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1.
Medicine (Baltimore) ; 100(25): e26198, 2021 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-34160384

RESUMO

BACKGROUND: In silico medicine allows for pre-clinical and clinical simulated assessment of medical technologies and the building of patient-specific models to support medical decisions and forecast personal health status. While there is increasing trust in the potential central role of in silico medicine, there is a need to recognize its degree of reliability and evaluate its economic impact. An in silico platform has been developed within a Horizon 2020-funded project (In-Silc) for simulations functional to designing, developing, and assessing drug-eluting bioresorbable vascular scaffolds.The main purpose of this study was to compare the costs of 2 alternative strategies: the adoption of In-Silc platform versus the performance of only physical bench tests. METHODS: A case study was provided by a medical device company. The values of the model parameters were principally set by the project partners, with use of interviews and semi-structured questionnaires, and, when not available, through literature searches or derived by statistical techniques. An economic model was built to represent the 2 scenarios. RESULTS: The InSilc strategy is superior to the adoption of physical bench tests only. Ceteris paribus, the costs are 424,355€ for the former versus 857,811€ for the latter. CONCLUSIONS: In silico medicine tools can decrease the cost of the research and development of medical devices such as bioresorbable vascular scaffolds. Further studies are needed to explore the impact of such solutions on the innovation capacity of companies and the consequent potential advantages for target patients and the healthcare system.


Assuntos
Implantes Absorvíveis , Simulação por Computador/economia , Stents Farmacológicos , Desenho de Equipamento/métodos , Teste de Materiais/métodos , Desenho Assistido por Computador , Análise Custo-Benefício , Desenho de Equipamento/economia , Humanos , Teste de Materiais/economia , Reprodutibilidade dos Testes
3.
Medicine (Baltimore) ; 100(19): e25765, 2021 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-34106607

RESUMO

ABSTRACT: This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 1:1 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years.We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5 years. The rates of MACE (5.3% vs 12.8%, P = .431), death (5.3% vs 10.3%, P = .675), TLR (2.6% vs 2.6%, P = 1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, P = .358) at 5 years did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5 years.The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Implantes Absorvíveis , Adulto , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/uso terapêutico , Doença da Artéria Coronariana/mortalidade , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Polímeros , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , República da Coreia , Sirolimo/uso terapêutico , Resultado do Tratamento
4.
Int J Mol Sci ; 22(11)2021 May 26.
Artigo em Inglês | MEDLINE | ID: mdl-34073521

RESUMO

In this study, we investigated the effect of mTOR inhibitor (mTORi) drug-eluting biodegradable stent (DE stent), a putative restenosis-inhibiting device for coronary artery, on thermal-injury-related ureteral stricture in rabbits. In vitro evaluation confirmed the dose-dependent effect of mTORi, i.e., rapamycin, on fibrotic markers in ureteral component cell lines. Upper ureteral fibrosis was induced by ureteral thermal injury in open surgery, which was followed by insertion of biodegradable stents, with or without rapamycin drug-eluting. Immunohistochemistry and Western blotting were performed 4 weeks after the operation to determine gross anatomy changes, collagen deposition, expression of epithelial-mesenchymal transition markers, including Smad, α-SMA, and SNAI 1. Ureteral thermal injury resulted in severe ipsilateral hydronephrosis. The levels of type III collagen, Smad, α-SMA, and SNAI 1 were increased 28 days after ureteral thermal injury. Treatment with mTORi-eluting biodegradable stents significantly attenuated thermal injury-induced urinary tract obstruction and reduced the level of fibrosis proteins, i.e., type III collagen. TGF-ß and EMT signaling pathway markers, Smad and SNAI 1, were significantly modified in DE stent-treated thermal-injury-related ureteral stricture rabbits. These results suggested that intra-ureteral administration of rapamycin by DE stent provides modification of fibrosis signaling pathway, and inhibiting mTOR may result in fibrotic process change.


