RESUMO
OBJECTIVES: To propose a classification system for characterizing angiographic femoropopliteal artery restenosis patterns associated with common endovascular modalities. BACKGROUND: Peripheral artery disease is a worldwide issue affecting millions of people. Despite a myriad of endovascular technologies available to treat peripheral artery disease of the femoropopliteal arteries, restenosis remains a common failure mode. Characterizing common patterns of restenosis is important to discern the potential impact of baseline patient, lesion, and procedural characteristics, as well as treatment modalities on either the primary success or the failure patterns associated with restenosis. METHODS: Studies included in the analysis were from previous core laboratory-adjudicated femoropopliteal artery disease trials and registries reflecting a wide array of treatment modalities. RESULTS: From the subjects enrolled and analyzed, there were 403 total angiograms for analysis and adjudication. Target lesion revascularization images of the 32 validation cases were evaluated for index treated length, diameter stenosis, and lesion morphology characteristics. The following lesion types are proposed: Type 1 "Focal" pattern, which may be "Edge Proximal" or "Edge Distal" depending on location; a Type 2 "Multifocal" pattern which may also exhibit edge restenosis, but may also be "Edge Bilateral"; a Type 3 "Moderate" pattern and a Type 4 "Diffuse" pattern; and finally, a Type 5 "Occlusion". CONCLUSIONS: A classification system that enables healthcare professionals to anticipate and describe failures following the index procedure, thereby impacting the choice of options for retreatment, may facilitate consistency and standardization within the heterogeneous field of endovascular device treatments for the femoropopliteal artery.
Assuntos
Angiografia/métodos , Procedimentos Endovasculares/efeitos adversos , Artéria Femoral/diagnóstico por imagem , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Artéria Poplítea/diagnóstico por imagem , Consenso , Constrição Patológica , Humanos , Doença Arterial Periférica/classificação , Valor Preditivo dos Testes , Recidiva , Índice de Gravidade de Doença , Terminologia como Assunto , Resultado do TratamentoRESUMO
BACKGROUND: The provisional approach for bifurcation stenting with side-branch balloon angioplasty is associated with dissections and suboptimal results requiring kissing balloon techniques or bailout stenting. We hypothesized that using a scoring balloon for the side branch and a drug-eluting stent for the main vessel might improve outcomes of true bifurcation lesions. METHODS AND RESULTS: A total of 93 patients with complex bifurcations were enrolled in a multicenter, single-arm, prospective clinical trial. A drug-eluting stent was deployed in the main vessel following dilatation of the side-branch stenosis with a scoring balloon. The overall angiographic success rate was 93.5%, and procedural success rate was 91.4%. The final diameter stenosis was 13.9% ± 7.2% for the main vessel and 33.3% ± 22.9% for the side branch. Crossover to stent deployment in the side branch was required in 10.8%. The postscoring balloon dissection rate was 8.2% and 6% (all ≤ class C) for the main vessel and side branch respectively, which was reduced to 1.1 and 2.1% poststenting. At 9-month follow-up, the composite MACE rate [cardiac death, myocardial infarction, or target lesion revascularization (TLR)] was 5.4%, including a TLR rate of 3.3% (1.1% from hospital discharge to 9 months). CONCLUSION: The 9-month results of the AGILITY trial support a simple provisional strategy for treating complex true bifurcation lesions with deployment of a drug-eluting stent in the main vessel after dilatation of the side-branch vessel with a scoring balloon. This strategy was associated with excellent and safe procedural results, a low rate of crossover to side-branch stenting, and favorable outcomes.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Cateteres Cardíacos , Estenose Coronária/terapia , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Angiografia Coronária , Estenose Coronária/diagnóstico , Estenose Coronária/mortalidade , Trombose Coronária/etiologia , Stents Farmacológicos , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Estudos Prospectivos , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
BACKGROUND: With the changing health care environment, cost effectiveness is an important adjunct to clinical investigation when assessing new medical devices. This study presents an economic model to evaluate cost effectiveness of coronary stents. METHODS: Markov modeling was developed comparing total costs (Medicare payer perspective) between TAXUS Liberté and TAXUS Express based on 3-year clinical outcomes from the TAXUS ATLAS Small Vessel and Long Lesion trials. RESULTS: The TAXUS Liberté 2.25-mm stent provided cost savings relative to TAXUS Express from a payer perspective ($17,605 vs. $20,281), driven by reduced target vessel revascularization (0.16 events/patient vs. 0.33 events/patient). In probabilistic sensitivity analyses, TAXUS Liberté was less costly with fewer major adverse cardiac events in over 99% of parameter sets. The TAXUS Liberté Long (38 mm) stent was cost neutral relative to TAXUS Express from a payer perspective ($18,545 vs. $18,551) with fewer myocardial infarctions and cardiac deaths. Accounting for angiography-driven revascularizations, TAXUS Liberté 2.25 mm still provided cost savings relative to TAXUS Express ($16,822 vs. $19,139), although TAXUS Liberté Long was more expensive than TAXUS Express ($17,886 vs. $17,652). From a hospital perspective, TAXUS Liberté Long provided cost savings up to a price premium of $671/stent, driven by fewer stents employed per patient. CONCLUSIONS: This analysis confirms the utility of economic modeling in assessing new stent platforms. TAXUS Liberté 2.25 mm is economically dominant relative to TAXUS Express when treating small vessels. TAXUS Liberté Long is cost neutral to modestly more costly than TAXUS Express 2.25 mm from a payer perspective.
