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1.
J Vasc Interv Radiol ; 31(9): 1410-1418.e10, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32868016

RESUMO

PURPOSE: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]). RESULTS: In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes. CONCLUSIONS: In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Artéria Femoral , Disparidades nos Níveis de Saúde , Doença Arterial Periférica/terapia , Artéria Poplítea , Dispositivos de Acesso Vascular , Fatores Etários , Idoso , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Progressão da Doença , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Fatores de Risco , Fatores Sexuais , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
2.
J Vasc Interv Radiol ; 31(10): 1661-1667, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32921564

RESUMO

PURPOSE: To evaluate safety and efficacy of percutaneous mechanical thrombectomy using the Rotarex catheter combined with drug-coated balloon (DCB) in treatment of femoropopliteal artery occlusive disease. MATERIALS AND METHODS: Between January 2016 and February 2018, 81 patients with acute or subacute femoropopliteal artery occlusions were treated with the Rotarex catheter combined with DCB. Lesions were classified according to the onset of symptoms as acutely (< 14 d) or subacutely (14 d to 3 mo) occluded. The mean lesion length was 12.1 cm ± 6.7. The primary endpoint was target lesion patency at 1 year as evaluated by duplex ultrasound (peak systolic velocity ratio < 2.4) and freedom from clinically indicated target lesion revascularization. Amputation rate, major adverse events, and ankle-brachial index at 12 months were evaluated. RESULTS: Technical success rate was 100% (n = 81). Bailout stents were necessary in 14 patients owing to residual stenosis or flow-limiting dissection. Additional thrombolysis was applied in 10 interventions. No major adverse events occurred during hospital stay. There were 9 restenosis cases during the 12-month follow-up period. Primary patency rate was 87.3% (62/71), and freedom from target lesion revascularization rate was 90.1% (64/71). Ankle-brachial index significantly increased from 0.46 ± 0.15 to 0.77 ± 0.14 during follow-up. The amputation rate was 1.4% at 12 months. CONCLUSIONS: These initial data from 2 centers suggest that the combination of the Rotarex catheter and DCB may be safe and effective for treatment of acute or subacute thrombotic femoropopliteal occlusion with superior immediate and midterm results achieved.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Artéria Femoral , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Trombectomia , Dispositivos de Acesso Vascular , Idoso , Idoso de 80 Anos ou mais , Amputação , Angioplastia com Balão/efeitos adversos , Pequim , Fármacos Cardiovasculares/efeitos adversos , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Recidiva , Estudos Retrospectivos , Fatores de Risco , Trombectomia/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
3.
Cardiovasc Ther ; 2020: 4158363, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32934664

RESUMO

Objective: To investigate the efficacy of drug-coated balloon (DCB) treatment for de novo coronary artery lesions in randomized controlled trials (RCTs). Background: DCB was an effective therapy for patients with in-stent restenosis. However, the efficacy of DCB in patients with de novo coronary artery lesions is still unknown. Methods: Eligible studies were searched on PubMed, Web of Science, EMBASE, and Cochrane Library Database. Systematic review and meta-analyses of RCTs were performed comparing DCB with non-DCB devices (such as plain old balloon angioplasty (POBA), bare-metal stents (BMS), or drug-eluting stents (DES)) for the treatment of de novo lesions. Trial sequential meta-analysis (TSA) was performed to assess the false positive and false negative errors. Results: A total of 2,137 patients enrolled in 12 RCTs were analyzed. Overall, no significant difference in target lesion revascularization (TLR) was found, but there were numerically lower rates after DCB treatment at 6 to 12 months follow-up (RR: 0.69; 95% CI: 0.47 to 1.01; P = 0.06; TSA-adjusted CI: 0.41 to 1.16). TSA showed that at least 1,000 more randomized patients are needed to conclude the effect on TLR. A subgroup analysis from high bleeding risk patients revealed that DCB treatment was associated with lower rate of TLR (RR: 0.10; 95% CI: 0.01 to 0.78; P = 0.03). The systematic review illustrated that the rate of bailout stenting was lower and decreased gradually. Conclusions: DCB treatment was associated with a trend toward lower TLR when compared with controls. For patients at bleeding risk, DCB treatment was superior to BMS in TLR.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Fármacos Cardiovasculares/efeitos adversos , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Desenho de Equipamento , Feminino , Hemorragia/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
4.
Emerg Med Clin North Am ; 38(4): 857-869, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32981622

RESUMO

The obesity pandemic now affects hundreds of millions of people worldwide. As obesity rates continue to increase, emergency physicians are called on with increasing frequency to resuscitate obese patients. This article discusses important anatomic, physiologic, and practical challenges imposed by obesity on resuscitative care. Impacts on hemodynamic monitoring, airway and ventilator management, and pharmacologic therapy are discussed. Finally, several important clinical scenarios (trauma, cardiac arrest, and sepsis), in which alterations to standard treatments may benefit obese patients, are highlighted.


