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1.
Medicine (Baltimore) ; 99(33): e20805, 2020 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-32871971

RESUMO

Patients with acute coronary syndrome (ACS) have an increased serum level of calprotectin. The purpose of present study was to analyze the prognostic significance of serum calprotectin levels in elderly diabetic patients underwent percutaneous coronary intervention (PCI) due to ACS.A total of 273 consecutive elderly diabetic patients underwent PCI for primary ACS were enrolled. Serum calprotectin levels were measured before PCI, and baseline clinical characteristics of all patients were collected. All patients were followed up at regular interval for major adverse cardiovascular events (MACEs) during 1 year after PCI. MACEs include cardiovascular death, nonfatal myocardial infarction, and target vessel revascularization (TVR). The predicting value of serum calprotectin for MACEs was analyzed by using univariate and multivariate analysis and receiver-operating characteristic curve (ROC).At the endpoint of this study, 47 patients of all 273 patients had MACEs. According to optimal cutoff value of calprotectin for predicting MACEs by ROC analysis, all patients were stratified into a high calprotectin group and a low calprotectin group. The incidence rate of MACEs and TVR in high calprotectin group was prominently higher than that in low calprotectin group (21.9% vs 11.5%, P = .02). In multivariable COX regression analysis adjusting for potential confounders, serum calprotectin level remains as an independent risk predictor of MACE (hazard ratio, 1.56; 95% confidence interval [CI]: 1.08-4.62; P = .01).In diabetic patients with a comorbidity of ACS, a high serum level of calprotectin is associated to a higher MACE rate after PCI.


Assuntos
Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/cirurgia , Complicações do Diabetes/sangue , Complexo Antígeno L1 Leucocitário/sangue , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/epidemiologia , Idoso , Biomarcadores/sangue , Estudos de Coortes , Comorbidade , Complicações do Diabetes/epidemiologia , Complicações do Diabetes/cirurgia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/sangue , Prognóstico
2.
JAMA ; 324(8): 761-771, 2020 08 25.
Artigo em Inglês | MEDLINE | ID: mdl-32840598

RESUMO

Importance: After percutaneous coronary intervention (PCI), patients with CYP2C19*2 or *3 loss-of-function (LOF) variants treated with clopidogrel have increased risk of ischemic events. Whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes is unknown. Objective: To determine the effect of a genotype-guided oral P2Y12 inhibitor strategy on ischemic outcomes in CYP2C19 LOF carriers after PCI. Design, Setting, and Participants: Open-label randomized clinical trial of 5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD). Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019. Interventions: Patients randomized to the genotype-guided group (n = 2652) underwent point-of-care genotyping. CYP2C19 LOF carriers were prescribed ticagrelor and noncarriers clopidogrel. Patients randomized to the conventional group (n = 2650) were prescribed clopidogrel and underwent genotyping after 12 months. Main Outcomes and Measures: The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia at 12 months. A secondary end point was major or minor bleeding at 12 months. The primary analysis was in patients with CYP2C19 LOF variants, and secondary analysis included all randomized patients. The trial had 85% power to detect a minimum hazard ratio of 0.50. Results: Among 5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial. Of 1849 with CYP2C19 LOF variants, 764 of 903 (85%) assigned to genotype-guided therapy received ticagrelor, and 932 of 946 (99%) assigned to conventional therapy received clopidogrel. The primary end point occurred in 35 of 903 CYP2C19 LOF carriers (4.0%) in the genotype-guided therapy group and 54 of 946 (5.9%) in the conventional therapy group at 12 months (hazard ratio [HR], 0.66 [95% CI, 0.43-1.02]; P = .06). None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58). Among all randomized patients, the primary end point occurred in 113 of 2641 (4.4%) in the genotype-guided group and 135 of 2635 (5.3%) in the conventional group (HR, 0.84 [95% CI, 0.65-1.07]; P = .16). Conclusions and Relevance: Among CYP2C19 LOF carriers with ACS and stable CAD undergoing PCI, genotype-guided selection of an oral P2Y12 inhibitor, compared with conventional clopidogrel therapy without point-of-care genotyping, resulted in no statistically significant difference in a composite end point of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia based on the prespecified analysis plan and the treatment effect that the study was powered to detect at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT01742117.


