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1.
JACC Asia ; 2(2): 170-179, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36339121

RESUMO

Background: Drug-coated balloons (DCBs) offer an effective treatment for in-stent restenosis (ISR). The Genoss DCB is a novel paclitaxel-coated balloon with a shellac plus vitamin E excipient that enhances drug delivery to the target lesion, minimizing restenosis. Objectives: This study aimed to investigate the angiographic efficacy, clinical safety, and effectiveness of the novel shellac plus vitamin E-based DCB in a randomized controlled trial designed to enable regulatory approval of this new device in South Korea. Methods: This noninferiority trial randomized patients experiencing their first ISR to the novel shellac plus vitamin E-based DCB or the reference SeQuent Please iopromide-based DCB in a 1:1 ratio. All patients underwent planned angiographic and clinical follow-up at 6 months. The study was powered for the primary endpoint of 6 months in-segment late lumen loss (LLL). Results: A total of 82 patients from 7 centers were randomized to either the novel shellac plus vitamin E-based DCB group (n = 41) or the reference iopromide-based DCB group (n = 41). The 6-month in-segment LLL was 0.15 ± 0.43 mm with the novel DCB compared with 0.24 ± 0.39 mm with the reference device. The 1-sided 97.5% upper confidence limit of the difference was 0.13 mm, lower than the noninferiority limit of 0.29 mm, achieving noninferiority (P for noninferiority = 0.001). Major cardiovascular events were comparable between 2 groups at 6 months (7.7% for the novel DCB vs 10.3% for the reference DCB; P = 0.692). Conclusions: In this multicenter, head-to-head comparison randomized trial, the novel shellac plus vitamin E-based DCB showed a comparable result to the reference iopromide-based device for the primary endpoint of 6-month in-segment LLL for the treatment of coronary ISR. (Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patient With Coronary In-stent Restenosis; NCT04405063).

2.
Circulation ; 146(9): 687-698, 2022 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-35946404

RESUMO

BACKGROUND: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. METHODS: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. RESULTS: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64). CONCLUSIONS: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01070771.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Estenose Coronária/diagnóstico , Humanos , Qualidade de Vida , Medicina Estatal , Resultado do Tratamento
3.
Artigo em Inglês | MEDLINE | ID: mdl-36001991

RESUMO

AIMS: The aim of this study was to investigate the impact on 10-year survival of patient-reported anginal status at 1-year following percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in patients with left main coronary artery disease (LMCAD) and/or 3-vessel CAD (3VD). METHODS AND RESULTS: In this post-hoc analysis of the randomized SYNTAX Extended Survival study, patients were classified as having residual angina (RA) if their self-reported Seattle Angina Questionnaire angina frequency scale (SAQ-AF) was ≤ 90 at 1-year follow-up post revascularization with PCI or CABG. The primary endpoint of all-cause death at 10 years was compared between the RA and no-RA groups. A sensitivity analysis was performed using 6-month SAQ-AF.At 1-year, 373 (26.1%) out of 1428 patients reported RA. Whilst RA at 1-year was an independent correlate of repeat revascularization at 5 years (18.3% vs. 11.5%; adjusted hazard ratio [HR]: 1.54; 95% confidence interval [CI]: 1.10-2.15), it was not associated with all-cause death at 10 years (22.1% vs. 21.6%; adjusted HR: 1.11; 95%CI: 0.83-1.47). These results were consistent when stratified by modality of revascularization (PCI or CABG) or by anginal frequency. The sensitivity analysis replicating the analyses based on 6-month angina status resulted in similar findings. CONCLUSION: Among patients with LMCAD and/or 3VD, patient-reported RA at 1-year post revascularization was independently associated with repeat revascularization at 5 years, however it did not significantly increase 10-year mortality, irrespective of the primary modality of revascularization.

