RESUMO

BACKGROUND: Assessment of the safety and clinical performance of the Sirolimus-Eluting Bioabsorbable Magnesium Scaffold (DREAMS 2G) from the combined analysis of BIOSOLVE- II and -III studies at 36 months. METHODS A total of 184 subjects have been enrolled in the BIOSOLVE-II and -III studies. Clinical follow-ups are scheduled at 1, 6, 12, 24, and 36 months plus 60 months for BIOSOLVE-II. Angiographies are planned at 6 months and voluntarily at 12 and 36 months in BIOSOLVE-II, and 1 angiography is mandatory at 12 months in the BIOSOLVE-III study. Dual antiplatelet therapy is recommended for a minimum of 6 months. The angiographic results are analyzed by an independent core laboratory and all clinical events were adjudicated by an independent clinical events committee. RESULTS A total of 117 men and 67 women with 189 lesions, mean age 65.5 _ 10.8 years, were enrolled at 18 sites in Europe, Brazil, and Singapore. Hypertension was presente in 79.3% of the subjects and 62% had hyperlipidemia. The mean lesion length was 12.6 _ 5.1 mm with a mean reference vessel diameter of 2.70 _ 0.43 mm. At 12 months, 97 patients had available angiographic follow-up. There was no difference in late lumen loss between the 2 studies; in the overall population, it was 0.25 _ 0.31 mm in-segment and 0.39 _ 0.34 mm in-scaffold. The target lesion failure (TLF) rate of the combined population was 3.3%, including 2 cardiac deaths (1.1%), 1 target vessel myocardial infarction (0.6%), and 3 clinically driven target lesion revascularizations (1.7%). The 36-month clinical data of BIOSOLVE- II study are available. Target lesion failure occurred in 8 patients (6.8%) and included 2 cardiac deaths (1.7%), 1 target vessel myocardial infarction (0.9%), and 5 clinically driven target lesion revascularizations (4.3%). No definite or probable scaffold thrombosis was observed. The 36- month clinical visits are ongoing for BIOSOLVE-III patients and data of the combined cohort will be available upon presentation. CONCLUSION The 36-month results of DREAMS 2G, meaning 2 years beyond the completion of resorption, are encouraging on safety and clinical performance standpoints. They will be presented for a larger population of subjects enrolled in the BIOSOLVE-II and -III studies. (AU)

Assuntos

Reestenose Coronária , Stents Farmacológicos

RESUMO

Introduction and objective: The edge vascular response (EVR) remains unknown in second generation drugeluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities. Methods: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. Results: The segment-level grayscale IVUS (n=10), virtual histology IVUS (n=10), and OCT (n=18) analysis did not showany significant changes after 12months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p=0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm2 (p = 0.012) and 2.49 ± 1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ± 0.48mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm2 (p = 0.023) and 0.17 ± 0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm2 (p = 0.045) in a distal frame. Conclusion: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process a the edges of the RMS. Summary: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imagingmodalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over timein the segment- and frame-level analysis of the 5mm segments proximal and distal of the actual RMS. As a result, after 12months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.

Assuntos

Humanos , Ultrassonografia de Intervenção , Tomografia de Coerência Óptica

RESUMO

OBJECTIVES: The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation. BACKGROUND: Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication. METHODS: The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated. RESULTS: The 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe. CONCLUSIONS: In the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years.

Assuntos

Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/análogos & derivados , Idoso , Ásia/epidemiologia , Austrália , Fármacos Cardiovasculares/efeitos adversos , Ensaios Clínicos como Assunto , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/epidemiologia , Quimioterapia Combinada , Europa (Continente)/epidemiologia , Medicina Baseada em Evidências , Feminino , Humanos , Incidência , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , América do Norte/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/administração & dosagem , Desenho de Prótese , Fatores de Risco , Sirolimo/administração & dosagem , Sirolimo/efeitos adversos , América do Sul/epidemiologia , Fatores de Tempo , Resultado do Tratamento

