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1.
Lancet ; 396(10261): 1504-1510, 2020 11 07.
Artigo em Inglês | MEDLINE | ID: mdl-33091360

RESUMO

BACKGROUND: In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention. METHODS: In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing. FINDINGS: Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance. INTERPRETATION: There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years. FUNDING: Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.


Assuntos
Angioplastia Coronária com Balão/normas , Doença da Artéria Coronariana/terapia , Stents Farmacológicos/normas , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/mortalidade , Doença da Artéria Coronariana/mortalidade , Stents Farmacológicos/efeitos adversos , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Resultado do Tratamento
2.
Minerva Med ; 111(4): 315-323, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33032393

RESUMO

BACKGROUND: The registry investigated clinical outcomes after 12 months of implantation of ultra-thin strut (60 µm) biodegradable polymer-coated Tetrilimus everolimus-eluting stents (EES; Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in patients with atherosclerotic coronary lesions. Additionally, sub-group analysis was performed to evaluate outcomes of ultra-long (44/48 mm) Tetrilimus EES in patients with long lesions. METHODS: This was an observational, single-center, single-arm and investigator-initiated retrospective registry. In this all-comers registry, patients who underwent implantation of Tetrilimus EES for treatment of coronary artery disease during routine clinical practice between February-2016 and August-2016 at tertiary care center of India were included. Primary endpoint was occurrence of any major adverse cardiac event (MACE) up to 12 months' follow-up. MACE was a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Similar endpoints were observed in sub-group patients. RESULTS: Total 766 stents were implanted to treat 695 lesions in 558 patients. Of treated lesions, 11.4% lesions were type B2 and 78.3% were type C lesions. In sub-group analysis of 143 patients, a total of 155 long coronary lesions were intervened successfully with only one stent been implanted per lesion. At 12 months' follow-up, four (0.7%) cases of cardiac death, eight (1.4%) of MI, and two (0.4%) of TLR were reported, resulting in a 2.5% rate of MACE. The MACE rate was 2.8% in sub-group patients. CONCLUSIONS: Twelve months' clinical data demonstrated favorable safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice and also in patients with ultra-long lesions.


Assuntos
Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Everolimo/administração & dosagem , Implantes Absorvíveis , Idoso , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polímeros , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Stents , Resultado do Tratamento
3.
Beijing Da Xue Xue Bao Yi Xue Ban ; 52(5): 856-862, 2020 Oct 18.
Artigo em Chinês | MEDLINE | ID: mdl-33047719

RESUMO

OBJECTIVE: To elucidate the correlation between CKLF-like marvel transmembrane domain containing member (CMTM5) gene and the risk of in-stent restenosis (ISR) with coronary artery disease (CAD) patients and to detect the effects and mechanisms of CMTM5-stimulated genes on human vascular endothelial cells (ECs) proliferation and migration. METHODS: A total of 124 hospitalized patients in Shijitan Hospital were enrolled in this study. All the CAD patients were detected with platelet reactivity and grouped into two groups according to platelet reactivity; ISR was conformed by coronary angiography; RT-PCR method was used to detect CMTM5 gene expression; The CMTM5 over expression, reduction and control EC lines were established; Cell count, MTT, Brdu and flow cytometry methods were used to detect the proliferation of ECs, scratch and transwell experiments to test the migration of ECs, Western blot was used to detect signal path expressions. RESULTS: CMTM5 gene expression in HAPR (High on aspirin platelet reactivity) group was 1.72 times compared with No-HAPR group, which was significantly higher than No-HAPR group. HAPR group ISR rate was 25.8% (8 cases), the incidence of No-HAPR ISR group was 9.7% (9 cases), and the results showed that in HAPR group, the incidence of ISR was significantly higher than that in No-HAPR group (P=0.04, OR=0.04, 95%CI=1.16-7.52), which showed that CMTM5 gene was significantly correlated with the risk of ISR. In HAPR group ISR rate was 25.8% (8 cases), the incidence of ISR in No-HAPR group was 9.7% (9 cases), and the results showed that the risk of ISR in HAPR group was significantly higher than that in No-HAPR group. All the results showed that CMTM5 was significantly correlated with the risk of ISR in CAD patients (P < 0.05). CMTM5 overexpression inhibited the proliferation and migration ability of ECs (P < 0.05), PI3K/Akt signaling pathways were involved in the role of regulation on ECs. CONCLUSION: Our results revealed that CMTM5 gene was closely related with ISR, CMTM5 overexpression may repress ECs proliferation and migration through regulating PI3K-Akt signaling.