Assuntos
Implantes Absorvíveis , Stents Farmacológicos , Sirolimo , Serina-Treonina Quinases TOR/antagonistas & inibidores , Obstrução Ureteral , Animais , Fibrose , Coelhos , Sirolimo/química , Sirolimo/farmacologia , Serina-Treonina Quinases TOR/metabolismo , Obstrução Ureteral/metabolismo , Obstrução Ureteral/patologia , Obstrução Ureteral/terapia
5.
Atherosclerosis ; 328: 62-73, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34102425

RESUMO

BACKGROUND AND AIMS: The everolimus-eluting stent (EES), one of the effective stents for in-stent restenosis (ISR), has a lower incidence of stent thrombosis; however, the underlying mechanism remains unknown. This study aimed to identify the effects of everolimus on vascular metabolism and thrombogenicity and examine their mechanistic link. METHODS: EESs and bare-metal stents were implanted in rabbit iliac arteries with smooth muscle cell (SMC)-rich neointima induced by endothelial denudation. Four weeks after stent implantation, the stented arteries were examined for histological analysis and metabolomics. Additionally, everolimus effects in coronary artery SMCs metabolism, tissue factor (TF) expression, and procoagulant activity were assessed in vitro. RESULTS: EES-implanted arteries showed decreased neointima formation, less SMCs infiltration, and reduced TF expression. Concomitantly, they were metabolically characterized by increased levels of metabolites in amino acids, such as glutamine. Similarly, everolimus increased intracellular glutamine levels, decreased TF expression, and reduced procoagulant activity in SMCs in vitro. On the contrary, exogenous glutamine administration also increased intracellular glutamine level, decreased TF expression, and reduced procoagulant activity despite enhanced mammalian target of rapamycin (mTOR) activity. CONCLUSIONS: Intracellular glutamine level is likely to determine vascular SMC-related thrombogenicity regardless of mTOR pathway activity. Therefore, increased intracellular glutamine level might contribute partially to the beneficial effect of EES use on stent thrombosis.


Assuntos
Fármacos Cardiovasculares , Reestenose Coronária , Stents Farmacológicos , Intervenção Coronária Percutânea , Animais , Glutamina , Músculo Liso Vascular , Miócitos de Músculo Liso , Desenho de Prótese , Coelhos
6.
J Cardiothorac Surg ; 16(1): 178, 2021 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-34154628

RESUMO

BACKGROUND: Drug-coated balloon (DCB) is a new technology that has emerged in recent years and has been proven to be effective and safe in the treatment of in-stent restenosis. The purpose of this article is to observe the safety and effectiveness of drug-coated balloons in patients with acute myocardial infarction. METHOD: We selected 80 patients admitted to the hospital for STEMI from January 2018 to December 2019. The subjects were randomly divided into a Yinyi (Liaoning) Biotech Bingo Drug Coated Balloon treatment group (balloon group, n = 38) and a drug-eluting stent (DES) treatment group (stent group, n = 42). Patients were followed up to understand the incidence of major adverse cardiovascular events (MACE) at 1 month, 6 months and 1 year after surgery. Coronary angiography was rechecked 1 year after surgery to understand the late lumen loss (LLL) in the two groups. RESULT: During the one-year follow-up, the LLL of the target lesion in the balloon group was -0.12±0.46 mm, while the target lesion in the stent group was 0.14±0.37 mm ( P <0.05). Within 1 year, the incidence of MACE in the balloon group was 11%, while the incidence of MACE in the stent group was 12%. There was no significant difference between the two groups. IN CONCLUSION: When PCI is used for STEMI, only DCB therapy is safe and effective, and has shown good clinical effects during a one-year follow-up period.


