Search

The aim of this substudy of the EXAMINATION-EXTEND was to analyze 10-year outcomes according to the patient's age at the time of the first ST-elevation myocardial infarction (STEMI). Of 1,498 patients with STEMI included in the EXAMINATION-EXTEND study, those with a previous history of coronary ischemic even or ischemic stroke were excluded from this analysis. The remaining 1,375 patients were divided into 4 age groups: 75 years. The primary end point was 10-year patient-oriented composite end point (POCE) of all-cause death, any MI, or any revascularization. At 10-year follow-up, patients aged 75 years, led by a lower incidence of all-cause death (75 years: 61.6%, p = 0.001). Cardiac death was more prevalent in the older group (75 years: 35.5%, p = 0.001). In the landmark analyses, between 5- and 10-year follow-up, young patients exhibited a higher incidence of any revascularization (65 years: 1.6%, p = 0.001). In conclusion, in patients with a first STEMI, advanced age was associated with high rates of POCE at 10-year follow-up due to all-cause and cardiac death. Conversely, younger patients exhibited a high risk of revascularization at long-term follow-up.

The long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain.The aim of this study was to report the 3-year clinical outcomes of the MAGSTEMI trial.This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee.Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000).At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.

El implante de TAVI se ha convertido en la primera opción de tratamiento en pacientes con estenosis aórtica severa de alto riesgo. Muchas veces el factor limitante es la ruta de acceso para llevar la prótesis a su lugar. Con este caso clínico breve mostramos cómo el implante transcava es una opción que puede resolver estos casos complejos.

The appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear.One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population.Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P = 0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, -2.82 percentage points; 95% CI, -4.40 to -1.24; P0.001 for superiority).One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding. (Funded by Terumo; MASTER DAPT ClinicalTrials.gov number, NCT03023020.).

Supplemental Digital Content is available in the text., Background: The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear. Methods: In the investigator-initiated, randomize, open-label MASTER DAPT trial (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen), 4579 patients at high bleeding risk were randomized after 1-month dual APT to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication. In this subgroup analysis, we report outcomes of populations with or without an OAC indication. In the population with an OAC indication, patients changed immediately to single APT for 5 months (abbreviated regimen) or continued ≥2 months of dual APT and single APT thereafter (nonabbreviated regimen). Patients without an OAC indication changed to single APT for 11 months (abbreviated regimen) or continued ≥5 months of dual APT and single APT thereafter (nonabbreviated regimen). Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes (composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium 3 or 5 bleeding events); major adverse cardiac and cerebral events (all-cause death, myocardial infarction, and stroke); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. Results: Net adverse clinical outcomes or major adverse cardiac and cerebral events did not differ with abbreviated versus nonabbreviated APT regimens in patients with OAC indication (n=1666; hazard ratio [HR], 0.83 [95% CI, 0.60–1.15]; and HR, 0.88 [95% CI, 0.60–1.30], respectively) or without OAC indication (n=2913; HR, 1.01 [95% CI, 0.77–1.33]; or HR, 1.06 [95% CI, 0.79–1.44]; Pinteraction=0.35 and 0.45, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding did not significantly differ in patients with OAC indication (HR, 0.83 [95% CI, 0.62–1.12]) but was lower with abbreviated APT in patients without OAC indication (HR, 0.55 [95% CI, 0.41–0.74]; Pinteraction=0.057). The difference in bleeding in patients without OAC indication was driven mainly by a reduction in Bleeding Academic Research Consortium 2 bleedings (HR, 0.48 [95% CI, 0.33–0.69]; Pinteraction=0.021). Conclusions: Rates of net adverse clinical outcomes and major adverse cardiac and cerebral events did not differ with abbreviated APT in patients with high bleeding risk with or without an OAC indication and resulted in lower bleeding rates in patients without an OAC indication. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03023020.

