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Background The optimal time point of staged percutaneous coronary intervention (PCI) among patients with acute coronary syndrome (ACS) remains a matter of debate. Quantitative flow ratio (QFR) is a novel noninvasive method to assess the hemodynamic significance of coronary stenoses. We aimed to investigate whether QFR could refine the timing of staged PCI of non‐target vessels (non‐TVs) on top of clinical judgment for patients with ACS. Methods and Results For this cohort study, patients with ACS from Bern University Hospital, Switzerland, scheduled to undergo out‐of‐hospital non‐TV staged PCI were eligible. The primary end point was the composite of non‐TV myocardial infarction and urgent unplanned non‐TV PCI before planned staged PCI. The association between lowest QFR per patient measured in the non‐TV (from index angiogram) and the primary end point was assessed using multivariable adjusted Cox proportional hazards regressions with QFR included as linear or penalized spline (nonlinear) term. QFR was measured in 1093 of 1432 patients with ACS scheduled to undergo non‐TV staged PCI. Median time to staged PCI was 28 days. The primary end point occurred in 5% of the patients. In multivariable analysis (1018 patients), there was no independent association between non‐TV QFR and the primary end point (hazard ratio, 0.87 [95% CI, 0.69–1.05] per 0.1 increase; P=0.125; nonlinear P=0.648). Conclusions In selected patients with ACS scheduled to undergo staged PCI at a median of 4 weeks after index PCI, QFR did not emerge as an independent predictor of non‐TV events before planned staged PCI. Thus, this study does not provide conceptual evidence that QFR is helpful to refine the timing of staged PCI on top of clinical judgment. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02241291.

Background The prevalence of calcific aortic stenosis and amyloid transthyretin cardiomyopathy (ATTR‐CM) increase with age, and they often coexist. The objective was to determine the prevalence of ATTR‐CM in patients with severe aortic stenosis and evaluate differences in presentations and outcomes of patients with concomitant ATTR‐CM undergoing transcatheter aortic valve implantation. Methods and Results Prospective screening for ATTR‐CM with Technetium99‐3,3‐diphosphono‐1,2‐propanodicarboxylic acid bone scintigraphy was performed in 315 patients referred with severe aortic stenosis between August 2019 and August 2021. Myocardial Technetium99‐3,3‐diphosphono‐1,2‐propanodicarboxylic acid tracer uptake was detected in 34 patients (10.8%), leading to a diagnosis of ATTR‐CM in 30 patients (Perugini ≥2: 9.5%). Age (85.7±4.9 versus 82.8±4.5; P=0.001), male sex (82.4% versus 57.7%; P=0.005), and prior carpal tunnel surgery (17.6% versus 4.3%; P=0.007) were associated with coexisting ATTR‐CM, as were ECG (discordant QRS voltage to left ventricular wall thickness [42% versus 12%; P

Background In view of the rising global burden of severe symptomatic aortic stenosis, its early recognition and treatment is key. Although patients with classical low‐flow, low‐gradient (C‐LFLG) aortic stenosis have higher rates of death after transcatheter aortic valve implantation (TAVI) when compared with patients with high‐gradient (HG) aortic stenosis, there is conflicting evidence on the death rate in patients with severe paradoxical low‐flow, low‐gradient (P‐LFLG) aortic stenosis. Therefore, we aimed to compare outcomes in real‐world patients with severe HG, C‐LFLG, and P‐LFLG aortic stenosis undergoing TAVI. Methods and Results Clinical outcomes up to 5 years were addressed in the 3 groups of patients enrolled in the prospective, national, multicenter SwissTAVI registry. A total of 8914 patients undergoing TAVI at 15 heart valve centers in Switzerland were analyzed for the purpose of this study. We observed a significant difference in time to death at 1 year after TAVI, with the lowest observed in HG (8.8%) aortic stenosis, followed by P‐LFLG (11.5%; hazard ratio [HR], 1.35 [95% CI, 1.16–1.56]; P

