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1.
Yonsei Med J ; 60(9): 824-831, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31433580

RESUMO

PURPOSE: We evaluated the incidence, predictors, and prognosis of coronary artery aneurysm (CAA) after second-generation drug-eluting stent (DES) implantation. MATERIALS AND METHODS: A total of 976 consecutive patients (1245 lesions) who underwent follow-up angiography after second-generation DES implantation were analyzed. Incidence and predictors of CAA were assessed, and clinical prognosis was compared with 34 cases of CAA after first-generation DES implantation using previous CAA registry data. RESULTS: All 10 cases of CAA (0.80% per lesion) in 10 patients (1.02% per patient) were detected at follow up. Compared to lesions without CAA, those with CAA had greater involvement of the proximal segment (90% vs. 51%, p=0.014), a higher proportion of pre-intervention, a Thrombolysis in Myocardial Infarction score of 0 or 1 flow (80% vs. 16%, p<0.001), more chronic total occlusions (40% vs. 10%, p<0.001), and longer implanted stents (41.9±23.2 mm vs. 28.8±14.8 mm, p=0.006). As for CAA morphology, instances of CAA after second-generation DES were predominantly the single fusiform type (90%), whereas instances of CAA after first-generation DES were multiple saccular (47%) and single saccular (35%) types (p<0.001). Myocardial infarction with stent thrombosis occurred in 5 patients with CAA after first-generation DES (15%), and no adverse events were observed in patients with CAA after second-generation DES over a median follow-up duration of 4.3 years (p=0.047, log-rank). CONCLUSION: Although CAAs after second-generation DES implantation were detected at a similar incidence to that for CAAs after first-generation DES implantation, second-generation DES-related CAAs had different morphologies and more benign clinical outcomes versus first-generation DES-related CAAs.


Assuntos
Aneurisma Coronário/epidemiologia , Stents Farmacológicos/efeitos adversos , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Idoso , Aneurisma Coronário/diagnóstico por imagem , Aneurisma Coronário/terapia , Angiografia Coronária , Reestenose Coronária/terapia , Vasos Coronários , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , Prognóstico , Sistema de Registros , Trombose/complicações , Fatores de Tempo , Resultado do Tratamento
2.
Medicine (Baltimore) ; 98(32): e16767, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31393396

RESUMO

There are limited long-term outcome data comparing BioLinx polymer (B)-zotarolimus-eluting stents (ZES) with phosphorylcholine polymer (P)-ZES. The aim of this study was to compare the efficacy and safety of B-ZES with P-ZES in patients who underwent percutaneous coronary intervention (PCI) during a 3-year follow-up period.One thousand two hundred fifty four patients who underwent PCI with P-ZES (Endeavor [ZES-E] or Endeavor sprint [ZES-S], n = 356) or B-ZES (Endeavor resolute [ZES-R] or Resolute Integrity [ZES-I], n = 889) were enrolled. The primary endpoint was major adverse cardiac events (MACE); the composite of total death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), non-target vessel revascularization (Non-TVR), and the secondary endpoint was stent thrombosis (ST).After PSM, 2 propensity-matched (PSM) groups (275 pairs, n = 550, C-statistic = 0.730) were generated. During the 3-year follow-up period, the cumulative incidence of MACE (hazard ratio [HR], 1.525; 95% confidence interval [CI], 0.920-2.526; P = .101) and ST (HR, 1.248; 95% CI, 0.335-4.4649; P = .741) were similar between P-ZES and B-ZES after PSM. However, TLR rate was significantly higher in ZES-S than ZES-I (11.3% vs 3.8%, log rank P = .029) and TVR rate was higher in ZES-S than ZES-R (14.1% vs 4.8%, log rank P = .025).In this single-center, all-comer registry, despite different polymers, P-ZES, and B-ZES showed comparable safety and efficacy during a 3-year follow-up period after PCI.


