RESUMO
Abstract Background: In multivessel disease patients with moderate stenosis, fractional flow reserve (FFR) allows the analysis of the lesions and guides treatment, and could contribute to the cost-effectiveness (CE) of non-pharmacological stents (NPS). Objectives: To evaluate CE and clinical impact of FFR-guided versus angiography-guided angioplasty (ANGIO) in multivessel patients using NPS. Methods: Multivessel disease patients were prospectively randomized to FFR or ANGIO groups during a 5 year-period and followed for < 12 months. Outcomes measures were major adverse cardiac events (MACE), restenosis and CE. Results: We studied 69 patients, 47 (68.1%) men, aged 62.0 ± 9.0 years, 34 (49.2%) in FFR group and 53 (50.7%) in ANGIO group, with stable angina or acute coronary syndrome. In FFR, there were 26 patients with biarterial disease (76.5%) and 8 (23.5%) with triarterial disease, and in ANGIO, 24 (68.6%) with biarterial and 11 (31.4%) with triarterial disease. Twelve MACEs were observed - 3 deaths: 2 (5.8%) in FFR and 1 (2.8%) in ANGIO, 9 (13.0%) angina: 4(11.7%) in FFR and 5(14.2%) in ANGIO, 6 restenosis: 2(5.8%) in FFR and 4 (11.4%) in ANGIO. Angiography detected 87(53.0%) lesions in FFR, 39(23.7%) with PCI and 48(29.3%) with medical treatment; and 77 (47.0%) lesions in ANGIO, all treated with angioplasty. Thirty-nine (33.3%) stents were registered in FFR (0.45 ± 0.50 stents/lesion) and 78 (1.05 ± 0.22 stents/lesion) in ANGIO (p = 0.0001), 51.4% greater in ANGIO than FFR. CE analysis revealed a cost of BRL 5,045.97 BRL 5,430.60 in ANGIO and FFR, respectively. The difference of effectiveness was of 1.82%. Conclusion: FFR reduced the number of lesions treated and stents, and the need for target-lesion revascularization, with a CE comparable with that of angiography.
Resumo Fundamentos: Em pacientes multiarteriais e lesões moderadas, a reserva de fluxo fracionada (FFR) avalia cada lesão e direciona o tratamento, podendo ser útil no custo-efetividade (CE) de implante de stents não farmacológicos (SNF). Objetivos: Avaliar CE e impacto clínico da angioplastia + FFR versus angioplastia + angiografia (ANGIO), em multiarteriais, utilizando SNF. Métodos: pacientes com doença multiarteriais foram randomizados prospectivamente durante ±5 anos para FFR ou ANGIO, e acompanhados por até 12 meses. Foram avaliados eventos cardíacos maiores (ECAM), reestenose e CE. Resultados: foram incluídos 69 pacientes, 47(68,1%) homens, 34(49,2%) no FFR e 35(50,7%) no ANGIO, idade 62,0 ± 9,0 anos, com angina estável e Síndrome Coronariana Aguda estabilizada. No FFR, havia 26 com doença (76,5%) biarterial e 8 (23,5%) triarterial, e no grupo ANGIO, 24(68,6%) biarteriais e 11(31,4%) triarteriais. Ocorreram 12(17,3%) ECAM - 3(4,3%) óbitos: 2(5,8%) no FFR e 1(2,8%) no ANGIO, 9(13,0%) anginas, 4(11,7%) no FFR e 5(14,2%) no ANGIO, 6 reestenoses: 2(5,8%) no FFR e 4 (11,4%) no ANGIO. Angiografia detectou 87(53,0%) lesões no FFR, 39(23,7%) com ICP e 48(29,3%) com tratamento clínico; e 77(47,0%) lesões no ANGIO, todas submetidas à angioplastia. Quanto aos stents, registrou-se 39(33,3%) (0,45 ± 0,50 stents/lesão) no FFR e 78(66,6%) (1,05 ± 0,22 stents/lesão) no ANGIO (p = 0,0001); ANGIO utilizou 51,4% a mais que o FFR. Análise de CE revelou um custo de R$5045,97 e R$5.430,60 nos grupos ANGIO e FFR, respectivamente. A diferença de efetividade foi 1,82%. Conclusões: FFR diminuiu o número de lesões tratadas e de stents e necessidade de revascularização do vaso-alvo, com CE comparável ao da angiografia.
Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Angioplastia Coronária com Balão/métodos , Angiografia Coronária/métodos , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Síndrome Coronariana Aguda/terapia , Angina Estável/terapia , Fatores de Tempo , Angioplastia Coronária com Balão/economia , Stents , Estudos Prospectivos , Resultado do Tratamento , Angiografia Coronária/economia , Análise Custo-Benefício , Estatísticas não Paramétricas , Reestenose Coronária/mortalidade , Reestenose Coronária/terapia , Estimativa de Kaplan-Meier , Síndrome Coronariana Aguda/economia , Síndrome Coronariana Aguda/patologia , Angina Estável/economia , Angina Estável/mortalidadeRESUMO
BACKGROUND: In multivessel disease patients with moderate stenosis, fractional flow reserve (FFR) allows the analysis of the lesions and guides treatment, and could contribute to the cost-effectiveness (CE) of non-pharmacological stents (NPS). OBJECTIVES: To evaluate CE and clinical impact of FFR-guided versus angiography-guided angioplasty (ANGIO) in multivessel patients using NPS. METHODS: Multivessel disease patients were prospectively randomized to FFR or ANGIO groups during a 5 year-period and followed for < 12 months. Outcomes measures were major adverse cardiac events (MACE), restenosis and CE. RESULTS: We studied 69 patients, 47 (68.1%) men, aged 62.0 ± 9.0 years, 34 (49.2%) in FFR group and 53 (50.7%) in ANGIO group, with stable angina or acute coronary syndrome. In FFR, there were 26 patients with biarterial disease (76.5%) and 8 (23.5%) with triarterial disease, and in ANGIO, 24 (68.6%) with biarterial and 11 (31.4%) with triarterial disease. Twelve MACEs were observed - 3 deaths: 2 (5.8%) in FFR and 1 (2.8%) in ANGIO, 9 (13.0%) angina: 4(11.7%) in FFR and 5(14.2%) in ANGIO, 6 restenosis: 2(5.8%) in FFR and 4 (11.4%) in ANGIO. Angiography detected 87(53.0%) lesions in FFR, 39(23.7%) with PCI and 48(29.3%) with medical treatment; and 77 (47.0%) lesions in ANGIO, all treated with angioplasty. Thirty-nine (33.3%) stents were registered in FFR (0.45 ± 0.50 stents/lesion) and 78 (1.05 ± 0.22 stents/lesion) in ANGIO (p = 0.0001), 51.4% greater in ANGIO than FFR. CE analysis revealed a cost of BRL 5,045.97 BRL 5,430.60 in ANGIO and FFR, respectively. The difference of effectiveness was of 1.82%. CONCLUSION: FFR reduced the number of lesions treated and stents, and the need for target-lesion revascularization, with a CE comparable with that of angiography.
Assuntos
Síndrome Coronariana Aguda/terapia , Angina Estável/terapia , Angioplastia Coronária com Balão/métodos , Angiografia Coronária/métodos , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Síndrome Coronariana Aguda/economia , Síndrome Coronariana Aguda/patologia , Idoso , Angina Estável/economia , Angina Estável/mortalidade , Angioplastia Coronária com Balão/economia , Angiografia Coronária/economia , Reestenose Coronária/mortalidade , Reestenose Coronária/terapia , Análise Custo-Benefício , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estatísticas não Paramétricas , Stents , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). OBJECTIVE: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. METHODS: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. RESULTS: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). CONCLUSION: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings.
Assuntos
Síndrome Coronariana Aguda/terapia , Angioplastia Coronária com Balão/instrumentação , Reestenose Coronária/terapia , Stents Farmacológicos , Paclitaxel/uso terapêutico , Síndrome Coronariana Aguda/mortalidade , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/métodos , Materiais Revestidos Biocompatíveis , Reestenose Coronária/mortalidade , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Desenho de Prótese , Reprodutibilidade dos Testes , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Estatísticas não Paramétricas , Fatores de Tempo , Resultado do TratamentoRESUMO
Abstract Background: The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). Objective: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. Methods: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. Results: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). Conclusion: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings.