Assuntos
Obesidade/complicações , Ressuscitação/métodos , Manuseio das Vias Aéreas/métodos , Analgésicos/administração & dosagem , Antibacterianos/administração & dosagem , Composição Corporal , Fármacos Cardiovasculares/administração & dosagem , Doenças Cardiovasculares/complicações , Relação Dose-Resposta a Droga , Serviço Hospitalar de Emergência , Parada Cardíaca/terapia , Humanos , Hipnóticos e Sedativos/administração & dosagem , Medidas de Volume Pulmonar , Consumo de Oxigênio , Farmacocinética , Respiração com Pressão Positiva , Sepse/complicações , Sepse/terapia , Ferimentos e Lesões/complicações , Ferimentos e Lesões/terapia
5.
Life Sci ; 261: 118306, 2020 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-32828943

RESUMO

AIMS: Diabetic cardiomyopathy (DCM) is a common diabetes complication that can cause arrhythmia, heart failure, and even sudden death. Ranolazine is an antianginal agent used to treat chronic stable angina and has been demonstrated as an effective treatment for many cardiovascular diseases. However, the mechanism by which ranolazine alleviates DCM is unclear, motivating this study investigating the effects of ranolazine in DCM. MATERIALS AND METHODS: DCM rats were treated with one of three doses of ranolazine (10, 30, and 90 mg/kg/day) for 12 weeks. B-cell lymphoma 2 (Bcl-2), Bcl-2 associated X protein (Bax), cysteinyl aspartate specific proteinase-3 (Caspase-3), Notch homolog 1 (NOTCH1), and Neuregulin 1 (NRG1) expression was assayed using western blot and qRT-PCR. Cardiac changes were assayed using echocardiography, CT, HE staining, and Masson's trichrome staining. TUNEL staining and flow cytometry were used to detect cell apoptosis. NOTCH1 inhibitor (DAPT) was used to explore the mechanism of ranolazine. KEY FINDINGS: Compared with the DCM group, the ranolazine groups had no obvious weight loss and significantly decreased blood glucose levels. Ranolazine prevented diabetes-caused cardiac injury. Ranolazine also decreased the number of apoptotic cells and altered the expression of apoptosis-related mRNAs and proteins. Ranolazine-induced NOTCH1 activated NRG1 and inhibited the downstream apoptosis-related pathway, while DAPT partially inhibited ranolazine-induced NOTCH1 and NRG1 expression. SIGNIFICANCE: To our knowledge, this study is the first to demonstrate that ranolazine protects against DCM-induced apoptosis by activating the NOTCH1/NRG1 signaling pathway. Moreover, our study identified new mechanisms involved in DCM.


Assuntos
Fármacos Cardiovasculares/farmacologia , Diabetes Mellitus Experimental/tratamento farmacológico , Cardiomiopatias Diabéticas/prevenção & controle , Ranolazina/farmacologia , Animais , Apoptose/efeitos dos fármacos , Glicemia/efeitos dos fármacos , Fármacos Cardiovasculares/administração & dosagem , Diabetes Mellitus Experimental/complicações , Diabetes Mellitus Experimental/fisiopatologia , Cardiomiopatias Diabéticas/fisiopatologia , Relação Dose-Resposta a Droga , Masculino , Neuregulina-1/metabolismo , Ranolazina/administração & dosagem , Ratos , Ratos Sprague-Dawley , Receptor Notch1/metabolismo , Transdução de Sinais/efeitos dos fármacos
6.
Ann Vasc Surg ; 69: 454.e13-454.e16, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32768530

RESUMO

A 27-year-old male patient suffering from dizziness and right amaurosis was diagnosed with Takayasu arteritis (TA). Computed tomography angiography showed that all the supra-aortic arteries were occluded except an aberrant right subclavian artery. The patient underwent drug-coated balloon dilatation at the lesion of the right common carotid artery and performed well after the procedure. Six months later, the patient's symptoms have not recurred and computed tomography angiography showed the right carotid artery remains patency. The supra-aortic artery lesions in TA may be a potential novel indication for a drug-coated balloon.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Artéria Carótida Primitiva , Estenose das Carótidas/terapia , Paclitaxel/administração & dosagem , Arterite de Takayasu/complicações , Dispositivos de Acesso Vascular , Adulto , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/etiologia , Estenose das Carótidas/fisiopatologia , Humanos , Masculino , Arterite de Takayasu/diagnóstico , Resultado do Tratamento , Grau de Desobstrução Vascular
7.
Eur J Vasc Endovasc Surg ; 60(4): 549-558, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32807674

