Transcatheter Therapy for the Tricuspid Valve: A Focused Review of Edge-to-Edge Repair and Orthotopic Valve Replacement.

PURPOSE OF REVIEW: Patients with severe tricuspid regurgitation (TR) are at risk for significant morbidity and mortality. Transcatheter tricuspid valve interventions (TTVI) may offer patients less invasive treatment alternatives to surgery. This review evaluates the most common class of device currently used worldwide to treat TR, tricuspid transcatheter edge-to-edge repair (T-TEER) and orthotopic transcatheter tricuspid valve replacement (TTVR), both of which are now approved in the USA and Europe. RECENT FINDINGS: The first pivotal randomized clinical trial, TRILUMINATE, demonstrated that T-TEER can safely reduce TR and is associated with improved health status outcomes. However, results of this trial have raised questions about whether this device can provide sufficient TR reduction to impact clinical outcomes. Orthotopic TTVR has recently gained attention with initial data suggesting near-complete TR elimination. The current review examines the technical features and anatomic limitations of the most commonly used devices for T-TEER and orthotopic TTVR, discusses the current clinical data for these devices, and offers a theoretical construct for device selection.

Transcatheter versus surgical aortic valve replacement in lower-risk and higher-risk patients: a meta-analysis of randomized trials.

AIMS: Additional randomized clinical trial (RCT) data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) is available, including longer term follow-up. A meta-analysis comparing TAVI to SAVR was performed. A pragmatic risk classification was applied, partitioning lower-risk and higher-risk patients. METHODS AND RESULTS: The main endpoints were death, strokes, and the composite of death or disabling stroke, occurring at 1 year (early) or after 1 year (later). A random-effects meta-analysis was performed. Eight RCTs with 8698 patients were included. In lower-risk patients, at 1 year, the risk of death was lower after TAVI compared with SAVR [relative risk (RR) 0.67; 95% confidence interval (CI) 0.47 to 0.96, P = 0.031], as was death or disabling stroke (RR 0.68; 95% CI 0.50 to 0.92, P = 0.014). There were no differences in strokes. After 1 year, in lower-risk patients, there were no significant differences in all main outcomes. In higher-risk patients, there were no significant differences in main outcomes. New-onset atrial fibrillation, major bleeding, and acute kidney injury occurred less after TAVI; new pacemakers, vascular complications, and paravalvular leak occurred more after TAVI. CONCLUSION: In lower-risk patients, there was an early mortality reduction with TAVI, but no differences after later follow-up. There was also an early reduction in the composite of death or disabling stroke, with no difference at later follow-up. There were no significant differences for higher-risk patients. Informed therapy decisions may be more dependent on the temporality of events or secondary endpoints than the long-term occurrence of main clinical outcomes.

The role of vitamin D in cardiovascular disease and COVID-19.

Patients with pre-existing cardiovascular disease (CVD) are at high risk for adverse outcomes with coronavirus disease 2019 (COVID-19). Further, COVID-19 infection is associated with numerous cardiovascular (CV) complications including arrhythmia, myocardial injury, cardiomyopathy, and thrombotic events. Increased susceptibility to COVID-19 and CV complications related to COVID-19 may be in part related to immune dysregulation and inflammation associated with CV disease which is exacerbated with viral infection. Vitamin D plays a major role in immune function and exerts anti-inflammatory effects, which may prove important in the context of CVD and COVID-19. To date, studies have shown minimal benefit for vitamin D supplementation in patients with COVID-19, though there are no studies specific to patients with CVD and related complications. Further, given that vitamin D has important protective effects on the CV system, including augmentation of myocardial contractility and anti-thrombotic effects, it is unknown if supplementation with vitamin D can mitigate CVD complications associated with COVID-19.

Long-term follow-up after ultrathin vs. conventional 2nd-generation drug-eluting stents: a systematic review and meta-analysis of randomized controlled trials.