4.
Int J Cardiol ; 368: 28-38, 2022 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-35944766

RESUMO

AIMS: To investigate geographic disparity in long-term mortality following revascularization in patients with complex coronary artery disease (CAD). METHODS AND RESULTS: The SYNTAXES trial randomized 1800 patients with three-vessel and/or left main CAD to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) and assessed their survival at 10 years. Patients were stratified according to the region of recruitment: North America (N-A, n = 245), Eastern Europe (E-E, n = 189), Northern Europe (N-E, n = 425), Southern Europe (S-E, n = 263), and Western Europe (W-E, n = 678), which also served as the reference group. Compared to W-E, patients were younger in E-E (62 vs 65 years, p < 0.001), and less frequently male in N-A (65.3% vs 79.6%, p < 0.001). Diabetes (16.0% vs 25.4%, p < 0.001) and peripheral vascular disease (6.8% vs 10.9%, p = 0.025) were less frequent in N-E than W-E. Ejection fraction was highest in W-E (62% vs 56%, p < 0.001). Compared to W-E, the mean anatomic SYNTAX score was higher in S-E (29 vs 31, p = 0.008) and lower in N-A (26, p < 0.001). Crude ten-year mortality was similar in N-A (31.6%), and W-E (30.7%), and significantly lower in E-E (22.5%, p = 0.041), N-E (21.9%, p = 0.003) and S-E (22.0%, p = 0.014). Compared to W-E, adjusted mortality in N-E (HR 0.85, p = 0.019) and S-E (HR 0.72, p = 0.043) remain significantly lower after adjustment for pre- and peri-procedural factors, but no significant interaction (Pinteraction = 0.728) between region and modality of revascularization was seen. CONCLUSION: In the era of globalization, knowledge, and understanding of geographic disparity are of paramount importance for the correct interpretation of global studies.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Humanos , Masculino , Intervenção Coronária Percutânea/métodos , Resultado do Tratamento
6.
Expert Rev Cardiovasc Ther ; 20(7): 549-566, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35899781

RESUMO

INTRODUCTION: Non-obstructive coronary arteries (NOCA) are present in 39.7% to 62.4% of patients who undergo elective angiography. Coronary microcirculation (<400 µm) is not visible on angiography therefore functional assessment, invasive or noninvasive plays a prior role to help provide a more personalized diagnosis of angina. AREA COVERED: In this review, we revisit the pathophysiology, clinical importance, and invasive assessment of the coronary microcirculation, and discuss angiography-derived indices of microvascular resistance. A comprehensive literature review over four decades is also undertaken. EXPERT OPINION: The coronary microvasculature plays an important role in flow autoregulation and metabolic regulation. Invasive assessment of microvascular resistance is a validated modality with independent prognostic value, nevertheless, its routine application is hampered by the requirement of intravascular instrumentation and hyperemic agents. The angiography-derived index of microvascular resistance has emerged as a promising surrogate in pilot studies, however, more data are needed to validate and compare the diagnostic and prognostic accuracy of different equations as well as to illustrate the relationship between angiography-derived parameters for epicardial coronary arteries and those for the microvasculature.


Assuntos
Doença da Artéria Coronariana , Vasos Coronários , Angina Pectoris , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Circulação Coronária/fisiologia , Vasos Coronários/diagnóstico por imagem , Coração , Humanos , Microcirculação/fisiologia
7.
Circulation ; 146(17): 1268-1280, 2022 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-35862109

