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Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP. Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected] Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

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Page 1: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

Page 2: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

Impacto dos ensaios clínicos EXCEL e NOBLE nas decisões de tratamento da lesão de tronco de

coronária esquerda

As publicações dos estudos EXCEL e NOBLE, descritos a seguir, trouxeram mais evidências para auxiliar

na decisão do melhor tratamento da lesão de tronco de artéria coronária esquerda. Mas também

mostraram alguns fatores confundidores, já que o estudo NOBLE foi favorável à revascularização

cirúrgica e o estudo EXCEL mostrou equivalência com a intervenção coronária percutânea (ICP).

Ambos os estudos foram financiados pelas companhias que fabricam o stent coronário empregado,

consequentemente há que se analisar os vieses que este tipo de relação impõe.

Evidências principalmente derivadas do estudo Syntax já haviam mostrado que pacientes com lesão de

tronco e alto risco (escore Syntax > 32) beneficiavam-se mais do tratamento cirúrgico (recomendação

classe I); entretanto, pacientes com escore Syntax < 32 (risco baixo e intermediário) poderiam ter

resultados similares com ambas as terapias. Como o estudo Syntax não teve poder para definir essa

questão, houve necessidade de estudos adicionais.

Portanto, o estudo EXCEL foi desenhado para avaliar comparativamente as terapias de revascularização

miocárdica cirúrgica e percutânea, em pacientes com lesão de TCE e escore Syntax < 32.

O EXCEL é um estudo randomizado multicêntrico internacional e não cego, executado para comparar os

resultados do tratamento da lesão de tronco com a ICP utilizando o stent eluído com everolimus

(XIENCE, Abbott Vascular), com a cirurgia de revascularização do miocárdio (CRM).

A conclusão do EXCEL foi que, em 3 anos de acompanhamento, nos pacientes com lesão de tronco de

coronária esquerda de risco baixo e intermediário, a ICP com stents eluidos com everolimus foi não-

inferior à CRM, com respeito às taxas de desfecho composto de morte, AVC e infarto do miocárdio.

Entretanto, a análise em 3 anos não confere poder de recomendação. Neste subgrupo de pacientes de

risco baixo e intermediário, estudos anteriores já mostraram que o beneficio de sobrevida conferido

pela cirurgia aparece em longo-prazo, após 5 anos de seguimento. Portanto haverá necessidade de se

esperar os resultados em 5 anos para conclusões mais plausíveis. De fato, analisando as curvas do

desfecho "morte por todas as causas", os resultados começam a se separar a partir de 18 meses de

Page 3: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos

desfechos AVC e infarto também mostram tendências semelhantes.

No estudo NOBLE, postulou-se a hipótese que a ICP com stents eluídos com droga iria produzir

resultados clínicos não inferiores à CRM, em 1200 pacientes com lesão de tronco de artéria coronária

esquerda não protegida. O desfecho primário foi um composto dos principais eventos adversos

cardíacos e cerebrovasculares (MACCE; morte de qualquer causa, infarto do miocárdio, nova

revascularização e AVC).

A conclusão do estudo NOBLE, em 5 anos de acompanhamento, foi de que as taxas de MACCE foram de

29% para ICP e 19% para CRM, excedendo o limite de não-inferioridade, e que a CRM foi

significantemente melhor do que a ICP (p = 0,0066). Na interpretação, os autores concluíram que os

achados deste estudo sugerem que a CRM pode ser melhor do que a PCI para o tratamento da lesão de

tronco de artéria coronária esquerda.

Interessante observar que os resultados em 3 anos do NOBLE não mostram diferenças entre ICP e CRM,

que só apareceram após 5 anos de seguimento e deram a conclusão final do estudo.

Em virtude do elevado custo deste tipo de estudo, é provável não haja outros em curto e médio prazo.

Portanto, dadas essas diferenças, não se espera mudança no momento em recomendações das

Diretrizes para o tratamento da lesão de tronco. Recomendações finais das Diretrizes seguirão os

resultados de 5 anos do estudo EXCEL.

Walter J. Gomes

EXCEL Trial: pacientes com lesão de TCE de SYNTAX score baixo ou intermediário podem ser tratados

com stents de everolimus.

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease.

NEJM, Oct 2016 - DOI: 10.1056/NEJMoa1610227

BACKGROUND

Patients with obstructive left main coronary artery disease are usually treated with coronaryartery

bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable

alternative to CABG in selected patients with left main coronary disease.

