P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial

Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS.

P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial.

Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS. (ClinicalTrials.gov: NCT04360720).

Age-Related Effects of COVID-19 Pandemic on Mechanical Reperfusion and 30-Day Mortality for STEMI: Results of the ISACS-STEMI COVID-19 Registry.

BACKGROUND: The constraints in the management of patients with ST-segment elevation myocardial infarction (STEMI) during the COVID-19 pandemic have been suggested to have severely impacted mortality levels. The aim of the current analysis is to evaluate the age-related effects of the COVID-19 pandemic on mechanical reperfusion and 30-day mortality for STEMI within the registry ISACS-STEMI COVID-19. METHODS: This retrospective multicenter registry was performed in high-volume PPCI centers on four continents and included STEMI patients undergoing PPCI in March-June 2019 and 2020. Patients were divided according to age (< or ≥75 years). The main outcomes were the incidence and timing of PPCI, (ischemia time longer than 12 h and door-to-balloon longer than 30 min), and in-hospital or 30-day mortality. RESULTS: We included 16,683 patients undergoing PPCI in 109 centers. In 2020, during the pandemic, there was a significant reduction in PPCI as compared to 2019 (IRR 0.843 (95%-CI: 0.825-0.861, p < 0.0001). We found a significant age-related reduction (7%, p = 0.015), with a larger effect on elderly than on younger patients. Furthermore, we observed significantly higher 30-day mortality during the pandemic period, especially among the elderly (13.6% vs. 17.9%, adjusted HR (95% CI) = 1.55 [1.24-1.93], p < 0.001) as compared to younger patients (4.8% vs. 5.7%; adjusted HR (95% CI) = 1.25 [1.05-1.49], p = 0.013), as a potential consequence of the significantly longer ischemia time observed during the pandemic. CONCLUSIONS: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a 16% reduction in PPCI procedures, with a larger reduction and a longer delay to treatment among elderly patients, which may have contributed to increase in-hospital and 30-day mortality during the pandemic.

Gender Difference in the Effects of COVID-19 Pandemic on Mechanical Reperfusion and 30-Day Mortality for STEMI: Results of the ISACS-STEMI COVID-19 Registry.

BACKGROUND: Several reports have demonstrated the impact of the COVID-19 pandemic on the management and outcome of patients with ST-segment elevation myocardial infarction (STEMI). The aim of the current analysis is to investigate the potential gender difference in the effects of the COVID-19 pandemic on mechanical reperfusion and 30-day mortality for STEMI patients within the ISACS-STEMI COVID-19 Registry. METHODS: This retrospective multicenter registry was performed in high-volume primary percutaneous coronary intervention (PPCI) centers on four continents and included STEMI patients undergoing PPCIs in March-June 2019 and 2020. Patients were divided according to gender. The main outcomes were the incidence and timing of the PPCI, (ischemia time ≥ 12 h and door-to-balloon ≥ 30 min) and in-hospital or 30-day mortality. RESULTS: We included 16683 STEMI patients undergoing PPCIs in 109 centers. In 2020 during the pandemic, there was a significant reduction in PPCIs compared to 2019 (IRR 0.843 (95% CI: 0.825-0.861, p < 0.0001). We did not find a significant gender difference in the effects of the COVID-19 pandemic on the numbers of STEMI patients, which were similarly reduced from 2019 to 2020 in both groups, or in the mortality rates. Compared to prepandemia, 30-day mortality was significantly higher during the pandemic period among female (12.1% vs. 8.7%; adjusted HR [95% CI] = 1.66 [1.31-2.11], p < 0.001) but not male patients (5.8% vs. 6.7%; adjusted HR [95% CI] = 1.14 [0.96-1.34], p = 0.12). CONCLUSIONS: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a 16% reduction in PPCI procedures similarly observed in both genders. Furthermore, we observed significantly increased in-hospital and 30-day mortality rates during the pandemic only among females. Trial registration number: NCT 04412655.