Assuntos
Doença da Artéria Coronariana , Reestenose Coronária , Stents Farmacológicos , Quimiocinas , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Células Endoteliais , Humanos , Proteínas com Domínio MARVEL , Fosfatidilinositol 3-Quinases , Proteínas Supressoras de Tumor
5.
Arq Bras Cardiol ; 115(1): 80-89, 2020 07.
Artigo em Inglês, Português | MEDLINE | ID: mdl-32813829

RESUMO

Background The use of drug-eluting stents (DESs), compared with bare-metal stents (BMSs), in percutaneous coronary intervention (PCI) has reduced the rate of restenosis, without an impact on mortality but with an increase in costs. Medical literature lacks randomized studies that economically compare these 2 stent types within the reality of the Brazilian Unified Public Health System (SUS). Objective To estimate the incremental cost-effectiveness ratio (ICER) between DES and BMS in SUS patients with single-vessel coronary artery disease. Methods Over a 3-year period, patients with symptomatic single-vessel coronary artery disease were randomized in a 1:2 ratio to receive a DES or BMS during PCI, with a 1-year clinical follow-up. The evaluation included in-stent restenosis (ISR), target lesion revascularization (TLR), major adverse events, and cost-effectiveness for each group. P-values <0.05 were considered significant. Results In the DES group, of 74 patients (96.1%) who completed the follow-up, 1 developed ISR (1.4%), 1 had TLR (1.4%), and 1 died (1.4%), with no cases of thrombosis. In the BMS group, of 141 patients (91.5%), ISR occurred in 14 (10.1%), TLR in 10 (7.3%), death in 3 (2.1%), and thrombosis in 1 (0.74%). In the economic analysis, the cost of the procedure was R$ 5,722.21 in the DES group and R$ 4,085.21 in the BMS group. The effectiveness by ISR and TLR was 8.7% for DES and 5.9% for BMS, with an ICER of R$ 18,816.09 and R$ 27,745.76, respectively. Conclusions In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol. 2020; 115(1):80-89).


Assuntos
Reestenose Coronária , Stents Farmacológicos , Intervenção Coronária Percutânea , Brasil , Reestenose Coronária/prevenção & controle , Análise Custo-Benefício , Stents Farmacológicos/efeitos adversos , Humanos , Desenho de Prótese , Saúde Pública , Fatores de Risco , Stents/efeitos adversos , Resultado do Tratamento
6.
Medicine (Baltimore) ; 99(34): e21885, 2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32846847