Assuntos
Clopidogrel/uso terapêutico , Doença da Artéria Coronariana/genética , Inibidores do Citocromo P-450 CYP2C19/uso terapêutico , Citocromo P-450 CYP2C19/genética , Intervenção Coronária Percutânea/efeitos adversos , Medicina de Precisão , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Ticagrelor/uso terapêutico , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/genética , Síndrome Coronariana Aguda/cirurgia , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Clopidogrel/efeitos adversos , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/terapia , Inibidores do Citocromo P-450 CYP2C19/efeitos adversos , Feminino , Genótipo , Técnicas de Genotipagem , Hemorragia/induzido quimicamente , Heterozigoto , Humanos , Mutação com Perda de Função , Masculino , Pessoa de Meia-Idade , Testes Imediatos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Ticagrelor/efeitos adversos
3.
Am Heart J ; 227: 111-117, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32739537

RESUMO

BACKGROUND: Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued. METHODS: The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure. CONCLUSIONS: The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Sirolimo/administração & dosagem , Implantes Absorvíveis , Estudos de Equivalência como Asunto , Humanos , Estudos Multicêntricos como Assunto , Polímeros , Estudos Prospectivos , Desenho de Prótese
4.
Am Heart J ; 228: 1-7, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32739652

RESUMO

BACKGROUND: Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear. STUDY DESIGN: The OPT-BIRISK trial is a multicenter, double-blinded, placebo-controlled randomized study designed to test the superiority of extended antiplatelet therapy with clopidogrel monotherapy compared with aspirin and clopidogrel for reduction of bleeding events in ACS patients with both high bleeding and high ischemic risks ("bi-risk"). A total of 7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS will be randomized to receive clopidogrel monotherapy or aspirin plus clopidogrel for 9 months followed by aspirin monotherapy for 3 months. The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization. The key secondary end point is major adverse cardiac and cerebral events at 9 months after randomization, defined as a composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization. CONCLUSIONS: OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.


Assuntos
Síndrome Coronariana Aguda , Aspirina , Clopidogrel , Hemorragia , Risco Ajustado/métodos , Acidente Vascular Cerebral , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Adulto , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Clopidogrel/administração & dosagem , Clopidogrel/efeitos adversos , Método Duplo-Cego , Stents Farmacológicos/efeitos adversos , Terapia Antiplaquetária Dupla/efeitos adversos , Terapia Antiplaquetária Dupla/métodos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Agregação de Plaquetas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/induzido quimicamente , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
5.
PLoS One ; 15(7): e0234655, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32614851

RESUMO

Inconsistent results exist regarding the treatment effectiveness of immediate versus deferred percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). This meta-analysis aimed to evaluate the efficacy and safety of immediate versus deferred PCI in ACS patients. PubMed, EMBASE, and Cochrane Library electronic databases were systematically searched from their inception up to August 2019. Random-effects models were employed to calculate pooled relative risks (RRs) and weight mean differences (WMDs) with 95% confidence intervals (CIs). A total of 10 randomized controlled trials (RCTs) that recruited 3350 patients were selected for inclusion in the final meta-analysis. Four trials included patients with non-ST elevation ACS (NSTEACS), whereas the remaining six trials included patients with ST elevation myocardial infarction (STEMI). There were no significant differences between immediate versus deferred PCI for the risk of major adverse cardiovascular events (NSTEACS patients: RR, 0.76, 95%CI, 0.33-1.75, P = 0.513; STEMI patients: RR, 1.24, 95%CI, 0.80-1.92, P = 0.335), myocardial infarction (NSTEACS patients: RR, 0.88, 95%CI, 0.27-2.81, P = 0.826; STEMI patients: RR, 0.86, 95%CI, 0.43-1.74, P = 0.678), all-cause mortality (NSTEACS patients: RR, 0.85, 95%CI, 0.38-1.88, P = 0.686; STEMI patients: RR, 1.16, 95%CI, 0.82-1.66, P = 0.407), target vessel revascularisation (NSTEACS patients: RR, 1.26, 95%CI, 0.29-5.43, P = 0.756; STEMI patients: RR, 1.01, 95%CI, 0.51-1.97, P = 0.988), or major bleeding (NSTEACS patients: RR, 0.99, 95%CI, 0.64-1.54, P = 0.972; STEMI patients: RR, 0.90, 95%CI, 0.45-1.77, P = 0.753). Although patients who underwent immediate PCI may experience increased incidences of cardiac death (RR, 1.19, 95%CI, 0.69-2.07, P = 0.525) and no or slow reflow (RR, 1.60, 95%CI, 0.91-2.84, P = 0.105), these increases were not statistically significant. We noted that immediate versus deferred PCI was associated with a reduced incidence of myocardial brush grade 3 (RR, 0.70, 95%CI, 0.56-0.88, P = 0.002); however, no significant differences were observed between immediate and deferred PCI for TIMI III flow (RR, 0.98, 95%CI, 0.93-1.03, P = 0.453), complete ST-segment resolution (RR, 0.93, 95%CI, 0.75-1.17, P = 0.548), and ejection fraction (WMD, -1.05, 95%CI, -2.58 to 0.49, P = 0.182). The findings of this study suggested that deferred PCI did not yield significant benefits for clinical endpoints. Further large-scale RCTs should be conducted to verify the findings of this study.


