Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19.

BACKGROUND: Prior studies of therapeutic-dose anticoagulation in patients with COVID-19 have reported conflicting results. OBJECTIVES: We sought to determine the safety and effectiveness of therapeutic-dose anticoagulation in noncritically ill patients with COVID-19. METHODS: Patients hospitalized with COVID-19 not requiring intensive care unit treatment were randomized to prophylactic-dose enoxaparin, therapeutic-dose enoxaparin, or therapeutic-dose apixaban. The primary outcome was the 30-day composite of all-cause mortality, requirement for intensive care unit-level of care, systemic thromboembolism, or ischemic stroke assessed in the combined therapeutic-dose groups compared with the prophylactic-dose group. RESULTS: Between August 26, 2020, and September 19, 2022, 3,398 noncritically ill patients hospitalized with COVID-19 were randomized to prophylactic-dose enoxaparin (n = 1,141), therapeutic-dose enoxaparin (n = 1,136), or therapeutic-dose apixaban (n = 1,121) at 76 centers in 10 countries. The 30-day primary outcome occurred in 13.2% of patients in the prophylactic-dose group and 11.3% of patients in the combined therapeutic-dose groups (HR: 0.85; 95% CI: 0.69-1.04; P = 0.11). All-cause mortality occurred in 7.0% of patients treated with prophylactic-dose enoxaparin and 4.9% of patients treated with therapeutic-dose anticoagulation (HR: 0.70; 95% CI: 0.52-0.93; P = 0.01), and intubation was required in 8.4% vs 6.4% of patients, respectively (HR: 0.75; 95% CI: 0.58-0.98; P = 0.03). Results were similar in the 2 therapeutic-dose groups, and major bleeding in all 3 groups was infrequent. CONCLUSIONS: Among noncritically ill patients hospitalized with COVID-19, the 30-day primary composite outcome was not significantly reduced with therapeutic-dose anticoagulation compared with prophylactic-dose anticoagulation. However, fewer patients who were treated with therapeutic-dose anticoagulation required intubation and fewer died (FREEDOM COVID [FREEDOM COVID Anticoagulation Strategy]; NCT04512079).

SYNTAX Score in Patients With Diabetes Undergoing Coronary Revascularization in the FREEDOM Trial.

BACKGROUND: Diabetes mellitus (DM) is associated with complex coronary artery disease (CAD), which in turn results in increased morbidity and mortality from cardiovascular disease. OBJECTIVES: This study sought to evaluate the utility of SYNTAX score (SS) for predicting future cardiovascular events in patients with DM and complex CAD undergoing either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). METHODS: The FREEDOM (Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease) trial randomized patients with DM and multivessel CAD to undergo either PCI with drug-eluting stents or CABG. The SS was calculated retrospectively by a core laboratory. The endpoint of hard cardiovascular events (HCE) was a composite of death from any cause, nonfatal myocardial infarction, and nonfatal stroke, while the endpoint of major adverse cardiac and cerebrovascular events (MACCE) was a composite of HCE and repeat revascularization. RESULTS: A total of 1,900 patients were randomized to PCI (n = 953) or CABG (n = 947). The SS was considered an independent predictor of 5-year MACCE (hazard ratio per unit of SS: 1.02; 95% confidence interval: 1.00 to 1.03; p = 0.014) and HCE (hazard ratio per unit of SS: 1.03; 95% confidence interval: 1.01 to 1.04; p = 0.002) in the PCI cohort, but not in the CABG group. There was a higher incidence of MACCE in PCI patients with low, intermediate, and high SS compared with those who underwent CABG (36.6% vs. 25.9%, p = 0.02; 43.9% vs. 26.8%, p < 0.001; 48.7% vs. 29.7%, p = 0.003, respectively). CONCLUSIONS: In DM patients with multivessel CAD, the complexity of CAD evaluated by the SS is an independent risk factor for MACCE and HCE only in patients undergoing PCI. The SS should not be utilized to guide the choice of coronary revascularization in patients with DM and multivessel CAD. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).

Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial.