RESUMO

The use of a drug-eluting stent (DES) in patients with acute myocardial infarction (AMI) treated with percutaneous coronary intervention is conventional. However, the effect of DES on new-onset atrial fibrillation (AF) after AMI still remains unclear.By using data from Taiwan's National Health Insurance Research Database, a total of 17,741 patients with ST-elevation myocardial infarction (STEMI) and 17,631 patients with non-ST-elevation myocardial infarction (NSTEMI) treated with percutaneous coronary intervention were analyzed to investigate the risk of new-onset AF after index admission of AMI.There were 26.5% (N = 4696) of patients with STEMI and 39.5% (N = 6967) of patients with NSTEMI received DES implantation. Upon 1-year follow-up, we observed that DES placement was associated with a reduced 1-year risk of new-onset AF in the patients with NSTEMI (adjusted hazard ratio [aHR] = 0.74, 95% confidence interval [CI] = 0.59-0.93, P = .009) after adjustment for clinical relevant variables. This benefit was consistent with that in the patients with NSTEMI who were ≥75 years old, had a CHA2DS2-VASc score of ≥2, and did not receive intra-aortic balloon pump insertion (aHR = 0.72, 95% CI = 0.53-0.98, P = .039; aHR = 0.73, 95% CI = 0.586-0.92, P = .006; and aHR = 0.71, 95% CI = 0.56-0.90, P = .004; respectively). However, DES placement had a neutral effect on the risk of new-onset AF in the patients with STEMI.Compared with the use of BMS, the use of DES might reduce the risk of new-onset AF in patients with NSTEMI.


Assuntos
Stents Farmacológicos/efeitos adversos , Infarto do Miocárdio/cirurgia , Infarto do Miocárdio sem Supradesnível do Segmento ST/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/etiologia , Estudos de Casos e Controles , Stents Farmacológicos/economia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio sem Supradesnível do Segmento ST/complicações , Infarto do Miocárdio sem Supradesnível do Segmento ST/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/complicações , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Taiwan/epidemiologia
7.
Medicine (Baltimore) ; 99(31): e21554, 2020 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-32756213

RESUMO

BACKGROUND: Bioresorbable vascular scaffolds (BVS) completely resorb within 3 years after placement into the coronary artery. The safety and effectiveness of bioabsorbable scaffolds are of critical importance during this 3-year period. OBJECTIVE: We performed a meta-analysis to compare the safety and efficacy of BVS and second-generation drug-eluting stents (DES) at 3 years after implantation. METHODS: Published randomized trials comparing BVS to second-generation DES for the treatment of coronary artery disease were identified within PubMed, EMBASE, Cochrane Library, Web of Science, and relevant Web sites with publication dates through June 2019. The primary efficacy endpoint was target lesion failure. The primary safety endpoint was definite/probable stent/scaffold thrombosis. Secondary outcomes were cardiac death, target vessel myocardial infarction, ischemia-driven target lesion revascularization, and a patient-oriented composite end point. RESULTS: Six randomized controlled trials, with a total of 5,412 patients (BVS n = 3,177; DES n = 2,235), were included. At 3 years, BVS was associated with higher rates of target lesion failure (OR = 1.33, 95%CI: 1.10-1.60, P = 0.003) and definite/probable stent/scaffold thrombosis (OR = 3.75, 95% CI: 2.22-6.35, P < .00001)compared with DES. The incidence of target vessel myocardial infarction (OR = 1.68, 95% CI: 1.30-2.17, P < .0001), ischemia-driven target lesion revascularization (OR = 1.46, 95% CI: 1.14-1.86, P = .003), and the patient-oriented composite end point(OR = 1.20, 95% CI: 1.04-1.39, P = .01) were higher for those treated with BVS compared with DES. However, there was no significant difference in risk of cardiac death (OR = 0.94, 95%CI: 0.61-1.45, P = .79) between treatment groups. CONCLUSIONS: At the 3-year follow-up, BVS was inferior to second-generation DES in both safety and efficacy.


Assuntos
Implantes Absorvíveis/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Morte , Humanos , Infarto do Miocárdio/etiologia , Revascularização Miocárdica/estatística & dados numéricos , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Trombose/etiologia
8.
Am Heart J ; 228: 1-7, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32739652

RESUMO

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


Assuntos
Síndrome Coronariana Aguda , Aspirina , Clopidogrel , Hemorragia , Risco Ajustado/métodos , Acidente Vascular Cerebral , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Adulto , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Clopidogrel/administração & dosagem , Clopidogrel/efeitos adversos , Método Duplo-Cego , Stents Farmacológicos/efeitos adversos , Terapia Antiplaquetária Dupla/efeitos adversos , Terapia Antiplaquetária Dupla/métodos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Agregação de Plaquetas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/induzido quimicamente , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
9.
Am J Cardiol ; 132: 52-58, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-32768142