Effect of randomized prophylactic nitroglycerin on radial artery spasm during transradial catheterization: an analysis based on operator experience

One limitation to transradial access (TRA) is the occurrence of spasms (RAS), for which the use of prophylactic medications is recommended. Improvement in TRA material combined with the increase in operators' expertise, might mitigate this benefit. We assess the effect of preventive nitroglycerin on RAS during TRA, evaluating the role of the operator's experience. Patients received 500 µg nitroglycerin or placebo. The operator's expertise was classified as: inexperienced (I), intermediate (M), and experienced (E). 2040 patients were included. Prophylactic use of nitroglycerin did not reduce RAS (10.8% vs. 13.4% (placebo), p = 0.07). RAS incidence was 14.5% in I, 12.5% in M, and 9.7% in E (p = 0.01). In group I, nitroglycerin reduced RAS (17.4% vs. 11.1%, p = 0.04), which was not observed in other groups. Overall, nitroglycerin does not prevent RAS, which is more common among inexperienced operators. More experienced operators could abolish preventive nitroglycerin use.

Effect of randomized prophylactic nitroglycerin on radial artery spasm during transradial catheterization: An analysis based on operator experience.

One limitation to transradial access (TRA) is the occurrence of spasms (RAS), for which the use of prophylactic medications is recommended. Improvement in TRA material combined with the increase in operators' expertise, might mitigate this benefit. We assess the effect of preventive nitroglycerin on RAS during TRA, evaluating the role of the operator's experience. Patients received 500 µg nitroglycerin or placebo. The operator's expertise was classified as: inexperienced (I), intermediate (M), and experienced (E). 2040 patients were included. Prophylactic use of nitroglycerin did not reduce RAS (10.8% vs. 13.4% (placebo), p = 0.07). RAS incidence was 14.5% in I, 12.5% in M, and 9.7% in E (p = 0.01). In group I, nitroglycerin reduced RAS (17.4% vs. 11.1%, p = 0.04), which was not observed in other groups. Overall, nitroglycerin does not prevent RAS, which is more common among inexperienced operators. More experienced operators could abolish preventive nitroglycerin use.

SARS-CoV-2 Positivity, Stent Thrombosis, and 30-day Mortality in STEMI Patients Undergoing Mechanical Reperfusion.

SARS-Cov-2 has been suggested to promote thrombotic complications and higher mortality. The aim of the present study was to evaluate the impact of SARS-CoV-2 positivity on in-hospital outcome and 30-day mortality in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) enrolled in the International Survey on Acute Coronary Syndromes ST-segment elevation Myocardial Infarction (ISACS-STEMI COVID-19 registry. The 109 SARS-CoV-2 positive patients were compared with 2005 SARS-CoV-2 negative patients. Positive patients were older (P = .002), less often active smokers (P = .002), and hypercholesterolemic (P = .006), they presented more often later than 12 h (P = .037), more often to the hub and were more often in cardiogenic shock (P = .02), or requiring rescue percutaneous coronary intervention after failed thrombolysis (P < .0001). Lower postprocedural Thrombolysis in Myocardial Infarction 3 flow (P = .029) and more thrombectomy (P = .046) were observed. SARS-CoV-2 was associated with a significantly higher in-hospital mortality (25.7 vs 7%, adjusted Odds Ratio (OR) [95% Confidence Interval] = 3.2 [1.71-5.99], P < .001) in-hospital definite in-stent thrombosis (6.4 vs 1.1%, adjusted Odds Ratio [95% CI] = 6.26 [2.41-16.25], P < .001) and 30-day mortality (34.4 vs 8.5%, adjusted Hazard Ratio [95% CI] = 2.16 [1.45-3.23], P < .001), confirming that SARS-CoV-2 positivity is associated with impaired reperfusion, with negative prognostic consequences.

Efeito da nitroglicerina no espasmo e na oclusão da artéria radial em cateterismos transradiais realizados em mulheres / Effect of nitroglycerin on radial artery spasm and occlusion in transradial catheterizations performed in women

