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2.
Arch Cardiovasc Dis ; 112(8-9): 469-484, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31262635

RESUMO

BACKGROUND: Current drug-eluting stents (c-DESs) reduce the occurrence of ischaemic events, but expose recipients to stent thrombosis and bleeding secondary to preventive antiplatelet therapy. To date, comparative data on the relative effectiveness and safety of the various c-DESs in real life are limited. AIM: To compare ischaemic and bleeding risks across the major c-DESs used in France. METHODS: French national health insurance reimbursement and hospitalization databases were used. Patients implanted with a c-DES in 2014 were followed for 1 year. The risks of ischaemic events (revascularization, myocardial infarction and/or stroke), major bleeding events and death were compared across six c-DESs (XIENCE®, PROMUS®, RESOLUTE®, BIOMATRIX®, NOBORI® and ORSIRO®), using multilevel Cox models adjusted for baseline individual and hospital characteristics. RESULTS: A total of 52,891 subjects were included: 34.4% with XIENCE®; 27.6% with PROMUS®; 24.0% with RESOLUTE®; 8.0% with BIOMATRIX®; 5.0% with NOBORI®; and 1.0% with ORSIRO®. Among them, 9378 had at least one event (ischaemic, 6064; major bleeding, 1968; death, 2411), resulting in an overall incidence rate of 19 per 100 person-years. In the multivariable analysis, the risk of ischaemic events, major bleeding events or death did not differ between the c-DESs overall (adjusted hazard ratios between 0.85 [95% confidence interval 0.68-1.07] and 1.04 [95% confidence interval 0.98-1.10] compared with XIENCE® used as the reference) and when each outcome was considered separately. CONCLUSIONS: In real life, major ischaemic and bleeding risks do not differ across the various c-DESs over the first year following implantation. Future studies are needed to assess comparative c-DES effectiveness and safety longer term.


Assuntos
Doença da Artéria Coronariana/terapia , Trombose Coronária/epidemiologia , Stents Farmacológicos , Hemorragia/induzido quimicamente , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação de Plaquetas/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/mortalidade , Bases de Dados Factuais , Feminino , França/epidemiologia , Hemorragia/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/administração & dosagem , Desenho de Prótese , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
3.
EuroIntervention ; 15(7): 607-614, 2019 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-31147308

RESUMO

AIMS: Although the proof of concept of the bioresorbable vascular scaffold (BRS) is well documented, device-related adverse outcomes with first-generation BRS indicate longer-term surveillance. The current study provides insights into the safety and performance of the MeRes100, a novel second-generation sirolimus-eluting BRS, beyond one-year up to three-year follow-up (FU). METHODS AND RESULTS: A total of 108 enrolled patients with de novo coronary artery lesions who underwent implantation of MeRes100 as part of the first-in-human MeRes-1 trial were followed up clinically beyond one year at two and three years and with multiple modality imaging at six months and two years. At three-year FU, the cumulative major adverse cardiac events rate was 1.87%, in the form of two ischaemia-driven target lesion revascularisations. No scaffold thrombosis was reported. Between six months and two years at quantitative coronary angiography, in-segment late lumen loss (LLL) (0.15±0.22 mm vs. 0.23±0.32 mm; p=0.18) and in-scaffold LLL (0.13±0.22 mm vs. 0.24±0.34 mm; p=0.10) changed insignificantly. IVUS subset analysis revealed a non-significant reduction in mean lumen area (6.17±1.28 mm2 vs. 5.47±1.50 mm2; p=0.21) and minimum lumen area (5.14±1.19 mm2 vs. 4.05±1.42 mm2; p=0.10) at two years compared to post-procedural measurements. OCT subset analysis demonstrated 99.24±2.27% neointimal strut coverage. CONCLUSIONS: The extended outcomes of the MeRes-1 trial demonstrated sustained efficacy and safety of the MeRes100 BRS with maintained lumen patency up to two years by multimodality imaging and no very late scaffold thrombosis up to three-year clinical FU.The MeRes-1 trial is registered at the Clinical Trials Registry-India. CTRI Number: CTRI/2015/04/005706.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Vasos Coronários/efeitos dos fármacos , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Fármacos Cardiovasculares/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Everolimo/efeitos adversos , Seguimentos , Humanos , Índia , Intervenção Coronária Percutânea/efeitos adversos , Sirolimo/efeitos adversos , Resultado do Tratamento
4.
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
5.
Int J Cardiovasc Imaging ; 35(7): 1199-1210, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31053981

