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1.
J Cardiothorac Surg ; 16(1): 323, 2021 Nov 03.
Artigo em Inglês | MEDLINE | ID: mdl-34732197

RESUMO

OBJECTIVES: The PROSE trial purpose is to investigate whether the incidence of thromboembolic-related complications is reduced with a current generation mechanical prosthesis (On-X Life Technologies/CryoLife Inc.-On-X) compared with a previous generation mechanical prosthesis (St Jude Medical-SJM). The primary purpose of the initial report is to document the preoperative demographics, and the preoperative and operative risk factors by individual prosthesis and by Western and Developing populations. METHODS: The PROSE study was conducted in 28 worldwide centres and incorporated 855 subjects randomized between 2003 and 2016. The study enrollment was discontinued on August 31, 2016. The preoperative demographics incorporated age, gender, functional class, etiology, prosthetic degeneration, primary rhythm, primary valve lesion, weight, height, BSA and BMI. The preoperative and operative evaluation incorporated 24 risk factors. RESULTS: The total patient population (855) incorporated On-X population (462) and the St Jude Medical population (393). There was no significant difference of any of the preoperative demographics between the On-X and SJM groups. The preoperative and operative risk factors evaluation showed there was no significant difference between the On-X and St Jude Medical populations. The preoperative and operative risk factors by valve position (aortic and mitral) also documented no differentiation. The dominant preoperative demographics of the Western world population were older age, male gender, sinus rhythm, aortic stenosis, congenital aortic lesion, and mitral regurgitation. The dominant demographics of the Developing world population were rheumatic etiology, atrial fibrillation, aortic regurgitation, mixed aortic lesions, mitral stenosis and mixed mitral lesions. The Developing world group had only one significant risk factor, congestive heart failure. The majority of the preoperative and operative risk factors were significant in the Western world population. CONCLUSIONS: The preoperative demographics do not differentiate the prostheses but do differentiate the Western and Developing world populations. The preoperative and operative risk factors do not differentiate the prostheses BUT do differentiate the Western and Developing world populations.


Assuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Idoso , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Incidência , Masculino , Valva Mitral/cirurgia , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco
2.
Lancet ; 2021 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-34793745

RESUMO

BACKGROUND: The optimal revascularisation strategy for patients with left main coronary artery disease is uncertain. We therefore aimed to evaluate long-term outcomes for patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents versus coronary artery bypass grafting (CABG). METHODS: In this individual patient data meta-analysis, we searched MEDLINE, Embase, and the Cochrane database using the search terms "left main", "percutaneous coronary intervention" or "stent", and "coronary artery bypass graft*" to identify randomised controlled trials (RCTs) published in English between database inception and Aug 31, 2021, comparing PCI with drug-eluting stents with CABG in patients with left main coronary artery disease that had at least 5 years of patient follow-up for all-cause mortality. Two authors (MSS and BAB) identified studies meeting the criteria. The primary endpoint was 5-year all-cause mortality. Secondary endpoints were cardiovascular death, spontaneous myocardial infarction, procedural myocardial infarction, stroke, and repeat revascularisation. We used a one-stage approach; event rates were calculated by use of the Kaplan-Meier method and treatment group comparisons were made by use of a Cox frailty model, with trial as a random effect. In Bayesian analyses, the probabilities of absolute risk differences in the primary endpoint between PCI and CABG being more than 0·0%, and at least 1·0%, 2·5%, or 5·0%, were calculated. FINDINGS: Our literature search yielded 1599 results, of which four RCTs-SYNTAX, PRECOMBAT, NOBLE, and EXCEL-meeting our inclusion criteria were included in our meta-analysis. 4394 patients, with a median SYNTAX score of 25·0 (IQR 18·0-31·0), were randomly assigned to PCI (n=2197) or CABG (n=2197). The Kaplan-Meier estimate of 5-year all-cause death was 11·2% (95% CI 9·9-12·6) with PCI and 10·2% (9·0-11·6) with CABG (hazard ratio 1·10, 95% CI 0·91-1·32; p=0·33), resulting in a non-statistically significant absolute risk difference of 0·9% (95% CI -0·9 to 2·8). In Bayesian analyses, there was an 85·7% probability that death at 5 years was greater with PCI than with CABG; this difference was more likely than not less than 1·0% (<0·2% per year). The numerical difference in mortality was comprised more of non-cardiovascular than cardiovascular death. Spontaneous myocardial infarction (6·2%, 95% CI 5·2-7·3 vs 2·6%, 2·0-3·4; hazard ratio [HR] 2·35, 95% CI 1·71-3·23; p<0·0001) and repeat revascularisation (18·3%, 16·7-20·0 vs 10·7%, 9·4-12·1; HR 1·78, 1·51-2·10; p<0·0001) were more common with PCI than with CABG. Differences in procedural myocardial infarction between strategies depended on the definition used. Overall, there was no difference in the risk of stroke between PCI (2·7%, 2·0-3·5) and CABG (3·1%, 2·4-3·9; HR 0·84, 0·59-1·21; p=0·36), but the risk was lower with PCI in the first year after randomisation (HR 0·37, 0·19-0·69). INTERPRETATION: Among patients with left main coronary artery disease and, largely, low or intermediate coronary anatomical complexity, there was no statistically significant difference in 5-year all-cause death between PCI and CABG, although a Bayesian approach suggested a difference probably exists (more likely than not <0·2% per year) favouring CABG. There were trade-offs in terms of the risk of myocardial infarction, stroke, and revascularisation. A heart team approach to communicate expected outcome differences might be useful to assist patients in reaching a treatment decision. FUNDING: No external funding.

