Search

The article discusses the findings of a trial called WATCH-TAVR, which studied the effectiveness of combining transcatheter aortic valve implantation (TAVI) with left atrial appendage occlusion (LAAO) in patients with aortic stenosis and atrial fibrillation. The trial found that the combined procedure was feasible and had a safety profile similar to previous trials of LAAO. However, it did not demonstrate superiority over TAVI alone in terms of major bleeding or mortality rates. The article emphasizes the need for further randomized trials to evaluate the benefits and safety of combined interventional procedures. [Extracted from the article]

Transcatheter aortic valve replacement (TAVR) is becoming widely used for the treatment of symptomatic severe aortic stenosis in patients with high surgical risk. Data from The PARTNER Trial (Placement of AoRtic TraNscathetER Valves) and the Medtronic CoreValve® U.S. Pivotal Investigational Device Exemption trial indicate that survival for extreme-risk patients is superior to best medical therapy and equivalent or superior to surgical aortic valve replacement (SAVR), although long-term durability remains unknown. Paravalvular leak remains higher in TAVR than SAVR, as does permanent pacemaker implantation in self-expanding valves. New-generation valves are addressing these issues, especially for paravalvular leak. There is strong evidence that TAVR is appropriate for both extreme-risk and high-risk patients with symptomatic severe aortic stenosis, and the continued development of new valves are making implantation more reliable. This review discusses the studies supporting the use of TAVR and explores current advances in the field. [ABSTRACT FROM AUTHOR]

Over the last 20 years, transcatheter aortic valve replacement (TAVR) has revolutionized the management of aortic stenosis and has become the standard of care across the entire spectrum of surgical risk. Expansion of TAVR in treating younger, lower-risk patients with longer life expectancies, and treating earlier in the disease process, has seen a continuous evolution in device technology, with several next-generation transcatheter heart valves developed to minimize procedural complications and improve patient outcomes. This review provides an update on the latest advances in transcatheter delivery systems, devices, and leaflet technology. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve implantation (TAVI) has become the standard of care in symptomatic older patients with severe aortic stenosis regardless of surgical risk. With the development of newer generation transcatheter bioprostheses, improved delivery systems, better preprocedure planning with imaging guidance, increased operator experience, shorter hospital length of stay, and low short- and mid-term complication rates, TAVI is gaining popularity among younger patients at low or intermediate surgical risk. Longterm outcomes and durability of transcatheter heart valves have become substantially important for this younger population due to their longer life expectancy. The lack of standardized definitions of bioprosthetic valve dysfunction and disagreement about how to account for the competing risks made comparison of transcatheter heart valves with surgical bioprostheses challenging until recently. In this review, the authors discuss the mid- to long-term (≥ 5 years) clinical outcomes observed in the landmark TAVI trials and analyze the available long-term durability data emphasizing the importance of using standardized definitions of bioprosthetic valve dysfunction. [ABSTRACT FROM AUTHOR]

The article focuses on a study which shows that dual antiplatelet therapy (DAPT) using a combination of aspirin and an antagonist of platelet receptor led to acceptable rates of stent thrombosis and of bleeding. According to the study, an approach to reduce the requisite duration of DAPT is implant either a stent that disappears or one containing a polymer that disappears.

Background--Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention with hemodynamic support may be feasible for these patients. Currently, there is no systematic comparative evaluation of hemodynamic support devices for this indication. Methods and Results--We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior hemodynamic support in comparison with IABP. with maximal decrease in cardiac power output from baseline of -0.04±0.24 W in comparison with -0.14±0.27 W for IABP (P=0.001). The primary end point (30-day major adverse events) was not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP, P=0.227 in the intent-to-treat population and 34.3% versus 42.2%, P=0.092 in the per protocol population. At 90 days, a strong trend toward decreased major adverse events was observed in Impella 2.5-supported patients in comparison with IABP: 40.6% versus 49.3%, P=0.066 in the intent-to-treat population and 40.0% versus 51.0%, P=0.023 in the per protocol population, respectively. Conclusions--The 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5-supported patients at 90 days. [ABSTRACT FROM AUTHOR]

The author focuses on the dilemma related to the duration of dual antiplatelet therapy in patients receiving intracardiac stents. Dual antiplatelet therapy combines aspirin and inhibitor of platelet P2Y12. He mentions that during early days of stent implantation, antithrombotic therapy was performed by doses of warfarin and heparin. He also opines on the use of drug-eluting stents and the risk of stent thrombosis associated with it.