RESUMO

We aimed to evaluate feasibility, early healing and self-correcting properties of the Desolve 150 bioresorbable scaffold (BRS) implanted in bifurcation lesions, using the simple, provisional side branch (SB) stenting technique. BIFSORB pilot was a proof-of-concept study enrolling 10 patients with stable angina pectoris and a bifurcation lesion with SB ≥ 2.5 mm and less than 50% diameter stenosis. Procedure and 1-month outcome was evaluated by optical coherence tomography (OCT) to assess scaffold performance and healing patterns. Nine patients were treated with Desolve 150 BRS and one delivery to the target bifurcation failed. Thrombus formation in the jailed SB ostium was seen in three cases, but was completely resolved at 1-month. OCT confirmed acute self-correcting properties. No clinical events were reported after six months. Scaffold diameter by OCT increased in the proximal main vessel from 3.09 ± 0.16 mm to 3.34 ± 0.18 mm (p = 0.01) and in distal main vessel from 2.82 ± 0.26 mm to 3.02 ± 0.29 mm (p < 0.01) at one-month follow-up. SB ostial diameter stenosis improved from 42 ± 15% to 34 ± 12% (p = 0.01). Malapposition was effectively reduced after 1 month from 4.1 (1.4; 6.1)% to 0.1 (0; 0.6)% (p = 0.002). Treatment of bifurcation lesions using Desolve 150 BRS was feasible except for a delivery failure and unsettling thrombus formation behind jailing SB struts, which was completely resolved at 1-month. Self-correcting and even self-expanding properties were confirmed.


Assuntos
Implantes Absorvíveis , Angina Estável/cirurgia , Doença da Artéria Coronariana/cirurgia , Estenose Coronária/cirurgia , Vasos Coronários/cirurgia , Intervenção Coronária Percutânea/instrumentação , Cicatrização , Idoso , Angina Estável/diagnóstico por imagem , Doença da Artéria Coronariana/diagnóstico por imagem , Estenose Coronária/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Projetos Piloto , Estudo de Prova de Conceito , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Tomografia de Coerência Óptica , Resultado do Tratamento
6.
Methodist Debakey Cardiovasc J ; 15(1): 81-85, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31049154

RESUMO

The entrapment of coronary intervention devices within the coronary vasculature is a rare but potentially devastating procedural complication. We report a case of an entrapped balloon and broken shaft that had to be retrieved by an open surgical approach. When device extraction is indicated and the use of snaring equipment is unsuccessful or inappropriate, a number of alternative percutaneous maneuvers can be attempted. These include (1) simple advancement and withdrawal of a trapped balloon, (2) use of a "buddy" wire to straighten the vessel and free the trapped device, (3) inflation of a buddy balloon adjacent to a trapped primary balloon to free the device, (4) partial inflation of a buddy balloon distal to a trapped device followed by gentle withdrawal, (5) use of an in-guide secondary balloon to trap the lost device, (6) advancement and twisting of guidewires to entwine the lost device, (7) saline dilution of trapped balloons, and (8) anchoring balloon and reverse-wire puncture of an undeflated and entrapped primary balloon. Careful consideration of various device retrieval strategies is indicated before resorting to open surgical retrieval in the rare instance of intracoronary device entrapment.


Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/instrumentação , Cateteres Cardíacos , Doença da Artéria Coronariana/cirurgia , Reestenose Coronária/cirurgia , Remoção de Dispositivo , Corpos Estranhos/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Stents Farmacológicos , Emergências , Falha de Equipamento , Corpos Estranhos/diagnóstico por imagem , Humanos , Masculino , Resultado do Tratamento , Ultrassonografia de Intervenção
7.
Int J Cardiovasc Imaging ; 35(4): 579-586, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30929102