AIMS: Contemporary 2nd-generation thin-strut drug-eluting stents (DES) are considered standard of care for revascularization of patients undergoing percutaneous coronary intervention. A previous meta-analysis of 10 randomized controlled trials (RCTs) with 11 658 patients demonstrated a 16% reduction in the 1-year risk of target lesion failure (TLF) with ultrathin-strut DES compared with conventional 2nd-generation thin-strut DES. Whether this benefit is sustained longer term is not known, and newer trial data may inform these relative outcomes. We therefore sought to perform an updated systematic review and meta-analysis of RCTs comparing clinical outcomes with ultrathin-strut DES (≤70 µm strut thickness) with conventional 2nd-generation thin-strut DES. METHODS AND RESULTS: We performed a random-effects meta-analysis of all RCTs comparing ultrathin-strut DES to conventional 2nd-generation thin-strut DES. The pre-specified primary endpoint was long-term TLF, a composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (CD-TLR). Secondary endpoints included the components of TLF, stent thrombosis (ST), and all-cause death. There were 16 eligible trials in which 20 701 patients were randomized. The weighted mean follow-up duration was 2.5 years. Ultrathin-strut DES were associated with a 15% reduction in long-term TLF compared with conventional 2nd-generation thin-strut DES [relative risk (RR) 0.85, 95% confidence interval (CI) 0.76-0.96, P = 0.008] driven by a 25% reduction in CD-TLR (RR 0.75, 95% CI 0.62-0.92, P = 0.005). There were no significant differences between stent types in the risks of MI, ST, cardiac death, or all-cause mortality. CONCLUSIONS: At a mean follow-up of 2.5 years, ultrathin-strut DES reduced the risk of TLF, driven by less CD-TLR compared with conventional 2nd-generation thin-strut DES, with similar risks of MI, ST, cardiac death, and all-cause mortality.

Pulmonary Embolism Response Team utilization during the COVID-19 pandemic.

Coronavirus disease 2019 (COVID-19) may predispose patients to venous thromboembolism (VTE). Limited data are available on the utilization of the Pulmonary Embolism Response Team (PERT) in the setting of the COVID-19 global pandemic. We performed a single-center study to evaluate treatment, mortality, and bleeding outcomes in patients who received PERT consultations in March and April 2020, compared to historical controls from the same period in 2019. Clinical data were abstracted from the electronic medical record. The primary study endpoints were inpatient mortality and GUSTO moderate-to-severe bleeding. The frequency of PERT utilization was nearly threefold higher during March and April 2020 (n = 74) compared to the same period in 2019 (n = 26). During the COVID-19 pandemic, there was significantly less PERT-guided invasive treatment (5.5% vs 23.1%, p = 0.02) with a numerical but not statistically significant trend toward an increase in the use of systemic fibrinolytic therapy (13.5% vs 3.9%, p = 0.3). There were nonsignificant trends toward higher in-hospital mortality or moderate-to-severe bleeding in patients receiving PERT consultations during the COVID-19 period compared to historical controls (mortality 14.9% vs 3.9%, p = 0.18 and moderate-to-severe bleeding 35.1% vs 19.2%, p = 0.13). In conclusion, PERT utilization was nearly threefold higher during the COVID-19 pandemic than during the historical control period. Among patients evaluated by PERT, in-hospital mortality or moderate-to-severe bleeding were not significantly different, despite being numerically higher, while invasive therapy was utilized less frequently during the COVID-19 pandemic.

Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality Among Patients With COVID-19 Admitted to the Intensive Care Unit: The INSPIRATION Randomized Clinical Trial.