Background Tricuspid regurgitation (TR) frequently develops in patients with long‐standing pulmonary hypertension, and both pathologies are associated with increased morbidity and mortality. This study aimed to improve prognostic assessment in patients with severe TR undergoing transcatheter tricuspid valve intervention (TTVI) by relating the extent of TR to pulmonary artery pressures. Methods and Results In this multicenter study, we included 533 patients undergoing TTVI for moderate‐to‐severe or severe TR. The proportionality framework was based on the ratio of tricuspid valve effective regurgitant orifice area to mean pulmonary artery pressure. An optimal threshold for tricuspid valve effective regurgitant orifice area/mean pulmonary artery pressure ratio was derived on 353 patients with regard to 2‐year all‐cause mortality and externally validated on 180 patients. Patients with a tricuspid valve effective regurgitant orifice area/mean pulmonary artery pressure ratio ≤1.25 mm2/mm Hg (defining proportionate TR) featured significantly lower 2‐year survival rates after TTVI than patients with disproportionate TR (56.6% versus 69.6%; P=0.005). In contrast with patients with disproportionate TR (n=398), patients with proportionate TR (n=135) showed more pronounced mPAP levels (37.9±9.06 mm Hg versus 27.9±8.17 mm Hg; P

Anomalous coronary arteries originating from the opposite sinus of Valsalva (ACAOS) are a challenge because of their various anatomic and clinical presentation. Although the prevalence is low, the absolute numbers of detected ACAOS are increasing because of the growing use of noninvasive anatomical imaging for ruling out coronary artery disease. As evidence‐based guidelines are lacking, treating physicians are left in uncertainty for the optimal management of such patients. The sole presence of ACAOS does not justify surgical correction, and therefore a thorough anatomic and hemodynamic assessment is warranted. Invasive and noninvasive multimodality imaging provides information to the clinical question whether the presence of ACAOS is an innocent coincidental finding, is responsible for the patient’s symptoms, or even might be a risk for sudden cardiac death. Based on recent clinical data, focusing on the pathophysiology of patients with ACAOS, myocardial ischemia is dependent on both the extent of fixed and dynamic components, represented by anatomic high‐risk features. These varying combinations should be considered individually in the decision making for the different therapeutic options. This state‐of‐the‐art review focuses on the advantages and limitations of the common contemporary surgical, interventional, and medical therapy with regard to the anatomy and pathophysiology of ACAOS. Further, we propose a therapeutic management algorithm based on current evidence on multimodality invasive and noninvasive imaging findings and highlight remaining gaps of knowledge.

Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention‐to‐treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention‐to‐treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per‐protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time‐varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all‐cause mortality or nonfatal Q‐wave myocardial infarction at 2 years. At 2‐year follow‐up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per‐protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75–1.03; P=0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79–1.26; P=0.99). The per‐protocol and intention‐to‐treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1‐year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.

Background Complete revascularization reduces cardiovascular events in patients with acute coronary syndromes (ACSs) and multivessel disease. The optimal time point of non–target‐vessel percutaneous coronary intervention (PCI) remains a matter of debate. The aim of this study was to investigate the impact of early (

Background Data comparing the frequency and outcomes of infective endocarditis (IE) after transcatheter (TAVR) to surgical aortic valve replacement (SAVR) are scarce. The objective of this study is to compare the incidence and outcomes of IE after TAVR using a supra‐annular, self‐expanding platform (CoreValve and Evolut) to SAVR. Methods and Results Data of 3 randomized clinical trials comparing TAVR to SAVR and a prospective continued TAVR access study were pooled. IE was defined on the basis of the modified Duke criteria. The cumulative incidence of IE was determined by modeling the cause‐specific hazard. Estimates of all‐cause mortality were calculated by means of the Kaplan–Meier method. Outcomes are reported for the valve‐implant cohort. During a mean follow‐up time of 2.17±1.51 years, 12 (0.5%) of 2249 patients undergoing TAVR and 21 (1.1%) of 1828 patients undergoing SAVR developed IE. Patients with IE more frequently had diabetes mellitus than those without (57.6% versus 34.2%; P=0.005). The cumulative incidence of IE was 1.01% (95% CI, 0.47%–1.96%) after TAVR and 1.58% (95% CI, 0.97%–2.46%) after SAVR (P=0.047) at 5 years. Among patients with IE, the rate of all‐cause mortality was 27.3% (95% CI, 1.0%–53.6%) in the TAVR and 51.8% (95% CI, 28.2%–75.3%) in the SAVR group at 1 year (log‐rank P=0.15). Conclusions Pooled prospectively collected data comparing TAVR with a supra‐annular, self‐expanding device to SAVR showed a low cumulative risk of IE irrespective of treatment modality, although the risk was lower in the TAVR implant group. Once IE occurred, mortality was high. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01240902, NCT01586910, NCT02701283.

