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1.
Am Heart J ; 228: 65-71, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32866927

RESUMO

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.


Assuntos
Doença da Artéria Coronariana , Vasos Coronários/diagnóstico por imagem , Intervenção Coronária Percutânea , Complicações Pós-Operatórias , Risco Ajustado/métodos , Ultrassonografia de Intervenção , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Cirurgia Assistida por Computador/métodos , Ultrassonografia de Intervenção/economia , Ultrassonografia de Intervenção/métodos
2.
Am Heart J ; 228: 72-80, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32871327

RESUMO

BACKGROUND: The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown. METHODS AND DESIGN: The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year. RESULTS: Up to the end of July 2020, approximately 1,200 "real-world" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023. CONCLUSION: This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.


Assuntos
Vasos Coronários/diagnóstico por imagem , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/prevenção & controle , Cirurgia Assistida por Computador/métodos , Tomografia de Coerência Óptica/métodos , Ultrassonografia de Intervenção/métodos , Pesquisa Comparativa da Efetividade , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/diagnóstico , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco Ajustado/métodos
3.
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
4.
Am Heart J ; 228: 8-16, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32745734

RESUMO

BACKGROUND: Gastrointestinal injury is a common complication in patients treated with antiplatelet agents after percutaneous coronary intervention (PCI). However, the effects of different antiplatelet regimens on the incidence and severity of gastrointestinal injury have not been well studied, principally due to the lack of a low-risk sensitive and accurate detection system. TRIAL DESIGN: OPT-PEACE is a multicenter, randomized, double-blind, placebo-controlled trial. Gastrointestinal injury will be evaluated with the ANKON magnetically controlled capsule endoscopy system (AMCE), a minimally invasive approach for detecting mucosal lesions in the stomach, duodenum and small intestine. Patients without AMCE-detected gastrointestinal erosions, ulceration or bleeding after drug-eluting stent implantation are enrolled and treated with open-label aspirin (100 mg/d) plus clopidogrel (75 mg/d) for 6 months. Thereafter, 480 event-free patients will undergo repeat AMCE and are randomly assigned in a 1:1:1 ratio to receive aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo for an additional 6 months. A final AMCE is performed at 12 months. The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment. CONCLUSIONS: OPT-PEACE is the first study to investigate the incidence and severity of gastrointestinal injury in patients receiving different antiplatelet therapy regimens after stent implantation. This trial will inform clinical decision-making for personalized antiplatelet therapy post-PCI.


Assuntos
Aspirina , Endoscopia por Cápsula/métodos , Clopidogrel , Doença da Artéria Coronariana , Hemorragia Gastrointestinal , Intervenção Coronária Percutânea , Adulto , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Clopidogrel/administração & dosagem , Clopidogrel/efeitos adversos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/cirurgia , Método Duplo-Cego , Stents Farmacológicos , Terapia Antiplaquetária Dupla/métodos , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/prevenção & controle , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Agregação de Plaquetas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco Ajustado/métodos
5.
Vasc Health Risk Manag ; 16: 257-270, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32753874

RESUMO

Purpose: Our study aimed at determining and comparing the mechanism of cardiovascular protection variables in moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) in patients with stable coronary heart disease (CHD) after coronary stenting. Participants and Methods: This experimental study used the same subject and cross-over design, involving eleven stable CHD patients after coronary stenting. These were randomly divided into two groups; MICT for 29 minutes at 50-60% heart rate reserve and HIIT with 4x4 minute intervals at 60-80% heart rate reserve, each followed by three minutes of active recovery at 40-50% heart rate reserve. These were conducted three times a week for two weeks. The participants' levels of adrenaline, noradrenaline, endothelial nitric oxide synthase (eNOS), extracellular superoxide dismutase (EC-SOD) activity assayed, and flow-mediated dilatation (FMD) were examined before and after treatments were completed. Results: The HIIT significantly increased the levels of noradrenaline and eNOS compared with MICT (p<0.05). Also, HIIT was better in maintaining EC-SOD activity and FMD compared with MICT (p<0.05). Through the noradrenalin pathway, HIIT had a direct and significant effect on eNOS and FMD (p<0.05) but MICT, through the noradrenaline pathways, had a direct and significant effect on eNOS (p<0.05), and through the EC-SOD activity pathways had a direct and significant effect on FMD (p<0.05). MICT reduced EC-SOD activity and also decreased the FMD value. Conclusion: HIIT is superior to MICT in increasing cardiovascular protection by increasing the concentrations of noradrenalin and eNOS, maintaining EC-SOD activity, and FMD in stable CHD patients after coronary stenting.