Assuntos
Angioplastia Coronária com Balão , Materiais Revestidos Biocompatíveis , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Angioplastia Coronária com Balão/efeitos adversos , Doenças Cardiovasculares/etiologia , Angiografia Coronária , Reestenose Coronária , Stents Farmacológicos/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Resultado do Tratamento
7.
Int J Mol Sci ; 22(11)2021 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-34063962

RESUMO

Drug-eluting stents have been widely implanted to prevent neointimal hyperplasia associated with bare metal stents. Conventional polymers and anti-proliferative drugs suffer from stent thrombosis due to the non-selective nature of the drugs and hypersensitivity to polymer degradation products. Alternatively, various herbal anti-proliferative agents are sought, of which biochanin A (an isoflavone phytoestrogen) was known to have anti-proliferative and vasculoprotective action. PLA-PEG diblock copolymer was tagged with heparin, whose degradation releases heparin locally and prevents thrombosis. To get a controlled drug release, biochanin A was loaded in layered double hydroxide nanoparticles (LDH), which are further encapsulated in a heparin-tagged PLA-PEG copolymer. LDH nanoparticles are synthesized by a co-precipitation process; in situ as well as ex situ loading of biochanin A were done. PLA-PEG-heparin copolymer was synthesized by esterification reaction, and the drug-loaded nanoparticles are coated. The formulation was characterized by FTIR, XRD, DSC, DLS, and TEM. In vitro drug release studies, protein adhesion, wettability, hemocompatibility, and degradation studies were performed. The drug release was modeled by mathematical models to further emphasize the mechanism of drug release. The developed drug-eluting stent coating is non-thrombogenic, and it offers close to zero-order release for 40 days, with complete polymer degradation in 14 weeks.


Assuntos
Genisteína/química , Heparina/química , Hidróxidos/química , Lactatos/química , Nanopartículas/química , Polietilenoglicóis/química , Polímeros/química , Sistemas de Liberação de Medicamentos/métodos , Liberação Controlada de Fármacos/fisiologia , Stents Farmacológicos , Humanos , Modelos Teóricos , Trombose/tratamento farmacológico
10.
Ann Palliat Med ; 10(5): 5633-5640, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-34107722

RESUMO

BACKGROUND: This study was conducted to analyze the influences of stent surface area (SSA), platelet distribution width (PDW), and the joint effect of these 2 risk factors on major adverse cardiovascular events (MACEs) in patients treated with percutaneous coronary intervention (PCI) together with drug-eluting stent (DES) implantation. METHODS: Based on a cross-sectional survey conducted between 2011 and 2012, a prospective cohort study was enrolled consiting of 442 patients who had undergone PCI with DES implantation. We categorized the participants into 4 subgroups according to PDW and SSA. Cox proportional hazards models were applied to explore the correlation of PDW and SSA with MACE incidence. RESULTS: During the 12 months of follow-up time, 87 patients experienced MACEs, which included 4 deaths (4.6%), 5 nonfatal myocardial infarctions (MIs) (5.75%), 9 ischemic strokes (10.34%), and 73 clinically relevant bleeding episodes (83.91%). The risks of MACEs were decreased by SSA and increased by PDW. However, the association of PDW or SSA with MACE was not statistically significant. Compared with the patients with PDW ≥13.5% and SSA <358.14 mm2, the multivariable adjusted hazard ratios [HRs; 95% confience interval (CI)] of the total MACEs for the patients with PDW <13.5% and SSA ≥358.14 mm2, and with PDW ≥13.5% and SSA ≥358.14 mm2 were 0.94 (95% CI: 0.55-1.64) and 0.37 (95% CI: 0.18-0.76), respectively. Additionally, the patients in the group of PDW <13.5% and SSA <358.14 mm2, and PDW ≥13.5% and SSA ≥358.14 mm2 had respective HRs of 0.47 (95% CI: 0.24-0.91) and 0.28 (95% CI: 0.13-0.63) for 12-month bleeding events when PDW ≥13.5% and SSA <358.14 mm2was used as a group reference. CONCLUSIONS: Our present results suggest that the joint effect of PDW and SSA was significantly correlated to MACE development in the patients treated with PCI (with DES implantation).


