RESUMO

BACKGROUND The optimal duration of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) varies based on ischemic and high bleeding risk (HBR) factors. METHODS Onyx ONE Clear was a prospective, global, multicenter study to assess the safety and effectiveness of 1-month DAPT in patients with HBR treated with Resolute Onyx zotarolimus-eluting stents (ZES). Patients with coronary artery disease and at least 1 HBR criterion were enrolled and prescribed DAPT for 1 month post-ZES implantation, followed by single antiplatelet therapy (SAPT) thereafter. The primary endpoint was composite of cardiac death or myocardial infarction (MI) from 1 month to 1 year. The current analysis presents final 2-year results from the study. RESULTS A total of 1,507 patients were analyzed at 2 years. Mean age was 74.0 9.5 years, 32.2% female, 38.8% with type 2 diabetes, 36.0% with previous revascularization, and 48.7% presented with an acute coronary syndrome. Patients were enrolled with mean 1.6 HBR criteria and 44.6% met 2 HBR criteria. Lesion characteristics included 50.0% moderate-to-severe calcification and 78.5% B2/C lesions. At 2 years, 81.1% of patients remained on SAPT, 5.6% received DAPT, and 12.5% were prescribed oral anticoagulation only. The composite of cardiac death or MI between 1 month and 2 years was 11.7%, with rates of 5.3% for cardiac death and 7.4% for MI. Most MIs were non-Q wave (6.7%). Rates of other secondary endpoints between 1 month and 2 years included 0.9% definite or probable stent thrombosis, 13.0% targetlesion failure, 4.7% clinically driven target-lesion revascularization, 2.6% stroke, and 6.2% Bleeding Academic Research Consortium (BARC) 3 to 5 bleeding events (Table 1). CONCLUSION Among patients with HBR treated with Resolute Onyx DES and SAPT after 1 month, 2-year ischemic event rates were acceptable despite an ongoing risk of major bleeding.

Assuntos

Inibidores da Agregação Plaquetária , Intervenção Coronária Percutânea

RESUMO

BACKGROUND: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients. METHODS: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention. RESULTS: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001). CONCLUSIONS: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention.

Assuntos

Stents Farmacológicos , Risco , Intervenção Coronária Percutânea

RESUMO

BACKGROUND Safety and effectiveness outcomes were examined at 1 year among high bleeding risk (HBR) patients treated with 1 month of dual antiplatelet therapy (DAPT) following PCI with zotarolimus eluting stents (ZES) (Resolute Onyx, Medtronic, Santa Rosa, Califor nia) according to lesion complexity (Table). METHODS The 1-year clinical outcomes were evaluated in HBR pa tients treated with ZES who were event-free following 1-month DAPT post-procedure with planned single antiplatelet therapy thereafter. Propensity score adjustment was performed to account for baseline differences (Table). RESULTS A total of 1,506 patients were stratified by complex (n » 395) or noncomplex (n » 1,111) PCI criteria (Table). Complex patients were more frequently men (72.2% vs. 66.1%; p » 0.03) and had higher rates of prior myocardial infarction (MI) (34.4% vs. 23.4%), prior CABG (24.1% vs. 8.9%), multivessel disease (78.2% vs. 39.8%), and B2/C lesion classification (84.2% vs. 75.6%), all p < 0.001. Complex patients had more lesions treated (1.7 vs. 1.2), longer stent length per patient (65.1 mm vs. 26.9 mm), and longer procedure time (58.8 min vs. 35.3 min), all p < 0.001. Procedural success was higher among noncomplex patients (90.8% vs. 82.0%; p < 0.001). In unadjusted analysis, the rate of MI was higher in patients with complex lesions (p » 0.04). How ever, no significant differences in any outcomes between patients with and without complex lesions were present after propensity score adjustment (Table). CONCLUSION Despite greater anatomic and procedural complexity, similar safety and effectiveness were observed in complex and noncomplex patients treated with 1-month DAPT following PCI with Resolute Onyx ZES after propensity score adjustment. These findings support 1-month DAPT among selected HBR patients undergoing PCI with Resolute Onyx ZES irrespective of lesion and procedural complexity.