Assuntos
Doença das Coronárias/terapia , Treinamento Intervalado de Alta Intensidade , Intervenção Coronária Percutânea/instrumentação , Stents , Adulto , Biomarcadores/sangue , Doença das Coronárias/sangue , Doença das Coronárias/diagnóstico por imagem , Doença das Coronárias/fisiopatologia , Estudos Cross-Over , Epinefrina/sangue , Tolerância ao Exercício , Feminino , Humanos , Indonésia , Masculino , Pessoa de Meia-Idade , Óxido Nítrico Sintase Tipo III/sangue , Norepinefrina/sangue , Intervenção Coronária Percutânea/efeitos adversos , Superóxido Dismutase/sangue , Fatores de Tempo , Resultado do Tratamento
6.
Int Heart J ; 61(4): 673-684, 2020 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-32684595

RESUMO

Hyperglycemia is an important risk factor for poor clinical outcomes in patients with acute myocardial infarction (AMI). The relative superiority of the long-term clinical outcomes of durable-polymer (DP) -based and biodegradable-polymer (BP) -based newer-generation drug-eluting stents (DESs) after successful percutaneous coronary intervention (PCI) in patients with AMI and prediabetes is not well established. We compared the clinical outcomes in such patients between DP-based and BP-based newer-generation DESs.A total of 4,377 patients with AMI and prediabetes were divided into the following two groups: the DP-DES group (n = 3,775; zotarolimus-eluting stents [ZES; n = 1,546] and everolimus-eluting stents [EES; n = 2,229]) and the BP-DES group (n = 602; biolimus-eluting stents [BES]). The primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as all-cause death, recurrent myocardial infarction (re-MI), or any repeat revascularization. The secondary endpoint was the occurrence of stent thrombosis (ST).The 2-year adjusted hazard ratio (aHR) of MACEs for ZES versus EES, ZES versus BES, EES versus BES, and ZES/EES versus BES (aHR: 1.125; 95% confidence interval [CI], 0.834-1.518; P = 0.440) were similar. The cumulative incidence of ST was also comparable between the DP-DES and BP-DES groups (aHR: 1.407; 95% CI, 0.476-4.158; P = 0.537). Moreover, the 2-year aHRs of all-cause death, CD, re-MI, target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR were similar.Patients with AMI and prediabetes who received DP-DES or BP-DES during PCI showed comparable safety and efficacy during the 2-year follow-up period.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Stents Farmacológicos/estatística & dados numéricos , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/instrumentação , Estado Pré-Diabético/complicações , Idoso , Antineoplásicos/administração & dosagem , Everolimo/administração & dosagem , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Sirolimo/administração & dosagem , Sirolimo/análogos & derivados
7.
Circ Cardiovasc Interv ; 13(1): e008383, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-32525410