Introdução: O benefício do cateterismo transradial já foi confirmado em pacientes do sexo feminino. Mulheres submetidas a exames por cateterismo transradial apresentam desafios únicos. A ocorrência de espasmo e oclusão da artéria radial após o procedimento é maior em mulheres. Objetivamos avaliar o benefício da nitroglicerina na redução de espasmo e oclusão da artéria radial em mulheres submetidas a cateterismo transradial. Métodos: Estudo multicêntrico, prospectivo, randomizado 2x2 fatorial, duplo-cego. Participantes foram randomizados para nitroglicerina 500mcg ou placebo em dois momentos: após colocação do introdutor hemostático e antes da retirada. A avaliação de espasmo da artéria radial foi clínica, por meio de escala dor. A avaliação da oclusão da artéria radial foi realizada com Doppler, nas primeiras 12 horas. Resultados: Foram incluídos 2.040 pacientes, sendo 774 (37,5%) mulheres. A média de idade foi similar entre os sexos (62,2 anos versus 61,5 anos; p=0,27). A incidência de espasmo da artéria radial foi maior nas mulheres (21,2% versus 6,6%; p<0,01), bem como a incidência de oclusão da artéria radial (3,4% versus 1,8%; p=0,03). O uso da nitroglicerina no início do procedimento não reduziu a incidência de espasmo da artéria radial em mulheres quando comparado com o placebo (19,7% versus 22,6%; p=0,34), tampouco as taxas de oclusão da artéria radial (4,3% versus 2,5%; p=0,17). O uso da nitroglicerina ao fim do procedimento não reduziu a incidência de oclusão da artéria em mulheres (2,8% versus 3,9%; p=0,37). Conclusões: O espasmo e a oclusão da artéria radial são mais frequentes em mulheres submetidas a cateterismo transradial quando comparadas aos homens. O uso da nitroglicerina não apresenta efeito benéfico na redução dessas incidências.

Background: The benefit of transradial catheterization is well established in female patients. Women undergoing transradial catheterization exams present with unique challenges. The occurrence of radial artery spasm and occlusion after the procedure is higher in women. The objective of this study was to evaluate the benefit of nitroglycerin in reducing radial artery spasm and occlusion in women undergoing transradial catheterization. Methods: This was a 2x2 factorial randomized, multicenter, prospective, double-blinded study. Participants were randomized to nitroglycerin 500mcg or placebo at two time points: after placement of the hemostatic introducer and before its removal. The evaluation of the radial artery spasm was clinical, using a pain scale The evaluation of the radial artery occlusion was performed with Doppler, in the first 12 hours. Results: A total of 2,040 patients were included, of which 774 (37.5%) were female. Mean age was similar between sexes (62.2 years versus 61.5 years; p=0.27). The incidence of radial artery spasm was higher in women (21.2% versus 6.6%; p<0.01), as well as the incidence of radial artery occlusion (3.4% versus 1.8%; p=0.03). The use of nitroglycerin at the beginning of the procedure did not reduce the incidence of radial artery spasm in women when compared with placebo (19.7% versus 22.6%; p=0.34), nor did the rates of radial artery occlusion (4.3% versus 2.5%; p=0.17). The use of nitroglycerin at the end of the procedure did not reduce the incidence of artery occlusion in women (2.8% versus 3.9%; p=0.37). Conclusions: Radial artery spasm and occlusion are more frequent in women undergoing transradial catheterization when compared to men. The use of nitroglycerin does not have a beneficial effect in reducing these incidences.

Impact of Smoking Status on Mortality in STEMI Patients Undergoing Mechanical Reperfusion for STEMI: Insights from the ISACS-STEMI COVID-19 Registry.

The so-called "smoking paradox", conditioning lower mortality in smokers among STEMI patients, has seldom been addressed in the settings of modern primary PCI protocols. The ISACS−STEMI COVID-19 is a large-scale retrospective multicenter registry addressing in-hospital mortality, reperfusion, and 30-day mortality among primary PCI patients in the era of the COVID-19 pandemic. Among the 16,083 STEMI patients, 6819 (42.3%) patients were active smokers, 2099 (13.1%) previous smokers, and 7165 (44.6%) non-smokers. Despite the impaired preprocedural recanalization (p < 0.001), active smokers had a significantly better postprocedural TIMI flow compared with non-smokers (p < 0.001); this was confirmed after adjustment for all baseline and procedural confounders, and the propensity score. Active smokers had a significantly lower in-hospital (p < 0.001) and 30-day (p < 0.001) mortality compared with non-smokers and previous smokers; this was confirmed after adjustment for all baseline and procedural confounders, and the propensity score. In conclusion, in our population, active smoking was significantly associated with improved epicardial recanalization and lower in-hospital and 30-day mortality compared with previous and non-smoking history.

