Impact of Surgical and Transcatheter Aortic Valve Replacement in Low-Gradient Aortic Stenosis: A Meta-Analysis

ObjectivesThe aim of this study was to assess the impact of aortic valve replacement (AVR) on survival in patients with each subclass of low-gradient (LG) aortic stenosis (AS) and to compare outcomes following surgical AVR (SAVR) and transcatheter AVR (TAVR).BackgroundLG severe AS encompasses a wide variety of pathophysiology, including classical low-flow, LG (LF-LG), paradoxical LF-LG, and normal-flow, LG (NF-LG) AS, and uncertainty exists regarding the impact of AVR on each subclass of LG AS.MethodsPubMed and Embase were queried through October 2020 to identify studies comparing survival with different management strategies (SAVR, TAVR, and conservative) in patients with LG AS. Pairwise meta-analysis comparing AVR versus conservative management and network meta-analysis comparing SAVR versus TAVR versus conservative management were performed.ResultsThirty-two studies with a total of 6,515 patients and a median follow-up time of 24.2 months (interquartile range: 36.5 months) were included. AVR was associated with a significant decrease in all-cause mortality in classical LF-LG (hazard ratio [HR]: 0.42; 95% confidence interval [CI]: 0.36 to 0.48), paradoxical LF-LG (HR: 0.41; 95% CI: 0.29 to 0.57), and NF-LG (HR: 0.41; 95% CI: 0.27 to 0.62) AS compared with conservative management. SAVR and TAVR were each associated with a decrease in all-cause mortality in classical LF-LG (HR: 0.46 [95% CI: 0.38 to 0.55] and 0.49 [95% CI: 0.37 to 0.64], respectively), paradoxical LF-LG (HR: 0.42 [95% CI: 0.28 to 0.65] and 0.42 [95% CI: 0.25 to 0.72], respectively), and NF-LG (HR: 0.40 [95% CI: 0.21 to 0.77] and 0.46 [95% CI: 0.26 to 0.84], respectively) AS compared with conservative management. No significant difference was observed between SAVR and TAVR.ConclusionsIn all subclasses of LG AS, AVR was associated with a significant decrease in all-cause mortality regardless of surgical or transcatheter approach.     

10-Year Follow-Up After Revascularization in Elderly Patients With Complex Coronary Artery Disease

BackgroundThe optimal revascularization strategy for the elderly with complex coronary artery disease remains unclear.ObjectivesThe goal of this study was to investigate 10-year all-cause mortality, life expectancy, 5-year major adverse cardiac or cerebrovascular events (MACCE), and 5-year quality of life (QOL) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in elderly individuals (>70 years old) with 3-vessel disease (3VD) and/or left main disease (LMD).MethodsIn the present pre-specified analysis on age of the SYNTAX Extended Survival study, 10-year all-cause death and 5-year MACCE were compared with Kaplan-Meier estimates and Cox proportional hazards models among elderly or nonelderly patients. Life expectancy was estimated by restricted mean survival time within 10 years, and QOL status according to the Seattle Angina Questionnaire up to 5 years was assessed by linear mixed-effects models.ResultsAmong 1,800 randomized patients, 575 patients (31.9%) were elderly. Ten-year mortality did not differ significantly between PCI and CABG in elderly (44.1% vs. 41.1%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.84 to 1.40) and nonelderly patients (21.1% vs. 16.6%; HR: 1.30; 95% CI: 1.00 to 1.69; p_interaction = 0.332). Among elderly patients, 5-year MACCE was comparable between PCI and CABG (39.4% vs. 35.1%; HR: 1.18; 95% CI: 0.90 to 1.56), whereas it was significantly higher in PCI over CABG among nonelderly patients (36.3% vs. 23.0%; HR: 1.69; 95% CI: 1.36 to 2.10; p_interaction = 0.043). There were no significant difference in life expectancy (mean difference: 0.2 years in favor of CABG; 95% CI: ?0.4 to 0.7) and 5-year QOL status between PCI and CABG among elderly patients.ConclusionsElderly patients with 3VD and/or LMD had comparable 10-year all-cause death, life expectancy, 5-year MACCE, and 5-year QOL status irrespective of revascularization mode. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050) (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972)     

Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization

ObjectivesThis study sought to evaluate the ability of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab to reduce the risk of complex coronary atherosclerosis requiring revascularization.BackgroundPCSK9 inhibitors induce plaque regression and reduce the risk of coronary revascularization overall.MethodsFOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) was a randomized trial of the PCSK9 inhibitor evolocumab versus placebo in 27,564 patients with stable atherosclerotic cardiovascular disease on statin therapy followed for a median of 2.2 years. Clinical documentation of revascularization events was blindly reviewed to assess coronary anatomy and procedural characteristics. Complex revascularization was the composite of complex percutaneous coronary intervention (PCI) (as per previous analyses, ≥1 of: multivessel PCI, ≥3 stents, ≥3 lesions treated, bifurcation PCI, or total stent length >60 mm) or coronary artery bypass grafting surgery (CABG).ResultsIn this study, 1,724 patients underwent coronary revascularization, including 1,482 who underwent PCI, 296 who underwent CABG, and 54 who underwent both. Complex revascularization was performed in 632 (37%) patients. Evolocumab reduced the risk of any coronary revascularization by 22% (hazard ratio [HR]: 0.78; 95% CI: 0.71 to 0.86; p < 0.001), simple PCI by 22% (HR: 0.78; 95% CI: 0.70 to 0.88; p < 0.001), complex PCI by 33% (HR: 0.67; 95% CI: 0.54 to 0.84; p < 0.001), CABG by 24% (HR: 0.76; 95% CI: 0.60 to 0.96; p = 0.019), and complex revascularization by 29% (HR: 0.71; 95% CI: 0.61 to 0.84; p < 0.001). The magnitude of the risk reduction with evolocumab in complex revascularization tended to increase over time (20%, 36%, and 41% risk reductions in the first, second, and beyond second years).ConclusionsAdding evolocumab to statin therapy significantly reduced the risk of developing complex coronary disease requiring revascularization, including complex PCI and CABG individually. (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER); NCT01764633.)     

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Rheumatic Aortic Stenosis

BackgroundPatients with rheumatic aortic stenosis (AS) were excluded from transcatheter aortic valve replacement (TAVR) trials.ObjectivesThe authors sought to examine outcomes with TAVR versus surgical aortic valve replacement (SAVR) in patients with rheumatic AS, and versus TAVR in nonrheumatic AS.MethodsThe authors identified Medicare beneficiaries who underwent TAVR or SAVR from October 2015 to December 2017, and then identified patients with rheumatic AS using prior validated International Classification of Diseases, Version 10 codes. Overlap propensity score weighting analysis was used to adjust for measured confounders. The primary study outcome was all-cause mortality. Multiple secondary outcomes were also examined.ResultsThe final study cohort included 1,159 patients with rheumatic AS who underwent aortic valve replacement (SAVR, n = 554; TAVR, n = 605), and 88,554 patients with nonrheumatic AS who underwent TAVR. Patients in the SAVR group were younger and with lower prevalence of most comorbidities and frailty scores. After median follow-up of 19 months (interquartile range: 13 to 26 months), there was no difference in all-cause mortality with TAVR versus SAVR (11.2 vs. 7.0 per 100 person-year; adjusted hazard ratio: 1.53; 95% confidence interval: 0.84 to 2.79; p = 0.2). Compared with TAVR in nonrheumatic AS, TAVR for rheumatic AS was associated with similar mortality (15.2 vs. 17.7 deaths per 100 person-years (adjusted hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.09; p = 0.2) after median follow-up of 17 months (interquartile range: 11 to 24 months). None of the rheumatic TAVR patients, <11 SAVR patients, and 242 nonrheumatic TAVR patients underwent repeat aortic valve replacement (124 redo-TAVR and 118 SAVR) at follow-up.ConclusionsCompared with SAVR, TAVR could represent a viable and possibly durable option for patients with rheumatic AS.     

Invasive Approaches in the Management of Cocaine-Associated Non–ST-Segment Elevation Myocardial Infarction

