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2.
Artigo em Inglês | MEDLINE | ID: mdl-32012453

RESUMO

BACKGROUND: A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI). METHODS: All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried. RESULTS: Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results. CONCLUSIONS: In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).

3.
EuroIntervention ; 15(15): e1299-e1300, 2020 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-32014833
4.
Nat Rev Cardiol ; 2020 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-31953535

RESUMO

Advances in antiplatelet therapies for patients with cardiovascular disease have improved patient outcomes over time, but the challenge of balancing the risks of ischaemia and bleeding remains substantial. Moreover, many patients with cardiovascular disease have a residual risk of ischaemic events despite receiving antiplatelet therapy. Therefore, novel strategies are needed to prevent clinical events through mechanisms beyond platelet inhibition and with an acceptable associated risk of bleeding. The advent of non-vitamin K antagonist oral anticoagulants, which attenuate fibrin formation by selective inhibition of factor Xa or thrombin, has renewed the interest in dual-pathway inhibition strategies that combine an antiplatelet agent with an anticoagulant drug. In this Review, we highlight the emerging pharmacological rationale and clinical development of dual-pathway inhibition strategies for the prevention of atherothrombotic events in patients with different manifestations of cardiovascular disease, such as coronary artery disease, cerebrovascular disease and peripheral artery disease.

5.
JACC Cardiovasc Interv ; 13(2): 257-260, 2020 Jan 27.
Artigo em Inglês | MEDLINE | ID: mdl-31973798

RESUMO

In the evolving scenario of transcatheter aortic valve replacement (TAVR), the topic of bioprosthetic valve durability is becoming increasingly important. Unfortunately, the definition of long-term durability of surgical and transcatheter bioprostheses has been inconsistent over time. Comparative studies of TAVR and surgical aortic valve replacement, or studies comparing TAVR devices, would benefit from the use of standardized definitions of valve durability. The definitions of structural valve deterioration and bioprosthetic valve failure developed by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) have been endorsed by both the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) and embraced by many investigators worldwide. In this viewpoint, the authors discuss the strengths and limitations of such approach, which is intended to balance the need for accuracy and simplicity in reporting of long-term durability.

6.
Clin Res Cardiol ; 2020 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-31925529

RESUMO

BACKGROUND: Impaired renal function (IRF) is associated with increased risks of both ischemic and bleeding events. Ticagrelor has been shown to provide greater absolute reduction in ischemic risk following acute coronary syndrome (ACS) in those with versus without IRF. METHODS: A pre-specified sub-analysis of the randomized GLOBAL LEADERS trial (n = 15,991) comparing the experimental strategy of 23-month ticagrelor monotherapy (after 1-month ticagrelor and aspirin dual anti-platelet therapy [DAPT]) with 12-month DAPT followed by 12-month aspirin after percutaneous coronary intervention (PCI) in ACS and stable coronary artery disease (CAD) patients stratified according to IRF (glomerular filtration rate < 60 ml/min/1.73 m2). RESULTS: At 2 years, patients with IRF (n = 2171) had a higher rate of the primary endpoint (all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction [MI](hazard ratio [HR] 1.64, 95% confidence interval [CI] 1.35-1.98, padj = 0.001), all-cause death, site-reported MI, all revascularization and BARC 3 or 5 type bleeding, compared with patients without IRF. Among patients with IRF, there were similar rates of the primary endpoint (HR 0.82, 95% CI 0.61-1.11, p = 0.192, pint = 0.680) and BARC 3 or 5 type bleeding (HR 1.10, 95% CI 0.71-1.71, p = 0.656, pint = 0.506) in the experimental versus the reference group. No significant interactions were seen between IRF and treatment effect for any of the secondary outcome variables. Among ACS patients with IRF, there were no between-group differences in the rates of the primary endpoint or BARC 3 or 5 type bleeding; however, the rates of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, MI, or revascularization (pint = 0.028) and net adverse clinical events (POCE and BARC 3 or 5 type bleeding) (pint = 0.045), were lower in the experimental versus the reference group. No treatment effects were found in stable CAD patients categorized according to presence of IRF. CONCLUSIONS: IRF negatively impacted long-term prognosis after PCI. There were no differential treatment effects found with regard to all-cause death or new Q-wave MI after PCI in patients with IRF treated with ticagrelor monotherapy. CLINICAL TRIAL REGISTRATION: The trial has been registered with ClinicalTrials.gov, number NCT01813435.