RESUMO

The purpose of this observational study was to investigate the feasibility, initial safety, and efficacy of the SeQuent® Please DCB (B. Braun Melsungen, Germany) for patients with de novo coronary lesions in vessels exceeding 3.0 mm in a consecutive series of all comer percutaneous coronary intervention. A total of 120 patients (135 lesions) with de novo coronary lesions in vessels ≥ 3.0 mm treated with DCB were enrolled in this single-centre prospective observational study. The primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac death, target vessel-myocardial infarction (TV-MI), and clinically driven target vessel revascularization (TLR) at 12 months. Safety endpoints included cardiac death, TV-MI, and definite target vessel thrombosis. 45.9% of the lesions were classified as complex (type B2/C). The reference vessel diameter was 3.09 ± 0.31 mm measured via quantitative coronary angiography analysis. Coronary dissections occurred in 42 patients (35.0%; Type A-B 14.1%; Type C 19.1%; Type D: 1.6%), two of which [1.6%; (type D dissection)] underwent bail-out stent implantation. 12-month follow-up was completed in 100% patients. The 12-month incidence of TLF was 3.4%. The clinically driven TLR occurred in four patients (3.4%). The incidence of TLR was low in patients without any detectable dissections, similar to those with dissections (3.8% vs. 2.5%; p = 0.146). No patient suffered cardiac death, TV-MI, or target vessel thrombosis. The study shows the feasibility, initial safety, and efficacy of coronary intervention using SeQuent® Please DCB for the treatment of patients with de novo lesion in vessels exceeding 3 mm. The study highlights that the coronary dissection (Type A-C) post DCB treatment occurs frequently but is safe at follow up.


Assuntos
Cateteres Cardíacos , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/cirurgia , Estenose Coronária/cirurgia , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Idoso , Fármacos Cardiovasculares/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/cirurgia , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
8.
Expert Rev Med Devices ; 16(4): 267-273, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30929525

RESUMO

INTRODUCTION: Use of a microcatheter is essential for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Several microcatheters have recently been introduced in clinical practice aiming to improve deliverability and resistance to deformation. Areas covered: We review the technical characteristics of several new microcatheters (Mamba, Mamba Flex, Teleport Control, Teleport, Nhancer Rx, Sasuke, and ReCross) and compare them with existing microcatheters. Expert opinion: The recently developed microcatheters offer additional options for guidewire support during CTO PCI. Accumulation of clinical experience and performance of comparative effectiveness studies are needed for better understanding the role of these devices in contemporary CTO PCI.


Assuntos
Cateterismo/métodos , Cateterismo/tendências , Oclusão Coronária/cirurgia , Doença Crônica , Angiografia Coronária , Humanos , Intervenção Coronária Percutânea/instrumentação , Resultado do Tratamento
9.
Medicine (Baltimore) ; 98(14): e15106, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30946377

RESUMO

INTRODUCTION: Coronary bifurcations are encountered in about 15% to 20% of percutaneous coronary interventions (PCIs). They are considered technically challenging and associated with worse clinical outcomes than nonbifurcation lesions. The BiOSS LIM C is a dedicated bifurcation balloon expandable stent made of cobalt-chromium alloy (strut thickness 70 µm) releasing sirolimus (1.4 µg/mm) from the surface of a biodegradable coating comprised of a copolymer of lactic and glycolic acids. CONCLUSION: The aim of the randomized, multicenter, open-label, controlled POLBOS III trial is to compare BiOSS LIM C with limus second-generation drug-eluting stents (DES) in the treatment of non-left main stem coronary bifurcations (ClinicalTrials.gov NCT03548272).


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Estenose Coronária/tratamento farmacológico , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Ensaios Clínicos Controlados Aleatórios como Assunto , Stents Metálicos Autoexpansíveis , Síndrome Coronariana Aguda/terapia , Cromo , Cobalto , Estenose Coronária/terapia , Humanos , Estudos Multicêntricos como Assunto , Projetos de Pesquisa , Sirolimo/administração & dosagem , Resultado do Tratamento
10.
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
11.
Cardiovasc Diabetol ; 18(1): 25, 2019 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-30851731