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Estudos Transversais , Stents Farmacológicos/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Fatores de Risco , Stents/efeitos adversos , Resultado do Tratamento
13.
J Cardiothorac Surg ; 16(1): 134, 2021 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-34001176

RESUMO

BACKGROUND: Stenosis at the opening and bifurcation of the anterior descending branch and circumflex branch around the end of the left main trunk is difficult to repair. Accurate positioning of a stent is the key problem. CASE PRESENTATIONS: Here we report the case of a 61-year-old man who suffered from paroxysmal chest pain for 1 year, without history of diabetes or hypertension. The coronary computed tomography showed mixed plaques in the proximal part of the anterior descending artery, with stenosis severe at 80-90%. The emergency coronary angiography showed occlusion of the anterior descending artery. During percutaneous coronary intervention, a drug-eluting stent was implanted into the anterior descending artery using the Szabo technique, supported by stent boost (StentBoost) imaging to pinpoint the location of the lesion. The patient's paroxysmal chest pain was relieved after the procedure. CONCLUSION: We used StentBoost to verify the accuracy of stent placement and the Szabo technique to rectify long-term coronary stenosis, which achieved satisfactory results. Combining the Szabo technique with StentBoost imaging was helpful to accurately evaluate the area and locate the stent when treating this ostial lesion of the anterior descending coronary artery.


Assuntos
Estenose Coronária/diagnóstico por imagem , Estenose Coronária/fisiopatologia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/fisiopatologia , Dor no Peito/cirurgia , Angiografia Coronária , Reestenose Coronária , Stents Farmacológicos , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Prognóstico , Resultado do Tratamento
14.
Curr Opin Cardiol ; 36(4): 390-396, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-33973929

RESUMO

PURPOSE OF REVIEW: Antiplatelet therapy is key to reduce systemic and local thrombotic events among patients undergoing percutaneous coronary interventions (PCI). Antiplatelet treatment regimens have been subject to continuous changes over the years, with a dual antiplatelet therapy (DAPT), consisting of aspirin and a P2Y12 inhibitor representing the cornerstone of treatment in these patients. RECENT FINDINGS: The need for less aggressive antithrombotic drugs to prevent local ischemic events with newer generation drug-eluting stent together with the increased understanding of the prognostic relevance of bleeding events in PCI patients, have prompted investigations aimed at identifying antiplatelet treatment regimens associated with a more favorable balance between ischemic and bleeding risks. Several key randomized controlled trials (RCTs) on antiplatelet regimens in patients undergoing PCI have been recently reported resulting in updates in practice guidelines. SUMMARY: This manuscript provides an overview of the advancements in the field deriving from key RCTs on antiplatelet regimens in patients undergoing PCI.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Aspirina/uso terapêutico , Quimioterapia Combinada , Humanos , Inibidores da Agregação Plaquetária/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto
15.
Am J Cardiol ; 150: 47-54, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-34011436

RESUMO

Controversy remains regarding the optimal antiplatelet regimen in patients with acute coronary syndrome (ACS). This study sought to investigate the efficacy and safety of P2Y12 inhibitor monotherapy compared with conventional dual antiplatelet therapy (DAPT) and aspirin monotherapy in patients with ACS undergoing percutaneous coronary intervention. Data on 4,453 patients were pooled from SMART-DATE and SMART-CHOICE randomized trials. Antiplatelet therapy regimens were categorized as P2Y12 inhibitor monotherapy (P2Y12 inhibitor monotherapy after 3-month DAPT), conventional DAPT (12-month or longer DAPT), and aspirin monotherapy (aspirin monotherapy after 6-month DAPT). The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE, a composite of all-cause death, myocardial infarction, and stroke). Inverse-probability of treatment-weighted (IPTW) analysis was performed. At 1 year, patients in the P2Y12 inhibitor monotherapy had a comparable risk of MACCE compared with those in the conventional DAPT (IPTW-adjusted hazard ratio [HR], 0.655; 95% confidence interval [CI] 0.393 to 1.094; p = 0.106), and tended to have a lower risk of MACCE than those in the aspirin monotherapy (IPTW-adjusted HR, 0.606; 95% CI, 0.347 to 1.058; p = 0.078). The adjusted hazard for the Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding was significantly lower in P2Y12 inhibitor monotherapy than in conventional DAPT (IPTW-adjusted HR, 0.341; 95% CI, 0.190 to 0.614; p < 0.001) and in aspirin monotherapy (IPTW-adjusted HR, 0.359; 95% CI, 0.182 to 0.708; p = 0.003). In conclusion, among patients with ACS undergoing PCI, P2Y12 inhibitor monotherapy after 3-month DAPT reduced risk of bleeding compared with conventional DAPT and aspirin monotherapy after 6-month DAPT without increasing MACCE.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Aspirina/uso terapêutico , Terapia Antiplaquetária Dupla , Inibidores da Agregação Plaquetária/uso terapêutico , Síndrome Coronariana Aguda/cirurgia , Idoso , Clopidogrel/uso terapêutico , Stents Farmacológicos , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Cloridrato de Prasugrel/uso terapêutico , Ticagrelor/uso terapêutico
16.
J Interv Cardiol ; 2021: 9934535, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34035674

