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1.
Circ Cardiovasc Qual Outcomes ; : CIRCOUTCOMES121008055, 2021 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-34666500

RESUMO

BACKGROUND: In clinical trials, the optimal method of adjudicating revascularization events as clinically or nonclinically indicated (CI) is to use an independent Clinical Events Committee (CEC). However, the Academic Research Consortium-2 currently recommends using physiological assessment. The level of agreement between these methods of adjudication remains unknown. METHODS: Data for all CEC adjudicated revascularization events among the 3457 patients followed-up for 2-years in the TALENT trial, and 3-years in the DESSOLVE III, PIONEER, and SYNTAX II trial were collected and readjudicated according to a quantitative flow ratio (QFR) analysis of the revascularized vessels, by an independent core lab blinded to the results of the conventional CEC adjudication. The κ statistic was used to assess the level of agreement between the 2 methods. RESULTS: In total, 351 CEC-adjudicated repeat revascularization events occurred, with retrospective QFR analysis successfully performed in 212 (60.4%). According to QFR analysis, 104 events (QFR ≤0.80) were adjudicated as CI revascularizations and 108 (QFR >0.80) were not. The agreement between CEC and QFR based adjudication was just fair (κ=0.335). Between the 2 methods of adjudication, there was a disagreement of 26.4% and 7.1% in CI and non-CI revascularization, respectively. Overall, the concordance and discordance rates were 66.5% and 33.5%, respectively. CONCLUSIONS: In this event-level analysis, QFR based adjudication had a relatively low agreement with CEC adjudication with respect to whether revascularization events were CI or not. CEC adjudication appears to overestimate CI revascularization as compared with QFR adjudication. Direct comparison between these 2 strategies in terms of revascularization adjudication is warranted in future trials. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: TALENT trial: NCT02870140, DESSOLVE III trial: NCT02385279, SYNTAX II: NCT02015832, and PIONEER trial: NCT02236975.

2.
Artigo em Inglês | MEDLINE | ID: mdl-34503909

RESUMO

BACKGROUND: Medical and/or economic reasons sometimes necessitate the staging of percutaneous coronary intervention (SPCI) procedures in patients with complex coronary artery disease; however, the impact of this on very long-term outcomes is unknown. The aim of the present study is to assess 10-year all-cause mortality in patients with the three-vessel disease (3VD) and/or left main disease (LM) undergoing SPCI. METHODS: This is a sub-analysis of patients undergoing SPCI in the SYNTAXES study, which investigated 10-year all-cause mortality in patients with 3VD and/or LM in the randomized SYNTAX trial, beyond its original 5-year follow-up. An SPCI was allowed within 72 h or, if renal insufficiency or contrast-induced nephropathy occurred, within 14 days of the index procedure. Mortality was compared between patients having SPCI versus those not having SPCI or undergoing CABG. PCI patients were further stratified according to 3VD or LM. RESULTS: In the SYNTAX PCI population (overall: n = 903, 3VD: n = 546, LM: n = 357), 125 (13.8%) patients underwent SPCI. Patients with SPCI had a higher 10-year mortality compared to those who didn't (40.0% vs 26.6%; hazard ratio [HR] 1.69; 95% confidence interval [CI] 1.23-2.32; p < 0.01) and those having CABG(40.0% vs 24.5%; HR 1.85; 95%CI 1.35-2.53; p < 0.01). Patients having SPCI with 3VD (n = 103) or LM (n = 22) had higher mortality than respective patients not having SPCI (3VD: 37.4% vs 27.1%; HR 1.52; 95%CI 1.05-2.21; p = 0.03 and LM: 51.8% vs 25.9%; HR 2.39; 95%CI 1.27-4.47; p = 0.01). CONCLUSIONS: At 10-year follow-up, SPCI was associated with higher mortality than single-session PCI, so that CABG may be preferable if a staged procedure is anticipated.