Assuntos
Síndrome Coronariana Aguda/cirurgia , Intervenção Coronária Percutânea , Tempo para o Tratamento , Idoso , Causas de Morte , Morte , Humanos , Pessoa de Meia-Idade , Mortalidade , Infarto do Miocárdio/epidemiologia , Reperfusão Miocárdica , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Hemorragia Pós-Operatória/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco , Volume Sistólico , Resultado do Tratamento
6.
PLoS One ; 15(7): e0235511, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32645042

RESUMO

BACKGROUND: There is recent new evidence regarding the combined use of direct oral antiocoagulants and antiplatelet agents in patients with Atrial Fibrillation undergoing PCI. PURPOSE: To compare the efficacy of dual antithrombotic treatment (DAT) including a direct oral anticoagulant (DOAC) and an antiplatelet agent versus triple antithrombotic treatment (TAT) with a vitamin K antagonist (VKA). DATA SOURCES: PubMed, SCOPUS and Google Scholar from through 09/09/2019; references of eligible studies; relevant scientific sessions abstracts and cardiology websites. STUDY SELECTION: Randomized controlled trials that compared DAT including a DOAC with TAT including a VKA and that reported at least the rates of stroke, Stent thrombosis and bleeding. DATA EXTRACTION: Two investigators independently extracted study data and assessed study quality. DATA SYNTHESIS: Four randomized trials that compared DAT including a DOAC with TAT including a VKA were available. Among these, one trial included two independent treatment arms with different DOAC dose, both compared against TAT. For this reason, the two arms were treated independently, resulting in 5 randomized comparisons available for meta-analysis, with a total of 8654 patients involved. The primary safety endpoint was significantly lower in the DAT arm (14.4%) compared to the TAT arm (23%) (RD = -0.08; p<0.001). In addition, we found no significant difference in the incidence of stroke between the treatment arms (p = 0.23). Similarly, no significant difference in the incidence of Stent Thrombosis between the treatment arms (p = 0.08). LIMITATIONS: All trials included were open-label, even though data were blindly analyzed. Qualifying criteria are heterogeneous. CONCLUSIONS: Compared TAT including a VKA, a therapeutic DAT regimen including a DOAC was associated with a significant reduction of the primary safety endpoint in AF patients undergoing PCI with stent implantation for an ACS or chronic coronary syndrome, while no significant difference was found in the rate of ischemic adverse events, including stroke, acute myocardial infarction or stent thrombosis.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Antitrombinas/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação de Plaquetas/uso terapêutico , Síndrome Coronariana Aguda/cirurgia , Antitrombinas/administração & dosagem , Antitrombinas/efeitos adversos , Fibrilação Atrial/cirurgia , Ensaios Clínicos como Assunto , Combinação de Medicamentos , Humanos , Inibidores da Agregação de Plaquetas/administração & dosagem
7.
PLoS One ; 15(6): e0234735, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32544195