Assuntos
Doença da Artéria Coronariana/economia , Stents Farmacológicos/economia , Modelos Econômicos , Antineoplásicos Fitogênicos/uso terapêutico , Doença da Artéria Coronariana/terapia , Análise Custo-Benefício , Stents Farmacológicos/efeitos adversos , Humanos , Cadeias de Markov , Paclitaxel/uso terapêutico , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Despite successful primary percutaneous coronary intervention (PCI) for treatment of ST-segment elevation myocardial infarction (STEMI), myocardial salvage is frequently suboptimal resulting in large infarctions with increased rates of heart failure and death. Microvascular dysfunction after the procedure is frequently present and contributes directly to poor outcomes in STEMI. Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) is a novel technology designed to mitigate microvascular dysfunction in STEMI. Non-randomized studies have suggested that PiCSO use during primary PCI in STEMI is safe, improves microvascular perfusion and reduces infarct size. Randomized trials are ongoing to investigate the safety and effectiveness of PiCSO in high-risk patients with anterior STEMI undergoing primary PCI.
Assuntos
Seio Coronário , Intervenção Coronária Percutânea , Humanos , Seio Coronário/diagnóstico por imagem , Intervenção Coronária Percutânea/efeitos adversosRESUMO
BACKGROUND: The long-term impact of treating de novo coronary lesions in native vessels and challenging small vessel and long lesion subsets with TAXUS Liberté stents is unknown. This report examines the 3-year efficacy and safety from the TAXUS ATLAS program. METHODS AND RESULTS: TAXUS ATLAS WH, Small Vessel, and Long Lesion are non-randomized studies comparing TAXUS Liberté (n = 871), TAXUS Liberté 2.25 mm (n = 261), and TAXUS Liberté 38 mm (n = 150) stents, respectively, to case-matched TAXUS Express historical controls. TAXUS Liberté demonstrated comparable 3-year rates of major adverse cardiac events (19.0% vs. 20.2%, P = 0.51) in de novo lesions, reduced target lesion revascularization (TLR, 10.0% vs. 22.1%, P = 0.008) in small vessels, and reduced myocardial infarction (MI, 2.9% vs. 10.4%; P = 0.01) and stent thrombosis (ST, 0.0% vs. 3.9%, P = 0.03) in long lesions vs. TAXUS Express. After propensity score adjustment, no statistically significant effect of TAXUS Liberté on TLR (9.7% vs. 16.9%, P = 0.12) in small vessels or MI (2.9% vs. 7.9%, P = 0.05) in long lesions was noted, although reduced ST (0.0% vs. 2.7%, P = 0.02) remained in long lesions. Multivariate analyses demonstrated that TAXUS Liberté treatment significantly reduced TLR by 66% in small vessels, and MI by 75% in long lesions, vs. TAXUS Express. CONCLUSIONS: TAXUS Liberté suggests durable 3-year effectiveness in reducing restenosis and improved clinical outcomes in small vessels and long lesions compared with TAXUS Express.
