Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis.

AIM: To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS). METHODS AND RESULTS: In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69-1.52, and HR: 1.24, 95% CI: 0.79-1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71-1.15, and HR: 0.91, 95% CI: 0.69-1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42-0.98, and HR: 0.70; 95% CI: 0.55-0.89; Pinteraction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT. CONCLUSION: In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity. CLINICAL TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed.

Biomarkers-based personalized follow-up in chronic heart failure improves patient's outcomes and reduces care associate cost.

BACKGROUND: Heart failure (HF) is a major and growing medical and economic problem, with high prevalence and incidence rates worldwide. Cardiac Biomarker is emerging as a novel tool for improving management of patients with HF with a reduced left ventricular ejection fraction (HFrEF). METHODS: This is a before and after interventional study, that assesses the impact of a personalized follow-up procedure for HF on patient's outcomes and care associated cost, based on a clinical model of risk stratification and personalized management according to that risk. A total of 192 patients were enrolled and studied before the intervention and again after the intervention. The primary objective was the rate of readmissions, due to a HF. Secondary outcome compared the rate of ED visits and quality of life improvement assessed by the number of patients who had reduced NYHA score. A cost-analysis was also performed on these data. RESULTS: Admission rates significantly decreased by 19.8% after the intervention (from 30.2 to 10.4), the total hospital admissions were reduced by 32 (from 78 to 46) and the total length of stay was reduced by 7 days (from 15 to 9 days). The rate of ED visits was reduced by 44% (from 64 to 20). Thirty-one percent of patients had an improved functional class score after the intervention, whereas only 7.8% got worse. The overall cost saving associated with the intervention was € 72,769 per patient (from € 201,189 to € 128,420) and €139,717.65 for the whole group over 1 year. CONCLUSIONS: A personalized follow-up of HF patients led to important outcome benefits and resulted in cost savings, mainly due to the reduction of patient hospitalization readmissions and a significant reduction of care-associated costs, suggesting that greater attention should be given to this high-risk cohort to minimize the risk of hospitalization readmissions.

Effectiveness and safety of AV node ablation after His bundle pacing in patients with uncontrolled atrial arrhythmias.

INTRODUCTION: In patients with uncontrolled atrial fibrillation, atrioventricular (AV) node ablation after permanent His bundle pacing (p-HBP) could be a therapeutic option for heart rate (HR) control. We aimed to demonstrate the advantages of AV node ablation with p-HBP, and to describe its effectiveness and safety. METHODS: This descriptive observational study included patients with uncontrolled permanent atrial arrhythmias who were candidates for HR control (January 2019 to July 2020) and underwent p-HBP and AV node ablation. RESULTS: A total of 39 patients were included. The median left ventricular ejection fraction (LVEF) was 55% (45-60); 46.1% in NYHA class II and 43.6% in NYHA class III. p-HBP was achieved in 92.3% (n = 36), and AV node ablation was successfully performed in all patients. The LVEF improved in patients with reduced LVEF (baseline, 35% [23.8-45.3%]; follow-up, 40% [35-56.5%], p < 0.05); the NYHA class also showed improvement (baseline, 71.4% patients in class III and 7.1% in class II, and at follow-up, 78.6% patients in class II and 14.3% in class I). In patients with previously normal LVEF, LVEF remained stable; nevertheless, a significant NYHA class improvement was observed (baseline, 63.6% class II and 31.8% class III patients; follow-up, 54.5% class I and 45.5% class II patients). The His thresholds and lead parameter values did not significantly change during the follow-up and remained stable. CONCLUSIONS: In patients with uncontrolled atrial arrhythmias who underwent AV node ablation after p-HBP, the NYHA class improved and the LVEF increased in those with reduced baseline LVEF. The values of pacing parameters were acceptable and remained stable during the follow-up.

Electrocardiographic patterns predictive of left bundle branch block correction with His bundle pacing.