Impact of chronic obstructive pulmonary disease on short-term outcome in patients with ST-elevation myocardial infarction during COVID-19 pandemic: insights from the international multicenter ISACS-STEMI registry.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is projected to become the third cause of mortality worldwide. COPD shares several pathophysiological mechanisms with cardiovascular disease, especially atherosclerosis. However, no definite answers are available on the prognostic role of COPD in the setting of ST elevation myocardial infarction (STEMI), especially during COVID-19 pandemic, among patients undergoing primary angioplasty, that is therefore the aim of the current study. METHODS: In the ISACS-STEMI COVID-19 registry we included retrospectively patients with STEMI treated with primary percutaneous coronary intervention (PCI) between March and June of 2019 and 2020 from 109 high-volume primary PCI centers in 4 continents. RESULTS: A total of 15,686 patients were included in this analysis. Of them, 810 (5.2%) subjects had a COPD diagnosis. They were more often elderly and with a more pronounced cardiovascular risk profile. No preminent procedural dissimilarities were noticed except for a lower proportion of dual antiplatelet therapy at discharge among COPD patients (98.9% vs. 98.1%, P = 0.038). With regards to short-term fatal outcomes, both in-hospital and 30-days mortality occurred more frequently among COPD patients, similarly in pre-COVID-19 and COVID-19 era. However, after adjustment for main baseline differences, COPD did not result as independent predictor for in-hospital death (adjusted OR [95% CI] = 0.913[0.658-1.266], P = 0.585) nor for 30-days mortality (adjusted OR [95% CI] = 0.850 [0.620-1.164], P = 0.310). No significant differences were detected in terms of SARS-CoV-2 positivity between the two groups. CONCLUSION: This is one of the largest studies investigating characteristics and outcome of COPD patients with STEMI undergoing primary angioplasty, especially during COVID pandemic. COPD was associated with significantly higher rates of in-hospital and 30-days mortality. However, this association disappeared after adjustment for baseline characteristics. Furthermore, COPD did not significantly affect SARS-CoV-2 positivity. TRIAL REGISTRATION NUMBER: NCT04412655 (2nd June 2020).

Efeito da nitroglicerina no espasmo e oclusão da artéria radial em cateterismos transradiais realizados em mulheres / Effect of nitroglycerin on radial artery spasm and occlusion in transradial catheterizations performed in women

INTRODUÇÃO: O benefício do cateterismo por acesso transradial (ATR) já foi confirmado em pacientes do sexo feminino. As mulheres submetidas a exames por esta via de acesso apresentam desafios únicos, geralmente relacionados a um menor calibre arterial. A ocorrência de espasmo (EAR) e oclusão da artéria (OAR) após o procedimento também são descritas como maiores em mulheres. OBJETIVOS Avaliar o benefício do uso de nitroglicerina na redução de EAR e OAR em mulheres submetidas a ATR. MÉTODOS: Estudo multicêntrico, prospectivo, randomizado 2x2 fatorial, duplo-cego. Participantes foram randomizados para nitroglicerina 500 mcg ou placebo em dois momentos: após a colocação do introdutor hemostático e antes da retirada do introdutor. Todos os pacientes receberam hemostasia patente ou de pressão mínima. A avaliação de EAR foi clínica, através de escala numérica de dor (graduada de 0 a 10), e foi definida como presente nos casos em que seja maior que 6. A avaliação de OAR foi realizada com ultrassonografia com Doppler, realizada nas primeiras 12 horas após o procedimento. RESULTADOS: Foram incluídos 2040 pacientes, sendo 774 (37,5%) mulheres. A média de idade foi similar entre os sexos (62,2 anos vs. 61,5; p=0,27), mas as mulheres apresentaram maior IMC (29,3 vs. 28,1; p<0,01) e artérias radiais menores (2,33 mm vs. 2,74; p<0,01) A incidência de EAR foi maior nas mulheres (21,2% vs. 6,6%; p<0,01), bem como a incidência de OAR (3,4% vs. 1,8%; p=0,03). O uso da nitroglicerina no início do procedimento não reduziu a incidência de EAR em mulheres quando comparado com o placebo (19,7% vs. 22,6%; p=0,34), tão pouco as taxas de OAR (4,3% vs 2,5%; p=0,17). O uso da nitroglicerina ao final do procedimento não reduziu a incidência de OAR em mulheres (2,8% vs. 3,9%; p=0,37). CONCLUSÕES: O EAR e a OAR são mais frequentes em mulheres submetidas a cateterismo por ATR quando comparado aos homens. O uso da nitroglicerina não apresenta efeito benéfico na redução destas incidências, independente do momento de utilização.