Assuntos
Stents , Humanos , TaxusRESUMO
Percutaneous coronary intervention (PCI) is the most common method of coronary revascularization. Over time, as operator skills and technical advances have improved procedural outcomes, the length of stay (LOS) has decreased. However, standardization in the definition of LOS following PCI has been challenging due to significant physician, procedural, and patient variables. Given the increased focus on both patient safety as well as the cost of medical care, system process issues are a concern and provide a driving force for standardization while simultaneously maintaining the quality of patient care. This document: (1) provides a summary of the existing published data on same-day patient discharge following PCI, (2) reviews studies that developed methods to predict risk following PCI, and (3) provides clarification of the terms used to define care settings following PCI. In addition, a decision matrix is proposed for the care of patients following PCI. It is intended to provide both the interventional cardiologist as well as the facilities, in which they are associated, a guide to allow for the appropriate LOS for the appropriate patient who could be considered for early discharge or outpatient intervention.
Assuntos
Assistência Ambulatorial/normas , Angioplastia Coronária com Balão/normas , Tempo de Internação , Alta do Paciente/normas , Qualidade da Assistência à Saúde/normas , Assistência Ambulatorial/economia , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/economia , Competência Clínica , Protocolos Clínicos , Custos de Cuidados de Saúde , Instalações de Saúde/normas , Humanos , Reembolso de Seguro de Saúde , Tempo de Internação/economia , Observação , Alta do Paciente/economia , Qualidade da Assistência à Saúde/economia , Medição de Risco , Terminologia como Assunto , Resultado do TratamentoRESUMO
AIMS: This study sought to investigate the 2-year outcomes of patients treated with the paclitaxel-eluting TAXUS((R)) stent (PES) or vascular brachytherapy (VBT), the previous 'gold standard therapy', for bare metal stent in-stent restenosis (ISR). METHODS AND RESULTS: In the TAXUS V-ISR trial, 396 patients with bare metal stent ISR referred for percutaneous coronary intervention were prospectively randomized to either PES or beta source VBT. The present analysis reports 24-month clinical outcomes from that study. Between 9 and 24 months, ischaemia-driven target lesion revascularization tended to be required less frequently with assignment to PES compared to VBT (5.3 vs. 10.3%, P = .07). As a result, ischaemia-driven target lesion revascularization at 24 months was significantly reduced with PES compared with VBT (10.1 vs. 21.6%, P = 0.003), as was ischaemia-driven target vessel revascularization (18.1 vs. 27.5%, P = .03). There were no significant differences between the two groups with regard to death, myocardial infarction, or target vessel thrombosis either between 12 and 24 months, or cumulative to 24 months. CONCLUSION: Freedom from clinical restenosis at 2 years is significantly enhanced after PES placement compared with VBT for bare metal stent ISR, with similar rates of death, myocardial infarction, and target vessel thrombosis.
Assuntos
Braquiterapia , Reestenose Coronária/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Moduladores de Tubulina/administração & dosagem , Idoso , Reestenose Coronária/mortalidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Fatores de Risco , Resultado do TratamentoAssuntos
Angioplastia Coronária com Balão/normas , Cardiologia/normas , Aprovação de Equipamentos/normas , Fraude , Política de Saúde , Medicare/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Stents/normas , Angioplastia Coronária com Balão/instrumentação , Angioplastia Coronária com Balão/legislação & jurisprudência , Cardiologia/legislação & jurisprudência , Aprovação de Equipamentos/legislação & jurisprudência , Fraude/legislação & jurisprudência , Humanos , Medicare/legislação & jurisprudência , Relações Médico-Paciente , Desenvolvimento de Programas , Opinião Pública , Garantia da Qualidade dos Cuidados de Saúde/legislação & jurisprudência , Regionalização da Saúde , Sociedades Médicas , Confiança , Estados UnidosRESUMO
