RESUMO
One limitation to transradial access (TRA) is the occurrence of spasms (RAS), for which the use of prophylactic medications is recommended. Improvement in TRA material combined with the increase in operators' expertise, might mitigate this benefit. We assess the effect of preventive nitroglycerin on RAS during TRA, evaluating the role of the operator's experience. Patients received 500 µg nitroglycerin or placebo. The operator's expertise was classified as: inexperienced (I), intermediate (M), and experienced (E). 2040 patients were included. Prophylactic use of nitroglycerin did not reduce RAS (10.8% vs. 13.4% (placebo), p = 0.07). RAS incidence was 14.5% in I, 12.5% in M, and 9.7% in E (p = 0.01). In group I, nitroglycerin reduced RAS (17.4% vs. 11.1%, p = 0.04), which was not observed in other groups. Overall, nitroglycerin does not prevent RAS, which is more common among inexperienced operators. More experienced operators could abolish preventive nitroglycerin use.
Assuntos
Nitroglicerina , Vasodilatadores , Humanos , Artéria Radial , Resultado do Tratamento , Cateterismo Cardíaco/efeitos adversos , Espasmo/diagnóstico , Espasmo/etiologia , Espasmo/prevenção & controleRESUMO
OBJECTIVES: To report clinical, angiographic characteristics, outcomes, and predictors of unsuccessful procedures in patients who underwent chronic total occlusion (CTO) percutaneous coronary interventions (PCI) in Latin America. BACKGROUND: CTO PCI has been increasingly performed worldwide, but there is a lack of information in this region. METHODS: An international multicenter registry was developed to collect data on CTO PCI performed in centers in Latin America. Patient, angiographic, procedural and outcome data were evaluated. Predictors of unsuccessful procedures were assessed by multivariable analysis. RESULTS: We have included data related to 1,040 CTO PCIs performed in seven countries in Latin America (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, and Puerto Rico). The mean age was 64 ± 10 years, and CTO PCI was performed mainly for angina control (81%) or treatment of a large ischemic area (30%). Overall technical success rate was 82.5%, and it was achieved with antegrade wire escalation in 81%, antegrade dissection/re-entry in 8% and with retrograde techniques in 11% of the successful procedures. Multivariable analysis identified moderate/severe calcification, a blunt proximal cap and a previous attempt as independent predictors of unsuccessful procedures. In-hospital major adverse cardiovascular events (MACE) occurred in 3.1% of the cases, death in 1% and cardiac tamponade in 0.9% CONCLUSIONS: CTO PCI in Latin America has been performed mainly for ischemia relief. Procedures were associated with a success rate above 80% and low incidence of MACE. Predictors of unsuccessful procedures were similar to those previously reported in the literature.
Assuntos
Oclusão Coronária/terapia , Intervenção Coronária Percutânea , Idoso , Doença Crônica , Angiografia Coronária , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/mortalidade , Feminino , Mortalidade Hospitalar , Humanos , América Latina , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Sistema de Registros , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: To compare the radial versus femoral approach using Angio-Seal for the incidence of access site complications among non-ST-segment elevation acute coronary syndrome patients undergoing invasive strategy. BACKGROUND: Arterial access is a major site of complications after invasive coronary procedures. Vascular closure devices provide more comfort to patients decreasing time to hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications. METHODS: Single-center non-inferiority trial where 240 patients were randomized to radial or femoral access using Angio-Seal. The primary objective was the occurrence of complications at the arterial puncture site until 30 days after the procedure. RESULTS: There were no baseline clinical differences between groups, except for a greater prevalence of female patients in the radial group (33.3 vs. 20.0%, P = 0.020). Hemostasis was achieved in the entire radial group with the use of TR Band and in 95% of the procedures in the femoral group with Angio-Seal (P = 0.029). Except for a higher incidence of asymptomatic arterial occlusion in the radial group, there were no differences among the other analyzed outcomes. According to the noninferiority test, the use of Angio-Seal was noninferior to the radial approach, considering the margin of 15% (12.5 vs. 13.3%, difference -0.83%, 95% CI -9.31 - 7.65, P for noninferiority <0.001). CONCLUSIONS: Angio-Seal seems noninferior in the incidence of access site complications at 30 days when compared with the radial approach. © 2016 Wiley Periodicals, Inc.