RESUMO

BACKGROUND: Clinical and anatomical characteristics are often considered key factors in deciding between percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with complex coronary artery disease (CAD) such as left-main CAD or 3-vessel disease. However, little is known about the interaction between self-reported preprocedural physical/mental health and clinical outcomes after revascularization. METHODS: This subgroup analysis of the SYNTAXES trial (SYNTAX Extended Survival), which is the extended follow-up of the randomized SYNTAX trial (Synergy Between PCI With Taxus and Cardiac Surgery) comparing PCI with CABG in patients with left-main CAD or 3-vessel disease, stratified patients by terciles of Physical (PCS) or Mental Component Summary (MCS) scores derived from the preprocedural 36-Item Short Form Health Survey, with higher PCS and MCS scores representing better physical and mental health, respectively. The primary end point was all-cause death at 10 years. RESULTS: A total of 1656 patients with preprocedural 36-Item Short Form Health Survey data were included in the present study. Both higher PCS and MCS were independently associated with lower 10-year mortality (10-point increase in PCS adjusted hazard ratio, 0.84 [95% CI, 0.73-0.97]; P=0.021; in MCS adjusted hazard ratio, 0.85 [95% CI, 0.76-0.95]; P=0.005). A significant survival benefit with CABG over PCI was observed in the highest PCS (>45.5) and MCS (>52.3) terciles with significant treatment-by-subgroup interactions (PCS Pinteraction=0.033, MCS Pinteraction=0.015). In patients with both high PCS (>45.5) and MCS (>52.3), 10-year mortality was significantly higher with PCI compared with CABG (30.5% versus 12.2%; hazard ratio, 2.87 [95% CI, 1.55-5.30]; P=0.001), whereas among those with low PCS (≤45.5) or low MCS (≤52.3), there were no significant differences in 10-year mortality between PCI and CABG, resulting in a significant treatment-by-subgroup interaction (Pinteraction=0.002). CONCLUSIONS: Among patients with left-main CAD or 3-vessel disease, patient-reported preprocedural physical and mental health status was strongly associated with long-term mortality and modified the relative treatment effects of PCI versus CABG. Patients with the best physical and mental health had better 10-year survival with CABG compared with PCI. Assessment of self-reported physical and mental health is important when selecting the optimal revascularization strategy. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; SYNTAXES Unique identifier: NCT03417050. URL: https://www. CLINICALTRIALS: gov; SYNTAX Unique identifier: NCT00114972.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Humanos , Doença da Artéria Coronariana/cirurgia , Saúde Mental , Medidas de Resultados Relatados pelo Paciente , Fatores de Risco , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto
8.
Heart ; 108(22): 1784-1791, 2022 10 28.
Artigo em Inglês | MEDLINE | ID: mdl-35732441

RESUMO

OBJECTIVE: We sought to investigate whether long-term clinical outcomes differ following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD) and lesions in the proximal left anterior descending artery (P-LAD). METHODS: This post-hoc analysis of the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) Extended Survival study included patients with 3VD who were classified according to the presence or absence of lesions located in the P-LAD. Ten-year all-cause death and 5-year major adverse cardiac or cerebrovascular events (MACCE) were assessed. RESULTS: Among 1088 patients with 3VD, 559 (51.4%) had involvement of P-LAD and their 10-year mortality was numerically higher following PCI versus CABG (28.9% vs 21.9%; HR: 1.39, 95% CI 0.99 to 1.95). Although patients without P-LAD lesions had significantly higher 10-year mortality following PCI compared with CABG, there was no evidence of a treatment-by-subgroup interaction (28.8% vs 20.2%; HR: 1.47, 95% CI 1.03 to 2.09, pinteraction=0.837). The incidence of MACCE at 5 years was significantly higher with PCI than CABG, irrespective of involvement of P-LAD (with P-LAD: HR: 1.86, 95% CI 1.36 to 2.55; without P-LAD: HR: 1.54, 95% CI 1.11 to 2.12; pinteraction=0.408). Individualised assessment using the SYNTAX Score II 2020 established that a quarter of patients with P-LAD lesions had significantly higher mortality with PCI than CABG, whereas in the remaining three-quarters CABG had similar mortality. CONCLUSIONS: Among patients with 3VD, the presence or absence of a P-LAD lesion was not associated with any treatment effect on long-term outcomes following PCI or CABG. TRIAL REGISTRATION NUMBER: SYNTAXES: NCT03417050; SYNTAX: NCT00114972.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Humanos , Artérias , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento
9.
Catheter Cardiovasc Interv ; 100(1): 72-82, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35500171