Antithrombotic therapy and revascularization are critical factors in managing patients presenting with acute coronary syndromes and are described in multiple guidelines documents. In addition to preventing intravascular thrombosis, they increase the risk of bleeding, which has been implicated as a risk factor in short- and long-term mortality. Randomized controlled trials provide useful aggregate information comparing the risks and benefits of various therapies. In this paper, we will use a case-based format to discuss optimal individualized antithrombotic treatments. [ABSTRACT FROM AUTHOR]

Antiplatelet therapy is the mainstay of treatment for patients with cardiovascular disease. However, some patients experience adverse cardiac events despite treatment with single- or dual-antiplatelet (aspirin and clopidogrel) therapy. Some of those events could be caused by low responsiveness to aspirin or clopidogrel. The frequency of this phenomenon has been reported to range from 1% to 45% for the 2 drugs. This wide range arises from the lack of a “gold-standard” definition to assess antiplatelet drug response and differences in assays, agonist concentrations, and cut-off points. Regardless of the variability in the incidence of aspirin or clopidogrel low responsiveness, several studies have indicated a clear relation between clopidogrel or aspirin low responsiveness and cardiovascular events. The evidence for an association between adverse clinical events and the results of ex vivo platelet function tests is stronger for clopidogrel than for aspirin. Currently, there is no established therapeutic approach for managing low response to aspirin or clopidogrel that has been shown in large trials to have clinical benefit. This review focuses on laboratory testing of antiplatelet response to aspirin and clopidogrel, the prevalence of low response, potential mechanisms, clinical significance, and prognostic value of this phenomenon and alternative approaches to optimize treatment in patients with low response to the drugs. [Copyright &y& Elsevier]

This paper, developed from the proceedings of the 2007 Platelet Colloquium, considers emerging constructs in platelet biology, preclinical models of thrombosis, and their potential application to the development of platelet-directed pharmacotherapies. Discussed first is the developmental biology of platelets, including megakaryocyte maturation, and the role of apoptotic and growth factors and other proteins in thrombopoiesis. A brief overview of current methods and observations from platelet proteomic analyses is also presented, illustrating the complex interplay of genes, gene expression, protein expression, and protein modification in various atherothrombotic phenotypes. The factor Xa-platelet interface is used as a working model for discussion of anticoagulants as platelet antagonists, highlighting the importance of receptor expression, substrate binding kinetics, platelet subpopulations, and cofactors in thrombosis. Finally, we discuss the use of emerging technologies—such as intravital microscopy and ex vivo perfusion chambers—as translatable platforms for investigating the role of platelets and their pharmacologic inhibition in human health and disease. [ABSTRACT FROM AUTHOR]