RESUMO

BACKGROUND: We investigated whether optical coherence tomography (OCT) guidance would reduce nonoptimal bioresorbable vascular scaffold (BVS) deployment. METHODS: This was a randomized controlled trial. Patients who required percutaneous coronary intervention for ischemic heart disease were recruited from 2 centers in Korea. The enrolled patients were randomly assigned to receive either OCT-guided BVS (Absorb; Abbott Vascular) implantation or angiography-guided BVS implantation using an optimized technique. The primary outcome was nonoptimal deployment, which was a composite outcome of the following parameters assessed by OCT: a minimal scaffold area <5 mm2, residual area stenosis >20%, incomplete apposition of the scaffold struts >5%, major edge dissection, or scaffold disruption. The secondary outcome was a procedural complication defined by the occurrence of no reflow, coronary perforation, or flow-limiting dissection. RESULTS: Between September 2016 and January 2018, 88 patients (90 lesions) were assigned to OCT guidance, while 88 patients (89 lesions) were assigned to angiography guidance. The recruitment was prematurely terminated in March 2018 because the manufacturer stopped supplying BVS. Postprocedural OCT data were available for 88 lesions with OCT guidance and for 88 lesions with angiography guidance. There was nonoptimal BVS deployment postprocedurally in 35.2% of patients in the OCT-guidance group and in 38.6% in the angiography-guidance group (absolute difference, -3.7% [95% CI, -19.0% to 11.6%]; P=0.64). There were no procedural complications in either group. CONCLUSIONS: OCT-guided BVS implantation did not reduce the incidence of nonoptimal deployment compared to that of angiography-guided BVS implantation (using optimized techniques). CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02894697.


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Intervenção Coronária Percutânea/instrumentação , Tomografia de Coerência Óptica , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/lesões , Feminino , Traumatismos Cardíacos/diagnóstico por imagem , Traumatismos Cardíacos/etiologia , Humanos , Masculino , Fenômeno de não Refluxo/diagnóstico por imagem , Fenômeno de não Refluxo/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Desenho de Prótese , Falha de Prótese , Fatores de Risco , Seul , Fatores de Tempo , Resultado do Tratamento
8.
Int J Cardiovasc Imaging ; 36(9): 1627-1635, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32385540

RESUMO

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


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Tomografia de Coerência Óptica , Idoso , Idoso de 80 Anos ou mais , Aterectomia Coronária , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Desenho de Prótese , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento
9.
Int J Cardiovasc Imaging ; 36(9): 1617-1626, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32462449

RESUMO

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


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Tomografia de Coerência Óptica , Calcificação Vascular/terapia , Idoso , Aterectomia Coronária , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Doença da Artéria Coronariana/diagnóstico por imagem , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Neointima , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem
10.
Thromb Haemost ; 120(5): 857-865, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32369856

RESUMO

BACKGROUND: Cilostazol-based dual antiplatelet therapy (DAPT) is widely used in patients with aspirin intolerance after coronary drug-eluting stent (DES) implantation in China. However, this empirical strategy is not recommended or even mentioned in Chinese or international guidelines due to a lack of evidence from large-scale studies. We aimed to explore the efficacy and safety of cilostazol-based DAPT in this special population. METHODS: In this cohort study, patients were grouped according to the DAPT strategy that they received after coronary DES implantation. The primary efficacy endpoint was major adverse cardiovascular and cerebrovascular events (MACCEs). Angiographic follow-up and major bleeding events were also recorded. RESULTS: A total of 918 patients receiving cilostazol-based DAPT due to aspirin intolerance were enrolled, matched with 918 patients receiving aspirin-based DAPT. After 15-month prospective follow-up, the cilostazol group had lower risk of MACCE (5.1% vs. 7.6%, propensity score adjusted hazard ratio = 0.671 [95% confidence interval 0.462-0.974], p = 0.036) compared with the aspirin group. Lower rate of coronary lesion progression was also found through follow-up angiography in the cilostazol group (17.4% vs. 23.6%, p = 0.022), especially in nontarget lesions (12.1% vs. 17.6%, p = 0.019). The two groups had the same risk of major bleeding events (0.8% vs. 0.4%, p = 0.364). CONCLUSION: In the current study, cilostazol is a good substitute for aspirin in patients who have aspirin intolerance but need DAPT after coronary DES implantation in China. However, large-scale randomized controlled trials were still required to further confirm its efficacy and safety.