CONTEXT: Restenosis within bare-metal stents is often treated with repeat percutaneous coronary intervention, although subsequent recurrence rates are high, with vascular brachytherapy (VBT) affording the best results. The effectiveness of drug-eluting stents in this setting has not been established. OBJECTIVE: To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in patients with restenotic lesions after prior stent implantation in native coronary arteries. DESIGN, SETTING, AND PATIENTS: Prospective, multicenter, randomized trial conducted between June 6, 2003, and July 16, 2004, at 37 North American academic and community-based institutions in 396 patients with in-stent restenosis of a previously implanted bare-metal coronary stent (vessel diameter, 2.5-3.75 mm; lesion length, < or =46 mm). INTERVENTIONS: Patients were randomly assigned to undergo angioplasty followed by VBT with a beta source (n = 201) or paclitaxel-eluting stent implantation (n = 195). Clinical and angiographic follow-up at 9 months was scheduled in all patients. MAIN OUTCOME MEASURE: Ischemia-driven target vessel revascularization at 9 months. RESULTS: Diabetes mellitus was present in 139 patients (35.1%). Median reference vessel diameter was 2.65 mm and median lesion length was 15.3 mm. In the VBT group, new stents were implanted in 22 patients (10.9%) and in the paclitaxel-eluting stent group, multiple stents were required in 57 patients (29.2%), with median stent length of 24 mm. Follow-up at 9 months was complete in 194 patients in the VBT group and 191 patients in the paclitaxel-eluting stent group (96.5% and 97.9%, respectively). For VBT and paclitaxel-eluting stents, respectively, the number of events and 9-month rates for ischemic target lesion revascularization were 27 (13.9%) vs 12 (6.3%) (relative risk [RR], 0.45; 95% confidence interval [CI], 0.24-0.86; P = .01); for ischemic target vessel revascularization, 34 (17.5%) vs 20 (10.5%) (RR, 0.60; 95% CI, 0.36-1.00; P = .046); and for overall major adverse cardiac events, 39 (20.1%) vs 22 (11.5%) (RR, 0.57; 95% CI, 0.35-0.93; P = .02), with similar rates of cardiac death or myocardial infarction (10 [5.2%] vs 7 [3.7%]; RR, 0.71; 95% CI, 0.28-1.83; P = .48) and target vessel thrombosis (5 [2.6%] vs 3 [1.6%]; RR, 0.61; 95% CI, 0.15-2.50; P = .72). Angiographic restenosis at 9 months was 31.2% (53 of 170 patients) with VBT and 14.5% (25 of 172 patients) with paclitaxel-eluting stents (RR, 0.47; 95% CI, 0.30-0.71; P<.001). CONCLUSION: Treatment of bare-metal in-stent restenotic lesions with paclitaxel-eluting stents rather than angioplasty followed by VBT reduces clinical and angiographic restenosis at 9 months and improves event-free survival. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00287573.
Assuntos
Braquiterapia , Reestenose Coronária/terapia , Paclitaxel/administração & dosagem , Stents , Idoso , Angioplastia Coronária com Balão , Angiografia Coronária , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
OBJECTIVES: To investigate primary angioplasty (PA) for high-risk acute myocardial infarction (AMI) at hospitals with no cardiac surgery on-site (No SOS), we hypothesized that a nonrandomized registry of such patients treated with PA would show clinical outcomes similar to those of a group randomized to transfer for PA, and that reperfusion would occur faster. BACKGROUND: Primary angioplasty provides outcomes superior to fibrinolytic therapy in AMI, but its use in community hospitals with No SOS has been limited. METHODS: Fibrinolytic-eligible patients with high-risk AMI prospectively consented if they had one or more high-risk characteristic. Nineteen hospitals with No SOS prospectively enrolled 500 patients for PA on-site. Seventy-one similar Air Primary Angioplasty in Myocardial Infarction trial patients were randomized to transfer for PA. RESULTS: Primary angioplasty was performed in 88% of patients. Patients transferred for PA had a longer mean time to treatment (187 vs. 120 min; p < 0.0001). Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 was achieved in 96% for on-site PA, 86% in the transfer group (p = 0.004). The combined primary end point of 30-day mortality, re-infarction, and disabling stroke occurred in 27 (5%) on-site PA patients and 6 (8.5%) transfer patients (p = 0.27). Unadjusted one-year mortality was improved in on-site PA patients compared with those transferred (6% vs. 13%, p = 0.043), but after adjustment for differences in baseline variables, this difference was not significant. CONCLUSIONS: On-site PA and transfer groups had similar 30-day outcomes and more rapid reperfusion for on-site PA. Primary angioplasty in high-risk AMI patients at hospitals with No SOS is safe, effective, and faster than PA after transfer to a surgical facility.