RESUMO

BACKGROUND: With the emerging interest in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA), there is a need to define an even broader group of patients with the syndrome of myocardial ischemia with non-obstructive coronary arteries (INOCA). There are limited data on the clinical characteristics and prognoses of such patients who present with symptoms of acute coronary syndrome (ACS) and undergo urgent coronary angiography that reveals no significant lesions. The aim of this observational study was to compare patients with ACS INOCA and those with ACS with obstructive coronary artery disease (OCAD) both within unadjusted cohorts and with propensity score matched controls. METHODS AND RESULTS: This observational study was based on the data from the Polish National Registry of Invasive Cardiology Procedures. Of 9744 patients included, 7624 had OCAD and 2120 had ACS INOCA. In unadjusted cohorts, the overall survival and incidence of major adverse cardiovascular events (MACE: death, cardiac arrest, myocardial infarction, stroke, and heart failure hospitalization) until 36 months were higher in patients with ACS OCAD. Following propensity matching, higher win ratios of death (p = 0.02), additional revascularizations by percutaneous coronary intervention or coronary artery bypass graft surgery (p<0.001), and cardiac hospitalization (p<0.001) were observed in these patients. In contrast, the win ratios of myocardial infarction (p = 0.74), heart failure hospitalization (p = 0.86), and MACE (p = 0.07) were not significantly different between the groups. CONCLUSIONS: The prognosis of patients with ACS INOCA was more favorable than that of patients with ACS OCAD; however, the differences diminished after adjustments for the initial clinical profiles. An ACS incident should not be judged as trivial even when cardiac markers remain stable and no significant lesions are found on angiography.


Assuntos
Síndrome Coronariana Aguda/patologia , Vasos Coronários/diagnóstico por imagem , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/cirurgia , Idoso , Angiografia Coronária , Ponte de Artéria Coronária , Feminino , Humanos , Estimativa de Kaplan-Meier , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Prognóstico , Pontuação de Propensão , Sistema de Registros , Fatores de Risco , Prevenção Secundária
8.
Eur J Intern Med ; 76: 100-101, 2020 06.
Artigo em Inglês | MEDLINE | ID: covidwho-183001
11.
Eur J Intern Med ; 76: 100-101, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32359887
14.
J Card Surg ; 35(6): 1375-1379, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32333444

RESUMO

Spontaneous bleeding is rare in patients with factor XI deficiency and significant bleeding usually occurs after a trauma or a surgical procedure. It is difficult to maintain hemostatic balance in these patients. In the present case report, a 68-year-old male patient with no chronic disease was scheduled for elective cardiopulmonary bypass surgery. Eight units of fresh-frozen plasma (FFP) were slowly infused and the operation was initiated with the activated partial thromboplastin time (aPTT) of 34.5, which was 108.7 in the preoperative period. Tranexamic acid bolus was administered before the skin incision and continued throughout the operation. Intraoperative aPTT was measured intermittently and a total of six units of FFP were administered. After 76 minutes of cross-clamp time, the patient was separated from cardiopulmonary bypass without any problem. There is no consensus regarding the management of bleeding during cardiac surgery in patients with factor XI deficiency. The common approach includes normalizing the factor levels via FFP infusion or factor concentrates in the preoperative period, proceeding with surgery following the replacement, and close monitoring of perioperative factor levels and aPTT values.


Assuntos
Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/cirurgia , Perda Sanguínea Cirúrgica/prevenção & controle , Ponte de Artéria Coronária , Deficiência do Fator XI/cirurgia , Assistência Perioperatória/métodos , Idoso , Ponte Cardiopulmonar , Procedimentos Cirúrgicos Eletivos , Fator XI/metabolismo , Deficiência do Fator XI/sangue , Deficiência do Fator XI/complicações , Humanos , Monitorização Intraoperatória , Tempo de Tromboplastina Parcial , Plasma , Ácido Tranexâmico/administração & dosagem
15.
Clin Appl Thromb Hemost ; 26: 1076029620912814, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32191493

