoracic Surgeons risk score). Kaplan-Meier estimates of the primary endpoint event rates at 1 year were 8.9% in the TAVI and 15.6% in the surgery group. This difference of -6.8% with an upper 95% confidence limit of -1.5% demonstrated the non-inferiority of TAVI (P < .001). The two-sided 95% confidence interval of -13.0% to -.5% further resulted in superiority (P = .034). The 1-year incidence of the primary endpoint components was: .9% with TAVI vs. 2.0% with surgery for death from any cause, 3.3% vs. 3.0% for stroke, and 5.8% vs. 11.4% for rehospitalization. CONCLUSIONS: Among women with severe aortic stenosis, the incidence of the composite of death, stroke, or rehospitalization at 1 year was lower with TAVI than with surgery. CLINICALTRIALS.GOV NUMBER: NCT04160130.

• MeSH
• Aortic Valve * surgery   MeSH
• Aortic Valve Stenosis * surgery   mortality   MeSH
• Stroke etiology   epidemiology   MeSH
• Heart Valve Prosthesis Implantation * methods   mortality   adverse effects   MeSH
• Humans MeSH
• Postoperative Complications mortality   epidemiology   MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Heart Valve Prosthesis MeSH
• Transcatheter Aortic Valve Replacement * methods   mortality   adverse effects   MeSH
• Treatment Outcome MeSH
• Patient Readmission statistics & numerical data   MeSH
• Check Tag
• Humans MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Randomized Controlled Trial MeSH
• Comparative Study MeSH

BACKGROUND: Management of recurrent mitral regurgitation (MR) or relevant iatrogenic mitral valve (MV) stenosis after mitral transcatheter edge-to-edge repair (M-TEER) emerges as an increasingly relevant clinical issue. Surgery after M-TEER is associated with higher morbidity and mortality. Electrosurgical leaflet laceration and stabilization of the implant (ELASTA-Clip) followed by transcatheter mitral valve replacement (TMVR) is an innovative, less-invasive treatment option for patients with TEER failure. OBJECTIVES: The authors sought to evaluate the early results of ELASTA-Clip followed by transapical TMVR in patients with symptomatic failed M-TEER (defined as persistent or recurrent MR, or iatrogenic MV stenosis). METHODS: Data from symptomatic patients with failed M-TEER who underwent ELASTA-Clip followed by compassionate use or commercial transapical TMVR using the Abbott Tendyne system were retrospectively collected from 8 tertiary care centers in 4 countries. Safety and efficacy of the procedure were assessed up to 1 year according to Mitral Valve Academic Research Consortium (MVARC) criteria. RESULTS: A total of 22 patients (mean age 77.8 ± 9.2 years, 40.9% [9/22] female) at high surgical risk (EuroSCORE II 8.0 ± 0.4, STS score 7.2% ± 1.1%) with symptomatic residual MR ≥3+ (n = 21) or iatrogenic MV stenosis (n = 1) after failed M-TEER were followed for a median period of 8.5 [Q1-Q3: 2.6-11.6] months. The ELASTA-Clip procedure (90.9% [20/22] transseptal, 9.1% [2/22] transapical) followed by TMVR were successful in all patients (22/22). Technical success according to MVARC was achieved in 21 patients (21/22, 95.4%) without left ventricular outflow tract obstruction or conversion to sternotomy. At 30 days, 3 patients had paravalvular leak progression, ischemic stroke occurred in 3 patients (3/20, 15.0%). Baseline MR (≥3+ in 95.5% [21/22]) was reduced to grade 1+ or less in all patients with durable results in 89.5% (17/19) (P < 0.001). NYHA functional class significantly improved to ≤II in 81.3% (13/16) at discharge (P < 0.001) and 72.2% (13/18) at last follow-up (P < 0.001). At 30 days, all patients (20/20) were alive. Three patients (3/20, 15.0%) were rehospitalized for heart failure (uncontrolled atrial fibrillation in 2 cases) and 1 of them (1/22, 4.5%) underwent a reintervention (valve retensioning). CONCLUSIONS: Transapical TMVR after ELASTA-Clip is a feasible and less invasive option for the management of failed M-TEER that can be performed with acceptable results in a carefully selected patient population. Particular attention is required to avoid paravalvular leakage and measures to minimize the risk of periprocedural cerebrovascular events need to be implemented in future larger-scale prospective studies with longer-term follow-up.