3.
Artigo em Inglês | MEDLINE | ID: mdl-34618017

RESUMO

OBJECTIVES: This study sought to evaluate the long-term differences in survival between multiple arterial grafts (MAG) and single arterial grafts (SAG) in patients who underwent coronary artery bypass grafting (CABG) in the SYNTAX study. METHODS: The present analysis included the randomized and registry-treated CABG patients (n = 1509) from the SYNTAX Extended Survival study (SYNTAXES). Patients with only venous (n = 42) or synthetic grafts (n = 1) were excluded. The primary end point was all-cause death at the longest follow-up. Multivariable Cox regression was used to adjust for differences in baseline characteristics. Sensitivity analysis using propensity matching with inverse probability for treatment weights was performed. RESULTS: Of the 1466 included patients, 465 (31.7%) received MAG and 1001 (68.3%) SAG. Patients receiving MAG were younger and at lower risk. At the longest follow-up of 12.6 years, all-cause death occurred in 23.6% of MAG and 40.0% of SAG patients [adjusted hazard ratio (HR) 0.74, 95% confidence interval (CI) (0.55-0.98); P = 0.038], which was confirmed by sensitivity analysis. MAG in patients with the three-vessel disease was associated with significant lower unadjusted and adjusted all-cause death at 12.6 years [adjusted HR 0.65, 95% CI (0.44-0.97); P = 0.033]. In contrast, no significance was observed after risk adjustment in patients with the left main disease, with and without diabetes, or among SYNTAX score tertiles. CONCLUSIONS: In the present post hoc analysis of all-comers patients from the SYNTAX trial, MAG resulted in markedly lower all-cause death at 12.6-year follow-up compared to a SAG strategy. Hence, this striking long-term survival benefit of MAG over SAG encourages more extensive use of multiple arterial grafting in selected patients with reasonable life expectancy. TRIAL REGISTRATION: SYNTAXES ClinicalTrials.gov reference: NCT03417050; SYNTAX ClinicalTrials.gov reference: NCT00114972.