RESUMO

BACKGROUND: Several studies have suggested that proton pump inhibitors (PPIs) may reduce the antiplatelet effects of clopidogrel and/or aspirin, possibly leading to cardiovascular events. AIMS: We aimed to investigate the association between PPI and clinical outcomes in patients treated with ticagrelor monotherapy or conventional antiplatelet therapy after percutaneous coronary intervention (PCI). METHODS: This is a subanalysis of the randomized GLOBAL LEADERS trial, comparing the experimental antiplatelet arm (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with the reference arm (12-month aspirin monotherapy following 12-month DAPT) after PCI. Patient-oriented composite endpoints (POCEs: all-cause mortality, myocardial infarction, stroke, or repeat revascularization) and its components were assessed stratified by PPI use as a time-dependent covariate in patients with the experiment or reference antiplatelet arm. RESULTS: Among 15,839 patients, 2115 patients (13.5%) experienced POCE at 2 years. In the reference arm, the use of PPIs was independently associated with POCE (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 1.12-1.44) and its individual components, whereas it was not in the experimental arm (HR: 1.04; 95% CI: 0.92-1.19; pinteraction = 0.035). During the second-year follow-up, patients taking aspirin with PPIs had a significantly higher risk of POCE compared to those on aspirin without PPIs (HR: 1.57; 95% CI: 1.27-1.94), whereas the risk did not differ significantly irrespective of PPI in ticagrelor monotherapy group (HR: 1.03; 95% CI: 0.83-1.28; pinteraction = 0.008). CONCLUSIONS: In contrast to conventional antiplatelet strategy, there were no evidence suggesting the interaction between ticagrelor monotherapy and PPIs on increased cardiovascular events, which should be confirmed in further studies. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov.


Assuntos
Infarto do Miocárdio , Intervenção Coronária Percutânea , Aspirina , Humanos , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Bomba de Prótons , Ticagrelor , Resultado do Tratamento
10.
J Am Coll Cardiol ; 80(1): 63-88, 2022 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-35597684

RESUMO

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.


Assuntos
Doença da Artéria Coronariana , Implante de Prótese de Valva Cardíaca , Ásia , Cateterismo Cardíaco/métodos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/terapia , Europa (Continente) , Coração , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Resultado do Tratamento , Estados Unidos/epidemiologia
11.
EuroIntervention ; 2022 May 18.
Artigo em Inglês | MEDLINE | ID: mdl-35583108

RESUMO

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.