Importance: Thrombotic events are commonly reported in critically ill patients with COVID-19. Limited data exist to guide the intensity of antithrombotic prophylaxis. Objective: To evaluate the effects of intermediate-dose vs standard-dose prophylactic anticoagulation among patients with COVID-19 admitted to the intensive care unit (ICU). Design, Setting, and Participants: Multicenter randomized trial with a 2 × 2 factorial design performed in 10 academic centers in Iran comparing intermediate-dose vs standard-dose prophylactic anticoagulation (first hypothesis) and statin therapy vs matching placebo (second hypothesis; not reported in this article) among adult patients admitted to the ICU with COVID-19. Patients were recruited between July 29, 2020, and November 19, 2020. The final follow-up date for the 30-day primary outcome was December 19, 2020. Interventions: Intermediate-dose (enoxaparin, 1 mg/kg daily) (n = 276) vs standard prophylactic anticoagulation (enoxaparin, 40 mg daily) (n = 286), with modification according to body weight and creatinine clearance. The assigned treatments were planned to be continued until completion of 30-day follow-up. Main Outcomes and Measures: The primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days, assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment. Prespecified safety outcomes included major bleeding according to the Bleeding Academic Research Consortium (type 3 or 5 definition), powered for noninferiority (a noninferiority margin of 1.8 based on odds ratio), and severe thrombocytopenia (platelet count <20 ×103/µL). All outcomes were blindly adjudicated. Results: Among 600 randomized patients, 562 (93.7%) were included in the primary analysis (median [interquartile range] age, 62 [50-71] years; 237 [42.2%] women). The primary efficacy outcome occurred in 126 patients (45.7%) in the intermediate-dose group and 126 patients (44.1%) in the standard-dose prophylaxis group (absolute risk difference, 1.5% [95% CI, -6.6% to 9.8%]; odds ratio, 1.06 [95% CI, 0.76-1.48]; P = .70). Major bleeding occurred in 7 patients (2.5%) in the intermediate-dose group and 4 patients (1.4%) in the standard-dose prophylaxis group (risk difference, 1.1% [1-sided 97.5% CI, -∞ to 3.4%]; odds ratio, 1.83 [1-sided 97.5% CI, 0.00-5.93]), not meeting the noninferiority criteria (P for noninferiority >.99). Severe thrombocytopenia occurred only in patients assigned to the intermediate-dose group (6 vs 0 patients; risk difference, 2.2% [95% CI, 0.4%-3.8%]; P = .01). Conclusions and Relevance: Among patients admitted to the ICU with COVID-19, intermediate-dose prophylactic anticoagulation, compared with standard-dose prophylactic anticoagulation, did not result in a significant difference in the primary outcome of a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days. These results do not support the routine empirical use of intermediate-dose prophylactic anticoagulation in unselected patients admitted to the ICU with COVID-19. Trial Registration: ClinicalTrials.gov Identifier: NCT04486508.

Adverse events beyond 1 year after percutaneous coronary intervention.

PURPOSE OF REVIEW: To provide a summary and critical appraisal of recent literature pertaining to very late adverse events (>1 year) after revascularization with percutaneous coronary intervention (PCI) with coronary stents. RECENT FINDINGS: Recent studies, including an individual patient-level pooled analysis of randomized trials and network meta-analysis have demonstrated that all coronary stents, including contemporary drug-eluting stents (DES), are associated with an ongoing risk of major adverse cardiovascular events related to the stented region beyond the first year after stent implantation, with rates ranging from 2 to 3% per year for at least 4 years. Patients also remain at additional risk for events originating outside the stented segments because of progressive de novo atherosclerotic disease. SUMMARY: Despite improvements in the management of coronary artery disease, patients remain at risk for very late adverse cardiovascular events both arising from the stented regions and other untreated segments of the coronary tree. Further advancements focused on primary prevention, stent design and procedural technique, and secondary prevention will be crucial to reducing rates of very late events and improving symptoms and prognosis of patients after PCI.

Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: An individual patient-level pooled data analysis.

BACKGROUND: Peripheral arterial disease (PAD) is one of the most common manifestations of atherosclerotic disease worldwide. Peripheral arterial calcification reduces acute success and long-term patency of endovascular therapy for PAD. Several calcium modification devices are available for use in peripheral interventions. Outcomes after peripheral intravascular lithotripsy (IVL), a novel approach using pulsatile sonic waves to treat luminal and medial calcium in patients with PAD, have not been extensively characterized. Therefore, we sought to perform an individual patient-level data (IPD) pooled analysis of available studies to evaluate the efficacy and safety of IVL in the treatment of PAD. METHODS AND RESULTS: We pooled IPD, including baseline and procedural variables, from five prospective studies which assessed IVL in the treatment of patients with extensive peripheral artery calcification. Final postprocedural percent diameter stenosis (%DS) and procedural angiographic complications were assessed by independent core laboratory. Efficacy endpoints were analyzed using linear mixed effects models and safety endpoints were tabulated overall and by vascular bed. Among 336 patients who underwent endovascular revascularization with use of IVL, there was a significant reduction between pre-procedural and final %DS of 55.1% (95% confidence interval 53.3-57.0%, p < .0001). Core-laboratory assessed lesion-level complications, including flow-limiting dissections (Types D-F), vessel perforation, distal embolization, thrombus, abrupt closure, and no reflow, occurred in 4/328 (1.22%) of treated lesions. CONCLUSIONS: The present IPD of five prospective studies, marking the largest analysis to date evaluating the use of IVL in significantly calcified PAD lesions, demonstrates this treatment strategy to be both effective and safe.

Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation-Individual patient data pooled analysis from 6 randomized controlled trials.

BACKGROUND: Drug-eluting stents (DESs) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation. METHODS: Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5 years. Primary outcome was TLF (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Cox proportional-hazards model was used to identify predictors of TLF. RESULTS: Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.9% at 30 days, 1 year, and 5 years, respectively. The only independent predictor of TLF at 30 days was stent length (hazard ratio [HR] 1.017, 95% CI 1.011-1.024, P < .0001). Moderate/severe calcification, stent length and post procedural diameter sthenosis were predictors between 30 days to 1 year but not at 1 to 5 years. Reference vessel diameter was the only lesion-related predictor at 5 years (P = .003). Clinical predictors of TLF between 30 days and 1 year were diabetes and hypertension (P < .01 for both), and between 1 and 5 years, diabetes (HR 1.40, 95% CI 1.13-1.73, P = .002), prior coronary artery bypass grafting (HR 2.52, 95% CI 1.92-3.30, P < .0001), and prior PCI (HR 1.29, 95% CI 1.02-1.64, P = .04) predicted TLF. CONCLUSIONS: Predictors of TLF vary in the early, late, and very late postprocedural periods. Reference vessel diameter was the only lesion-related predictor of long-term TLF; clinical predictors were diabetes, prior coronary artery bypass grafting, and prior PCI.

SYNTAX score and the risk of stent thrombosis after percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: an ACUITY trial substudy.

OBJECTIVE: We sought to investigate the relationship between the SYNTAX score (SS) and stent thrombosis (ST) in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI). BACKGROUND: The relationship between the SS and ST is undetermined. METHODS: We stratified 2,627 patients undergoing PCI in the ACUITY trial by SS tertile according to the current population (true tertiles, SS <7, SS = 7-12, and SS >12) and by the SYNTAX trial (original SYNTAX tertiles, SS <23, SS = 23-32, and SS >32). Thirty-day and 1-year rates of definite/probable ST were determined for each tertile. RESULTS: A total 30 (1.1%) and 41 (1.6%) definite/probable ST events occurred by 30 days and 1 year, respectively. When stratified by true tertiles, 30-day and 1-year rates of definite/probable ST were significantly greater in the highest tertile (SS >12; 2.0% and 2.8%) compared with the intermediate (SS = 7-12; 0.7% and 1.1%) and lowest tertiles (SS <7; 0.6% and 0.7%), P = 0.007 and P = 0.0009, respectively. When stratified by original SYNTAX tertiles, 30-day and 1-year rates of definite/probable ST were significantly greater in the highest (SS >32; 6.3% and 8.8%) and intermediate tertiles (SS = 23-32; 2.8% and 3.7%) compared with the lowest tertile (SS < 22; 0.8% and 1.2%), P <0.0001 for both. By multivariable analysis, the SS was an independent predictor for both 30-day and 1-year definite/probable ST. CONCLUSIONS: In patients with NSTE-ACS undergoing PCI, the extent and severity of CAD, as assessed by the SS before revascularization, was strongly associated with the occurrence of ST both at 30 days and 1 year. © 2014 Wiley Periodicals, Inc.

Post-PCI Antithrombotic Therapy in Patients Requiring Long-Term Anticoagulation.

