Randomized trial of effect of bariatric surgery on blood pressure after 5 years

BACKGROUND: Obesity represents a major obstacle for controlling hypertension, the leading risk factor for cardiovascular mortality. OBJECTIVES: The purpose of this study was to determine the long-term effects of bariatric surgery on hypertension control and remission. METHODS: We conducted a randomized clinical trial with subjects with obesity grade 1 or 2 plus hypertension using at least 2 medications. We excluded subjects with previous cardiovascular events and poorly controlled type 2 diabetes. Subjects were assigned to Roux-en-Y gastric bypass (RYGB) combined with medical therapy (MT) or MT alone. We reassessed the original primary outcome (reduction of at least 30% of the total antihypertensive medications while maintaining blood pressure levels <140/90 mm Hg) at 5 years. The main analysis followed the intention-to-treat principle. RESULTS: A total of 100 subjects were included (76% women, age 43.8 ± 9.2 years, body mass index: 36.9 ± 2.7 kg/m2). At 5 years, body mass index was 36.40 kg/m2 (95% CI: 35.28-37.52 kg/m2) for MT and 28.01 kg/m2 (95% CI: 26.95-29.08 kg/m2) for RYGB (P < 0.001). Compared with MT, RYGB promoted a significantly higher rate of number of medications reduction (80.7% vs 13.7%; relative risk: 5.91; 95% CI: 2.58-13.52; P < 0.001) and the mean number of antihypertensive medications was 2.97 (95% CI: 2.33-3.60) for MT and 0.80 (95% CI: 0.51-1.09) for RYGB (P < 0.001). The rates of hypertension remission were 2.4% vs 46.9% (relative risk: 19.66; 95% CI: 2.74-141.09; P < 0.001). Sensitivity analysis considering only completed cases revealed consistent results. Interestingly, the rate of apparent resistant hypertension was lower after RYGB (0% vs 15.2%). CONCLUSIONS: Bariatric surgery represents an effective and durable strategy to control hypertension and related polypharmacy in subjects with obesity. (GAstric bypass to Treat obEse Patients With steAdy hYpertension [GATEWAY]; NCT01784848).

Sirolimus-coated balloon with a microsphere-based technology for the treatment of de novo or restenotic coronary lesions

BACKGROUND: Non stent-based local drug delivery with drug-coated balloon (DCB) is an alternative to drug-eluting stent with favorable clinical applicability in the treatment of selected coronary lesions. Our purpose was to report the initial performance, safety and efficacy evaluations of a novel sirolimus-coated balloon in the treatment of coronary lesions. METHODS: This was a phase I (first-in-man), prospective, multicenter, single-arm trial evaluating the novel SELUTION SLR™ DCB (M.A. Med Alliance SA, Nyon, Switzerland), which incorporates a polymeric microsphere-based technology for controlled and continuous release of sirolimus, in the treatment of de novo or restenotic lesions. RESULTS: A total of 56 patients/lesions were enrolled between November/2018 and March/2019. Diabetes was found in 46.6 %, and de novo lesions represented 79.6 % of cases. Device and procedural/clinical success were 100 % and 96.4 %, respectively. There was only one major adverse cardiac event (target lesion revascularization) reported at late follow-up. By quantitative coronary angiography analysis, mean % diameter stenosis was 30.5 ± 16.7 %, late lumen loss was 0.26 ± 0.45 mm and angiographic binary restenosis occurred in 4 of 45 cases at 6-month angiographic follow-up. CONCLUSION: The novel SELUTION sirolimus-coated balloon demonstrated safety and efficacy in the treatment of diseased coronary vessels, including absence of mortality and relatively low late lumen loss at late follow-up.