Assuntos
Doenças Cardiovasculares/epidemiologia , Stents Farmacológicos/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Fosforilcolina/administração & dosagem , Sirolimo/análogos & derivados , Idoso , Doenças Cardiovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/mortalidade , Polímeros , Pontuação de Propensão , Desenho de Prótese , Reoperação , Sirolimo/administração & dosagem
3.
Angiology ; 70(10): 908-915, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31256614

RESUMO

The optimal treatment strategy for coronary chronic total occlusion (CTO) has not been well established. The benefit of percutaneous coronary intervention (PCI) was inferred mainly from observational studies comparing successful versus failed PCI without a control group receiving optimal medical therapy (OMT). We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies comparing PCI using drug-eluting stent (DES) versus OMT alone in patients with CTO. Eight studies were identified: 3 RCTs and 5 observational studies. Among a total of 4784 included patients, 2461 patients underwent PCI and 2323 patients received OMT. There was a significant association between PCI and lower cardiac mortality (odds ratio = 0.62; 95% confidence interval 0.42-0.93; P = .02). There was no significant difference between PCI and OMT regarding major adverse cardiac events, recurrent myocardial infarction (MI), repeat revascularization, or stroke. In the RCT subset (1399 patients), there was no significant difference between PCI and OMT regarding clinical outcomes. Compared with OMT alone, PCI with DES for CTO was associated with lower cardiac mortality, mainly driven by observational studies, without significant difference in recurrent MI or repeated revascularization. Further RCTs are needed to investigate the role of PCI for management of patients with CTO.


Assuntos
Oclusão Coronária/terapia , Stents Farmacológicos , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Oclusão Coronária/mortalidade , Stents Farmacológicos/efeitos adversos , Humanos , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/terapia , Resultado do Tratamento
5.
Angiology ; 70(9): 853-859, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31167539

RESUMO

This study evaluated the prognostic value of remnant lipoprotein cholesterol (RLP-C) as a predictor of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation in patients with coronary artery disease (CAD). Consecutive patients with CAD (n = 612) who underwent both successful coronary DES implantation and follow-up angiography ranging from 6 to 24 months were enrolled. The independent predictors of ISR were explored by multivariate logistic regression analysis; 95 (15.52%) patients were identified to have ISR. Multivariate logistic regression analysis showed that RLP-C concentration (odds ratio [OR]: 4.245, 95% confidence interval [CI]: 2.493-7.229), age (OR: 1.026, 95% CI: 1.002-1.051), diabetes mellitus (DM; OR: 1.811, 95% CI: 1.134-2.892), and lesion length (OR: 1.013, 95% CI: 1.002-1.024) were associated with ISR. Via subgroup analysis, we found that RLP-C was independently associated with ISR in both CAD with DM (OR: 4.154, 95% CI: 1.895-9.104) and CAD without DM (OR: 4.455, 95% CI: 2.097-9.464) groups. In the analysis of the receiver operating characteristics curve, RLP-C level >0.515 mmol/L exhibited 77.9% sensitivity and 56.5% specificity (area under the curve: 0.705, 95% CI: 0.648-0.762) in predicting ISR. In conclusion, RLP-C is independently associated with the development of ISR in patients with CAD after DES implantation.


Assuntos
Colesterol/sangue , Doença da Artéria Coronariana/etiologia , Reestenose Coronária/sangue , Stents Farmacológicos/efeitos adversos , Lipoproteínas/sangue , Idoso , Angiografia Coronária/métodos , Doença da Artéria Coronariana/sangue , Diabetes Mellitus/sangue , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Curva ROC
6.
Int Heart J ; 60(3): 521-526, 2019 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-31105145

RESUMO

Prior research has revealed poorer clinical outcomes after drug-eluting stent (DES) implantation for hemodialysis patients. This study aims to investigate the long-term clinical and angiographic outcomes after new-generation DES implantation for hemodialysis patients.We retrospectively enrolled 91 consecutive patients (118 lesions) who underwent successful new-generation DES (everolimus-, zotarolimus-, and biolimus-eluting stents) implantation for the first time. We measured the serum calcium and phosphorus levels in the blood samples obtained just before hemodialysis. The follow-up period of clinical events was, at least, 1.5 years. In this study, major adverse cardiac and cerebrovascular events (MACCE) and clinically driven target lesion revascularization were reported in 36 (39.6%) and 11 (12.1%) patients, respectively. The prevalence of peripheral artery disease was significantly higher in the MACCE group (41.7% versus 14.5%, P = 0.006). The serum calcium level was significantly higher in the MACCE group (9.34 ± 0.92 mg/dL versus 8.77 ± 0.88 mg/dL; P = 0.004). The multivariate Cox proportional hazards model revealed that the serum calcium level (hazard ratio, 1.86; 95% confidence interval [CI]: 1.26-2.77; P = 0.002), suboptimal (over 55 mg2/dL2) calcium-phosphorus product (hazard ratio, 3.27; 95% CI: 1.41-7.61; P = 0.006) and the coexistence of peripheral artery disease (hazard ratio, 3.15; 95% CI: 1.49-6.65; P = 0.003) were independent predictors of MACCE.For hemodialysis patients, MACCE remains a frequent occurrence after new-generation DES implantation and is associated with calcium-phosphate metabolism and peripheral artery disease.