Background: Endothelial progenitor cells (EPCs) are bone marrow-derived cells that are augmented in response to ischemia and incorporated into neovascularization sites. We sought to determine whether circulating EPCs are related to collateral formation following non-ST segment elevation myocardial infarction (NSTEMI). Methods: Twenty patients who underwent percutaneous coronary intervention (PCI) within a week of NSTEMI were divided into two groups: patients without collaterals (coll–, n = 10) and patients with Rentrop grade 3–4 collaterals (coll+, n = 10). Blood samples were drawn before PCI and 24 ± 2 h after PCI. EPC colonies were grown from peripheral blood mononuclear cells, characterized, and counted. Using flow cytometry the percentage of cells coexpressing vascular endothelial growth factor receptor-2 and CD133 was determined. Results: The coll+ group had higher degree of culprit vessel stenosis and lower initial thrombolysis in myocardial infarction flow grade. The relative number of EPCs before PCI was significantly higher in the coll+ group than in the coll– group (1.49 ± 0.9% vs. 0.77 ± 0.4%, p = 0.045). There were no significant intergroup differences in the number of EPC colony-forming cells. The number of EPC colonies increased in the coll– group after PCI (9.5 ± 4.8 to 14.0 ± 5.9/106 cells, p = 0.01). Conclusions: This study supports an association between circulating EPC levels and collateral formation in patients with an NSTEMI. Copyright © 2005 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Context In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, bivalirudin with provisional glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition was found to be noninferior to heparin plus planned Gp IIb/IIIa blockade in the prevention of acute ischemic end points and was associated with significantly less bleeding by 30 days after percutaneous coronary intervention (PCI). Objective To determine whether the efficacy of bivalirudin remains comparable with that of heparin plus Gp IIb/IIIa blockade over 6 months and 1 year. Design, Setting, and Participants Follow-up study to 1 year of a randomized, double-blind trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. Interventions Patients were randomly assigned to receive intravenously bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition, or to receive heparin (65 U/kg bolus), with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. Main Outcome Measures Incidence of death, myocardial infarction, or repeat revascularization by 6 months and death by 12 months after enrollment. Results At 6 months, death occurred in 1.4% of patients in the heparin plus Gp IIb/IIIa group and in 1.0% of patients in the bivalirudin group (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.43-1.14; P = .15). Myocardial infarction occurred in 7.4% and 8.2% of patients, respectively (HR, 1.12; 95% CI, 0.93-1.34; P = .24), and repeat revascularization was required in 11.4% and 12.1% of patients, respectively (HR, 1.06; 95% CI, 0.91-1.23; P = .45). By 1 year, death occurred in 2.46% of patients treated with heparin plus Gp IIb/IIIa blockade and in 1.89% of patients treated with bivalirudin (HR, 0.78; 95% CI, 0.55-1.11; P = .16). Nonsign... [ABSTRACT FROM AUTHOR]

: ObjectivesWe sought to determine whether elevation of plasma creatine kinase muscle-brain fraction (CK-MB) would be useful to triage patients with acute coronary syndromes (ACS) to early angiography/revascularization.: BackgroundIt is unknown whether the measurement of CK-MB is effective for triage to an aggressive management strategy.: MethodsPatients in the Treat Angina With Aggrastat and Determine Cost of Therapy With an Invasive or Conservative Strategy (TACTICS-TIMI) 18 study received aspirin, heparin, and tirofiban for treatment of ACS, were randomized to an invasive or a conservative strategy (angiography/revascularization between 4 and 48 h), and were followed up for a composite end point of death, myocardial infarction, or rehospitalization for ACS.: ResultsOf 2,220 patients, CK-MB was elevated in 826 (37%). Of the patients with negative CK-MB, troponin T was elevated in 361 (31.2%). Event rates at 30 and 180 days were twice as high in patients with elevated CK-MB than in patients without elevated CK-MB. Both groups had similar benefit from an invasive strategy; there was no evidence of interaction between CK-MB elevation and strategy on the composite end point at 30 or 180 days. When patients were stratified according to both CK-MB and troponin status, there was evidence of a benefit in the invasive strategy among patients who were CK-negative but troponin-positive (odds ratios [95% confidence interval]: 0.13 [0.04 to 0.39] at 30 days and 0.29 [0.16 to 0.52] at 180 days).: ConclusionsPatients with minimal amounts of recent onset myonecrosis but elevated risk as indicated by CK-MB and troponin, respectively, benefit most from invasive management. Determination of troponin levels yielded significant information regarding triage to an invasive strategy, particularly in CK-MB-negative patients. [Copyright &y& Elsevier]

Contrast-associated acute kidney injury (CA-AKI) is a fairly frequent complication of cardiovascular angiography and percutaneous coronary intervention (PCI). The risk is significantly higher in patients with advanced chronic kidney disease (CKD). Prevention is the only option for avoiding the significant morbidity and mortality associated with CA-AKI. This review provides a concise and clinically directed appraisal of the latest preprocedural and peri-procedural strategies to minimize the risk of CA-AKI in all patients undergoing PCI. By broadly implementing these evidence-based care bundles, we can dramatically improve outcomes in this vulnerable patient population. [ABSTRACT FROM AUTHOR]

Evaluates the effect of heptapeptide inhibitor eptifibatide in the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT II) phase III trial for the management of acute ischemia. Effect of the drug in decreasing risk for major hemorrhage, thrombocytopenia and the need for transfusions of red blood cells; Potent antiplatelet activity of the drug.