Avaliação de espasmo e oclusão de artéria radial após cateterismo transradial, considerando o calibre de introdutor utilizado / Evaluation of radial artery spasm and occlusion after transradial catheterization, considering the sheath gauge used

INTRODUÇÃO: O benefício do cateterismo por acesso transradial (ATR) está bem estabelecido, principalmente em intervenções coronárias, onde o uso de medicações aumenta o risco de sangramento. O uso da via no cateterismo diagnóstico permite maior conforto ao paciente e reduz complicações relacionadas com a via de acesso. A ocorrência de espasmo (EAR) e oclusão da artéria (OAR) são as complicações mais frequentes do ATR. O uso de introdutores de menor calibre poderia reduzir estas complicações. OBJETIVOS: Comparar a incidência de EAR e OAR em cateterismo diagnósticos, considerando-se o calibre do introdutor utilizado. MÉTODOS: Estudo multicêntrico, prospectivo, observacional. A escolha do introdutor a ser utilizado ficou a cargo do médico responsável pelo procedimento. Todos pacientes receberam heparina na dose de 5000 UI e receberam hemostasia patente ou de pressão mínima ao final do procedimento. A avaliação de EAR foi clínica, através de escala numérica de dor (graduada de 0 a 10), e foi definido como presente nos casos em que seja maior que 6. A avaliação de OAR foi realizada com ultrassonografia com Doppler, realizada nas primeiras 12 horas após o procedimento. RESULTADOS: Foram incluídos 1534 pacientes submetidos a cateterismo diagnóstico, sendo 625 (40,7%) mulheres. A maioria dos procedimentos foi em síndromes coronárias crônicas (61,5%). Foram utilizados introdutores 5F em 1185 (77,2%) e 6 F em 349 (22.8%), todos os procedimentos foram concluídos com o introdutor inicialmente escolhido, sem necessidade de troca. A relação introdutor: artéria foi maior que 1 em 43,4% dos pacientes no grupo 5F e 39,3%, no grupo 6F (p=0,19). A incidência de EAR foi igual nos dois calibres de introdutores utilizados (11,4% vs. 12,3%; p=0,63), bem como a incidência de OAR (2,8% vs. 2,0%; p=0,42). CONCLUSÕES: O EAR e a OAR tem frequência similar em cateterismo diagnósticos realizados com introdutores 5F ou 6F. O papel do hemodinamicista na escolha do calibre a ser utilizado pode ter colaborado com este resultado, visto que não houve diferença na relação de calibre entre introdutor: artéria nos dois grupos, portanto um trabalho randomizado poderia não apresentar o mesmo resultado.

Aplicação da tomografia de coerência óptica no tronco da coronária esquerda. Um estudo de factibilidade técnica / Application of optical coherence tomography in the left main coronary artery. A technical feasibility study