Background The optimal duration of dual antiplatelet therapy after coronary drug‐eluting stent placement in adults with stable coronary artery disease (SCAD) versus acute coronary syndromes (ACS) remains uncertain. Methods and Results This was a prespecified subgroup analysis of the GLOBAL LEADERS trial. Participants were randomly assigned 1:1 to the experimental or reference strategy, stratified by ACS (experimental, n=3750; reference, n=3737) versus SCAD (experimental, n=4230; reference, n=4251). The experimental strategy was 75 to 100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy. The reference strategy was 75 to 100 mg aspirin daily plus either 75 mg clopidogrel daily (for SCAD) or 90 mg ticagrelor twice daily (for ACS) for 12 months, followed by aspirin monotherapy for 12 months. The primary end point at 2 years was a composite of all‐cause mortality or non‐fatal centrally adjudicated new Q‐wave myocardial infarction. The key secondary safety end point was site‐reported Bleeding Academic Research Consortium grade 3 or 5 bleeding. The primary end point occurred in 147 (3.92%) versus 169 (4.52%) patients with ACS (rate ratio [RR], 0.86; 95% CI, 0.69–1.08; P=0.189), and in 157 (3.71%) versus 180 (4.23%) patients with SCAD (RR, 0.87; 95% CI, 0.71–1.08; P=0.221) with experimental and reference strategy, respectively (P‐interaction=0.926). Bleeding Academic Research Consortium grade 3 or 5 bleeding occurred in 73 (1.95%) versus 100 (2.68%) patients with ACS (RR, 0.73; 95% CI, 0.54–0.98; P=0.037), and in 90 (2.13%) versus 69 (1.62%) patients with SCAD (RR, 1.32; 95% CI, 0.97–1.81; P=0.081; P‐interaction=0.007). Conclusions While there was no evidence for differences in efficacy between treatment strategies by subgroup, the experimental strategy appeared to reduce bleeding risk in patients with ACS but not in patients with SCAD. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.

Background Female sex was not included among the high bleeding risk (HBR) criteria by the Academic Research Consortium (ARC) as it remains unclear whether it constitutes an HBR condition after percutaneous coronary intervention. We investigated whether female sex associates with HBR and assessed the performance of ARC HBR criteria separately in women and men. Methods and Results Among all consecutive patients undergoing percutaneous coronary intervention between 2009 and 2018, bleeding occurrences up to 1 year were prospectively collected and centrally adjudicated. All but one of the originally defined ARC HBR criteria were assessed, and the ARC HBR score generated accordingly. Among 16 821 patients, 25.6% were women. Compared with men, women were older and had lower creatinine clearance and hemoglobin values. After adjustment, female sex was independently associated with access‐site (adjusted hazard ratio, 2.14; 95% CI, 1.22–3.74; P=0.008) but not with overall or non–access‐site 1‐year Bleeding Academic Research Consortium 3 or 5 bleeding. This association remained consistent when the femoral but not the radial approach was chosen. The ARC HBR score discrimination, using the original criteria, was lower among women than men (c‐index 0.644 versus 0.688; P=0.048), whereas a revised ARC HBR score, in which age, creatinine clearance, and hemoglobin were modeled as continuous rather than dichotomized variables, performed similarly in both sexes. Conclusions Female sex is an independent predictor for access‐site bleeding but not for overall bleeding events at 1 year after percutaneous coronary intervention. The ARC HBR framework shows an overall good performance in both sexes, yet is lower in women than men, attributable to dichotomization of age, creatinine clearance, and hemoglobin values, which are differently distributed between sexes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02241291.

Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare‐metal and first‐generation drug‐eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer‐generation drug‐eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable‐polymer sirolimus‐eluting stent or a durable‐polymer everolimus‐eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target‐lesion failure (TLF) (cardiac death, target‐vessel myocardial infarction, or target‐lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P=0.003) and stent thrombosis rates (2.1% versus 0.2%; P