7.
Am J Cardiol ; 125(4): 491-499, 2020 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-31889527

RESUMO

Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with thin stents (<100 microns) in unprotected left main (ULM) or coronary bifurcation remain undefined. All consecutive patients presenting with a critical lesion of an ULM or involving a main coronary bifurcation who were treated with very thin strut stents were included. MACE (a composite end point of cardiovascular death, myocardial infarction [MI], target lesion revascularization [TLR], and stent thrombosis [ST]) was the primary endpoint, whereas target vessel revascularization (TVR) was the secondary endpoint, with particular attention to type and occurrence of ST and occurrence of ST, CV death, and MI during DAPT or after DAPT discontinuation. All analyses were performed according to length of DAPT dividing the patients in 3 groups: Short DAPT (3-months), intermediate DAPT (3 to 12 months), and long DAPT (12-months). A total of 117 patients were discharged with an indication for DAPT ≤3 months (median 1: 1 to 2.5), 200 for DAPT between 3 and 12 months (median 8: 7 to 10), and 1,958 with 12 months DAPT. After 12.8 months (8 to 20), MACE was significantly higher in the 3-month group compared with 3 to 12 and 12-month groups (9.4% vs 4.0% vs 7.2%, p ≤0.001), mainly driven by MI (4.4% vs 1.5% vs 3%, p ≤0.001) and overall ST (4.3% vs 1.5% vs 1.8%, p ≤0.001). Independent predictors of MACE were low GFR and a 2 stent strategy. Independent predictors of ST were DAPT duration <3 months and the use of a 2-stent strategy. In conclusion, even stents with very thin strut when implanted in real-life ULM or coronary bifurcation patients discharged with short DAPT have a relevant risk of ST, which remains high although not significant after DAPT cessation.

8.
Cardiol J ; 2020 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-31960945

RESUMO

BACKGROUND: The optimal antithrombotic regimen for patients with atrial fibrillation (AF) and chronic coronary syndromes beyond 1 year after percutaneous coronary intervention (PCI) is a matter of debate. For these patients, guidelines recommend oral anticoagulation (OAC) alone, but the risk of thrombotic complications remains a concern. The aim of this study was to characterize the incidence, presentation and use of antithrombotic therapy in patients with AF, prior stenting > 12 months and new ST-segment elevation myocardial infarction (STEMI). METHODS: Consecutive patients were selected from an institutional registry over a 3-year period if they matched the following criteria: 1) STEMI undergoing primary PCI; 2) AF; 3) chronic coronary syndrome with prior stenting > 12 months. RESULTS: Among 852 consecutive STEMI patients undergoing primary PCI, the prevalence of AF was 4.1%, and 6 (0.9%) patients met all the inclusion criteria. Substantial heterogeneity in antithrombotic treatment for these patients was noted (e.g., OAC alone, OAC plus a single antiplatelet agent, no antithrombotic therapy). In 50% of patients, the STEMI episode was linked to a previously stented lesion or documented plaque. CONCLUSIONS: This case review illustrates the wide heterogeneity in antithrombotic pharmacotherapy among AF patients presenting with STEMI > 12 months after PCI. The underlying reason for STEMI is only partly related to disease progression or stent-related events. This finding suggests that multiple mechanisms of recurrence may be advocated, and are not only limited to antithrombotic therapy but may be explained by the natural history of coronary artery disease in remote vessels.