Assuntos
Síndrome Coronariana Aguda/terapia , Cateterismo Cardíaco/métodos , Artéria Femoral , Hemorragia/prevenção & controle , Técnicas Hemostáticas/instrumentação , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Intervenção Coronária Percutânea/métodos , Artéria Radial , Dispositivos de Oclusão Vascular , Síndrome Coronariana Aguda/diagnóstico , Fatores Etários , Idoso , Brasil , Cateterismo Cardíaco/efeitos adversos , Desenho de Equipamento , Feminino , Hemorragia/sangue , Hemorragia/etiologia , Hemostasia , Técnicas Hemostáticas/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Intervenção Coronária Percutânea/efeitos adversos , Punções , Fatores de Tempo , Resultado do TratamentoRESUMO
Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS. (ClinicalTrials.gov: NCT04360720).
Assuntos
Síndrome Coronariana Aguda , Stents Farmacológicos , Intervenção Coronária Percutânea , Humanos , Inibidores da Agregação Plaquetária/uso terapêutico , Ticagrelor/uso terapêutico , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Cloridrato de Prasugrel/uso terapêutico , Intervenção Coronária Percutânea/efeitos adversos , Quimioterapia Combinada , Aspirina/uso terapêutico , Hemorragia/induzido quimicamente , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency. BACKGROUND: The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO. METHODS: The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 µg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound. RESULTS: A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO. CONCLUSIONS: The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).
Assuntos
Arteriopatias Oclusivas , Artéria Radial , Arteriopatias Oclusivas/diagnóstico por imagem , Arteriopatias Oclusivas/etiologia , Arteriopatias Oclusivas/prevenção & controle , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Humanos , Nitroglicerina/efeitos adversos , Estudos Prospectivos , Artéria Radial/diagnóstico por imagem , Espasmo/complicações , Espasmo/prevenção & controle , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to compare two hemostatic techniques, minimum pressure technique and patent hemostasis, on radial artery occlusion (RAO) after transradial catheterization. BACKGROUND: RAO is an infrequent complication of transradial procedures. One of the strategies used to reduce this complication is the patent hemostasis technique. Use of minimum pressure in hemostatic wristband, without monitoring patency, might have the same efficacy for preventing RAO. METHODS: This is a multicenter study encompassing patients submitted to transradial catheterization. After pneumatic wristband application, the band was deflated to the lowest allowable volume while preserving hemostasis. Radial artery patency was subsequently evaluated. The group with no return of plethysmographic curve was labeled "minimum pressure," and the group in which the signal returned was labeled "patent hemostasis." RAO was verified by Doppler evaluation within the first 24 hours of the procedure. RESULTS: A total of 1082 patients were enrolled, with mean age of 61.4 ± 10.4 years. The majority (61.0%) were male and 34.5% had diabetes. Patent hemostasis was achieved in only 213 cases (20%). Early RAO occurred in 16 patients (1.8%) in the minimum pressure group and in 4 patients (1.9%) in the patent hemostasis group (P=.97). No major bleeding was observed among the entire cohort. EASY scale for hematoma grade was similar between the cohorts (EASY grades 1-3: 7.0% in the minimum pressure group vs 7.5% in the patent hemostasis group; P=.96). CONCLUSION: Checking radial patency during hemostatic compression may not be necessary after the procedure when adopting a mild and short hemostatic compression.
Assuntos
Arteriopatias Oclusivas , Cateterismo Periférico , Técnicas Hemostáticas , Grau de Desobstrução Vascular , Idoso , Arteriopatias Oclusivas/diagnóstico , Arteriopatias Oclusivas/etiologia , Arteriopatias Oclusivas/prevenção & controle , Cateterismo Cardíaco/efeitos adversos , Feminino , Hemostasia , Humanos , Masculino , Pessoa de Meia-Idade , Punções/efeitos adversos , Artéria RadialRESUMO
Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS.
RESUMO
ABSTRACT: Objectives. The aim of this study was to compare two hemostatic techniques, minimum pressure technique and patent hemostasis, on radial artery occlusion (RAO) after trans-radial catheterization. Background. RAO is an infrequent complication of trans-radial procedures. One of the strategies used to reduce this complication is the patent hemostasis technique. Use of minimum pressure in hemostatic wristband, without monitoring patency, might have the same efficacy for preventing RAO. Methods. This is a multicenter study encompassing patients submitted to trans-radial catheterization. After pneumatic wristband application, the band was deflated to the lowest allowable volume while preserving hemostasis. Radial artery patency was subsequently evaluated. The group with no return of plethysmography curve was labeled "minimum pressure," and the group in which the signal returned was labeled "patent hemostasis." RAO was verified by Doppler evaluation within the first 24 hours of the procedure. Results. A total of 1082 patients were enrolled, with mean age of 61.4 ± 10.4 years. The majority (61.0%) were male and 34.5% had diabetes. Patent hemostasis was achieved in only 213 cases (20%). Early RAO occurred in 16 patients (1.8%) in the minimum pressure group and in 4 patients (1.9%) in the patent hemostasis group (P=.97). No major bleeding was observed among the entire cohort. EASY scale for hematoma grade was similar between the cohorts (EASY grades 1-3: 7.0% in the minimum pressure group vs 7.5% in the patent hemostasis group; P=.96). Conclusion. Checking radial patency during hemostatic compression may not be necessary after the procedure when adopting a mild and short hemostatic compression
Assuntos
Artéria Radial , Intervenção Coronária Percutânea , Hemostasia , CateterismoRESUMO
One limitation to transradial access (TRA) is the occurrence of spasms (RAS), for which the use of prophylactic medications is recommended. Improvement in TRA material combined with the increase in operators' expertise, might mitigate this benefit. We assess the effect of preventive nitroglycerin on RAS during TRA, evaluating the role of the operator's experience. Patients received 500 µg nitroglycerin or placebo. The operator's expertise was classified as: inexperienced (I), intermediate (M), and experienced (E). 2040 patients were included. Prophylactic use of nitroglycerin did not reduce RAS (10.8% vs. 13.4% (placebo), p = 0.07). RAS incidence was 14.5% in I, 12.5% in M, and 9.7% in E (p = 0.01). In group I, nitroglycerin reduced RAS (17.4% vs. 11.1%, p = 0.04), which was not observed in other groups. Overall, nitroglycerin does not prevent RAS, which is more common among inexperienced operators. More experienced operators could abolish preventive nitroglycerin use.
Assuntos
Humanos , Vasodilatadores , Nitroglicerina , Espasmo/epidemiologia , Cateterismo Cardíaco/efeitos adversos , Resultado do Tratamento , Artéria RadialRESUMO
OBJECTIVES: The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency. BACKGROUND: The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO. METHODS: The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 µg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound. RESULTS: A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed reestablishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO. Conclusions: The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).
Assuntos
Nitroglicerina , Artéria Radial , Ecocardiografia Doppler em CoresRESUMO
AIMS: The aim of this study was to investigate the angiographic and intravascular ultrasound (IVUS) findings of the Endeavor zotarolimus-eluting stent (ZES) in patients from a "real-world" clinical practice. METHODS AND RESULTS: From January to March 2006, 100 patients undergoing routine or emergency percutaneous intervention were prospectively enrolled at one institution. Overall, 39% of the patients were diabetics and 80.8% of lesions were type B2/C. A total of 140 lesions were successfully treated with 174 ZES, and procedural success was 98%. Mean vessel diameter was 2.69 mm and mean lesion length was 16.0 mm; at 6-month angiographic follow-up (completed in 96%), in-stent late lumen loss was 0.66 mm, and in-segment restenosis was 8.2%. Angiographic restenosis was increased among diabetics (15.5 vs. 2.6%, p=0.009), and diabetes was the only significant predictor of angiographic restenosis (OR=15.27 [95%CI 2.45-95.04], p=0.003). By IVUS (performed in 88% at 6-month), % volume obstruction was 14.4+/-13.4%, and there was no late acquired incomplete stent apposition (ISA). At 1-year, overall MACE rate was 6%, including 5 TLRs (4% of patients), with no occurrence of stent thrombosis. CONCLUSIONS: In this prospective "real-world" experience, the ZES demonstrated favourable angiographic and IVUS results in complex patients, with overall in-stent late lumen loss of 0.66 mm, and absence of late acquired ISA. At 1-year, there were no safety concerns including absence of death and stent thrombosis.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Angiografia Coronária , Doença da Artéria Coronariana/terapia , Reestenose Coronária/diagnóstico , Stents Farmacológicos , Sirolimo/análogos & derivados , Ultrassonografia de Intervenção , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/etiologia , Reestenose Coronária/mortalidade , Reestenose Coronária/prevenção & controle , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Medição de Risco , Fatores de Risco , Sirolimo/administração & dosagem , Trombose/etiologia , Trombose/prevenção & controle , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES:To compare the radial versus femoral approach using Angio-Seal for the incidence of access site complications among non-ST-segment elevation acute coronary syndrome patients undergoing invasive strategy. BACKGROUND: Arterial access is a major site of complications after invasive coronary procedures. Vascular closure devices provide more comfort to patients decreasing time to hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications. METHODS: Single-center non-inferiority trial where 240 patients were randomized to radial or femoral access using Angio-Seal. The primary objective was the occurrence of complications at the arterial puncture site until 30 days after the procedure...