High risk coronavirus disease 2019: The primary results of the CoronaHeart multi-center cohort study

BACKGROUND: Patients with Coronavirus Disease 2019 (COVID-19) may present high risk features during hospitalization, including cardiovascular manifestations. However, less is known about the factors that may further increase the risk of death in these patients. METHODS: We included patients with COVID-19 and high risk features according to clinical and/or laboratory criteria at 21 sites in Brazil from June 10th to October 23rd of 2020. All variables were collected until hospital discharge or in-hospital death. RESULTS: A total of 2546 participants were included (mean age 65 years; 60.3% male). Overall, 70.8% were admitted to intensive care units and 54.2% had elevated troponin levels. In-hospital mortality was 41.7%. An interaction among sex, age and mortality was found (p = 0.007). Younger women presented higher rates of death than men (30.0% vs 22.9%), while older men presented higher rates of death than women (57.6% vs 49.2%). The strongest factors associated with in-hospital mortality were need for mechanical ventilation (odds ratio [OR] 8.2, 95% confidence interval [CI] 5.4­12.7), elevated C-reactive protein (OR 2.3, 95% CI 1.7­2.9), cancer (OR 1.8, 95 %CI 1.2­2.9), and elevated troponin levels (OR 1.8, 95% CI 1.4­2.3). A risk score was developed for risk assessment of in-hospital mortality. CONCLUSIONS: This cohort showed that patients with COVID-19 and high risk features have an elevated rate of in-hospital mortality with differences according to age and sex. These results highlight unique aspects of this population and might help identifying patients who may benefit from more careful initial surveillance and potential subsequent interventional therapies

Renal denervation for the treatment of ventricular arrhythmias: A systematic review and meta-analysis

INTRODUCTION: Ventricular arrhythmias (VAs) are a major cause of morbidity and mortality in patients with heart disease. Recent studies evaluated the effect of renal denervation (RDN) on the occurrence of VAs. We conducted a systematic review and meta-analysis to determine the efficacy and safety of this procedure. METHODS AND RESULTS: A systematic search of the literature was performed to identify studies that evaluated the use of RDN for the management of VAs. Primary outcomes were reduction in the number of VAs and implantable cardioverter-defibrillator (ICD) therapies. Secondary outcomes were changes in blood pressure and renal function. Ten studies (152 patients) were included in the meta-analysis. RDN was associated with a reduction in the number of VAs, antitachycardia pacing, ICD shocks, and overall ICD therapies of 3.53 events/patient/month (95% confidence interval [CI] = -5.48 to -1.57), 2.86 events/patient/month (95% CI = -4.09 to -1.63), 2.04 events/patient/month (95% CI = -2.12 to -1.97), and 2.68 events/patient/month (95% CI = -3.58 to -1.78), respectively. Periprocedural adverse events occurred in 1.23% of patients and no significant changes were seen in blood pressure or renal function. CONCLUSIONS: In patients with refractory VAs, RDN was associated with a reduction in the number of VAs and ICD therapies, and was shown to be a safe procedure.

Optical coherence tomography versus intravascular ultrasound and angiography to guide percutaneous coronary interventions: the iSIGHT Randomized Trial

BACKGROUND: Specific algorithms for use of optical coherence tomography (OCT) to guide percutaneous coronary intervention (PCI) are scarce. Also, the relative benefits of intravascular imaging guidance have not been tested against an optimized angiography-guided PCI strategy. In iSIGHT (Optical Coherence Tomography Versus Intravascular Ultrasound and Angiography to Guide Percutaneous Coronary Interventions), we aimed to investigate whether OCT-guided PCI achieves noninferior stent expansion compared with intravascular ultrasound (IVUS) guidance and if both imaging modalities lead to superior stent expansion compared with an optimized angiography-based strategy. METHODS: Patients ≥18 years old undergoing PCI for ≥1 lesion in native coronaries of 2.25 to 4.00 mm in diameter were randomized 1:1:1 to OCT-, IVUS-, or angiography-guided PCI. Predetermined guidance protocols were applied in all groups. An external elastic membrane­based protocol was used for stent sizing by OCT and IVUS. The primary end point was noninferiority of stent expansion (minimum stent area ≥90% of the average reference lumen area), measured by post-PCI OCT, in OCT-guided versus IVUS-guided PCI (noninferiority margin, 6.5%). RESULTS: One hundred fifty-one patients (156 lesions) were randomly allocated to OCT (51 lesions [32.7%]), IVUS (52 lesions [33.3%]), or angiography (53 lesions [34.0%]). Stent expansion with OCT guidance (98.01±16.14%) was noninferior to IVUS (91.69±15.75%; 1-sided lower 95% CI, 0.55 mm2; Pnon-inferiority<0.001) and superior to angiography (90.53±14.84%, P=0.041). IVUS and angiography obtained similar stent expansions (P=0.921). Stent edge dissection and periprocedural complication rates were not significantly different among the groups. CONCLUSIONS: Stent expansion with OCT guidance using a dedicated external elastic membrane­based sizing strategy was noninferior to that achieved with IVUS and superior to an optimized angiographic strategy.