Objective: To assess the safety and short- and long-term outcomes of percutaneous transluminal coronary angioplasty in octogenarians.Design: Retrospective chart review of clinical series.Setting: Referral-based university medical center.Patients: Consecutive series of 54 octogenarian patients (mean age, 82.4 years) who had percutaneous transluminal coronary angioplasty between March 1980 and December 1988. Of these patients, 91% presented with severe angina (Canadian Cardiovascular Society Class III or IV); 59% had unstable angina. Twenty-six patients (48%) had had a previous myocardial infarction and 15 (28%) had had previous coronary artery bypass surgery. Multivessel disease was present in 44 patients (81%). Follow-up ranged from 1 to 50 months (mean, 19 months).Intervention: Percutaneous transluminal coronary angioplasty.Measurements and Main Results: The angiographic success rate was 50 of 54 (93%; 95% CI, 81% to 98%) and the clinical success rate was 49 of 54 (91%; CI, 79% to 97%). Two patients had procedure-related myocardial infarction. Two patients died in the hospital, 1 from cardiac tamponade because of pacemaker perforation and 1 from cardiogenic shock after a myocardial infarction despite successful angioplasty. During the follow-up period 4 patients required bypass surgery, 2 had myocardial infarction, and 7 died (4 deaths were cardiac). Eleven patients (20%) had re-stenosis, 7 of whom were managed with repeat angioplasty, including 1 patient who had four procedures. At follow-up, 42 of 45 survivors (93%) were asymptomatic or had class II angina. The Kaplan-Meier survival for all patients, including those who died in the hospital, was 87% at 1 year and 80% at 3 years. Cumulative freedom from major cardiac events (death, myocardial infarction, or coronary bypass surgery) was 81% at 1 year and 78% at 3 years.Conclusions: Percutaneous transluminal coronary angioplasty can be done in octogenarians with a high rate of angiographic and clinical success, low complication rate, and a favorable long-term (3-year) outcome. As such, it is a treatment option in managing advanced coronary artery disease in this fragile group of patients. [ABSTRACT FROM AUTHOR]

An introduction to the journal is presented in which the editor discusses the steps in revitalizing view of coronary artery thrombosis and provide target for pharmacologic treatment of acutre coronary syndromes.

The article presents a study which compared the effectiveness of transcatheter aortic valve replacement (TAVR) against surgical aortic valve replacement (SAVR) as standard treatments for patients with inoperable aortic stenosis. The study is part of the Placement of Aortic Transcatheter Valves (PARTNER) programme. Among the data obtained are cardiovascular mortality, the risk of stroke, and mean survival of the study participants.

Background: Neurological events after aortic valve interventions are associated with increased mortality and morbidity. Transcatheter aortic valve replacement (TAVR) is increasingly offered for lower-risk patients with severe aortic stenosis, previously considered candidates for surgical aortic valve replacement (SAVR). Differences in post-procedural neurological events have important implications in treatment allocation.Objectives: The authors sought to analyze the neurological events in the randomized SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial.Methods: Patients with severe, symptomatic aortic stenosis at intermediate surgical risk were randomized 1:1 to TAVR or SAVR. The rates of neurological events and quality of life were analyzed at 30 days, and 6 and 12 months post-procedure in a modified intention-to-treat population (mean age 79.8 ± 6.2 years; N = 1,660).Results: The rates of early (30-day) stroke and post-procedural encephalopathy were higher after SAVR versus TAVR (5.4% vs. 3.3%; p = 0.031; and 7.8% vs. 1.6%; p < 0.001, respectively). At 12 months, the rate of stroke was not different between SAVR and TAVR (6.9% vs. 5.2%; p = 0.136). Early stroke and early encephalopathy resulted in an elevated mortality at 12 months in both treatment groups. Quality of life after an early stroke was significantly lower in SAVR versus TAVR patients at 30 days and was similar at 6 and 12 months.Conclusions: The early stroke rate was lower after TAVR than SAVR. In patients with early strokes, QOL improved earlier after TAVR. At 12-month follow-up, stroke rates and QOL were not different between TAVR and SAVR patients. (Surgical Replacement and Transcatheter Aortic Valve Implantation [SURTAVI]; NCT01586910). [ABSTRACT FROM AUTHOR]

