RESUMO
AIMS: An observational nationwide all-comers prospective register study to analyse outcomes after coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in unprotected left main coronary artery (LMCA) disease. METHODS AND RESULTS: All patients undergoing coronary angiography in Sweden are registered in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registry. Between 01/01/2005 and 12/31/2015, 11 137 patients with LMCA disease underwent CABG (n = 9364) or PCI (n = 1773). Patients with previous CABG, ST-elevation myocardial infarction (MI) or cardiac shock were excluded. Death, MI, stroke, and new revascularization during follow-up until 12/31/2015 were identified using national registries. Cox regression with inverse probability weighting (IPW) and an instrumental variable (IV), administrative region, were used. Patients undergoing PCI were older, had higher prevalence of comorbidity but lower prevalence of three-vessel disease. PCI patients had higher mortality than CABG patients after adjustments for known cofounders with IPW analysis (hazard ratio [HR] 2.0 [95% confidence interval (CI) 1.5-2.7]) and known/unknown confounders with IV analysis (HR 1.5 [95% CI 1.1-2.0]). PCI was associated with higher incidence of major adverse cardiovascular and cerebrovascular events (MACCE; death, MI, stroke, or new revascularization) than CABG, with IV analysis (HR 2.8 [95% CI 1.8-4.5]). There was a quantitative interaction for diabetic status regarding mortality (P = 0.014) translating into 3.6 years (95% CI 3.3-4.0) longer median survival time favouring CABG in patients with diabetes. CONCLUSION: In this non-randomized study, CABG in patients with LMCA disease was associated with lower mortality and fewer MACCE compared to PCI after multivariable adjustment for known and unknown confounders.
Assuntos
Doença da Artéria Coronariana , Diabetes Mellitus , Intervenção Coronária Percutânea , Acidente Vascular Cerebral , Humanos , Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea/métodos , Resultado do Tratamento , Ponte de Artéria Coronária/métodos , Diabetes Mellitus/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Sistema de RegistrosRESUMO
BACKGROUND: The comparative efficacy of various anticoagulation strategies has not been clearly established in patients with acute myocardial infarction who are undergoing percutaneous coronary intervention (PCI) according to current practice, which includes the use of radial-artery access for PCI and administration of potent P2Y12 inhibitors without the planned use of glycoprotein IIb/IIIa inhibitors. METHODS: In this multicenter, randomized, registry-based, open-label clinical trial, we enrolled patients with either ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) who were undergoing PCI and receiving treatment with a potent P2Y12 inhibitor (ticagrelor, prasugrel, or cangrelor) without the planned use of glycoprotein IIb/IIIa inhibitors. The patients were randomly assigned to receive bivalirudin or heparin during PCI, which was performed predominantly with the use of radial-artery access. The primary end point was a composite of death from any cause, myocardial infarction, or major bleeding during 180 days of follow-up. RESULTS: A total of 6006 patients (3005 with STEMI and 3001 with NSTEMI) were enrolled in the trial. At 180 days, a primary end-point event had occurred in 12.3% of the patients (369 of 3004) in the bivalirudin group and in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.10; P=0.54). The results were consistent between patients with STEMI and those with NSTEMI and across other major subgroups. Myocardial infarction occurred in 2.0% of the patients in the bivalirudin group and in 2.4% in the heparin group (hazard ratio, 0.84; 95% CI, 0.60 to 1.19; P=0.33), major bleeding in 8.6% and 8.6%, respectively (hazard ratio, 1.00; 95% CI, 0.84 to 1.19; P=0.98), definite stent thrombosis in 0.4% and 0.7%, respectively (hazard ratio, 0.54; 95% CI, 0.27 to 1.10; P=0.09), and death in 2.9% and 2.8%, respectively (hazard ratio, 1.05; 95% CI, 0.78 to 1.41; P=0.76). CONCLUSIONS: Among patients undergoing PCI for myocardial infarction, the rate of the composite of death from any cause, myocardial infarction, or major bleeding was not lower among those who received bivalirudin than among those who received heparin monotherapy. (Funded by the Swedish Heart-Lung Foundation and others; VALIDATE-SWEDEHEART ClinicalTrialsRegister.eu number, 2012-005260-10 ; ClinicalTrials.gov number, NCT02311231 .).