ObjectivesThe aim of this study was to determine the impact of invasive approaches and revascularization in patients with cocaine-associated non–ST-segment elevation myocardial infarction (NSTEMI).BackgroundThe role of invasive approaches in cocaine-associated NSTEMI is uncertain.MethodsThis retrospective cohort study identified 3,735 patients with NSTEMI and history of cocaine use from the Nationwide Readmissions Database from 2016 to 2017. Invasive approaches were defined as coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG). Revascularization was defined as PCI and CABG. The primary efficacy outcome was major adverse cardiac events (MACE), and the primary safety outcome was emergent revascularization. Nonadherence was identified using appropriate International Classification of Diseases-Tenth Revision codes. Two propensity-matched cohorts were generated (noninvasive vs. invasive and noninvasive vs. revascularization) through multivariate logistic regression.ResultsIn the propensity score–matched cohorts, an invasive approach (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.56 to 0.92; p = 0.008) and revascularization (HR: 0.54; 95% CI: 0.40 to 0.73; p < 0.001) (compared with a noninvasive approach) were associated with a lower rate of MACE, without an increase in emergent revascularization. On stratification, PCI and CABG individually were associated with a lower rate of MACE. Emergent revascularization was increased with PCI (HR: 1.78; 95% CI: 1.12 to 2.81; p = 0.014) but not with CABG. Nonadherent patients after PCI and CABG did not have significant difference in rate of MACE. PCI in nonadherent patients was associated with an increase in emergent revascularization (HR: 4.45; 95% CI: 2.07 to 9.57; p < 0.001).ConclusionsInvasive approaches and revascularization for cocaine-associated NSTEMI are associated with lower morbidity. A history of medical nonadherence was not associated with a difference in morbidity but was associated with an increased risk for emergent revascularization with PCI.     

Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement: An Updated Meta-Analysis

ObjectivesThe aim of this study was to evaluate early results of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) versus redo surgical aortic valve replacement (SAVR) for structural valve degeneration (SVD).BackgroundViV TAVR has been increasingly used for SVD, but it remains unknown whether it produces better or at least comparable results as redo SAVR.MethodsObservational studies comparing ViV TAVR and redo SAVR were identified in a systematic search of published research. Random-effects meta-analysis was performed, comparing clinical outcomes between the 2 groups.ResultsTwelve publications including a total of 16,207 patients (ViV TAVR, n = 8,048; redo SAVR, n = 8,159) were included from studies published from 2015 to 2020. In the pooled analysis, ViV TAVR was associated with lower rates of 30-day mortality overall (odds ratio [OR]: 0.52; 95% confidence interval [CI]: 0.39 to 0.68; p < 0.001) and for matched populations (OR: 0.419; 95% CI: 0.278 to 0.632; p = 0.003), major bleeding (OR 0.48; 95% CI: 0.28 to 0.80; p = 0.013), as well as with shorter hospital stay (OR: ?3.30; 95% CI: ?4.52 to ?2.08; p < 0.001). In contrast, ViV TAVR was associated with higher rates of severe patient-prosthesis mismatch (OR: 4.63; 95% CI: 3.05 to 7.03; p < 0.001). The search revealed an important lack of comparative studies with long-term results.ConclusionsViV TAVR is a valuable option in the treatment of patients with SVD because of its lower incidence of post-operative complications and better early survival compared with redo SAVR. However, ViV TAVR is associated with higher rates of myocardial infarction and severe patient-prosthesis mismatch.     

Real-World Examination of Revascularization Strategies for Left Main Coronary Disease in Ontario,Canada

BackgroundRandomized trials have compared percutaneous coronary intervention and coronary artery bypass grafting (CABG) in patients with left main coronary artery disease undergoing nonemergent revascularization. However, there is a paucity of real-world contemporary observational studies comparing percutaneous coronary intervention (PCI) and CABG.ObjectivesThe purpose of this study was to compare the long-term clinical outcomes of CABG versus PCI in patients with left main coronary disease.MethodsClinical and administrative databases for Ontario, Canada, were linked to obtain records of all patients with angiographic evidence of left main coronary artery disease (≥50% stenosis) treated with either isolated CABG or PCI from 2008 to 2020. Emergent, cardiogenic shock, and ST-segment elevation myocardial infarction patients were excluded. Baseline characteristics of patients were compared and 1:1 propensity score matching was performed. Late mortality and major adverse cardiac and cerebrovascular events were compared between the matched groups using a Cox proportional hazard model.ResultsAfter exclusions, 1,299 and 21,287 patients underwent PCI and CABG, respectively. Prior to matching, PCI patients were older (age 75.2 vs 68.0 years) and more likely to be women (34.6% vs 20.1%), although they had less CAD burden. Propensity score matching on 25 baseline covariates yielded 1,128 well-matched pairs. There was no difference in early mortality between PCI and CABG (5.5% vs 3.9%; P = 0.075). Over 7-year follow-up, all-cause mortality (53.6% vs 35.2%; HR: 1.63; 95% CI: 1.42-1.87; P < 0.001) and major adverse cardiac and cerebrovascular events (66.8% vs 48.6%; HR: 1.77; 95% CI: 1.57-2.00) were significantly higher with PCI than CABG.ConclusionsCABG was the most common revascularization strategy in this real-world registry. Patients undergoing PCI were much older and of higher risk at baseline. After matching, there was no difference in early mortality but improved late survival and freedom from major adverse cardiac and cerebrovascular events with CABG.     

ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement

BackgroundAmong patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk.ObjectivesThe goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR.MethodsThis was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries.ResultsMedian door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk.ConclusionsSTEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes.     

The Effect of Coronary Lesion Complexity and Preprocedural Revascularization on 5-Year Outcomes After TAVR

BackgroundAortic stenosis and coronary artery disease (CAD) frequently coincide. However, the management of coexisting CAD in patients undergoing transcatheter aortic valve replacement (TAVR) remains controversial.ObjectivesThis study sought to determine whether the presence of CAD, its complexity, and angiography-guided percutaneous coronary intervention (PCI) are associated with outcomes after TAVR.MethodsAll patients undergoing TAVR at a tertiary referral center between 2008 and 2020 were included in a prospective observational study. Baseline SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score (SS) and, whenever applicable, a residual SS after PCI were calculated. A multivariate analysis was performed to determine the effect of CAD, stratified according to complexity, and PCI on 5-year outcomes.ResultsIn 604 patients, the presence of CAD and its complexity were significantly associated with worse 5-year survival (SS 0: 67.9% vs SS 1-22: 56.1% vs SS >22: 53.0%; log-rank P = 0.027) and increased cardiovascular mortality (SS 0: 15.1% vs SS 1-22: 24.0% vs SS >22: 27.8%; log-rank P = 0.024) after TAVR. Having noncomplex CAD (SS 1-22) was an independent predictor for increased all-cause mortality (HR: 1.43; P = 0.046), while complex CAD (SS >22) increased cardiovascular mortality significantly (HR: 1.84; P = 0.041). Angiography-guided PCI or completeness of revascularization was not associated with different outcomes.ConclusionsThe presence of CAD and its anatomical complexity in patients undergoing TAVR are associated with significantly worse 5-year outcomes. However, angiography-guided PCI did not improve outcomes, highlighting the need for further research into physiology-guided PCI.     

Postoperative Atrial Fibrillation or Flutter Following Transcatheter or Surgical Aortic Valve Replacement: PARTNER 3 Trial

ObjectivesThe aim of this study was to assess the incidence and prognostic impact of early and late postoperative atrial fibrillation or flutter (POAF) in patients with severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).BackgroundThere is an ongoing controversy regarding the incidence, recurrence rate, and prognostic impact of early (in-hospital) POAF and late (postdischarge) POAF in patients with AS undergoing TAVR or SAVR.MethodsIn the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial, patients with severe AS at low surgical risk were randomized to TAVR or SAVR. Analyses were performed in the as-treated population excluding patients with preexistent atrial fibrillation or flutter.ResultsAmong 781 patients included in the analysis, early POAF occurred in 152 (19.5%) (18 of 415 [4.3%] and 134 of 366 [36.6%] following TAVR and SAVR, respectively). Following discharge, 58 new or recurrent late POAF events occurred within 1 year following the index procedure in 55 of 781 patients (7.0%). Early POAF was not an independent predictor of late POAF following discharge (odds ratio: 1.04; 95% CI: 0.52-2.08; P = 0.90). Following adjustment, early POAF was not an independent predictor of the composite outcome of death, stroke, or rehospitalization (hazard ratio: 1.10; 95% CI: 0.64-1.92; P = 0.72), whereas late POAF was associated with an increased adjusted risk for the composite outcome (hazard ratio: 8.90; 95% CI: 5.02-15.74; P < 0.0001), irrespective of treatment modality.ConclusionsIn the PARTNER 3 trial, early POAF was more frequent following SAVR compared with TAVR. Late POAF, but not early POAF, was significantly associated with worse outcomes at 2 years, irrespective of treatment modality.     

Outcomes Following Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: SWEDEHEART Observational Study