BACKGROUND: The Inspiron™ sirolimus-eluting stent (SES) is a low-dose, ultra-thin-strut cobalt-chromium stent abluminally coated with biodegradable polymers (BP). Previous results from the INSPIRON-I trial, a first-in-man study, have proven the efficacy of the novel stent in reducing neointimal proliferation. The present report aims at evaluating the long-term clinical outcomes of patients enrolled into the INSPIRON-I trial (Clinical Trials Gov. identifier: NCT01093391). METHODS: A total of 57 patients (60 lesions) were randomly allocated in a 2:1 ratio to treatment with the Inspiron™ SES vs. its equivalent Cronus™ bare metal stent (BMS, both by Scitech Medical™, Aparecida de Goiânia, Goiás, Brazil), in four tertiary centers. The primary endpoint of the present analysis was the occurrence of major adverse cardiac events (MACE) [death, myocardial infarction (MI), target vessel revascularization (TVR) and/or target lesion revascularization (TLR)] at 4 years. RESULTS: Baseline clinical and angiographic characteristics of both groups were similar. After 4 years, the primary endpoint occurred in 7.9% vs. 23.5% of patients in Inspiron and control groups respectively (P=0.11). The rate of death/MI was similar between the groups, but there was a significant decrease in the risk of repeat revascularization in the Inspiron group compared to the control arm TLR (0.0% vs. 23.5% respectively, P=0.02). There were no stent thromboses in the study population. CONCLUSIONS: The novel Inspiron™ SES showed a sustained safe and effective clinical profile after 4-year of follow-up, with very low adverse events and null stent thrombosis (ST) occurrence.

Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial

Background: The Inspiron™ sirolimus-eluting stent (SES) is a low-dose, ultra-thin-strut cobalt-chromium stent abluminally coated with biodegradable polymers (BP). Previous results from the INSPIRON-I trial, a first-in-man study, have proven the efficacy of the novel stent in reducing neointimal proliferation. The present report aims at evaluating the long-term clinical outcomes of patients enrolled into the INSPIRON-I trial (Clinical Trials Gov. identifier: NCT01093391).Methods: A total of 57 patients (60 lesions) were randomly allocated in a 2:1 ratio to treatment with the Inspiron™ SES vs. its equivalent Cronus™ bare metal stent (BMS, both by Scitech Medical™, Aparecida de Goiânia, Goiás, Brazil), in four tertiary centers. The primary endpoint of the present analysis was the occurrence of major adverse cardiac events (MACE) [death, myocardial infarction (MI), target vessel revascularization (TVR) and/or target lesion revascularization (TLR)] at 4 years.Results: Baseline clinical and angiographic characteristics of both groups were similar. After 4 years, the primary endpoint occurred in 7.9% vs. 23.5% of patients in Inspiron and control groups respectively (P=0.11)...

First-in-man randomised comparison of a novel sirolimus-eluting stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial.

AIMS: The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy. METHODS AND RESULTS: This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis. CONCLUSIONS: Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.

Long term follow-up of drug eluting versus bare metal stents in the treatment of saphenous vein graft lesions.

INTRODUCTION: The safety and effectiveness of drug-eluting stent (DES) compared with bare metal stents (BMS) for the treatment of saphenous vein graft (SVG) disease is controversial, especially because of the lack of long-term follow-up. The aim of this study was to address the late outcome of DES versus BMS for the treatment of SVG lesions. METHODS: A matched, case-control study included 82 patients in each group. Patients groups were matched by gender, age, clinical presentation, and diabetes. The primary study end point was occurrence of major adverse cardiovascular events (MACE). Secondary end points included death, cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). RESULTS: Clinical and angiographic characteristics were similar between the groups. At 6 months, TVR (hazard ratio [HR] 6.12, 95% confidence interval [CI] 1.39 to 26.93, P = 0.05), and MACE (HR 2.54, 95% CI 1.08 to 5.98, P = 0.04) were higher in the BMS group. At 4 years the risks of MI (P = 0.21), TVR (P = 0.99), and MACE (P = 0.21) were similar between both groups. However, the rates of death (HR 2.74, 95% CI 1.11 to 6.74, P = 0.04) and cardiac death (HR 4.26, 95% CI 1.59 to 11.35, P = 0.01) were significantly higher in the BMS group. CONCLUSIONS: These results suggest that the use of DES compared with BMS in the treatment of SVG lesions reduces TVR and MACE at 6 months of follow-up, a benefit that was lost over the next 3-4 years.