• MeSH
• Time Factors MeSH
• Heart Valve Prosthesis Implantation * instrumentation   adverse effects   MeSH
• Compassionate Use Trials MeSH
• Electrosurgery adverse effects   MeSH
• Iatrogenic Disease MeSH
• Humans MeSH
• Mitral Valve * surgery   diagnostic imaging   physiopathology   MeSH
• Mitral Valve Insufficiency * surgery   diagnostic imaging   physiopathology   etiology   MeSH
• Mitral Valve Stenosis * surgery   diagnostic imaging   physiopathology   etiology   MeSH
• Treatment Failure MeSH
• Recovery of Function MeSH
• Recurrence * MeSH
• Retrospective Studies MeSH
• Risk Factors MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Heart Valve Prosthesis * MeSH
• Cardiac Catheterization * instrumentation   adverse effects   MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Geographicals
• Europe MeSH

AIMS: Screening logs have the potential to appraise the actual prevalence and distribution of predefined patient subsets, avoiding selection biases, which are inevitably and potentially present in randomised trials and real-world registries, respectively. We aimed to assess the prevalence of high bleeding risk (HBR) characteristics in the real world and the external validity of the MASTER DAPT trial. METHODS AND RESULTS: All consecutive patients who underwent percutaneous coronary intervention (PCI) for at least two consecutive weeks across 65 sites participating in the trial were entered into a screening log. Of 2,847 consecutive patients, 1,098 (38.6 %) were HBR and 109 (9.9 %) consented for trial participation. PRECISE-DAPT score ≥ 25 was the most frequent HBR feature, followed by advanced age, use of oral anticoagulation (OAC) and anaemia. Compared with consecutive HBR patients, consenting patients were older (≥ 75 years: 69 % versus 62 %, absolute standardized difference [SD] 0.16), more frequently male (78 % versus 71 %, absolute SD 0.18), had higher use of OAC (38 % versus 20 %, absolute SD 0.39), treatment with steroids or nonsteroidal anti-inflammatory drugs (10 % versus 5 %, SD 0.16), and prior cerebrovascular events (10 % versus 6 %, absolute SD 0.18) but lower PRECISE DAPT score ≥ 25 (54 % versus 66 %, absolute SD 0.24). CONCLUSIONS: The HBR criteria distribution differed between consecutive versus selectively included HBR patients, suggesting the existence of selection biases in the trial population.

• MeSH
• Anticoagulants adverse effects   therapeutic use   administration & dosage   MeSH
• Dual Anti-Platelet Therapy adverse effects   methods   MeSH
• Risk Assessment MeSH
• Platelet Aggregation Inhibitors * adverse effects   therapeutic use   MeSH
• Percutaneous Coronary Intervention * MeSH
• Hemorrhage * chemically induced   epidemiology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Risk Factors MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Patient Selection MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH

BACKGROUND: Clinical outcomes and treatment selection after completing the randomized phase of modern trials, investigating antiplatelet therapy (APT) after percutaneous coronary intervention (PCI), are unknown. OBJECTIVES: The authors sought to investigate cumulative 15-month and 12-to-15-month outcomes after PCI during routine care in the MASTER DAPT trial. METHODS: The MASTER DAPT trial randomized 4,579 high bleeding risk patients to abbreviated (n = 2,295) or standard (n = 2,284) APT regimens. Coprimary outcomes were net adverse clinical outcomes (NACE) (all-cause death, myocardial infarction, stroke, and BARC 3 or 5 bleeding); major adverse cardiac and cerebral events (MACCE) (all-cause death, myocardial infarction, and stroke); and BARC type 2, 3, or 5 bleeding. RESULTS: At 15 months, prior allocation to a standard APT regimen was associated with greater use of intensified APT; NACE and MACCE did not differ between abbreviated vs standard APT (HR: 0.92 [95% CI: 0.76-1.12]; P = 0.399 and HR: 0.94 [95% CI: 0.76-1.17]; P = 0.579; respectively), as during the routine care period (HR: 0.81 [95% CI: 0.50-1.30]; P = 0.387 and HR: 0.74 [95% CI: 0.43-1.26]; P = 0.268; respectively). BARC 2, 3, or 5 was lower with abbreviated APT at 15 months (HR: 0.68 [95% CI: 0.56-0.83]; P = 0.0001) and did not differ during the routine care period. The treatment effects during routine care were consistent with those observed within 12 months after PCI. CONCLUSIONS: At 15 months, NACE and MACCE did not differ in the 2 study groups, whereas the risk of major or clinically relevant nonmajor bleeding remained lower with abbreviated compared with standard APT. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

• MeSH
• Stroke * etiology   prevention & control   MeSH
• Myocardial Infarction * complications   MeSH
• Platelet Aggregation Inhibitors MeSH
• Drug Therapy, Combination MeSH
• Percutaneous Coronary Intervention * adverse effects   methods   MeSH
• Hemorrhage chemically induced   MeSH
• Humans MeSH
• Drug-Eluting Stents * adverse effects   MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Randomized Controlled Trial MeSH

BACKGROUND: The optimal duration of antiplatelet therapy (APT) after coronary stenting in patients at high bleeding risk (HBR) presenting with an acute coronary syndrome remains unclear. OBJECTIVES: The objective of this study was to investigate the safety and efficacy of an abbreviated APT regimen after coronary stenting in an HBR population presenting with acute or recent myocardial infarction. METHODS: In the MASTER DAPT trial, 4,579 patients at HBR were randomized after 1 month of dual APT (DAPT) to abbreviated (DAPT stopped and 11 months single APT or 5 months in patients with oral anticoagulants) or nonabbreviated APT (DAPT for minimum 3 months) strategies. Randomization was stratified by acute or recent myocardial infarction at index procedure. Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes events (NACE); major adverse cardiac and cerebral events (MACCE); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. RESULTS: NACE and MACCE did not differ with abbreviated vs nonabbreviated APT regimens in patients with an acute or recent myocardial infarction (n = 1,780; HR: 0.83; 95% CI: 0.61-1.12 and HR: 0.86; 95% CI: 0.62-1.19, respectively) or without an acute or recent myocardial infarction (n = 2,799; HR: 1.03; 95% CI: 0.77-1.38 and HR: 1.13; 95% CI: 0.80-1.59; Pinteraction = 0.31 and 0.25, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding was significantly reduced in patients with or without an acute or recent myocardial infarction (HR: 0.65; 95% CI: 0.46-0.91 and HR: 0.71; 95% CI: 0.54-0.92; Pinteraction = 0.72) with abbreviated APT. CONCLUSIONS: A 1-month DAPT strategy in patients with HBR presenting with an acute or recent myocardial infarction results in similar NACE and MACCE rates and reduces bleedings compared with a nonabbreviated DAPT strategy. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

• MeSH
• Anticoagulants therapeutic use   MeSH
• Dimaprit analogs & derivatives   MeSH
• Myocardial Infarction * drug therapy   MeSH
• Platelet Aggregation Inhibitors adverse effects   MeSH
• Drug Therapy, Combination MeSH
• Percutaneous Coronary Intervention * methods   MeSH
• Hemorrhage chemically induced   epidemiology   MeSH
• Humans MeSH
• Polymers MeSH
• Stents MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Randomized Controlled Trial MeSH