RESUMO

Limited data exist on the comparison of clinical outcomes after first- and second-generation drug-eluting stent (DES) thrombosis. From the Retrospective Multicenter Registry of Stent Thrombosis (ST) After First- and Second-Generation DES Implantation registry, this study evaluated 655 ST patients (first-generation DES thrombosis [G1-ST], n = 342; second-generation DES thrombosis [G2-ST], n = 313). After propensity score matching, the final study population consisted of 159 matched patients. The primary end point was the cumulative 1-year incidence of mortality. The mortality after G2-ST at 1 year was similar to that after G1-ST (23.0% vs 22.9%, p = 0.76). Also, the G2-ST group showed a significantly lower rate of target lesion revascularization than the G1-ST group (9.7% vs 17.1%, p = 0.01). Risk factors of 1-year mortality included cardiogenic shock or arrest at the time of ST, multivessel ST, left ventricular ejection fraction ≤40%, advanced age, and final thrombolysis in myocardial infarction flow grade ≤2. In conclusion, patients with G2-ST showed a similar 1-year mortality to those with G1-ST, highlighting that ST remains a life-threatening complication in the second-generation DES era.


Assuntos
Trombose Coronária/epidemiologia , Stents Farmacológicos/efeitos adversos , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Pontuação de Propensão , Idoso , Angiografia Coronária , Trombose Coronária/diagnóstico , Feminino , Seguimentos , Humanos , Incidência , Japão/epidemiologia , Masculino , Falha de Prótese , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo
10.
PLoS One ; 15(7): e0235673, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32645029

RESUMO

BACKGROUND AND OBJECTIVES: This study sought to compare clinical outcomes between bioresorbable scaffolds (BRS) and durable polymer everolimus-eluting metallic stents (DP-EES) in patients with acute myocardial infarction (AMI) undergoing successful percutaneous coronary intervention (PCI). METHODS: From March 2016 to October 2017, 952 patients with AMI without cardiogenic shock undergoing successful PCI with BRS (n = 136) or DP-EES (n = 816) were enrolled from a multicenter, observational Korea Acute Myocardial Infarction Registry. RESULTS: In the crude population, there was no significant difference in the 1-year rate of device-oriented composite endpoint (DOCE) and device thrombosis between the BRS and DP-EES groups (2.2% vs. 4.8%, hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.13-1.41, p = 0.163; 0.7% vs. 0.5%, HR 1.49, 95% CI 0.16-13.4, p = 0.719, respectively). BRS implantation was opted in younger patients (53.7 vs. 62.6 years, p < 0.001) with low-risk profiles, and intravascular image-guided PCI was more preferred in the BRS group (60.3% vs. 27.2%, p < 0.001). CONCLUSIONS: At 1-year follow-up, no differences in the rate of DOCE and device thrombosis were observed between patients with AMI treated with BRS and those treated with DP-EES. Our data suggest that imaging-guided BRS implantation in young patients with low risk profiles could be a reasonable strategy in the setting of AMI.


Assuntos
Implantes Absorvíveis/efeitos adversos , Stents Farmacológicos/efeitos adversos , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Doença Aguda/terapia , Adulto , Idoso , Fármacos Cardiovasculares/uso terapêutico , Determinação de Ponto Final , Everolimo/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/terapia , Modelos de Riscos Proporcionais , República da Coreia , Trombose/etiologia , Tecidos Suporte/efeitos adversos , Resultado do Tratamento
11.
Yonsei Med J ; 61(7): 597-605, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32608203