3.
J Am Coll Cardiol ; 78(12): 1227-1238, 2021 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-34531023

RESUMO

BACKGROUND: The SYNTAX score II 2020 (SSII-2020) was derived from cross correlation and externally validated in randomized trials to predict death and major adverse cardiac and cerebrovascular events (MACE) following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with 3-vessel disease (3VD) and/or left main coronary artery disease (LMCAD). OBJECTIVES: The authors aimed to investigate the SSII-2020's value in identifying the safest modality of revascularization in a non-randomized setting. METHODS: Five-year mortality and MACE were assessed in 7,362 patients with 3VD and/or LMCAD enrolled in a Japanese PCI/CABG registry. The discriminative abilities of the SSII-2020 were assessed using Harrell's C statistic. Agreement between observed and predicted event rates following PCI or CABG and treatment benefit (absolute risk difference [ARD]) for these outcomes were assessed by calibration plots. RESULTS: The SSII-2020 for 5-year mortality well predicted the prognosis after PCI and CABG (C-index = 0.72, intercept = -0.11, slope = 0.92). When patients were grouped according to the predicted 5-year mortality ARD, <4.5% (equipoise of PCI and CABG) and ≥4.5% (CABG better), the observed mortality rates after PCI and CABG were not significantly different in patients with lower predicted ARD (observed ARD: 2.1% [95% CI: -0.4% to 4.4%]), and the significant difference in survival in favor of CABG was observed in patients with higher predicted ARD (observed ARD: 9.7% [95% CI: 6.1%-13.3%]). For MACE, the SSII-2020 could not recommend a specific treatment with sufficient accuracy. CONCLUSIONS: The SSII-2020 for predicting 5-year death has the potential to support decision making on revascularization in patients with 3VD and/or LMCAD.

4.
Eur Heart J ; 2021 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-34405232

RESUMO

AIMS: The aim of this article was to compare rates of all-cause death at 10 years following coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in patients with or without diabetes. METHODS AND RESULTS: The SYNTAXES study evaluated up to 10-year survival of 1800 patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) randomized to receive either PCI or CABG in the SYNTAX trial. Ten-year all-cause death according to diabetic status and revascularization strategy was examined. In diabetics (n = 452), the risk of mortality was numerically higher with PCI compared with CABG at 5 years [19.6% vs. 13.3%, hazard ratio (HR): 1.53, 95% confidence interval (CI): 0.96, 2.43, P = 0.075], with the opposite seen between 5 and 10 years (PCI vs. CABG: 20.8% vs. 24.4%, HR: 0.82, 95% CI: 0.52, 1.27, P = 0.366). Irrespective of diabetic status, there was no significant difference in all-cause death at 10 years between patients receiving PCI or CABG, the absolute treatment difference was 1.9% in diabetics (PCI vs. CABG: 36.4% vs. 34.5%, difference: 1.9%, 95% CI: -7.6%, 11.1%, P = 0.551). Among insulin-treated patients (n = 182), all-cause death at 10 years was numerically higher with PCI (47.9% vs. 39.6%, difference: 8.2%, 95% CI: -6.5%, 22.5%, P = 0.227). CONCLUSIONS: The treatment effects of PCI vs. CABG on all-cause death at 10 years in patients with 3VD and/or LMCAD were similar irrespective of the presence of diabetes. There may, however, be a survival benefit with CABG in patients with insulin-treated diabetes. The association between revascularization strategy and very long-term ischaemic and safety outcomes for patients with diabetes needs further investigation in dedicated trials. TRIAL REGISTRATION: SYNTAX: ClinicalTrials.gov reference: NCT00114972 and SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.

5.
Eur Heart J ; 2021 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-34405875

RESUMO

AIM: The aim of this study was to compare long-term all-cause mortality between patients receiving percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) using multiple (MAG) or single arterial grafting (SAG). METHODS AND RESULTS: The current study is a post hoc analysis of the SYNTAX Extended Survival Study, which compared PCI with CABG in patients with three-vessel (3VD) and/or left main coronary artery disease (LMCAD) and evaluated survival with ≥10 years of follow-up. The primary endpoint was all-cause mortality at maximum follow-up (median 11.9 years) assessed in the as-treated population. Of the 1743 patients, 901 (51.7%) underwent PCI, 532 (30.5%) received SAG, and 310 (17.8%) had MAG. At maximum follow-up, all-cause death occurred in 305 (33.9%), 175 (32.9%), and 70 (22.6%) patients in the PCI, SAG, and MAG groups, respectively (P < 0.001). Multiple arterial grafting [adjusted hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.49-0.89], but not SAG (adjusted HR 0.83, 95% CI 0.67-1.03), was associated with significantly lower all-cause mortality compared with PCI. In patients with 3VD, both MAG (adjusted HR 0.55, 95% CI 0.37-0.81) and SAG (adjusted HR 0.68, 95% CI 0.50-0.91) were associated with significantly lower mortality than PCI, whereas in LMCAD patients, no significant differences between PCI and MAG (adjusted HR 0.90, 95% CI 0.56-1.46) or SAG (adjusted HR 1.11, 95% CI 0.81-1.53) were observed. In patients with revascularization of all three major myocardial territories, a positive correlation was observed between the number of myocardial territories receiving arterial grafts and survival (Ptrend = 0.003). CONCLUSION: Our findings suggest that MAG might be the more desirable configuration for CABG to achieve lower long-term all-cause mortality than PCI in patients with 3VD and/or LMCAD. TRIAL REGISTRATION: Registered on clinicaltrial.gov. SYNTAXES: NCT03417050 (https://clinicaltrials.gov/ct2/show/NCT03417050); SYNTAX: NCT00114972 (https://www.clinicaltrials.gov/ct2/show/NCT00114972).