Although the concept of precision medicine, in which healthcare is tailored to the molecular and clinical characteristics of each individual, is not new, its implementation in clinical practice has been heterogenous. In some medical specialties, precision medicine has gone from being just a promise to a reality that achieves better patient outcomes. This is a fact if we consider, for example, the great advances made in the genetic diagnosis and subsequent treatment of countless hereditary diseases, such as cystic fibrosis, which have improved the life expectancy of many of the affected children. In the field of oncology, the development of targeted therapies has prolonged the survival of patients with breast, lung, colorectal, melanoma, and hematological malignancies. In other disciplines, clinical milestones are perhaps less well known, but no less important. The current challenge is to expand and generalize the use of technologies that are central to precision medicine, such as massively parallel sequencing, to improve the management (prevention and treatment) of complex conditions such as cardiovascular, kidney, or autoimmune diseases. This process requires investment in specialized expertise, multidisciplinary collaboration, and the nationwide organization of genetic laboratories for diagnosis of specific diseases.

OBJECTIVES We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions. BACKGROUND The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath. METHODS Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium. RESULTS This registry included 255 patients (mean age 83 ± 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9-5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 ± 0.5 cm2 , mean gradient was 6.9 ± 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker. CONCLUSIONS Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.

Background Even when low-density lipoprotein-cholesterol (LDL-C) levels are lower than guideline thresholds, a residual risk of atherosclerosis remains. It is unknown whether triglyceride (TG) levels are associated with subclinical atherosclerosis and vascular inflammation regardless of LDL-C. Objectives This study sought to assess the association between serum TG levels and early atherosclerosis and vascular inflammation in apparently healthy individuals. Methods An observational, longitudinal, and prospective cohort study, including 3,754 middle-aged individuals with low to moderate cardiovascular risk from the PESA (Progression of Early Subclinical Atherosclerosis) study who were consecutively recruited between June 2010 and February 2014, was conducted. Peripheral atherosclerotic plaques were assessed by 2-dimensional vascular ultrasound, and coronary artery calcification (CAC) was assessed by noncontrast computed tomography, whereas vascular inflammation was assessed by fluorine-18 fluorodeoxyglucose uptake on positron emission tomography. Results Atherosclerotic plaques and CAC were observed in 58.0% and 16.8% of participants, respectively, whereas vascular inflammation was evident in 46.7% of evaluated participants. After multivariate adjustment, TG levels ≥150 mg/dl showed an association with subclinical noncoronary atherosclerosis (odds ratio [OR]: 1.35; 95% confidence interval [CI]: 1.08 to 1.68; p = 0.008). This association was significant for groups with high LDL-C (OR: 1.42; 95% CI: 1.11 to 1.80; p = 0.005) and normal LDL-C (OR: 1.85; 95% CI: 1.08 to 3.18; p = 0.008). No association was found between TG level and CAC score. TG levels ≥150 mg/dl were significantly associated with the presence of arterial inflammation (OR: 2.09; 95% CI: 1.29 to 3.40; p = 0.003). Conclusions In individuals with low to moderate cardiovascular risk, hypertriglyceridemia was associated with subclinical atherosclerosis and vascular inflammation, even in participants with normal LDL-C levels. (Progression of Early Subclinical Atherosclerosis [PESA]; NCT01410318), Central Illustration

Purpose: The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype. Methods: The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST). Results: We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01–2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91–6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients. Conclusions: Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.