RESUMO

Introduction: This network meta-analysis aimed to evaluate the efficacy and safety of different dual antiplatelet therapies (DAPTs) after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). Methods: Randomized controlled trials (RCTs) comparing longer-term (>12 months) DAPT (L-DAPT), 12-month DAPT (DAPT 12Mo), 6-month DAPT (DAPT 6Mo), 3-month DAPT followed by aspirin monotherapy (DAPT 3Mo + ASA), 3-month DAPT followed by a P2Y12 receptor inhibitor monotherapy (DAPT 3Mo + P2Y12), or 1-month DAPT with a P2Y12 receptor inhibitor monotherapy (DAPT 1Mo + P2Y12) were searched. Primary endpoints were all-cause mortality, cardiac death, myocardial infarction (MI), major bleeding, any bleeding, definite or probable stent thrombosis (ST), and net adverse clinical events (NACE). This Bayesian network meta-analysis was performed with the random-effects model. Results: Twenty-four RCTs (n = 81339) were included. In comparison with L-DAPT, DAPT 6Mo (OR: 0.50, 95% CI: 0.29-0.83), DAPT 3Mo + P2Y12 (OR: 0.38, 95% CI: 0.18-0.82), DAPT 3Mo + ASA (OR: 0.44, 95% CI: 0.17-0.98), and DAPT 1Mo + P2Y12 (OR: 0.45, 95% CI: 0.14-0.93) were associated with a lower risk of major bleeding. DAPT 3Mo + P2Y12 (OR: 0.58, 95% CI: 0.38-0.88) reduced the risk of any bleeding when compared with DAPT 12Mo. L-DAPT decreased the risk of MI and definite or probable stent ST when compared with DAPT 6Mo. DAPT 3Mo + P2Y12 decreased the risk of NACE in comparison with DAPT 6Mo and DAPT 12Mo. No significant difference in all-cause mortality and cardiac death was observed. In patients with acute coronary syndrome, DAPT 6Mo was comparable to DAPT 12Mo. Conclusion: Short-term (1-3 months) DAPT is noninferior to DAPT 6Mo after DESs implantation, while L-DAPT reduces MI and definite or probable ST rates. DAPT 3Mo + P2Y12 might be a reasonable trade-off in patients with high risk of bleeding accompanied by ischemia.


Assuntos
Reestenose Coronária/prevenção & controle , Quimioterapia Combinada , Stents Farmacológicos , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/farmacologia , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Metanálise em Rede , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Risco Ajustado/métodos
17.
Int Heart J ; 62(3): 510-519, 2021 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-33994509