7.
Clin Res Cardiol ; 110(10): 1680-1691, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34432113

RESUMO

AIMS: To investigate the impact of established cardiovascular disease (CVD) on 10-year all-cause death following coronary revascularization in patients with complex coronary artery disease (CAD). METHODS: The SYNTAXES study assessed vital status out to 10 years of patients with complex CAD enrolled in the SYNTAX trial. The relative efficacy of PCI versus CABG in terms of 10-year all-cause death was assessed according to co-existing CVD. RESULTS: Established CVD status was recorded in 1771 (98.3%) patients, of whom 827 (46.7%) had established CVD. Compared to those without CVD, patients with CVD had a significantly higher risk of 10-year all-cause death (31.4% vs. 21.7%; adjusted HR: 1.40; 95% CI 1.08-1.80, p = 0.010). In patients with CVD, PCI had a non-significant numerically higher risk of 10-year all-cause death compared with CABG (35.9% vs. 27.2%; adjusted HR: 1.14; 95% CI 0.83-1.58, p = 0.412). The relative treatment effects of PCI versus CABG on 10-year all-cause death in patients with complex CAD were similar irrespective of the presence of CVD (p-interaction = 0.986). Only those patients with CVD in ≥ 2 territories had a higher risk of 10-year all-cause death (adjusted HR: 2.99, 95% CI 2.11-4.23, p < 0.001) compared to those without CVD. CONCLUSIONS: The presence of CVD involving more than one territory was associated with a significantly increased risk of 10-year all-cause death, which was non-significantly higher in complex CAD patients treated with PCI compared with CABG. Acceptable long-term outcomes were observed, suggesting that patients with established CVD should not be precluded from undergoing invasive angiography or revascularization. TRIAL REGISTRATION: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.

8.
Int J Cardiol ; 341: 9-12, 2021 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-34375706

RESUMO

BACKGROUND: The significant interaction between major infection and 5-year mortality after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for complex coronary artery disease (CAD) was observed previously. However, the very long-term outcomes beyond 5 years remains unclear. METHODS AND RESULTS: This is a subgroup analysis of the SYNTAX Extended Survival (SYNTAXES) trial, which is the extended follow-up of the randomized SYNTAX trial comparing PCI versus CABG in patients with three-vessel disease (3VD) or left-main CAD (LMCAD). Out of 1517 patients enrolled in the SYNTAX trial with available survival status from 5 to 10 years, 140 patients had experienced major infections and survived at 5 years (major infection group). From 5 to 10 years, the mortality of major infection group was 19.8% whereas the mortality of no major infection group was 15.1% (p = 0.157). After the adjustment of other clinical factors, the risk of mortality from 5 to 10 years did not significantly differ between major infection and no major infection groups (HR: 1.10; 95% CI: 0.62-1.96; p = 0.740). When stratified by the presence or absence of periprocedural major infections, defined as a major infection within 60 days after index procedure, there was also no significant difference in 10-year mortality between two groups (30.8% vs. 24.5%; p = 0.057). CONCLUSIONS: Despite the initial association between major infections and 5 years mortality, postprocedural major infection was not evident in the 10 years follow-up, suggesting that the impact of major infection on mortality subsided over time beyond 5 years. TRIAL REGISTRATION: SYNTAXES ClinicalTrials.gov reference: NCT03417050 SYNTAX ClinicalTrials.gov reference: NCT00114972.