11.
EuroIntervention ; 15(13): 1190-1198, 2020 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-31475907

RESUMO

Percutaneous coronary intervention with implantation of drug-eluting stents has become the most commonly performed revascularisation procedure in patients with symptomatic coronary artery disease. Continuous iterations of coronary devices incorporating changes in platform materials, geometry, strut thickness, drug release mechanisms and antiproliferative drugs have progressively reduced the rate of device-related adverse clinical events. Objective performance criteria have been proposed for clinical and angiographic outcomes of drug-eluting stents. The rate of device success has been recognised as an intraprocedural endpoint to evaluate the mechanical ability to complete a procedure with the specific device assigned by protocol in randomised comparative trials. The European Commission and the U.S. Food and Drug Administration both provide guidance documents, including the mechanistic evaluation of coronary stents, which recommend operational definitions of device success. While the majority of clinical trials investigating drug-eluting stents have adopted this endpoint definition, inconsistencies in application limit the reliability of comparisons across different trials reporting device success rates. In addition, it is not uncommon that device success rates are not reported by investigators. A consistent definition of device success is essential to allow scientific comparisons of this technical performance endpoint between devices across different trials. Therefore, we performed a systematic evaluation of definitions and reporting of device success in clinical trials. We propose an extended definition as well as considerations for approaching the determination of the device success rates in future percutaneous coronary intervention trials.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Humanos , Reprodutibilidade dos Testes , Resultado do Tratamento
13.
Ther Adv Cardiovasc Dis ; 13: 1753944719893274, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31823688

RESUMO

Oral antiplatelet drugs are crucially important for patients with acute coronary syndrome or stable coronary artery disease undergoing percutaneous coronary intervention (PCI). In recent decades, several clinical trials have focused on reducing periprocedural ischemic events in patients undergoing PCI by means of more rapid platelet inhibition with the use of intravenous antiplatelet drugs. Glycoprotein IIb/IIIa receptor inhibitors (GPIs) block the final common pathway of platelet aggregation and enable potent inhibition in the peri-PCI period. In recent years, however, the use of GPIs has decreased due to bleeding concerns and the availability of more potent oral P2Y12 inhibitors. Cangrelor is an intravenous P2Y12 receptor antagonist. In a large-scale regulatory trial, cangrelor administration during PCI allowed for rapid, potent and rapidly reversible inhibition of platelet aggregation, with an anti-ischemic benefit and no increase in major bleeding. This article aims to provide an overview of general pharmacology, supporting evidence and current status of intravenous antiplatelet therapies (GPIs and cangrelor), with a focus on contemporary indications for their clinical use.


Assuntos
Síndrome Coronariana Aguda/terapia , Monofosfato de Adenosina/análogos & derivados , Plaquetas/efeitos dos fármacos , Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas/administração & dosagem , Agregação Plaquetária/efeitos dos fármacos , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/diagnóstico , Monofosfato de Adenosina/administração & dosagem , Monofosfato de Adenosina/efeitos adversos , Administração Intravenosa , Animais , Plaquetas/metabolismo , Doença da Artéria Coronariana/sangue , Doença da Artéria Coronariana/diagnóstico , Hemorragia/induzido quimicamente , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação de Plaquetas/efeitos adversos , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/metabolismo , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
14.
Ther Adv Cardiovasc Dis ; 13: 1753944719891688, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31814532