Resumo Fundamento: O papel de balões farmacológicos (BFs) no tratamento de reestenose intra-stent (RIS) não está bem definido, particularmente em na síndrome coronária aguda (SCA). Objetivo: Comparar desfechos clínicos do uso de BF com stents farmacológicos (SFs) de segunda geração no tratamento de RIS em uma população real com alta prevalência de SCA. Métodos: Foi realizada uma análise retrospectiva de pacientes consecutivos com RIS tratados com um BF comparados a pacientes tratados com SF de segunda geração. O desfecho primário incluiu eventos cardiovasculares adversos importantes (morte por todas as causas, infarto do miocárdio não fatal, e revascularização da lesão alvo). As comparações foram realizadas pelo modelo proporcional de riscos de Cox ajustado e análise de Kaplan-Meier com log-rank. Resultados: A coorte incluiu 91 pacientes tratados com BF e 89 pacientes tratados com um SF (75% com SCA). O tempo mediano de acompanhamento foi de 26 meses. Eventos cardiovasculares adversos importantes ocorreram em 33 pacientes (36%) no grupo BF, e em 17 (19%) no grupo SF (p log-rank = 0,02). Após ajuste multivariado, não houve diferença significativa entre os grupos (HR para BF = 1,45 [IC95%: 0,75-2,83]; p = 0,27). As taxas de mortalidade de 1 ano foram 11% com BF, e 3% com SF (p = 0,04; HR ajustado = 2,85 [IC95%: 0,98-8,32; p = 0,06). Conclusão: Em uma população com alta prevalência de SCA, observou-se um aumento não significativo nas taxas de eventos cardiovasculares adversos importantes com o uso de BF comparado ao uso de SF de segunda geração para o tratamento de RIS, principalmente pelo aumento na taxa de mortalidade. É necessário um ensaio clínico controlado, randomizado, com poder estatístico adequado para confirmar esses achados.
Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Angioplastia Coronária com Balão/instrumentação , Paclitaxel/uso terapêutico , Reestenose Coronária/terapia , Síndrome Coronariana Aguda/terapia , Stents Farmacológicos/efeitos adversos , Desenho de Prótese , Fatores de Tempo , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/métodos , Análise Multivariada , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Estatísticas não Paramétricas , Medição de Risco , Materiais Revestidos Biocompatíveis , Reestenose Coronária/mortalidade , Estimativa de Kaplan-Meier , Síndrome Coronariana Aguda/mortalidadeRESUMO
In-stent restenosis (ISR) remains a concern even in the drug-eluting stent (DES) era and carries a high risk of recurrence. Brachytherapy is being used as an alternative treatment for resistant ISR, yet the safety and efficacy of this approach has not been well studied. We analyzed the outcomes of 101 patients who underwent coronary brachytherapy for resistant DES ISR. Baseline demographic, clinical, procedural, and outcome data were collected by phone and from electronic records. Comorbidities and overt cardiovascular disease were highly prevalent. Median previous stent layers were 2 with a maximum of 5 layers. Procedural angiographic success rate was 97% and median time to discharge was 1 day after brachytherapy. The primary outcome of target vessel revascularization was 24% at 1 year, 32% at 2 years, and 42% at 3 years. The rate of nonfatal myocardial infarction was 0% at 1 year, 3.5% at 2 years, and 6% at 3 years. The rate of all-cause mortality was 8.5% at 1 year, 12% at 2 years, and 16% at 3 years. We observed only 1 case of late stent thrombosis. After multivariable adjustment, female gender (hazard ratio 2.37, 95% confidence interval 1.02 to 5.52, p = 0.04) and diffuse ISR pattern (hazard ratio 2.95, 95% confidence interval 1.21 to 7.17, p = 0.01) were independently associated with the primary outcome. In conclusion, brachytherapy is feasible for the treatment of resistant DES ISR and is associated with high immediate procedural success and reasonable efficacy in a complex patient population. This approach might be used as an alternative for these patients.