9.
Eur Heart J ; 2021 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-34338767

RESUMO

AIMS: Data suggest that women have worse outcomes than men after coronary artery bypass grafting (CABG), but results have been inconsistent across studies. Due to the large differences in baseline characteristics between sexes, suboptimal risk adjustment due to low-quality data may be the reason for the observed differences. To overcome this limitation, we undertook a systematic review and pooled analysis of high-quality individual patient data from large CABG trials to compare the adjusted outcomes of women and men. METHODS AND RESULTS: The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), stroke, and repeat revascularization (major adverse cardiac and cerebrovascular events, MACCE). The secondary outcome was all-cause mortality. Multivariable mixed-effect Cox regression was used. Four trials involving 13 193 patients (10 479 males; 2714 females) were included. Over 5 years of follow-up, women had a significantly higher risk of MACCE [adjusted hazard ratio (HR) 1.12, 95% confidence interval (CI) 1.04-1.21; P = 0.004] but similar mortality (adjusted HR 1.03, 95% CI 0.94-1.14; P = 0.51) compared to men. Women had higher incidence of MI (adjusted HR 1.30, 95% CI 1.11-1.52) and repeat revascularization (adjusted HR 1.22, 95% CI 1.04-1.43) but not stroke (adjusted HR 1.17, 95% CI 0.90-1.52). The difference in MACCE between sexes was not significant in patients 75 years and older. The use of off-pump surgery and multiple arterial grafting did not modify the difference between sexes. CONCLUSIONS: Women have worse outcomes than men in the first 5 years after CABG. This difference is not significant in patients aged over 75 years and is not affected by the surgical technique.

10.
J Am Coll Cardiol ; 78(7): 713-736, 2021 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-34384554

RESUMO

Coronary computed tomography angiography (CTA) has shown great technological improvements over the last 2 decades. High accuracy of CTA in detecting significant coronary stenosis has promoted CTA as a substitute for conventional invasive coronary angiography in patients with suspected coronary artery disease. In patients with coronary stenosis, CTA-derived physiological assessment is surrogate for intracoronary pressure and velocity wires, and renders possible decision-making about revascularization solely based on computed tomography. Computed tomography coronary anatomy with functionality assessment could potentially become a first line in diagnosis. Noninvasive imaging assessment of plaque burden and morphology is becoming a valuable substitute for intravascular imaging. Recently, wall shear stress and perivascular inflammation have been introduced. These assessments could support risk management for both primary and secondary cardiovascular prevention. Anatomy, functionality, and plaque composition by CTA tend to replace invasive assessment. Complete CTA assessment could provide a 1-stop-shop for diagnosis, risk management, and decision-making on treatment.

12.
J Am Coll Cardiol ; 78(1): 27-38, 2021 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-34210411

RESUMO

BACKGROUND: The benefit of optimal medical therapy (OMT) on 5-year outcomes in patients with 3-vessel disease and/or left main disease after percutaneous coronary intervention or coronary artery bypass grafting (CABG) was demonstrated in the randomized SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial. OBJECTIVES: The objective of this analysis is to assess the impact of the status of OMT at 5 years on 10-year mortality after percutaneous coronary intervention or CABG. METHODS: This is a subanalysis of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which evaluated for up to 10 years the vital status of patients who were originally enrolled in the SYNTAX trial. OMT was defined as the combination of 4 types of medications: at least 1 antiplatelet drug, statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and beta-blocker. After stratifying participants by the number of individual OMT agents at 5 years and randomized treatment, a landmark analysis was conducted to assess the association between treatment response and 10-year mortality. RESULTS: In 1,472 patients, patients on OMT at 5 years had a significantly lower mortality at 10 years compared with those on ≤2 types of medications (13.1% vs 19.9%; adjusted HR: 0.470; 95% CI: 0.292-0.757; P = 0.002) but had a mortality similar to those on 3 types of medications. Furthermore, patients undergoing CABG with the individual OMT agents, antiplatelet drug and statin, at 5 years had lower 10-year mortality than those without. CONCLUSIONS: In patients with 3-vessel and/or left main disease undergoing percutaneous coronary intervention or CABG, medication status at 5 years had a significant impact on 10-year mortality. Patients on OMT with guideline-recommended pharmacologic therapy at 5 years had a survival benefit. (Synergy Between PCI With Taxus and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; Taxus Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).