RESUMO

PURPOSE: Although current guidelines recommend the administration of dual antiplatelet therapy (DAPT) for up to 12 months after the implantation of a drug-eluting stent (DES), extended DAPT is frequently used in real-world practice. MATERIALS AND METHODS: From the Korean Multicenter Angioplasty Team registry, we identified a total of 1414 patients who used DAPT for >3 years after DES implantation (extended-DAPT group) and conducted a landmark analysis at 36 months after the index procedure. We evaluated the determinants for and long-term outcomes of extended DAPT and compared the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite of all-cause death, myocardial infarction, stent thrombosis, and stroke, between the extended-DAPT group and the guideline-DAPT group [DAPT <1 year after DES implantation (n=1273)]. RESULTS: Multivariate analysis indicated the occurrence of acute coronary syndrome as the most significant clinical determinant of the use of extended DAPT. Bifurcation, stent diameter ≤3.0 mm, total stented length ≥28 mm, and use of first-generation DESs were also significant angiographic and procedural determinants. MACCE rates were similar between the extended-DAPT group and the guideline-DAPT group in crude analysis [hazard ratio (HR), 1.08; 95% confidence interval (CI), 0.69-1.68; p=0.739] and after propensity matching (HR, 1.22; 95% CI, 0.72-2.07; p=0.453). Major bleeding rates were comparable between the two groups. CONCLUSION: In patients undergoing percutaneous coronary intervention, indefinite use of DAPT does not show superior outcomes to those of guideline-DAPT. Major bleeding rates are also similar.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Doença da Artéria Coronariana/tratamento farmacológico , Stents Farmacológicos/efeitos adversos , Terapia Antiplaquetária Dupla/métodos , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Agregação de Plaquetas/uso terapêutico , Idoso , Doenças Cardiovasculares/epidemiologia , Doença da Artéria Coronariana/cirurgia , Doença da Artéria Coronariana/terapia , Trombose Coronária/prevenção & controle , Quimioterapia Combinada , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/etiologia , Inibidores da Agregação de Plaquetas/efeitos adversos , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Trombose/complicações , Fatores de Tempo , Resultado do Tratamento
12.
Expert Rev Med Devices ; 17(7): 671-682, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32543934

RESUMO

INTRODUCTION: Coronary percutaneous interventions have evolved from plain old balloon angioplasty (POBA) to stent implantation, which itself evolved from bare-metal stents (BMS) to the new biodegradable stents which try to restore endothelial function. Currently, the most commonly used stent is the everolimus-eluting stent. AREAS COVERED: This review will cover the current status of durable polymer everolimus-eluting stent, its history, and future perspectives. Nowadays, the everolimus-eluting stent is the most used device in the acute and chronic settings due to its safety and efficacy. EXPERT OPINION: Durable polymer everolimus-eluting stent, supported by much evidence, has demonstrated its efficacy and safety, not only in de novo artery lesions, but in multiples scenarios, such as the acute setting and diabetic population, becoming one of the most polyvalent stents available. Nowadays, research is focused on the reduction of antiplatelet treatment duration. Similar rates of stent thrombosis with short dual antiplatelet treatment regimens of 1 to 3 months compared to pronged treatment have been observed. However, specific studies should be performed to evaluate this possibility.


Assuntos
Stents Farmacológicos/tendências , Everolimo/uso terapêutico , Polímeros/química , Síndrome Coronariana Aguda/tratamento farmacológico , Stents Farmacológicos/efeitos adversos , Everolimo/efeitos adversos , Everolimo/química , Humanos , Resultado do Tratamento
13.
PLoS One ; 15(6): e0234362, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32520973