Three-Year Outcomes of Bariatric Surgery in Patients With Obesity and Hypertension: A Randomized Clinical Trial

Hypertension is a leading cause of cardiovascular mortality (1). Its unfavorable impact is potentially explained by several factors, including the asymptomatic nature of this condition, poor medication adherence, and high burden of comorbid conditions, including obesity (1, 2). Hypertension occurs mostly in persons with excess weight and is often poorly controlled in patients with obesity (3, 4), and pharmacologic treatment of obesity has modest impact on blood pressure (BP) reduction (5). Bariatric surgery is the most effective method to treat obesity (6 ­ 8). Although recent research efforts have focused on metabolic improvement and diabetes resolution (9 ­12), growing interest has been devoted to evaluating the effects of this surgery on hypertension (13­15). The GATEWAY (Gastric Bypass to Treat Obese Patients With Steady Hypertension) trial focused on hypertension and included patients with mild obesity (body mass index [BMI], 30 to 34.9 kg/m2 ) and those with a BMI greater than 35 kg/m2 per current guidelines. The 1-year results showed that patients with coexisting obesity and hypertension were able to reduce or completely discontinue their antihypertensive medications after surgery, while maintaining a controlled BP and a similar 24-hour BP profile (16, 17). However, midterm effects of bariatric surgery on office and 24-hour BP measurements in a broad population of patients with obesity and hypertension remain uncertain. Here, we present the 3-year results from the GATEWAY trial. METHODS The GATEWAY trial is a randomized, nonblinded, single-center, investigator-initiated clinical trial performed at Heart Hospital in Sa˜ o Paulo, Brazil. Study design (18) and 1-year results (16) were previously pub lished; the full protocol, approved by the Research Ethics Board at the Heart Hospital (HCor), and the statistical analysis plan are available in Supplements 1 and 2 (available at Annals.org). The follow-up period for the primary end point was 12 months, but we prespecified that all patients would be scheduled for a 3-year and 5-year extension study. Here, we present the 3-year outcomes.

Comparação randomizada de intervenções coronárias percutâneas guiadas por tomografia de coerência óptica versus ultrassom intravascular versus angiografia. Estudo randomizado ISIGHT / Randomized comparison of percutaneous coronary interventions guided by optical coherence tomography versus intravascular ultrasound versus angiography. ISIGHT Randomized Study