First-in-man randomised comparison of a novel sirolimuselutingstent with abluminal biodegradable polymer and thinstrutcobalt-chromium alloy: INSPIRON-I trial

The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-elutingstent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromiumalloy.Methods and results: This is a randomised, multicentre comparison between Inspiron and a stent with thesame metallic structure but without polymer coating or drug elution (Cronus). The primary objective was toevaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstructionas measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE).Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographiccharacteristics of both groups were similar. At six months, the in-segment LLL was reduced in theInspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), aswell as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidenceof MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesionrevascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis.Conclusions: Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloyproved effective in reducing restenosis at six months.

Pseudoaneurisma: rara complicação do acesso radial / Pseudoaneurysm: a rare complications of radial access

A via radial apresenta menores taxas de complicações vasculares para realização de cinecoronariografia. O pseudoaneurisma da artéria radial é uma complicação rara desse procedimento. O diagnóstico precoce é essencial para evitar complicações como ruptura espontânea, isquemia e síndrome compartimental. Neste relato é descrito um caso de pseudoaneurisma da artéria radial direita após realização de cinecoronariografia eletiva. O diagnóstico foi confirmado por ultrassonografia com Doppler, que evidenciou pseudoaneurisma da artéria radial na face anteromedial do antebraço, medindo 3,7 x 2,5 cm, com colo de 0,7 cm. O tratamento foi feito com curativo compressivo local e nova ultrassonografia com Doppler, realizada 12 horas após, demonstrou resolução do pseudoaneurisma.

The radial approach has lower vascular complication rates for coronary angiography. Radial artery pseudoaneurysm is a rare complication of this procedure. Early diagnosis is essential to avoid complications such as spontaneous rupture, ischemia and compartment syndrome. We describe a case of pseudoaneurysm of the right radial artery after elective coronary angiography. Diagnosis was confirmed by Doppler ultrasound, which revealed a pseudoaneurysm of the radial artery on the anteromedial surface of the forearm, measuring 3.7 x 2.5 cm, with a neck of 0.7 cm. Treatment was done with local compressive dressing and a new Doppler ultrasound, performed 12 hours later, demonstrated resolution of the pseudoaneurysm.

Desfechos tardios da intervenção coronária percutânea com stent farmacológico em pontes de veia safena: dados do Registro InCor / Late percutaneous coronary intervention outcomes with drug-eluting stent in saphenous vein grafts: data from the InCor Registry

Introdução: A segurança e a eficácia do uso de stent farmacológico para o tratamento de lesões em ponte de veia safena (PVS) ainda é motivo de controvérsia. Este estudo avaliou a evolução tardia de pacientes com lesões em PVS tratados com stent farmacológico. Métodos: Registro unicêntrico que incluiu todos os pacientes submetidos a intervenção em PVS com stent farmacológico (n = 82), sem restrições clínicas ou angiográficas, no período de 2003 a 2009. Foram avaliadas as taxas de eventos cardíacos adversos maiores (ECAM), óbito, infarto agudo do miocárdio (IAM), revascularização do vaso-alvo (RVA) e trombose de stent. Resultados: A média de idade foi de 67,8 + 10,2 anos, a maioria era do sexo masculino (85,4%), 40,2% eram diabéticos e 52,4% eram portadores de angina estável. Foi utilizado 1,45 + 0,5 stent por paciente, empregando-se ostent CypherTM na maioria (61%) dos casos. O diâmetro dos stents foi de 3,22 + 0,39 mm e o comprimento, de 20,1 +7,3 mm. A taxa de sucesso angiográfico foi de 96,3%. No seguimento de 4,1 anos, a taxa de ECAM foi de 28%, com 6% de óbito, 19,5% de IAM e 18,2% de RVA. Nesse período ocorreram dois casos de trombose de stent definitiva ou provável (2,4%). Conclusões: Os resultados demonstraram, em seguimento muito tardio, altas taxas de ECAM em pacientes com lesões de PVS tratados com stent farmacológico, provavelmente pelo aspecto mais agressivo da doença vascular em enxertos venosos.