4.
J Cardiothorac Surg ; 16(1): 195, 2021 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-34243799

RESUMO

BACKGROUND: Intraoperative graft assessment with tools like Transit Time Flow Measurement (TTFM) is imperative for quality control in coronary surgery. We investigated the variation of TTFM parameters before and after protamine administration to identify new benchmark parameters for graft quality assessment. METHODS: The database of the REQUEST ("REgistry for QUality AssESsmenT with Ultrasound Imaging and TTFM in Cardiac Bypass Surgery") study was retrospectively reviewed. A per graft analysis was performed. Only single grafts (i.e., no sequential nor composite grafts) where both pre- and post-protamine TTFM values were recorded with an acoustical coupling index > 30% were included. Grafts with incomplete data and mixed grafts (arterio-venous) were excluded. A second analysis was performed including single grafts only in the same MAP range pre- and post- protamine administration. RESULTS: After adjusting for MAP, we found a small increase in MGF (29 mL/min to 30 mL/min, p = 0.009) and decrease in PI (2.3 to 2.2, p <  0.001) were observed after the administration of protamine. These changes were especially notable for venous conduits and for CABG procedures performed on-pump. CONCLUSION: The small changes in TTFM parameters observed before and after protamine administration seem to be clinically irrelevant, despite being statistically significant in aggregate. Our data do not support a need to perform TTFM measurements both before and after protamine administration. A single TTFM measurement taken either before or after protamine may suffice to achieve reliable data on each graft's performance. Depending on the specific clinical situation and intraoperative changes, more measurements may be informative. TRIAL REGISTRATION: Clinical Trials Number: NCT02385344 , registered February 17th, 2015.


Assuntos
Ponte de Artéria Coronária , Circulação Coronária , Antagonistas de Heparina/uso terapêutico , Protaminas/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Velocidade do Fluxo Sanguíneo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Grau de Desobstrução Vascular
5.
JAMA Cardiol ; 5(10): 1102-1112, 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-32639521

RESUMO

Importance: Whether intervention should be performed in patients with asymptomatic severe aortic stenosis (AS) remains debated. Objective: To meta-analyze the natural history of asymptomatic severe AS and examine the association of early intervention with survival. Data Sources: PubMed, Embase, and Cochrane databases were searched from inception to February 1, 2020. Study Selection: Observational studies of adult patients with asymptomatic severe AS. Data Extraction and Synthesis: Two investigators independently extracted study and patient characteristics, follow-up time, events, and prognostic indicators of events. Random-effects models were used to derive pooled estimates. Main Outcomes and Measures: The meta-analysis on natural history was performed on the primary end point of all-cause death occurring during a conservative treatment period, with secondary end points consisting of cardiac death, death due to heart failure, sudden death, development of symptoms, development of an indication for aortic valve intervention, and aortic valve intervention. The primary end point for the meta-analysis of early intervention vs a conservative strategy was all-cause death during long-term follow-up. Finally, meta-analysis was performed on the association of prognostic indicators with the composite of death or aortic valve intervention found in multivariable models. Results: A total of 29 studies with 4075 patients with 11 901 years of follow-up were included. Pooled rates per 100 patients per year were 4.8 (95% CI, 3.6-6.4) for all-cause death, 3.0 (95% CI, 2.2-4.1) for cardiac death, 2.0 (95% CI, 1.3-3.1) for death due to heart failure, 1.1 (95% CI, 0.6-2.1) for sudden death, 18.1 (95% CI, 12.8-25.4) for an indication for aortic valve intervention, 18.5 (95% CI, 13.4-25.5) for development of symptoms, and 19.2 (95% CI, 15.5-23.8) for aortic valve intervention. Early intervention was associated with a significant reduction in long-term mortality (hazard ratio, 0.38; 95% CI, 0.25-0.58). Factors associated with worse prognosis were severity of AS, low-flow AS, left ventricular damage, and atherosclerotic risk factors. Conclusions and Relevance: Data from observational studies and a recent randomized clinical trial suggest that many patients with asymptomatic severe AS develop an indication for aortic valve intervention, and their deaths are mostly cardiac but not only sudden. Other end points besides sudden death should be considered during the decision to perform early intervention that are associated with improved survival.