BACKGROUND: In some randomized clinical trials, transradial access (TRA) compared with transfemoral access (TFA) was associated with lower mortality in patients with coronary artery disease undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter randomized clinical trials and whether these associations are modified by patient or procedural characteristics. METHODS: We performed an individual patient data meta-analysis of multicenter randomized clinical trials comparing TRA with TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention. The primary outcome was all-cause mortality and the co-primary outcome was major bleeding at 30 days. The primary analysis was conducted by 1-stage mixed-effects models on the basis of the intention-to-treat cohort. The effect of access site on mortality and major bleeding was assessed further by multivariable analysis. The relationship among access site, bleeding, and mortality was investigated by natural effect model mediation analysis with multivariable adjustment. RESULTS: A total of 21 600 patients (10 775 TRA, 10 825 TFA) from 7 randomized clinical trials were included. The median age was 63.9 years, 31.9% were women, 95% presented with acute coronary syndrome, and 75.2% underwent percutaneous coronary intervention. All-cause mortality (1.6% versus 2.1%; hazard ratio, 0.77 [95% CI, 0.63-0.95]; P=0.012) and major bleeding (1.5% versus 2.7%; odds ratio, 0.55 [95% CI, 0.45-0.67]; P<0.001) were lower with TRA. Subgroup analyses for mortality showed consistent results, except for baseline hemoglobin level (Pinteraction=0.003), indicating that the benefit of TRA was substantial in patients with moderate or severe anemia, whereas it was not significant in patients with milder or no baseline anemia. After adjustment, TRA remained associated with 24% and 51% relative risk reduction of all-cause mortality and major bleeding, respectively. A mediation analysis showed that the benefit of TRA on mortality was only partially driven by major bleeding prevention and ancillary mechanisms are required to fully explain the causal association. CONCLUSIONS: TRA is associated with lower all-cause mortality and major bleeding at 30 days compared with TFA. The effect on mortality was driven by patients with anemia. The reduction in major bleeding only partially explains the mortality benefit. REGISTRATION: URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42018109664.

• MeSH
• Femoral Artery diagnostic imaging   MeSH
• Radial Artery MeSH
• Coronary Angiography * adverse effects   MeSH
• Percutaneous Coronary Intervention * adverse effects   MeSH
• Hemorrhage etiology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Multicenter Studies as Topic MeSH
• Randomized Controlled Trials as Topic MeSH
• Risk Factors MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Meta-Analysis MeSH

BACKGROUND: Nonadherence to antiplatelet therapy after percutaneous coronary intervention (PCI) is common, even in clinical trials. OBJECTIVES: The purpose of this study was to investigate the impact of nonadherence to study protocol regimens in the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen) trial. METHODS: At 1-month after PCI, 4,579 high bleeding risk patients were randomized to single antiplatelet therapy (SAPT) for 11 months (or 5 months in patients on oral anticoagulation [OAC]) or dual antiplatelet therapy (DAPT) for ≥2 months followed by SAPT. Coprimary outcomes included net adverse clinical events (NACE), major adverse cardiac and cerebral events (MACE), and major or clinically relevant nonmajor bleeding (MCB) at 335 days. Inverse probability-of-censoring weights were used to correct for nonadherence Academic Research Consortium type 2 or 3. RESULTS: In total, 464 (20.2%) patients in the abbreviated-treatment and 214 (9.4%) in the standard-treatment groups incurred nonadherence Academic Research Consortium type 2 or 3. At inverse probability-of-censoring weights analyses, NACE (HR: 1.01; 95% CI: 0.88-1.27) or MACE (HR: 1.07; 95% CI: 0.83-1.40) did not differ, and MCB was lower with abbreviated compared with standard treatment (HR: 0.51; 95% CI: 0.60-0.73) consistently across OAC subgroups; among OAC patients, SAPT discontinuation 6 months after PCI was associated with similar MACE and lower MCB (HR: 0.47; 95% CI: 0.22-0.99) compared with SAPT continuation. CONCLUSIONS: In the MASTER DAPT adherent population, 1-month compared with ≥3-month DAPT was associated with similar NACE or MACE and lower MCB. Among OAC patients, SAPT discontinuation after 6 months was associated with similar MACE and lower MCB than SAPT continuation (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