INTRODUCTION: Permanent His bundle pacing (p-HBP) could be an alternative for traditional cardiac resynchronization therapy (CRT), but an important limitation is that p-HBP cannot always correct the left bundle branch block (LBBB). The purpose of this article is to assess electrocardiographic patterns of LBBB that can predict electrocardiographic response (QRS narrowing) to His bundle pacing. METHODS: We designed a prospective descriptive study of patients with LBBB and CRT indication proposed for CRT by p-HBP. We analyzed the correlation between the different electrocardiographic patterns and the correction of conduction disturbance (LBBB). RESULTS: We included 70 patients. Pacing at the location where His bundle electrogram was recorded narrowed the QRS in 81.4% (n = 57). Basically, we identified two electrocardiographic patterns in lead V1: QS or rS. The QS pattern was a sensitivity of 56%, a specificity of 84.6%, and a positive predictive value (PPV) of 94.1% to predict the correction of the LBBB (area under the curve [AUC] = .70). In patients with rS pattern, a ratio between the descending and the ascending S wave component duration ≥0.64 was a very good predictor of the correction of the LBBB (AUC = .968); with a value ≥0.64, the sensitivity, specificity, and PPV was 92%, 100%, and 100%, respectively. CONCLUSIONS: In patients with LBBB and CRT indication, the QS pattern in lead V1 predicts the correction of the QRS with HBP. In the case of rS pattern in lead V1, the ratio descending/ascending S wave component duration has a strong correlation with the LBBB correction.

Association of acute kidney injury and bleeding events with mortality after radial or femoral access in patients with acute coronary syndrome undergoing invasive management: secondary analysis of a randomized clinical trial.

AIMS: In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) trial, adults with acute coronary syndrome undergoing coronary intervention who were allocated to radial access had a lower risk of bleeding, acute kidney injury (AKI), and all-cause mortality, as compared with those allocated to femoral access. The mechanism of the mortality benefit of radial access remained unclear. METHODS AND RESULTS: We used multistate and competing risk models to determine the effects of radial and femoral access on bleeding, AKI and all-cause mortality in the MATRIX trial and to disentangle the relationship between these different types of events. There were large relative risk reductions in mortality for radial compared with femoral access for the transition from AKI to death [hazard ratio (HR) 0.55, 95% confidence interval (CI) 0.31-0.97] and for the pathway from coronary intervention to AKI to death (HR 0.49, 95% CI 0.26-0.92). Conversely, there was little evidence for a difference between radial and femoral groups for the transition from bleeding to death (HR 1.05, 95% CI 0.42-2.64) and the pathway from coronary intervention to bleeding to death (HR 0.84, 95% CI 0.28-2.49). CONCLUSION: The prevention of AKI appeared predominantly responsible for the mortality benefit of radial as compared with femoral access in the MATRIX trial. There was little evidence for an equally important, independent role of bleeding.

Everolimus drug-eluting stent performance in patients with long coronary lesions: The multicenter Longprime registry.

OBJECTIVES: To assess the efficacy and safety of the Xience Prime everolimus-eluting stent (EES) in long coronary lesions in a real-world population. BACKGROUND: Long lesions are considered difficult technically and in terms of achieving successful clinical outcomes. With first generation DES, MACE can be as high as 10% at a short-medium term follow-up. There are a few data available in this subset regarding the use of second generation DES METHODS: A prospective, multicenter registry of consecutive patients (aged 64.8 ± 11.2 years, 77% men and 33% diabetics) in 29 tertiary hospitals with de novo > 24 mm lesions in vessels of 2.25-4 mm was performed. The primary and secondary endpoints were major adverse cardiac events (MACE; cardiac death, myocardial infarction, and target lesion revascularization) and stent thrombosis (ST) at 1, 12, and 24 months. Patients were on dual antiplatelet therapy during 12 months. RESULTS: A total of 610 patients with 705 long lesions were included (1.2 per patient). Lesion length was 34.59 ± 11.17 mm and vessel size 2.93 ± 0.41 mm. Stented length was 39.83 ± 14.08 mm (1.4 stents per lesion). Predilatation/postdiltatation was performed in 75 and 33% of the cases, intravascular ultrasound in 15%. The device success rate was 99.1%. MACE and ST rates at 1, 12, and 24-months follow-up were 0.3, 2.1, and 5.4% and 0.2, 0.7, and 1.5%, respectively. CONCLUSION: In this real-world population, the Xience Prime EES performs extremely well in long lesions, with a very low rate of both MACE and ST.

Trapping as retrieval technique to resolve a ruptured and entrapped coronary balloon catheter.

A 69 year old male, with a previous percutaneous revascularization of the mid-circumflex with a bare metal stent in 2007 was admitted to our centre for unstable angina. The angiography showed a severely calcified coronary tree with a functionally severe plaque on the proximal left anterior descending artery (LAD) and a critical focal lesion on the proximal right coronary artery. After a high pressure predilation on the proximal LAD, the balloon ruptured causing a retrograde LAD-left main (LM) dissection that was rapidly sealed with three overlapping zotarolimus-eluting stents from medial LAD to LM. We then used a new non-compliant balloon for successive aggressive postdilation. After a difficult handling, when the balloon catheter was pulled out of the body and we realized that the tip and membranous part of the balloon-catheter was separated from the rest, and entangled at the LM. After a first approach to retrieve the dislodged balloon with a snare, the ruptured balloon was successfully removed by trapping and withdrawing the whole system, including the guiding catheter and the wire.

Subclavian angioplasty during coronary interventions using radial approach.

BACKGROUND: In the past years, the percentage of percutaneous coronary angiography and coronary interventions using radial access had significantly increased due to its higher safety, lower risk of major bleeding, and hence lower cardiovascular mortality. Subclavian artery stenosis is one of the challenges that may be met during transradial coronary interventions, which may necessitate femoral access crossover or conversion. AIMS: To evaluate the feasibility and safety of performing subclavian angioplasty via radial access during complex coronary interventions using the forearm approach. METHODS: A series of patients with complex radial approach due to subclavian stenosis received subclavian angioplasty during the procedure. We included 48 patients out of 22 500 procedures performed from February 2009 to February 2020. All patients did not have alternative vascular access due to extensive peripheral arterial disease (previous history of iliac stenting or distal aortic occlusion, which makes femoral access crossover difficult; also the contralateral radial/ulnar artery was very faint or not detectable at all). RESULTS: Mean age was 72 (10) years and 67% of patients were males. Subclavian angioplasty was successfully done in all patients via ipsilateral radial access; 44 patients (91.7%) required subclavian stenting, and 4 patients were treated by subclavian angioplasty without stenting. Coronary angiography or intervention was perfectly achieved through the revascularized subclavian artery; coronary stenting was successfully done in 36 patients as indicated. CONCLUSIONS: It can be concluded that percutaneous subclavian artery angioplasty can be done safely and effectively to facilitate complex transradial coronary procedures with an acceptable immediate technical success, especially in patients without alternative vascular access. Also, we may conclude that subclavian angioplasty may be successfully performed in patients with symptomatic upper limb ischemia, via the radial approach.

Genetics and biochemistry of familial hypercholesterolemia in Southwest of the Iberian Peninsula. / Particularidades genéticas y bioquímicas de la hipercolesterolemia familiar en el suroeste de la Península Ibérica.

So far, most cases of hypercholesterolaemia (60-80%) are attributed to pathogenic variants in the LDLR gene. Only 1-5% of cases are caused by variants in the APOB gene, and 0-3% by variants in the PCSK9 gene. There is a large variety in known pathogenic mutations of the LDLR gene, while for those affecting the APOB gene, the highest incidence is p.Arg3527Gln, described predominantly in Central European and North American populations. In the Iberian Peninsula the predominant gene affected is that of the LDL receptor, similar to the rest of the world, with the involvement of the APOB gene being described in individuals from the northwest, and anecdotal in the rest of the territory. A genetics analysis was performed on the population attending the first year of a lipid clinic in southwestern Spain with a 6-point score from the Dutch lipid clinics. The genetic, biochemical and clinical findings are described. The first findings show indications of a possible higher prevalence of patients with mutation in the APOB gene compared to other territories. Historical evidence is presented that could give a possible explanation to this, thus supporting the assumption.

Long-term effects of coronavirus disease 2019 on the cardiovascular system, CV COVID registry: A structured summary of a study protocol.

BACKGROUND: Patients presenting with the coronavirus-2019 disease (COVID-19) may have a high risk of cardiovascular adverse events, including death from cardiovascular causes. The long-term cardiovascular outcomes of these patients are entirely unknown. We aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and to determine their long-term cardiovascular outcomes. STUDY AND DESIGN: This is a multicenter, observational, retrospective registry to be conducted at 17 centers in Spain and Italy (ClinicalTrials.gov number: NCT04359927). Consecutive patients older than 18 years, who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 in the participating institutions, will be included since March 2020, to August 2020. Patients will be classified into two groups, according to the results of the RT-PCR: COVID-19 positive or negative. The primary outcome will be cardiovascular mortality at 1 year. The secondary outcomes will be acute myocardial infarction, stroke, heart failure hospitalization, pulmonary embolism, and serious cardiac arrhythmias, at 1 year. Outcomes will be compared between the two groups. Events will be adjudicated by an independent clinical event committee. CONCLUSION: The results of this registry will contribute to a better understanding of the long-term cardiovascular implications of the COVID19.

Vitamin K Antagonists and Direct Oral Anticoagulants in Nonagenarian Patients With Atrial Fibrillation.