Assuntos
Angioplastia Coronária com Balão/estatística & dados numéricos , Infarto do Miocárdio/terapia , Salas Cirúrgicas , Avaliação de Resultados em Cuidados de Saúde , Transferência de Pacientes/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Estudos Prospectivos , Sistema de Registros , Fatores de Tempo , Estados Unidos , Listas de EsperaRESUMO
Up to 5% of patients given heparin develop heparin-induced thrombocytopenia (HIT). These patients may need anticoagulation for acute coronary syndromes (ACS) or percutaneous coronary intervention (PCI), a clinical challenge given the limited alternatives. In a prospective, open-label study, we evaluated the safety and efficacy of bivalirudin in patients with HIT or HIT with thrombotic syndrome (HITTS) undergoing PCI. Patients aged 18 years were enrolled in 24 centers in 2 countries. Bivalirudin was given 5 minutes before PCI (1 mg/kg bolus; 2.5 mg/kg/hour infusion for 4 hours [high-dose group] or 0.75 mg/kg bolus; 1.75 mg/kg/hour infusion [low-dose group]). Clinical and hematological measures were assessed within 24 hours after starting bivalirudin, just before PCI, just before sheath removal, and 48 hours after treatment or at discharge, whichever occurred first. The primary endpoint was major bleeding 48 hours after discontinuation or until discharge, whichever occurred first. From July 1999 to February 2003, 52 patients were recruited. Procedural success (TIMI grade 3 flow and < 50% stenosis) was achieved in 98% of patients, and clinical success (absence of death, emergency bypass surgery, or Q-wave infarction) was achieved in 96%. One high-dose patient who underwent elective bypass surgery had major bleeding (1.9%; 95% CI: 0.05 10.65%), and 7 patients had minor bleeding. No patient had significant thrombocytopenia (platelet count < 50 109/L) after treatment. One patient in the low-dose group died from cardiac arrest ~46 hours after uncomplicated PCI. Bivalirudin appeared safe and provided effective anticoagulation during PCI. These data, and extensive experience with bivalirudin in PCI, support its use in high-risk patients with HIT requiring PCI.
Assuntos
Angioplastia Coronária com Balão/métodos , Anticoagulantes/uso terapêutico , Heparina/efeitos adversos , Hirudinas/análogos & derivados , Fragmentos de Peptídeos/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Trombocitopenia/induzido quimicamente , Idoso , Angina Instável/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/terapia , Estudos Prospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: To investigate the difference in neointimal hyperplasia (NIH) between ST-segment elevation myocardial infarction (STEMI), stable angina pectoris (SAP), and unstable angina pectoris (UAP). PATIENTS AND METHODS: From formal core laboratory intravascular ultrasound substudies, we compared NIH after paclitaxel-eluting stents (PES) or bare metal stents (BMS) in STEMI lesions from HORIZONS-AMI trial with SAP and UAP lesions from TAXUS IV, V, and ATLAS studies. RESULTS: At follow-up, %NIH at the minimum lumen area (MLA) site was less in STEMI (n=212) than in UAP (n=233) and SAP (n=440) lesions treated with PES (19.6 vs. 26.2 vs. 25.0%, P=0.002; all intravascular ultrasound data shown as least-square means in abstract) and less in STEMI (n=66) than in UAP (n=72) and SAP (n=143) lesions treated with BMS (34.0 vs. 26.7 vs. 45.5%, P=0.0003). As a result, MLA at follow-up was larger in STEMI than in UAP and SAP lesions treated with PES (5.9 vs. 5.2 vs. 5.0 mm, P<0.0001) or treated with BMS (5.1 vs. 4.3 vs. 4.0 mm, P=0.002). Net volume obstruction ([NIH/stent volume]×100) at follow-up was significantly less in STEMI than in UAP and SAP lesions treated with PES (7.8 vs. 13.4 vs. 13.4%, P<0.0001) or BMS (20.6 vs. 28.5 vs. 32.1%, P<0.0001). Multivariate linear regression analysis showed that STEMI was correlated independently and inversely with net volume obstruction compared with SAP (regression coefficient -6.99, P<0.0001) or UAP (regression coefficient -6.29, P<0.0001). CONCLUSION: Implantation of PES or BMS in STEMI compared with UAP and SAP was associated with less NIH.