RESUMO

A recent thinner strut drug-eluting stent might facilitate early strut coverage after its placement. We aimed to investigate early vascular healing responses after the placement of an ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) compared to those with a durable-polymer everolimus-eluting stent (DP-EES) using optical coherence tomography (OCT) imaging.This study included 40 patients with chronic coronary syndrome (CCS) who underwent OCT-guided percutaneous coronary intervention (PCI). Twenty patients each received either BP-SES or DP-EES implantation. OCT was performed immediately after stent placement (baseline) and at 1-month follow-up.At one month, the percentage of uncovered struts reduced significantly in both the BP-SES (80.9 ± 10.3% to 2.9 ± 1.7%; P < 0.001) and DP-EES (81.9 ± 13.0% to 5.7 ± 1.8%; P < 0.001) groups, and the percentage was lower in the BP-SES group than in the DP-EES group (P < 0.001). In the BP-SES group, the percentage of malapposed struts also decreased significantly at 1 month (4.9 ± 3.7% to 2.6 ± 3.0%; P = 0.025), which was comparable to that of the DP-EES group (2.5 ± 2.2%; P = 0.860). The optimal cut-off value of the distance between the strut and vessel surface immediately after the placement to predict resolved malapposed struts was ≤ 160 µm for BP-SES and ≤ 190 µm for DP-EES.Compared to DP-EES, ultrathin-strut BP-SES demonstrated favorable vascular responses at one month, with a lower rate of uncovered struts and a comparable rate of malapposed struts.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Doença das Coronárias/cirurgia , Stents Farmacológicos/estatística & dados numéricos , Intervenção Coronária Percutânea/instrumentação , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/administração & dosagem , Doença das Coronárias/diagnóstico por imagem , Everolimo/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sirolimo/administração & dosagem , Tomografia de Coerência Óptica
18.
J Endovasc Ther ; 28(4): 555-566, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33843364

RESUMO

PURPOSE: The performance of sirolimus-coated devices has not been studied in patients with chronic limb-threatening ischemia patients. PRESTIGE aims to investigate the 6-month efficacy and safety profile of the Selution Sustained Limus Release (SLR) sirolimus-eluting balloon for treatment of TASC II C and D tibial occlusive lesions in patients with CLTI. MATERIALS AND METHODS: PRESTIGE is a pilot prospective, nonrandomized, single-arm, multi-investigator, single-center clinical study. Endpoints were adverse event-free survival at 1 month, technical success rate, primary tibial patency at 6 months, limb salvage success, target lesion revascularization (TLR), and amputation free survival (AFS). RESULTS: A total of 25 patients were included. There were 17 (68.0%) males; mean age, 63.7±9.73 years. CLTI severity was based on the Rutherford scale (R5=25/25; 100.0%). Significant comorbidities included diabetes mellitus (n=22; 88.0%) and end-stage renal failure (n=11; 44.0%). A total of 33 atherosclerotic lesions were treated (TASC II D=15 (45.5%)). Mean lesion length treated was 191±111 mm. Technical success was 100%. Primary tibial patency at 6 months was 22/27 (81.5%) and freedom from clinically driven TLR was 25/30 (83.3%). AFS was 21/25 (84.0%; 3 deaths and 1 major lower extremity amputation). Mean Rutherford score improved from 5.00 at baseline to 1.14±2.10 (p<0.05) at 6 months. There was a wound healing rate of 13/22 (59.1%) and 17/21 (81.0%) at 3 and 6 months respectively. CONCLUSIONS: Selution SLR drug-eluting balloon is a safe and efficacious modality in treating complex tibial arterial occlusive lesions in what is an otherwise frail cohort of CLTI patients, with a high prevalence of diabetes and end-stage renal failure. Technical and clinical success rates are high and 6-month target lesion patency and AFS are more than satisfactory.


Assuntos
Angioplastia com Balão , Stents Farmacológicos , Doença Arterial Periférica , Idoso , Angioplastia com Balão/efeitos adversos , Humanos , Isquemia/diagnóstico por imagem , Isquemia/terapia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Estudos Prospectivos , Sirolimo/efeitos adversos , Resultado do Tratamento , Grau de Desobstrução Vascular
19.
Dtsch Arztebl Int ; 118(6): 88-95, 2021 02 12.
Artigo em Inglês | MEDLINE | ID: mdl-33827749