RESUMO

OBJECTIVE: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort. METHODS: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan-Meier method and Cox regression. RESULTS: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78-0.91), amputation or death (HR 0.87, 95% CI 0.81-0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80-0.92) were observed. CONCLUSION: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Stents Farmacológicos , Procedimentos Endovasculares/instrumentação , Isquemia/terapia , Perna (Membro)/irrigação sanguínea , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Demandas Administrativas em Assistência à Saúde , Idoso , Idoso de 80 Anos ou mais , Amputação , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Alemanha , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Pontuação de Propensão , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
8.
N Engl J Med ; 383(8): 733-742, 2020 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-32813949

RESUMO

BACKGROUND: Standard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor. Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes. METHODS: In this prospective, single-blinded, 1:1 randomized trial, we enrolled 330 participants at 29 international sites. Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation. After successful high-pressure percutaneous transluminal angioplasty, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon. The primary effectiveness end point was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or access-circuit thrombosis during the 6 months after the index procedure. The primary safety end point, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points). The primary analyses included all participants with available end-point data. Additional sensitivity analyses were performed to assess the effect of missing data. RESULTS: A total of 330 participants underwent randomization; 170 were assigned to receive treatment with a drug-coated balloon, and 160 were assigned to receive treatment with a standard balloon. During the 6 months after the index procedure, target-lesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P<0.001). Drug-coated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, -0.2 percentage points; 95% CI, -5.5 to 5.0; P = 0.002 for noninferiority). Sensitivity analyses confirmed the results of the primary analyses. CONCLUSIONS: Drug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit-related serious adverse events within 30 days. (Funded by Medtronic; IN.PACT AV Access Study ClinicalTrials.gov number, NCT03041467.).


Assuntos
Angioplastia com Balão/métodos , Derivação Arteriovenosa Cirúrgica , Fármacos Cardiovasculares/administração & dosagem , Paclitaxel/administração & dosagem , Dispositivos de Acesso Vascular/efeitos adversos , Grau de Desobstrução Vascular , Idoso , Angioplastia com Balão/instrumentação , Derivação Arteriovenosa Cirúrgica/instrumentação , Fármacos Cardiovasculares/efeitos adversos , Materiais Revestidos Biocompatíveis , Constrição Patológica/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Estudos Prospectivos , Diálise Renal/efeitos adversos , Método Simples-Cego , Extremidade Superior/irrigação sanguínea
9.
Ann Vasc Surg ; 69: 451.e1-451.e4, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32615205

RESUMO

We present here a case of an uncommon cutaneous manifestation after paclitaxel-coated balloon angioplasty. In this case, the patient underwent drug-coated balloon angioplasty for stenosis of a prior vein bypass graft. The patient subsequently developed extensive cutaneous lesions not confined to a single arterial distribution. This case represents a rare complication related to paclitaxel-eluting balloons and provides a cautionary tale as well as clinical acumen for providers in using such devices in their practice.


Assuntos
Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Embolia/etiologia , Oclusão de Enxerto Vascular/terapia , Extremidade Inferior/irrigação sanguínea , Paclitaxel/administração & dosagem , Dispositivos de Acesso Vascular , Analgésicos/uso terapêutico , Embolia/diagnóstico , Embolia/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
10.
J Endovasc Ther ; 27(5): 683-690, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32666871

