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OBJECTIVES/BACKGROUND: In patients with multivessel coronary artery disease (MVD) the decision whether to treat a single culprit vessel or to perform multivessel revascularisation may be challenging. The purpose of this study was to evaluate the long-term outcome of multivessel percutaneous coronary intervention (MV-PCI) versus culprit vessel only (CV-PCI) in patients with stable coronary artery disease or non-ST elevation acute coronary syndrome. METHODS: In this dual-centre, prospective, randomised study a total 215 patients with MVD were randomly assigned to MV-PCI or CV-PCI. The primary endpoint was the occurrence of major adverse cardiac events (MACE) including death, myocardial infarction (MI), and repeat revascularisation. Secondary endpoints were the combined endpoint of death or MI, the individual components of the primary endpoint, and the occurrence of stent thrombosis. Patients were followed up to 5 years after enrolment. RESULTS: The occurrence of the primary endpoint was similar at 28% versus 31% in the MV-PCI and CV-PCI group, respectively (hazard ratio [HR] 0.87, 95% confidence interval [CI]: 0.53-1.44, pâ¯= 0.59). The rate of repeat revascularisation was 15% versus 24% (HR 0.59, 95% CI 0.32 to 1.11, pâ¯= 0.11), whereas definite or probable stent thrombosis occurred in 2% versus 0% (pâ¯= 0.44). CONCLUSIONS: In this randomised study comparing the strategies for MV-PCI and CV-PCI in patients with MVD, no difference was found in the occurrence of MACE after 5 years. We observed a numerically higher rate of death or MI and a lower rate of repeat revascularisation after MV-PCI, although these findings were not statistically significant.
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BACKGROUND: The OPTIMA trial was a randomised multicentre trial exploring the influence of the timing of percutaneous coronary intervention (PCI) on patient outcomes in an intermediate to high risk non-ST-elevation acute coronary syndrome (NSTE-ACS) population. In order to decide the best treatment strategy for patients presenting with NSTE-ACS, long-term outcomes are essential. METHODS: Five-year follow-up data from 133 of the 142 patients could be retrieved (94 %). The primary endpoint was a composite of death and spontaneous myocardial infarction (MI). Spontaneous MI was defined as MI occurring more than 30 days after randomisation. Secondary endpoints were the individual outcomes of death, spontaneous MI or re-PCI. RESULTS: No significant difference with respect to the primary endpoint was observed (17.8 vs. 10.1 %; HR 1.55, 95 % CI: 0.73-4.22, p = 0.21). There was no significant difference in mortality rate. However, spontaneous MI was significantly more common in the group receiving immediate PCI (11.0 vs. 1.4 %; HR 4.46, 95 % CI: 1.21-16.50, p = 0.02). We did not find a significant difference between the groups with respect to re-PCI rate. CONCLUSION: There was no difference in the composite of death and spontaneous MI. The trial suggests an increased long-term risk of spontaneous MI for patients treated with immediate PCI.
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We describe a case of critical hand ischaemia after transradial cardiac catheterisation. The patient presented with hand ischaemia 5 days after transradial coronary angiography. Urgent angiography demonstrated radial artery occlusion with embolisation to the palmar arch and digital arteries. The ischaemia was refractory to an extensive thrombolytic regimen, and subsequently, the patient was referred to the vascular surgeon for urgent thrombectomy and patch angioplasty. The patient recovered slowly and no amputation was necessary, but complaints of right hand numbness and paresthesia of all digits remained.
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BACKGROUND: The field of acute coronary syndromes is characterised by an increasing tendency towards early invasive catheter-based diagnostics and therapeutics-a practice based on observational and retrospective data. OBJECTIVE: To compare immediate versus deferred angioplasty in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) METHODS: A randomised, prospective multicentre trial was performed in patients admitted with NSTE-ACS, eligible for percutaneous coronary intervention (PCI). Interim analysis was performed after enrolment of 251 patients; PCI was appropriate in 142 patients. These patients were randomised to immediate PCI (n = 73) or deferred PCI (24-48 h) (n = 69). Patients received protocol-driven glycoprotein IIb/IIIa blockers, aspirin and clopidogrel. The primary end point was a composite of death, non-fatal myocardial infarction (MI) or unplanned revascularisation, at 30 days. After hospital discharge outpatient follow-up was performed at 30 days and 6 months. RESULTS: The incidence at 30 days of the primary end point was 60% in the group receiving immediate PCI and 39% in the group receiving deferred PCI (relative risk (RR) = 1.5, 95% CI 1.09 to 2.15; p = 0.004). No deaths occurred in either group. MI was significantly more common in the group receiving immediate PCI (60% vs 38%, RR = 1.6, 95% CI 1.12 to 2.28, p = 0.005). Unplanned revascularisation was similar in both groups. The observed difference was preserved over 6-months' follow-up. CONCLUSIONS: Immediate PCI was associated with an increased rate of MI in comparison with a 24-48 h deferred strategy, despite aggressive antithrombotic treatment. The results suggest that PCI for high-risk patients with non-refractory NSTE-ACS should be delayed for at least 24 h after hospital admission. TRIAL REGISTRATION NUMBER: ISRCTN80874637.
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Síndrome Coronariana Aguda/terapia , Angioplastia Coronária com Balão , Infarto do Miocárdio/epidemiologia , Síndrome Coronariana Aguda/mortalidade , Angioplastia Coronária com Balão/efeitos adversos , Aspirina/uso terapêutico , Clopidogrel , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Inibidores da Agregação Plaquetária/uso terapêutico , Estudos Prospectivos , Ticlopidina/análogos & derivados , Ticlopidina/uso terapêutico , Fatores de Tempo , Resultado do TratamentoRESUMO
AIM: The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months. METHODS: Patients (n =1,197) treated for single coronary artery stenosis were enrolled in a prospective, randomized, double-blind study and randomly assigned to receive the Endeavor zotarolimus-eluting phosphorylcholine polymer-coated stent (n= 598) or the same bare metal stent but without the drug or the polymer coating (n=599). RESULTS: The 2 groups were well matched in baseline characteristics. Diabetes was present in 20.1% of patients; the mean reference vessel diameter was 2.75 mm; and the mean lesion length was 14.2 mm. The primary end point of target vessel failure at 9 months was reduced from 15.1% with the bare metal stent to 7.9% with the Endeavor (P=0.0001), and the rate of major adverse cardiac events was reduced from 14.4% with the bare metal stent to 7.3% with the Endeavor (P=0.0001). Target lesion revascularization was 4.6% with Endeavor compared with 11.8% with the bare metal stent (P=0.0001). The rate of stent thrombosis was 0.5% with the Endeavor, which was not significantly different from 1.2% with the bare metal stent. In 531 patients submitted to angiographic follow-up, late loss was reduced from 1.03+/-0.58 to 0.61+/-0.46 (P<0.001) in stent and from 0.72+/-0.61 to 0.36+/-0.46 (P<0.001) in segment. The rate of in-segment restenosis was reduced from 35% to 13.2% with Endeavor (P<0.0001). There was no excessive edge stenosis, aneurysm formation, or late acquired malposition by intravascular ultrasound imaging. Differences in clinical outcome were maintained at 12 and 24 months (P<0.0001). CONCLUSIONS: Compared with bare metal stents, the Endeavor stent is safe and reduces the rates of clinical and angiographic restenosis at 9, 12, and 24 months.
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Fármacos Cardiovasculares/uso terapêutico , Angiografia Coronária , Reestenose Coronária/prevenção & controle , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/terapia , Sirolimo/análogos & derivados , Stents , Idoso , Austrália , Reestenose Coronária/diagnóstico por imagem , Estenose Coronária/tratamento farmacológico , Estenose Coronária/cirurgia , Método Duplo-Cego , Sistemas de Liberação de Medicamentos , Desenho de Equipamento , Europa (Continente) , Feminino , Humanos , Israel , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Ilhas do Pacífico , Fosforilcolina , Estudos Prospectivos , Sirolimo/uso terapêutico , Resultado do TratamentoRESUMO
Interventional cardiology is an expanding field within cardiovascular medicine and today it is generally accepted that cardiologists require specific training, knowledge and skills. Hospitals where coronary interventions are performed must be properly equipped and able to provide specialised care. Percutaneous coronary interventions are frequently used for coronary revascularisation. The public should have confidence in the uniformity of high quality care. Therefore, such quality of care should be maintained by certification of the individual operators, general guidelines for institutional requirements and formal audits. The Netherlands Society of Cardiology (NVVC) will be implementing a new registration system for cardiologists with a subspecialisation that will include registration for interventional cardiology. The NVVC asked the Working Group of Interventional Cardiology (WIC) to update the 1994 Dutch guidelines on operator and institutional competence, and requirements for training in interventional cardiology in order to incorporate them into the official directives. The present guidelines represent the expert opinion of the Dutch interventional cardiology community and are in accordance with international regulations. After two rounds of discussion, the NVVC approved the guidelines in November 2004 during the autumn meeting.
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OBJECTIVES: Comparison of the in-hospital success rates, procedural costs and short-term clinical outcomes of direct stenting versus stenting after balloon predilatation. METHODS: Altogether, 400 patients with angina pectoris and/or myocardial ischaemia due to coronary stenoses in a single native vessel were randomised to either direct stenting or stenting after predilatation. Baseline characteristics were evenly distributed between the two groups. RESULTS: Procedural success rates were similar (96.0% direct stenting group vs. 94.5% predilatation) as well as final successful stent implantation (98.3 vs. 97.8%), while the primary success rate of direct stenting alone was 88.3%, p=0.01. In multivariate analysis, angiographic lesion calcification was an independent predictor of unsuccessful direct stenting (odds ratio 7.1, 95% confidence interval 2.8-18.2, p<0.0001). Rates of troponin I rises >0.15 µg/l, used as a measure of distal embolisation, were similar in both groups (17.8 vs. 17.1%). Rates of major adverse cardiac events at 30 days were 4.5% in the direct stenting group versus 5.5% in the predilated group (ns). Direct stenting was associated with savings in fluoroscopy time, and angiographic contrast agent use, and a reduction in utilisation of angioplasty balloons (0.4 vs. 1.17 balloons per patient, p<0.001). Mean per patient procedural costs associated with direct stenting versus predilatation were 2545±914 versus 2763±842 (p=0.01), despite the implantation of more stents in the directly stented group. CONCLUSION: Compared with a strategy of stenting preceded by balloon predilatation, direct stenting was equally safe and effective, with similar in-hospital and 30-day clinical outcomes, and modest procedural cost-savings. A calcified lesion predicted unsuccessful direct stenting.
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OBJECTIVES: To review the currently available data from studies assessing feasibility, safety, clinical outcome and cost-effectiveness of direct stenting. BACKGROUND: With technical advances of stent designs and their delivery systems a new strategy has become increasingly popular: direct stent implantation without prior balloon dilatation. METHODS: The Medline database was searched from January 1996 to March 2001 for clinical trials investigating direct stenting using the index terms direct stenting, coronary intervention, percutaneous transluminal coronary angioplasty (PTCA), PCI, angioplasty and ischemic heart disease. Studies were chosen based on the number of patients involved and endpoints mentioned. Data not yet published but presented at recent international meetings were also included. A comparison between direct stenting and stenting with predilatation was performed using for the latter results of the randomized trials supplemented with Benestent II data. RESULTS: At least 26 studies have investigated direct stenting, showing high primary and final success rates with few complications. Direct stenting provides a way to reduce costs, shorten procedural and fluoroscopy times and lower material consumption. Immediate and long-term clinical outcomes appear to be similar to stenting with predilatation. Preliminary results of large randomized trials with angiographic follow-up indicate that restenosis rates are similar to those of conventional stenting strategies. CONCLUSIONS: Direct stenting compared with stenting with predilatation is feasible, safe, faster and more cost-effective. The evidence to date shows similar late outcomes.
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Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/economia , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/economia , Estenose Coronária/economia , Estenose Coronária/terapia , Análise Custo-Benefício/economia , Avaliação de Resultados em Cuidados de Saúde , Stents/efeitos adversos , Stents/economia , Estudos de Viabilidade , Humanos , Fatores de TempoRESUMO
STUDY OBJECTIVE: To compare the long-term angiographic, clinical and economic outcome of direct stenting vs stenting after balloon predilatation. PATIENT POPULATION AND METHODS: Four hundred patients with coronary stenoses in a single native vessel were randomized to direct stenting vs stenting after predilatation. A major adverse cardiac and cerebral event (MACCE) was defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vessel-related percutaneous coronary intervention, target lesion revascularization, coronary artery bypass surgery and stroke. RESULTS: Stents were successfully implanted in 98.3% of patients randomized to direct stenting vs 97.8% randomized to stenting preceded by predilatation. The primary success rate of direct stenting was 88.3%, vs 97.8% for stenting preceded by balloon dilatation (P=0.01). The angiographic follow-up at 6 months included 333 of the 400 patients (83%). The binary in-stent restenosis rate was 23.1% of 163 patients randomized to direct stenting vs 18.8% of 166 patients randomized to balloon predilatation (P=0.32). By 185+/-25 days, MACCE had occurred in 31 of 200 (15.5%) patients randomized to direct stenting, vs 33 of 200 (16.5%) randomized to predilatation (P=0.89). At 6 months, costs associated with the direct stenting strategy (Euros 3222/patient) were similar to those associated with predilatation (Euros 3428/patient, P=0.43). However, procedural costs were significantly lower. It is noteworthy that, on multivariate analysis, a baseline C-reactive protein level >10 mg l(-1)was a predictor of restenosis (odds ratio: 2.10, P=0.025) as well as of MACCE (odds ratio: 1.94, P=0.045). CONCLUSIONS: Compared to stenting preceded by balloon predilatation, direct stenting was associated with similar 6-month restenosis and MACCE rates. Procedural, but not overall 6-month costs, were reduced by direct stenting. An increased baseline CRP level was an independent predictor of adverse long-term outcome after coronary stent implantation.
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Reestenose Coronária/prevenção & controle , Estenose Coronária/terapia , Stents , Angina Pectoris/economia , Angina Pectoris/terapia , Cateterismo/economia , Cateterismo/métodos , Reestenose Coronária/economia , Estenose Coronária/economia , Análise Custo-Benefício , Falha de Equipamento , Feminino , Seguimentos , Oclusão de Enxerto Vascular/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/economia , Infarto do Miocárdio/prevenção & controle , Stents/economia , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/terapia , Resultado do TratamentoRESUMO
This study tested the safety and feasibility of coronary angioplasty on an outpatient basis. The purpose of this approach includes cost-effectiveness and patient comfort. Included were 159 patients treated with balloon angioplasty or intracoronary stent placement, all performed via the radial artery with 6 French guiding catheters. Patients were selected for same-day discharge based on the absence of any adverse predictor for subacute occlusion or unfavorable clinical outcome during the first 24 hr after successful PTCA. One hundred and six (66%) patients were discharged 4-6 hr after PTCA. Stents were used in 40% of patients. There were no cardiac or vascular complications. We conclude that outpatient PTCA, performed via the radial artery, is both safe and feasible in a large part of a routine PTCA population.
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Procedimentos Cirúrgicos Ambulatórios , Angioplastia Coronária com Balão , Angina Pectoris/terapia , Determinação de Ponto Final , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Resultado do TratamentoAssuntos
Angioplastia com Balão , Anticorpos Monoclonais/uso terapêutico , Trombose Coronária/tratamento farmacológico , Fragmentos Fab das Imunoglobulinas/uso terapêutico , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Terapia de Salvação , Abciximab , Angiografia Coronária , Trombose Coronária/diagnóstico por imagem , Feminino , Humanos , Pessoa de Meia-Idade , Falha de TratamentoRESUMO
BACKGROUND: The CAPTURE study (c 7E3 A nti P latelet T herapy in U nstable Re fractory angina) was designed to assess outcome in patients with refractory angina undergoing angioplasty, receiving either abciximab or placebo. METHODS: One thousand two hundred and sixty-five patients with refractory unstable angina, defined as recurrent myocardial ischaemia despite medical treatment including heparin and nitrates were enrolled. After angiography, patients received an infusion of abciximab or placebo over 18-24 h preceding angioplasty, continuing until 1 h after the procedure. In 1197 patients undergoing angioplasty the angiographic committee centrally reviewed the baseline as well as the procedural angiograms. Coronary flow and lesion characteristics were assessed in the baseline angiogram as well as before intervention. Angiographic outcome, reason for failure as well as complications were assessed after angioplasty. RESULTS: At 30 days follow-up, patients receiving abciximab (n=595) compared with placebo (n=602) had a 30% reduction in the composite primary end-point death, myocardial infarction or urgent (re)intervention: 10.8% vs 15.4% (P=0.017). Baseline demographics were identical in the angiogram available group compared with the total study group. At 30 days, the non-angiogram available patients showed a higher incidence of events compared to those in whom the angiogram was reviewed: 19.4 vs 13.1% (P=ns). Lesion characteristics and coronary flow were not different at baseline between the placebo and abciximab groups. A primary end-point was reached in 9.6% of both placebo and abciximab patients with type A or B(1)lesions, in 17.0% vs 12.0% with type B(2)lesions, and in 19.1% vs 11.5% with type >B(2)or C lesions. Sixty-one percent of placebo and abciximab patients had TIMI 3 flow at baseline angiography. Pre-angioplasty TIMI 3 flow was observed in 69% and 72% respectively. The thrombus was resolved between the angiograms in 22% and 43% respectively, in the placebo and abciximab groups (P=0. 033). Angiographic success of the procedure was achieved in 88% and 94% in the placebo and abciximab patients, respectively (P<0.001). Stents were implanted in the ischaemia-related artery in 56 and 60 patients, respectively. However, failure of the stent procedure was more frequent in the placebo group than in the abciximab group, nine vs no patients (P=0.003). CONCLUSION: More frequent thrombus resolution was observed and a higher angiographic success rate was achieved in patients treated with abciximab before and during angioplasty compared with placebo. Patients with complex lesions as the underlying pathology reached fewer end-points if treated with abciximab before and during angioplasty.
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Angina Instável/diagnóstico por imagem , Angina Instável/tratamento farmacológico , Angioplastia Coronária com Balão , Anticorpos Monoclonais/uso terapêutico , Angiografia Coronária , Fragmentos Fab das Imunoglobulinas/uso terapêutico , Inibidores da Agregação Plaquetária/uso terapêutico , Abciximab , Idoso , Trombose Coronária/prevenção & controle , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Stents , Resultado do TratamentoRESUMO
OBJECTIVES: The purpose of this study was to compare recombinant hirudin and heparin as adjuncts to streptokinase thrombolysis in patients with acute myocardial infarction (AMI). BACKGROUND: Experimental studies and previous small clinical trials suggest that specific thrombin inhibition improves early patency rates and clinical outcome in patients treated with streptokinase. METHODS: In a randomized double-blind, multicenter trial, 1,208 patients with AMI < or =6 h were treated with aspirin and streptokinase and randomized to receive recombinant hirudin (lepirudin, i.v. bolus of 0.2 mg/kg, followed by subcutaneous (s.c.) injections of 0.5 mg/kg b.i.d. for 5 to 7 days) or heparin (i.v. placebo bolus, followed by s.c. injections of 12,500 IU b.i.d. for 5 to 7 days). A total of 447 patients were included in the angiographic substudy in which the primary end point, 90-min Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 of the infarct-related artery, was evaluated, while the other two-thirds served as "safety group" in which only clinical end points were evaluated. As an additional efficacy parameter the ST-segment resolution at 90 and 180 min was measured in all patients. RESULTS: TIMI flow grade 3 was observed in 40.7% in the lepirudin and in 33.5% in the heparin group (p = 0.16), respectively. In the entire study population the proportion of patients with complete ST resolution at 90 min (28% vs. 22%, p = 0.05) and at 180 min (52% vs. 48%, p = 0.18) after start of therapy tended to be higher in the lepirudin group. There was no significant difference in the incidence of hemorrhagic stroke (0.2% vs. 0.3%) or total stroke (1.2% vs. 1.5%), reinfarction rate (4.6% vs. 5.1%) and total mortality rate (6.8% vs. 6.4%) at 30 days, as well as the combined end point of death, nonfatal stroke, nonfatal reinfarction, rescue-percutaneous transluminal coronary angioplasty and refractory angina (22.7 vs. 24.3%) were not statistically different between the two groups. CONCLUSIONS: Lepirudin as adjunct to thrombolysis with streptokinase did not significantly improve restoration of blood flow in the infarct vessel as assessed by angiography, but was associated with an accelerated ST resolution. There was no increase in the risk of major bleedings with lepirudin compared to heparin.
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Anticoagulantes/uso terapêutico , Fibrinolíticos/uso terapêutico , Hirudinas/análogos & derivados , Infarto do Miocárdio/tratamento farmacológico , Estreptoquinase/uso terapêutico , Terapia Trombolítica , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Eletrocardiografia/efeitos dos fármacos , Feminino , Fibrinolíticos/efeitos adversos , Heparina/efeitos adversos , Heparina/uso terapêutico , Terapia com Hirudina , Hirudinas/efeitos adversos , Humanos , Infusões Intravenosas , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Estudos Prospectivos , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Recidiva , Estreptoquinase/efeitos adversos , Taxa de Sobrevida , Resultado do TratamentoRESUMO
This prospective study was designed to determine the feasibility of AVE gfx premounted stent systems in combination with 6 Fr guides. Between 1 April and 12 August 1997, 230 patients underwent AVE gfx coronary stent implantation via 6 Fr guides. The radial approach was used in 146 patients (63.5%). In 230 procedures (293 lesions), 237 guiding catheters were used. A total of 331 AVE gfx stents were implanted, 1.4 per patient. Backup, opacification, and friction were considered good in 85.8%, 96.4%, and 76.7%, respectively. Slight and severe friction was felt during combined use of long (> or = 18 mm), large-sized (3.5 mm) stents and small-sized guiding catheters (inner diameter, 0.061-0.062"). The presence of a second protecting guidewire impaired passage of the AVE gfx stent, also in large 6 Fr guides (ID 0.064"). Of 331, 320 (96.7%) stents were successfully deployed at the initial attempt. Ten stents (3%) had to be retrieved. Six of these were successfully placed at a second attempt and three slipped off the balloon, all successfully retrieved from the patient's circulation. At 1 month, 217 patients (94.4%) were free of events. The AVE gfx stent is compatible with 6 Fr guiding catheters. Use of new-generation, large-bore 6 Fr gc (> or = 0.064") is recommended.
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Angioplastia Coronária com Balão/instrumentação , Vasos Coronários , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Angiografia Coronária , Doença das Coronárias/diagnóstico por imagem , Doença das Coronárias/terapia , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Stents/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVES: This study sought to compare procedural and clinical outcomes of percutaneous transluminal coronary angioplasty (PTCA) performed with 6F guiding catheters introduced through the radial, brachial or femoral arteries. BACKGROUND: Transradial PTCA has been demonstrated to be an effective and safe alternative to transfemoral PTCA; however, no randomized data are currently available. METHODS: A randomized comparison between transradial, transbrachial and transfemoral PTCA with 6F guiding catheters was performed in 900 patients. Primary end points were entry site and angioplasty related. Secondary end points were quantitative coronary analysis after PTCA, procedural and fluoroscopy times, consumption of angioplasty equipment and length of hospital stay. RESULTS: Successful coronary cannulation was achieved in 279 (93.0%), 287 (95.7%) and 299 (99.7%) patients randomized to undergo PTCA by the radial, brachial and femoral approaches, respectively. PTCA success was achieved in 91.7%, 90.7% and 90.7% (p = NS) of patients, with 88.0%, 87.7% and 90.0% event free at 1-month follow-up, respectively (p = NS). Major entry site complications were encountered in seven patients (2.3%) in the transbrachial group, six (2.0%) in the transfemoral group and none in the transradial group (p = 0.035). Transradial PTCA led to asymptomatic loss of radial pulsations in nine patients (3%). Procedural and fluoroscopy times were similar, as were consumption of guiding and balloon catheters and length of hospital stay ([mean +/- SD] 1.5 +/- 2.5, 1.8 +/- 3.8 and 1.8 +/- 4.2 days, respectively). CONCLUSIONS: With experience, procedural and clinical outcomes of PTCA were similar for the three subgroups, but access failure is more common during transradial PTCA. Major access site complications were more frequently encountered after transbrachial and transfemoral PTCA.