Objectives This final report from the REMEDEE Registry assessed the long‐term safety and efficacy of the dual‐therapy COMBO stent in a large unselected patient population. Background The bio‐engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual‐therapy pro‐healing stent. Data of long‐term safety and efficacy of the this stent is lacking. Methods The prospective, multicenter, investigator‐initiated REMEDEE Registry evaluated clinical outcomes after COMBO stent implantation in daily clinical practice. One thousand patients were enrolled between June 2013 and March 2014. Results Five‐year follow‐up data were obtained in 97.2% of patients. At 5‐years, target lesion failure (TLF) (composite of cardiac death, target‐vessel myocardial infarction, or target lesion revascularization) was present in 145 patients (14.8%). Definite or probable stent thrombosis (ST) occurred in 0.9%, with no additional case beyond 3‐years of follow‐up. In males, 5‐year TLF‐rate was 15.6 versus 12.6% in females (p = .22). Patients without diabetes mellitus (DM) had TLF‐rate of 11.4%, noninsulin‐treated DM 22.7% (p = .001) and insulin‐treated DM 41.2% (p < .001). Patients presenting with non‐ST segment elevation acute coronary syndrome (NSTE‐ACS) had higher incidence of TLF compared to non‐ACS (20.4 vs. 13.3%; p = .008), while incidence with STE‐ACS was comparable to non‐ACS (10.7 vs. 13.3%; p = .43). Conclusion Percutaneous coronary intervention with the dual‐therapy COMBO stent in unselected patient population shows low rates of TLF and ST to 5 years. Remarkably, no case of ST was noted beyond 3 years.

Older patients who undergo coronary interventions are at greater risk of ischemic events and less likely to tolerate prolonged dual antiplatelet therapy (DAPT) due to bleeding risk. The COMBO biodegradable polymer sirolimus-eluting stent promotes rapid endothelialization through endothelial progenitor cell capture technology which may be advantageous in elderly patients. We compared 1-year clinical outcomes and DAPT cessation events in patients >75 versus ≤75 years from the MASCOT registry. MASCOT was a prospective, multicenter cohort study of all-comers undergoing attempted COMBO stenting. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a nontarget vessel or clinically driven target lesion revascularization. Bleeding was adjudicated using the Bleeding Academic Research Consortium criteria. Adjusted outcomes were analyzed using Cox regression methods. The study included 18% (n = 479) patients >75 years and 72% (n = 2,135) patients ≤75 years. One-year TLF occurred in 4.6% patients >75 years versus 3.1% patients ≤75years of age, p = 0.10; adj hazard ratio 1.36, 95% confidence intervals 0.77 to 2.38, p = 0.29. There were no significant differences in cardiac death (1.7% vs 1.3%, p = 0.55), MI (2.1% vs 1.2%, p = 0.14), target lesion revascularization (1.7% vs 1.4%, p = 0.60) and definite stent thrombosis (0.8% vs 0.4%, p = 0.19). Major Bleeding Academic Research Consortium 3,5 bleeding (3.1% vs 1.5%, p = 0.01) and DAPT cessation rates (32.4% vs 23.0%, p 75 years treated with COMBO stents had similar TLF but significantly greater incidence of bleeding than younger patients and DAPT cessation in one-third of patients over 1 year.

Resumen Introduccion y objetivos El objetivo es evaluar el impacto del acceso vascular en las complicaciones hemorragicas tras una intervencion coronaria percutanea en pacientes con alto riesgo de sangrado (ARS) a los 30 dias y a los 2 anos. Metodos El presente estudio es un subanalisis predefinido del estudio LEADERS FREE, que incluyo a 2.432 pacientes con ARS y en el que el stent farmacoactivo Biolimus A9 resulto superior al stent convencional en seguridad y eficacia. Resultados El acceso radial (AR) se utilizo en 1.454 pacientes (59,8%) y el femoral (AF), en 978 (40,2%), ambos a eleccion del operador. La seguridad y los beneficios del stent farmacoactivo sobre el convencional fueron independientes del acceso vascular. A los 30 dias y a los 2 anos, habian sufrido un sangrado mayor el 2,4 y el 7,5% de los pacientes con AR y el 4,6 y el 10,9% de los pacientes con AF (p = 0,003), la mayoria en ambos grupos (el 2,1 y el 7,0% del de AR; el 3,2 y el 9,4% del de AF) no relacionados con el sitio de acceso vascular. El AR se asocio con una reduccion significativa en las tasas ajustadas de sangrado mayor tanto a 30 dias (HR = 1,98; IC95%, 1,25-3,11; p = 0,003) como a 2 anos de seguimiento (HR = 1,51; IC95%, 1,14-2,01; p = 0,003). Conclusiones Los operadores prefirieron el AR en la mayoria de los pacientes con ARS, lo cual se asocio con una reduccion significativa del sangrado mayor. Asimismo, un numero significativo de sangrados en el seguimiento de esta poblacion son no relacionados con el acceso vascular.