Assuntos
Angina Estável/terapia , Angina Instável/terapia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Infarto do Miocárdio/terapia , Neointima/patologia , Idoso , Angina Estável/patologia , Angina Instável/patologia , Angiografia Coronária , Feminino , Humanos , Hiperplasia , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/patologia , Neointima/diagnóstico por imagem , Paclitaxel , Ensaios Clínicos Controlados Aleatórios como Assunto , Stents , Moduladores de Tubulina , Ultrassonografia de IntervençãoRESUMO
BACKGROUND: Previous studies have not addressed vessel response >5 mm distal to the stent edge. Therefore, we investigated the impact of paclitaxel-eluting stents (PES) versus bare metal stents (BMS) on distal vessels in the serial intravascular ultrasound substudies of TAXUS IV, V, and VI. METHODS AND RESULTS: TAXUS IV, V, and VI were double-blind, randomized, multicenter, controlled trials comparing PES with BMS. In their intravascular ultrasound substudies, 103 patients (54 BMS, 49 PES) had intravascular ultrasound data ≥10 mm distal to the stent both postprocedure and at 9 months follow-up. Baseline characteristics were similar between the 2 groups. Multilevel modeling was used to account for the variation between patients and within patients among distal segments. Effect of stent type, time, and their interaction was tested using a mixed effect model controlling for distal segments. Postprocedure lumen and vessel were not significantly different between PES versus BMS; however, lumen (P=0.006) and vessel (P=0.0001) were significantly reduced for BMS at 9-month follow-up but not for PES. Conversely, there was a significant plaque increase from postprocedure to 9-month follow-up for PES (P=0.0008) but not for BMS. These vessel responses were statistically consistent among 0- to 5-mm versus 5- to 10-mm versus 10- to 15-mm segments distal to the stent in both groups. CONCLUSIONS: PES use was associated with plaque increase from baseline to 9-month follow-up >5 mm distal to the stent along with positive remodeling, whereas BMS use was associated with negative remodeling and no plaque increase. These vessel responses were consistent in 5-mm long subsegments: 0 to 5 mm versus 5 to 10 mm versus 10 to 15 mm distal to the stent. CLINICAL TRIAL REGISTRATION: URL: HTTP://WWW.CLINICALTRIAL.GOV. Unique identifiers: TAXUS IV: NCT00292474; TAXUS V: NCT00301522; TAXUS VI: NCT00297804.
Assuntos
Implante de Prótese Vascular , Doença da Artéria Coronariana/tratamento farmacológico , Oclusão Coronária/tratamento farmacológico , Stents Farmacológicos/efeitos adversos , Paclitaxel/administração & dosagem , Complicações Pós-Operatórias/tratamento farmacológico , Idoso , Doença da Artéria Coronariana/patologia , Doença da Artéria Coronariana/cirurgia , Oclusão Coronária/patologia , Oclusão Coronária/cirurgia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Complicações Pós-Operatórias/patologia , Complicações Pós-Operatórias/cirurgia , Ultrassonografia de Intervenção , CicatrizaçãoRESUMO
The Integrity Coronary Stent System (Medtronic Vascular, CA, USA) is a low-profile, open-cell, cobalt-chromium-alloy advanced bare-metal iteration of the well-known Driver/Micro-Driver Coronary Stent System (Medtronic Vascular). The Integrity stent is made with a process called continuous sinusoid technology. This process allows stent construction via wrapping a single thin strand of wire around a mandrel in a sinusoid configuration, with laser fusion of adjacent crowns. The wire-forming process and fusion pattern provide the stent with a continuous preferential bending plane, intended to allow easier access to, and smoother tracking within, distal and tortuous vessels while radial strength is maintained. Continuous sinusoid technology represents innovation in the design of stent platforms and will provide a future stent platform for newer technology, including drug-eluting stent platforms, drug-filled stents and core wire stents.
Assuntos
Desenho de Prótese/métodos , Stents , Ligas de Cromo , Ensaios Clínicos como Assunto , HumanosRESUMO
OBJECTIVES: This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES). BACKGROUND: Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events. METHODS: Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss. RESULTS: At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015). CONCLUSIONS: Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).
Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Sirolimo/análogos & derivados , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Estudos Prospectivos , Desenho de Prótese , Medição de Risco , Fatores de Risco , Sirolimo/administração & dosagem , Trombose/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
Stent design, metal alloy composition, and strut thickness may influence late lumen loss and clinical outcomes after bare metal stent deployment; however, their impact on outcomes after drug-eluting stent deployment is unknown. Although the TAXUS Liberté and ION paclitaxel-eluting stents use similar polymer and drug, the ION stent incorporates a novel thin-strut platinum chromium metal alloy and cell design. We therefore compared patient-level data from 2,298 subjects enrolled into the TAXUS ATLAS (TAXUS Liberté) and PERSEUS (ION) clinical trials. Propensity-score (1:1) matching was performed to adjust for covariate imbalance between stent types. Twelve-month major adverse cardiac events were less frequent after use of the ION compared to the TAXUS Liberté (12.7% vs 8.3%, p <0.001, unadjusted; 12.0% vs 7.5%, p = 0.007, propensity matched) largely because of decreased non-Q-wave myocardial infarction (MI; 2.9% vs 1.4%, p = 0.01, unadjusted; 3.2% vs 0.9%, p = 0.004, propensity matched). The MI difference was predominantly periprocedural and in patients treated with a single stent. In conclusion, this exploratory post hoc analysis demonstrated that the ION was associated with fewer adverse clinical events than the TAXUS Liberté because of decreased non-Q-wave MI. Stent platform-related variables may influence clinical outcomes after drug-eluting stent use despite similar polymer and drug elution. Differences in adjunctive pharmacotherapy and/or stenting technique may also be contributory.