RESUMO

Shear stress (SS)-induced platelet activation is suggested as an essential mechanism of the acute coronary syndrome (ACS). We aimed to compare SS-induced thrombotic and thrombolytic activities among 3 treatment regimens in patients with ACS who underwent percutaneous coronary intervention (PCI). Patients were nonrandomly enrolled and treated with one of 3 regimens (TICA: ticagrelor 180 mg/d; RIVA: clopidogrel 75 mg/d and rivaroxaban 5 mg/d; CLP: clopidogrel 75 mg/d), administered in addition to aspirin (100 mg/d) for 30 days. The global thrombosis test was applied to measure SS-induced thrombotic (occlusion time [OT]) and thrombolytic activity (lysis time [LT]) at day 2 and 30. Aspirin reaction unit (ARU) and P2Y12 reaction unit (PRU) were simultaneously measured using VerifyNow. Group differences in the OT, LT, ARU, and PRU were evaluated. Seventy-five patients (25 patients in each group) finished 30 days of follow-up. Clinical and angiographic characteristics did not differ among the 3 groups, except ACS subtype and pre-PCI coronary flow. No major adverse cardiovascular events occurred in any group during follow-up. The OT and LT did not differ among the 3 groups at day 30 (OT: TICA, 447.2 ± 87.1 vs RIVA, 458.5 ± 70.3, vs CLP, 471.9 ± 90.7, LT: 1522.3 ± 426.5 vs 1734.6 ± 454.3 vs 1510.2 ± 593.9) despite significant differences in the PRU among the 3 groups. Shear stress-induced thrombotic and thrombolytic activities did not differ among the 3 investigated antithrombotic treatments.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Estresse Fisiológico , Síndrome Coronariana Aguda/cirurgia , Adulto , Idoso , Combinação de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas/uso terapêutico , Estudos Prospectivos
16.
Medicine (Baltimore) ; 99(10): e19458, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32150103

RESUMO

BACKGROUND: Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes. METHODS: We searched PubMed, Embase, the Cochrane Library, Web of Science, and relevant web sites for studies with a follow-up of ≥ 1 years that studied percutaneous coronary interventions with BVS vs second-generation DES in acute coronary syndromes. A meta-analysis was performed with the software RevMan following the standards of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. RESULTS: Five studies, 2 randomized controlled trials, and 3 observational studies, with a total of 1758 patients (BVS n = 917; DES n = 841) and a median follow-up duration of 24 months, were included. BVS, when compared with DES, resulted in higher rates of target lesion revascularization (TLR) (OR, 2.20; 95% CI, 1.12-3.64; P = .02) and stent/scaffold thrombosis (ST/ScT) (OR = 2.35, 95% CI: 1.13-4.89, P = .02). When TLR due to device thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR: 1.67, 95% CI: 0.73-3.82, P = .22). The risk for all-cause death (OR = 1.32 95% CI: 0.61-2.88, P = .48), cardiac death (OR = 1.29, 95% CI: 0.58-2.86 P = .52), target vessel myocardial infarction (OR = 1.50, 95% CI: 0.86-2.61, P = .15), and target lesion failure (OR = 1.34, 95% CI: 0.76-2.35, P = .31) did not differ between BVS and DES groups. CONCLUSION: At mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.


Assuntos
Implantes Absorvíveis , Síndrome Coronariana Aguda/cirurgia , Stents Farmacológicos , Tecidos Suporte , Everolimo , Humanos , Intervenção Coronária Percutânea , Desenho de Prótese , Fatores de Risco , Resultado do Tratamento
17.
Ann Intern Med ; 172(7): 474-483, 2020 04 07.
Artigo em Inglês | MEDLINE | ID: mdl-32176890

RESUMO

Background: The safety and effectiveness of dual therapy (direct oral anticoagulant [DOAC] plus P2Y12 inhibitor) versus triple therapy (vitamin K antagonist plus aspirin and P2Y12 inhibitor) in patients with nonvalvular atrial fibrillation (AF) after percutaneous coronary intervention (PCI) is unclear. Purpose: To examine the effects of dual versus triple therapy on bleeding and ischemic outcomes in adults with AF after PCI. Data Sources: Searches of PubMed, EMBASE, and the Cochrane Library (inception to 31 December 2019) and ClinicalTrials.gov (7 January 2020) without language restrictions; journal Web sites; and reference lists. Study Selection: Randomized controlled trials that compared the effects of dual versus triple therapy on bleeding, mortality, and ischemic events in adults with AF after PCI. Data Extraction: Two independent investigators abstracted data, assessed the quality of evidence, and rated the certainty of evidence. Data Synthesis: Four trials encompassing 7953 patients were selected. At the median follow-up of 1 year, high-certainty evidence showed that dual therapy was associated with reduced risk for major bleeding compared with triple therapy (risk difference [RD], -0.013 [95% CI, -0.025 to -0.002]). Low-certainty evidence showed inconclusive effects of dual versus triple therapy on risks for all-cause mortality (RD, 0.004 [CI, -0.010 to 0.017]), cardiovascular mortality (RD, 0.001 [CI, -0.011 to 0.013]), myocardial infarction (RD, 0.003 [CI, -0.010 to 0.017]), stent thrombosis (RD, 0.003 [CI, -0.005 to 0.010]), and stroke (RD, -0.003 [CI, -0.010 to 0.005]). The upper bounds of the CIs for these effects were compatible with possible increased risks with dual therapy. Limitation: Heterogeneity of study designs, dosages of DOACs, and types of P2Y12 inhibitors. Conclusion: In adults with AF after PCI, dual therapy reduces risk for bleeding compared with triple therapy, whereas its effects on risks for death and ischemic end points are still unclear. Primary Funding Source: None.