Assuntos
Antagonistas Adrenérgicos beta/administração & dosagem , Antagonistas de Receptores de Angiotensina/administração & dosagem , Inibidores da Enzima Conversora de Angiotensina/administração & dosagem , Ponte de Artéria Coronária , Doença da Artéria Coronariana , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/administração & dosagem , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Quimioterapia Combinada/métodos , Quimioterapia Combinada/estatística & dados numéricos , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Período Pós-Operatório , Resultado do Tratamento
13.
Eur Heart J Acute Cardiovasc Care ; 10(7): 756-773, 2021 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-34212187

RESUMO

AIM: To evaluate the efficacy and safety of ticagrelor monotherapy beyond 1 month and up to 24 months vs. standard 12-month dual antiplatelet therapy (DAPT) with aspirin and ticagrelor followed by aspirin monotherapy among ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) in the GLOBAL LEADERS trial. METHODS AND RESULTS: We performed a post hoc analysis of STEMI patients in the GLOBAL LEADERS trial comparing experimental ticagrelor monotherapy (1062 patients) with standard 12-month DAPT (1030 patients). We evaluated predefined primary and secondary endpoints in both treatment arms. Rates of net adverse clinical events (NACE), patient-oriented composite endpoints (POCE), and bleeding academic research consortium (BARC)-defined bleeding Type 3 or 5 were also evaluated. At 2 years, there were no significant differences in rates of primary endpoints in patients who had STEMI [0.89 (0.61-1.31)]. There were similar rates of NACE and POCE in both experimental and reference treatment groups at 2 years post-PCI [hazard ratio (HR) 0.96 (0.77-1.20) and 0.96 (0.77-1.21), respectively]. BARC 3 or 5 bleeding events were numerically less in experimental compared to reference treatment groups at 1 year [HR 0.55 (0.27-1.13)] and 2 years [0.61 (0.32-1.16)]. CONCLUSION: Presentation with STEMI has not influenced the incidence of GLOBAL LEADERS defined primary endpoints. There were no significant differences in rates of NACE, POCE, and BARC bleeding between the two treatment groups up to 2 years of follow-up. Although these findings should be viewed as exploratory, they expand the evidence on potential safety of aspirin-free antiplatelet strategies after PCI in STEMI.

14.
J Am Coll Cardiol ; 78(4): 384-407, 2021 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-34294273

RESUMO

Over the last 4 decades, percutaneous coronary intervention has evolved dramatically and is now an acceptable treatment option for patients with advanced coronary artery disease. However, trialists have struggled to establish the respective roles for percutaneous coronary intervention and coronary artery bypass graft surgery, especially in patients with multivessel disease and unprotected left-main stem coronary artery disease. Several pivotal trials and meta-analyses comparing these 2 revascularization strategies have enabled the relative merits of each technique to be established with regard to the type of ischemic syndrome, the coronary anatomy, and the patient's overall comorbidity. Precision medicine with individualized prognosis is emerging as an important method of selecting treatment. However, the never-ending advancement of technology, in conjunction with the emergence of novel pharmacological agents, will in the future continue to force us to reconsider the evolving question: "Which treatment strategy is better and for which patient?"