INTRODUÇÃO: Imagem intravascular é de grande valia na avaliação de estenoses ambíguas e para guiar procedimentos de intervenção coronária percutânea (ICP) no tronco da coronária esquerda (TCE). A necessidade de injeção de contraste para remoção transitória do sangue intraluminal e o grande calibre deste segmento vascular são considerados os principais impedimentos para a utilização da tomografia de coerência óptica (OCT) no TCE. OBJETIVOS: Documentar a factibilidade do uso da OCT na avaliação de lesões no TCE, incluindo a visualização de seu óstio. MÉTODOS: Estudo prospectivo, unicêntrico, de braço único, que avaliou procedimentos consecutivos no TCE no período de Agosto a Dezembro de 2020. O desfecho primário é a qualidade das imagens obtidas, definidas como visualização clara da parede vascular sem contaminação por sangue em ≥ 80% da circunferência do vaso. RESULTADOS: Dezoito pacientes foram incluídos, com um total de 29 corridas de OCT. Destas, 20 (68,9%) foram adquiridas pré-ICP e 9 (31,1%) pós-ICP. A média das idades foi 60,1±12,3 anos, 12 (66,7%) eram homens e 5 (27,8%) diabéticos. Síndrome coronária aguda foi a apresentação de 11 (61,1%) pacientes. A via radial foi utilizada em 13 (72,2%). As lesões do TCE localizavam-se no segmento distal em 9 (50%), corpo 4 (22.2%) e 5 (27,8%) possuíam doença difusa ou predominantemente ostial. Foram utilizados cateteres-guia Judkins Left em 10 (55,6%) e Extra Back-up em 8 (44,4%). Injeção manual de contraste foi realizada em todos os casos. Um total de 8,97±1,52 mL de contraste foi utilizado, sem diferença significativa (p=0,378) entre as imagens pré-ICP (9,15±1,66 mL) e pós-ICP (8,60±1,17 mL) O diâmetro luminal do TCE mediu 4,54±0,72mm (3,21 a 6,08mm) nas imagens pré-ICP e 4,65±0,51mm (3,91 a 5,23mm) nas imagens pós-ICP. O óstio do TCE e sua abertura para a aorta foi visualizado em todos os casos. A distância do cateter-guia até o óstio do TCE mediu 0,81±0,71mm (0,2 a 2,9mm). 1.971 imagens transversais consecutivas de OCT foram analisadas nos segmentos de TCE. Destas, 5,4% foram classificadas como baixa qualidade (≥20% da circunferência vascular ocultada por sangue), e distribuídas mais frequentemente próximas ao cateter-guia (figura). CONCLUSÕES: Utilização da OCT no TCE é possível, com administração de pouco volume de contraste e obtenção de imagens de boa qualidade, incluindo a visualização do óstio do TCE. Sua aplicação em maior escala, e reprodutibilidade por outros operadores necessita ser avaliada.

Evaluation of Ventricular Remodeling and Prognosis in Patients with Aortic Stenosis Who Underwent Surgical or Percutaneous Transcatheter Aortic Valve Replacement

ABSTRACT Introduction: Aortic stenosis is the most common heart valve disease in the world, and patients that present with symptoms have a high mortality rate. Aortic valve replacement has the objective of promote left ventricular remodeling, reduce symptoms, and increase overall survival. The objective of this study is to evaluate reverse remodeling of the left ventricle in patients with severe and symptomatic aortic stenosis who underwent surgical or percutaneous transcatheter aortic valve replacement. Methods: This is a longitudinal, prospective, non-concurrent, non-randomized unicentric study with patients who underwent aortic valve replacement. Echocardiogram was performed before and after replacement procedure to evaluate several remodeling indexes. Results: Of 91 patients, 77 (84.6%) underwent surgical aortic valve replacement, and 14 (15.4%) underwent percutaneous transcatheter aortic valve replacement. Mean age was 68,96±11,98 years, and most patients were male. Remodeling evaluation revealed that patients who decreased left ventricular index mass (53% vs. 38.9%; P=0,019) and those who reduced the mass/volume ratio (30.4% vs. 68.9%; P<0,001) presented with positive left ventricular remodeling. No endpoint difference was found in those with positive remodeling. Conclusion: Regarding the left ventricular remodeling in patients with severe and symptomatic aortic valve stenosis who underwent percutaneous transcatheter or surgical valve replacement, there is a positive increment in remodeling, however it remains in concentric hypertrophic shape. Implication of these findings remains uncertain and to be studied in large dedicated trials with clinical endpoints.

Evaluation of Ventricular Remodeling and Prognosis in Patients with Aortic Stenosis Who Underwent Surgical or Percutaneous Transcatheter Aortic Valve Replacement.