Assuntos
Aspirina/uso terapêutico , Cilostazol/uso terapêutico , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Terapia Antiplaquetária Dupla , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação de Plaquetas/uso terapêutico , Aspirina/efeitos adversos , China , Cilostazol/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação de Plaquetas/efeitos adversos , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
11.
Cardiovasc Ther ; 2020: 4351469, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32405323

RESUMO

Aim: To evaluate the clinical impact of ß-blocker in patients with adequate left ventricular ejection function (LVEF) who underwent percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). Methods: A total of 10,724 consecutive patients who underwent PCI throughout 2013 were prospectively enrolled in the study. Among these, we analyzed 5,631 ACS patients who were discharged with LVEF ≥ 40%. Patients were then compared according to the ß-blocker prescription at discharge. Results: During a 2-year follow-up, no significant association was observed of ß-blocker use with all-cause mortality (with ß-blockers 47/5,043 (0.9%) vs. without ß-blocker use 8/588 (1.4%); hazard ratio (HR) 0.762, 95% confidence interval 0.36 to 1.64; P = 0.485), cardiac death, myocardial infarction (MI), or major adverse cardiovascular and cerebrovascular events. Subgroup analysis demonstrated that the ß-blocker use at discharge reduced the 2-year mortality in patients with unstable angina (UA) (HR 0.42, 95% CI 0.19 to 0.94, P = 0.034). Landmark analysis at 1 year showed that patients with UA who were discharged with ß-blockers had lower mortality (HR 0.17, 95% CI 0.04-0.65, P = 0.010) and cardiac death (HR 0.12, 95% CI 0.01-0.99, P = 0.049) than those discharged without ß-blockers. However, the benefit was lost beyond 1 year. No differences in outcomes were recorded in the AMI or overall population. Conclusions: We present that ß-blocker significantly lowers the rate of all-cause death up to 1 year, in UA patients who have undergone PCI and have adequate LVEF. Its role in patients with AMI also deserves further exploration.


Assuntos
Síndrome Coronariana Aguda/terapia , Antagonistas Adrenérgicos beta/uso terapêutico , Alta do Paciente , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/fisiopatologia , Causas de Morte , China , Progressão da Doença , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Estudos Prospectivos , Fatores de Risco , Stents , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Função Ventricular Esquerda
12.
Cardiovasc Ther ; 2020: 6760205, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32411301

RESUMO

Aim: The marked variation in bifurcation anatomy has brought about an ongoing search for stents specifically constructed for coronary bifurcations. This study aimed to analyze the angiographic restenosis prevalence and patterns and predictors of different patterns in dedicated bifurcation BiOSS® vs. current generation drug-eluting stents implanted in coronary bifurcation lesions based on data from two clinical trials POLBOS I and II. Methods: Dedicated bifurcation BiOSS® stents were compared with drug-eluting stents (DES) in patients with stable coronary artery disease (CAD) or nonST elevation acute coronary syndrome (NSTE-ACS) (POLBOS I: paclitaxel eluting BiOSS® Expert vs. DES; POLBOS II: sirolimus eluting BiOSS® LIM vs. DES). Provisional T-stenting was the default treatment. Morphological pattern of in-stent restenosis according to the modified Mehran classification adopted for bifurcation lesions was assessed with bifurcation dedicated quantitative coronary angiographic software (CAAS 5.11, Pie Medical Imaging BV, the Netherlands). Results: In total, 445 patients (222 patients in BiOSS group and 223 patients in DES group) were included into the analysis. In BiOSS group 24 cases of angiographic restenosis (10.8%) were recorded, and in DES group-17 cases (7.6%) at 12 months follow-up (angiographic control rate at follow-up-90.3%). In the BiOSS group most frequent medina classification in restenotic cases was 0.0.1 (25%), whereas in DES-0.0.1 and 0.1.1 (23.5% each). In multivariate regression analysis proximal optimization technique was associated with the lowest chance for restenosis (OR 0.15, 95% CI 0.06-0.33), whereas diabetes on insulin was associated with the highest risk of restenosis (OR 4.21, 95% CI 1.48-11.44). Conclusions: The angiographic restenosis pattern and rate was similar between BiOSS stents and DES in coronary bifurcation lesions.