Abstract Since the approval of the first transcatheter aortic valve replacement (TAVR) device in 2011, this technology has undergone substantial enhancements and exponential growth. However, valve thrombosis and residual paravalvular leaks (PVL) are among the challenges that require further investigation. Recently, monitoring von Willebrand factor (vWF) multimers has emerged as a tool to help evaluate the severity of PVL after TAVR. Following TAVR, vWF large multimers recovery have been documented. The role of large vWF multimers recovery and their interactions with platelets, and the endothelium have not been entirely elucidated. In this review, we discuss vWF synthesis and its role in aortic stenosis. We further provide an overview of the studies that investigated changes affecting vWF multimers following TAVR and the role of HMW vWF multimers monitoring in the determination of PVL severity. We also offer potential future directions for what will be fertile ground for research in this field. Highlights • Von Willebrand Factor undergoes structure changes under different flow conditions. • Monitoring von Willebrand Factor multimers after TAVR provides a tool to determine PVL severity. • The role of vWF-platelet interactions after TAVR warrants further investigation. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Soluble CD40 Ligand in Acute Coronary Syndromes" in the March 20, 2003 issue.

Background: Death in high- and intermediate-risk patients after self-expanding transcatheter (TAVR) and surgical aortic valve replacement (surgery) differed in mechanisms and timing. In both risk groups, 1-year all-cause mortality was lower in TAVR than in surgery patients. The differences in mechanism and timing of death in low-risk patients has not been studied. This report explores the mechanisms of death during 3 time periods; 0 to 30 days (early), 31 to 120 days (recovery), and 121 to 365 days (late).Methods: We retrospectively examined the mechanisms and timing of death following TAVR or surgery in the randomized Evolut Low Risk Trial. Patients were enrolled between March 2016 and November 2018 from 86 designated TAVR centers. Mechanisms of death were categorized as due to technical reasons, failure to repair, complications linked to death, failure to recover or other.Results: All-cause mortality at 1 year was 2.2% for TAVR and 2.8% for surgery, p = 0.44. Early deaths included 3 TAVR patients, all due to technical reasons, and 8 surgery patients (1 technical, 5 complications and 2 failed to recover). Recovery period deaths included 6 TAVR patients (4 complications, 1 failed to recover and 1 other), and 1 surgery patient from complications of valve endocarditis. Late period deaths included 6 TAVR patients and 9 surgery patients, primarily due to complications.Conclusions: In this low-risk study cohort, no patient died from failure to repair the valve; reduction in procedural complications in the TAVR and surgery groups remain opportunities for further improvement in outcomes. Clinical Trial Registrations (clinicaltrials.gov): NCT02701283 (Evolut Low Risk). [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to evaluate whether baseline tricuspid regurgitation (TR) impacted clinical outcomes after mitral valve transcatheter edge-to-edge repair (M-TEER) for severe secondary mitral regurgitation (MR).Background: Baseline TR is common among patients undergoing M-TEER for secondary MR, although its impact on clinical outcomes is unclear.Methods: The Cochrane Library, PubMed/MEDLINE, and Google Scholar were searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines from January 1, 2011 through January 31, 2021. Randomized controlled trials and nonrandomized prospective studies that evaluated baseline TR by echocardiography before M-TEER for MR were included. The primary outcome was a composite of mortality and heart failure hospitalization (HFH) at 1-year.Results: A total of 5 studies (n = 1395 patients) were included in the primary analysis. Concurrent moderate/severe TR was associated with a worse 1 year composite of all-cause mortality and HFH (OR: 2.13; 95% CI: 1.12-4.05; p = 0.02) after M-TEER for severe MR. In studies that reported TR grade pre- and post-M-TEER for severe MR, 32% of patients with moderate-to-severe baseline TR had a reduction in TR severity after the intervention.Conclusions: Baseline moderate-to-severe TR was associated with increased 1-year mortality and heart failure hospitalizations among patients undergoing M-TEER. Further randomized studies are needed to assess the interaction of TR among patients undergoing M-TEER. [ABSTRACT FROM AUTHOR]