Background The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer with an anti-CD34+ antibody coating for early endothelialization. Objective We investigated for geographical differences in outcomes after percutaneous coronary intervention (PCI) with the COMBO stent among Asians and Europeans. Methods The COMBO Collaboration is a pooled patient-level analysis of the MASCOT and REMEDEE registries of all-comers undergoing attempted COMBO stent PCI. The primary outcome was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR). Results This study included 604 Asians (17.9%) and 2775 Europeans (82.1%). Asians were younger and included fewer females, with a higher prevalence of diabetes mellitus but lower prevalence of other comorbidities than Europeans. Asians had a higher prevalence of ACC/AHA C type lesions and received longer stent lengths. More Asians than Europeans were discharged on clopidogrel (86.5% vs 62.8%) rather than potent P2Y12 inhibitors. One-year TLF occurred in 4.0% Asians and 4.1% of Europeans, p = 0.93. The incidence of cardiac death was higher in Asians (2.8% vs. 1.3%, p = 0.007) with similar rates of TV-MI (1.5% vs. 1.2%, p = 0.54) and definite stent thrombosis (0.3% vs. 0.5%, p = 0.84) and lower incidence of TLR than Europeans (1.0% vs. 2.5%, p = 0.025). After adjustment, differences for cardiac death and TLR were no longer significant. Conclusions In the COMBO collaboration, although 1-year TLF was similar regardless of geography, Asians experienced higher rates of cardiac death and lower TLR than Europeans, while incidence of TV-MI and ST was similar in both regions. Adjusted differences did not reach statistical significance. Clinicaltrial.gov identifier-numbers NCT01874002 (REMEDEE Registry), NCT02183454 (MASCOT registry).

Introduction and objectives In de novo heart failure with reduced ejection fraction (HFrEF) current guidelines support, an initial double combination therapy with angiotensin converting enzyme inhibitors/angiotensin-receptor blockers and betablockers, only adding minerocorticoid receptor antagonists if after treatment optimization left ventricular ejection fraction (LVEF) is still under 40%. An initial triple combination therapy could be an attractive initial approach in the stability phase after an acute HF episode in debut HFrEF; which is what we describe in this report and analyze the factors related to the treatment with triple neurohormonal blockade (TNHB). Methods Retrospective study of patients discharged from our centre between January 2009 and January 2016 with de novo HFrEF after an acute HF episode with these criteria: 15–85 year-old, creatinine ≤2.5 mg/dL, potassium Results A total of 280 patients fulfilled the criteria, 58% of them were discharged on TNHB. Mean age was 65.4 ± 12.5 years, LVEF 29.8 ± 7.3% and median NT-ProBNP 2917 pg/mL. After a mean follow-up of 43.4 ± 26.6 months, 72 patients died (25.7%), with a mean survival of 76 months. Patients treated with TNHB had a better risk profile (they were younger, better creatinine and lower pulmonary pressures) but poorer LVEF (28.7 ± 7.4% vs. 31.4 ± 6.7%; P = .002). Mean survival on TNHB was better (months, 82.1 ± 3.0 vs. 68.6 ± 3.8; P = .007). Multivariate analysis showed that TNHB was an independent predictor of better survival (HR, 1.79; 1.05–3.05; P = .03). Conclusions TNHB is commonly used in debut HFrEF, especially in younger patients with worse LVEF. In our cohort TNHB was an independent factor related to better survival.