Page 4: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

METHODS

We randomly assigned 1905 eligible patients with left main coronary artery disease of low or

intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with

fluoropolymer-based cobalt–chromium everolimus-eluting stents (PCI group, 948 patients) or CABG

(CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy

between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or

lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature,

with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary

anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or

myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end

point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a

composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a

composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event

rates were based on Kaplan–Meier estimates in time-to-first-event analyses.

RESULTS

At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in

14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence

limit, 4.0 percentage points; P = 0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79

to 1.26; P = 0.98 for superiority). The secondary end-point event of death, stroke, or myocardial

infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group

(P<0.001 for noninferiority, P = 0.008 for superiority). The secondary end-point event of death, stroke,

myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients

in the PCI group and in 19.1% in the CABG group (P = 0.01 for noninferiority, P = 0.10 for superiority).

CONCLUSIONS

In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site

assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the

composite end point of death, stroke, or myocardial infarction at 3 years.

Page 5: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

NOBLE Trial: em pacientes com lesão de TCE, angioplastia falha em atingir desfechos de não-

inferioridade, em comparação à cirurgia .

Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of

unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial.

Lancet, Oct 2016 – DOI: 10.1016/S0140-6736(16)32052-9

BACKGROUND

Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease. METHODS

In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint

Page 6: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specifi ed otherwise. This trial is registered with ClinicalTrials.gov identifi er, number NCT01496651. RESULTS

Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11–1·96), exceeding the limit for non-inferiority, and CABG was signifi cantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18–2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67–1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40–5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04–2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93–5·48, p=0·073) for stroke. CONCLUSION

The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease.

Page 7: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

Resultados de 5 anos do ART Trial: duas mamárias não reduzem desfechos cardiovasculares, e

aumentam taxa de mediastinite.

Randomized Trial of Bilateral versus Single Internal-Thoracic-Artery Grafts.

NEJM, Nov 2016 - DOI: 10.1056/NEJMoa1610021.

BACKGROUND

The use of bilateral internal thoracic (mammary) arteries for coronary-artery bypassgrafting (CABG) may

improve long-term outcomes as compared with the use of a single internal-thoracic-artery plus vein

grafts.

METHODS

We randomly assigned patients scheduled for CABG to undergo single or bilateral internal-thoracic-

artery grafting in 28 cardiac surgical centers in seven countries.

The primary outcome was death from any cause at 10 years. The composite of death from any cause,

myocardial infarction, or stroke was a secondary outcome. Interim analyses were prespecified at 5 years

of follow-up.

RESULTS

A total of 3102 patients were enrolled; 1554 were randomly assigned to undergo single internal-

thoracic-artery grafting (the single-graft group) and 1548 to undergo bilateral internal-thoracic-artery

grafting (the bilateral-graft group). At 5 years of follow-up, the rate of death was 8.7% in the bilateral-

graft group and 8.4% in the single-graft group (hazard ratio, 1.04; 95% confidence interval [CI], 0.81 to

1.32; P = 0.77), and the rate of the composite of death from any cause, myocardial infarction, or stroke

was 12.2% and 12.7%, respectively (hazard ratio, 0.96; 95% CI, 0.79 to 1.17; P = 0.69). The rate of sternal

wound complication was 3.5% in the bilateral graft group versus 1.9% in the single-graft group (P =

0.005), and the rate of sternal reconstruction was 1.9% versus 0.6% (P = 0.002).

CONCLUSIONS

Among patients undergoing CABG, there was no significant difference between those receiving single

internal-thoracic-artery grafts and those receiving bilateral internal-thoracic-artery grafts with regard to

mortality or the rates of cardiovascular events at 5 years of follow-up. There were more sternal wound

Page 8: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

complications with bilateral internal-thoracic-artery grafting than with single internal-thoracic artery

grafting. Ten-year follow-up is ongoing.

Comentário Editorial:

A ATIE é considerado o enxerto de excelência a ser usado na cirurgia de revascularização do miocárdio.

Estudos observacionais têm demonstrado que a utilização de duas ATI pode ser capaz de promover uma

redução na mortalidade, em torno de 20%, se comparado ao uso único, a longo prazo. Apesar disto, a

utilização de duas ATI tem baixa taxa de uso na Europa e Estados Unidos, pela alegada maior

complexidade técnica, maior mortalidade e morbidade, e por não haver estudos randomizados que

comprovem o seu real benefício.