RESUMO

Purpose: To evaluate the safety and efficacy of the novel SELUTION sustained-limus-release (SLR) drug-eluting balloon (DEB) in the treatment of femoropopliteal lesions. Materials and Methods: Between October 2016 and May 2017, 50 subjects (mean age 69.6±10.4 years; 29 men) with symptomatic moderate to severe lower limb ischemia (Rutherford categories 2 or 3) were enrolled at 4 German centers for the SELUTION SLR first-in-human trial (ClinicalTrials.gov NCT02941224). The SELUTION SLR utilizes micro-reservoirs (biodegradable polymer spheres containing sirolimus) embedded within an amphipathic membrane coated onto an angioplasty balloon. The biodegradable reservoirs are transferred to the target vessel lumen during brief balloon inflation. The primary trial objective was comparison of angiographic late lumen loss at 6 months against an objective performance criterion (OPC) value of 1.04 mm for uncoated balloon angioplasty. Secondary endpoints included device, procedural, and clinical success; clinical and imaging assessments of primary patency and restenosis; functional assessments including Rutherford category and ankle-brachial index (ABI); and major adverse events [composite of cardiovascular mortality, index limb amputation, target limb thrombosis, and clinically-driven target lesion revascularization (CD-TLR)]. Results: At 6 months, median angiographic late lumen loss following SELUTION SLR treatment was 0.19 mm (range -1.16 to 3.07). Mean angiographic late lumen loss (n=34) was 0.29±0.84 mm (95% CI -0.01 to 0.58), significantly lower than the 1.04-mm OPC value (p<0.001). The rate of primary patency by duplex ultrasound was 88.4%, and freedom from angiographic binary restenosis was 91.2%. Through 6 months, there was significant improvement over baseline in Rutherford categories (p<0.001) and in ABI measurements (p<0.001). A single case (2%) of CD-TLR occurred at 5 months. There were no other major adverse events. Conclusion: Through 6 months, the SELUTION SLR DEB appears to inhibit restenosis effectively and safely, improving outcomes in subjects with symptomatic femoropopliteal disease.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Sirolimo/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Constrição Patológica , Preparações de Ação Retardada , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Alemanha , Humanos , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
11.
Clin Interv Aging ; 15: 715-722, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32546989

RESUMO

Background: There is little research in the efficacy and safety of a pharmaco-invasive strategy (PIS) in patients ≥75 years versus <75 years of age. We aimed to evaluate and compare the influence of advanced age on the risk of death and major adverse cardiac events (MACE) in patients undergoing PIS. Methods: Between January 2010 and November 2016, 14 municipal emergency rooms in São Paulo, Brazil, used full-dose tenecteplase to treat patients with STEMI as part of a pharmaco-invasive strategy for a local network implementation. Results: A total of 1852 patients undergoing PIS were evaluated, of which 160 (9%) were ≥75 years of age. Compared to patients <75 years, those ≥75 years were more often female, had lower body mass index, higher rates of hypertension; higher incidence of hypothyroidism, chronic renal failure, prior stroke, and diabetes. Compared to patients <75 years of age, in-hospital MACE and mortality were higher in patients with ≥75 years (6.5% versus 19.4%; p<0.001; and 4.0% versus 18.2%; p<0.001, respectively). Patients ≥75 years had higher rates of in-hospital major bleeding (2.7% versus 5.6%; p=0.04) and higher incidence of cardiogenic shock (7.0% versus 19.6%; p<0.001). By multivariable analysis, age ≥75 years was independent predictor of MACE (OR 3.57, 95% CI 1.72 to 7.42, p=0.001) and death (OR 2.07, 95% CI 1.12-3.82, p=0.020). Conclusion: In patients with ST-segment elevation myocardial infarction undergoing PIS, age ≥75 years was an independent factor that entailed a 3.5-fold higher MACE and 2-fold higher mortality rate compared to patients <75 years of age.


Assuntos
Fármacos Cardiovasculares , Mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST , Idoso , Fármacos Cardiovasculares/administração & dosagem , Fármacos Cardiovasculares/efeitos adversos , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Administração dos Cuidados ao Paciente/métodos , Intervenção Coronária Percutânea/efeitos adversos , Medição de Risco , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia
12.
J Endovasc Ther ; 27(5): 693-705, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32583749

RESUMO

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral , Claudicação Intermitente/terapia , Isquemia/terapia , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Constrição Patológica , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Recuperação de Função Fisiológica , Sistema de Registros , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
14.
Eur J Vasc Endovasc Surg ; 60(2): 220-229, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32370918