• MeSH
• Medication Adherence MeSH
• Platelet Aggregation Inhibitors therapeutic use   MeSH
• Drug Therapy, Combination MeSH
• Percutaneous Coronary Intervention * methods   MeSH
• Hemorrhage chemically induced   drug therapy   epidemiology   MeSH
• Humans MeSH
• Polymers MeSH
• Drug-Eluting Stents * adverse effects   MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Randomized Controlled Trial MeSH

OBJECTIVES: The aim of this study was to define the optimal fluoroscopic viewing angles of both coronary ostia and important coronary bifurcations by using 3-dimensional multislice computed tomographic data. BACKGROUND: Optimal fluoroscopic projections are crucial for coronary imaging and interventions. Historically, coronary fluoroscopic viewing angles were derived empirically from experienced operators. METHODS: In this analysis, 100 consecutive patients who underwent computed tomographic coronary angiography (CTCA) for suspected coronary artery disease were studied. A CTCA-based method is described to define optimal viewing angles of both coronary ostia and important coronary bifurcations to guide percutaneous coronary interventions. RESULTS: The average optimal viewing angle for ostial left main stenting was left anterior oblique (LAO) 37°, cranial (CRA) 22° (95% confidence interval [CI]: LAO 33° to 40°, CRA 19° to 25°) and for ostial right coronary stenting was LAO 79°, CRA 41° (95% CI: LAO 74° to 84°, CRA 37° to 45°). Estimated mean optimal viewing angles for bifurcation stenting were as follows: left main: LAO 0°, caudal (CAU) 49° (95% CI: right anterior oblique [RAO] 8° to LAO 8°, CAU 43° to 54°); left anterior descending with first diagonal branch: LAO 11°, CRA 71° (95% CI: RAO 6° to LAO 27°, CRA 66° to 77°); left circumflex bifurcation with first marginal branch: LAO 24°, CAU 33° (95% CI: LAO 15° to 33°, CAU 25° to 41°); and posterior descending artery and posterolateral branch: LAO 44°, CRA 34° (95% CI: LAO 35° to 52°, CRA 27° to 41°). CONCLUSIONS: CTCA can suggest optimal fluoroscopic viewing angles of coronary artery ostia and bifurcations. As the frequency of use of diagnostic CTCA increases in the future, it has the potential to provide additional information for planning and guiding percutaneous coronary intervention procedures.

• MeSH
• Computed Tomography Angiography * MeSH
• Fluoroscopy MeSH
• Coronary Angiography MeSH
• Humans MeSH
• Multidetector Computed Tomography * MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH

BACKGROUND: Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk. METHODS/DESIGN: The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life. DISCUSSION: The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis. TRIAL REGISTRATION: clinicaltrials.gov: NCT04160130.

• MeSH
• Aortic Valve * diagnostic imaging   surgery   MeSH
• Aortic Valve Stenosis * diagnosis   physiopathology   psychology   surgery   MeSH
• Quality of Life * MeSH
• Humans MeSH
• Postoperative Complications * diagnosis   physiopathology   prevention & control   psychology   MeSH
• Randomized Controlled Trials as Topic MeSH
• Risk Factors MeSH
• Aged MeSH
• Heart Valve Prosthesis * adverse effects   classification   MeSH
• Severity of Illness Index MeSH
• Transcatheter Aortic Valve Replacement * adverse effects   instrumentation   methods   MeSH
• Outcome and Process Assessment, Health Care MeSH
• Health Status MeSH
• Risk Adjustment methods   MeSH
• Check Tag
• Humans MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial Protocol MeSH