Bioresorbable scaffolds (BRS) were conceived to ensure transient coronary artery support during antiproliferative drug delivery. However, the Absorb everolimus-eluting bioresorbable scaffold was found to be inferior to everolimus-eluting metallic stents (EES) in moderately complex coronary anatomies. We sought to investigate whether the Absorb represents a valuable option for the percutaneous treatment of patients with ST-elevation myocardial infarction (STEMI).We pooled the individual patient data of two randomised trials specifically designed to investigate the performance of Absorb versus EES in patients with acute myocardial infarction (MI). The primary outcome was lesion (in-segment) diameter stenosis at angiographic follow-up. The main secondary outcome was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI and target lesion revascularisation at one year. A total of 388 patients with STEMI were allocated to Absorb (n=227) or EES (n=161). Angiographic follow-up at one year was available for 332 (85.6%) patients. Lesion diameter stenosis was comparable between Absorb and EES (22.8±9.8% versus 23.6±11.2%; mean difference -0.8%, 95% confidence interval [CI]: -3.18-1.48, p=0.47). DOCE occurred in 21 patients at one year, with similar distribution between the Absorb and EES groups (5.3% versus 5.6%; hazard ratio 0.95, 95% CI: 0.40-2.26, p=0.91).This pooled analysis provides evidence for a comparable angiographic performance and suggests similar clinical performance of Absorb and EES in STEMI patients undergoing percutaneous revascularisation. The long-term durability of Absorb and the extent to which newer BRS platforms might have a potential role in STEMI deserve further investigation. Both trials were registered at www.clinicaltrials.gov (NCT01942070 and NCT01986803).

Background: Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI).Methods/Design: The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non–inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non–inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years.The PIONEER IV trial aims to demonstrate non–inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy.Clinical Trial Registration: ClinicalTrials.govUnique Identifier: NCT04923191Classifications: Interventional Cardiology

Background: The use of poly- l -lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period ( Methods: This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment–elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). Results: Between June 2017 and June 2018, 150 ST-segment–elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P =0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P P P =0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P =1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (−8.3±3.5% versus −2.4±1.3% in the SES group, P =0.003). Conclusions: When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03234348.

Mitral regurgitation is the second-most frequent valvular heart disease in Europe and it is associated with high morbidity and mortality. Recognition of MR should encourage the assessment of its etiology, severity, and mechanism in order to determine the best therapeutic approach. Mitral valve surgery constitutes the first-line therapy; however, transcatheter procedures have emerged as an alternative option to treat inoperable and high-risk surgical patients. In patients with suitable anatomy, the transcatheter edge-to-edge mitral leaflet repair is the most frequently applied procedure. In non-reparable patients, transcatheter mitral valve replacement (TMVR) has appeared as a promising intervention. Thus, currently TMVR represents a new treatment option for inoperable or high-risk patients with degenerated or failed bioprosthetic valves (valve-in-valve); failed repairs, (valve-in-ring); inoperable or high-risk patients with native mitral valve anatomy, or those with severe annular calcifications, or valve-in-mitral annular calcification. The patient selection requires multimodality imaging pre-procedural planning to select the best approach and device, study the anatomical landing zone and assess the risk of left ventricular outflow tract obstruction. In the present review, we aimed to highlight the main considerations for TMVR planning from an imaging perspective; before, during, and after TMVR.