INTRODUÇÃO: Intervenção coronária percutânea (ICP) guiada por ultrassom intracoronário (USIC) associou-se com menor ocorrência de eventos adversos em comparação com ICP guiada por angiografia. A tomografia de coerência óptica (TCO) possui resolução 10 vezes maior que a do USIC. No entanto, seu papel como guia de ICP foi pouco estudado. Nosso objetivo primário é avaliar a não inferioridade da ICP guiada por TCO em comparação com a guia por USIC quanto ao desfecho primário de expansão dos stents ao final do procedimento de ICP. MÉTODOS: Pacientes com ≥ 1 lesão em coronárias nativas com 2,25-4,0 mm de diâmetro, foram randomizados (1:1:1), em blocos de 9, para ICP guiada por angiografia, USIC, e TCO. Com um α unicaudal de 0,05 e margem de não inferioridade de 6,85% para expansão dos stents, 150 pacientes (50 em cada grupo) fornece poder de 80% para investigar a não inferioridade da ICP guiada por TCO em comparação com guia por USIC. Caso a não inferioridade fosse alcançada para o desfecho primário, testamos, de forma hierárquica, a superioridade da ICP guiada por TCO vs. ICP guiada por USIC e angiografia, e ICP guiada por USIC vs. ICP guiada por angiografia. RESULTADOS: 151 pacientes foram randomizados para ICP guiada por TCO (n=51), USIC (n=51) e angiografia (n=49). A área mínima do stent pós-ICP foi semelhante entre os grupos (TCO: 7,18 ± 2,66 mm vs. USIC: 6,97 ± 2,09 mm vs. angiografia: 7,26 ± 2,48 mm, p=0.820). A expansão dos stents foi 98,01 ± 16,14% nas ICP guiadas por TCO, 91,69 ± 15,75% nas guiadas por USIC e 90,53 ± 14,84% nas guiadas por angiografia (p=0.035). Expansões obtidas sob guia da TCO foram não inferiores às obtidas com USIC (diferença TCO-USIC: 7,00; IC 95%: -0,39 a 14,39, p<0,001). Na análise hierárquica, expansão por TCO foi superior à angiografia (p=0,041), mas não superior ao USIC (p=0,067). ICP guiada por USIC não foi superior à guiada por angiografia (p=0.923). O porcentual de hastes dos stents mal apostas foi menor em ICP guiadas por TCO (TCO: 1.74 ± 1.49% vs. USIC: 3.35 ± 4.03% vs. angiografia: 4.20 ± 6.85%, p=0.035). Não houve diferença significativa quanto à ocorrência de dissecção de bordas (TCO: 15,7% vs. USIC: 15,7% vs. angiografia: 22,6%, p=0,610), e complicações dos procedimentos. CONCLUSÕES: ICP guiada por TCO gerou expansão dos stents não inferiores às obtidas com USIC, e superiores às obtidas por angiografia, com melhor aposição das hastes e sem aumento de complicações. Estes resultados indicam que TCO pode ser utilizada com segurança para guiar ICP. Seu impacto clínico deve ser futuramente investigado. (AU)

Effect of a multifaceted quality improvement intervention on the prescription of evidence based treatment in patients at high cardiovascular risk in Brazil The BRIDGE Cardiovascular Prevention Cluster Randomized Clinical Trial

RESULTS Of the 1619 included patients,1029 (63.6%) weremale,1327(82.0%) had coronary artery disease (843[52.1%] with prioracutemyo cardial infarction),355(21.9%)had priorischemicstroke ortransientischemicattack,and197 (12.2%) had peripheral vascular disease,andthemean( SD) age was 65.6 (10.5) years. Among randomized clusters, 30 (75%) were cardiology sites, 6 (15%) were primary careunits,and 26 (65%) were teaching institutions.Amonge ligible patients,thosein intervention clusters were more like ly to receive aprescription of evidence-based therapies thant hose in control clusters (73.5%[515of701] vs58.7% [493of840];oddsratio,2.30;95%CI,1.14-4.65). There were no differences between the intervention and control group swithregard storisk factor control(ie,hyperlipidemia,hypertension,ordiabetes).Ratesofeducationforsmokingcessationwere higher among current smokers in the intervention group thanin the control group (51.9%[364of701] vs18.2%[153of840];oddsratio,11.24;95%CI,2.20-57.43).Therateofcardiovascularmortality,acute myocardial infarction,andstrokewas2.6%for patients from intervention cluster sand 3.4%forthose in the control group (hazardratio, 0.76;95%CI,0.43-1.34). (AU)

Effects of bariatric surgery versus medical therapy on the 24-hour ambulatory blood pressure and the prevalence of resistant hypertension

Bariatric surgery is an effective strategy for blood pressure (BP) reduction, but most of the evidence relies on office BP measurements. In this study, we evaluated the impact of bariatric surgery on 24-hour BP profile, BP variability, and resistant hypertension prevalence. This is a randomized trial including obese patients with grade 1 and 2 using at least 2 antihypertensive drugs at maximal doses or >2 at moderate doses. Patients were allocated to either Roux-en-Y Gastric Bypass (RYGB) combined with medical therapy or medical therapy alone for 12 months. The primary outcome was the 24-hour BP profile and variability (average real variability of daytime and night time BP). We evaluated the nondipping status and prevalence of resistant hypertension as secondary end points. We included 100 patients (76% female, body mass index, 36.9±2.7 kg/m2). The 24-hour BP profile (including nondipping status) was similar after 12 months, but the RYGB group required less antihypertensive classes as compared to the medical therapy alone (0 [0­1] versus 3 [2.5­4] classes; P<0.01). The average real variability of systolic nighttime BP was lower after RYGB as compared to medical therapy (between-group difference, −1.63; 95% CI, −2.91 to −0.36; P=0.01). Prevalence of resistant hypertension was similar at baseline (RYGB, 10% versus MT, 16%; P=0.38), but it was significantly lower in the RYGB at 12 months (0% versus 14.9%; P<0.001). In conclusion, RYGB significantly reduced antihypertensive medications while promoting similar 24-hour BP profile and nondipping status. Interestingly, bariatric surgery improved BP variability and may decrease the burden of resistant hypertension associated with obesity. (AU)

Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T types of lymphocytes evaluation in acute myocardial infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial

BACKGROUND: Early reperfusion of the occluded coronary artery during acute myocardial infarction is considered crucial for reduction of infarcted mass and recovery of ventricular function. Effective microcirculation and the balance between protective and harmful lymphocytes may have roles in reperfusion injury and may affect final ventricular remodeling. METHODS/DESIGN: BATTLE-AMI is an open-label, randomized trial comparing the effects of four therapeutic strategies (rosuvastatin/ticagrelor, rosuvastatin/clopidogrel, simvastatin plus ezetimibe/ticagrelor, or simvastatin plus ezetimibe/clopidogrel) on infarcted mass and left ventricular ejection fraction (LVEF) (blinded endpoints) in patients with ST-segment elevation myocardial infarction submitted to fibrinolytic therapy before coronary angiogram (pharmacoinvasive strategy). All patients (n = 300, 75 per arm) will be followed up for six months. The effects of treatment on subsets of B and T lymphocytes will be determined by flow-cytometry/ELISPOT and will be correlated with the infarcted mass, LVEF, and microcirculation perfusion obtained by cardiac magnetic resonance imaging. The primary hypothesis is that the combined rosuvastatin/ticagrelor therapy will be superior to other therapies (particularly for the comparison with simvastatin plus ezetimibe/clopidogrel) for the achievement of better LVEF at 30 days (primary endpoint) and smaller infarcted mass (secondary endpoint) at 30 days and six months...

Diabetes and cardiovascular events in high-risk patients: Insights from a multicenter registry in a middle-income country

AIMS:The aim of this study was to determine the rate of major clinical events and its determinants in patients with previous cardiovascular event or not, and with or without diabetes from a middle-income country.METHODS:REACT study is a multicenter registry conducted between July 2010 and May 2013 in Brazil. Patients were eligible if they were over 45years old and high cardiovascular risk. Patients were followed for 12months; data were collected regarding adherence to evidence-based therapies and occurrence of clinical events (all-cause mortality, non-fatal cardiac arrest, myocardial infarction, or stroke).

Desfechos clínicos tardios de pacientes diabéticos tratados com stents farmacológicos eluidores de sirolimus ou everolimus: uma análise do registro DESIRE / Late clinical outcomes of diabetic patients treated with sirolimus or everolimus drug-eluting stents: an analysis of the DESIRE registry