7.
J Am Coll Cardiol ; 75(13): 1593-1604, 2020 04 07.
Artigo em Inglês | MEDLINE | ID: mdl-32241376

RESUMO

Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Análise Custo-Benefício , Interpretação Estatística de Dados , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
8.
Eur J Heart Fail ; 22(5): 871-879, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32043709

RESUMO

AIM: To evaluate the impact of left ventricular ejection fraction (LVEF) on 3-year outcomes in patients with left main coronary artery disease (LMCAD) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the EXCEL trial. METHODS AND RESULTS: The EXCEL trial randomized patients with LMCAD to PCI with everolimus-eluting stents (n = 948) or CABG (n = 957). Among 1804 patients with known baseline LVEF, 74 (4.1%) had LVEF <40% [heart failure with reduced ejection fraction (HFrEF)], 152 (8.4%) LVEF 40-49% [heart failure with mid-range ejection fraction (HFmrEF)] and 1578 (87.5%) LVEF ≥50% (heart failure with preserved ejection fraction). Patients with HFrEF vs. HFmrEF vs. preserved LVEF experienced a longer postoperative hospital stay (9.0 vs. 7.0 vs. 6.0 days, P = 0.02) with greater peri-procedural complications after CABG, while hospital stay after PCI was unaffected by LVEF (1.5 vs. 2.0 vs. 1.0 days, P = 0.20). The composite primary endpoint of death, stroke, or myocardial infarction at 3 years was 29.3% (PCI) vs. 27.6% (CABG) in patients with HFrEF, 16.2% vs. 15.0% in patients with HFmrEF, and 14.5% vs. 14.6% in those with preserved LVEF, respectively (Pinteraction  = 0.90). Smoothing spline analysis demonstrated that the 3-year risk of all-cause death increased when LVEF decreased, both in patients undergoing CABG and PCI. CONCLUSION: In the EXCEL trial, the composite rate of death, stroke or myocardial infarction at 3 years was significantly higher in patients with HFrEF compared with HFmrEF or preserved LVEF, driven by an increased rate of all-cause death. No significant differences after PCI vs. CABG were observed among patients with HFrEF, HFmrEF and preserved LVEF. Longer-term follow-up could provide important insights on differences in clinical outcomes that might emerge over time. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01205776.


Assuntos
Doença da Artéria Coronariana , Insuficiência Cardíaca , Intervenção Coronária Percutânea , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/cirurgia , Vasos Coronários , Humanos , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
9.
J Thorac Cardiovasc Surg ; 159(4): 1283-1292.e2, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31685277

RESUMO

OBJECTIVES: We evaluated the influence of transit-time flow measurement with epicardial and epiaortic high-frequency ultrasound in patients undergoing coronary artery bypass grafting procedure. METHODS: The Registry for Quality Assessment with Ultrasound Imaging and Transit-time Flow Measurement in Cardiac Bypass Surgery study is a multicenter, prospective study among 7 international centers performing coronary artery bypass grafting procedures. The primary end point was any change in the planned surgical procedure. Major secondary end points consisted of the rate and reason for surgical changes related to the aorta, in situ conduits, coronary targets, and completed grafts, and the rate of in-hospital mortality and major morbidity. RESULTS: Between April 2015 and December 2017, 1046 patients were enrolled. Of those, 1016 were included in the final analyses. Mean age was 65.9 years, 14.0% were women, and diabetes was present in 39.6%. Off-pump procedures were performed in 39.6% and bilateral internal thoracic arteries in 30.5%. The primary end point occurred in 25.2% of patients (n = 256) and in 77% (197 out of 256) this was based on transit-time flow measurement and/or high-frequency ultrasound. Surgical changes were related to the aorta in 9.9%, to in situ conduits in 2.7%, and the coronary targets in 22.6%. Graft revision occurred in 7.8%, including revisions of the proximal and/or distal anastomosis in 6.6%. In-hospital adverse event rates were 0.6% for mortality, 1.0% for cerebrovascular events, and 0.3% for myocardial infarction. CONCLUSIONS: Surgical changes related to the aorta, conduits, coronary targets, and anastomosis were made in 25% of patients. This was associated with low operative mortality and low major morbidity. Transit-time flow measurement and high-frequency ultrasound may improve the quality, safety, and efficacy of coronary artery bypass grafting procedures and should be considered as a routine procedural aspect.