13.
JAMA Netw Open ; 5(5): e2214594, 2022 05 02.
Artigo em Inglês | MEDLINE | ID: mdl-35639378

RESUMO

Importance: Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation for patients with atrial fibrillation. However, the performance of LAAO among East Asian patients is unknown. Objective: To document the procedural success rate and configurations, major adverse event rates, and antithrombotic medication regimens during and after LAAO procedures among patients in China. Design, Setting, and Participants: In this cohort study, consecutive patients from 39 Chinese centers undergoing LAAO were prospectively enrolled between April 1, 2019, and October 31, 2020. Periprocedural and intraprocedural techniques and postprocedural medications were left to the surgeon's discretion. Data were analyzed from July 1 to November 1, 2021. Exposure: LAAO for patients with atrial fibrillation. Main Outcomes and Measures: The main outcomes were procedural success and complication rates periprocedure and major adverse event rates of death, stroke, systemic embolism, and bleeding events at 30 days postprocedure; the composite end point of death, stroke, and systemic embolism was also analyzed. Unadjusted and multivariable-adjusted logistic regression analyses were performed to assess the associations of periprocedural techniques (types of anesthesia, intraprocedural imaging modalities, and combined ablation procedure) with 30-day adverse events. Results: Among 3096 enrolled participants, 1782 participants (57.6%) were men, and the mean (SD) age was 69 (9) years. Participants had a high risk of stroke (mean [SD] cardiovascular risk score, 4.0 [1.8]) and a moderate-to-high risk of bleeding (mean [SD] bleeding risk score, 2.4 [1.2]). A total of 1287 procedures (41.6%) were performed under local anesthesia, while 493 procedures (15.9%) used only fluoroscopy guidance. In 1297 procedures (41.9%), LAAO implantation was combined with radiofrequency ablation or cryoablation for atrial fibrillation. Procedural success was achieved in 3032 patients (97.9%). At 30-day follow-up, the rate of the composite end point of death, stroke, or systemic embolism was 0.52% (95% CI, 0.32%-0.84%), and the rate of any life-threatening or major bleeding was 1.23% (95% CI, 0.90%-1.68%). No significant associations were observed between the procedural success or 30-day adverse events and the types of anesthesia (general or local), intraprocedural imaging (transesophageal echocardiography, fluoroscopy, or intracardiac echocardiography), or whether a combined ablation procedure was performed or not. In centers performing at least 40 procedures per year, compared with those performing fewer than 40 procedures per year, procedural success was significantly higher (adjusted odd ratio [aOR], 1.97; 95% CI, 1.01-3.53; P = .02) and risk of life-threatening or major bleeding was significantly lower (aOR, 0.42; 95% CI, 0.21-0.87; P = .02). Conclusions and Relevance: These findings suggest that patients with a high risk of stroke and moderate to high risk of bleeding who underwent implantation of a LAAO device in Chinese centers had high rates of procedural success and low rates of short-term ischemic and bleeding events.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Embolia , Acidente Vascular Cerebral , Idoso , Apêndice Atrial/cirurgia , Fibrilação Atrial/complicações , Fibrilação Atrial/cirurgia , China/epidemiologia , Estudos de Coortes , Embolia/complicações , Feminino , Hemorragia , Humanos , Masculino , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento
14.
JACC Cardiovasc Interv ; 15(12): 1231-1242, 2022 06 27.
Artigo em Inglês | MEDLINE | ID: mdl-35595676

RESUMO

BACKGROUND: Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with higher rates of adverse events, and currently it is unclear whether PCI or coronary artery bypass grafting (CABG) is the safer treatment for these patients at very long-term follow-up. OBJECTIVES: The aim of this study was to investigate the impact of bifurcation lesions on individual predicted and observed all-cause 10-year mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial. METHODS: In the SYNTAXES (SYNTAX Extended Survival) study, 10-year observed and individual predicted mortality derived from the SYNTAX score 2020 (SS-2020) was compared between patients with ≥1 bifurcation (n = 1,300) and those with no bifurcations (n = 487). RESULTS: Among patients treated with PCI, patients with >1 bifurcation lesion compared with those without bifurcation lesions had a significantly higher risk for all-cause death (19.8% vs 30.1%; HR: 1.55; 95% CI: 1.12-2.14; P = 0.007), whereas following CABG, mortality was similar in patients with and those without bifurcation lesions (23.3% vs 23.0%; HR: 0.81; 95% CI: 0.59-1.12; P = 0.207; Pinteraction = 0.006). In PCI patients, a 2-stent vs a 1-stent technique was associated with higher mortality (33.3% vs 25.9%; HR: 1.51; 95% CI: 1.06-2.14; P = 0.021). According to the SS-2020, among those with ≥1 bifurcation, there was equipoise for all-cause mortality between PCI and CABG in 2 quartiles of the population, whereas CABG was superior to PCI in the 2 remaining quartiles. CONCLUSIONS: Bifurcation lesions require special attention from the heart team, considering the higher 10-year all-cause mortality associated with PCI. Careful evaluation of bifurcation lesion complexity and calculation of individualized 10-year prognosis using the SS-2020 may therefore be helpful in decision making. (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
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Ponte de Artéria Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Humanos , Fatores de Risco , Resultado do Tratamento
15.
EuroIntervention ; 18(5): e377-e388, 2022 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-35260381