Assuntos
Síndrome Coronariana Aguda/terapia , Angiografia Coronária , Doença da Artéria Coronariana/terapia , Reestenose Coronária/diagnóstico por imagem , Stents Farmacológicos , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Intervenção Coronária Percutânea/instrumentação , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/epidemiologia , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/epidemiologia , Reestenose Coronária/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio sem Supradesnível do Segmento ST/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Polônia/epidemiologia , Valor Preditivo dos Testes , Prevalência , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Resultado do Tratamento
13.
Angiology ; 71(8): 721-725, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32431159

RESUMO

We report the prevalence of coronary artery disease (CAD) in asymptomatic patients with end-stage kidney disease (ESKD) on hemodialysis and explore the best revascularization strategies prior to kidney transplantation. This is a retrospective single-center study, which included all patients who were candidates for kidney transplantation and underwent coronary angiography between 2003 and 2018. All included patients underwent coronary angiography without noninvasive testing and were asymptomatic cardiac-wise. Out of the 368 patients with ESRD, 45% had coronary vessel disease, 17% had 3-vessel disease, 11% had 2-vessel disease, 5.2% had significant left main artery narrowing, and 17% had single-vessel disease. Patients with 3-vessel disease had the worst survival rate at 5 and 10 years. The patients with significant 3-vessel disease or left main artery involvement underwent revascularization; 19% underwent coronary artery bypass grafting, 5% had stenting of the coronary arteries, and 4.7% were on maximal medical therapy. The patients who underwent stenting had a better survival than those on medical therapy, but the difference was not significant (P = .445). Our findings reflect a high prevalence of CAD in patients with ESKD. There is a need for further studies to evaluate benefits of cardiovascular screening in this patient population.


Assuntos
Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Falência Renal Crônica/cirurgia , Transplante de Rim , Adulto , Idoso , Doenças Assintomáticas , Fármacos Cardiovasculares/uso terapêutico , Ponte de Artéria Coronária , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/terapia , Feminino , Humanos , Falência Renal Crônica/diagnóstico , Falência Renal Crônica/mortalidade , Transplante de Rim/efeitos adversos , Transplante de Rim/mortalidade , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/instrumentação , Valor Preditivo dos Testes , Prevalência , Estudos Retrospectivos , Fatores de Risco , Arábia Saudita/epidemiologia , Stents , Fatores de Tempo , Resultado do Tratamento
14.
Medicine (Baltimore) ; 99(20): e20168, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32443334

RESUMO

BACKGROUND: Traditional coronary angiography (CA) as a main technique has been used to determine the coronary artery anatomy and guide percutaneous coronary intervention (PCI). We mainly focused on whether the new techniques could improve the patients' mortality, major adverse cardiovascular events (MACEs), and myocardial infarction. METHODS: For the network meta-analysis, we searched the trials of different PCI guidances from MEDLINE, Current Contents Connect, Google Scholar, EMBASE, Cochrane Library, PubMed, Science Direct, and Web of Science. The last search date was December 10, 2018. RESULTS: The analyses of all results found that there was no significant difference in mortality among the groups. Randomized clinical trials (RCT) analysis showed that intravascular ultrasound (IVUS)-guided PCI was significantly superior to CA, fractional flow reserve, instantaneous wave-free ratio, optical coherence tomography. However, CA, fractional flow reserve, instantaneous wave-free ratio, and optical coherence tomography showed no difference in reducing mortality. The analyses of all results found that there was no significant difference in the incidence of MACEs among the groups. RCTs analysis showed that IVUS-guided PCI was significantly superior to CA, but there was no significant difference among the other groups. The analyses of all results or RCTs showed that there was no significant difference in myocardial infarction incidence among the groups. CONCLUSION: IVUS-guided PCI is an effective method to decrease all-cause death MACEs.