Assuntos
Anticoagulantes/uso terapêutico , Heparina/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Fragmentos de Peptídeos/uso terapêutico , Intervenção Coronária Percutânea , Idoso , Anticoagulantes/efeitos adversos , Terapia Combinada , Feminino , Hemorragia/induzido quimicamente , Heparina/administração & dosagem , Hirudinas/efeitos adversos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Fragmentos de Peptídeos/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/uso terapêuticoRESUMO
BACKGROUND: Women irradiated for left-sided breast cancer (BC) have an increased risk of coronary artery disease compared to women with right-sided BC. We describe the distribution of radiation dose in segments of coronary arteries in women receiving adjuvant radiotherapy (RT) for left- or right-sided BC. MATERIAL AND METHODS: Fifteen women with BC, seven left-sided and eight right-sided, who had received three-dimensional conformal radiotherapy (3DCRT), constituted the study base. The heart and the segments of the coronary arteries were defined as separate organs at risk (OAR), and the mean and maximum radiation doses were calculated for each OAR. RESULTS: In women with left-sided BC, irrespective of if regional lymph node RT was given or not, maximum dose in mid and distal left anterior descending artery (mdLAD) was approximately 50 Gy in 6/7 patients, whereas women with right-sided BC mainly received low doses of radiation. In women with left-sided BC, 6/7 patients had substantially higher mean dose to the distal LAD than to the heart, ranging from 30 to 55 Gy and 3 to13 Gy, respectively. CONCLUSION: We found a pronounced difference of radiation dose distribution in the coronary arteries between women with left- and right-sided BC. Women with left-sided BC had almost full treatment dose in parts of mdLAD, regardless of if regional lymph node irradiation was given or not, while women with right-sided BC mainly received low doses to the coronary arteries.
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Vasos Coronários/efeitos da radiação , Órgãos em Risco/efeitos da radiação , Dosagem Radioterapêutica , Radioterapia Conformacional/efeitos adversos , Neoplasias Unilaterais da Mama/radioterapia , Idoso , Angiografia Coronária , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/etiologia , Feminino , Humanos , Linfonodos/efeitos da radiação , Pessoa de Meia-IdadeRESUMO
AIMS: The aim of this study was to evaluate clinical outcome for different indications for PCI in an unselected, nationwide PCI population at short- and long-term follow-up. METHODS AND RESULTS: We evaluated clinical outcome up to six years after PCI in all patients undergoing a PCI procedure for different indications in Sweden between 2006 and 2010. A total of 70,479 patients were treated for stable coronary artery disease (CAD) (21.0%), unstable angina (11.0%), non-ST-elevation myocardial infarction (NSTEMI) (36.6%) and ST-elevation myocardial infarction (STEMI) (31.4%). Mortality was higher in STEMI patients at one year after PCI (9.6%) compared to NSTEMI (4.7%), unstable angina (2.2%) and stable CAD (2.0%). At one year after PCI until the end of follow-up, the adjusted mortality risk (one to six years after PCI) and the risk of myocardial infarction were comparable between NSTEMI and STEMI patients and lower in patients with unstable angina and stable CAD. The adjusted risk of stent thrombosis and heart failure was highest in STEMI patients. CONCLUSIONS: The risk of short-term mortality, heart failure and stent thrombosis is highest for STEMI patients after PCI. Therapies to reduce stent thrombosis and heart failure appear to be most important in decreasing mortality in patients with STEMI or NSTEMI undergoing PCI.