Assuntos
Velocidade do Fluxo Sanguíneo , Ponte de Artéria Coronária , Ultrassonografia/métodos , Idoso , Ponte de Artéria Coronária/mortalidade , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Complicações Pós-Operatórias , Estudos Prospectivos , Sistema de Registros , Reoperação/estatística & dados numéricos
10.
EuroIntervention ; 16(1): 36-43, 2020 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-31422924

RESUMO

AIMS: Accurate risk prediction in patients undergoing revascularisation is essential. We aimed to assess the predictive performance of Society of Thoracic Surgeons (STS) risk models in patients with left main coronary artery disease (LMCAD) undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention with everolimus-eluting stents (PCI-EES). METHODS AND RESULTS: The predictive performance of STS risk models for perioperative mortality, stroke and renal failure was evaluated for their discriminative ability (C statistic) and calibration (Hosmer-Lemeshow goodness-of-fit-test; χ2 and p-values) among patients with LMCAD undergoing PCI-EES (n=935) and CABG (n=923) from the randomised EXCEL trial. STS risk scores, in CABG patients, showed good discrimination for 30-day mortality and average discrimination for stroke (C statistic 0.730 and 0.629, respectively) with average calibration. For PCI, STS risk scores had no discrimination for mortality (C statistic 0.507), yet good discrimination (C statistic 0.751) and calibration for stroke. The predictive performance for renal failure was good for CABG (C statistic 0.82), yet poor for PCI (C statistic 0.59). CONCLUSIONS: In selected patients with LMCAD from the EXCEL trial, STS risk models showed good predictive performance for CABG yet lacked predictive performance for PCI for perioperative mortality and renal failure. The STS stroke risk model was surprisingly more discriminating in PCI compared to CABG. Improved and procedure-specific risk prediction instruments are needed to accurately estimate adverse events after LMCAD revascularisation by CABG and PCI. ClinicalTrials.gov Identifier: NCT01205776.


Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Everolimo/administração & dosagem , Everolimo/farmacologia , Humanos , Prognóstico , Sociedades Médicas , Cirurgiões , Resultado do Tratamento
11.
EuroIntervention ; 16(3): 218-224, 2020 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-31763982

RESUMO

AIMS: The impact of final kissing balloon inflation (FKBI) after percutaneous coronary intervention (PCI) of bifurcation lesions on long-term clinical outcomes remains controversial. We sought to determine the impact of FKBI on four-year outcomes after PCI of distal left main (LM) bifurcation lesions. METHODS AND RESULTS: The EXCEL trial compared PCI with everolimus-eluting stents and coronary artery bypass graft surgery (CABG) in patients with left main (LM) disease. We examined four-year clinical outcomes after PCI of distal LM bifurcation lesions according to use of FKBI. The primary endpoint was the composite rate of death, myocardial infarction (MI), or stroke. The major secondary endpoint was the composite rate of death, MI, stroke, or ischaemia-driven revascularisation (IDR). Among 948 patients randomised to PCI, 759 had distal LM lesions treated, 430 of which were treated with one stent and 329 of which were treated with two or more stents. The four-year rates of the primary and major secondary endpoints were similar with versus without FKBI in both the one-stent and ≥2-stent groups in both unadjusted and adjusted analyses. CONCLUSIONS: In the EXCEL trial, the performance of FKBI after PCI of distal LM bifurcation lesions was not associated with improved four-year clinical outcomes regardless of whether one stent or ≥2 stents were implanted.


Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/patologia , Stents Farmacológicos/efeitos adversos , Everolimo/uso terapêutico , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Pesquisa Comparativa da Efetividade , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Humanos , Infarto do Miocárdio/patologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Acidente Vascular Cerebral/patologia , Resultado do Tratamento
12.
Artigo em Inglês | MEDLINE | ID: mdl-31864696