Aims Despite aortic stenosis (AS) relief, patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk of developing heart failure (HF) within first months of intervention. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of HF hospitalization in individuals with diabetes mellitus (DM), reduced left ventricular ejection fraction (LVEF) and chronic kidney disease (CKD). However, the effect of SGLT-2 inhibitors on outcomes after TAVI is unknown. The Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) trial is designed to assess the clinical benefit and safety of the SGLT-2 inhibitor dapagliflozin in patients undergoing TAVI. Methods DapaTAVI is an independent pragmatic, controlled, prospective, randomized, open-label blinded end-point, multi-center trial conducted in Spain, evaluating the effect of dapagliflozin 10 mg/day on the risk of death and worsening HF in patients with severe AS undergoing a TAVI. Candidate patients should have prior history of HF admission plus ≥1 of the following criteria: 1) DM, 2) LVEF ≤40%, or 3) estimated glomerular filtrate rate between 25 and 75 mL/min/1.73 m2. A total of 1020 patients will be randomized (1:1) to dapagliflozin versus no dapagliflozin. Key secondary outcomes include: (i) Incidence rate of individual components of the primary outcome; (ii) Cardiovascular mortality; (iii) The composite of HF hospitalization or CV death; (iv) Total number of recurrent HF hospitalizations. Conclusion DapaTAVI will determine the efficacy and safety of dapagliflozin in a broad spectrum of frail patients after AS relief by TAVI. This article is protected by copyright. All rights reserved.

Aims The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial. Methods and results SYNTAX II was a multicentre, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, P < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, P < 0.001), and myocardial infarction (MI) (2.7% vs. 10.4%, P < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, P < 0.001) and spontaneous MI (2.3% vs. 6.9%, P = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, P = 0.013) reflecting a lower rate of cardiac death (2.8% vs. 8.4%, P < 0.001). Major adverse cardiac and cerebrovascular events’ outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, P = 0.35). Conclusions Use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.

Cardiovascular diseases are the primary cause of deaths in the world. Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. Due to its high prevalence and associated risks, early detection of AF is an important objective for healthcare systems worldwide. The growing demand for medical assistance implies increased expenses, which could be limited by implementing ambulatory monitoring techniques based on wearable devices, thus, reducing the number of people requiring observation in hospitals. One of the main challenges in this context is related to the large amount of data from patients to be analyzed, which points to the suitability of using computational intelligence techniques for it. The selection of the features to be extracted from data plays a key role in order for any classifier of heart rhythm to provide good results in this regard. This paper demonstrates that it is possible to achieve an accurate detection of AF using a very low number of relatively simple features extracted from photoplethysmographic signals, enabling the use of affordable wearable devices (with scarce processing and data storage resources) with this purpose over long periods of time. This fact has been validated in experiments using data from real patients under medical supervision.

ObjectivesTo assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. BackgroundThe use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. MethodsAmong 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n =225) or PP-EES (n =231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9months. ResultsIn this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p =.29 and 10.2 vs. 13.4%; p =.29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p =.33 and 0.9 vs. 1.7%; p =.43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar. ConclusionsThese results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.

INTRODUCTION AND OBJECTIVES Health outcomes research is done from clinical registries or administrative databases. The aim of this work was to evaluate the concordance of the Minimum Basic Data Set (MBDS) with the DIOCLES (Descripcion de la Cardiopatia Isquemica en el Territorio Espanol) registry and to analyze the implications of use of the MBDS in the study of acute coronary syndrome in Spain. METHODS Through indirect identifiers, DIOCLES was linked with MBDS and unique matches were selected. Some of most relevant variables for risk adjustment of in-hospital mortality due to acute myocardial infarction were considered. Kappa coefficient was used to evaluate the concordance; sensitivity, specificity and positive and negative predictive values to measure the validity of the MBDS, and the area under ROC (receiver operating characteristic) curve to calculate its discrimination. The results were compared among hospitals quintiles according to their contribution to DIOCLES. The influence of unmatched episodes on results was assessed by a sensitivity analysis, using looser linking criteria. RESULTS Overall, 1539 (60.85%) unique matches were achieved. The prevalence was higher in DIOCLES (acute myocardial infarction: 71.09%; Killip 3-4: 9.17%; cerebrovascular accident: 0.97%; thrombolysis: 8.64%; angioplasty: 61.92% and coronary bypass: 1.75%) than in the MBDS (P < .001). The agreement level observed was almost perfect (κ = 0.863). The MBDS showed a sensitivity of 85.10% and a specificity of 98.31%. Most results were confirmed by using sensitivity analysis (79.95% episodes matched). CONCLUSIONS The MBDS can be a useful tool for outcomes research of acute coronary syndrome in Spain. The contrast of DIOCLES and MBDS with medical records could verify their validity.