Background: The safety and efficacy of drug-eluting stents in the treatment of saphenous vein graft (SVG) lesions remains controversial. This study assessed the late follow-up of patients with SVG lesions treated with drug-eluting stents. Methods: Single center registry including patients undergoingSVG interventions using drug-eluting stents (n = 82), without clinical or angiographic exclusion criteria, from 2003 to 2009. The rates of major adverse cardiac events (MACE), death, acute myocardial infarction (AMI), target vessel revascularization (TVR) and stent thrombosis were evaluated. Results: Mean age was 67.8 + 10.2 years, most of them were male (85.4%), 40.2% were diabetic and 52.4% had stable angina. An average of 1.45 + 0.5 stents per patient were implanted and CypherTM was the stent used in most ofthe cases (61%). Stent diameter was 3.22 + 0.39 mm and stent length was 20.1 + 7.3 mm. Angiographic success rate was 96.3%. In the 4.1-year follow-up, the rate of MACE was 28%, death 6%, AMI 19.5% and TVR 18.2%. Therewere two cases of definitive or probable stent thrombosis (2.4%) within the follow-up period. Conclusions: Longtermfollow-up showed high MACE rates in patients with SVG lesions treated with drug-eluting stents, probably due tothe accelerated atherosclerosis that develops within the grafted vein conduits.

Infarto agudo do miocárdio complicado por choque cardiogênico: efeito da circulação colateral nos resultados da intervenção coronária percutânea primária: dados do Registro InCor / Acute myocardial infarction complicated by cardiogenic shock: effect of collateral circulation in primary coronary intervention results: data from the InCor Registry

Introdução: A presença de circulação colateral no contexto do infarto agudo do miocárdio (IAM) pode exercer um fator de proteção, levando a menor área de infarto e melhor função ventricular. Este trabalho procurou examinar as características clínicas dos pacientes com diferentes graus de circulação colateral e a influência desta na evolução do IAM com supra desnivelamento de segmento ST (IAMCSST) complicado com choque cardiogênico à admissão hospitalar e tratados com intervenção coronária percutânea (ICP) primária. Métodos: Registro unicêntrico que realizou seguimento prospectivo no período de 2001 a 2009, incluindo105 pacientes divididos em dois grupos, de acordo com o grau de circulação colateral: grupo 1, circulação colateral graus 0/1 (n = 83); e grupo 2, circulação colateral graus 2/3 (n = 22). As características clínicas e angiográficas e os desfechos hospitalares foram comparados entre os grupos. Resultados: Ambos os grupos foram semelhantes em relação às características clínicas, exceto pela menor média de idade (65,9 anos vs. 57,8 anos; P = 0,015) e maior tendência ao tabagismo atual no grupo com colateral graus 2/3 (15,7% vs. 31,8%; P = 0,08). Quanto às características angiográficas, nos indivíduos com colateral graus 2/3 houve maior frequência de lesões/paciente (1,3 lesão vs. 1,8 lesão; P = 0,02) e maior acometimento de bifurcação coronária (18,5% vs. 36,4%; P = 0,03). Na evolução intra-hospitalar ficou evidenciada menor mortalidade nos pacientes com circulação colateral exuberante (49,4% vs. 27,3%, risco relativo de 0,55; P = 0,05). Conclusões: Em pacientes com IAMCSST e choque cardiogênico tratados com ICP primária a presença de circulação colateral pode favorecer um melhor prognóstico na evolução intra-hospitalar.

Background: The presence of collateral circulation in the context of acute myocardial infarction (AMI) may play aprotective role, leading to smaller infarction areas and improvedventricular function. This study was aimed at assessing the clinical characteristics of patients with different degrees of collateral circulation and the effect on outcomes of ST segment elevation AMI (STEMI) complicated by cardiogenic shock at hospital admission and treated by primary percutaneouscoronary intervention (PCI). Methods: Single center registry with a prospective follow-up from 2001 to 2009, including 105 patients divided into two groups, according to the degree of collateral circulation: Group 1, collateral circulationgrades 0/1 (n = 83); and Group 2, collateral circulation grades 2/3 (n = 22). Clinical and angiographic characteristics and hospital outcomes were compared between groups. Results: The clinical characteristics of both groups were similar, except for a lower mean age (65.9 years vs. 57.8years; P = 0.015) and a trend to current smoking in the grade 2/3 group (15.7% vs. 31.8%; P = 0.08). As to angiographiccharacteristics, individuals with grades 2/3 had a higher rate of lesions per patient (1.3 vs. 1.8; P = 0.02) and more bifurcation lesions (18.5% vs. 36.4%; P = 0.03). In-hospital outcomes showed lower mortality in patients with good collateral circulation (49.4% vs. 27.3%, relative risk 0.55; P = 0.05). Conclusions: In patients with STEMI and cardiogenic shock treated by primary PCI, the presence of collateral circulationmay improve in-hospital prognosis.