RESUMO

BACKGROUND: Patients with diabetes mellitus are at an increased risk for adverse clinical events following percutaneous coronary interventions (PCI). However, the clinical impact of diabetes mellitus (DM) on second-generation drug-eluting stent (DES) implantation is not well-known. The aim of the current analysis was to examine the clinical impact of DM on clinical outcomes and the time sequence of associated risks in patients treated with second-generation DES. METHODS: Using patient-level data from two stent-specific, all-comer, prospective DES registries, we evaluated 1,913 patients who underwent PCI with second-generation DES between Feb 2009 and Dec 2013. The primary outcomes assessed were two-year major cardiac adverse events (MACE), composite endpoints of death from any cause, myocardial infarction (MI), and any repeat revascularization. We classified 0-1 year as the early period and 1-2 years as the late period. Landmark analyses were performed according to diabetes mellitus status. RESULTS: There were 1,913 patients with 2,614 lesions included in the pooled dataset. The median duration of clinical follow-up in the overall population was 2.0 years (interquartile range 1.9-2.1). Patients with DM had more cardiovascular risk factors than patients without DM. In multivariate analyses, the presence of DM and renal failure were strong predictors of MACE and target-vessel revascularization (TVR). After inverse probability of treatment weighting (IPTW) analyses, patients with DM had significantly increased rates of 2-year MACE (HR 2.07, 95% CI; 1.50-2.86; P <0.001). In landmark analyses, patients with DM had significantly higher rates of MACE in the early period (0-1 year) (HR 3.04, 95% CI; 1.97-4.68; P < 0.001) after IPTW adjustment, but these findings or trends were not observed in the late period (1-2 year) (HR 1.24, 95% CI; 0.74-2.07; P = 0.41). CONCLUSIONS: In the second-generation DES era, the clinical impact of DM significantly increased the 2-year event rate of MACE, mainly caused by clinical events in the early period (0-1 year). Careful observation of patients with DM is advised in the early period following PCI with second-generation DES.


Assuntos
Complicações do Diabetes/metabolismo , Stents Farmacológicos/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Idoso , Doença da Artéria Coronariana/complicações , Complicações do Diabetes/terapia , Diabetes Mellitus/etiologia , Diabetes Mellitus/metabolismo , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Sistema de Registros , República da Coreia/epidemiologia , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
14.
EuroIntervention ; 16(8): 645-653, 2020 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-32451321

RESUMO

AIMS: The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS). METHODS AND RESULTS: The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: -1.2%-3.0%, p non-inferiority <0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [HR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group. CONCLUSIONS: In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Stents Farmacológicos/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Desenho de Prótese , Tecidos Suporte , Resultado do Tratamento
15.
J Interv Cardiol ; 2020: 2985435, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32405273

RESUMO

Background/Aim: The relation between complex percutaneous coronary intervention (PCI), high bleeding risk (HBR), and adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterized. This study sought to investigate the ischemic and bleeding events after complex PCI including stratification according to HBR estimated by PARIS bleeding risk score. Methods: Between January 2013 and December 2013, 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. Complex PCI was defined when having at least one of the following characteristics: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, unprotected left main PCI, in-stent restenosis target lesion, and severely calcified lesion. The primary ischemic endpoint was major adverse cardiovascular events (MACE) (composite of cardiac death, myocardial infarction, definite/probable stent thrombosis, and target lesion revascularization), and primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Results: The median duration of follow-up was 29 months. In adjusted Cox regression analysis, patients having complex PCI procedures experienced higher risks of MACE (hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.38-1.92; P < 0.001), compared with noncomplex PCI. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HR: 0.86 [0.66-1.11]; P = 0.238). There was no statistical interaction between HBR (PARIS bleeding score ≥8 or <8) and complex PCI in regard to MACE (adjusted P interaction = 0.388) and clinically relevant bleeding (adjusted P interaction = 0.279). Conclusions: Patients who had undergone complex PCI resulted in substantially more ischemic events, without an increase in clinically relevant bleeding risk, and these associations did not seem to be modified by HBR status. More intensified antiplatelet therapy may be beneficial for patients with complex percutaneous coronary revascularization procedures.