OBJECTIVES: Nonagenarian patients are underrepresented in clinical trials that have evaluated oral anticoagulation in patients with atrial fibrillation (AF). The aim of this study was to assess the pronostic impact of oral anticoagulation in patients with AF age ≥90 years. DESIGN: Retrospective multicenter study of nonagenarian patients with AF. SETTING AND PARTICIPANTS: A total of 1750 nonagenarian inpatients and outpatients with nonvalvular AF between January 2013 and December 2018 in 3 Spanish health areas were studied. METHODS: Patients were divided into 3 groups based on antithrombotic therapy: nonoral anticoagulants (30.5%), vitamin-K antagonists (VKAs; 28.6%), and direct oral anticoagulants (DOACs; 40.9%). During a mean follow-up of 23.6 ± 6.6 months, efficacy outcomes (death and embolic events) were evaluated using a Cox regression analysis and safety outcomes (bleeding requiring hospitalization) by competing-risk regression. Results were complemented with a propensity score matching analysis. RESULTS: During follow-up, 988 patients died (56.5%), 180 had embolic events (10.3%), and 186 had major bleeding (10.6%). After multivariable adjustment, DOACs were associated with a lower risk of death and embolic events than nonanticoagulation [hazard ratio (HR) 0.75, 95% confidence interval (CI)] 0.61‒0.92), but VKAs were not (HR 0.87, 95% CI 0.72‒1.05). These results were confirmed after propensity score matching analysis. For bleeding, both DOACs and VKAs proved to be associated with a higher risk (HR for DOAC 1.43; 95% CI 0.97‒2.13; HR for VKA 1.94; 95% CI 1.31‒2.88), although findings for DOACs were not statistically significant (P = .074). For intracranial hemorrhage (ICH), only VKAs-not DOACs-presented a higher risk of ICH (HR 4.43; 95% CI 1.48‒13.31). CONCLUSIONS AND IMPLICATIONS: In nonagenarian patients with AF, DOACs led to a reduction in mortality and embolic events in comparison with nonanticoagulation. This reduction was not observed with VKAs. Although both DOACs and VKAs increased the risk of bleeding, only VKAs were associated with higher ICH rates.

First-in-man randomised comparison of the Angiolite durable fluoroacrylate polymer-based sirolimus-eluting stent versus a durable fluoropolymer-based everolimus-eluting stent in patients with coronary artery disease: the ANGIOLITE trial.

AIMS: The durable fluoroacrylate polymer-based sirolimus-eluting stent (Angiolite SES) has shown promising preclinical and clinical results regarding inflammatory vascular reaction and neointimal healing. We aimed to compare performance between the Angiolite SES and an everolimus-eluting stent (EES) in patients with coronary artery disease. METHODS AND RESULTS: The ANGIOLITE trial, a prospective, randomised, multicentre trial, compared the restenosis parameters of both stents in de novo coronary lesions. The primary endpoint was late lumen loss at six-month angiographic follow-up. In-stent healing was assessed by optical coherence tomography (OCT). The main clinical endpoint was target lesion failure (TLF) evaluated up to 24 months. A total of 223 patients were randomised 1:1 to EES or SES. At six months, in-stent late lumen loss was 0.08 mm (±0.38) for EES vs 0.04 mm (±0.39) for SES (difference=-0.04 mm, 95% CI: -0.15, 0.07, p for non-inferiority=0.002). By OCT, the rate of uncovered to total number of struts score >30% was comparable between the groups whereas neointimal thickness was reduced in the SES arm (9.0% [7.6, 10.6] vs 9.9% [8.5, 11.3], p=0.41; and 86.4 [81.6, 91.2] µm vs 72.1 [68.2, 76.0] µm, p<0.01, respectively). At 24 months, TLF occurred in eight patients (7.6% [3.3, 14.5]) in the EES arm and in seven patients (7.1% [2.9, 14.0]) in the SES arm (p=0.88). The definite/probable stent thrombosis rate was comparable between the groups (1.9% [0.2, 6.7] vs 1.0% [0.0, 5.5] EES vs SES, respectively; p=0.59). CONCLUSIONS: This trial demonstrates similar antirestenotic efficacy at midterm follow-up of the Angiolite SES vs an EES. Clinical endpoints were comparable between the groups at two-year follow-up. Visual summary. Main results of the ANGIOLITE trial.

Spontaneous Coronary Artery Dissection and Hypothyroidism.