Assuntos
Angiografia/métodos , Cálcio/sangue , Stents Farmacológicos/efeitos adversos , Doença Arterial Periférica/epidemiologia , Fósforo/sangue , Diálise Renal/instrumentação , Idoso , Everolimo/administração & dosagem , Feminino , Seguimentos , Humanos , Imunossupressores/administração & dosagem , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/etiologia , Prevalência , Estudos Retrospectivos , Sirolimo/administração & dosagem , Sirolimo/análogos & derivados
7.
J Cardiovasc Surg (Torino) ; 60(4): 433-438, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31058479

RESUMO

When the FDA approved the use of a paclitaxel-coated stent in the peripheral arteries in November of 2012, a new era in the treatment of peripheral arterial disease (PAD) emerged. This marked, for the first time in the United States, that a drug-eluting device was available to treat this complex arterial bed, and has likely changed forever how PAD is treated. Prior to this, US physicians had been using drug-eluting stents (DES) in the coronary arteries for 8 years with exceptional results in both safety and efficacy. Since the Zilver®PTX® (Cook Medical, Bloomington, IN USA) was released, multiple drug-coated balloons (DCB) with paclitaxel have been approved in the US, as has another DES, the Eluvia™ stent (Boston Scientific, Minneapolis, MN USA).


Assuntos
Angioplastia com Balão/instrumentação , Stents Farmacológicos , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Aprovação de Equipamentos , Stents Farmacológicos/efeitos adversos , Humanos , Paclitaxel/efeitos adversos , Paclitaxel/farmacocinética , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/cirurgia , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados Unidos , United States Food and Drug Administration
8.
Medicine (Baltimore) ; 98(21): e15622, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31124941

RESUMO

BACKGROUND: Drug-coated balloon as a novel therapeutic strategy has been used to treat restenosis in cases of bare metal and drug-eluting stents. However, evidence of its safety and efficacy is scarce in de novo small coronary artery vessel disease. This meta-analysis aimed to compare the safety and efficacy of the drug-coated balloon and the drug-eluting stent. METHODS: The PubMed, EMBASE, Web of Science, and Cochrane library databases were searched for studies published up to October 17, 2018. Studies comparing the drug-coated balloon with the drug-eluting stent strategy in patients with de novo small coronary artery vessel disease (reference diameter, <3 mm) were identified. The clinical outcomes were nonfatal myocardial infarction, cardiac death, all-cause death, target lesion revascularization, and target-vessel revascularization. Data were analyzed using the statistical software RevMan (version 5.3). Fixed effects models were performed to calculate the pooled odds ratios (ORs) and 95% confidence intervals (95% CIs). Sensitivity analyses were used to detect potential sources of heterogeneity, while subgroup analyses were implemented to assess the differential effects. RESULTS: Three randomized controlled trials and 3 nonrandomized controlled studies were identified. Six studies including a total of 1800 patients compared the differences between the drug-coated balloon and the drug-eluting stent strategies in patients with de novo small coronary artery vessel disease. The results indicated that the drug-coated balloon strategy was associated with a significant reduction in nonfatal myocardial infarction (OR 0.53, 95% CI 0.31-0.90, P = .02) compared with the drug-eluting stent strategy, while insignificant inter-strategy differences were observed in cardiac death (OR 1.56, 95% CI 0.73-3.33, P = .25), all-cause death (OR 0.56, 95% CI 0.25-1.23, P = .15), target lesion revascularization (OR 1.24, 95% CI 0.73-2.1, P = .43), and target-vessel revascularization (OR 0.95, 95% CI 0.59-1.52, P = .84). CONCLUSIONS: This meta-analysis suggests that the drug-coated balloon strategy is noninferior to the drug-eluting stent strategy, delivering a good outcome in nonfatal myocardial infarction, and can be recommended as an optimal treatment strategy in patients with de novo small coronary artery vessel disease. Larger randomized controlled studies with longer follow-up periods are needed to further confirm the benefits of the drug-coated balloon strategy.


Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Infarto do Miocárdio/etiologia , Complicações Pós-Operatórias/etiologia , Idoso , Angioplastia Coronária com Balão/instrumentação , Angioplastia Coronária com Balão/métodos , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/patologia , Vasos Coronários/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Ensaios Clínicos Controlados não Aleatórios como Assunto , Razão de Chances , Complicações Pós-Operatórias/mortalidade , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
9.
Angiology ; 70(9): 867-877, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31088127

RESUMO

The PREdicting bleeding Complications In patients undergoing Stent implantation and subsEquent Dual Antiplatelet Therapy (PRECISE-DAPT) score has been validated to predict bleeding complications in patients undergoing stent implantation and dual antiplatelet therapy. This score does not include the platelet count (PC), which has been shown to be an independent marker of mortality in patients with acute coronary syndrome (ACS). We assessed the role of the PRECISE-DAPT score calculated on admission for mortality risk prediction and evaluated whether the predictive accuracy of this score improved by adding the PC. In a retrospective cohort study of 1000 patients with ACS, after adjustment for relevant covariates, a PRECISE-DAPT score ≥25 was independently associated with mortality (hazard ratio [HR]: 7.91; 95% confidence interval [CI]: 4.37-14.30). When this score was combined with PC, compared to patients with PRECISE-DAPT <25 and PC ≥150 × 109/L, the adjusted HR was 7.2 (95% CI 2.4-21.6) for those with PRECISE-DAPT <25 and PC <150 × 109/L; 10.7 (95% CI: 5.2-21.9) for those with PRECISE-DAPT ≥25 and PC ≥150 × 109/L; and 17.9 (95% CI 7.0-45.4) for those with PRECISE-DAPT ≥25 and PC <150 × 109/L. Selecting thresholds for high-risk designation, the PRECISE-DAPT score integrated with PC had a higher prediction value, compared to the PRECISE-DAPT and Global Registry of Acute Coronary Events scores.


Assuntos
Síndrome Coronariana Aguda/mortalidade , Stents Farmacológicos/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Contagem de Plaquetas , Valor Preditivo dos Testes , Síndrome Coronariana Aguda/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/complicações , Quimioterapia Combinada/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Inibidores da Agregação de Plaquetas/uso terapêutico , Contagem de Plaquetas/métodos , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Medição de Risco
10.
Medicine (Baltimore) ; 98(22): e15797, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31145306

RESUMO

OBJECTIVE: This study evaluated the clinical value of drug-coated balloons for patients with small-vessel coronary artery disease (SVD). METHODS: A computerized literature search was performed using the databases to conduct a meta-analysis and evaluate the clinical value of drug-coated balloons among patients with SVD. RESULTS: This review enrolling 1545 patients receiving drug-coated balloons and 1010 patients receiving stents (including drug-eluting stents and bare-metal stents). The meta-analysis results showed that the incidence of major adverse cardiovascular events among patients with SVD did not significantly differ between the drug-coated balloon group and the stent group within 1 postoperative year (odds ratio = 0.81, P = .5). A subgroup analysis showed that the incidence of myocardial infarction among the drug-coated balloon group was significantly lower than that among the stent group (odds ratio = 0.58, P = .04). Nevertheless, the late lumen loss of the drug-coated balloon group was significantly lower than that of the stent group (mean difference = 0.31, P = .01). CONCLUSIONS: Drug-coated balloons can be used to effectively reduce the incidence of myocardial infarction in patients with SVD within 1 year and decrease the extent of late lumen loss without increasing the incidence of major adverse cardiovascular events.


Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Infarto do Miocárdio/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Fármacos Cardiovasculares/administração & dosagem , Estudos de Casos e Controles , Doença da Artéria Coronariana/patologia , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Feminino , Humanos , Incidência , Masculino , Infarto do Miocárdio/etiologia , Razão de Chances , Complicações Pós-Operatórias/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Stents Metálicos Autoexpansíveis/efeitos adversos , Resultado do Tratamento
11.
Lancet ; 393(10190): 2503-2510, 2019 06 22.
Artigo em Inglês | MEDLINE | ID: mdl-31056295

RESUMO

BACKGROUND: New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear. METHODS: We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520. FINDINGS: We obtained individual data for 26 616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78-0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71-0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78-1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88-1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50-0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50-0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year. INTERPRETATION: The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year. FUNDING: Bern University Hospital.