RESUMO

OBJECTIVE: Several recent-generation surgical tissue valves have been found to have bleeding rates exceeding rates recommended by regulatory bodies. We explored bleeding events using data from the Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial for the Avalus valve (Medtronic, Minneapolis, Minn) to examine whether this end point remains relevant for the evaluation of bioprostheses. METHODS: Patients (n = 1115) underwent aortic valve replacement. Bleeding and thromboembolic event episodes in patients within 3 years postimplant were analyzed for frequency, timing, and severity, focusing on patients taking antiplatelet/anticoagulant medications at the time of the event. Clinical and hemodynamic outcomes are also reported. RESULTS: At 3 years, the Kaplan-Meier cumulative probability estimate of all-cause death was 7.2% (cardiac, 3.6%; valve-related, 1.1%). The Kaplan-Meier cumulative probability estimates of all and major hemorrhage were 8.7% and 5.2%, respectively. Ninety-nine bleeding events occurred in 86 patients: most occurred >30 days postsurgery. Among the 51 late major bleeds, in 5 cases the patients were taking anticoagulant/antiplatelet medication for prophylaxis after surgical aortic valve replacement at the time of the event, whereas the remaining patients were taking medications for other reasons. Age (hazard ratio, 1.035; 95% confidence interval, 1.004-1.068), peripheral vascular disease (hazard ratio, 2.135; 95% confidence interval, 1.106-4.122), renal dysfunction (hazard ratio, 1.920; 95% confidence interval, 1.055-3.494), and antithrombotic medication use at the time of the event (hazard ratio, 1.417; 95% confidence interval, 1.048-1.915) were associated with late bleeds (major and minor). CONCLUSIONS: Overall clinical outcomes demonstrated low mortality and few complications except for major bleeding. Most bleeding events occurred >30 days after surgery and in patients taking antiplatelet and/or anticoagulation for indications other than postimplant prophylaxis.

13.
Lancet ; 394(10206): 1325-1334, 2019 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-31488373

RESUMO

BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 248 (28%) patients had died after PCI and 212 (24%) after CABG (hazard ratio 1·19 [95% CI 0·99-1·43], p=0·066). Among patients with three-vessel disease, 153 (28%) of 546 had died after PCI versus 114 (21%) of 549 after CABG (hazard ratio 1·42 [95% CI 1·11-1·81]), and among patients with left main coronary artery disease, 95 (27%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0·92 [0·69-1·22], pinteraction=0·023). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0·60) and no linear trend across SYNTAX score tertiles (ptrend=0·20). INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up).


Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea , Idoso , Doença da Artéria Coronariana/patologia , Stents Farmacológicos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Taxa de Sobrevida , Resultado do Tratamento
14.
N Engl J Med ; 381(19): 1820-1830, 2019 11 07.
Artigo em Inglês | MEDLINE | ID: mdl-31562798

RESUMO

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).


Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea , Idoso , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Everolimo/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Isquemia Miocárdica/terapia , Razão de Chances , Acidente Vascular Cerebral/epidemiologia
15.
JAMA Cardiol ; 4(8): 810-814, 2019 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-31215985

RESUMO

Importance: Surgical aortic valve replacement (SAVR) has increased risk for patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery. Transcatheter aortic valve replacement (TAVR) may be an alternative. Objective: To compare TAVR with SAVR outcomes in patients at intermediate operative risk with prior CABG surgery. Design, Setting, and Participants: In this post hoc analysis of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) noninferiority randomized clinical trial, patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017. Those with a history of CABG surgery were considered for analysis. Data were analyzed from September to December 2017. Interventions: A total of 1746 patients were enrolled and randomized 1:1 to self-expanding TAVR or SAVR. An implant was attempted in 1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR. Main Outcomes and Measures: The primary outcome was all-cause mortality or disabling stroke at 1-year follow-up. Efficacy outcomes included quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year. Results: Of the 136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years. The mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.0% (1.6%) in the TAVR cohort and 5.2% (1.7%) in the SAVR cohort. All-cause mortality or disabling stroke at 1-year follow-up was 8.9% (95% CI, 5.2-15.2) in the TAVR cohort and 6.7% (95% CI, 3.5-12.8) in the SAVR cohort (log-rank P = .53). Compared with patients receiving SAVR, the mean (SD) Kansas City Cardiomyopathy Questionnaire summary score was significantly better among patients receiving TAVR at 30 days (81.4 [19.2] vs 69.7 [22.6]; P < .001); treatments were similar at 1 year (85.7 [14.6] vs 82.8 [18.4]; P = .19). Compared with patients in the SAVR cohort, those in the TAVR cohort showed greater mean (SD) improvement in distance walked at 1 year (48.3 [120.6] m vs 16.8 [88.7] m; P = .04). Conclusions and Relevance: Both TAVR and SAVR were safe for intermediate-risk patients with AS and prior CABG surgery. The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up. Trial Registration: ClinicalTrials.gov identifier: NCT01586910.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Ponte de Artéria Coronária , Implante de Prótese de Valva Cardíaca/métodos , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Masculino , Medição de Risco , Substituição da Valva Aórtica Transcateter , Resultado do Tratamento
16.
EuroIntervention ; 15(6): e531-e538, 2019 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-31186220