RESUMO

AIMS: To evaluate the rate of clinical events and bleeding risk according to age in patients undergoing percutaneous coronary intervention (PCI) with a new-generation drug-eluting stent (DES) enrolled in the RESOLUTE Global Clinical Program. METHODS: This study represents a pooled analysis of five trials included in the RESOLUTE program including 5,130 patients, of whom 1,675 (32.6%) were ≥70 years old (elderly patients). RESULTS: After adjusting for confounders, age ≥70 years was a significant predictor of high mortality at 30 days (0.6 vs. 0.1%, P = 0.017) and 2 years (7.2 vs. 2%, P < 0.001). No differences were seen with respect to acute myocardial infarction (MI) or target lesion and vessel revascularization rates between young and elderly patients. Bleeding rates were higher in the elderly throughout follow-up. In the elderly, 7 of the 27 (26%) patients with bleeding episodes died, with a median time between bleeding episode to death of 21 days. In the younger population, 1 patient of 17 with a bleeding episode died (400 days later). CONCLUSIONS: Elderly patients undergoing PCI with a new-generation DES have increased mortality and bleeding risk, with similar rates of acute MI and repeat revascularization. Bleeding risk was higher in the elderly and strongly related to death. Target lesion failure rates were not significantly different between the two age groups, suggesting that the Resolute zotarolimus-eluting stent (R-ZES) is effective for patients younger and older than 70 years of age. R-ZES may be recommended for elderly patients when PCI with a DES is identified as a suitable option.

Assuntos

Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/análogos & derivados , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Feminino , Hemorragia/etiologia , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/etiologia , Estudos Observacionais como Assunto , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Sirolimo/administração & dosagem , Fatores de Tempo , Resultado do Tratamento

RESUMO

BACKGROUND:Diabetes mellitus has worse outcome after percutaneous coronary intervention.AIM:We assessed stent thrombosis (ST), major adverse cardiac events (MACE), and major bleeding rates at 1 year after implantation of sirolimus-eluting stents (SES) in patients with diabetes mellitus in a large multicenter registry.METHODS:From May 2006 to April 2008, 15,147 unselected consecutive patients were enrolled at 320 centers in 56 countries in a prospective, observational registry after implantation of ≥ 1 SES. Source data were verified in 20% randomly chosen patients at > 100 sites. Adverse events were adjudicated by an independent Clinical Event Committee.RESULTS:Complete follow-up at 1 year was obtained in 13,693 (92%) patients, 4,577 (30%) of whom were diabetics. Within diabetics, 1,238 (9%) were insulin-treated diabetics (ITD). Diabetics were older (64 vs. 62 years, P < 0.001), with higher incidence of major coronary risk factors, co-morbidities, and triple-vessel coronary artery disease. Coronary lesions had smaller reference vessel diameter (2.88 ± 0.46 vs. 2.93 ± 0.45 mm, P < 0.001) and were more often heavily calcified (26.1% vs. 22.6%, P < 0.001). At 1 year, diabetics had higher MACE rate (6.8% vs. 3.9%, P < 0.001) driven by ITD (10.6% vs. 5.5%, P < 0.001). Finally, diabetics had significant increase in ST (1.7% vs. 0.7%, P < 0.001), principally owing to ITD (3.4% vs. 1.1%, P < 0.001). There was an overall low risk of major bleeding during follow-up, without significant difference among subgroups.CONCLUSIONS:In the e-SELECT registry, diabetics represented 30% of patients undergoing SES implantation and had significantly more co-morbidities and complex coronary lesions. Although 1-year follow-up documented good overall outcome in diabetics, higher ST and MACE rates were observed, mainly driven by ITD.