RESUMO

BACKGROUND: The optimal antiplatelet strategy in the second year after percutaneous coronary intervention (PCI) remains unclear. AIMS: We aimed to compare ticagrelor monotherapy with aspirin monotherapy on clinical outcomes beyond 1 year post-PCI. METHODS: This post hoc subanalysis of the open-label, all-comers, randomised GLOBAL LEADERS trial, which compared 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) with 12-month aspirin monotherapy following 12-month DAPT, only included patients who, at 12 months, were free from ischaemic and bleeding events and were adherent to their assigned antiplatelet therapy. The incidences of ischaemic events (all-cause death, any myocardial infarction, or any stroke) and bleeding events (Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) during the second year (12-24 months) were compared between patients receiving either ticagrelor or aspirin monotherapy. RESULTS: The present analysis included 11,121 (ticagrelor monotherapy n=5,308, and aspirin monotherapy n=5,813) of the 15,991 patients enrolled in GLOBAL LEADERS. During the second year, the ischaemic composite endpoint was lower with ticagrelor monotherapy compared to aspirin monotherapy (1.9% vs 2.6%: log-rank p=0.014, adjusted hazard ratio [HR] 0.74, 95% confidence interval [CI]: 0.58-0.96; p=0.022), which was primarily driven by a reduced risk of myocardial infarction. In contrast, BARC type 3 or 5 bleeding was numerically higher with ticagrelor monotherapy (0.5% vs 0.3%: log-rank p=0.051, adjusted HR 1.89, 95% CI: 1.03-3.45; p=0.005). CONCLUSIONS: Patients free from events at the end of the first year post-PCI and who adhered to their prescribed regimen had a reduced risk of ischaemic events compared to aspirin monotherapy in the second year post-PCI. CLINICALTRIALS: gov: NCT01813435.


Assuntos
Infarto do Miocárdio , Intervenção Coronária Percutânea , Aspirina/uso terapêutico , Quimioterapia Combinada , Hemorragia/etiologia , Humanos , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Ticagrelor/uso terapêutico , Resultado do Tratamento
16.
EuroIntervention ; 18(6): 492-502, 2022 Aug 19.
Artigo em Inglês | MEDLINE | ID: mdl-35285804

RESUMO

BACKGROUND: In the TALENT study, the sirolimus-eluting ultrathin strut Supraflex stent was non-inferior to the XIENCE stent for a device-oriented composite endpoint (DoCE: defined as cardiac death, target vessel myocardial infarction [TV-MI], or clinically indicated target lesion revascularisation [CI-TLR]) at 12 months. AIMS: This study investigated the 3-year outcomes of the TALENT trial and long-term impact of ultrathin drug-eluting stents (DES), compared to the XIENCE everolimus-eluting thin stent. METHODS: The TALENT trial is a prospective, multicentre, randomised all-comers trial comparing the Supraflex sirolimus-eluting stent with the XIENCE everolimus-eluting stent, with planned follow-up for 3 years. RESULTS: The TALENT trial enrolled 1,435 patients (Supraflex n=720, XIENCE n=715) with 3-year follow-up data available in 97.8% in the Supraflex group, and in 98.9% in the XIENCE group. At 3 years, DoCE occurred in 57 patients (8.1%) in the Supraflex group, and in 66 patients (9.4%) in the XIENCE group (p=0.406). There were no significant between-group differences in rates of cardiac death, TV-MI or CI-TLR. The rates of definite or probable stent thrombosis were low and similar between groups (1.1% vs 1.4%; p=0.640). In a meta-analysis of long-term follow-up (3-5 years), ultrathin strut DES tended to reduce DoCE (relative risk 0.89 [0.79-1.01]; p=0.068), compared to thicker strut DES. The risks for cardiac death and definite or probable stent thrombosis were similar between ultrathin strut DES and thicker strut DES. CONCLUSIONS: At 3-year follow-up, the use of the Supraflex stent was at least as safe and efficacious as the XIENCE stent in an all-comers population. CLINICALTRIALS: gov: NCT02870140.