Assuntos
Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/instrumentação , Stents/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Stents Farmacológicos/efeitos adversos , Estudos de Equivalência como Asunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Razão de Chances , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Resultado do Tratamento
12.
BMJ Case Rep ; 12(4)2019 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-30962209

RESUMO

Tranexamic acid (TXA) is an antifibrinolytic which minimises bleeding and transfusions, with thrombotic risk. Our patient had known coronary artery disease with post-TXA acute ST-elevation myocardial infarction (STEMI) due to in-stent thrombosis. He had five drug-eluting stents (DES): two overlapping DES in mid-LAD (3 years ago), and two overlapping DES in distal right coronary artery and one DES in obtuse-marginal (1.5 years ago). After TXA, both overlapping stent locations thrombosed. Of nine reports of post-TXA acute MI, only one had complex stent anatomy (bifurcation stent to left circumflex/first obtuse-marginal) with other single stents, and only the complex stent thrombosed. Post-TXA MI was more often STEMI caused by arterial thrombosis, rather than non-STEMI caused by blood loss, hypotension or demand ischaemia. Overlapping and bifurcation stents thrombosed; single stents remained patent. In conclusion, overlapping stents, bifurcation stents, excessive stent length and previous in-stent restenosis/thrombosis may increase thrombotic risk. TXA should be administered cautiously with complex stent anatomy.


Assuntos
Antifibrinolíticos/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologia , Trombose/tratamento farmacológico , Ácido Tranexâmico/efeitos adversos , Stents Farmacológicos/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Trombose/cirurgia
13.
Sheng Wu Yi Xue Gong Cheng Xue Za Zhi ; 36(2): 232-237, 2019 Apr 25.
Artigo em Chinês | MEDLINE | ID: mdl-31016939

RESUMO

New biodegradable intravascular stent can reduce risk of foreign bodies retained, thus, it is widely concerned and some of the products have been introduced into the clinic. However, the characteristic of biodegradable may lead to more safety concerns associated with thrombosis. To ensure the safety, the thrombus formation experiment in vivo needs to be carefully designed and evaluated based on GB/T 16886.4 standard, but current standard do not provide explicit testing and evaluating methods. Establishing animal model with experimental pigs, the study compares biodegradable coronary stents and metal stents by simulating clinical implantation in vivo on the thrombus formation in the implanting process, and after the short-term and long-term implantation. The evaluation methods include gross observation, digital subtraction angiography intraoperative analysis, optical coherence tomography analysis, scanning electron microscopy and so on. The results show that combining these methods could comprehensively evaluate the whole process of the thrombus formation from the beginning of implantation to the end of preclinical animal experiments, so that, it may better predict the clinical thrombosis risk, and the selection of the control was very important. The study tries to use the comparison examples of thrombosis on the new medical instrument to provide the clue for thrombosis evaluation in vivo on similar instruments and show the methodology on the preclinical evaluation.


Assuntos
Implantes Absorvíveis/efeitos adversos , Stents Farmacológicos/efeitos adversos , Trombose/etiologia , Animais , Polímeros , Suínos , Tomografia de Coerência Óptica , Resultado do Tratamento
14.
EuroIntervention ; 15(9): e779-e787, 2019 Oct 04.
Artigo em Inglês | MEDLINE | ID: mdl-31012854