Stents farmacológicos (SF) de segunda geração demonstraram melhor desempenho clínico que os de primeira geração, sobretudo pela redução nas taxas de trombose, mas ainda não está claro se esse benefício se estende a diabéticos da prática diária. Objetivamos comparar o desempenho de pacientes diabéticos não selecionados tratados com SF eluidores de sirolimus (SES; primeira geração) vs. SF eluidoresde everolimus (SEE; segunda geração).Métodos: Entre 2007 e 2014, 798 diabéticos foram tratados com SES (n = 414) ou SEE (n = 384) e incluídosnesta análise. Seguimento clínico tardio foi obtido em 99,4% da população e os grupos foram comparados quanto à ocorrência de eventos cardíacos adversos maiores (ECAM) e trombose de stent. Resultados: A idade da população foi semelhante, com predomínio do sexo masculino. Em ambas as coortes, a apresentação clínica mais frequente foi a doença coronária estável. Número de vasos tratados (1,50 ± 0,62 vs. 1,52 ± 0,72; p = 0,88) e extensão total de stents (36,1 ± 20,4 mm vs. 37,7 ± 22,2 mm; p = 0,32) foram semelhantes. Os pacientes tratados com SEE apresentaram menores taxas de ECAM (15% vs. 6,8%; p < 0,001), sobretudo à custa de menor mortalidade cardíaca (5,3% vs. 1,3%; p < 0,001). Observou-se também menor ocorrência de trombose de stent definitiva/provável com SF de segunda geração (3,4% vs. 0,5%; p = 0,004).Conclusões: Nesta experiência unicêntrica, o uso de SEE em diabéticos mostrou-se com menor mortalidadecardíaca e trombose da endoprótese. Esse benefício se fez mais evidente no seguimento mais tardio...

Despite the better clinical performance of second-generation drug-eluting stents (DES)when compared to first-generation DES in controlled trials, mainly due to reduction in thrombosis rate, it remains unclear whether this benefit extends to diabetic patients treated in the daily practice. We sought to compare the clinical outcomes of unselected diabetic patients treated with either sirolimus eluting stents - SES (first-generation DES) or everolimus-eluting stents - EES (second-generation DES). Methods: Between January 2007 and October 2014 a total of 798 diabetic patients were treated with SES(n = 414) and EES (n = 384). Long-term clinical follow-up was achieved in 99,4% of the population andthe groups were compared regarding the occurrence of major adverse cardiac events (MACE) and stent thrombosis. Results: In both cohorts age was similar, and most patients were male. Stable coronary disease was the most frequent clinical presentation. The number of treated vessels (1.50 ± 0.62 vs. 1.52 ± 0.72; p = 0.88)and the total stent length (36.1 ± 20.4 vs. 37.7 ± 22.2 mm; p = 0.32) were similar between groups. Patients treated with EES showed lower rates of MACE (15% vs. 6.8%, p < 0.001), mainly due to a lower cardiac death(5.3% vs. 1.3%, p < 0.001). There was also less definitive/ probable thrombosis with the second generation DES (3.4% vs. 0.5%, p = 0.004)...

Vessel remodeling and plaque distribution in side branchof complex coronary bifurcation lesions: a grayscaleintravascular ultrasound study

To investigate vessel remodeling and plaquedistribution in side branch (SB) of true coronary bifurcationlesions with SB disease extending from its ostium. A total of62 patients with single de novo true bifurcation lesions withSB with severe and extensive disease were enrolled. Of that,45 patients/lesions underwent pre-intervention intravascularultrasound (IVUS) at the SB. Left anterior descending wasthe most prevalent target vessel ([85 %). All lesions hadsignificant involvement of both branches of the bifurcation,and the majority were classified as type 1,1,1 according to theMedina classification. Considering the subset with IVUSimaging, mean lesion length, reference diameter and %diameter stenosis in the SB were 8.88 ± 4.61 mm,2.68 ± 0.59, and 70.2 ± 16.0 %, respectively. Also, meanproximal (take-off) and distal (carina) angles were142.3 ± 21.9 and 60.7 ± 22.4 , respectively. At minimumlumena area (MLA) site, mean external elastic membraneand MLA cross-sectional areas were 6.70 ± 2.08 and1.87 ± 0.93 mm2, respectively; given that the mean distancemeasured between the SB origin and MLA site was/1 mm. In addition, mean plaque burden was 67.9 % andmean remodeling index was 0.78 ± 0.21. Importantly, only9 cases out of 45 presented remodeling index [1.0.Also, plaque distribution analysis within the SB ostium demonstrated preferable plaque positioning in the oppositeside to the flow divider. In conclusions, significant negativeremodeling is a frequent encounter in SB of complex coronarybifurcation lesions presenting with extensive and severedisease; in addition, plaque distribution in the SB ostiumappears to be asymmetric in relation to the parent vessel, asplaque burden is mostly found in regions of low wall shearstress including the opposite side to the flow divider withinthe bifurcation anatomy.