RESUMO

BACKGROUND: Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention prolonging the time interval of percutaneous treatment options. METHODS: The ABSORB DM Benelux Study is a dedicated prospective, international study to evaluate the midterm safety and efficacy of EE-BRS in DM patients. All DM patients that received ≥ 1 EE-BRS for any indication were enrolled and prospectively followed. Study endpoints were major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction (MI) and ischemic-driven target vessel revascularization (TVR); target lesion failure (TLF): a composite of cardiac death (CD), target vessel MI, and ischemic-driven target lesion revascularization (TLR), as well as definite or probable scaffold thrombosis (ScT). RESULTS: Between April 2015 till March 2017, 150 DM patients and 188 lesions were treated and followed up to 3 years. Device implantation success was 100%. MACE occurred in 15.2% (event rate of 8.8 per 100 PY). TLF was reported in 11.7% (7.0 events per 100 PY). CD, target vessel MI, ischemic-driven TLR occurred in 3.4%, 3.6% and 5.5% respectively, while ScT was observed in 1.4%. There were no occurrences of late or very late ScT. CONCLUSION: EE-BRS treatment in DM patients shows comparable midterm safety and efficacy outcomes when historically compared with modern DES. New-generation EE-BRS might offer an attractive alternative to metallic DES in treatment of fast progressing atherosclerosis population as in DM patients. Trial registration NTR5447. Registered 05 October 2015, retrospectively registered.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/cirurgia , Diabetes Mellitus/epidemiologia , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Idoso , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/epidemiologia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/mortalidade , Europa (Continente)/epidemiologia , Everolimo/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
13.
J Cardiovasc Med (Hagerstown) ; 20(5): 313-320, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30921269

RESUMO

AIMS: To systematically review literature comparing bare metal stent (BMS) to drug-eluting stent (DES) in end-stage renal disease (ESRD) patients on dialysis. ESRD patients on dialysis often suffer from accelerated atherosclerosis and higher rate of stent-related complications including major adverse cardiovascular events. Because dialysis usually qualifies ineligibility for randomized clinical trials, an evidenced-based stent choice for these patients is scarce. METHODS: PUBMED, CINHAL, COCHRANE, EMBASE and WEB OF SCIENCE were searched for studies comparing BMS vs. DES outcome in ESRD patients on dialysis. RESULTS: Twenty studies including 64 232 patients were considered. The use of DES was significantly associated with a reduction in all-cause mortality [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.76-0.89], death from a cardiovascular cause (OR 0.80, 95% CI 0.76-0.84) and target lesion revascularization/target vessel revascularization (OR 0.73, 95% CI 0.53-1.00). No significant difference was found in stent thrombosis (OR 1.08, 95% CI 0.50-2.33) and myocardial infarction incidence (OR 0.91, 95% CI 0.69-1.20). CONCLUSIONS: Our meta-analysis shows a significant reduction in all-cause and cardiovascular mortality with the use of DES over BMS in dialyzed patients. Despite the lack of randomized studies, systematic use of DES in these high-risk patients should thus reasonably be considered as a first option in percutaneous coronary intervention candidates.


Assuntos
Stents Farmacológicos , Falência Renal Crônica/terapia , Metais , Isquemia Miocárdica/cirurgia , Intervenção Coronária Percutânea/instrumentação , Diálise Renal , Stents , Idoso , Feminino , Humanos , Falência Renal Crônica/diagnóstico , Falência Renal Crônica/mortalidade , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Diálise Renal/efeitos adversos , Diálise Renal/mortalidade , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
14.
Trials ; 20(1): 162, 2019 Mar 08.
Artigo em Inglês | MEDLINE | ID: mdl-30850023

RESUMO

BACKGROUND: Primary percutaneous coronary intervention (PCI) for patients presenting with acute myocardial infarction (AMI) caused by left main coronary artery occlusion is associated with significantly higher mortality and risks of major adverse cardiovascular events. Deferred stent implantation may improve prognosis of primary PCI by reducing distal embolization and no-reflow phenomenon. There is no randomized clinical trial focusing on the effect and outcome of deferred stent implantation on primary PCI for left main coronary artery occlusion in contrast with conventional strategy. METHODS: The Optimal Strategy of Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction due to Unprotected Left Main Coronary Artery Occlusion (OPTIMAL) study (ClinicalTrials.gov Identifier: NCT03282773) is an open-label, randomized, multicenter clinical trial in which 480 patients presenting with AMI caused by left main coronary artery occlusion recruited from 30 hospitals in mainland China will be randomly assigned 1:1 to immediate stenting or deferred stenting (scheduled 4-10 days after primary angioplasty) groups. The primary endpoint is a composite of all-cause mortality or recurrent myocardial infarction at 30 days after randomization. The secondary outcomes include all-cause mortality, cardiac death, recurrent myocardial infarction, and unplanned target vessel revascularization at 30 days, 6 months, and 12 months. DISCUSSION: The OPTIMAL study is designed to compare the clinical performance of deferred stenting with that of immediate stenting for AMI caused by left main coronary artery occlusion. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03282773 . Registered on 10 September 2017.


