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1.
JAMA Cardiol ; 8(7): 703-708, 2023 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-37203243

RESUMO

Importance: Titanium-nitride-oxide (TiNO)-coated stents show faster strut coverage compared with drug-eluting stents without excessive intimal-hyperplasia observed in bare metal stents. It is important to study long-term clinical outcomes after treatment of patients with an acute coronary syndrome (ACS) by TiNO-coated stents, which are neither drug-eluting stents nor bare metal stents. Objective: To compare the rate of main composite outcome of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 5 years in patients with ACS randomized to receive either a TiNO-coated stent or a third-generation everolimus-eluting stent (EES). Design, Setting, and Participants: This multicenter, randomized, controlled, open-label trial was conducted in 12 clinical sites in 5 European countries and enrolled patients from January 2014 to August 2016. Patients presenting with ACS (ST-segment elevation MI, non-ST-segment elevation MI, and unstable angina) with at least 1 de novo lesion were randomized to receive either a TiNO-coated stent or an EES. The present report analyzes the long-term follow-up for the main composite outcome and its individual components. Analysis took place between November 2022 to March 2023. Main outcome: The primary end point was a composite of cardiac death, MI, or target lesion revascularization at 12-month follow-up. Results: A total of 1491 patients with ACS were randomly assigned to receive either TiNO-coated stents (989 [66.3%]) or EES (502 [33.7%]). The mean (SD) age was 62.7 (10.8) years, and 363 (24.3%) were female. At 5 years, the main composite outcome events occurred in 111 patients (11.2%) in the TiNO group vs 60 patients (12%) in the EES group (hazard ratio [HR], 0.94; 95% CI, 0.69-1.28; P = .69). The rate of cardiac death was 0.9% (9 of 989) vs 3.0% (15 of 502) (HR, 0.30; 95% CI, 0.13-0.69; P = .005), the rate of MI was 4.6% (45 of 989) vs 7.0% (35 of 502) (HR, 0.64; 95% CI, 0.41-0.99; P = .049), the rate of stent thrombosis was 1.2% (12 of 989) vs 2.8% (14 of 502) (HR, 0.43; 95% CI, 0.20-0.93; P = .034), and the rate of target lesion revascularization was 7.4% (73 of 989) vs 6.4% (32 of 502) (HR, 1.16; 95% CI, 0.77-1.76; P = .47) in the TiNO-coated stent arm and in the EES arm, respectively. Conclusion and relevance: In this study, patients with ACS had a main composite outcome that was not different 5 years after TiNO-coated stent or EES. Trial Registration: ClinicalTrials.gov Identifier: NCT02049229.


Assuntos
Síndrome Coronariana Aguda , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Everolimo/farmacologia , Everolimo/uso terapêutico , Síndrome Coronariana Aguda/cirurgia , Síndrome Coronariana Aguda/tratamento farmacológico , Resultado do Tratamento , Intervenção Coronária Percutânea/efeitos adversos , Stents , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , Morte
2.
JAMA Netw Open ; 6(1): e2253942, 2023 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-36719679

RESUMO

Importance: Each approach for primary total hip arthroplasty (THA) has a long learning curve, so a surgeon's choice to change their preferred approach needs to be guided by clear justifications. However, current evidence does not suggest that any of the THA approaches are more beneficial than others, and the choice of approach is mainly based on the knowledge and experience of the surgeon and individual patient characteristics. Objective: To assess the efficacy and safety associated with different surgical approaches for THA. Data Sources: A comprehensive search of PubMed, EMBASE, and Cochrane databases from inception to March 26, 2022; reference lists of eligible trials; and related reviews. Study Selection: Randomized clinical trials (RCTs) comparing different surgical approaches, including the 2-incision approach, direct anterior approach (DAA), direct lateral approach (DLA), minimally invasive direct lateral approach (MIS-DLA), minimally invasive anterolateral approach (MIS-ALA), posterior approach (PA), minimally invasive posterior approach (MIS-PA), and supercapsular percutaneously assisted total hip arthroplasty (SuperPath), for primary THA. Data Extraction and Synthesis: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, 2 reviewers independently extracted data on study participants, interventions, and outcomes as well as assessed the risk of bias using the Cochrane risk of bias tool and the certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation framework. A frequentist framework was used to inform a series of random-effects network meta-analyses. Main Outcomes and Measures: The outcomes were hip score (range, 0-100, with higher scores indicating better overall hip condition), pain score (range, 0-100, with higher scores indicating more pain), hospitalization time, operation time, quality of life score, blood loss, cup abduction angle, and cup anteversion angle. Results: Of 2130 retrieved studies, 63 RCTs including 4859 participants (median [IQR] age, 64.0 [60.3-66.5] years; median [IQR] percentage male, 46.74% [38.64%-54.74%]) were eligible for analysis. Eight surgical approaches were evaluated. For hip score, DAA (mean difference [MD], 4.04; 95% CI, 1.92 to 6.16; moderate certainty), MIS-ALA (MD, 3.00; 95% CI, 0.43 to 5.59; moderate certainty), MIS-DLA (MD, 3.37; 95% CI, 1.05 to 5.68; moderate certainty), MIS-PA (MD, 4.46; 95% CI, 1.60 to 7.31; moderate certainty), PA (MD, 4.37; 95% CI, 1.87 to 6.88; high certainty), and SuperPath (MD, 5.00; 95% CI, 0.58 to 9.42; high certainty) were associated with greater improvement in hip score compared with DLA. DLA was associated with lower decrease in pain score than SuperPath (MD, 1.16; 95% CI, 0.13 to 2.20; high certainty) and MIS-DLA (MD, 0.90; 95% CI, 0.04 to 1.76; moderate certainty). PA was associated with shorter operation times compared with 2-incision (MD, -23.85 minutes; 95% CI, -36.60 to -11.10 minutes; high certainty), DAA (MD, -13.94 minutes; 95% CI, -18.79 to -9.08 minutes; moderate certainty), DLA (MD, -10.50 minutes; 95% CI, -16.07 to -4.94 minutes; high certainty), MIS-ALA (MD, -6.76 minutes; 95% CI, -12.86 to -0.65 minutes; moderate certainty), and SuperPath (MD, -13.91 minutes; 95% CI, -21.87 to -5.95 minutes; moderate certainty). The incidence of 6 types of complications did not differ significantly between the approaches. Conclusions and Relevance: In this study, moderate to high certainty evidence indicated that compared with PA, all surgical approaches except DLA were associated with similar improvements of hip score but longer operation time. DLA was associated with smaller improvement of hip score. The safety of the different approaches did not show significant differences. These findings will help health professionals and patients with better clinical decision-making and also provide references for policy makers.


Assuntos
Artroplastia de Quadril , Masculino , Humanos , Pessoa de Meia-Idade , Metanálise em Rede , Dor
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