INTRODUCTION: Aortic stenosis is the most common heart valve disease in the world, and patients that present with symptoms have a high mortality rate. Aortic valve replacement has the objective of promote left ventricular remodeling, reduce symptoms, and increase overall survival. The objective of this study is to evaluate reverse remodeling of the left ventricle in patients with severe and symptomatic aortic stenosis who underwent surgical or percutaneous transcatheter aortic valve replacement. METHODS: This is a longitudinal, prospective, non-concurrent, non-randomized unicentric study with patients who underwent aortic valve replacement. Echocardiogram was performed before and after replacement procedure to evaluate several remodeling indexes. RESULTS: Of 91 patients, 77 (84.6%) underwent surgical aortic valve replacement, and 14 (15.4%) underwent percutaneous transcatheter aortic valve replacement. Mean age was 68,96±11,98 years, and most patients were male. Remodeling evaluation revealed that patients who decreased left ventricular index mass (53% vs. 38.9%; P=0,019) and those who reduced the mass/volume ratio (30.4% vs. 68.9%; P<0,001) presented with positive left ventricular remodeling. No endpoint difference was found in those with positive remodeling. CONCLUSION: Regarding the left ventricular remodeling in patients with severe and symptomatic aortic valve stenosis who underwent percutaneous transcatheter or surgical valve replacement, there is a positive increment in remodeling, however it remains in concentric hypertrophic shape. Implication of these findings remains uncertain and to be studied in large dedicated trials with clinical endpoints.

Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial.

OBJECTIVES: The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency. BACKGROUND: The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO. METHODS: The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 µg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound. RESULTS: A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO. CONCLUSIONS: The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).

Randomized clinical trial on prevention of radial occlusion after transradial access using Nitroglycerin: PATENS trial

OBJECTIVES: The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency. BACKGROUND: The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO. METHODS: The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 µg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound. RESULTS: A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed reestablishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO. Conclusions: The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).

COVID-19 pandemic, mechanical reperfusion and 30-day mortality in ST elevation myocardial infarction.

OBJECTIVE: The initial data of the International Study on Acute Coronary Syndromes - ST Elevation Myocardial Infarction COVID-19 showed in Europe a remarkable reduction in primary percutaneous coronary intervention procedures and higher in-hospital mortality during the initial phase of the pandemic as compared with the prepandemic period. The aim of the current study was to provide the final results of the registry, subsequently extended outside Europe with a larger inclusion period (up to June 2020) and longer follow-up (up to 30 days). METHODS: This is a retrospective multicentre registry in 109 high-volume primary percutaneous coronary intervention (PPCI) centres from Europe, Latin America, South-East Asia and North Africa, enrolling 16 674 patients with ST segment elevation myocardial infarction (STEMI) undergoing PPPCI in March/June 2019 and 2020. The main study outcomes were the incidence of PPCI, delayed treatment (ischaemia time >12 hours and door-to-balloon >30 min), in-hospital and 30-day mortality. RESULTS: In 2020, during the pandemic, there was a significant reduction in PPCI as compared with 2019 (incidence rate ratio 0.843, 95% CI 0.825 to 0.861, p<0.0001). This reduction was significantly associated with age, being higher in older adults (>75 years) (p=0.015), and was not related to the peak of cases or deaths due to COVID-19. The heterogeneity among centres was high (p<0.001). Furthermore, the pandemic was associated with a significant increase in door-to-balloon time (40 (25-70) min vs 40 (25-64) min, p=0.01) and total ischaemia time (225 (135-410) min vs 196 (120-355) min, p<0.001), which may have contributed to the higher in-hospital (6.5% vs 5.3%, p<0.001) and 30-day (8% vs 6.5%, p=0.001) mortality observed during the pandemic. CONCLUSION: Percutaneous revascularisation for STEMI was significantly affected by the COVID-19 pandemic, with a 16% reduction in PPCI procedures, especially among older patients (about 20%), and longer delays to treatment, which may have contributed to the increased in-hospital and 30-day mortality during the pandemic. TRIAL REGISTRATION NUMBER: NCT04412655.

Efeito da nitroglicerina pré-cateterismo transradial sobre o espasmo de artéria radial: análise baseada na experiência do operador / Effect of nitroglycerin pre-transradial catheterization on radial artery spasm: analysis based on operator experience