Assuntos
Síndrome Coronariana Aguda/cirurgia , Fibrilação Atrial/tratamento farmacológico , Intervenção Coronária Percutânea , Terapia Trombolítica/métodos , Aspirina/uso terapêutico , Quimioterapia Combinada , Fibrinolíticos/uso terapêutico , Humanos , Inibidores da Agregação de Plaquetas/uso terapêutico , Complicações Pós-Operatórias/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Medicine (Baltimore) ; 99(8): e19119, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32080086

RESUMO

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.


Assuntos
Antibacterianos/uso terapêutico , Stents Farmacológicos/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/uso terapêutico , Implantes Absorvíveis/efeitos adversos , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/cirurgia , Idoso , Implante de Prótese Vascular/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Diabetes Mellitus/epidemiologia , Stents Farmacológicos/tendências , Oclusão de Enxerto Vascular/epidemiologia , Humanos , Pessoa de Meia-Idade , Infarto do Miocárdio sem Supradesnível do Segmento ST/complicações , Infarto do Miocárdio sem Supradesnível do Segmento ST/epidemiologia , Polímeros , Padrões de Prática Médica/normas , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/complicações , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Resultado do Tratamento
20.
Am J Cardiol ; 125(8): 1142-1147, 2020 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-32087994

RESUMO

Bleeding risk stratification is an unresolved issue in older adults. Anemia may reflect subclinical blood losses that can be exacerbated after percutaneous coronary intervention . We sought to prospectively determine the contribution of anemia to the risk of bleeding in 448 consecutive patients aged 75 or more years, treated by percutaneous coronary interventions without concomitant indication for oral anticoagulation. We evaluated the effect of WHO-defined anemia on the incidence of 1-year nonaccess site-related major bleeding. The prevalence of anemia was 39%, and 13.1% of anemic and 5.2% of nonanemic patients suffered a bleeding event (hazard ratio 2.75, 95% confidence interval 1.37 to 5.54, p = 0.004). Neither PRECISE-DAPT nor CRUSADE scores were superior to hemoglobin for the prediction of bleeding. In conclusion, anemia is a powerful predictor of bleeding with potential utility for simplifying tailoring therapies.


Assuntos
Síndrome Coronariana Aguda/cirurgia , Anemia/epidemiologia , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação de Plaquetas/uso terapêutico , Hemorragia Pós-Operatória/epidemiologia , Síndrome Coronariana Aguda/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Angina Instável/epidemiologia , Angina Instável/cirurgia , Anticoagulantes/uso terapêutico , Antitrombinas/uso terapêutico , Aspirina/uso terapêutico , Causas de Morte , Clopidogrel/uso terapêutico , Comorbidade , Doença da Artéria Coronariana/epidemiologia , Stents Farmacológicos , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/mortalidade , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/mortalidade , Heparina/uso terapêutico , Hirudinas , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/epidemiologia , Hemorragias Intracranianas/mortalidade , Estimativa de Kaplan-Meier , Masculino , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/cirurgia , Fragmentos de Peptídeos/uso terapêutico , Cuidados Pós-Operatórios , Hemorragia Pós-Operatória/induzido quimicamente , Hemorragia Pós-Operatória/mortalidade , Cloridrato de Prasugrel/uso terapêutico , Modelos de Riscos Proporcionais , Estudos Prospectivos , Proteínas Recombinantes/uso terapêutico , Medição de Risco , Stents , Ticagrelor/uso terapêutico , Doenças Urológicas/induzido quimicamente , Doenças Urológicas/epidemiologia , Doenças Urológicas/mortalidade
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