Assuntos

Diabetes Mellitus , Hemorragia/complicações , Intervenção Coronária Percutânea , Sirolimo , Stents , Trombose

RESUMO

Aims: Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomesof a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesiumscaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device. Methods and results: The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novolesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at6 months, and—if subjects consented—at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42patients: in-segment late lumen loss 0.20 + 0.21 mm vs. 0.25 + 0.22 mm, P » 0.117, D 0.05 + 0.21 mm (95%CI: 20.01;0.12); in-scaffold late lumen loss 0.37 + 0.25 mm vs. 0.39 +0.27 mm, P » 0.446, D 0.03 + 0.22 (95%CI: 20.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroboratedthe QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause,one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional eventoccurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienceda definite or probable scaffold thrombosis...

Assuntos

Doença da Artéria Coronariana , Magnésio , Sonhos , Stents

RESUMO

Background Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorb...

Assuntos

Implantes Absorvíveis , Stents

RESUMO

OBJECTIVES: We evaluated the safety and effectiveness of the Resolute™ zotarolimus-eluting stent (R-ZES) in real-world clinical practice through 3 years. BACKGROUND: A randomized comparison of the R-ZES and the XIENCE V™ everolimus-eluting stent showed no difference in any outcomes through 3-year follow-up in high-volume academic centers. RESOLUTE International is a confirmatory trial designed to evaluate the R-ZES in real-world clinical practice. METHODS: RESOLUTE International is a single arm, observational trial that enrolled 2,349 patients from 88 centers with only a few inclusion and exclusion criteria. The primary end-point was the composite of cardiac death and target vessel myocardial infarction (TV-MI) at 1 year. Secondary end-points include target lesion failure (TLF), target vessel revascularization (TVR), and their components, and stent thrombosis (ST). RESULTS: At 3 years 97.2% of patients completed clinical follow-up. The mean age was 63.4 ± 11.2 years, 77.8% were male, and 30.4% had diabetes. The average number of stents per patient was 1.6 ± 1.0; and mean stent length was 30.9 ± 20.5 mm. Dual antiplatelet therapy was used in 91.1% of patients at 1 year, 43.0% at 2 years, and 34.6% at 3 years. Cardiac death and TV-MI occurred in 161 patients (7.0%). There were 6 (0.3%) very late ST events for a total ST rate of 1.1% through 3 years. The rates of clinically driven target lesion revascularization (TLR), TVR, and TLF were 5.7%, 7.4%, and 11.4%, respectively. CONCLUSIONS: The safety and effectiveness of the R-ZES through 3 years in this real-world all-comer study was consistent with previously reported all-comer trials.

Assuntos

Stents Farmacológicos , Sirolimo/análogos & derivados , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/terapia , Estudos Prospectivos , Sirolimo/uso terapêutico , Resultado do Tratamento

RESUMO

AIMS: To provide clinical outcome data from everyday practice for the new generation Resolute zotarolimus-eluting stent (R-ZES). METHODS AND RESULTS: Patients were eligible if placement of ≥1 R-ZES was intended. There were no restrictions on clinical indication, number of treated vessels, and lesion characteristics. The primary endpoint was the adjudicated cumulative 1-year incidence of cardiac death and target vessel myocardial infarction. Twenty-five per cent of the patients were randomly selected for monitoring. We recruited 2,349 patients with 3,147 lesions (1.6±1.0 stents per patient); 46.0% of patients had acute coronary syndrome, 30.5% were diabetic, and ≥1 complex criterion for stent placement was present in 67.5% of patients. One-year follow-up was complete in 97.9% of patients. The 1-year incidence of the primary endpoint was 4.3% (95% CI: 3.5% to 5.2%) and for ARC definite and probable stent thrombosis, 0.9% (0.5% to 1.3%). Clinically driven target lesion revascularisation and target lesion failure were 3.4% (2.7% to 4.3%) and 7.0% (6.0% to 8.2%), respectively. These findings were consistent across all lesion and patient subsets analysed. There were no significant differences in outcomes between monitored and unmonitored patients. CONCLUSIONS: In everyday practice, the R-ZES performed similarly well as in the RESOLUTE All Comers randomised trial.