Assuntos
Reestenose Coronária/prevenção & controle , Stents Farmacológicos , Infarto do Miocárdio/prevenção & controle , Paclitaxel/administração & dosagem , Moduladores de Tubulina/administração & dosagem , Distribuição de Qui-Quadrado , Ensaios Clínicos como Assunto , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Desenho de Prótese , Medição de Risco , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: The objective of this intravascular ultrasound (IVUS) analysis was to evaluate the vascular response of the thin-strut TAXUS Liberté stent compared with the otherwise identical TAXUS Express stent. METHODS AND MATERIALS: The TAXUS ATLAS and TAXUS ATLAS Long Lesion studies are nonrandomized trials comparing the thin-strut TAXUS Liberté stent to historical TAXUS Express controls from the TAXUS IV and TAXUS V trials. A total of 377 patients enrolled in the two TAXUS ATLAS studies were randomly selected for the IVUS subset and compared to 314 TAXUS Express IVUS controls. RESULTS: Despite increased lesion complexity in the TAXUS Liberté group, neointimal formation at 9 months was similar in both stents (TAXUS Liberté 13.8±11.0%; TAXUS Express 13.1±13.8%, P=.56). However, this neointima covered more of the overall stent in the TAXUS Liberté (67.9±32.5%) compared with the TAXUS Express (54.4±37.2%, P<.001), suggesting more uniform neointimal distribution. TAXUS Liberté also showed less pronounced negative remodeling at both stent edges and had significantly less (4.3% vs. 9.6%, P=.04) late incomplete stent apposition (ISA). CONCLUSIONS: Despite identical polymer and drug release characteristic, the thin-strut TAXUS Liberté stent demonstrates improved neointimal coverage, better edge remodeling, and less late ISA vs. TAXUS Express, hereby highlighting the importance of the platform design for drug-eluting stents.
Assuntos
Reestenose Coronária/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Desenho de Prótese/métodos , Fármacos Cardiovasculares/administração & dosagem , Reestenose Coronária/prevenção & controle , Estenose Coronária/cirurgia , Vasos Coronários/efeitos dos fármacos , Vasos Coronários/cirurgia , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Estudos Prospectivos , Stents , Resultado do Tratamento , Túnica Íntima/diagnóstico por imagem , Túnica Íntima/efeitos dos fármacos , Ultrassonografia de Intervenção/métodosRESUMO
The incidence and predictors of major adverse cardiac events after percutaneous coronary intervention of saphenous vein grafts have not been evaluated in the era of routine embolic protection device (EPD) use and the current standards of antiplatelet therapy. The Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter System (AMEthyst) is the largest randomized trial of vein graft intervention comparing the Interceptor EPD and either the GuardWire or FilterWire EPD as the control. The baseline demographic, procedural, and clinical characteristics and the 30-day major adverse cardiac events ([MACE] death, myocardial infarction, and repeat revascularization [either surgery or percutaneous coronary intervention] of the target vessel) were recorded for 748 patients who had undergone vein graft intervention with distal embolic protection. At 30 days, MACE had occurred in 58 patients (7.8%). The univariate predictors of MACE at 30 days included plaque volume (odds ratio 1.005/mm(3), p <0.0001), target lesion length (odds ratio 1.046/mm, p <0.001), vein graft degeneration score (odds ratio 1.631, p = 0.001), coronary narrowing classification (odds ratio 1.697, p = 0.004), reference vessel diameter (odds ratio 1.689, p = 0.004), and male gender (odds ratio 2.406, p = 0.046) and was independent of device type (p = 0.74). The plaque volume was the most important and only multivariate predictor of MACE. The highest quartile of plaque volume defined a subset at particular risk, despite EPD use (MACE 15.8% vs 5.0%, p <0.001). In conclusion, in a patient population in which EPD and preprocedure thienopyridine therapy were uniformly implemented, MACE occurred with an incidence of 7.8% at 30 days. An increasing plaque volume was the most important determinant of MACE and defined a population at particular risk.