Assuntos
Angiografia Coronária , Infarto do Miocárdio/cirurgia , Revascularização Miocárdica , Intervenção Coronária Percutânea , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão , Angiografia Coronária/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Revascularização Miocárdica/efeitos adversos , Revascularização Miocárdica/métodos , Sistema de Registros , Fatores de Risco , Suécia , Tempo , Resultado do TratamentoRESUMO
The interest in rotational atherectomy (RA) has increased over the past decade as a consequence of more complex and calcified coronary stenoses being attempted with percutaneous coronary interventions. Yet adoption of RA is hampered by several factors: amongst others, by the lack of a standardised protocol. This European expert consensus document stems from the awareness of the large heterogeneity in the protocols adopted to perform rotational atherectomy. The objective of the present document is to provide some points of consensus among highly experienced operators on the most controversial steps of RA in an attempt to build the basis of a standardised and universally accepted protocol.
Assuntos
Aterectomia Coronária/normas , Estenose Coronária/terapia , Calcificação Vascular/terapia , Aterectomia Coronária/efeitos adversos , Consenso , Estenose Coronária/diagnóstico , Humanos , Padrões de Prática Médica/normas , Resultado do Tratamento , Calcificação Vascular/diagnósticoRESUMO
BACKGROUND: The clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) is uncertain. We aimed to evaluate whether thrombus aspiration reduces mortality. METHODS: We conducted a multicenter, prospective, randomized, controlled, open-label clinical trial, with enrollment of patients from the national comprehensive Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and end points evaluated through national registries. A total of 7244 patients with STEMI undergoing PCI were randomly assigned to manual thrombus aspiration followed by PCI or to PCI only. The primary end point was all-cause mortality at 30 days. RESULTS: No patients were lost to follow-up. Death from any cause occurred in 2.8% of the patients in the thrombus-aspiration group (103 of 3621), as compared with 3.0% in the PCI-only group (110 of 3623) (hazard ratio, 0.94; 95% confidence interval [CI], 0.72 to 1.22; P=0.63). The rates of hospitalization for recurrent myocardial infarction at 30 days were 0.5% and 0.9% in the two groups, respectively (hazard ratio, 0.61; 95% CI, 0.34 to 1.07; P=0.09), and the rates of stent thrombosis were 0.2% and 0.5%, respectively (hazard ratio, 0.47; 95% CI, 0.20 to 1.02; P=0.06). There were no significant differences between the groups with respect to the rate of stroke or neurologic complications at the time of discharge (P=0.87). The results were consistent across all major prespecified subgroups, including subgroups defined according to thrombus burden and coronary flow before PCI. CONCLUSIONS: Routine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT01093404.).
Assuntos
Trombose Coronária/terapia , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Trombectomia , Idoso , Terapia Combinada , Eletrocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Estudos Prospectivos , Recidiva , Sucção , Trombectomia/instrumentação , Trombectomia/métodos , Tempo para o TratamentoRESUMO
AIMS: The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical results through two years from the EVOLVE FHU trial. METHODS AND RESULTS: EVOLVE recruited 291 patients from 29 centres. At six months, IVUS-assessed in-stent net volume obstruction was 3.40 ± 5.06% for PROMUS Element (PE) vs. 2.68 ± 4.60% for SYNERGY (p=0.34) and 3.09 ± 4.29% for SYNERGY ½ dose (p=0.68 vs. PE). There were no significant differences between groups for any other measured IVUS parameter including resolved, persistent, and late-acquired incomplete stent apposition (ISA). At two years, target lesion failure (TLF) was 6.1% for PE vs. 5.5% for SYNERGY (p=0.87) and 5.2% for SYNERGY ½ dose (p=0.81). There were no significant differences between groups for cardiac death, repeat revascularisation, MI or stent thrombosis through two years. CONCLUSIONS: At six months, everolimus delivered from an ultrathin bioabsorbable abluminal polymer resulted in equivalent net volume obstruction and ISA compared with a permanent polymer EES. There were no significant differences between PE and either SYNERGY stent for any major cardiac endpoint through two years. Clinical trials number: NCT01135225.
Assuntos
Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Polímeros , Sirolimo/análogos & derivados , Ultrassonografia de Intervenção , Austrália , Distribuição de Qui-Quadrado , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/etiologia , Europa (Continente) , Everolimo , Humanos , Estimativa de Kaplan-Meier , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/etiologia , Nova Zelândia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Valor Preditivo dos Testes , Desenho de Prótese , Fatores de Risco , Sirolimo/administração & dosagem , Fatores de Tempo , Resultado do TratamentoRESUMO
Aims: The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical results through two years from the EVOLVE FHU trial. Methods and results: EVOLVE recruited 291 patients from 29 centres. At six months, IVUS-assessed in-stent net volume obstruction was 3.40±5.06% for PROMUS Element (PE) vs. 2.68±4.60% for SYNERGY (p=0.34) and 3.09±4.29% for SYNERGY ½ dose (p=0.68 vs. PE). There were no significant differences between groups for any other measured IVUS parameter including resolved, persistent, and late-acquired incomplete stent apposition (ISA). At two years, target lesion failure (TLF) was 6.1% for PE vs. 5.5% for SYNERGY (p=0.87) and 5.2% for SYNERGY ½ dose (p=0.81). There were no significant differences between groups for cardiac death, repeat revascularisation, MI or stent thrombosis through two years. Conclusions: At six months, everolimus delivered from an ultrathin bioabsorbable abluminal polymer resulted in equivalent net volume obstruction and ISA compared with a permanent polymer EES. There were no significant differences between PE and either SYNERGY stent for any major cardiac endpoint through two years. Clinical trials number: NCT01135225.
RESUMO
OBJECTIVES: This study sought to report the 5-year follow-up results of the Nordic Bifurcation Study. BACKGROUND: Randomized clinical trials with short-term follow-up have indicated that coronary bifurcation lesions may be optimally treated using the optional side branch stenting strategy. METHODS: A total of 413 patients with a coronary bifurcation lesion were randomly assigned to a simple stenting strategy of main vessel (MV) and optional stenting of side branch (SB) or to a complex stenting strategy, namely, stenting of both MV and SB. RESULTS: Five-year clinical follow-up data were available for 404 (98%) patients. The combined safety and efficacy endpoint of cardiac death, non-procedure-related myocardial infarction, and target vessel revascularization were seen in 15.8% in the optional SB stenting group as compared to 21.8% in the MV and SB stenting group (p = 0.15). All-cause death was seen in 5.9% versus 10.4% (p = 0.16) and non-procedure-related myocardial infarction in 4% versus 7.9% (p = 0.09) in the optional SB stenting group versus the MV and SB stenting group, respectively. The rates of target vessel revascularization were 13.4% versus 18.3% (p = 0.14) and the rates of definite stent thrombosis were 3% versus 1.5% (p = 0.31) in the optional SB stenting group versus the MV and SB stenting group, respectively. CONCLUSIONS: At 5-year follow-up in the Nordic Bifurcation Study, the clinical outcomes after simple optional side branch stenting remained at least equal to the more complex strategy of planned stenting of both the main vessel and the side branch.