ObjectivesThis study was performed to investigate long-term, clinically important outcomes in patients who underwent permanent pacemaker implantation after transcatheter aortic valve replacement (TAVR).BackgroundThe impact of permanent pacemaker implantation after TAVR is unknown, and prior studies have produced conflicting results.MethodsIn this nationwide, population-based cohort study, the study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018 from the SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) register. Additional baseline characteristics and information about outcomes were obtained by individual crosslinking with other national health data registers. Unadjusted and multivariable-adjusted analyses were performed using Cox proportional hazards regression.ResultsOf 3,420 patients, 481 (14.1%) underwent permanent pacemaker implantation within 30 days after TAVR. The survival rate at 1, 5, and 10 years was 90.0%, 52.7%, and 10.9% in the pacemaker group and 92.7%, 53.8%, and 15.3% in the nonpacemaker group, respectively (HR: 1.03; 95% CI: 0.88-1.22; P = 0.692). The median follow-up was 2.7 years (interquartile range: 2.5, and maximum 11.8 years). There was no difference in the risk of cardiovascular death (HR: 0.91; 95% CI: 0.71-1.18; P = 0.611), heart failure (HR: 1.23; 95% CI: 0.92-1.63; P = 0.157), or endocarditis (HR: 0.90; 95% CI: 0.47-1.69; P = 0.734) between the groups.ConclusionsThe study found no difference in long-term survival between patients who did and did not undergo permanent pacemaker implantation after TAVR. As the use of TAVR expands to include younger and low-risk patients with a long life expectancy, it will become increasingly important to understand the impact of permanent pacemaker implantation after TAVR.     

Thrombotic Risk and Cardiovascular Events in Patients With Revascularization Deferral After Fractional Flow Reserve Assessment

ObjectivesThe aim of this study was to evaluate the impact of thrombotic risk on the occurrence of cardiovascular events in patients with coronary artery disease with deferred revascularization after fractional flow reserve (FFR) measurements.BackgroundDeferral of revascularization on the basis of FFR is generally considered to be safe, but after deferral, some patients have cardiovascular events over time.MethodsFrom J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), 1,263 patients with deferral of revascularization on the basis of FFR were evaluated. The association between thrombotic risk as assessed by CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) thrombotic score and 5-year target vessel failure (TVF) and major adverse cardiac and cerebrovascular events (MACCE) was investigated.ResultsFFR and high thrombotic risk (HTR) were associated with increased risk for 5-year TVF (FFR per 0.01-unit decrease: HR: 1.08; 95% CI: 1.05-1.11; P < 0.001; HTR: HR: 2.16; 95% CI: 1.37-3.39; P < 0.001) and MACCE (FFR per 0.01-unit decrease: HR: 1.05; 95% CI: 1.02-1.06; P < 0.001; HTR: HR: 2.11; 95% CI: 1.56-2.84; P = 0.001). Patients with HTR had higher risk for 5-year TVF (HR: 2.30; 95% CI: 1.45-3.66; P < 0.001) and MACCE (HR: 2.34; 95% CI: 1.75-3.13; P < 0.001) than those without HTR, even when they had negative FFR.ConclusionsAssessment of thrombotic risk provides additional prognostic value to FFR in predicting 5-year TVF and MACCE in patients with deferral of revascularization after FFR measurements. (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry; UMIN000014473)     

10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification

ObjectivesThe aim of this study was to assess 10-year all-cause mortality in patients with heavily calcified lesions (HCLs) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).BackgroundLimited data are available on very long term outcomes in patients with HCLs according to the mode of revascularization.MethodsThis substudy of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study assessed 10-year all-cause mortality according to the presence of HCLs within lesions with >50% diameter stenosis and identified during the calculation of the anatomical SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score among 1,800 patients with the 3-vessel disease and/or left main disease randomized to PCI or CABG in the SYNTAX trial. Patients with HCLs were further stratified according to disease type (3-vessel disease or left main disease) and assigned treatment (PCI or CABG).ResultsThe 532 patients with ≥1 HCL had a higher crude mortality rate at 10 years than those without (36.4% vs 22.3%; HR: 1.79; 95% CI: 1.49-2.16; P < 0.001). After adjustment, an HCL remained an independent predictor of 10-year mortality (HR: 1.36; 95% CI: 1.09-1.69; P = 0.006). There was a significant interaction in mortality between treatment effect (PCI and CABG) and the presence or absence of HCLs (P_interaction = 0.005). In patients without HCLs, mortality was significantly higher after PCI than after CABG (26.0% vs 18.8%; HR: 1.44; 95% CI: 0.97-1.41; P = 0.003), whereas in those with HCLs, there was no significant difference (34.0% vs 39.0%; HR: 0.85; 95% CI: 0.64-1.13; P = 0.264).ConclusionsAt 10 years, the presence of an HCL was an independent predictor of mortality, with a similar prognosis following PCI or CABG. Whether HCLs require special consideration when deciding the mode of revascularization beyond their current contribution to the anatomical SYNTAX score deserves further evaluation. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972)     

Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions

BackgroundThe long-term clinical benefit after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with total occlusions (TOs) and complex coronary artery disease has not yet been clarified.ObjectivesThe objective of this analysis was to assess 10-year all-cause mortality in patients with TOs undergoing PCI or CABG.MethodsThis is a subanalysis of patients with at least 1 TO in the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which investigated 10-year all-cause mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial, beyond its original 5-year follow-up. Patients with TOs were further stratified according to the status of TO recanalization or revascularization.ResultsOf 1,800 randomized patients to the PCI or CABG arm, 460 patients had at least 1 lesion of TO. In patients with TOs, the status of TO recanalization or revascularization was not associated with 10-year all-cause mortality, irrespective of the assigned treatment (PCI arm: 29.9% vs. 29.4%; adjusted hazard ratio [HR]: 0.992; 95% confidence interval [CI]: 0.474 to 2.075; p = 0.982; and CABG arm: 28.0% vs. 21.4%; adjusted HR: 0.656; 95% CI: 0.281 to 1.533; p = 0.330). When TOs existed in left main and/or left anterior descending artery, the status of TO recanalization or revascularization did not have an impact on the mortality (34.5% vs. 26.9%; adjusted HR: 0.896; 95% CI: 0.314 to 2.555; p = 0.837).ConclusionsAt 10-year follow-up, the status of TO recanalization or revascularization did not affect mortality, irrespective of the assigned treatment and location of TOs. The present study might support contemporary practice among high-volume chronic TO-PCI centers where recanalization is primarily offered to patients for the management of angina refractory to medical therapy when myocardial viability is confirmed. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972)     

Impact of Moderate Aortic Stenosis on Long-Term Clinical Outcomes: A Systematic Review and Meta-Analysis

BackgroundThe clinical course of patients with moderate aortic stenosis (AS) remains incompletely defined.ObjectivesThis study sought to analyze the clinical course of moderate AS and compare it with other stages of the disease.MethodsMultiple electronic databases were searched to identify studies on adult moderate AS. Random-effects models were used to derive pooled estimates. The primary endpoint was all-cause death. The secondary endpoints were cardiac death, heart failure, sudden death, and aortic valve replacement.ResultsAmong a total of 25 studies (12,143 moderate AS patients, 3.7 years of follow-up), pooled rates per 100 person-years were 9.0 (95% CI: 6.9 to 11.7) for all-cause death, 4.9 (95% CI: 3.1 to 7.5) for cardiac death, 3.9 (95% CI: 1.9 to 8.2) for heart failure, 1.1 (95% CI: 0.8 to 1.5) for sudden death, and 7.2 (95% CI: 4.3 to 12.2) for aortic valve replacement. Meta-regression analyses detected that diabetes (P = 0.019), coronary artery disease (P = 0.017), presence of symptoms (P < 0.001), and left ventricle (LV) dysfunction (P = 0.009) were associated with a significant impact on the overall estimate of all-cause death. All-cause mortality was higher in patients with reduced LV ejection fraction (<50%) than with normal LV ejection fraction: 16.5 (95% CI: 5.2 to 52.3) and 4.2 (95% CI: 1.4 to 12.8) per 100 person-years, respectively. Compared with moderate AS, the incidence rate difference of all-cause mortality was -3.9 (95% CI: -6.7 to -1.1) for no or mild AS and +2.2 (95% CI: +0.8 to +3.5) for severe AS patients.ConclusionsModerate AS appears to be associated with a mortality risk higher than no or mild AS but lower than severe AS, which increases in specific population subsets. The impact of early intervention in moderate AS patients having high-risk features deserves further investigation.     

Temporal Trends and Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis

ObjectivesThe purpose of this study was to assess the temporal trends of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis (AS), and to compare the outcomes between TAVR and surgical aortic valve replacement (SAVR) in this population.BackgroundRandomized trials comparing TAVR to SAVR in AS with bicuspid valve are lacking.MethodsThe study queried the National Inpatient Sample database (years 2012 to 2016) to identify hospitalizations for bicuspid AS who underwent isolated aortic valve replacement. A propensity-matched analysis was used to compare outcomes of hospitalizations for TAVR versus SAVR for bicuspid AS and TAVR for bicuspid AS versus tricuspid AS.ResultsThe analysis included 31,895 hospitalizations with bicuspid AS, of whom 1,055 (3.3%) underwent TAVR. TAVR was increasingly utilized during the study period for bicuspid AS (p_trend = 0.002). After matching, TAVR and SAVR had similar in-hospital mortality (3.1% vs. 3.1%; odds ratio: 1.00; 95% confidence interval: 0.60 to 1.67). There was no difference between TAVR and SAVR in the rates of cardiac arrest, cardiogenic shock, acute kidney injury, hemopericardium, cardiac tamponade, or acute stroke. TAVR was associated with lower rates of acute myocardial infarction, post-operative bleeding, vascular complications, and discharge to nursing facility as well as a shorter length of hospital stay. On the contrary, TAVR was associated with a higher incidence of complete heart block and permanent pacemaker insertion. TAVR for bicuspid AS was associated with similar in-hospital mortality compared with tricuspid AS.ConclusionsThis nationwide analysis showed similar in-hospital mortality for TAVR and SAVR in patients with bicuspid AS. TAVR for bicuspid AS was also associated with similar in-hospital mortality compared with tricuspid AS. Further studies are needed to evaluate long-term outcomes of TAVR for bicuspid AS.     