Assuntos

Stents , Infarto do Miocárdio

RESUMO

BACKGROUND The Onyx ONE and Onyx ONE CLEAR studies demonstrated favorable safety and effectiveness in patients at high bleeding risk (HBR) who were event-free 1 month following Resolute Onyx zotarolimus-eluting stent (ZES) implantation and were then treated with single antiplatelet therapy (SAPT) through to 1 year. The present analysis assessed outcomes in patients with versus without history of atrial fibrillation (AF) in whom oral anticoagulant (OAC) use is common. METHODS HBR patients who were event-free at 1 month were sepa rated into 2 groups according to history of AF. Clinical outcomes be tween 1 and 12 months were assessed. RESULTS Among 1,506 patients who were event-free at 1 month in whom treatment with SAPT was intended, 536 (35.6%) had a history of AF and 970 (64.4%) did not. The mean number of HBR criteria at enrollment was 1.7 for AF compared with 1.5 for non-AF patients (p < 0.001). AF patients were more likely to be men (73% vs. 65%; p » 0.001), were more likely to have had prior PCI (34% vs. 28%; p » 0.03) or CABG (16% vs. 11%; p » 0.003), and were more likely taking OACs (80.6% vs. 10.6%; p < 0.001). At 1 year, 89% of AF and non-AF patients were taking SAPT (p » 1.00), although 85.8% of AF patients and 12.4% of non-AF patients were taking OAC (p < 0.001). Ischemic event rates were similar between AF and non-AF groups: target lesion failure (8.5% vs. 7.9%), cardiac death (2.8% vs. 2.5%), myocardial infarction (4.7% vs. 4.9%), target lesion revascularization (2.8% vs. 3.6%), and definite/probable stent thrombosis (0.4% vs. 0.8%), all p > 0.05. BARC 2 to 5 (16.0% vs. 9.4%) bleeding events were higher for AF compared with non-AF patients (p < 0.001) driven by BARC 2 bleeding; BARC 3 to 5 events were similar (4.5% vs. 3.7%; p » 0.49). CONCLUSION After Resolute Onyx ZES implantation in HBR patients and intended treatment of SAPT after 1 month, despite differences in baseline characteristics, ischemic events were similar but moderate bleeding events were higher in patients with versus without a history of AF. Further studies are warranted to optimize management of AF patients post-stenting to minimize the bleeding.

Assuntos

Fibrilação Atrial , Hemorragia/complicações , Stents Farmacológicos

RESUMO

OBJECTIVES: To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial. BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations. METHODS: A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up. RESULTS: Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%. CONCLUSION: At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.

Assuntos

Stents Farmacológicos , Intervenção Coronária Percutânea , Sirolimo , Células Progenitoras Endoteliais

RESUMO

BACKGROUND AND RATIONALE: Polymer-free drug-eluting stent (DES) implantation in combination with 1-month dual antiplatelet therapy (DAPT) has shown superior safety and efficacy outcomes compared with bare-metal stents among patients with high-bleeding risk (HBR) treated with 1-month DAPT. The safety and efficacy of the newer-generation durable-polymer DES Resolute Onyx compared with polymer-free DES among HBR patients treated with 1-month DAPT is unknown. TRIAL DESIGN: The Onyx ONE global randomized trial is an international, prospective, randomized, blinded, controlled study enrolling HBR patients undergoing percutaneous coronary intervention. The trial will randomize up to 2,000 patients in a 1:1 fashion to receive either the durable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom DES. After index procedure, patients in both arms will be treated with 1month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end end point of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary end point is target lesion failure (defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) at 1year. Patient follow-up is planned for 1, 2, and 6months and 1 and 2years after the procedure. CONCLUSIONS: The Onyx ONE global randomized trial is the first study to directly compare the safety and efficacy of a durable polymer DES (Resolute Onyx) with a polymer-free DES (BioFreedom) in HBR patients treated with 1month of DAPT.

Assuntos

Inibidores da Agregação Plaquetária , Stents , Hemorragia

RESUMO

OBJECTIVES:This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease.BACKGROUND:Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution.METHODS:The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data...

Assuntos

Intervenção Coronária Percutânea , Stents Farmacológicos

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

OBJECTIVES: This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months. BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations. METHODS: One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events. RESULTS: The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group. CONCLUSIONS: In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.