RESUMO

OBJECTIVE: Paclitaxel based drug coated balloons (DCBs) and drug eluting stents (DESs) may be associated with increased mortality in patients with peripheral arterial occlusive disease (PAOD), based on a recent meta-analysis. This study, however, had a number of limitations, which have been discussed at great length among the vascular community. The aim of this research was to assess the association between paclitaxel based endovascular treatment (PTX) in the femoropopliteal (F-P) segment and mortality, adjusting for relevant risk factors and including patients with chronic limb threatening ischaemia (CLTI). METHODS: This was a retrospective cohort study of a prospectively maintained multicentre (three sites) database of patients with claudication or CLTI. Patients having F-P angioplasty between 1 January 2014 and 30 May 2019 with or without PTX were included. Survival was compared in Cox regression analyses adjusted for parameters of the Charlson comorbidity index. A separate nested case matched (based on each individual's Charlson index) analysis was performed to compare mortality rates between those who received PTX and those who did not. RESULTS: A total of 2 071 patients were analysed: 966 patients (46.6%) were treated with PTX (952 [46%] had CLTI and 1 119 [54%] severe claudication [Rutherford stage 3]). Over a 24 month median follow up, 456 (22.1%) patients died. Using multivariable Cox regression, PTX was not associated with mortality (HR 0.94, p = .46), even when assessed separately for those with intermittent claudication (HR 1.30, p = .15) or CLTI (HR 0.81, p = .060). In the case matched analysis (885 matched pairs of patients), PTX was not associated with mortality (HR 0.89, p = .17). Paclitaxel dose and use of a DCB or DES were not associated with mortality in any subanalysis. CONCLUSION: When relevant risk factors were taken into account, there were no associations between PTX and mid term mortality in patients with PAOD.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Stents Farmacológicos , Artéria Femoral , Claudicação Intermitente/terapia , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Fármacos Cardiovasculares/efeitos adversos , Bases de Dados Factuais , Inglaterra , Feminino , Artéria Femoral/diagnóstico por imagem , Grécia , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/mortalidade , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Artéria Poplítea/diagnóstico por imagem , Desenho de Prótese , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
15.
Eur J Prev Cardiol ; 27(10): 1017-1025, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32391719

RESUMO

Patients with cardiovascular risk factors or established cardiovascular disease have an increased risk of developing coronavirus disease 19 and have a worse outcome when infected, but translating this notion into effective action is challenging. At present it is unclear whether cardiovascular therapies may reduce the likelihood of infection, or improve the survival of infected patients. Given the crucial importance of this issue for clinical cardiologists and all specialists dealing with coronavirus disease 19, we tried to recapitulate the current evidence and provide some practical recommendations.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/epidemiologia , Causas de Morte , Infecções por Coronavirus/epidemiologia , Pandemias/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Fármacos Cardiovasculares/farmacologia , Doenças Cardiovasculares/diagnóstico , Comorbidade , Infecções por Coronavirus/prevenção & controle , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Prevalência , Medição de Risco , Análise de Sobrevida
16.
JACC Cardiovasc Interv ; 13(9): 1100-1109, 2020 05 11.
Artigo em Inglês | MEDLINE | ID: mdl-32381186

RESUMO

OBJECTIVES: The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis. BACKGROUND: The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates. METHODS: A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods. RESULTS: Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]). CONCLUSIONS: At 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/análogos & derivados , Idoso , Bélgica , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Trombose Coronária/etiologia , Feminino , Humanos , Israel , Masculino , Pessoa de Meia-Idade , Países Baixos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Desenho de Prótese , Sirolimo/administração & dosagem , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
17.
J Endovasc Ther ; 27(4): 616-622, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32469296

RESUMO

Purpose: To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR (Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) registry. Materials and Methods: A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Results: Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. Conclusion: The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Procedimentos Endovasculares/instrumentação , Everolimo/administração & dosagem , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Amputação , Grupo com Ancestrais do Continente Asiático , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Procedimentos Endovasculares/efeitos adversos , Everolimo/efeitos adversos , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/etnologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/etnologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Singapura , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular , Cicatrização
18.
Circ Cardiovasc Interv ; 13(6): e008737, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32466676