The number of patients who undergo percutaneous coronary intervention (PCI) and additionally require chronic anticoagulation for a variety of indications is not insignificant. The choice of antithrombotic therapy after PCI in patients with chronic indications for anticoagulation therapy remains a challenge for interventional cardiologists, as the risk of bleeding must be adequately weighed against the benefit of preventing future ischemic events. While these clinical scenarios are encountered in approximately 10 % of patients undergoing PCI, current practice guidelines do not sufficiently guide physicians as to how to best treat these PCI patients requiring chronic anticoagulation. Notwithstanding the clinical difficulties of treating such patients, there are several recent studies and analyses that have assessed optimal antithrombotic strategies in the PCI population, and there are several others that are currently underway. This review evaluates the currently available data and clinical scenarios commonly encountered by treating physicians.

Percutaneous Coronary Revascularization Strategies After Myocardial Infarction: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Complete revascularization with percutaneous coronary intervention improves outcomes compared with culprit revascularization following myocardial infarction (MI) with multivessel coronary artery disease. An all-cause mortality reduction has never been demonstrated. Debate also remains regarding the optimal timing of complete revascularization (immediate or staged), and method of evaluation of nonculprit lesions (physiology or angiography). OBJECTIVES: This study aims to perform an updated systematic review with frequentist and Bayesian network meta-analyses including the totality of randomized data investigating revascularization strategies in patients presenting with MI and multivessel coronary artery disease. METHODS: The primary comparison tested complete vs culprit revascularization. Timing and methods of achieving complete revascularization were assessed. The prespecified primary outcome was all-cause mortality. Outcomes were expressed as relative risk (RR) (95% CI). RESULTS: Twenty-four eligible trials randomized 16,371 patients (weighted mean follow-up: 26.4 months). Compared with culprit revascularization, complete revascularization reduced all-cause mortality in patients with any MI (RR: 0.85; 95% CI: 0.74-0.99; P = 0.04). Cardiovascular mortality, MI, major adverse cardiac events and repeat revascularization were also significantly reduced. In patients presenting with ST-segment elevation myocardial infarction, the point estimate for all-cause mortality with complete revascularization was RR: 0.91 (95% CI: 0.78-1.05; P = 0.18). Rates of stent thrombosis, major bleeding, and acute kidney injury were similar. Immediate complete revascularization ranked higher than staged complete revascularization for all endpoints. CONCLUSIONS: Complete revascularization following MI reduces all-cause mortality, cardiovascular mortality, MI, major adverse cardiac events, and repeat revascularization. There may be benefits to immediate complete revascularization, but additional head-to-head trials are needed.

Off-Label Use of Peripheral Paclitaxel Drug-Coated Balloons in Management of Recurrent Coronary In-Stent Restenosis.

Background: While not available for clinical use in the United States, dedicated drug-coated balloons (DCB) are currently under investigation for the management of coronary in-stent restenosis (ISR). Peripheral drug-coated balloons (P-DCB) have been used off-label for coronary ISR. Further data regarding this practice are needed. We aimed to describe outcomes in patients who underwent off-label P-DCB angioplasty for coronary ISR. Methods: We analyzed data on P-DCB angioplasty for coronary ISR at a single high-volume center between April 1, 2015, and December 30, 2017. Demographic and procedural details were collected, with systematic follow-up as clinically indicated. Results: Data from 31 patients treated with P-DCB angioplasty (mean age 68.0 ± 10.7 years) with coronary ISR (17 recurrent and 14 first time) were analyzed. Most patients presented with high-grade angina (81%) or myocardial infarction (13%). Treated ISR lesions were in native coronary arteries (68%), saphenous vein grafts (SVG, 23%), and the left internal mammary artery (10%). Diffuse intrastent ISR was common (69%) with a mean lesion length of 21.7 ± 12.4 mm. No postprocedural myocardial infarction occurred and 1 nonprocedural mortality occurred during index admission. At follow-up (median: 283, interquartile range [IQR]: 354 days), repeat angiography was performed in 19 patients (median: 212, IQR: 188 days), and 11 patients had target lesion recurrent ISR (Kaplan-Meier event-free survival estimate: 44.7%, 95% CI, 26.1%-76.5%). Conclusions: In the absence of availability of dedicated coronary DCB, treatment of coronary ISR using P-DCB angioplasty was feasible, although follow-up demonstrated continued risk for recurrent ISR in this high-risk population.