Assuntos

Angioplastia Coronária com Balão/métodos , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Infarto do Miocárdio/epidemiologia , Sirolimo/análogos & derivados , Idoso , Angioplastia Coronária com Balão/instrumentação , Argentina , Determinação de Ponto Final , Europa (Continente) , Feminino , Seguimentos , Humanos , Incidência , Índia , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , África do Sul , Taxa de Sobrevida , Resultado do Tratamento

RESUMO

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 Assunto

RESUMO

Objectives This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher SelectPlus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of baremetalstents (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, multicenterand international registry encompassing virtually all subsets of patients and lesions treated with atleast 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis allpatients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint wasmajor 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 myocardialinfarction (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 inpatients 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 lesionrevascularization recurrence and no apparent safety concern. (J Am Coll Cardiol Intv 2012;5:64–71) © 2012by the American College of Cardiology Foundation.

Assuntos

Sirolimo , Stents

RESUMO

OBJECTIVES: The aim of this study was to identify the worldwide practice of Cypher Select (Cordis Corporation, Bridgewater, New Jersey) or Cypher Select Plus sirolimus-eluting stent (SES) in patients 80 years of age (octogenarian) and to identify clinical outcomes in this patient population. BACKGROUND: The use of drug-eluting stents in elderly patients may have different features compared with younger patients. METHODS: Between 2006 and 2008, 15,147 patients from 320 hospitals in 56 countries were enrolled in a registry. Initial implantation and follow-up outcome information obtained at 1-year follow-up in 675 octogenarian patients were compared with those in 14,472 nonoctogenarian patients. RESULTS: Octogenarians had significantly more comorbidities and had higher Charlson comorbidity index scores (1.5 ± 1.6 vs. 1.0 ± 1.3, p < 0.001). Rates of cardiac death (3.3% vs. 0.9%, p < 0.001), myocardial infarction (2.3% vs. 1.9%, p = 0.021), and definite or probable stent thrombosis (2.3% vs. 0.9%, p = 0.0002), and major bleeding (2.0% vs. 0.9%, p = 0.015) were significantly higher in octogenarians at 1 year; however, there was no significant difference in the rate of target lesion revascularization between the 2 groups (3.2% vs. 2.2%, p = 0.12). In octogenarians, a high Charlson comorbidity index was an independent predictor of death and stent thrombosis up to 360 days from the index procedure (hazard ratio: 1.3, 95% confidence interval: 1.1 to 1.5, p < 0.001, and hazard ratio: 1.5, 95% confidence interval: 1.3 to 1.8, p < 0.001, respectively). CONCLUSIONS: Stenting with SES may be an effective therapeutic option in elderly patients, with acceptable rates of complications and a very low rate of repeat revascularization as demonstrated by this e-SELECT (A Multi-Center Post-Market Surveillance Registry) subgroup analysis.

Assuntos

Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Stents Farmacológicos , Sirolimo/administração & dosagem , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Austrália , Europa (Continente) , Feminino , Fibrinolíticos/uso terapêutico , Humanos , Internet , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , América do Norte , Seleção de Pacientes , Inibidores da Agregação Plaquetária/uso terapêutico , Vigilância de Produtos Comercializados , Modelos de Riscos Proporcionais , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , República da Coreia , Medição de Risco , Fatores de Risco , América do Sul , Trombose/etiologia , Fatores de Tempo , Resultado do Tratamento