16.
J Am Coll Cardiol ; 77(22): 2761-2773, 2021 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-34082905

RESUMO

BACKGROUND: The optimal revascularization strategy for the elderly with complex coronary artery disease remains unclear. OBJECTIVES: The goal of this study was to investigate 10-year all-cause mortality, life expectancy, 5-year major adverse cardiac or cerebrovascular events (MACCE), and 5-year quality of life (QOL) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in elderly individuals (>70 years old) with 3-vessel disease (3VD) and/or left main disease (LMD). METHODS: In the present pre-specified analysis on age of the SYNTAX Extended Survival study, 10-year all-cause death and 5-year MACCE were compared with Kaplan-Meier estimates and Cox proportional hazards models among elderly or nonelderly patients. Life expectancy was estimated by restricted mean survival time within 10 years, and QOL status according to the Seattle Angina Questionnaire up to 5 years was assessed by linear mixed-effects models. RESULTS: Among 1,800 randomized patients, 575 patients (31.9%) were elderly. Ten-year mortality did not differ significantly between PCI and CABG in elderly (44.1% vs. 41.1%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.84 to 1.40) and nonelderly patients (21.1% vs. 16.6%; HR: 1.30; 95% CI: 1.00 to 1.69; pinteraction = 0.332). Among elderly patients, 5-year MACCE was comparable between PCI and CABG (39.4% vs. 35.1%; HR: 1.18; 95% CI: 0.90 to 1.56), whereas it was significantly higher in PCI over CABG among nonelderly patients (36.3% vs. 23.0%; HR: 1.69; 95% CI: 1.36 to 2.10; pinteraction = 0.043). There were no significant difference in life expectancy (mean difference: 0.2 years in favor of CABG; 95% CI: -0.4 to 0.7) and 5-year QOL status between PCI and CABG among elderly patients. CONCLUSIONS: Elderly patients with 3VD and/or LMD had comparable 10-year all-cause death, life expectancy, 5-year MACCE, and 5-year QOL status irrespective of revascularization mode. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050) (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).

17.
Am Heart J ; 239: 19-26, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33992606

RESUMO

Angiography-derived physiological assessment of coronary lesions has emerged as an alternative to wire-based assessment aiming at less-invasiveness and shorter procedural time as well as cost effectiveness in physiology-guided decision making. However, current available image-derived physiology software have limitations including the requirement of multiple projections and are time consuming. METHODS/DESIGN: The ReVEAL iFR (Radiographic imaging Validation and EvALuation for Angio-iFR) trial is a multicenter, multicontinental, validation study which aims to validate the diagnostic accuracy of the Angio-iFR medical software device (Philips, San Diego, US) in patients undergoing angiography for Chronic Coronary Syndrome (CCS). The Angio-iFR will enable operators to predict both the iFR and FFR value within a few seconds from a single projection of cine angiography by using a lumped parameter fluid dynamics model. Approximately 440 patients with at least one de-novo 40% to 90% stenosis by visual angiographic assessment will be enrolled in the study. The primary endpoint is the sensitivity and specificity of the iFR and FFR for a given lesion compared to the corresponding invasive measures. The enrollment started in August 2019, and was completed in March 2021. SUMMARY: The Angio-iFR system has the potential of simplifying physiological evaluation of coronary stenosis compared with available systems, providing estimates of both FFR and iFR. The ReVEAL iFR study will investigate the predictive performance of the novel Angio-iFR software in CCS patients. Ultimately, based on its unique characteristics, the Angio-iFR system may contribute to improve adoption of functional coronary assessment and the workflow in the catheter laboratory.


Assuntos
Angiografia Coronária , Estenose Coronária/diagnóstico por imagem , Vasos Coronários , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Software/normas , Angiografia Coronária/métodos , Angiografia Coronária/tendências , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/fisiopatologia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/fisiopatologia , Precisão da Medição Dimensional , Humanos , Avaliação de Resultados em Cuidados de Saúde , Valor Preditivo dos Testes , Sensibilidade e Especificidade , Índice de Gravidade de Doença
18.
Am J Cardiol ; 151: 30-38, 2021 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-34049676

RESUMO

Numerous studies have demonstrated a paradoxical association between higher baseline body mass index (BMI) and lower long-term mortality risk after coronary revascularization, known as the "obesity paradox", possibly relying on the single use of BMI. The current study is a post-hoc analysis of the SYNTAX Extended Survival (SYNTAXES) trial, which is the extended follow-up of the SYNTAX trial comparing percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) in patients with left-main coronary artery disease (LMCAD) or three-vessel disease (3VD). Patients were stratified according to baseline BMI and/or waist circumference (WC). Out of 1,800 patients, 1,799 (99.9%) and 1,587 (88.2%) had available baseline BMI and WC data, respectively. Of those, 1,327 (73.8%) patients had High BMI (≥25 kg/m2), whereas 705 (44.4%) patients had High WC (>102 cm for men or >88 cm for women). When stratified by both BMI and WC, 10-year mortality risk was significantly higher in patients with Low BMI/Low WC (adjusted hazard ratio [HR]: 1.65; 95% confidence interval [CI]: 1.09 to 2.51), Low BMI/ High WC (adjusted HR: 2.74; 95% CI: 1.12 to 6.69), or High BMI/High WC (adjusted HR: 1.59; 95% CI: 1.11 to 2.27) compared to those with High BMI/Low WC. In conclusion, the "obesity paradox" following coronary revascularization would be driven by low long-term mortality risk of the High BMI/Low WC group. Body composition should be assessed by the combination of BMI and WC in the appropriate evaluation of the long-term risk of obesity in patients with LMCAD or 3VD.