Assuntos
Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Intervenção Coronária Percutânea/instrumentação , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Angiografia Coronária/normas , Doença da Artéria Coronariana/complicações , Vasos Coronários/anatomia & histologia , Procedimentos Endovasculares/instrumentação , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Humanos , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/mortalidade , Metanálise em Rede , Intervenção Coronária Percutânea/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Tomografia de Coerência Óptica/métodos , Tomografia de Coerência Óptica/estatística & dados numéricos , Ultrassonografia de Intervenção/métodos , Ultrassonografia de Intervenção/estatística & dados numéricos
15.
Prog Cardiovasc Dis ; 63(3): 243-248, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32247786

RESUMO

AIMS: We aimed to determine the efficacy and safety of different anti-platelet regimens after percutaneous coronary intervention (PCI) with drug eluting stent (DES) implantation using a network meta-analysis of randomized controlled trials (RCTs). METHODS: RCTs comparing shorter duration (≤6 months) of dual antiplatelet therapy (S-DAPT) with either aspirin (ASA) or P2Y12 inhibitor monotherapy against longer duration (≥12 months) DAPT (L-DAPT) after PCI were searched in the MEDLINE, EMBASE and COCHRANE databases. End-points of interest were all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stent thrombosis (ST), major bleeding and major or minor bleeding. Network meta-analyses were performed using frequentist approach. RESULTS: Eighteen RCTs with total of 57,942 patients met the inclusion and exclusion criteria. This included 14 RCTs (N = 28,853) of S-DAPT with ASA monotherapy and 4 RCTs (N = 29,089) with P2Y12 inhibitor monotherapy. Compared with L-DAPT, the odds of MI were higher with S-DAPT with ASA monotherapy [OR 1.23; 95% CI 1.01-1.48], but not with P2Y12 inhibitor monotherapy [0.98; 0.85-1.14]. Both S-DAPT regimens lowered rates of major bleeding when compared with L-DAPT; ASA monotherapy [0.70; 0.49-1.00] and P2Y12 monotherapy [0.67; 0.45-0.98]. There were no differences in risks of all-cause or CV death between either regimen of S-DAPT and L-DAPT. However, in the acute coronary syndrome subgroup, ASA monotherapy was associated with increased risk of ST [1.55; 1.021-2.36] but P2Y12 monotherapy was not [0.93; 0.58-1.48]. CONCLUSION: Amongst patients undergoing DES implantation, S-DAPT with P2Y12 inhibitor monotherapy reduces bleeding without increased risk of MI or ST compared with L-DAPT. Prospective trials are needed to evaluate if S-DAPT with P2Y12 monotherapy is superior to S-DAPT with ASA monotherapy for ischemic protection.


Assuntos
Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Terapia Antiplaquetária Dupla , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação de Plaquetas/administração & dosagem , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/mortalidade , Trombose Coronária/prevenção & controle , Terapia Antiplaquetária Dupla/efeitos adversos , Terapia Antiplaquetária Dupla/mortalidade , Hemorragia/induzido quimicamente , Humanos , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/prevenção & controle , Metanálise em Rede , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação de Plaquetas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
16.
Am J Cardiol ; 125(11): 1624-1630, 2020 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-32279841

RESUMO

Clinical benefits of bioresorbable vascular scaffold (BVS) implantation for long coronary lesions were not sufficiently evaluated. The efficacy and safety of BVS and metallic everolimus-eluting stent (EES) were compared for the treatment of long coronary narrowings. A total of 341 patients with diffuse long lesions (requiring device length ≥28 mm) were randomized to receive either BVS (n = 171) or EES (n = 170) implantation. The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months. The trial was terminated early because the manufacturer stopped supplying BVS. The mean lesion length was 32.2 ± 13.1 mm in the BVS group and 35.3 ± 13.0 mm in the EES group. The 12-month follow-up was completed in 332 patients (97.4%). At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio = 0.49, 95% confidence interval = 0.09 to 2.67, p = 0.398). Definite or probable device thrombosis occurred in 1 patient (0.6%) in the BVS group and 1 patient (0.6%) in the EES group (hazard ratio = 1.00, 95% confidence interval = 0.06 to 15.94, p = 0.998). In conclusion, in patients with long native coronary artery disease, significant differences between BVS and EES were not observed regarding the primary composite endpoint of death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization at 12 months. However, due to the early termination of this trial and a low number of events, the results cannot be considered clinically relevant (clinicalTrials.gov Identifier: NCT02796157).


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Tecidos Suporte , Idoso , Angina Estável/cirurgia , Angina Instável/cirurgia , Término Precoce de Ensaios Clínicos , Everolimo/administração & dosagem , Feminino , Cardiopatias/mortalidade , Humanos , Imunossupressores/administração & dosagem , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/cirurgia , Revascularização Miocárdica/estatística & dados numéricos , Modelos de Riscos Proporcionais , Desenho de Prótese , Trombose
17.
Cardiovasc Diabetol ; 19(1): 42, 2020 03 31.
Artigo em Inglês | MEDLINE | ID: mdl-32234045

RESUMO

BACKGROUND: Stress cardiovascular magnetic resonance (CMR) to screen for silent myocardial ischaemia in asymptomatic high risk patients with type 2 diabetes mellitus (DM) has never been performed, and its effectiveness is unknown. Our aim was to determine the feasibility of a screening programme using stress CMR by obtaining preliminary data on the prevalence of silent ischaemia caused by obstructive coronary artery disease (CAD) and quantify myocardial perfusion in asymptomatic high risk patients with type 2 diabetes. METHODS: In this prospective cohort study, we recruited 63 asymptomatic DM patients (mean age 66 years ± 4.4 years; 77.8% male); with Framingham risk score ≥ 20% from 3 sites from June 2017 to August 2018. Normal volunteers were recruited to determine normal global myocardial perfusion reserve index (MPRI). Adenosine stress CMR and global MPRI was performed and measured in all subjects. Positive stress CMR cases were referred for catheter coronary angiography (CCA) with/without fractional flow reserve (FFR) measurements. Positive CCA was defined as an FFR ≤ 0.8 or coronary narrowing ≥ 70%. Patients were followed up for major adverse cardiovascular events. Prevalence is presented as patient numbers and percentage. Mann-Whitney U test was used to compare global MPRI between patients and normal volunteers. RESULTS: 13 patients had positive stress CMR with positive CCA (20.6% of patient population), while 9 patients with positive stress CMR examinations had a negative CCA. 5 patients (7.9%) had infarcts detected of which 2 patients had no stress perfusion defects. 12 patients had coronary artery stents inserted, whilst 1 patient declined stent placement. DM patients had lower global MPRI than normal volunteers (n = 7) (1.43 ± 0.27 vs 1.83 ± 0.31 respectively; p < 0.01). After a median follow-up of 653 days, there was no death, heart failure, acute coronary syndrome hospitalisation or stroke. CONCLUSION: 20.6% of asymptomatic DM patients (with Framingham risk ≥ 20%) had silent obstructive CAD. Furthermore, asymptomatic patients have reduced global MPRI than normal volunteers. TRIAL REGISTRATION: ClinicalTrials.gov Registration Number: NCT03263728 on 28th August 2017; https://clinicaltrials.gov/ct2/show/NCT03263728.


Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Circulação Coronária , Diabetes Mellitus Tipo 2/epidemiologia , Imagem Cinética por Ressonância Magnética , Infarto do Miocárdio/diagnóstico por imagem , Imagem de Perfusão do Miocárdio/métodos , Adenosina/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Doenças Assintomáticas , Estudos de Casos e Controles , Angiografia Coronária , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/terapia , Diabetes Mellitus Tipo 2/diagnóstico , Estudos de Viabilidade , Feminino , Hong Kong/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/fisiopatologia , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/instrumentação , Projetos Piloto , Valor Preditivo dos Testes , Prevalência , Estudos Prospectivos , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento , Vasodilatadores/administração & dosagem
18.
Cardiovasc Ther ; 2020: 6495036, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32328172

RESUMO

Conflicting results have been reported so far in pooled analyses and studies evaluating the optimum duration of dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS) patients. However, randomized clinical trials dedicated to this specific setting of higher thrombotic risk patients have only recently been completed, pointing at the noninferiority of a shorter strategy as compared to the traditional 12-month DAPT, furthermore allowing to reduce the risk of major bleeding complications. Therefore, a reconsideration of current clinical practice and guidelines should be certainly be advocated in light of the most recent updates, especially among ACS patients treated with percutaneous coronary intervention (PCI) and modern drug-eluting stents (DES). Our aim was to provide a comprehensive review of the available evidence on the optimal DAPT duration in ACS patients.


Assuntos
Síndrome Coronariana Aguda/terapia , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas/administração & dosagem , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/fisiopatologia , Tomada de Decisão Clínica , Esquema de Medicação , Quimioterapia Combinada , Stents Farmacológicos , Hemorragia/induzido quimicamente , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação de Plaquetas/efeitos adversos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
19.
Cardiovasc Drugs Ther ; 34(3): 335-344, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32212061

RESUMO

OBJECTIVES: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. METHODS: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. RESULTS: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis. CONCLUSION: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Terapia Antiplaquetária Dupla , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação de Plaquetas/administração & dosagem , Sirolimo/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/etiologia , Trombose Coronária/prevenção & controle , Terapia Antiplaquetária Dupla/efeitos adversos , Terapia Antiplaquetária Dupla/mortalidade , Feminino , Fidelidade a Diretrizes , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Estudos Observacionais como Assunto , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação de Plaquetas/efeitos adversos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica , Desenho de Prótese , Medição de Risco , Fatores de Risco , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
20.
Ther Adv Cardiovasc Dis ; 14: 1753944720911329, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32168991

RESUMO

BACKGROUND: The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies. METHODS: A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness. RESULTS: Reported NI trials, with the most frequently chosen clinical endpoint of major adverse cardiac events (MACE), had NI margins ranging from 1.66% to 5.00%, resulting in patient populations of 400-1500 per treatment group. Clinical study endpoints comprising of MACE complemented with rates of bleeding complications and stent thrombosis (ST) are suggested to conduct a statistically and clinically meaningful NI trial. Study designs with surrogate endpoints amenable to intrapatient randomizations, are a very attractive option to reduce the number of necessary patients by about half. Comparative clinical endpoint studies with MACE and ST/bleeding rates to study a shortened dual antiplatelet therapy (DAPT) in coronary stent trials are feasible, whereas ST as the sole primary endpoint is not useful. CONCLUSIONS: Expanded composite clinical endpoints (MACE complemented by ST and bleeding rates and intrapatient randomization for selected surrogate endpoints) may be suitable tools to meet future needs in device approval, recertification and reimbursement.


Assuntos
Doença da Artéria Coronariana/terapia , Determinação de Ponto Final , Estudos de Equivalência como Asunto , Intervenção Coronária Percutânea , Projetos de Pesquisa , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Trombose Coronária , Quimioterapia Combinada , Hemorragia/induzido quimicamente , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Agregação de Plaquetas/efeitos adversos , Fatores de Risco , Tamanho da Amostra , Stents , Fatores de Tempo , Resultado do Tratamento
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