RESUMO

AIMS: The impact of an occluded right coronary artery (RCA) in patients with left main coronary artery disease (LMCAD) undergoing revascularisation is unknown. We compared outcomes for patients with LMCAD randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of an occluded RCA in the EXCEL trial. METHODS AND RESULTS: The EXCEL trial randomised 1,905 patients with LMCAD and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus CABG. Patients were categorised according to whether they had an occluded RCA at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at three years. Among 1,753 patients with a dominant RCA by core laboratory analysis, the RCA was occluded in 130 (7.4%) at baseline. PCI was attempted in 34 of 65 patients with an occluded RCA (52.3%) and was successful in 27 (79.4% of those attempted; 41.5% of all RCAs recanalised). The RCA was bypassed in 42 of 65 patients with an occluded RCA (64.6%; p=0.0008 versus PCI). The three-year absolute and relative rates of the primary endpoint were similar between PCI and CABG, in patients with or without an occluded RCA (pinteraction=0.92). CONCLUSIONS: In the EXCEL trial, the presence of an occluded RCA at baseline did not confer a worse three-year prognosis in patients undergoing revascularisation for LMCAD and did not affect the relative outcomes of PCI versus CABG in this high-risk patient cohort.


Assuntos
Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Oclusão de Enxerto Vascular , Intervenção Coronária Percutânea/métodos , Acidente Vascular Cerebral/epidemiologia , Humanos , Prognóstico , Fatores de Tempo , Resultado do Tratamento
17.
J Am Coll Cardiol ; 73(15): 1877-1886, 2019 04 23.
Artigo em Inglês | MEDLINE | ID: mdl-30999989

RESUMO

BACKGROUND: Although results of percutaneous coronary intervention (PCI) have been steadily improving, whether surgical outcomes have improved over time is not fully elucidated. OBJECTIVES: This study sought to compare the current outcomes of patients undergoing coronary artery bypass grafting (CABG) with prior surgical results, in the context of randomized trials including the left main (LM) coronary artery stem. METHODS: The authors performed a propensity-matched analysis of patients randomized to CABG in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) (enrollment period 2005 to 2007) and EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) (enrollment period 2010 to 2014) trials. All patients had left main (LM) disease with or without multivessel disease. Adjustment was based on 15 clinical and angiographic variables, including anatomic SYNTAX score, with a 2:1 ratio for the EXCEL and SYNTAX trials, collectively analyzing 909 subjects (n = 580 and n = 329, respectively). The primary endpoint was the composite of all-cause death, myocardial infarction (MI), stroke, or ischemia-driven revascularization at 3 years. RESULTS: Baseline characteristics, anatomic SYNTAX score, number and types of grafts, and duration of hospitalization for the procedures were similar in both groups. CABG procedures in the EXCEL compared with the SYNTAX trial were more often off-pump (29.6% vs. 15.4%; p < 0.001), and guideline-directed medical therapies were used more frequently in the EXCEL surgical cohort. The primary endpoint occurred in 14.0% and 20.9% (p = 0.008) of patients in the EXCEL and SYNTAX trials, respectively. With the exception of MI (4.1% vs. 3.7%), all nonhierarchical events tended to contribute to the improved outcomes in the more recent trial: all-cause death (5.5% vs. 8.5%), stroke (3.1% vs. 5.1%), and ischemia-driven revascularization (7.1% vs. 9.4%) in the EXCEL and SYNTAX trials, respectively. CONCLUSIONS: Over a 5- to 7-year period, significant improvement in event-free survival after surgical revascularization for LM disease at 3 years was noted between the SYNTAX and EXCEL trials, consistent with improving results with cardiac surgery over time. (Synergy Between PCI With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972; Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).