Assuntos
Doença da Artéria Coronariana , Vasos Coronários/patologia , Intervenção Coronária Percutânea , Hemorragia Pós-Operatória/diagnóstico , Estudos de Coortes , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação de Plaquetas/administração & dosagem , Hemorragia Pós-Operatória/prevenção & controle , Sistema de Registros/estatística & dados numéricos , Risco Ajustado/métodos , Fatores de Risco , Índice de Gravidade de Doença
16.
Expert Rev Med Devices ; 17(5): 383-390, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32274941

RESUMO

Introduction: Coronary angioplasty with the use of stents transformed the percutaneous treatment of coronary artery disease. First-generation drug-eluting stents reduced the risk of restenosis but carried a threat of late stent thrombosis. Second-generation drug-eluting stents resolved these issues and have proven so far very good safety and efficacy performance.Areas covered: This article aims to describe the new XIENCE® Sierra everolimus-eluting coronary stent system, to analyze the available data so far with regards to the safety, the effectiveness, and the overall clinical performance of the device and to seek future perspectives.Expert opinion: XIENCE® Sierra everolimus-eluting coronary stent carries all the positive features of the precursor stents of the XIENCE® family and brings an ultra-low crossing profile which further increases deliverability and flexibility. CoCr-everolimus-eluting stents are among if not the most extensively investigated coronary stents and have demonstrated over the years a consistently remarkable low risk of acute, subacute, late, and very late stent thrombosis and are considered a trustworthy device in the interventional management of complex coronary artery disease.


Assuntos
Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Equipamentos e Provisões/efeitos adversos , Ensaios Clínicos como Assunto , Everolimo/uso terapêutico , Humanos , Vigilância de Produtos Comercializados , Resultado do Tratamento
17.
Clin Appl Thromb Hemost ; 26: 1076029620915979, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32243192

RESUMO

To evaluate the efficacy and safety of TurboHawk plaque rotation system combined with drug-coated balloon in treating lower extremity arterial disease (LEAD) of diabetes patients, a total of 145 diabetic patients with LEAD from March 2015 to September 2016 were recruited in our study. Lower extremity arterial disease was diagnosed by ultrasound and CT angiography (CTA). According to the surgical method, 65 cases underwent TurboHawk plaque rotation combined with drug-coated balloon (group A), 80 cases underwent simple drug-coated balloon expansion (group B). The characteristics of lesion, function test, ankle-brachial index (ABI), and postoperative complications were analyzed. All the patients were followed up at 1, 3, 6, 12, and 24 months after operation. At baseline, there was no difference in all the characteristics between the 2 groups. The early postoperation minimum lumen diameter (MLD), lumen stenosis rate, and ABI in 2 groups both improved. As the follow-up time increased, patients in group A had significantly higher MLD and ABL value, as well as lower level of lumen stenosis rate, restenosis rate, late lumen loss, and target lesion revascularization (all P < .05). Accordingly, functional testing revealed the 6-minute walk distance, 6-minute claudication distance, resting ABI, and post-exercise ABI in group A were significantly higher than those in group B (all P < .05). Besides, major graft reintervention (4.62% vs 11.25%) and major adverse limb events (6.15% vs 12.5%) in group A occurred less frequently than group B (all P < .05). In conclusion, the long-term effect of the combined approach was better than only drug-coated balloon in LEAD in Chinese diabetes patients.


Assuntos
Angiopatias Diabéticas/terapia , Extremidade Inferior , Doença Arterial Periférica/terapia , Adulto , Idoso , Stents Farmacológicos/efeitos adversos , Feminino , Técnica de Placa Hemolítica , Humanos , Masculino , Pessoa de Meia-Idade
18.
Expert Rev Med Devices ; 17(4): 267-275, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32151183