RESUMO

A sizable proportion of coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) with stent implantation have an indication for treatment with oral anticoagulant therapy (OAC). The coexistence of atrial fibrillation (AF) and the need for PCI expose patients to a higher risk of developing thrombotic complications, and a multitargeted antithrombotic treatment strategy, addressing both platelet- and coagulation-mediated triggering mechanisms of thrombosis, is necessary for ensuring full protection from ischemic hazards. The increased bleeding risk identified with triple antithrombotic therapy has driven the search for alternative treatment modalities and pharmacological combination strategies aimed at achieving an optimal balance between safety and efficacy in this complex clinical scenario. Over a short time period, the paradigms surrounding the management of patients undergoing PCI who require OAC have substantially evolved. In this review, we summarize and critically evaluate the results of recent randomized clinical trials investigating the pharmacological management of patients who, in addition to antiplatelet therapy, have an indication for OAC treatment before or at the time of a PCI procedure.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Doença da Artéria Coronariana/terapia , Trombose Coronária/prevenção & controle , Fibrinolíticos/uso terapêutico , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas/uso terapêutico , Anticoagulantes/efeitos adversos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Tomada de Decisão Clínica , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/epidemiologia , Trombose Coronária/diagnóstico , Trombose Coronária/epidemiologia , Fibrinolíticos/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação de Plaquetas/efeitos adversos , Medição de Risco , Fatores de Risco , Resultado do Tratamento
15.
EuroIntervention ; 15(11): e939-e942, 2019 Dec 06.
Artigo em Inglês | MEDLINE | ID: mdl-31806580
16.
Artigo em Inglês | MEDLINE | ID: mdl-31830264

RESUMO

AIMS: The aim of the present meta-analysis was to evaluate the efficacy and safety of non-vitamin-K oral antagonists (NOACs) versus vitamin-K antagonists (VKAs) in elderly patients with atrial fibrillation (AF) and indirectly compare NOACs in this population. METHODS AND RESULTS: MEDLINE, Cochrane, ISI Web of Sciences, and SCOPUS were searched for randomized or adjusted observational studies comparing NOACs versus VKAs for stroke prevention in AF patients≥75 years. The primary efficacy and safety outcomes of this meta-analysis were the composite of stroke and systemic embolism (SSE) and major bleedings, respectively. Other secondary outcomes were also analyzed.The analysis included 22 studies enrolling 440,281 AF patients≥75 years. The risk of SSE was significantly lower with NOACs versus VKAs (HR, 0.79; 95%CI, 0.70-0.89), whereas no differences were found for major bleedings (HR, 0.94; 95%CI, 0.85-1.05). NOACs reduced the risk of intracranial bleeding (HR, 0.46; 95%CI, 0.38-0.58), hemorrhagic stroke (HR, 0.61; 95%CI, 0.48-0.79) and fatal bleeding (HR, 0.46; 95%CI, 0.30-0.72) but increased gastrointestinal bleedings (HR, 1.46; 95%CI, 1.30-1.65), compared to VKAs.The adjusted indirect comparison showed no significant differences in term of SSE between NOAC agents. Conversely, the risk of major bleeding was higher for rivaroxaban versus apixaban (HR, 1.69; 95%CI, 1.39-2.08) and edoxaban (HR, 1.37; 95%CI, 1.14-1.67), and for dabigatran versus apixaban (HR, 1.47; 95%CI, 1.18-1.85). CONCLUSION: In elderly patients with AF, NOACs are associated to a lower risk of SSE, intracranial bleeding, hemorrhagic stroke and fatal bleeding than VKAs, but increase gastrointestinal bleedings. In this analysis, the safety profile of individual NOAC agents was significantly different.

17.
Artigo em Inglês | MEDLINE | ID: mdl-31860158

RESUMO

OBJECTIVES: To evaluate the independent clinical impact of stent structural features in a large cohort of patients undergoing unprotected left main (ULM) or coronary bifurcation percutaneous coronary intervention (PCI) with a range of very thin strut stents. BACKGROUND: Clinical impact of structural features of contemporary stents remains to be defined. METHODS: All consecutive patients enrolled in the veRy thin stents for patients with left mAIn or bifurcatioN in real life (RAIN) registry were included. The following stent structural features were studied: antiproliferative drugs (everolimus vs. sirolimus vs. zotarolimus), strut material (platinum-chromium vs. cobalt-chromium), polymer (bioresorbable vs. durable), number of crowns (<8 vs. ≥8) and number of connectors (<3 vs. ≥3). For small diameter stents (≤2.5 mm), struct thickness (74 vs. 80/81 µm) was also tested. Target lesion failure (TLF), a composite of target lesion revascularization and stent thrombosis, was the primary endpoint. Multivariate analysis was performed with Cox regression models. RESULTS: Out of 2,707 patients, 110 (4.1%) experienced a TLF event after 16 months (12-18). After adjustment for confounders, an increased number of connectors (adjusted hazard ratio [adj-HR] 0.62, 95% confidence interval (CI) 0.39-0.99, p = .04) reduced risk of TLF, driven by stents with ≥2.5 mm diameter (HR 0.54, 95% CI 0.32-0.93, p = .02). This independent relationship was lost for stents with diameter <2.5 mm, where only strut thickness appeared to impact. Conversely, no independent relationship of polymer type, number of crowns, and the specific limus-family eluted drug with outcomes was observed. CONCLUSIONS: Among a range of contemporary very thin stent models, an increased number of connectors improved device-related outcomes in this investigated high-risk procedural setting.