Cross-Validation of Risk Scores for Patients Undergoing Transcatheter Edge-to-Edge Repair for Mitral Regurgitation.

Background: Risk scores may identify patients with mitral regurgitation (MR) who are at risk for adverse events, but who may still benefit from transcatheter edge-to-edge repair (TEER). We sought to cross-validate the MitraScore and COAPT risk score to predict adverse events in patients undergoing TEER. Methods: MitraScore validation was carried out in the COAPT population which included 614 patients with FMR who were randomized 1:1 to guideline-directed medical therapy (GDMT) with or without TEER and were followed for 2 years. Validation of the COAPT risk score was carried out in 1007 patients from the MIVNUT registry of TEER-treated patients with both FMR and degenerative MR who were followed for a mean of 2.1 years. The predictive value was assessed using the area under the receiver operating characteristic curve (AUC) plots. The primary outcome was all-cause mortality. Results: The MitraScore had fair to good predictive accuracy for mortality in the overall COAPT trial population (AUC, 0.67); its accuracy was higher in patients treated with TEER (AUC, 0.74) than GDMT alone (AUC, 0.65). The COAPT risk score had fair predictive accuracy for death in the overall MitraScore cohort (AUC, 0.64), which was similar in patients with FMR and degenerative MR (AUC, 0.64 and 0.66, respectively). There was a consistent benefit of treatment with TEER plus GDMT compared with GDMT alone in the COAPT trial population across all MitraScore risk strata. Conclusions: The COAPT risk score and MitraScore are simple tools that are useful for the prediction of 2-year mortality in patients eligible for or undergoing treatment with TEER.

Cerebral Embolic Protection in Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) is a treatment option for patients with symptomatic severe aortic stenosis across the entire spectrum of surgical risk. Recent trial data have led to the expansion of TAVR into lower-risk patients. With iterative technological advances and successive increases in procedural experience, the occurrence of complications following TAVR has declined. One of the most feared complications remains stroke, and patients consider stroke a worse outcome than death. There has therefore been great interest in strategies to mitigate the risk of stroke in patients undergoing TAVR. In this paper, we will discuss mechanisms and predictors of stroke after TAVR and describe the currently available cerebral embolic protection devices, including their design and relevant clinical studies pertaining to their use. We will also review the current overall evidence base for cerebral embolic protection during TAVR and ongoing randomized controlled trials. Finally, we will discuss our pragmatic recommendations for the use of cerebral embolic protection devices in patients undergoing TAVR.

Long-Term Outcomes of Randomized Controlled Trials Comparing Percutaneous Left Atrial Appendage Closure to Oral Anticoagulation for Nonvalvular Atrial Fibrillation: A Meta-Analysis.

Background: Oral anticoagulation (OAC) has been considered the standard of care for stroke prophylaxis for patients with nonvalvular atrial fibrillation; however, many individuals are unable or unwilling to take long-term OAC. The safety and efficacy of percutaneous left atrial appendage closure (LAAC) have been controversial, and new trial data have recently emerged. We therefore sought to perform an updated meta-analysis of randomized clinical trials (RCTs) comparing OAC to percutaneous LAAC, focusing on individual clinical endpoints. Methods: We performed a systematic search of the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from January 2000 through December 2021 for all RCTs comparing percutaneous LAAC to OAC in patients with nonvalvular atrial fibrillation. Fixed and random effects meta-analyses of hazard ratios (HRs) were performed using the longest follow-up duration available by intention-to-treat. The prespecified primary endpoint was all-cause mortality. Results: Three RCTs enrolling 1516 patients were identified. The weighted mean follow-up was 54.7 months. LAAC was associated with a reduced risk of all-cause mortality (HR 0.76; 95% confidence interval [CI], 0.59-0.96; p = 0.023), hemorrhagic stroke (HR 0.24; 95% CI, 0.09-0.61; p = 0.003), and major nonprocedural bleeding (HR 0.52; 95% CI, 0.37-0.74; p < 0.001). There was no significant difference between LAAC and OAC for any other endpoints. Conclusions: The available evidence from RCTs suggests LAAC therapy is associated with reduced long-term risk of death compared with OAC. This may be driven by reductions in hemorrhagic stroke and major nonprocedural bleeding. There were no significant differences in the risk of all stroke. Further large-scale clinical trials are needed to validate these findings.