Assuntos
Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/tendências , Idoso , Doença da Artéria Coronariana/diagnóstico , Reestenose Coronária/diagnóstico , Reestenose Coronária/epidemiologia , Reestenose Coronária/prevenção & controle , Dinamarca/epidemiologia , Feminino , Finlândia/epidemiologia , Seguimentos , Humanos , Letônia/epidemiologia , Masculino , Pessoa de Meia-Idade , Noruega/epidemiologia , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Suécia/epidemiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to describe the characteristics and outcome of all consecutive patients treated with percutaneous coronary intervention (PCI) in an unselected nationwide cohort over the past 2 decades. BACKGROUND: Over the last 20 years, treatment with PCI has evolved dramatically, but the change in patient characteristics has not been well described. METHODS: We included all patients undergoing a PCI procedure for the first time between January 1990 and December 2010 from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry). Patients were divided into different cohorts on the basis of the year of the first PCI procedure. RESULTS: A total of 144,039 patients was included. The mean age increased from 60.1 ± 9.9 years in 1990 to 1995 to 67.1 ± 11.2 years in 2009 to 2010. The proportion of patients presenting with unstable coronary artery disease and ST-segment elevation myocardial infarction increased from 27.4% and 6.2% to 47.7% and 32.5%, respectively. Diabetes mellitus and multivessel disease were more often present in the later-year cohorts. The 1-year mortality increased from 2.2% in 1990 to 1995 to 5.9% in 2009 to 2010, but after adjustment for age and indication, a modest decrease was shown, mainly in ST-segment elevation myocardial infarction patients. CONCLUSIONS: Characteristics of PCI patients have changed substantially over time, reflecting the establishment of new evidence. The increasing age and proportion of patients undergoing PCI for acute coronary syndromes greatly influence outcome. Understanding the changing patient characteristics is important for the translation of evidence to real-world clinical practice.
Assuntos
Angina Instável/terapia , Angioplastia Coronária com Balão/estatística & dados numéricos , Angiografia Coronária/estatística & dados numéricos , Angiopatias Diabéticas/terapia , Infarto do Miocárdio/terapia , Sistema de Registros , Revisão da Utilização de Recursos de Saúde/tendências , Fatores Etários , Idoso , Angina Instável/mortalidade , Estudos de Coortes , Angiopatias Diabéticas/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Modelos de Riscos Proporcionais , Análise de Sobrevida , Suécia , Resultado do TratamentoRESUMO
BACKGROUND: The safety and efficacy of the Promus Element stent have been recently demonstrated in a selected population from one randomized trial. The aim of this study was to describe the initial clinical experience with the everolimus eluting platinum chromium stent (Promus Element) in unselected patients from a real life nationwide registry. METHODS: The Promus Element DES was compared to all other DES implanted in Sweden (with more than 500 implants) from November 2009 to March 2011. The results were assessed using Cox regression. RESULTS: A total of 13,577 stents (Promus Element, n=2724, Cypher, n=782; Endeavor, n=747; Taxus Liberté, n=1393, Xience V/Promus, n=4832, Resolute, n=1566, Xience Prime, n=4832) were implanted at 8375 procedures. At one year the restenosis rate in the Promus Element was not significantly different from the overall DES group (2.8% vs. 2.7%, adjusted HR:1.17, 95% CI: 0.75-1.75). A significantly lower restenosis rate was observed in the Promus Element when compared with Endeavor (2.8% vs. 5.8%; adjusted HR: 0.44; 95% CI: 0.26-0.74). The stent thrombosis (ST) rate at one year was not significantly different in the Promus Element as compared with the overall DES group (0.2% vs. 0.5% adjusted HR: 0.59; 95% CI: 025-1.40). ST rate was significantly lower as compared with Endeavor stent (0.2% vs. 0.8%; HR: 0.24; 95% CI: 0.08-0.67). CONCLUSIONS: In a large unselected population the Promus Element stent appears to be safe and effective with a low risk of restenosis and ST.