O ART Trial é um estudo randomizado, cujo desenho tem como objetivo primário avaliar a mortalidade

em 10 anos, entre dois grupos de pacientes submetidos a cirurgia de revascularização do miocárdio

isolada, com uma ou duas ATI. Como objetivo secundário, avalição de mortalidade, infarto agudo do

miocárdio (IAM) e acidente vascular cerebral (AVC) em 5 e 10 anos. É um estudo multicêntrico que

Page 9: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

envolveu 28 centros de 7 países, sem envolvimento de nenhum suporte da indústria farmacêutica.

Foram randomizados 3102 pacientes, 1554 no grupo de uma. e 1548 no grupo de duas.

Os resultados em um ano mostraram não haver diferença na mortalidade imediata entres dois grupos,

o que é considerado uma das justificativas pela sua não utilização, de maneira rotineira.

Aos cinco anos, também não houve diferença na mortalidade tardia entre os dois grupos, assim como o

risco de IAM e AVC. Houve uma maior incidência de infecção de ferida operatória no grupo que utilizou

as duas ATI, mais frequente nos pacientes diabéticos e obesos. Face ao baixo risco de complicações

desta natureza, sobretudo quando se disseca a ATI de forma esqueletizada, penso que é um risco que

deve-se correr em havendo uma comprovação na sobrevida tardia, o que só saberemos na análise de 10

anos.

Ressaltam-se ainda outros aspectos importantes desse estudo, como:

- A alta utilização de antiagregantes plaquetários (90%), estatinas (90%), beta-bloqueadores (75%), IECA

(75%), muito superior à maioria dos estudos que comparam cirurgia versus angioplastia.

- A degeneração dos enxertos venosos começam a se agravar após os cinco anos.

- Apesar de não apresentar diferença com 5 anos, as evidências tardias de maior patência da ATI são

robustas.

Em síntese, na análise de 5 anos do estudo ART , observou-se excelente evolução em 5 anos nos dois

grupos, confirmou-se que o uso das duas ATIE é seguro, não houve diferença na mortalidade, IAM, AVC,

e no sangramento com necessidade de reintervenção, e os pacientes diabéticos e obesos requerem

atenção maior quanto a complicações de ferida operatória. Visto que o objetivo primário é avaliar a

mortalidade de 10 anos, temos de aguardar os resultados finais para uma conclusão definitiva.

Fernando Moraes Neto

Comitê de segurança interrompe trial francês sobre intervenção coronária percutânea, por aumento

de mortalidade na angioplastia guiada por FFR.

FUTURE: FFR-Guided Revascularization vs. Angioplasty in CAD Patients.

ACC News Nov 14, 2016.

Page 10: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

www.acc.org/latest-in-cardiology/articles/2016/11/10/15/56/mon-1145amet-future-real-world-

comparison-of-ffr-guided-management-aha-2016#sthash.1g3f6XT9.dpuf

Fractional flow-reserve (FFR)-guided revascularization may not be a safe treatment strategy decision

tool in patients with multivessel coronary artery disease (CAD), according to the results of the FUTURE

Trial presented Nov. 14 during AHA 2016. In a multicenter, controlled, randomized trial, Gilles Rioufol,

MD, PhD, et al., explored FFR-guided revascularization in comparison with angioplasty alone among

patients with multivessel CAD. Acute coronary syndrome and stable coronary artery disease consecutive

patients were randomized to either FFR-guided management or traditional management. The primary

end point was a composite of major adverse cardiovascular events, including all-cause death, non-fatal

heart attack, stroke and repeat coronary revascularization at one year. The trial was scheduled to

include 1,728 patients over 39 centers in France.

The study’s independent data safety monitoring board recommended to stop study enrollment due to a

significant greater mortality in the FFR-group after analysis of the first 836 randomized patients.

The interim results for the 933 included patients show at least a non-significant excess of mortality trend

in the FFR group and no clinical benefit of FFR in comparison with angioplasty. Researchers conclude

that in complex, high-risk patients, FFR may not help for treatment decisions and could be associated

with a negative safety signal. "Unfortunately, the Data Safety Monitoring

Board stopped the trial prematurely and therefore the trial is not informative," commented Deepak L.

Bhatt, MD, MPH, FACC. "I do sympathize with and commend the investigators for presenting the trial, as

researchers have an obligation to present all human research.

However, there is nothing here that should influence current clinical practice." "The early termination of

this study leaves behind questions without definitive answers," adds Richard A. Chazal, MD, FACC,

president of the ACC.

Page 11: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

No mundo real, pacientes com estenose aórtica grave de risco intermediário, apresentam maior

mortalidade com TAVI do que com cirurgia convencional, aponta Registro GARY.