Assuntos
Oclusão Coronária/cirurgia , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , China , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/mortalidade , Oclusão Coronária/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/fisiopatologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
15.
Int J Cardiovasc Imaging ; 35(2): 237-238, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30835009

RESUMO

With exponential rise in percutaneous treatments of coronary disease in the last two decades, pseudoaneurysms of coronary vessels have been described, often as a consequence of previous coronary interventions. Nevertheless, pseudoaneurysms are still rarely encountered in clinical practice (0.3-6%) and pose a great challenge when it comes to management of this clinical entity. Our case not only highlights the rarity of pseudoaneurysms but also educates clinicians through these imaging series about the existence of successful percutaneous therapeutic approaches in such patient population, such as covered stent grafts as portrayed in this case. To our knowledge, this is the first case of a covered stent graft use in coronary pseudoaneurysm unrelated to previous coronary intervention.


Assuntos
Falso Aneurisma/cirurgia , Aneurisma Coronário/cirurgia , Intervenção Coronária Percutânea/instrumentação , Stents , Adulto , Falso Aneurisma/diagnóstico por imagem , Angiografia por Tomografia Computadorizada , Aneurisma Coronário/diagnóstico por imagem , Angiografia Coronária/métodos , Ecocardiografia , Feminino , Humanos , Tomografia Computadorizada Multidetectores , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Resultado do Tratamento
16.
Arch Cardiovasc Dis ; 112(5): 296-304, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30898474

RESUMO

BACKGROUND: Coronary angiography data are scarce for black patients with diabetes. AIM: To assess coronary angiography findings in patients with diabetes at the Abidjan Heart Institute. METHODS: This observational cross-sectional survey was conducted between 1 April 2010 and 31 December 2014. All patients admitted for known or suspected coronary artery disease who underwent coronary angiography were included in the Registre Prospectif des Actes de Cardiologie Interventionnelle de l'Institut de Cardiologie d'Abidjan. We analysed and compared coronary angiographical findings in patients with and without diabetes. RESULTS: Eighty patients with diabetes were compared with 353 patients without diabetes. Patients with diabetes were significantly older (58.7±8.9 vs 52.1±11.5 years; P<0.001). Hypertension and hypertriglyceridaemia were significantly associated with diabetes (P<0.001 and P=0.04, respectively). A higher proportion of patients with diabetes had an abnormal coronary angiogram (85.0% vs 67.7%; P=0.002). Coronary artery disease in patients with diabetes was predominantly characterized by multivessel disease (P<0.001). Cardiovascular risk factors associated with diabetes influenced the severity of coronary lesions. A SYNTAX score≥33 was found in a higher proportion of patients with diabetes (12.5% vs 7.1%). In the multivariable logistic regression, after adjustment, age>60 years (hazard ratio 2.53, 95% confidence interval 1.59-4.04; P<0.001) and diabetes (hazard ratio 2.12, 95% confidence interval 1.26-3.57; P=0.004) were associated with multivessel coronary artery disease. CONCLUSIONS: In our study, diabetes emerged as a risk factor for multivessel coronary artery disease. Future studies should help to define the long-term prognosis of these patients, and to assess the benefits of myocardial revascularization procedures.