Resumen Introduccion y objetivos La investigacion de resultados en salud utiliza tanto registros clinicos como bases de datos administrativas. El objetivo de este trabajo es evaluar la concordancia del Conjunto Minimo Basico de Datos (CMBD) con el registro DIOCLES (Descripcion de la Cardiopatia Isquemica en el Territorio Espanol) y su utilidad en la investigacion de resultados del sindrome coronario agudo en Espana. Metodos Mediante identificadores indirectos, se vinculo el DIOCLES con el CMBD y se seleccionaron los emparejamientos unicos. Considerando algunas de las variables mas relevantes para ajustar por riesgo la mortalidad intrahospitalaria por infarto agudo de miocardio, se calculo la concordancia interobservadores, la sensibilidad, la especificidad y los valores predictivos positivo y negativo para medir la validez del CMBD, y el area bajo la curva ROC (receiver operating characteristic) para determinar su discriminacion. Los resultados se compararon entre quintiles de hospitales segun su contribucion a DIOCLES. El impacto de los emparejamientos fallidos se evaluo mediante un analisis de sensibilidad con criterios de vinculacion mas laxos. Resultados Se lograron 1.539 (60,85%) emparejamientos unicos. Entre los episodios emparejados, la prevalencia fue mayor en el DIOCLES (infarto agudo de miocardio, el 71,09%; Killip 3-4, el 9,17%; accidente cerebrovascular, el 0,97%; trombolisis, el 8,64%; angioplastia, el 61,92%, y bypass, el 1,75%) que en el CMBD (p Conclusiones El CMBD puede ser un instrumento util para la investigacion de resultados del sindrome coronario agudo en Espana. El contraste de DIOCLES y CMBD con las historias clinicas podria verificar su validez.

Background: The bio-engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual-therapy pro-healing stent. This novel technology may allow a shorter duration of dual antiplatelet therapy (DAPT) after stenting. We present the first 3 year clinical outcomes of patients treated with COMBO stent. Methods and results: The prospective, multicenter, investigator-initiated, all-comers REMEDEE Registry evaluates clinical outcomes after COMBO stent treatment. A 1,000 patients were enrolled between June 2013 and March 2014. Patients had a mean of 65 years ±11, 26% of the patients were females and 18% diabetics. More than 50% of patients presented with acute coronary syndrome, 60% of treated lesions were AHA/ACC lesion type B2 or C. Target lesion failure (TLF) at 3 year follow-up occurred in 10.7% of patients (N = 105). The separate components cardiac death, target vessel myocardial infarction and target lesion revascularization occurred in 4.1%, 2.0%, and 7.1%, respectively of patients. Definite stent thrombosis (ST) was observed in 0.7% of all patients. At 3-year follow-up there were only 73 patients taking DAPT. Conclusions: At 3-year follow-up, patients treated with COMBO stent in the present large prospective all-comers cohort, continue to show good clinical outcomes. Clinicaltrials.gov identifier: NCT01874002. Condensed abstract: The COMBO stent is a sirolimus-eluting stent with a luminal anti-CD34-antibody layer, that binds endothelial progenitor cells. These cells can differentiate to endothelial cells and stimulate early endothelialization of the stent. The REMEDEE Registry is the first large, multicenter, prospective, cohort study evaluating the clinical outcomes of 1,000 all-comers patients treated with COMBO stent. Target lesion failure at 3 year follow-up was 10.7% and the rate of definite ST was 0.7%.