Stark Mortality Differences Seen in GARY Registry Tracking TAVR and Surgical Replacement. ACC

News Nov 14, 2016.

http://www.acc.org/latest-in-cardiology/articles/2016/11/10/15/56/mon-1145amet-germany-

patients-at-intermediate-surgical-risk-aha-2016

New findings from Germany show that intermediate-risk patients with aortic stenosis enrolled in a

national registry there faced significantly higher 1-year mortality if they were treated with

transcatheter aortic valve replacement (TAVR) rather than with surgical valve replacement (SAVR).

Almost 50.000 patients were enrolled in the GARY registry between January 2011 and December 2013,

of whom 22.7% were deemed to be at intermediate surgical risk (logistic EuroSCORE I of 10-20%). After

exclusions, 5.997 patients with isolated TAVR or SAVR were included in the analysis. Baseline

differences between groups were striking, with TAVR-treated patients showing higher-risk

characteristics across the board, including greater age, higher surgical risk scores, worse heart failure,

Page 12: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

more prior MI, more atrial fibrillation, and many others. In an analysis looking at reasons underlying

the choice of TAVR over surgery, the most frequent reason was patient age, followed by frailty.

Importantly there were also major differences in the proportion of patients treated with either

approach according to the hospital site, with some sites performing no TAVR cases and others 100%

TAVR. Next the authors did a propensity-score matched analysis, stratifying patients according to their

level of risk by quintiles. Here again, however, a significant overall difference was seen in rates of all-

cause mortality between the surgery-treated and TAVR-treated patients (10.89% vs 15.52%; difference

4.63%; 95% CI: 1.75-7.52%). Looking only at transfemoral TAVR patients, who made up 75% of this

group, the differences was smaller but still statistically significant.

According to the authors, for differences in specific complication rates between TAVR and SAVR, an

individualized therapeutic decision by a dedicated heart team, based on the clinical situation of the

patient and the associated procedural risk, may be the best approach for the group of patients at

intermediate surgical risk. However, they note that the retrospective analysis from registry data is not

the method of choice to compare two treatment strategies as it should only be done by randomized

controlled trials.

Avaliação da frequência e dos preditores de bloqueio AV permanente, após TAVI: resultados do

STS/ACC Registry.

Page 13: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

Incidence, Predictors, and Outcomes of Permanent Pacemaker Implantation Following Transcatheter

Aortic Valve Replacement: Analysis From the U.S. Society of Thoracic Surgeons/American College of

Cardiology TVT Registry.

JACC Cardiovasc Interv 2016;9:2189-2199.

OBJECTIVE

The purpose of this study was to evaluate the incidence, predictors, and

clinical outcomes of permanent pacemaker (PPM) implantation following transcatheter aortic valve repl

acement (TAVR).

BACKGROUND

Conduction abnormalities leading to PPM implantation are common complications following TAVR.

Whether PPM placement can be predicted or is associated with adverse outcomes is unclear.

METHODS

A retrospective cohort study of patients undergoing TAVR in the United States at 229 sites between

November 2011 and September 2014 was performed using

the Society of Thoracic Surgeons/American Collegeof Cardiology TVT Registry and the Centers for

Medicare and Medicaid Services database.

RESULTS

PPM placement was required within 30 days of TAVR in 651 of 9.785 patients (6.7%) and varied among

those receiving self-expanding valves (25.1%) versus balloon-expanding valves (4.3%).

Positive predictors of PPM implantation were age (per 5-year increment, odds ratio: 1.07; 95%

confidence interval [CI]: 1.01 to 1.15), prior conduction defect (odds ratio: 1.93; 95% CI: 1.63 to 2.29),

and use of self-expanding valve (odds ratio: 7.56; 95% CI: 5.98 to 9.56). PPM implantation was

associated with longer median hospital stay (7 days vs. 6 days; p < 0.001) and intensive care unit stay

(56.7 h vs. 45.0 h; p < 0.001). PPM implantation was also associated with increased mortality (24.1% vs.

19.6%; hazard ratio [HR]: 1.31; 95% CI: 1.09 to 1.58) and a composite of mortality or heart failure

admission (37.3% vs. 28.5%; hazard ratio HR: 1.33; 95% CI: 1.13 to 1.56) at 1 year but not with heart

failure admission alone (16.5% vs. 12.9%; HR: 1.23; 95% CI: 0.92 to 1.63).

Page 14: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

CONCLUSION

Early PPM implantation is a common complication following TAVR, and it is associated with higher

mortality and a composite of mortality or heart failure admission at 1 year.

SENTINEL Trial: uso de dispositivos de proteção embólica durante TAVI não diminui taxa de eventos

cerebrovasculares.

Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement.

JACC, oct 2016. DOI: 10.1016/j.jacc.2016.10.023.

BACKGROUND

Neurological events and brain infarction after transcatheter aortic valve replacement (TAVR) are

concerns which may be reduced with transcatheter embolic protection (TEP).

OBJECTIVE

Evaluate the safety and efficacy of TEP during TAVR.

METHODS

Page 15: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

Nineteen centers randomized 363 patients undergoing TAVR to safety (n=123), device imaging (n=121),

and control imaging (n=119). The primary safety endpoint was major adverse cardiac and

cerebrovascular events (MACCE) at 30 days and the primary efficacy endpoint was reduction in new

lesion volume in protected brain territories on MRI scans at 2-7 days. Patients underwent

neurocognitive assessments and the debris captured was analyzed.

RESULTS

MACCE (7.3%) was non-inferior to the performance goal (18.3%, p noninferior<0.001) and not

statistically different from control (9.9%, p=0.41). New lesion volume was 178.0 mm3 in controls and

102.8 mm3 in the device arm (p=0.33). A post hoc multivariable analysis identified preexisting lesion

volume and valve type to be predictors of new lesion volume. Strokes at 30 days were 9.1% in controls

and 5.6% in device patients (p=0.25). Although neurocognitive function was similar in control and device

patients, there was correlation between lesion volume and neurocognitive decline (p=0.0022).

Histopathologic debris, found within filters in 99% of patients, included thrombus, calcification, valve

tissue, artery wall and foreign material.

CONCLUSIONS

TEP was safe, captured embolic debris 99% patients, and did not change neurocognitive function.

Reduction in new lesion volume on MR scans was not statistically significant.

Page 16: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

Em pacientes diabéticos com doença coronária multiarterial, a insuficiência renal influencia nos

desfechos da angioplastia ou cirurgia de revascularização? Subanálise do estudo FREEDOM.

Comparative efficacy of coronary artery by-pass surgery vs. percutaneous coronary intervention in

patients with diabetes and multivesselcoronary artery disease with or without chronic kidney disease.

Eur Heart J, aug 2016 – DOI: 10.1093/eurheartj/ehw378

BACKGROUND

The optimal method of coronary revascularization among patients with diabetes mellitus (DM)

and multivessel coronary artery disease (CAD) complicated by chronic kidney disease (CKD) remains

unknown.

OBJECTIVE

To examine the impact of coronary artery bypass surgery (CABG) vs. percutaneous coronary intervention (PCI) on cardiovascular outcomes in patients with diabetes with and without CKD. METHODS

We conducted an 'as-treated' subgroup analysis of the FREEDOM trial to examine the

therapeutic efficacy of CABG vs. PCI among patients with DM stratified by the presence (n = 451) or

absence (n = 1392) of CKD. We defined CKD as an estimated glomerular filtration rate

(eGFR) < 60 mL/min/1.73m2. Baseline characteristics and clinical outcomes were compared between PCI

and CABG groups within each CKD stratum. The primary endpoint was the composite occurrence of all-

cause death, stroke or myocardial infarction [major adverse cardiovascular and cerebrovascular events

(MACCE)]. Event rates were estimated at 5 years using the Kaplan-Meier approach and hazard ratios

(HRs) for CABG (vs. PCI) were generated using Cox regression.

RESULTS

Patients with CKD (mean eGFR 47 mL/min/1.73m2) were older and more often female compared to

those without renal impairment. Over a median follow-up of 3.8 years, the effect of CABG on MACCE

was consistent among those with CKD (26.0% vs. 35.6%; HR [95% CI]: 0.73 [0.50-1.05]) and without CKD

(16.2% vs. 23.6%; HR [95% CI)]: 0.76 [0.58-1.00]) with no evidence of interaction (pint = 0.83). Stroke

rates were non-significantly higher with CABG whereas rates of MI and repeat revascularization were

significantly reduced with CABG in both groups.

CONCLUSIONS:

Page 17: BOLETIM SBCCV 05-2016 · Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016 acompanhamento, com maior mortalidade no grupo ICP. As curvas de seguimento comparativa dos desfechos

Rua Afonso Celso, 1178 - Vila Mariana - São Paulo/SP.

Telefone: (11) 3849-0341 - Fax: (11) 5096-0079 - Email: [email protected]

Boletim Científico SBCCV Data: 22/11/2016 Número 05/2016

Compared to PCI, the effects of CABG on long-term risks for MACCE observed in the FREEDOM trial are

preserved among patients with mild to moderate CKD.