Assuntos
Angioplastia Coronária com Balão/métodos , Cromo , Angiografia Coronária/métodos , Stents Farmacológicos , Platina , Sirolimo/análogos & derivados , Idoso , Reestenose Coronária/epidemiologia , Reestenose Coronária/prevenção & controle , Everolimo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Sirolimo/administração & dosagem , Suécia/epidemiologia , Resultado do TratamentoRESUMO
PURPOSE: To study distribution of coronary artery stenosis among patients with breast cancer (BC) and to assess correlation between radiotherapy (RT) and location of stenosis. PATIENTS AND METHODS: A Swedish BC cohort diagnosed from 1970 to 2003 was linked to registers of coronary angiography from 1990 to 2004, which yielded 199 patients. Stenoses of the coronary arteries were graded from 0 to 5, where 0 indicated a normal vessel and 5 indicated occlusion. Two hotspot areas for radiation were defined: proximal right coronary artery (prox RCA), mid and distal left anterior descending artery and distal diagonal (mdLAD + dD). RT regimens were categorized as high or low risk of irradiating the hotspot areas. Left breast/chest wall was considered high risk for mdLAD + dD; left internal mammary chain (IMC), high risk for prox RCA and mdLAD + dD from 1970 to 1995 and thereafter solely for mdLAD + dD; and right IMC, high risk for prox RCA. Other RT targets and no RT were considered low risk. Results were expressed in odds ratios (ORs) and 95% CIs. RESULTS: For irradiated left- versus right-sided BC, the OR for grade 3 to 5 stenosis in mdLAD + dD was 4.38 (95% CI, 1.64 to 11.7), and for grade 4 to 5 stenosis, the OR was 7.22 (95% CI, 1.64 to 31.8). For high-risk RT versus low-risk or no RT, the OR for grade 3 to 5 stenosis in hotspot areas was 1.90 (95% CI, 1.11 to 3.24). CONCLUSION: An increase of stenosis in mdLAD + dD in irradiated left-sided BC and an association between high-risk RT and stenosis in hotspot areas for radiation indicate a direct link between radiation and location of coronary stenoses.
Assuntos
Neoplasias da Mama/epidemiologia , Neoplasias da Mama/radioterapia , Estenose Coronária/epidemiologia , Lesões por Radiação/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Angiografia Coronária/métodos , Estenose Coronária/etiologia , Feminino , Humanos , Pessoa de Meia-Idade , Lesões por Radiação/etiologia , Radioterapia/efeitos adversos , Radioterapia/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Suécia/epidemiologiaRESUMO
BACKGROUND: It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting with and without FKBD. METHODS AND RESULTS: We randomized 477 patients with a bifurcation lesion to FKBD (n=238) or no FKBD (n=239) after MV stenting. The primary end point was major adverse cardiac events: cardiac death, non-procedure-related index lesion myocardial infarction, target lesion revascularization, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty-six patients had a quantitative coronary assessment. At 8 months, the rate of binary (re)stenosis in the entire bifurcation lesion (MV and side branch) was 11.0% versus 17.3% (P=0.11), in the MV was 3.1% versus 2.5% (P=0.68), and in the side branch was 7.9% versus 15.4% (P=0.039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20.0% (P=0.024) in the FKBD and no-FKBD groups, respectively. CONCLUSIONS: MV stenting strategies with and without FKBD were associated with similar clinical outcomes. FKBD reduced angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.
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Angioplastia Coronária com Balão , Doença da Artéria Coronariana/patologia , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Idoso , Angioplastia Coronária com Balão/métodos , Doença da Artéria Coronariana/epidemiologia , Dinamarca/epidemiologia , Feminino , Finlândia/epidemiologia , Seguimentos , Humanos , Letônia/epidemiologia , Masculino , Pessoa de Meia-Idade , Noruega/epidemiologia , Suécia/epidemiologiaAssuntos
Parada Cardíaca/terapia , Infarto do Miocárdio/terapia , Esqui/lesões , Adulto , Reanimação Cardiopulmonar , Serviços Médicos de Emergência/organização & administração , Predisposição Genética para Doença , Parada Cardíaca/etiologia , Parada Cardíaca/genética , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/genética , Resistência Física , Fatores de Risco , Resultado do TratamentoRESUMO
AIMS: The risk of stent thrombosis has been reported to increase with percutaneous coronary intervention (PCI) complexity. The present study reports the pre-specified secondary endpoint of a 14-month stent thrombosis and major adverse cardiac events in patients stented with a simple versus a complex bifurcation technique using sirolimus eluting stents (SES). METHODS AND RESULTS: A total of 413 patients with a coronary bifurcation lesion were randomised to a simple treatment strategy; stenting of main vessel and optional stenting of side branch (MV group), or to a complex stenting strategy; stenting of both main vessel and side branch (MV+SB group). Mortality data were available in all patients and 14-month clinical follow-up data in 395 (96%) of the patients. After 14 months, the rates of definite, probable and possible stent thrombosis (ARC criteria) were 1.0% vs. 0.5%, 1.0% vs. 0% and 0.5% vs. 0% (ns) in the MV and in the MV+SB groups, respectively. Rates of MACE were 9.5% in the MV group and 8.2% in the MV+SB group (ns). Total death was seen in 2.4% vs. 1.0% and non-PCI related myocardial infarction in 2.0% vs. 1.0% in the MV and the MV+SB groups, respectively. CONCLUSIONS: After 14 months, two months after recommended cessation of dual antiplatelet therapy, the rates of stent thrombosis and major adverse cardiac events were low and independent of treatment complexity in patients treated with SES for coronary artery bifurcation lesions.