RESUMO

AIMS: The aim of this study was to investigate the prognostic value of fractional flow reserve (FFR) and a novel index (the D-index) of residual diffuse disease after intravascular ultrasound (IVUS)-guided second-generation drug-eluting stent (DES) implantation. METHODS AND RESULTS: We evaluated 201 patients (201 lesions) who underwent IVUS-guided second-generation DES implantation in the left anterior descending artery with pre- and post-intervention physiological evaluations. Post-intervention hyperaemic pullback pressure recording was used to quantify residual diffuse disease using the novel D-index, defined as the difference between the distal stent and the far distal FFR values divided by distance. Clinical outcomes were assessed by vessel-oriented composite endpoints (VOCE) and major adverse cardiac events (MACE). The incremental discriminant and reclassification abilities of far distal FFR or D-index for VOCE and MACE were compared. Post intervention, far distal FFR and D-indices were significantly lower in vessels with VOCE. The optimal far distal FFR and D-index cut-off values for VOCE and MACE were 0.86 and 0.017 cm, respectively. Although both indices remained significant predictors of VOCE, only the D-index proved to be a significant predictor of MACE and significantly improved the incremental reclassification ability for MACE. CONCLUSIONS: Residual diffuse disease assessed by the D-index after IVUS-guided second-generation DES implantation can help to predict both VOCE and MACE, while far distal FFR can help to predict VOCE specifically.


Assuntos
Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Intervenção Coronária Percutânea/métodos , Ultrassonografia de Intervenção , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/fisiopatologia , Stents Farmacológicos/efeitos adversos , Humanos , Período Pós-Operatório , Prognóstico , Stents , Resultado do Tratamento
15.
Lancet ; 393(10175): 987-997, 2019 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-30827782

RESUMO

BACKGROUND: Supraflex is a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts. We aimed to compare Supraflex with the standard of care, Xience, an everolimus-eluting stent with a durable polymer coating, regarding clinical outcomes with a randomised trial in an all-comer population. METHODS: We did a prospective, randomised, single-blind, multicentre study (TALENT) across 23 centres in Europe (the Netherlands, Poland, the UK, Spain, Bulgaria, Hungary, and Italy). Eligible participants were aged 18 years or older, had one or more coronary artery stenosis of 50% or greater in a native coronary artery, saphenous venous graft, or arterial bypass conduit, and had a reference vessel diameter of 2·25-4·50 mm. Patients underwent percutaneous coronary intervention in an all-comer manner. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts (Supraflex) or an everolimus-eluting stent with a durable polymer coating (Xience). Randomisation was done by local investigators by use of a web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between groups at 12 months after the procedure, assessed in an intention-to-treat population. On assumption of 1-year composite endpoint prevalence of 8·3%, a margin of 4·0% was defined for non-inferiority of the Supraflex group compared with the Xience group. This trial is registered with ClinicalTrials.gov, number NCT02870140. FINDINGS: Between Oct 21, 2016, and July 3, 2017, 1435 patients with 1046 lesions were randomly assigned to Supraflex, of whom 720 received the index procedure, and 715 patients with 1030 lesions were assigned to Xience, all receiving the index procedure. At 12 months, the primary endpoint had occurred in 35 patients (4·9 %) in the Supraflex group and in 37 patients (5·3%) in the Xience group (absolute difference -0·3% [one-sided 95% upper confidence bound 1·6%], pnon-inferiority<0·0001). Definite or probable stent thrombosis prevalence, a safety indicator, was low in both groups and did not differ between them. INTERPRETATION: The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. Supraflex seems a safe and effective alternative drug-eluting stent to other stents in clinical practice. FUNDING: European Cardiovascular Research Institute.


Assuntos
Aterosclerose/terapia , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Idoso , Stents Farmacológicos/efeitos adversos , Determinação de Ponto Final , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Método Simples-Cego , Trombose/etiologia
17.
Laryngoscope ; 129(7): 1494-1496, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30597569

RESUMO

Bioabsorbable corticosteroid-eluting sinus stents (BCES) are used to optimize healing after sinus surgery. We report a patient with BCES placed through a dural defect. A 70 year old underwent sinus surgery. Postoperatively, the patient developed mental status changes. The patient was taken to the operating room and eight BCES were identified, with one extending through the skull base. The stents were extracted and the defect was repaired. The patient recovered well. This is the first significant complication associated with BCES. Thorough review of preoperative imaging, understanding of skull base anatomy, and careful use of BCES are critical for safety. LEVEL OF EVIDENCE: NA Laryngoscope, 129:1494-1496, 2019.