RESUMO

Objectives The aim of this study was to identify the worldwide practice of Cypher Select (CordisCorporation, Bridgewater, New Jersey) or Cypher Select Plus sirolimus-eluting stent (SES) in patients80 years of age (octogenarian) and to identify clinical outcomes in this patient population.Background The use of drug-eluting stents in elderly patients may have different features comparedwith younger patients.Methods Between 2006 and 2008, 15,147 patients from 320 hospitals in 56 countries were enrolledin a registry. Initial implantation and follow-up outcome information obtained at 1-year follow-up in675 octogenarian patients were compared with those in 14,472 nonoctogenarian patients.Results Octogenarians had significantly more comorbidities and had higher Charlson comorbidityindex scores (1.5 1.6 vs. 1.0 1.3, p 0.001). Rates of cardiac death (3.3% vs. 0.9%, p 0.001),myocardial infarction (2.3% vs. 1.9%, p 0.021), and definite or probable stent thrombosis (2.3% vs.0.9%, p 0.0002), and major bleeding (2.0% vs. 0.9%, p 0.015) were significantly higher in octogenariansat 1 year; however, there was no significant difference in the rate of target lesion revascularizationbetween the 2 groups (3.2% vs. 2.2%, p 0.12). In octogenarians, a high Charlson comorbidityindex was an independent predictor of death and stent thrombosis up to 360 days from theindex procedure (hazard ratio: 1.3, 95% confidence interval: 1.1 to 1.5, p 0.001, and hazard ratio:1.5, 95% confidence interval: 1.3 to 1.8, p 0.001, respectively).Conclusions Stenting with SES may be an effective therapeutic option in elderly patients, with acceptablerates of complications and a very low rate of repeat revascularization as demonstrated bythis e-SELECT (A Multi-Center Post-Market Surveillance Registry) subgroup analysis. (J Am CollCardiol Intv 2011;4:982–91) © 2011 by the American College of Cardiology Foundation.

Assuntos

Doença da Artéria Coronariana , Doença das Coronárias , Hemorragia/complicações , Intervenção Coronária Percutânea , Sirolimo , Stents

RESUMO

Aims: Performing percutaneous coronary intervention (PCI) to multiple coronary lesions during the same procedurehas potential economic and social advantages. However comprehensive outcome data of real world practicein a large population is limited. We aimed to compare short- and long-term outcomes between patients with multivesselcoronary artery disease who either underwent single- or multivessel PCI within the e-SELECT registry.Methods and results: The e-SELECT registry combines data collected at 320 medical centres in 56 countrieswhere patients received CYPHER Select® or CYPHER Select® Plus sirolimus-eluting stent (SES). Rates of myocardialinfarction and major adverse cardiac event (MACE) (defined as any death, myocardial infarction or targetlesion revascularisation) were compared between patients undergoing single-vessel versus multivessel PCI. A totalof 15,147 patients who satisfied the inclusion criteria were included in the e-SELECT registry. Two thousand twohundred and seventy-eight (2,278) subjects (15%) underwent multivessel PCI and 12,869 (85%) had single-vesselPCI. The mean age was higher in the multivessel PCI group (63 vs. 62 years, p<0.001) and there was a higherprevalence of diabetes mellitus (32.4 vs. 30.0%, p=0.02). Lesions were more complex in the single-PCI groupwhile pre- and post-dilatation were less common in the multivessel PCI group. Myocardial infarction within thefirst 30 days post PCI was more common in the multivessel PCI group (1.9 vs. 0.8%, p<0.001) and most of theinfarctions were periprocedural (1.3 vs. 0.6%, p=0.001). Mortality and myocardial infarction at one-year werehigher in the multivessel PCI group resulting in a significantly higher MACE (6.1 vs. 4.6%, p=0.005)...

Assuntos

Reestenose Coronária , Revascularização Miocárdica , Stents Farmacológicos

RESUMO

Objectives The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) ina large, unselected population treated with sirolimus-eluting stents (SES).Background Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relativeincidence and predisposing factors among large populations treated worldwide are unclear.Methods The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidenceof: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with theSTEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelettherapy (DAPT) and to 1-year clinical outcomes.Results The mean age of the sample was 62 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index 3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliancewith DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse eventrates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlsonindex were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-causemortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%)experienced both MB and ST during the entire 1-year follow-up period.Conclusions In this worldwide population treated with 1 SES, the reported compliance with DAPT was good, and the incidenceof ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient.

Assuntos

Hemorragia/complicações , Stents Farmacológicos , Terapêutica , Trombose