Stents convencionais de aço inoxidável vs. cromo-cobalto: imapcto clínico da liga metálica no cenário atual - registro InCor / Stainless steel versus cobalt-chromium bare metal stents: clinical impact of the metal alloy in a real world scenario – InCor registry

Introdução: Há alguns anos estudos demonstraram que stents de cromo-cobalto, com hastes mais finas, reduziram de forma expressiva a reestenose coronária, comparativamente aos stents convencionais de aço inoxidável disponíveis na época. Desde então, stents com hastes < 100 µm e diferentes ligas metálicas estão disponíveis para uso clínico. O objetivo deste estudo foi avaliar a existência de diferenças nos resultados clínicos de pacientes submetidos a intervenção coronária percutânea (ICP) com stents de hastes finas e diferentes ligas metálicas. Métodos: Registro unicêntrico, em que foram comparados os resultados de pacientes submetidos a ICP com stent de aço inoxidável (n = 135) vs. stent de cromo-cobalto (n = 181). O desfecho primário foi a ocorrência de eventos cardíacos adversos maiores (ECAM), definidos pela ocorrência de óbito, infarto agudo do miocárdio (IAM) ou revascularização do vaso-alvo (RVA) no seguimento tardio. Resultados: A média de idade dos pacientes foi de 64 ± 11 anos, com 32,6% de diabéticos e 65,5% com síndrome coronária aguda à admissão, sem diferenças na maioria das características clínicas e angiográficas avaliadas entre os grupos. Na comparação das características do procedimento, a estratégia de implante direto do stent foi mais frequente no grupo cromo-cobalto (30,3% vs. 40,2%; P = 0,04). Ao final de mediana de 500 dias de seguimento, não houve diferenças significativas entre os grupos para a ocorrência de ECAM (15,5% vs. 16,5%; P = 0,6), óbito (4,6% vs. 6,8%; P = 0,29), IAM (2,7% vs. 4,1%; P = 0,41) ou RVA (10,4% vs. 10,1%; P = 0,97). Conclusões: Nessa população do mundo real os stents de cromo-cobalto apresentaram eficácia e segurança semelhantes às dos stents de aço inoxidável, porém com menor necessidade de instrumentação coronária.

Background: Years ago studies demonstrated that the use of cobalt-chromium stents with thinner struts significantly reduced coronary restenosis when compared to conventional stainless steel stents available at the time. Since then, stents with struts < 100 μm and different metal alloys are available for clinicaluse. The objective of this study was to assess differences in the clinical outcomes of patients undergoing percutaneous coronary intervention (PCI) with thin strut stents and differentmetal alloys. Methods: Single center registry comparing the results of patients undergoing PCI with stainless steel stents (n = 135) vs. cobalt-chromium bare metal stents (n = 181).The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined by death, acute myocardial infarction (AMI) or target vessel revascularization (TVR) in thelate follow-up. Results: Mean patient age was 64 ± 11 years, 32.6% were diabetic and 65.5% had acute coronary syndrome at admission, with no differences for most of the clinical andangiographic characteristics assessed between groups. The use of direct stenting was more frequent in the cobalt-chromium group (30.3% vs. 40.2%; P = 0.04). After a median of500 days of follow up, there was no statistically significant difference between groups for the occurrence of MACE (15.5% vs. 16.5%; P = 0.6), death (4.6% vs. 6.8%; P = 0.29),AMI (2.7% vs. 4.1%; P = 0.41) or TVR (10.4% vs. 10.1%; P = 0.97). Conclusions: In this real world population, cobaltchromiumstents had similar efficacy and safety when compared to stainless steel stents, but with less coronary instrumentation.