Assuntos
Implantes Absorvíveis/efeitos adversos , Stents Farmacológicos/efeitos adversos , Procedimentos Cirúrgicos Nasais/efeitos adversos , Complicações Pós-Operatórias/etiologia , Base do Crânio/lesões , Corticosteroides , Idoso , Humanos , Masculino , Procedimentos Cirúrgicos Nasais/instrumentação , Seios Paranasais/cirurgia
18.
Medicine (Baltimore) ; 97(45): e13208, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30407362

RESUMO

RATIONALE: The safety and efficacy of drug-coated balloon (DCB) technology have primarily been proven in the treatment of coronary in-stent restenosis. Whereas increasing evidences show that DCB use was feasible in certain de novo coronary lesions. In 2012, Vassilev reported the 1st case in which a coronary aneurysm formed after a DCB was used to treat drug-eluting stent (DES) restenosis. To date, limited information has been reported on coronary artery aneurysm (CAA) development following DCB treatment of de novo lesions. PATIENT CONCERNS: A 42-year-old male underwent delayed coronary angiography due to extensive anterior wall myocardial infarction. After balloon predilation in the mid-left anterior descending (LAD) artery, the residual 30% stenosis without major dissection was treated with a DCB. Angiographic follow-up at 6 and 12 months revealed an aneurysm in the treated area of the LAD artery, with positive vascular remodeling behind this aneurysm. A 54-year-old male with nonstent thrombosis elevation myocardial infarction underwent elective catheterization. Coronary angiography revealed critical stenosis in the LAD and significant narrowing at the distal segments of both the left circumflex artery (LCX) and the nondominant right coronary artery. After predilation of the lesion in the LCX, the residual 30% stenosis was treated with a DCB. The lesion in the LAD was treated with a DCB either. Angiography follow-up at 6 months revealed good results in the LAD; however, an aneurysm was observed in the DCB-treated area of the LCX. DIAGNOSIS: The CAA formation after DCB treatment of de novo lesions. INTERVENTIONS AND OUTCOMES: Because the 2 patients were asymptomatic upon diagnosis, the aneurysms were left untreated. Long-term dual antiplatelet therapy and intense follow-up were recommended. LESSONS: Our cases raise questions regarding the safety of DCB treatment for de novo lesions in real-world contexts. There might be a need to clarify the appropriate doses for drugs coated on DCBs. Although indications for DCB treatment for de novo coronary lesions should not be overly aggressively broadened, the potential role of such treatment in this context merits additional elucidation in future studies.


Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Aneurisma Coronário/etiologia , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Adulto , Angioplastia Coronária com Balão/métodos , Angiografia Coronária/métodos , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/uso terapêutico , Resultado do Tratamento
19.
Lancet ; 392(10151): 940-949, 2018 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-30166073

RESUMO

BACKGROUND: We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. METHODS: GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with follow-up completed. FINDINGS: Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3·81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4·37%) participants in the control group (rate ratio 0·87 [95% CI 0·75-1·01]; p=0·073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0·93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2·04% vs 2·12%; rate ratio 0·97 [95% CI 0·78-1·20]; p=0·77). INTERPRETATION: Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. FUNDING: AstraZeneca, Biosensors, and The Medicines Company.


Assuntos
Adenosina/análogos & derivados , Aspirina/administração & dosagem , Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio/mortalidade , Inibidores da Agregação de Plaquetas/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Adenosina/administração & dosagem , Idoso , Clopidogrel , Angiografia Coronária , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/mortalidade , Quimioterapia Combinada , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea , Ticagrelor , Ticlopidina/administração & dosagem , Ticlopidina/análogos & derivados
20.
Lancet ; 392(10149): 737-746, 2018 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-30170848

RESUMO

BACKGROUND: Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a biodegradable polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes. METHODS: In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared biodegradable-polymer sirolimus-eluting stents with durable-polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov, number NCT01443104. FINDINGS: 2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with biodegradable-polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88-1·31; p=0·487). All-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable-polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06-1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51-2·05; p=0·950). INTERPRETATION: 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with biodegradable-polymer stents eluting sirolimus than in those treated with durable-polymer stents eluting everolimus warrant careful observation in ongoing clinical trials. FUNDING: Clinical Trials Unit of the University of Bern and Biotronik.


Assuntos
Síndrome Coronariana Aguda/cirurgia , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Implantes Absorvíveis , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Causas de Morte , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/mortalidade , Stents Farmacológicos/efeitos adversos , Feminino , Seguimentos , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Polímeros , Desenho de Prótese , Falha de Prótese/etiologia , Método Simples-Cego , Trombose/etiologia , Resultado do Tratamento
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