RESUMO

BACKGROUND: Numerous randomized clinical trials have demonstrated the superiority of thin-strut biodegradable polymer second-generation drug-eluting stent to the first-generation drug-eluting stent and the noninferiority to the thin-strut second-generation permanent polymer drug-eluting stent. Data on long-term clinical outcomes with a novel ultrathin drug-eluting stent, to date, are limited. METHODS: The DESSOLVE III trial (Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System for Revascularization of Coronary Arteries; n=1398) is a prospective, multicenter, single-blinded, all-comers, randomized controlled trial (NCT02385279), allocating in a 1:1 ratio to either ultrathin-strut biodegradable polymer MiStent sirolimus-eluting stent or to thin-strut permanent polymer Xience everolimus-eluting stent. The primary end point was device-oriented composite end point, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. The secondary end point was patient-oriented composite end point, defined as the composite of all-cause mortality, any myocardial infarction, or any revascularization. RESULTS: At 3 years, follow-up data were available in 1381 patients (98.8%). The primary end point of device-oriented composite end point occurred in 10.5% for MiStent sirolimus-eluting stent and in 11.5% for Xience everolimus-eluting stent (P=0.55). Rates of cardiac death (3.9% versus 3.8%; P=0.88), target vessel myocardial infarction (3.2% versus 2.5%; P=0.43), and clinically indicated target lesion revascularization (5.2% versus 6.5%; P=0.30) did not differ significantly between the 2 devices. The rate of definite or probable stent thrombosis was infrequent and similar between the 2 arms (1.2% versus 1.5%; P=0.64). The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent. The risk of patient-oriented composite end point was comparable between the 2 groups (22.7% versus 22.9%; P=0.34). CONCLUSIONS: In the DESSOLVE III trial, early safety and efficacy with MiStent sirolimus-eluting bioabsorbable polymer-coated stent are confirmed at a longer term follow-up when compared with Xience everolimus-eluting permanent polymer-coated stent in a large all-comers population. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02385279.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Stents Farmacológicos , Everolimo/administração & dosagem , Isquemia Miocárdica/terapia , Intervenção Coronária Percutânea/instrumentação , Polímeros/química , Idoso , Fármacos Cardiovasculares/efeitos adversos , Europa (Continente) , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento
19.
Int J Cardiovasc Imaging ; 36(9): 1617-1626, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32462449

RESUMO

Chronic second-generation drug-eluting stent recoil in severely calcified coronary lesions has not been studied. We aimed to evaluate chronic stent recoil by optical coherence tomography (OCT) in severely calcified lesions treated with thin strut stents after rotational atherectomy. In 28 lesions (26 patients with 23% on hemodialysis) treated with everolimus-eluting stents after rotational atherectomy, baseline and 8-month follow-up OCT were compared. Stent recoil was defined as >10% decrease in stent area from baseline to follow-up. Overall, there was no change in minimal stent area (6.0 mm2 [5.0, 8.1] to 6.0 mm2 [4.8, 8.6], p = 0.51) from baseline to follow-up, although neointimal hyperplasia measured 16.3 ± 15.8%. Thirty-six percent of lesions showed stent recoil associated with 6 non-nodular calcifications, 1 calcified nodule, and 3 stent deformations. The overall mean calcium angle with attenuation decreased (54° [29-76] to 31° [19-48], p < 0.0001), and calcium without attenuation increased (28° [21-67] to 64° [34-93], p < 0.0001), but primarily at the location of stent recoil. Furthermore, in the stent recoil segments in 10 recoil lesions, the stent circumference decreased primarily at non-calcium segments rather than at calcium with or without attenuation. One lesion with stent recoil and 2 lesions without stent recoil required repeat revascularization. Thin strut stents can chronically recoil in severely calcified lesions, but this rarely causes restenosis.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Tomografia de Coerência Óptica , Calcificação Vascular/terapia , Idoso , Aterectomia Coronária , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Doença da Artéria Coronariana/diagnóstico por imagem , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Neointima , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem
20.
Int J Cardiovasc Imaging ; 36(9): 1627-1635, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32385540

RESUMO

Long-term safety of second generation drug-eluting stents (DES) has not yet been evaluated. We sought to evaluate the very late phase (> 3 years) vascular response after second generation everolimus-eluting stent (EES) as compared with first generation sirolimus-eluting stent (SES) by using optical coherence tomography (OCT). We examined the vascular response in 39 patients with a total of 55 DESs [31 EESs (mean 54 months after stenting) and 24 first generation SES (mean 66 months after stenting)] by OCT. The frequency of lesions with any malapposed stent struts (19% vs. 46%, p = 0.035) and evagination (6% vs. 42%, p = 0.002) was significantly lower. Segments with malapposed stent struts were significantly shorter (0.4 ± 0.9 mm vs. 1.9 ± 3.5 mm, p = 0.024), maximal malapposition area and malapposition volume were significantly smaller (0.26 ± 0.38 mm2 vs. 0.95 ± 1.54 mm2, p = 0.019, and 0.78 ± 1.35 mm3 vs. 6.22 ± 15.76 mm3, p = 0.016, respectively) in EES. Compared with first generation SES, second generation EES showed more favourable vascular responses at the very late phase.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Tomografia de Coerência Óptica , Idoso , Idoso de 80 Anos ou mais , Aterectomia Coronária , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Desenho de Prótese , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento
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