Characteristics and Outcomes of Patients With History of CABG Undergoing Cardiac Catheterization Via the Radial Versus Femoral Approach

ObjectivesThe aims of this study were to examine rates of radial artery access in post–coronary artery bypass grafting (CABG) patients undergoing diagnostic catherization and/or percutaneous coronary intervention (PCI), whether operators with higher procedural volumes and higher percentage radial use were more likely to perform diagnostic catherization and/or PCI via the radial approach in post-CABG patients, and clinical and procedural outcomes in post-CABG patients who undergo diagnostic catherization and/or PCI via the radial or femoral approach.BackgroundThere are limited data comparing outcomes of patients with prior CABG undergoing transradial or transfemoral diagnostic catheterization and/or PCI.MethodsUsing the National Cardiovascular Data Registry CathPCI Registry, all diagnostic catheterizations and PCIs performed in patients with prior CABG from July 1, 2009, to March 31, 2018 (n = 1,279,058, 1,173 sites) were evaluated. Temporal trends in transradial access were examined, and mortality, bleeding, vascular complications, and procedural metrics were compared between transradial and transfemoral access.ResultsThe rate of transradial access increased from 1.4% to 18.7% over the study period. Transradial access was associated with decreased mortality (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.75 to 0.91), decreased bleeding (OR: 0.57; 95% CI: 0.51 to 0.63), decreased vascular complications (OR: 0.38; 95% CI: 0.30 to 0.47), increased PCI procedural success (OR: 1.11; 95% CI: 1.06 to 1.16; p < 0.0001), and significantly decreased contrast volume across all procedure types. Transradial access was associated with shorter fluoroscopy time for PCI-only procedures but longer fluoroscopy time for diagnostic procedures plus ad hoc PCI and diagnostic procedures only. Operators with a higher rate of transradial access in non-CABG patients were more likely to perform transradial access in patients with prior CABG.ConclusionsThe rate of transradial artery access in patients with prior CABG undergoing diagnostic catheterization and/or PCI has increased over the past decade in the United States, and it was more often performed by operators using a transradial approach in non-CABG patients. Compared with transfemoral access, transradial access was associated with improved clinical outcomes in patients with prior CABG.     

Ticagrelor vs Prasugrel in a Contemporary Real-World Cohort Undergoing Percutaneous Coronary Intervention

BackgroundPotent P2Y₁₂ agents such as ticagrelor and prasugrel are increasingly utilized across the clinical spectrum of patients undergoing percutaneous coronary intervention (PCI). There is a paucity of data supporting their use in a patient population inclusive of both acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients.ObjectivesThe authors compared the efficacy and safety of ticagrelor and prasugrel in a real-world contemporary PCI cohort.MethodsConsecutive patients undergoing PCI between 2014 and 2019 discharged on either prasugrel or ticagrelor were included from the prospectively collected institutional PCI registry. Primary endpoint was the composite of death and myocardial infarction (MI), with secondary outcomes including rates of bleeding, stroke, and target vessel revascularization at 1 year.ResultsOverall, 3,858 patients were included in the study (ticagrelor: n = 2,771; prasugrel: n = 1,087), and a majority (48.4%) underwent PCI in the context of CCS. Patients prescribed ticagrelor were more likely to be female, have a history of cerebrovascular disease, and have ACS presentation, while those receiving prasugrel were more likely to be White with a higher prevalence of prior revascularization. No difference in the risk of death or MI was noted across the groups (ticagrelor vs prasugrel: 3.3% vs 3.1%; HR: 0.88; 95% CI: 0.54-1.43; P = 0.59). Rates of target vessel revascularization were significantly lower in the ticagrelor cohort (9.3% vs 14.0%; adjusted HR: 0.71; 95% CI: 0.55-0.91; P = 0.007) with no differences in stroke or bleeding. The results were consistent in patients with CCS (HR: 0.84; 95% CI: 0.46-1.54) and ACS (HR: 1.18; 95% CI: 0.46-1.54), without evidence of interaction (P = 0.37), and confirmed across multivariable adjustment and propensity score stratification analysis.ConclusionsIn this contemporary patient population undergoing PCI, prasugrel and ticagrelor were associated with similar 1-year efficacy and safety.     

Impact of Periprocedural Adverse Events After PCI and CABG on 5-Year Mortality: The EXCEL Trial

BackgroundThe relative risks for different periprocedural major adverse events (MAE) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) on subsequent mortality have not been described.ObjectivesThe aim of this study was to assess the association between periprocedural MAE occurring within 30 days postprocedure and early and late mortality after left main coronary artery revascularization by PCI and CABG.MethodsIn the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, patients with left main disease were randomized to PCI vs CABG. The associations between 12 prespecified nonfatal MAE and subsequent 5-year all-cause and cardiovascular death in 1,858 patients were examined using logistic regression.ResultsOne or more nonfatal MAE occurred in 111 of 935 patients (11.9%) after PCI and 419 of 923 patients (45.4%) after CABG (P < 0.0001). Patients with MAE were older and had more baseline comorbidities. Within 5 years, all-cause death occurred in 117 and 87 patients after PCI and CABG, respectively. Experiencing an MAE was a strong independent predictor of 5-year mortality after both PCI (adjusted OR: 4.61; 95% CI: 2.71-7.82) and CABG (adjusted OR: 3.25; 95% CI: 1.95-5.41). These associations were present within the first 30 days and between 30 days and 5 years postprocedure. Major or minor bleeding with blood transfusion ≥2 U was an independent predictor of 5-year mortality after both procedures. Stroke, unplanned revascularization for ischemia, and renal failure were significantly associated with mortality only after CABG.ConclusionsIn the EXCEL trial, nonfatal periprocedural MAE were strongly associated with early and late mortality after both PCI and CABG for left main disease.     

Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis Outside Randomized Trials

BackgroundRecent randomized trials including low-risk patients showed positive results for transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR), but patients with non-tricuspid aortic valve (NTAV), severe coronary artery disease (SevCAD), and those requiring concomitant mitral/tricuspid valve (CMTV) or concomitant ascending aorta replacement (CAAR) interventions were excluded.ObjectivesThis study sought to evaluate the presence and impact of the main clinical variables not evaluated in TAVR versus SAVR trials (NTAV, SevCAD, and CMTV or CAAR intervention) in a large series of consecutive low-risk patients with severe aortic stenosis (SAS) undergoing SAVR.MethodsSingle-center study including consecutive patients with SAS and low surgical risk (Society of Thoracic Surgeons score of <4%) undergoing SAVR. Baseline, procedural characteristics, and 30-day outcomes were prospectively collected.ResultsOf 6,772 patients with SAS who underwent SAVR between 2000 and 2019, 5,310 (78.4%) exhibited a low surgical risk (mean Society of Thoracic Surgeons score: 1.94 ± 0.87%). Of these, 2,165 patients (40.8%) had at least 1 of the following: NTAV (n = 1,468, 27.6%), SevCAD (n = 307, 5.8%), CMTV (n = 306, 5.8%), and CAAR (n = 560, 10.5%). The 30-day mortality and stroke rates for the overall low-risk SAS cohort were 1.9% and 2.4%, respectively. The mortality rate was similar in the SevCAD (2.6%) and CAAR (2.1%) groups versus the rest of the cohort (odds ratio [OR]: 1.79; 95% confidence interval [CI]: 0.85 to 3.75, and OR: 1.64; 95% CI: 0.88 to 3.05, respectively), lower in the NTAV group (0.9%; OR: 0.42; 95% CI: 0.22 to 0.81), and higher in the CMTV group (5.9%; OR: 2.61; 95% CI: 1.51 to 4.5).ConclusionsIn a real-world setting, close to one-half of the low-risk patients with SAS undergoing SAVR exhibited at least 1 major criterion not evaluated in TAVR versus SAVR randomized trials. Clinical outcomes were better than or similar to those predicted by surgical scores in all groups but those patients requiring CMTV intervention. These results may help determine the impact of implementing the results of TAVR-SAVR trials in real practice and may inform future trials in specific groups.