Long-term Incidence of Myocardial Infarction and Death After CABG and PCI for Isolated Left Anterior Descending Artery Disease: A Meta-analysis of Randomized Controlled Trials.

Background: To compare the long-term incidence of myocardial infarction (MI) and death in patients randomized to coronary artery bypass grafting (CABG) vs percutaneous coronary intervention (PCI) for treatment of isolated left anterior descending (LAD) coronary artery disease. Methods: We systematically identified all randomized controlled trials comparing PCI with stenting to CABG with a left internal mammary artery (LIMA) graft in patients with isolated LAD disease who had at least 4 years of follow-up. The primary outcome of interest was MI. Secondary outcomes were all-cause mortality and target vessel revascularization (TVR). Results: Four trials were included in the current analysis, with a total of 573 patients randomized to CABG with a LIMA (n = 285) vs PCI (n = 288) and followed for 4 to 10 years. At latest follow-up (weighted mean 8.3 years), there was no statistically significant difference in the risk of MI between CABG and PCI (relative risk [RR], 1.33; 95% CI, 0.62-2.83; P = .46), nor was there a statistically significant difference in mortality between the groups (RR, 1.04; 95% CI, 0.70-1.65; P = .84). There was a significantly lower risk of TVR after CABG compared with PCI (RR, 0.27; 95% CI, 0.15-0.46; P < .001). Conclusions: The current meta-analysis suggests that there is insufficient evidence that CABG with a LIMA confers protection against MI or death compared to PCI with a stent for isolated LAD disease. CABG was, however, associated with reduced rates of TVR.

Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients.

BACKGROUND: Previous studies demonstrated transcatheter aortic valve replacement (TAVR) with an earlier generation balloon-expandable valve to be noninferior to surgical aortic valve replacement (SAVR) for death and disabling stroke in intermediate-risk patients with symptomatic, severe aortic stenosis at 5 years. However, limited long-term data are available with the more contemporary SAPIEN 3 (S3) bioprosthesis. OBJECTIVES: The aim of this study was to compare 5-year risk-adjusted outcomes in intermediate-risk patients undergoing S3 TAVR vs SAVR. METHODS: Propensity score matching was performed to account for baseline differences in intermediate-risk patients undergoing S3 TAVR in the PARTNER 2 (Placement of Aortic Transcatheter Valves) S3 single-arm study and SAVR in the PARTNER 2A randomized clinical trial. The primary composite endpoint consisted of 5-year all-cause death and disabling stroke. RESULTS: A total of 783 matched pairs of intermediate-risk patients with severe aortic stenosis were studied. There were no differences in the primary endpoint between S3 TAVR and SAVR at 5 years (40.2% vs 42.7%; HR: 0.87; 95% CI: 0.74-1.03; P = 0.10). The incidence of mild or greater paravalvular regurgitation was more common after S3 TAVR. There were no differences in structural valve deterioration-related stage 2 and 3 hemodynamic valve deterioration or bioprosthetic valve failure. CONCLUSIONS: In this propensity-matched analysis of intermediate-risk patients, 5-year rates of death and disabling stroke were similar between S3 TAVR and SAVR. Rates of structural valve deterioration-related hemodynamic valve deterioration were similar, but paravalvular regurgitation was more common after S3 TAVR. Longer-term follow-up is needed to further evaluate differences in late adverse clinical events and bioprosthetic valve durability. (PII S3i [PARTNER II Trial: Placement of Aortic Transcatheter Valves II - S3 Intermediate], NCT03222128; PII A (PARTNER II Trial: Placement of Aortic Transcatheter Valves II - XT Intermediate and High Risk], NCT01314313).