Assuntos
Angioplastia , Síndrome Coronariana AgudaRESUMO
Introdução: Aposição incompleta (AI) é descrita após implante de stents farmacológicos (SF) e pode associar-se à trombose de stents. Em razão de diferentes plataformas, polímeros e fármacos utilizados, diferenças na eficácia e na segurança entre SF também são esperadas. Objetivo: Avaliar a incidência de AI persistente e tardia após implante de stents com sirolimus (SES) e com zotarolimus (ZES) e a evolução dos pacientes que apresentem essa alteração. Método: Análise de 242 pacientes tratados com SF (175 pacientes com SES Cypher® e 67 pacientes com ZES Endeavor) e submetidos a ultra-sonografia intracoronária após o implante e aos seis meses. Resultados: No grupo tratado com SES, 7 (4%) pacientes apresentaram AI tardia e 12 (6,8%), AI persistente. No grupo tratado com ZES, nenhum caso de AI tardia foi identificado e, em 4 pacientes, observou-se AI após o implante e que desapareceu aos seis meses. Nos pacientes com AI tardia, observou-se aumento evolutivo dos volumes do vaso (de 377,2 ± 148,9 mm3 para 431,9 ± 155,1 mm3; p = 0,51)e da placa (de 206,1 ± 51,5 mm3 para 236,9 ± 68,4 mm3; p = 0,36). O volume de hiperplasia intimal foi maior após ZES (16,6 ± 5,8 mm3 vs. 5,1 ± 5,5 mm3; p < 0,0001). Após nove meses, não ocorreram eventos cardíacos adversos nos pacientes com AI. Conclusão: A incidência de AI tardia foi de 2,9% e observada após SES. A presença de AI não esteve relacionada a eventos adversos a médio prazo.
Background: Incomplete stent apposition (ISA) has been documented after drug-eluting stents (DES) and could be related to stent thrombosis. Because DES differ in metal platform, polymer and pharmacological agent, differences in performance and safety are expected. Objective: We sought to investigate the frequency and clinical consequences of ISA after implantation of sirolimus- (SES) and zotarolimuseluting stents (ZES). Methods: 242 patients (pts) who underwent DES placement (175 pts with Cypher® and 67 pts with EndeavorTM stents) had serial intravascular ultrasound (IVUS) performed (at index procedure and after 6-months). Results: 7 pts (4%) had late-acquired ISA after SES. Another 12 (6.8%) pts treated with SES had persistent ISA. Among pts treated with ZES, none had late ISA and 4 had ISA observed after stent implantation that completely resolved at 6-months. There was an increase in vessel (377.2 ± 148.9 to 431.9 ± 155.1 mm3, p = 0.51) and in plaque volume (206.1 ± 51.53 to 236.91 ± 68.4 mm3, p=0.36) in pts with late ISA. Amount of neointimal hyperplasia was significantly higher in ZES than SES (16.6 ± 5.8 mm3 vs 5.1 ± 5.5 mm3, p < 0.0001). After 9 months, no adverse clinical event was observed in pts with ISA. Conclusion: Overall incidence of IVUS-detected late incomplete DES apposition was 2.9%, all after SES. The presence of ISA was not related to clinical adverse events during mid term follow-up.