INTRODUÇÃO: O uso da artéria radial como acesso arterial para o cateterismo cardíaco tem sido preferencial devido a vantagens clínicas demonstradas. Um dos limitantes do uso da artéria como via de acesso é a ocorrência de espasmo (EAR), para o qual se recomenda o uso de medicações espasmolíticas profiláticas. A nitroglicerina é uma droga vasodilatadora que tem sido usada para este fim. O benefício da medicação na prevenção do espasmo poderia ser influenciado pela experiência do operador. OBJETIVOS: Avaliar a redução na incidência de EAR, por avaliação clínica, em pacientes submetidos a cateterismo cardíaco por via transradial (ATR) submetidos à pré-medicação com nitroglicerina intra-arterial, comparado àqueles que não receberam pré-medicação com nitroglicerina. MÉTODOS: Ensaio clínico prospectivo, multicêntrico, randomizado, duplo-cego, placebo controlado. Um grupo recebeu nitroglicerina, na dose de 500 μg, diluída em 10ml de soro fisiológico através do introdutor, e um segundo grupo, que recebeu placebo (SF). A avaliação de espasmo foi clínica, através de escala numérica de dor (graduada de 0 a 10), e será definido como presente nos casos em que seja maior que 6. A experiência do operador foi classificada como: inexperiente (I) (menos que 100 procedimento por ATR realizados); experientes (E) (de 100 a 1000 ATR) e altamente experientes (A) (mais que 1000 ATR). RESULTADOS: Foram incluídos 1991 pacientes, com média de 61,8 anos, sendo 61,7% do sexo masculino e 36,6% com diabetes. Operadores I realizaram 454 (22,8%) procedimentos; E, 949 (47,7%) e A, 588 (29,5%). A incidência de espasmo foi de 14,5% no grupo I, 12,5% no grupo E e 9,7% no grupo A (p=0,01 para comparação entre o grupo I e A). A mudança de via de acesso também foi mais comum no grupo I (3,5% vs. 2,5% (E) vs. 0,2% (A), p<0,01). No grupo I, o uso profilático de nitroglicerina reduziu a incidência de espasmo (17,9% vs. 11,1%, p=0,04), o que não ocorreu no grupo E (13,3% vs. 11,8%, p=0,49) ou no grupo A (10,2% vs. 9,2%, p=0,68). O uso de medicação vasodilatadora de resgate também foi mais comum no grupo I (3,1% vs. 2,9% (E) vs. 0,5% (A), p<0,01). CONCLUSÕES: O EAR é mais comum no início da curva de aprendizado do ATR, nesta situação o uso profilático da nitroglicerina, na dose de 500 μg, reduz a ocorrência de EAR, este efeito benéfico da nitroglicerina não é observado com operadores mais experientes.

Prevention of radial artery occlusion after transradial access using nitroglycerin (Patens Trial)

BACKGROUND The use of transradial access (TRA) for coronary catheterization has increased over the years because of the reduced rates of vascular complications and easier postprocedural manage ment. Radial artery occlusion (RAO) remains the Achilles heel of TRA. Intra-arterial nitroglycerin could result in a significant reduction of RAO. The vasodilation may enhance antegrade flow in the artery that reduces stasis-induced thrombosis, but it could also minimize endo thelial trauma when used early in the procedure. The main objective of this study is to evaluate whether nitroglycerin at the beginning or end of TRA may preserve the patency of the artery. METHODS We conducted a prospective, multicenter, randomized, 2 2 factorial, placebo-controlled, 2-blinded study and enrolled patients submitted to catheterization by TRA. Patients received either 500 mg nitroglycerin or placebo given intra-arterially through the sheath at 2 moments: early, after sheath insertion, and late, at the end of the radial procedure. All patients received at least 5,000 UI heparin, sheaths were removed immediately after the catheterization, and a radial pneumatic wristband was applied intending patent or minimum pressure hemostasis. The primary outcome was the incidence of RAO, verified by Doppler evaluation within the first 24 hours, and every patient with confirmed RAO was further evaluated 30 days later. RESULTS A total of 1,894 patients were enrolled, with a mean age of 61.7 10.3 years. The majority (61.6%) were male, and 36.5% had diabetes. The clinical indication was ACS in 47.9%. RAO occurred in 49 patients (2.6%) by Doppler evaluation. Fifteen patients (30.6%) showed re-establishment of flow at 30-day Doppler assessment. Nitroglycerin, as compared with placebo, did not reduce the risk of RAO in either of the 2 moments used (early: 2.4% vs 2.8%, P » 0.65 or late: 2.8% vs 2.4%, P » 0.65, respectively). In the multivariate anal ysis, the size of the radial artery, obtaining access with a single puncture, operator inexperience, and the presence of spasm were associated with RAO. CONCLUSION In the present study, the use of nitroglycerin is not associated with a reduced incidence of RAO regardless of the admin istration time