Assuntos

Anticorpos/administração & dosagem , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Estenose Coronária/terapia , Stents Farmacológicos , Células Endoteliais/patologia , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Células-Tronco/patologia , Idoso , Antígenos CD34/imunologia , Ásia , Austrália , Brasil , Angiografia Coronária , Reestenose Coronária/etiologia , Estenose Coronária/imunologia , Estenose Coronária/mortalidade , Estenose Coronária/patologia , Trombose Coronária/etiologia , Células Endoteliais/imunologia , Europa (Continente) , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Fatores de Risco , Células-Tronco/imunologia , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia de Intervenção

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

The Sparrow stent system (Biosensors International) consists of a self-expanding, ultra-thin nitinol stent mounted within a 0.014½ guidewire designed for small or tortuous coronary lesions. We compared the intravascular ultrasound (IVUS) findings between the novel self-expanding sirolimus-eluting stent (Sparrow-SES) and a conventional balloon-expandable sirolimus-eluting stent (Cypher-SES) in patients with small coronary disease. Methods. We examined 14 lesions treated with the Sparrow-SES from CARE II, compared with 22 small vessel lesions treated with Cypher-SES. IVUS examination was performed post-procedure and 8 months later. Volumetric data were standardized by length as volume index (VI; mm3/mm). Results. While baseline stent VI trended smaller in Sparrow-SES, follow-up stent VI became similar between the 2 groups due to a significant increase of stent VI in self-expanding Sparrow-SES during the follow-up period. At 8 months, Sparrow-SES showed greater neointima than Cypher-SES (0.8 ± 0.6 mm3/mm vs 0.2 ± 0.2 mm3/mm; P<.001). However, the decrease in lumen VI was only 0.3 ± 0.7 mm3/mm in Sparrow-SES, as compared to 0.1 ± 0.3 mm3/mm in Cypher-SES (P=.259), since the late loss due to neointimal hyperplasia was partly counterbalanced by the chronic stent expansion in Sparrow-SES. Conclusion. While 8-month follow-up of Sparrow-SES revealed greater amounts of neointimal hyperplasia compared with conventional Cypher-SES, chronic stent expansion preserved the lumen by increasing stent volume. This novel, guidewire-based, self-expanding stent system designed to be delivered through complex anatomies may be useful to treat patients with small-caliber coronary lesions by offering sufficient lumen preservation at follow-up.

Assuntos

Doença da Artéria Coronariana , Doença das Coronárias , Stents Farmacológicos

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

Background: The aim was to ascertain the 1-year clinical outcomes of 1,234 patients who underwent implantationsof sirolimus-eluting stents (SES) for acute myocardial infarction (MI) in the multinational e-SELECT registry.Methods: Fifteen thousand and one hundred and forty-seven patients treated with SES were entered in thee-SELECT registry, of whom 1,234 presented within <24 hours of onset of acute MI.Results: At 1 year, the rates of major adverse cardiac events (MACE) (5.5% vs. 4.8%; P = 0.28) were similarlylow in the acute and no acute MI groups. The rates of definite/probable stent thrombosis (ST) were higher inthe acute MI group (2.1%vs; 0.88%, P < 0.001). ST was a strong independent predictor of death at 1 year(HR 13.4; 95% CI 5.0, 36.0; P < 0.001) and MI (HR 58.9; 95% CI 26.9, 129.1; P < 0.001). Dual antiplatelettherapy (DAPT) compliance at 6 months was 96.0% in the acute MI versus 94.5% in the no acute MI group(P = 0.03).Conclusion: In selected patients presenting within <24 hours of acute MI onset and highly compliant with DAPT,SES implantation was associated with similar rates of MACE, though higher rates of ST, as compared to no acuteMI patients.Condensed abstractIn the e-SELECT registrywhich included 15,147 patients treated with sirolimus-eluting stent (SES), we ascertainedthe 1-year clinical outcomes of 1,234 patients who presented within <24 hours of acute MI onset. In acute MIpatients SES implantation was associated with similar rates of MACE, though higher rates of ST, as comparedto no acute MI patients (MACE: 5.5% vs. 4.8%; P = 0.28; ST: 2.1 vs. 0.88%, P < 0.001). (J Interven Cardiol2012;25:253–261).

Assuntos

Doença das Coronárias , Infarto do Miocárdio , Sirolimo

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 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

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