Assuntos
Angioplastia Coronária com Balão/métodos , Doença da Artéria Coronariana/patologia , Doença da Artéria Coronariana/terapia , Vasos Coronários/patologia , Stents Farmacológicos , Idoso , Feminino , Seguimentos , Humanos , Imunossupressores/administração & dosagem , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/uso terapêutico , Sirolimo/administração & dosagem , Trombose/prevenção & controle , Resultado do TratamentoRESUMO
BACKGROUND: The optimal stenting strategy in coronary artery bifurcation lesions is unknown. In the present study, a strategy of stenting both the main vessel and the side branch (MV+SB) was compared with a strategy of stenting the main vessel only, with optional stenting of the side branch (MV), with sirolimus-eluting stents. METHODS AND RESULTS: A total of 413 patients with a bifurcation lesion were randomized. The primary end point was a major adverse cardiac event: cardiac death, myocardial infarction, target-vessel revascularization, or stent thrombosis after 6 months. At 6 months, there were no significant differences in rates of major adverse cardiac events between the groups (MV+SB 3.4%, MV 2.9%; P=NS). In the MV+SB group, there were significantly longer procedure and fluoroscopy times, higher contrast volumes, and higher rates of procedure-related increases in biomarkers of myocardial injury. A total of 307 patients had a quantitative coronary assessment at the index procedure and after 8 months. The combined angiographic end point of diameter stenosis >50% of main vessel and occlusion of the side branch after 8 months was found in 5.3% in the MV group and 5.1% in the MV+SB group (P=NS). CONCLUSIONS: Independent of stenting strategy, excellent clinical and angiographic results were obtained with percutaneous treatment of de novo coronary artery bifurcation lesions with sirolimus-eluting stents. The simple stenting strategy used in the MV group was associated with reduced procedure and fluoroscopy times and lower rates of procedure-related biomarker elevation. Therefore, this strategy can be recommended as the routine bifurcation stenting technique.
Assuntos
Estenose Coronária/cirurgia , Stents , Angiografia Coronária , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Sirolimo/administração & dosagem , Sirolimo/uso terapêutico , Resultado do TratamentoRESUMO
OBJECTIVE: To analyse the cost-effectiveness of Taxus compared to a bare-metal stent in patients with coronary artery disease in the Swedish healthcare setting. DESIGN: A decision-analytic model combining clinical data on revascularization rates with Swedish unit costs for medical resources and utility data from the literature. RESULTS: For patients of moderate risk, the average cost per patient at 12 months is 72,200 SEK for Taxus and 66,900 SEK for a bare-metal stent, while the average cost for high risk patients is nearly equivalent (73,000 vs. 71,700 SEK). The cost per revascularization avoided is generally favourable, while the incremental cost per QALY gained varies depending on the assumptions made; from 2,351,000 SEK for patients of moderate risk at 12-months to cost saving at 24 months for high risk patients. Budget impact scenarios at 12 months are cost-neutral. CONCLUSION: The Taxus stent is cost-effective in high risk patients, particularly at 24 months. Although it may be less cost-effective for the general population, there is still a substantial offset of initial procedure costs through lower rate of repeat revascularizations.