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Angioplastia Coronária com Balão/métodos , Doença das Coronárias/terapia , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/instrumentação , Artéria Braquial , Cateterismo Cardíaco/métodos , Feminino , Artéria Femoral , Seguimentos , Humanos , Incidência , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Artéria Radial , Stents , Fatores de Tempo , Falha de Tratamento , Resultado do TratamentoRESUMO
Coronary angioplasty with 6F guiding catheters via the radial artery is associated with a minimal risk for major entry site-related complications. Although the incidence of radial artery occlusion (RAO) in the literature is approximately 30% after prolonged cannulations, little is known about the incidence and its clinical consequences of RAO following transradial percutaneous coronary angioplasty. In a prospective study, 563 patients with a normal Allen test were evaluated on patency and function of the radial artery after transradial angioplasty, by physical and ultrasound examination at discharge, and at 1 month follow-up. At discharge, 30 patients (5.3%) had clinical evidence of RAO. At follow-up, persistent RAO was found in 16 patients (2.8%). In this study we found a low incidence of RAO after transradial percutaneous coronary angioplasty. None of the patients with temporary or persistent RAO had any major clinical symptoms. Therefore, the occurrence of RAO can be considered a minor complication in patients with a previously good double blood supply to the hand.
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Angioplastia Coronária com Balão/efeitos adversos , Arteriopatias Oclusivas/etiologia , Artéria Radial , Idoso , Angioplastia Coronária com Balão/métodos , Arteriopatias Oclusivas/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Artéria Radial/diagnóstico por imagem , Stents , Fatores de Tempo , Ultrassonografia DopplerRESUMO
OBJECTIVES: This study was performed to explore the feasibility of coronary Palmaz-Schatz stent implantation on an outpatient basis. BACKGROUND: To optimize the applicability of coronary stenting by limiting bleeding complications and length of hospital stay, the transradial approach has been demonstrated to be an effective technique. Immediate ambulation opens the way to outpatient treatment. METHODS: Patients selected for Palmaz-Schatz stent implantation received anticoagulation with Coumadin. At an international normalized ratio > 2.5, stenting was performed through the radial approach. Starting in December 1994, patients were treated with Ticlopidin. Heparin was administered during the procedure. Suitability for same-day discharge was assessed on the basis of preprocedural, postprocedural and periprocedural criteria. Patients were mobilized after immediate sheath removal, followed by same-day discharge. Follow-up examinations were performed the next day, at 2 weeks and at 1 month after stenting. RESULTS: Of 188 patients who underwent Palmaz-Schatz coronary stent implantation through the radial artery between May 1994 and July 1995, 88 remained in the hospital for various reasons. In the 100 outpatients (Canadian Cardiovascular Society classes III and IV, n = 90 [90%]), 125 stents had been implanted to cover 110 lesions. No cardiac or bleeding events were encountered within 24 h (95% confidence interval 0 to 3.6) of stenting. At 2-week follow-up, one patient was readmitted (day 4) because of a bleeding abdominal aortic aneurysm requiring operation. Two patients were readmitted 2 weeks after discharge, one with subacute thrombosis and one with angina and anemia that was treated with blood transfusions. At 1-month follow-up, no complications were observed. CONCLUSIONS: After an optimal transradial Palmaz-Schatz coronary stent result, patients can safely be discharged on the day of treatment.