Assuntos
Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Trombose , Morte , Everolimo/uso terapêutico , Humanos , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Sirolimo/uso terapêutico , Stents , Trombose/etiologia , Resultado do Tratamento
17.
Am Heart J ; 246: 32-43, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34990582

RESUMO

BACKGROUND: Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI). METHODS/DESIGN: The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non-inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years. SUMMARY: The PIONEER IV trial aims to demonstrate non-inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov UNIQUE IDENTIFIER: NCT04923191 CLASSIFICATIONS: Interventional Cardiology.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Angiografia Coronária , Doença da Artéria Coronariana/terapia , Humanos , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Stents , Ticagrelor/uso terapêutico , Resultado do Tratamento
18.
JACC Cardiovasc Interv ; 15(2): 193-204, 2022 01 24.
Artigo em Inglês | MEDLINE | ID: mdl-34973904

RESUMO

OBJECTIVES: The aim of this study was to assess 10-year all-cause mortality in patients with heavily calcified lesions (HCLs) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). BACKGROUND: Limited data are available on very long term outcomes in patients with HCLs according to the mode of revascularization. METHODS: This substudy of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study assessed 10-year all-cause mortality according to the presence of HCLs within lesions with >50% diameter stenosis and identified during the calculation of the anatomical SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score among 1,800 patients with the 3-vessel disease and/or left main disease randomized to PCI or CABG in the SYNTAX trial. Patients with HCLs were further stratified according to disease type (3-vessel disease or left main disease) and assigned treatment (PCI or CABG). RESULTS: The 532 patients with ≥1 HCL had a higher crude mortality rate at 10 years than those without (36.4% vs 22.3%; HR: 1.79; 95% CI: 1.49-2.16; P < 0.001). After adjustment, an HCL remained an independent predictor of 10-year mortality (HR: 1.36; 95% CI: 1.09-1.69; P = 0.006). There was a significant interaction in mortality between treatment effect (PCI and CABG) and the presence or absence of HCLs (Pinteraction = 0.005). In patients without HCLs, mortality was significantly higher after PCI than after CABG (26.0% vs 18.8%; HR: 1.44; 95% CI: 0.97-1.41; P = 0.003), whereas in those with HCLs, there was no significant difference (34.0% vs 39.0%; HR: 0.85; 95% CI: 0.64-1.13; P = 0.264). CONCLUSIONS: At 10 years, the presence of an HCL was an independent predictor of mortality, with a similar prognosis following PCI or CABG. Whether HCLs require special consideration when deciding the mode of revascularization beyond their current contribution to the anatomical SYNTAX score deserves further evaluation. (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).


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento
19.
PLoS One ; 17(1): e0262861, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35073365

RESUMO

We sought to assess the impact of sex on in-hospital mortality of patients with COVID-19 infection in South Korea. The study recruited 5,628 prospective consecutive patients who were hospitalized in South Korea with COVID-19 infection, and enrolled in the Korea Centers for Disease Control and Prevention (KCDC) dataset between January 20, 2020, and April 30, 2020. The primary endpoint was in-hospital death from COVID-19. The cohort comprised of 3,308 women (59%) and 2,320 men (41%). In-hospital death was significantly lower in women than men (3.5% vs. 5.5%, hazard ratio (HR): 0.61; 95% confidence interval (CI): 0.47 to 0.79, p <0.001). Results were consistent after multivariable regression (HR: 0.59; 95% CI: 0.41 to 0.85, p = 0.023) and propensity score matching (HR: 0.51; 95% CI: 0.30 to 0.86, p = 0.012). In South Korea, women had a significantly lower risk of in-hospital death amongst those patients hospitalized with COVID-19 infection.


Assuntos
COVID-19/mortalidade , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Mortalidade Hospitalar , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , República da Coreia/epidemiologia , Estudos Retrospectivos , Risco , Fatores Sexuais , Adulto Jovem
20.
Cardiovasc Revasc Med ; 38: 124-126, 2022 05.
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.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares
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