Background In ST‐segment–elevation myocardial infarction, angiography‐based complete revascularization is superior to culprit‐lesion‐only percutaneous coronary intervention. Quantitative flow ratio (QFR) is a novel, noninvasive, vasodilator‐free method used to assess the hemodynamic significance of coronary stenoses. We aimed to investigate the incremental value of QFR over angiography in nonculprit lesions in patients with ST‐segment–elevation myocardial infarction undergoing angiography‐guided complete revascularization. Methods and Results This was a retrospective post hoc QFR analysis of untreated nontarget vessels (any degree of diameter stenosis [DS]) from the randomized multicenter COMFORTABLE AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST‐Elevation Myocardial Infarction) trial by assessors blinded for clinical outcomes. The primary end point was cardiac death, spontaneous nontarget vessel myocardial infarction, and clinically indicated nontarget vessel revascularization (ie, ≥70% DS by 2‐dimensional quantitative coronary angiography or ≥50% DS and ischemia) at 5 years. Of 1161 patients with ST‐segment–elevation myocardial infarction, 946 vessels in 617 patients were analyzable by QFR. At 5 years, the rate of the primary end point was significantly higher in patients with QFR ≤0.80 (n=35 patients, n=36 vessels) versus QFR >0.80 (n=582 patients, n=910 vessels) (62.9% versus 12.5%, respectively; hazard ratio [HR], 7.33 [95% CI, 4.54–11.83], P30% DS by 3‐dimensional quantitative coronary angiography. Conclusions Our study suggests incremental value of QFR over angiography‐guided percutaneous coronary intervention for nonculprit lesions among patients with ST‐segment–elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Background The choice of optimal drug‐eluting stent therapy for patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remains uncertain. We aimed to assess the long‐term clinical outcomes after percutaneous coronary intervention with biodegradable polymer sirolimus‐eluting stents (BP‐SES) versus durable polymer everolimus‐eluting stents (DP‐EES) in patients with DM. Methods and Results In a prespecified subgroup analysis of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization) trial (NCT01443104), patients randomly assigned to ultrathin‐strut BP‐SES or thin‐strut DP‐EES were stratified according to diabetic status. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, at 5 years. Among 2119 patients, 486 (22.9%) presented with DM. Compared with individuals without DM, patients with DM were older and had a greater baseline cardiac risk profile. In patients with DM, target lesion failure at 5 years occurred in 74 patients (cumulative incidence, 31.0%) treated with BP‐SES and 57 patients (25.8%) treated with DP‐EES (risk ratio, 1.23; 95% CI, 0.87–1.73 [P=0.24]). In individuals without DM, target lesion failure at 5 years occurred in 124 patients (16.8%) treated with BP‐SES and 132 patients (16.8%) treated with DP‐EES (risk ratio, 0.98; 95% CI, 0.77–1.26 [P=0.90; P for interaction=0.31]). Cumulative 5‐year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP‐SES or DP‐EES. There was no interaction between diabetic status and treatment effect of BP‐SES versus DP‐EES. Conclusions In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout 5 years between patients with DM treated with ultrathin‐strut BP‐SES or thin‐strut DP‐EES. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01443104.

Background Acute complete occlusion of a coronary artery results in progressive ischemia, moving from the endocardium to the epicardium (ie, wavefront). Dependent on time to reperfusion and collateral flow, myocardial infarction (MI) will manifest, with transmural MI portending poor prognosis. Late gadolinium enhancement cardiac magnetic resonance imaging can detect MI with high diagnostic accuracy. Primary percutaneous coronary intervention is the preferred reperfusion strategy in patients with ST‐segment–elevation MI with 121 minutes demonstrated increased infarct size, transmurality index, and transmurality grade (all P121 minutes causes a high grade of transmural necrosis. In this pure ST‐segment–elevation MI population, time to reperfusion to salvage myocardium was less than suggested by current guidelines.

BackgroundEarly withdrawal of recommended antiplatelet treatment with clopidogrel adversely affects prognosis following percutaneous coronary interventions. Optimal antiplatelet treatment is essential following ST‐segment elevation myocardial infarction (STEMI) given the increased risk of thrombotic complications. This study assessed the frequency, predictors, and clinical impact of early prasugrel cessation in patients with STEMI undergoing primary percutaneous coronary interventions. Methods and ResultsWe pooled patients with STEMI discharged on prasugrel in 2 prospective registries (Bern PCI Registry [NCT02241291] and SPUM‐ACS (Inflammation and Acute Coronary Syndromes) [NCT01000701]) and 1 STEMI trial (COMFORTABLE‐AMI (Comparison of Biomatrix Versus Gazelle in ST‐Elevation Myocardial Infarction) [NCT00962416]). Prasugrel treatment status at 1 year was categorized as no cessation; crossover to another P2Y12‐inhibitor; physician‐recommended discontinuation; and disruption because of bleeding, side effects, or patient noncompliance. In time‐dependent analyses, we assessed the impact of prasugrel cessation on the primary end point, a composite of cardiac death, myocardial infarction, and stroke. Of all 1830 included patients (17% women, mean age 59 years), 83% were treated with new‐generation drug‐eluting stents. At 1 year, any prasugrel cessation had occurred in 13.8% of patients including crossover (7.2%), discontinuation (3.7%), and disruption (2.9%). Independent predictors of any prasugrel cessation included female sex, age, and history of cerebrovascular event. The primary end point occurred in 5.2% of patients and was more frequent following disruption (hazard ratio 3.04, 95% confidence interval,1.34–6.91; P=0.008), without significant impact of crossover or discontinuation. Consistent findings were observed for all‐cause death, myocardial infarction, and stent thrombosis following prasugrel disruption. ConclusionsIn this contemporary study of patients with STEMI, early prasugrel cessation was not uncommon and primarily involved change to another P2Y12‐inhibitor. Disruption was the only type of early prasugrel cessation associated with statistically significant excess in ischemic risk within 1 year following primary percutaneous coronary interventions.

BackgroundOperator experience influences outcomes after percutaneous coronary intervention, but this association in the controlled setting of a randomized, clinical trial is unclear. Methods and ResultsWe investigated operator‐related outcomes (30‐day and 2‐year efficacy and safety end points) among patients undergoing percutaneous coronary intervention and randomized to different dual antiplatelet therapy durations and stent types. A total of 2003 patients were analyzed, and 7 operator groups were compared. The majority of preprocedural and postprocedural characteristics were imbalanced. The primary end point of the study, the composite of death, myocardial infarction, or cerebrovascular accidents, did not differ among operators at 30 days or 2 years. There were no significant differences also for all other individual and composite end points analyzed at 30 days and 2 years, except for 2‐year stent thrombosis (P=0.048) and bleeding events (P=0.022 for Bleeding Academic Research Consortium type 2, 3, or 5). Adjusted comparisons for the main end points showed slight differences among operators at 30 days, but not at 2 years. There was no interaction of operator with dual antiplatelet therapy duration (P=0.112) or stent type (P=0.300). Results remained entirely consistent when operators were stratified by their experience. ConclusionsThere was a weak signal of heterogeneity across study operators for the 30‐day, but not the 2‐year, main study outcomes. No clear effect of operator or operator experience was observed for the comparative efficacy and safety profile of the randomized stent types or dual antiplatelet therapy duration regimens. Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00611286.

BackgroundThe American College of Cardiology (ACC) and European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) have recently published recommendations for the use of proprotein convertase subtilisin/kexin‐9 (PCSK9) inhibitors in situations of very high risk. We aim to assess in the real world the suitability of PCSK9 inhibitors for acute coronary syndromes. Methods and ResultsWe analyzed a prospective Swiss cohort of 2023 patients hospitalized for acute coronary syndromes between 2009 and 2014 with available data for low‐density lipoprotein cholesterol and lipid‐lowering therapy at 1 year. Clinical familial hypercholesterolemia was defined using the Dutch Lipid Clinic Network algorithm as unlikely, possible, probable, or definite. We simulated a fixed relative reduction of 24% in low‐density lipoprotein cholesterol levels at 1 year in all patients not treated with ezetimibe, irrespective of the low‐density lipoprotein cholesterol levels and statin regimen. At 1 year, 94.3% of patients were treated with statin, 5.8% with ezetimibe, and 35.8% of patients had on‐target low‐density lipoprotein cholesterol levels (

BackgroundRehospitalizations (RHs) after ST‐elevation myocardial infarction carry a high economic burden and may deteriorate quality of life. Characterizing patients at higher risk may allow the design of preventive measures. We studied the frequency, reasons, and predictors for unplanned cardiac and noncardiac RHs in ST‐elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. Methods and ResultsIn this post‐hoc analysis of the COMFORTABLE AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST‐Elevation Myocardial Infarction; NCT00962416) trial including 1137 patients, unplanned cardiac and noncardiac RHs occurred in 133 (11.7%) and in 79 patients (6.9%), respectively, at 1 year. The most frequent reasons for unplanned cardiac RHs were recurrent chest pain without evidence of ischemia (20.4%), recurrent chest pain with ischemia and coronary intervention (16.9%), and ischemic events (16.9%). Unplanned noncardiac RHs occurred most frequently attributed to bleeding (24.5%), infections (14.3%), and cancer (9.1%). On multivariate analysis, left ventricular ejection fraction (22% increase in the rate of RHs per 10% decrease; P=0.03) and angiographic myocardial infarction Syntax score (34% increase per 10‐point increase; P=0.01) were independent predictors of unplanned cardiac RHs. Age emerged as the only independent predictor of unplanned noncardiac RHs. Regional differences for unplanned cardiac RHs were observed. ConclusionsAmong ST‐elevation myocardial infarction patients undergoing primary percutaneous coronary intervention in the setting of a randomized, clinical trial, unplanned cardiac RHs occurred in 12% with recurrent chest pain being the foremost reason. Unplanned noncardiac RHs occurred in 7% with bleeding as the leading cause. Left ventricular ejection fraction and Syntax score were independent predictors of unplanned cardiac RHs and identified patient subgroups in need for improved secondary prevention. Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00962416.

BackgroundThe safety and effectiveness of the fully repositionable LOTUS valve system as compared with the balloon‐expandable Edwards SAPIEN 3 prosthesis for the treatment of aortic stenosis has not been evaluated to date. Methods and ResultsAll patients undergoing transcatheter aortic valve implantation with the Edwards SAPIEN 3 or the LOTUS valve system were included into the Swiss Transcatheter Aortic Valve Implantation Registry. An adjusted analysis was performed to compare the early clinical safety outcome according to the Valve Academic Research Consortium‐2 definition. Between February 2014 and September 2015, 140 and 815 patients were treated with the LOTUS and the Edwards SAPIEN 3 valve, respectively. There was no difference in crude and adjusted analyses of the early safety outcome between patients treated with LOTUS (14.3%) and those treated with Edwards SAPIEN 3 (14.6%) (crude hazard ratio, 0.97; 95% CI, 0.61–1.56 [P=0.915]; adjusted hazard ratio, 1.03; 95% CI, 0.64–1.67 [P=0.909]). More than mild aortic regurgitation was

BackgroundNo data are available on the long‐term performance of ultrathin strut biodegradable polymer sirolimus‐eluting stents (BP‐SES). We reported 2‐year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP‐SES with durable‐polymer everolimus‐eluting stents (DP‐EES) in patients undergoing percutaneous coronary intervention. Methods and ResultsA total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP‐SES (n=1063) or DP‐EES (n=1056). Follow‐up at 2 years was available for 2048 patients (97%). The primary end point was target‐lesion failure, a composite of cardiac death, target‐vessel myocardial infarction, or clinically indicated target‐lesion revascularization. At 2 years, target‐lesion failure occurred in 107 patients (10.5%) in the BP‐SES arm and 107 patients (10.4%) in the DP‐EES arm (risk ratio [RR] 1.00, 95% CI 0.77–1.31, P=0.979). There were no significant differences between BP‐SES and DP‐EES with respect to cardiac death (RR 1.01, 95% CI 0.62–1.63, P=0.984), target‐vessel myocardial infarction (RR 0.91, 95% CI 0.60–1.39, P=0.669), target‐lesion revascularization (RR 1.17, 95% CI 0.81–1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56–3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP‐SES arm and 4 cases (0.4%) in the DP‐EES arm (P=0.423). In the prespecified subgroup of patients with ST‐segment elevation myocardial infarction, BP‐SES was associated with a lower risk of target‐lesion failure compared with DP‐EES (RR 0.48, 95% CI 0.23–0.99, P=0.043, Pinteraction=0.026). ConclusionsComparable safety and efficacy profiles of BP‐SES and DP‐EES were maintained throughout 2 years of follow‐up. Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.

BackgroundBiomarkers of myocardial injury increase frequently during transcatheter aortic valve implantation (TAVI). The impact of postprocedural cardiac troponin (cTn) elevation on short‐term outcomes remains controversial, and the association with long‐term prognosis is unknown. Methods and ResultsWe evaluated 577 consecutive patients with severe aortic stenosis treated with TAVI between 2007 and 2012. Myocardial injury, defined according to the Valve Academic Research Consortium (VARC)‐2 as post‐TAVI cardiac troponin T (cTnT) >15× the upper limit of normal, occurred in 338 patients (58.1%). In multivariate analyses, myocardial injury was associated with higher risk of all‐cause mortality at 30 days (adjusted hazard ratio [HR], 8.77; 95% CI, 2.07–37.12; P=0.003) and remained a significant predictor at 2 years (adjusted HR, 1.98; 95% CI, 1.36–2.88; P22) and myocardial injury (41.1%). ConclusionsVARC‐2–defined cTnT elevation emerged as a strong, independent predictor of 30‐day mortality and remained a modest, but significant, predictor throughout 2 years post‐TAVI. The prognostic value of cTnT elevation was modified by the presence and complexity of underlying CAD with highest mortality risk observed in patients combining SYNTAX score >22 and evidence of myocardial injury.