RESUMO

Introduction: Polymer-free drug-eluting stents are designed with stent surface modifications and drug-matrix formulations in order to release antiproliferative agents without the need of a polymer coating. Polymer-free technologies have the potential to overcome complications due to polymer persistence over time, such as local inflammatory reactions, delayed arterial healing, neoatherosclerosis, and subsequent ischemic adverse events.Areas covered: The Cre8 polymer-free amphilimus-eluting stent received CE mark in 2011 and was conceived with the aim of addressing the safety and efficacy limitations of early generation drug-eluting stents based on permanent polymer coatings. Besides the absence of polymer, the main features of the Cre8 stent include the abluminal reservoirs, the passive carbon film coating, and the antiproliferative agent formulation based on sirolimus mixed with free-fatty acid chain - namely amphilimus. This review will focus on the Cre8 development, technical characteristics, preclinical evidence, clinical efficacy and safety, and future perspectives.Expert opinion: The Cre8 stent has shown favorable angiographic and clinical outcomes at short and medium-term follow-up. This technology might provide a benefit in patients with diabetes. Further randomized evidence is required to provide an adequate clinical evaluation of this promising technology in patients with and without diabetes.


Assuntos
Doença da Artéria Coronariana/tratamento farmacológico , Stents Farmacológicos/efeitos adversos , Sirolimo/uso terapêutico , Ensaios Clínicos como Assunto , Humanos , Desenho de Prótese , Resultado do Tratamento
19.
Expert Rev Med Devices ; 17(4): 257-265, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32154750

RESUMO

Introduction: The increasing complexity of patients undergoing percutaneous coronary intervention (PCI) regarding both coronary anatomy and comorbidities requires dedicated devices. The Resolute Onyx (R-Onyx, Medtronic, CA, USA) stent is a novel durable polymer zotarolimus-eluting stent (ZES) promising better deliverability, increased radiopacity and lower thrombogenicity.Areas covered: In this review, we discuss device features, preclinical evidence, and clinical studies including patients treated with R-Onyx. The BIONYX and Onyx ONE studies were two major landmark trials demonstrating non-inferiority of R-Onyx as compared to other latest generation devices. We also elaborate on alternative innovations in drug-eluting stent (DES) technology and how R-Onyx fits into this field.Expert opinion: R-Onyx is designed to address the challenges of contemporary PCI, but evidence on its clinical performance is largely derived from studies on older generation devices from the ZES family. Nonetheless, all clinical studies on R-Onyx consistently show excellent outcomes, with particularly low rates of stent thrombosis, making it a promising candidate for short dual antiplatelet regimens. In addition, R-Onyx is available with a wide range of stent diameters allowing accurate sizing for both very small and very large coronary vessels.


Assuntos
Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Sirolimo/análogos & derivados , Ensaios Clínicos como Assunto , Humanos , Desenho de Prótese , Sirolimo/efeitos adversos , Sirolimo/uso terapêutico , Resultado do Tratamento
20.
J Interv Cardiol ; 2020: 3872704, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32180687

RESUMO

Objective: In this study, we sought to compare the efficacy and safety of the Xience Prime/Xience V/Promus EES and Biomatrix/Biomatrix Flex/Nobori BES with resolute integrity/resolute ZES using the grand drug-eluting stent (Grand-DES) registry. Background: Currently, new-generation drug-eluting stents (DESs) are used as the standard of care in patients undergoing percutaneous coronary intervention. No study has simultaneously compared everolimus-eluting stent (EES), biolimus-eluting stent (BES), and zotarolimus-eluting stent (ZES). Methods: Stent-related composite outcomes (target lesion failure) and patient-related composite outcomes were compared in crude and propensity score-matched analysis. Results: Of the 17,286 patients in the Grand-DES group, 5,137, 2,970, and 4,990 patients in the EES, BES, and ZES groups completed a three-year follow-up. In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%. Conclusions: In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.


Assuntos
Stents Farmacológicos , Everolimo/farmacologia , Intervenção Coronária Percutânea/instrumentação , Sirolimo/análogos & derivados , Stents Farmacológicos/efeitos adversos , Stents Farmacológicos/normas , Segurança de Equipamentos , Feminino , Humanos , Imunossupressores/farmacologia , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Pontuação de Propensão , Sistema de Registros/estatística & dados numéricos , Sirolimo/farmacologia , Resultado do Tratamento
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