RESUMO

BACKGROUND: The second edition of the German-Austrian S3 guideline contains updated evidence-based recommendations for the treatment of patients with infarction-related cardiogenic shock (ICS), whose mortality is several times higher than that of patients with a hemodynamically stable myocardial infarction (1). METHODS: In five consensus conferences, the experts developed 95 recommendations-including two statements-and seven algorithms with concrete instructions. RESULTS: Recanalization of the coronary vessel whose occlusion led to the infarction is crucial for the survival of patients with ICS. The recommended method of choice is primary percutaneous coronary intervention (pPCI) with the implantation of a drug-eluting stent (DES). If multiple coronary vessels are diseased, only the infarct artery (the "culprit lesion") should be stented at first. For cardiovascular pharmacotherapy-primarily with dobutamine and norepinephrine-the recommended hemodynamic target range for mean arterial blood pressure is 65-75 mmHg, with a cardiac index (CI) above 2.2 L/min/m2. For optimal treatment in intensive care, recommendations are given regarding the type of ventilation (invasive rather than non-invasive, lungprotective), nutrition (no nutritional intake in uncontrolled shock, no glutamine supplementation), thromboembolism prophylaxis (intravenous heparin rather than subcutaneous prophylaxis), und further topics. In case of pump failure, an intra-aortic balloon pump is not recommended; temporary mechanical support systems (Impella pumps, veno-arterial extracorporeal membrane oxygenation [VA-ECMO], and others) are hemodynamically more effective, but have not yet been convincingly shown to improve survival. CONCLUSION: Combined cardiological and intensive-care treatment is crucial for the survival of patients with ICS. Coronary treatment for ICS seems to have little potential for further improvement, while intensive-care methods can still be optimized.


Assuntos
Stents Farmacológicos , Infarto do Miocárdio , Áustria , Humanos , Balão Intra-Aórtico , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/etiologia , Choque Cardiogênico/terapia
20.
J Interv Cardiol ; 2021: 6654515, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33880087

RESUMO

Background: While thinner struts are associated with improved clinical outcomes in bare-metal stents (BMS), reducing strut thickness may affect drug delivery from drug-eluting stents (DES) and there are limited data comparing otherwise similar thin and thick strut DES. We assessed 2-year outcomes of patients treated with a thin strut (84-88um) cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) and compared these to patients treated with a stainless steel, biodegradable polymer, Biolimus A9-eluting stent (SS-BP-BES). Methods: In total, 1257 patients were studied: 400 patients from 12 centres receiving ≥1 CoCr-BP-BES in the prospective Biomatrix Alpha registry underwent prespecified comparison with 857 patients who received ≥1 Biomatrix Flex SS-BP-BES in the LEADERS study (historical control). The primary outcome was major adverse cardiac events (MACE)-cardiac death, myocardial infarction (MI), or clinically driven target vessel revascularization (cd-TVR). Propensity analysis was used to adjust for differences in baseline variables and a landmark analysis at day-3 to account for differences in periprocedural MI definitions. Results: MACE at 2 years occurred in 6.65% CoCr-BP-BES versus 13.23% SS-BP-BES groups (unadjusted HR 0.48 [0.31-0.73]; P=0.0005). Following propensity analysis, 2-year adjusted MACE rates were 7.4% versus 13.3% (HR 0.53 [0.35-0.79]; P=0.004). Definite or probable stent thrombosis, adjudicated using identical criteria in both studies, occurred less frequently with CoCr-BP-BES (1.12% vs. 3.22%; adjusted HR 0.32 [0.11-0.9]; P=0.034). In day-3 landmark analysis, the difference in 2-year MACE was no longer significant but there was a lower patient-orientated composite endpoint (11.7% vs. 18.4%; HR 0.6 [0.43-0.83]; P=0.006) and a trend to lower target vessel failure (5.8% vs. 9.1%; HR 0.63 [0.4-1.00]; P=0.078). Conclusion: At 2-year follow-up, propensity-adjusted analysis showed the thin strut (84-88um) Biomatrix Alpha CoCr-BP-BES was associated with improved clinical outcomes compared with the thicker strut (114-120um) Biomatrix Flex SS-BP-BES.


Assuntos
Síndrome Coronariana Aguda/terapia , Anti-Inflamatórios/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Sirolimo/análogos & derivados , Implantes Absorvíveis , Idoso , Ligas de Cromo , Trombose Coronária/etiologia , Stents Farmacológicos/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Polímeros , Estudos Prospectivos , Sistema de Registros , Sirolimo/administração & dosagem , Aço Inoxidável , Resultado do Tratamento
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