Assuntos
Estenose Coronária/cirurgia , Stents Farmacológicos , Embolia/prevenção & controle , Infarto do Miocárdio/epidemiologia , Revascularização Miocárdica/efeitos adversos , Veia Safena/transplante , Idoso , Clopidogrel , Angiografia Coronária , Estenose Coronária/diagnóstico por imagem , Embolia/epidemiologia , Embolia/etiologia , Feminino , Humanos , Incidência , Masculino , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/etiologia , Revascularização Miocárdica/métodos , Inibidores da Agregação Plaquetária/farmacologia , Prognóstico , Fatores de Risco , Taxa de Sobrevida , Ticlopidina/análogos & derivados , Ticlopidina/farmacologia , Estados Unidos/epidemiologiaRESUMO
OBJECTIVES: We conducted the "TAXUS Woman" analysis to assess the influence of sex on long-term outcomes after percutaneous coronary intervention using paclitaxel-eluting stents (PES) in a broad spectrum of patients. BACKGROUND: Previous studies indicate that the sex gap suggesting worse outcomes in women has narrowed. However, limited data are available on long-term sex-based outcomes with drug-eluting stents despite their extensive use in current practice. METHODS: We analyzed 2,271 PES-treated patients (women = 665), from 5 randomized trials and 7,492 PES-treated patients (women = 2,449) from 2 "real-world" registries. The trial and registry datasets were stratified by sex to compare long-term outcomes. Additionally, the outcomes in PES-treated women were compared with bare-metal stent-treated women (n = 395) in the randomized trials. RESULTS: In the randomized trials, PES-treated women had a lower target lesion revascularization (TLR) rate (11.5% vs. 22.6%, p < 0.001) than bare-metal stent-treated women, with no significant sex-based differences in death, myocardial infarction, stent thrombosis, or TLR through 5 years. In both the trials and the registries, although women had more adverse baseline characteristics including advanced age, hypertension, and diabetes, they had similar outcomes to men. In expanded-use patients, however, women showed significantly higher rates of death and TLR, although only the higher TLR rate was confirmed by multivariate analysis. CONCLUSIONS: This study of nearly 10,000 patients including more than 3,000 women demonstrates that despite their higher-risk profile, women have comparable benefits to men from percutaneous coronary intervention with PES except for a slightly higher revascularization rate in the high-risk cohort.
Assuntos
Angioplastia Coronária com Balão , Antineoplásicos Fitogênicos/uso terapêutico , Doença da Artéria Coronariana/tratamento farmacológico , Stents Farmacológicos , Paclitaxel/uso terapêutico , Idoso , Antineoplásicos Fitogênicos/administração & dosagem , Intervalos de Confiança , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/terapia , Reestenose Coronária/tratamento farmacológico , Reestenose Coronária/epidemiologia , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/epidemiologia , Paclitaxel/administração & dosagem , Distribuição de Poisson , Sistema de Registros , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to study the long-term clinical effects of routine angiographic follow-up and related reintervention after drug-eluting stenting. BACKGROUND: Prior stent trials have shown that protocol-mandated angiographic follow-up increases repeat interventions compared with clinical follow-up alone. The long-term clinical impact of this practice is unknown. METHODS: Long-term outcomes of patients assigned to routine angiographic follow-up in 3 large-scale TAXUS (Boston Scientific, Natick, Massachusetts) trials were compared with patients assigned to clinical follow-up alone, in a propensity score-adjusted patient-level meta-analysis. Outcomes were also compared in patients with treated versus untreated nonischemic intermediate lesions (quantitative angiographic stenosis between >or=40% and <70%) detected at angiographic follow-up. RESULTS: Target lesion revascularization (TLR) rates at 5 years were significantly higher in the angiographic compared with clinical follow-up cohort (18.3% vs. 11.1%, p < 0.001). This was due to more frequent treatment of intermediate lesions, but there was no associated reduction in rates of cardiac death or myocardial infarction (8.9% vs. 8.8%, p = 0.93). Of patients with nonischemic intermediate lesions, 17% who were not revascularized at the time of angiographic follow-up had a subsequent TLR, whereas 7% of patients who had TLR at this follow-up angiogram required additional revascularization during long-term follow-up. CONCLUSIONS: A strategy of routine angiographic follow-up increases oculostenotic revascularization of nonischemic intermediate lesions without affecting subsequent rates of cardiac death or myocardial infarction, and TLR was not required in 83% of those lesions. A conservative approach, in which repeat angiography is limited to patients with recurrent ischemia or progressive symptoms, minimizes repeat revascularization of nonischemic intermediate lesions and optimizes long-term event-free survival after drug-eluting stent implantation.