INTRODUCTION AND OBJECTIVES: Thyroid hormone affects the metabolism of all tissues in the body. The aim of this study was to analyze the prevalence and implications of thyroid disorders in a cohort of consecutive patients with spontaneous coronary artery dissection (SCAD). METHODS: A total of 73 patients with SCAD were analyzed. Baseline characteristics and clinical outcomes were compared between euthyroid and hypothyroid patients. Subsequently, the prevalence of thyroid function abnormalities and the clinical characteristics of SCAD patients were compared with those in 73 patients with acute coronary syndrome but without SCAD, matched by age, sex, and presentation. RESULTS: Mean age was 55 ± 12 years and 26% had hypothyroidism. Compared with patients with normal thyroid function, patients with SCAD and hypothyroidism were all women (100% vs 69%, P = .01), more frequently had dissection in distal (74% vs 41%, P = .03) and tortuous coronary segments (68% vs 41%, p = .03), and more frequently received conservative medical management (79% vs 41%, P = .007). During a mean clinical follow-up of 4.1 ± 3.8 years, 23% of the patients had adverse cardiac events irrespective of thyroid function status. The prevalence of hypothyroidism was higher in patients with SCAD than in matched patients with acute coronary syndrome without SCAD (26% vs 8%, P = .004). CONCLUSIONS: There is a high prevalence of hypothyroidism in patients with SCAD. Patients with SCAD and hypothyroidism are more frequently women, more frequently have distal dissections in tortuous vessels, and are more frequently managed with a conservative medical strategy.

Abluminal Neointimal Healing by Optical Coherence Tomography Assessment After Drug-Eluting Stent Implantation on Organized Recanalized Thrombus.

Six-month PCI follow-up results of left anterior descending (LAD) and circumflex (CX) drug-eluting stent implantation are presented. Angiography showed patent LAD and CX stents. However, OCT revealed almost all abluminal cavities were completely filled, which the authors surmise was due to a neointimal healing process.

Radial/Ulnar angioplasty in selected patients undergoing elective angiography or PCI using complex forearm approach.

BACKGROUND: Angioplasty on the radial artery have been performed with good success rates in patients with critical hand ischemia. We sought to assess the feasibility and safety of radial angioplasty on complex radial access in patients undergoing coronary angiography. METHODS/MATERIAL: A prospective series of procedures with complex radial/ulnar access to which radial-ulnar angioplasty (RU-A) was performed. We set goals of efficacy and safety that included the success rate of the procedure (need for ¨Crossover femoral¨) and the existence of radial pulse at one month. RESULTS: 18 cases of RU-A out of 11,500 procedures from March 2010 to July 2016 (0.15%) were included. The majority of the patients were men with a variety of cardiovascular risk factors (age 71±9; 94% Hypertensive, 56% Diabetic, 18% chronic kidney disease). The most common indication for radial/ulnar angioplasty was severe arteriosclerotic stenosis. Angioplasty was performed with different types of over the wire peripheral balloons (Mean diameter 4,3±1 and mean length 42±15mm), in one case a stent implantation was needed. The success rate was 100% without vascular complications at 1-month clinical and vascular doppler follow-up. CONCLUSIONS: Radial/ulnar artery angioplasty is feasible and safe in selected patients undergoing elective angiography or percutaneous coronary intervention using complex forearm approach.

Detection of spontaneous coronary artery spasm with optical coherence tomography in a patient with acute coronary syndrome.

We present 2 illustrative cases of acute coronary syndrome and spontaneous coronary artery spasm evaluated by optical coherence tomography. Different spasm patterns were showed by optical coherence tomography (OCT), according to whether there were underlying atherosclerotic plaques or not.

Bioresorbable Scaffolds in Spontaneous Coronary Artery Dissection: Long-Term Follow-Up in 4 Patients.

Spontaneous coronary artery dissection is a rare condition, and diagnosis and treatment are challenging among patients who present with acute coronary syndrome. Typically, the condition affects young females who have no underlying atherosclerotic disease. To date, few cases of bioresorbable scaffold implantation for the treatment of spontaneous coronary artery dissection have been reported. Therefore, we describe the cases of 4 patients whom we treated with scaffolds. We evaluated the long-term results by using intravascular ultrasound and optical coherence tomographic scanning.

Utility of 3D-OCT Imaging With Angiographic Co-Registration in Acute Coronary Syndrome With Normal or Near-Normal Coronary Arteries.

The OPTIS integrated system (St. Jude Medical) is a new technology allowing the online co-registration of optical coherence tomography (OCT) images with the angiogram in the catheterization laboratory. Additionally, 3D navigation can be performed. This integration of OCT information on an angiographic roadmap could find broad application in the characterization of substrates causing acute coronary syndromes with normal or near-normal coronary arteries. The utility of OCT with co-registration for the guidance of percutaneous coronary intervention could be considerable in the management of patients with acute coronary syndromes.