Assuntos
Grupo com Ancestrais do Continente Africano , Cateterismo Cardíaco , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/etnologia , Diabetes Mellitus/etnologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/cirurgia , Costa do Marfim/epidemiologia , Estudos Transversais , Diabetes Mellitus/diagnóstico , Stents Farmacológicos , Feminino , Inquéritos Epidemiológicos , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/instrumentação , Valor Preditivo dos Testes , Prognóstico , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença
17.
Atheroscler Suppl ; 36: 19-23, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30876528

RESUMO

Homozygous familial hypercholesterolemia developed into severe cardiovascular consequences early. Untreated HoFH usually cannot survive over 30 years old. Acute coronary syndrome(ACS) caused by plaque rupture is one of the main causes of death in HoFH. As the highest resolution intravascular imaging technique, optical coherence tomography(OCT) can clearly show the thickness and structural characteristics of atherosclerotic plaque caps. In this study, a Chinese male HoFH received percutaneous coronary intervention for unstable angina. After analyzed his genetic and follow-up data, OCT was performed during interventional therapy. Multiple lipid rich plaques accompanied with inflammatory cell infiltration and a thin-cap fibroatheroma(TCFA) were noted, which reflected the vulnerability of plaques. The utility of OCT had certain guiding significance for strategy of interventional therapy and the long-term drug management. And this case suggested that it was important to undergo OCT examination for patients with HoFH who required percutaneous coronary intervention.


Assuntos
Síndrome Coronariana Aguda/cirurgia , Doença da Artéria Coronariana/cirurgia , Homozigoto , Hiperlipoproteinemia Tipo II/genética , Mutação , Intervenção Coronária Percutânea , Receptores de LDL/genética , Tomografia de Coerência Óptica , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/etiologia , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/etiologia , Fibrose , Predisposição Genética para Doença , Humanos , Hiperlipoproteinemia Tipo II/complicações , Hiperlipoproteinemia Tipo II/diagnóstico , Masculino , Intervenção Coronária Percutânea/instrumentação , Fenótipo , Placa Aterosclerótica , Valor Preditivo dos Testes , Ruptura Espontânea , Stents , Resultado do Tratamento
18.
Int J Cardiovasc Imaging ; 35(7): 1189-1198, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30911857

RESUMO

Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58-1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52-1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19-0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/etiologia , Humanos , Países Baixos , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
20.
Int J Cardiovasc Imaging ; 35(6): 973-980, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30874980

RESUMO

The purpose of this study was to evaluate the vessel healing status 3 months after stent implantation of bioresorbable-polymer drug-eluting stents (BP-DESs) in comparison with durable-polymer DESs (DP-DESs) by angioscopy. Study design was a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful angioscopic examination at planned 3-month follow-up after the DES implantation in the native coronary artery were enrolled. We evaluated main, maximum, minimum strut coverage grades and coverage heterogeneity score defined as a difference between maximum and minimum coverage grades. All lesions were divided into three segments: proximal, mid, and distal segments. A total of 108 patients (66.6 ± 10 years) with 124 lesions were analyzed (BP-DES 57 patients 61 lesions 226 segments vs. DP-DES 57 patients 63 lesions 203 segments; six patients had both BP-DES and DP-DES). Patient and lesion demographics, procedural characteristics were well balanced. Main coverage grade (mean ± standard error; 1.08 ± 0.02 vs. 1.05 ± 0.03, p = 0.354) and minimum coverage grade (1.00 ± 0.00 vs. 1.00 ± 0.00, p > 0.999) were not significantly different between BP-DES and DP-DES groups. Maximum coverage grade was significantly higher in the BP-DES than in the DP-DES (1.45 ± 0.04 vs. 1.35 ± 0.04, p = 0.049). Coverage heterogeneity score did not differ between BP-DES and DP-DES groups (1.05 ± 0.07 vs. 0.90 ± 0.07, p = 0.162). At 3-month follow-up, the current BP-DES had higher maximum stent coverage than the contemporary DP-DES, while main and minimum coverage grades and heterogeneity of the neointimal coverage were comparable. Further prospective randomized trials should be conducted to evaluate the clinical significance of the present imaging results.


Assuntos
Implantes Absorvíveis , Angioscopia , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Polímeros/química , Cicatrização , Idoso , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/fisiopatologia , Vasos Coronários/patologia , Vasos Coronários/fisiopatologia , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Neointima , Intervenção Coronária Percutânea/efeitos adversos , Placa Aterosclerótica , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento
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