Assuntos
Ponte de Artéria Coronária/mortalidade , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea/mortalidade , Intervenção Coronária Percutânea/métodos , Idoso , Causas de Morte , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Stents Farmacológicos , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Prospectivos , Medição de Risco , Índice de Gravidade de Doença , Taxa de Sobrevida , Fatores de Tempo , Resultado do Tratamento
18.
Eur J Cardiothorac Surg ; 56(4): 654-663, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-30907418

RESUMO

Despite there being numerous studies of intraoperative graft flow assessment by transit-time flow measurement (TTFM) on outcomes after coronary artery bypass grafting (CABG), the adoption of contemporary TTFM is low. Therefore, on 31 January 2018, a systematic literature search was performed to identify articles that reported (i) the amount of grafts classified as abnormal or which were revised or (ii) an association between TTFM and outcomes during follow-up. Random-effects models were used to create pooled estimates with 95% confidence intervals (CI) of (i) the rate of graft revision per patient, (ii) the rate of graft revision per graft and (iii) the rate of graft revision among grafts deemed abnormal based on TTFM parameters. The search yielded 242 articles, and 66 original articles were included in the systematic review. Of those articles, 35 studies reported on abnormal grafts or graft revisions (8943 patients, 15 673 grafts) and were included in the meta-analysis. In 4.3% of patients (95% CI 3.3-5.7%, I2 = 73.9) a revision was required and 2.0% of grafts (95% CI 1.5-2.5%; I2 = 66.0) were revised. The pooled rate of graft revisions among abnormal grafts was 25.1% (95% CI 15.5-37.9%; I2 = 80.2). Studies reported sensitivity ranging from 0.250 to 0.457 and the specificity from 0.939 to 0.984. Reported negative predictive values ranged from 0.719 to 0.980 and reported positive predictive values ranged from 0.100 to 0.840. This systematic review and meta-analysis showed that TTFM could improve CABG procedures. However, due to heterogeneous data, drawing uniform conclusions appeared challenging. Future studies should focus on determining the optimal use of TTFM and assessing its diagnostic accuracy.


Assuntos
Ponte de Artéria Coronária/normas , Circulação Coronária , Humanos , Fatores de Tempo , Resultado do Tratamento
20.
Interact Cardiovasc Thorac Surg ; 28(6): 852-859, 2019 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-30753554

RESUMO

OBJECTIVES: Our goal was to evaluate the outcomes of the first patients treated by venous coronary artery bypass grafting (CABG) or percutaneous coronary interventions (PCIs) with balloon angioplasty at a single centre who have reached up to 40 years of life-long follow-up. METHODS: We analysed the outcomes of the first consecutive patients who underwent (venous) CABG (n = 1041) from 1971 to 1980 and PCI (n = 856) with balloon angioplasty between 1980 and 1985. Follow-up was successfully achieved in 98% of patients (median 39 years, range 36-46) who underwent CABG and in 97% (median 33 years, range 32-36) of patients who had PCI. RESULTS: The median age was 53 years in the CABG cohort and 57 years in the PCI cohort. A total of 82% of patients in the CABG group and 37% of those in the PCI group had multivessel coronary artery disease. The cumulative survival rates at 10, 20, 30 and 40 years were 77%, 39%, 14% and 4% after CABG, respectively, and at 10, 20, 30 and 35 years after PCI were 78%, 47%, 21% and 12%, respectively. The estimated life expectancy after CABG was 18 and 17 years after the PCI procedures. Repeat revascularization was performed in 36% and 57% of the patients in the CABG and PCI cohorts, respectively. CONCLUSIONS: This unique life-long follow-up analysis demonstrates that both CABG and PCI were excellent treatment options immediately after their introduction as the standard of care. These procedures were lifesaving, thereby indirectly enabling patients to be treated with newly developed methods and medical therapies during the follow-up years.


Assuntos
Doença da Artéria Coronariana/cirurgia , Previsões , Revascularização Miocárdica/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/mortalidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Intervenção Coronária Percutânea/métodos , Taxa de Sobrevida/tendências , Resultado do Tratamento , Adulto Jovem
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