Treatment of recurrent MR after initially successful MitraClip procedure can pose therapeutic challenges. We report a successful case of redo MitraClip to treat recurrent inter-clip MR due to progression of underlying degenerative valvular pathology with prolapsing posterior mitral leaflet between the two prior clips. In this vignette, we describe the novel use of quantitative coronary arteriography (QCA) to select redo MitraClip as the treatment strategy. [ABSTRACT FROM AUTHOR]

Background: Incidence of multivalvular heart disease is increasing, with aortic stenosis and mitral regurgitation being the most common. Data are limited on outcomes of patients undergoing multivalvular surgery. The purpose of this study was to evaluate contemporary trends and in-hospital outcomes for combined surgical aortic valve replacement (SAVR) and mitral valve repair (MVr) or replacement (MVR).Methods: We identified patient hospitalizations aged ≥18 years who underwent SAVR + MVr or MVR between 2004 and 2018 using the National Inpatient Sample. Data were weighted to estimate national estimates of the entire US hospitalized population. Exclusion criteria included endocarditis, history of heart transplant or left ventricular assist device, and any other concomitant valve surgery.Results: Between January 1, 2004, and December 31, 2018, there were 68,882 weighted admissions for SAVR with concomitant mitral valve surgery. Overall, in-hospital mortality was 8.34% with significantly higher inpatient mortality in SAVR + MVR group compared with SAVR + MVr group (9.91% vs 5.57%, p < 0.001). During the study period, adjusted in-hospital mortality decreased in both SAVR + MVr group (p-trend 0.004) and SAVR + MVR group (p-trend <0.001). Age ≥70 years was associated with higher in-hospital mortality compared to those < 70 years (9.95% vs 6.70%, p < 0.001).Conclusion: Combined aortic and mitral valve surgery is associated with a high risk of in-hospital mortality, especially in patients ≥ 70 years of age. Further research is needed to assess the role of transcatheter approaches in the treatment of multivalvular heart disease. [ABSTRACT FROM AUTHOR]

Left ventricular thrombi form due to the presence of Virchow's triad in patients with left ventricular systolic dysfunction. This complication increases the incidence of systemic embolization, hence anticoagulation is recommended to decrease this risk. Up to the present time, vitamin K antagonists are recommended by all societal guidelines for patients with left ventricular thrombi. Recently, several studies have investigated the role of different anticoagulants and yielded promising outcomes. This opinion article focuses on the evidence supporting vitamin K antagonists and direct oral anticoagulants in patients with left ventricular thrombi. [ABSTRACT FROM AUTHOR]

Background: The Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up.Objectives: The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial.Methods: A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints.Results: An attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: -1.4%; 95% Bayesian credible interval: -4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves.Conclusions: The complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283). [ABSTRACT FROM AUTHOR]

Secondary prevention trials have demonstrated the efficacy of statins in reducing cardiovascular morbidity and mortality in patients with coronary artery disease and events after percutaneous coronary intervention (PCI). However, there are few data describing the clinical value of statins in patients with coronary artery disease and chronic kidney disease (CKD) undergoing PCI. Of 10,148 patients who entered into Evaluation of Drug Eluting Stents and Ischemic Events, a multicenter registry of unselected patients undergoing PCI from July 2004 to December 2007, we studied 2,306 patients with CKD (estimated glomerular filtration rate ≤60 ml/min based on the Modified Diet in Renal Disease calculation). Patients were stratified into those receiving statins at discharge (n = 1,833, 79%) or not (n = 473, 21%). Patients in the statin group had a greater prevalence of hypertension, recent myocardial infarction (MI), and use of b blockers and angiotensin-converting enzyme inhibitors. Outcomes were assessed from discharge through 1-year follow-up. Oneyear all-cause mortality was 5.7% in statin group versus 8.7% in the no statin group (adjusted hazard ratio 0.55, 95% confidence interval 0.34 to 0.88). The composite of death, MI, and repeat revascularization was lower in statin group (adjusted hazard ratio 0.71, 95% confidence interval 0.51 to 0.99). In conclusion, among patients with CKD undergoing PCI, the prescription of statins at hospital discharge was associated with a significant improvement in subsequent outcomes including mortality and composite end point of death, MI, and repeat revascularization. [ABSTRACT FROM AUTHOR]