18.
Artigo em Inglês | MEDLINE | ID: mdl-31761640

RESUMO

BACKGROUND: The benefit of percutaneous mitral valve repair (PMVR) in patients with secondary MR is still debated. We aimed to compare the outcome of PMVR with optimal medical therapy (OMT) versus OMT alone in patients with secondary mitral regurgitation (MR) and to assess the role of potential effect modifiers. METHODS: We performed a systematic review and meta-analysis of 2 randomized clinical trials (RCT) and 7 non-randomized observational studies (nROS). Hazard ratios (HR) and 95% confidence intervals (CI) were pooled through inverse variance random-effects model to compute the summary effect size for all-cause death, cardiovascular death and cardiac-related hospitalization. Subgroup and meta-regression analysis were also performed. RESULTS: An overall population of 3118 individuals (67% men; mean age, 73 years) was included: 1775 PMVR+OMT and 1343 OMT patients, with mean follow-up of 24 ±â€¯15 months. PMVR+OMT was associated with a lower risk of all-cause death (HR: 0.77; 95% CI: 0.68-0.87), cardiovascular death (HR: 0.55; 95% CI: 0.34-0.89) and cardiac-related hospitalization (HR:0.77; 95% CI: 0.64-0.92). Meta-regression analysis showed that larger left ventricular end-diastolic volume index (LVEDVI) portends higher risk of all-cause death, cardiovascular death and cardiac-related hospitalization after PMVR (p < 0.001 for all). CONCLUSIONS: This study-level meta-analysis shows that PMVR+OMT is associated with reduced all-cause death, cardiovascular death and cardiac-related hospitalization when compared with OMT alone in secondary MR. LVEDVI is a predictive marker of efficacy, as patients with smaller LVEDVI have been shown to derive the largest benefit from PMVR.

20.
Eur Heart J Cardiovasc Imaging ; 20(11): 1187-1197, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31642920

RESUMO

The European Society of Cardiology (ESC) has recently published new guidelines on the diagnosis and management of chronic coronary syndromes (CCS). The 2019 guideline identified six common clinical scenarios of CCS defined by the different evolutionary phases of coronary artery disease (CAD), excluding the situations in which an acute coronary event, often with coronary thrombus formation, dominates the clinical presentation. This review aims at providing a summary of novel or revised concepts in the guidelines together with the recent data underlying the major changes on the use of cardiac imaging in patients with suspected or known CCS. Based on data from contemporary cohorts of patients referred for diagnostic testing, the pre-test probabilities of CAD based on age, sex and symptoms have been adjusted substantially downward as compared with 2013 ESC guidelines. Further, the impact of various risk factors and modifiers on the pre-test probability was highlighted and a new concept of 'Clinical likelihood of CAD' was introduced. Recommendations regarding diagnostic tests to establish or rule-out obstructive CAD have been updated with recent data on their diagnostic performance in different patient groups and impact on patient outcome. As the initial strategy to diagnose CAD in symptomatic patients, non-invasive functional imaging for myocardial ischaemia, coronary computed tomography angiography or invasive coronary angiography combined with functional evaluation may be used, unless obstructive CAD can be excluded by clinical assessment alone. When available, imaging tests instead of the exercise electrocardiogram are recommended when following the non-invasive diagnostic strategy.

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