Assuntos
Índice de Massa Corporal , Doença da Artéria Coronariana/cirurgia , Mortalidade , Revascularização Miocárdica , Obesidade/epidemiologia , Circunferência da Cintura , Idoso , Composição Corporal , Ponte de Artéria Coronária , Doença da Artéria Coronariana/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Prognóstico , Modelos de Riscos Proporcionais
19.
Catheter Cardiovasc Interv ; 98(3): E379-E387, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33951265

RESUMO

OBJECTIVES: We investigated the impact of total stent length (TSL) and average nominal stent diameter (ASD) on 10-year mortality after percutaneous coronary intervention (PCI) in the SYNTAXES trial. BACKGROUND: TSL and ASD in patients treated with PCI are associated with major adverse cardiovascular events. However, the treatment effect of PCI with extensive and/or small stenting as compared with coronary artery bypass grafting (CABG) for complex coronary artery disease has not been fully evaluated. METHODS: Impacts on mortality of extensive stenting defined as TSL >100 mm and small stenting as ASD <3 mm were analyzed in 893 PCI patients and were compared to 865 CABG patients. RESULTS: TSL as a continuous variable was significantly associated with 10-year mortality (adjusted hazard ratio [HR], 1.05 [1.01-1.09] per 10 mm increase). PCI patients with extensive stenting had a higher 10 year mortality than CABG patients (adjusted HR, 1.97 [1.41-2.74]) or not- extensive stenting PCI (adjusted HR, 1.94 [1.36-2.77]). Although ASD did not have a significant association with 10 year mortality (adjusted HR, 0.97 [0.85-1.11] per 0.25 mm increase), PCI with small stents was associated with a higher 10 year mortality, compared to CABG (adjusted HR, 1.66 [1.23-2.26]) and PCI performed with large stents (adjusted HR, 1.74 [1.19-2.53]). Patients treated with not-extensive and large stents had similar mortality rates (24.0 versus 23.8%) as those treated with CABG. CONCLUSIONS: Extensive and small stenting were associated with higher 10 year mortality, compared with CABG. When patients have to be treated with extensive or small stenting, revascularization with CABG should be preferred.

20.
Catheter Cardiovasc Interv ; 98(4): E513-E522, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34000088

RESUMO

OBJECTIVES: This study aimed to assess the predictive ability of the Global Registry of Acute Coronary Events (GRACE) risk score 2.0 in contemporary acute coronary syndrome (ACS) patients, and its relation to antiplatelet strategies. BACKGROUND: The predictive value of the GRACE risk score in the contemporary ACS cohort and the appropriate antiplatelet regimen according to the risk remain unclear. METHODS: This is a subgroup analysis of the all-comers, randomized GLOBAL LEADERS trial, comparing ticagrelor monotherapy versus conventional dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). The GRACE risk score 2.0 with 1-year mortality prediction was implemented. The randomized antiplatelet effect was assessed in predefined three GRACE risk-groups; low-risk (GRACE <109), moderate-risk (GRACE 109-140), and high-risk (GRACE >140). RESULTS: The GRACE risk score was available in 6,594 out of 7,487 ACS patients among whom 1,743, 2,823, and 2,028 patients were classified as low-risk, moderate-risk, and high-risk, respectively. At 1 year, all-cause mortality occurred in 120 patients (1.8%). The discrimination ability of the GRACE model was moderate (C-statistic = 0.742), whereas 1-year mortality risk was overestimated (mean predicted mortality rate: 3.9%; the Hosmer-Lemeshow chi-square: 21.47; p = 0.006). There were no significant interactions between the GRACE risk strata and effects of the ticagrelor monotherapy on ischemic or bleeding outcomes at 1 year compared to the reference strategy. CONCLUSION: The GRACE risk score 2.0 is valuable in discriminating high risk ACS patients, however, the recalibration of the score is recommended for better risk stratification. There is no significant differences in efficacy and safety of ticagrelor monotherapy across the three GRACE risk strata.

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