Assuntos
Braquiterapia/métodos , Reestenose Coronária/radioterapia , Stents Farmacológicos/efeitos adversos , Oclusão de Enxerto Vascular/radioterapia , Intervenção Coronária Percutânea/efeitos adversos , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/cirurgia , Reestenose Coronária/diagnóstico , Reestenose Coronária/mortalidade , Vasos Coronários , Feminino , Seguimentos , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/mortalidade , Humanos , Masculino , Massachusetts/epidemiologia , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Tomografia de Coerência Óptica , Resultado do Tratamento , Ultrassonografia de IntervençãoRESUMO
BACKGROUND: Clinical in-stent restenosis (CISR) is the main limitation of coronary angioplasty with stent implantation. OBJECTIVE: Describe the clinical and angiographic characteristics of CISR and the outcomes over a minimum follow-up of 12 months after its diagnosis and treatment. METHODS: We analyzed in 110 consecutive patients with CISR the clinical presentation, angiographic characteristics, treatment and combined primary outcomes (cardiovascular death, nonfatal acute myocardial infarction [AMI]) and combined secondary (unstable angina with hospitalization, target vessel revascularization and target lesion revascularization) during a minimal follow-up of one year. RESULTS: Mean age was 61 ± 11 years (68.2% males). Clinical presentations included acute coronary syndrome (ACS) in 62.7% and proliferative ISR in 34.5%. CISR was treated with implantation of drug-eluting stents (DES) in 36.4%, Bare Metal Stent (BMS) in 23.6%, myocardial revascularization surgery in 18.2%, balloon angioplasty in 15.5% and clinical treatment in 6.4%. During a median follow-up of 19.7 months, the primary outcome occurred in 18 patients, including 6 (5.5%) deaths and 13 (11.8%) AMI events. Twenty-four patients presented a secondary outcome. Predictors of the primary outcome were CISR with DES (HR = 4.36 [1.44-12.85]; p = 0.009) and clinical treatment for CISR (HR = 10.66 [2.53-44.87]; p = 0.001). Treatment of CISR with BMS (HR = 4.08 [1.75-9.48]; p = 0.001) and clinical therapy (HR = 6.29 [1.35-29.38]; p = 0.019) emerged as predictors of a secondary outcome. CONCLUSION: Patients with CISR present in most cases with ACS and with a high frequency of adverse events during a medium-term follow-up.
Assuntos
Reestenose Coronária/mortalidade , Reestenose Coronária/terapia , Revascularização Miocárdica/métodos , Intervenção Coronária Percutânea/métodos , Stents , Síndrome Coronariana Aguda/etiologia , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Angina Pectoris/etiologia , Angina Pectoris/mortalidade , Angina Pectoris/terapia , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Métodos Epidemiológicos , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. BACKGROUND: There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. METHODS: The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. RESULTS: Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). CONCLUSIONS: Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern.
Assuntos
Angioplastia Coronária com Balão , Reestenose Coronária/prevenção & controle , Stents Farmacológicos/estatística & dados numéricos , Imunossupressores/uso terapêutico , Sirolimo/uso terapêutico , Reestenose Coronária/mortalidade , Bases de Dados Factuais , Stents Farmacológicos/efeitos adversos , Europa (Continente) , Feminino , Indicadores Básicos de Saúde , Humanos , Internacionalidade , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Vigilância de Produtos Comercializados , Sistema de Registros , Estatística como AssuntoRESUMO
AIMS: Drug-eluting stents (DES) have become the first choice to treat BMS restenosis (ISR), replacing brachytherapy and all other available percutaneous approaches. Although markedly reduced, DES ISR still occurs and has been frequently treated with another DES, despite the lack of robust data supporting the safety and efficacy of this approach. We sought to compare the long term clinical outcomes of patients with BMS and DES ISR treated with another DES deployment. METHODS AND RESULTS: Between May 2002 and January 2008 a total of 158 patients with BMS restenosis and 58 patients with DES restenosis were treated with a DES and enrolled in this registry. Primary endpoint included the cumulative occurrence of major adverse cardiac events (MACE=cardiac death, myocardial infarction and target-vessel revascularisation) and stent thrombosis. Baseline clinical aspects did not significantly differ between the groups. There was a trend toward a higher incidence of DM in the DES cohort (36.1% vs. 32.9%, p=0.1). Mean time between first procedure and restenosis was significant longer in the DES population (178+/-61 days vs. 140+/-38 days, p=0.02). At the end of the follow-up period, 92.6% of the patients with BMS-ISR and 86.3% of those with DES-ISR were free of MACE (p<0.001). Patients with DES ISR had significant more recurrence of ISR but equivalent rates of cardiac death, MI and stent thrombosis. CONCLUSIONS: Percutaneous treatment of BMS or DES ISR with the implant of a DES represents a simple and safe approach with sustained long term results. However, the relatively high rate of ISR recurrence among patients with prior DES ISR demand the developing of more effective strategies for that subset of individuals.
Assuntos
Reestenose Coronária/epidemiologia , Stents Farmacológicos/efeitos adversos , Metais/efeitos adversos , Idoso , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/mortalidade , Vasos Coronários/patologia , Stents Farmacológicos/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Taxa de Sobrevida , Sobreviventes , Trombose/epidemiologia , Fatores de Tempo , Resultado do Tratamento , VasodilataçãoRESUMO
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
AIMS: Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown. METHODS AND RESULTS: Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios. CONCLUSIONS: A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions.