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1.
Circulation ; 140(19): 1569-1577, 2019 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-31474116

RESUMO

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) are at increased risk of developing heart failure. Sodium-glucose cotransporter-2 inhibitors reduce the risk of hospitalization for heart failure (HHF) in patients with T2DM. We aimed to develop and validate a practical clinical risk score for HHF in patients with T2DM and assess whether this score can identify high-risk patients with T2DM who have the greatest reduction in risk for HHF with a sodium-glucose cotransporter-2 inhibitor. METHODS: We developed a clinical risk score for HHF in 8212 patients with T2DM in the placebo arm of SAVOR-TIMI 53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53). Candidate variables were assessed using multivariable Cox regression, and independent clinical risk indicators achieving statistical significance of P<0.001 were included in the risk score. We externally validated the score in 8578 patients with T2DM in the placebo arm of DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58). The relative and absolute risk reductions in HHF with the sodium-glucose cotransporter-2 inhibitor dapagliflozin were assessed by baseline HHF risk. RESULTS: Five clinical variables were independent risk predictors of HHF: prior heart failure, history of atrial fibrillation, coronary artery disease, estimated glomerular filtration rate, and urine albumin-to-creatinine ratio. A simple integer-based score (0-7 points) using these predictors identified a >20-fold gradient of HHF risk (P for trend <0.001) in both the derivation and validation cohorts, with C indices of 0.81 and 0.78, respectively. Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively. CONCLUSIONS: Risk stratification using a novel clinical risk score for HHF in patients with T2DM identifies patients at higher risk for HHF who derive greater absolute benefit from sodium-glucose cotransporter-2 inhibition. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01107886 and NCT01730534.

2.
Eur Heart J Cardiovasc Pharmacother ; 5(4): 200-206, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31218354

RESUMO

AIMS: In PEGASUS-TIMI 54, ticagrelor significantly reduced the risk of the composite of major adverse cardiovascular (CV) events by 15-16% in stable patients with a prior myocardial infarction (MI) 1-3 years earlier. We report the efficacy and safety in the subpopulation recommended for treatment in the European (EU) label, i.e. treatment with 60 mg b.i.d. initiated up to 2 years from the MI, or within 1 year after stopping previous adenosine diphosphate receptor inhibitor treatment. METHODS AND RESULTS: Of the 21 162 patients enrolled in PEGASUS-TIMI 54, 10 779 patients were included in the primary analysis for this study, randomized to ticagrelor 60 mg (n = 5388) or matching placebo (n = 5391). The cumulative proportions of patients with events at 36 months were calculated by the Kaplan-Meier (KM) method. The composite of CV death, MI, or stroke occurred less frequently in the ticagrelor group (7.9% KM rate vs. 9.6%), hazard ratio (HR) 0.80 [95% confidence interval (CI) 0.70-0.91; P = 0.001]. Ticagrelor also reduced the risk of all-cause mortality, HR 0.80 (0.67-0.96; P = 0.018). Thrombolysis in myocardial infarction major bleeding was more frequent in the ticagrelor group 2.5% vs. 1.1%; HR 2.36 (1.65-3.39; P < 0.001). The corresponding HR for fatal or intracranial bleeding was 1.17 (0.68-2.01; P = 0.58). CONCLUSION: In PEGASUS-TIMI 54, treatment with ticagrelor 60 mg as recommended in the EU label, was associated with a relative risk reduction of 20% in CV death, MI, or stroke. Thrombolysis in myocardial infarction major bleeding was increased, but fatal or intracranial bleeding was similar to placebo. There appears to be a favourable benefit-risk ratio for long-term ticagrelor 60 mg in this population. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov NCT01225562.

3.
Clin Drug Investig ; 39(8): 765-773, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31140114

RESUMO

BACKGROUND AND OBJECTIVE: Ticagrelor is a P2Y12 receptor inhibitor approved as an antiplatelet drug for patients with acute coronary syndrome or a history of myocardial infarction. Ticagrelor is also being investigated for the reduction of vaso-occlusive crises in pediatric patients with sickle cell disease. A pediatric formulation suitable for this age range was developed; the development strategy is described. Primary objectives were determining the relative bioavailability of ticagrelor pediatric tablets and granules for oral suspension to the adult immediate-release tablet, and the pediatric tablets taken whole and dispersed/suspended in water to the granules for oral suspension. Bioequivalence between the pediatric tablet taken whole or suspended in water was also assessed. Secondary objectives were comparing the formulations' safety and tolerability. METHODS: We conducted a randomized, four-period, cross-over, single-dose study. Pharmacokinetic parameters were assessed for ticagrelor and its active metabolite AR-C124910XX. Bioequivalence was concluded if the 90% confidence intervals of the maximum plasma concentration and area under the plasma concentration-time curve ratios were contained completely within the 80.00-125.00% limits for ticagrelor/AR-C124910XX. RESULTS: Forty-four healthy adults (95% white; 57% male) were included. Similar bioavailability of ticagrelor (and AR-C124910XX) was demonstrated for all comparisons tested. Ticagrelor pediatric tablets taken whole were bioequivalent to pediatric tablets suspended in water. The plasma concentration-time profiles for ticagrelor and AR-C124910XX were similar, showing rapid ticagrelor absorption and AR-C124910XX formation. All formulations were well tolerated. CONCLUSION: Similar bioavailability of a new pediatric dispersible tablet formulation of ticagrelor for use across a wide age range of pediatric patients was demonstrated compared with other oral ticagrelor formulations. CLINICALTRIALS. GOV IDENTIFIER: NCT03126695. EUDRACT: 2017-000371-93.


Assuntos
Inibidores da Agregação de Plaquetas/farmacocinética , Antagonistas do Receptor Purinérgico P2Y/farmacocinética , Comprimidos , Ticagrelor/farmacocinética , Adenosina/análogos & derivados , Adolescente , Disponibilidade Biológica , Criança , Estudos Cross-Over , Feminino , Humanos , Masculino , Inibidores da Agregação de Plaquetas/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Equivalência Terapêutica , Ticagrelor/administração & dosagem
4.
Circulation ; 139(22): 2528-2536, 2019 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-30882238

RESUMO

BACKGROUND: In DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58), the sodium-glucose cotransporter 2 inhibitor dapagliflozin reduced the composite end point of cardiovascular death/hospitalization for heart failure (HHF) in a broad population of patients with type 2 diabetes mellitus. However, the impact of baseline left ventricular ejection fraction (EF) on the clinical benefit of sodium-glucose cotransporter 2 inhibition is unknown. METHODS: In the DECLARE-TIMI 58 trial, baseline heart failure (HF) status was collected from all patients, and EF was collected when available. HF with reduced EF (HFrEF) was defined as EF <45%. Outcomes of interest were the composite of cardiovascular death/HHF, its components, and all-cause mortality. RESULTS: Of 17 160 patients, 671 (3.9%) had HFrEF, 1316 (7.7%) had HF without known reduced EF, and 15 173 (88.4%) had no history of HF at baseline. Dapagliflozin reduced cardiovascular death/HHF more in patients with HFrEF (hazard ratio [HR], 0.62 [95% CI, 0.45-0.86]) than in those without HFrEF (HR, 0.88 [95% CI, 0.76-1.02]; P for interaction=0.046), in whom the treatment effect of dapagliflozin was similar in those with HF without known reduced EF (HR, 0.88 [95% CI, 0.66-1.17]) and those without HF (HR, 0.88 [95% CI, 0.74-1.03]). Whereas dapagliflozin reduced HHF both in those with (HR, 0.64 [95% CI, 0.43-0.95]) and in those without HFrEF (HR, 0.76 [95% CI, 0.62-0.92]), it reduced cardiovascular death only in patients with HFrEF (HR, 0.55 [95% CI, 0.34-0.90]) but not in those without HFrEF (HR, 1.08 [95% CI, 0.89-1.31]; P for interaction=0.012). Likewise, dapagliflozin reduced all-cause mortality in patients with HFrEF (HR, 0.59 [95% CI, 0.40-0.88;) but not in those without HFrEF (HR, 0.97 [95% CI, 0.86-1.10]; P for interaction=0.016). CONCLUSIONS: In the first sodium-glucose cotransporter 2 inhibitor cardiovascular outcome trial to evaluate patients with type 2 diabetes mellitus stratified by EF, we found that dapagliflozin reduced HHF in patients with and without HFrEF and reduced cardiovascular death and all-cause mortality in patients with HFrEF. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01730534.

5.
J Am Heart Assoc ; 7(22): e009260, 2018 11 20.
Artigo em Inglês | MEDLINE | ID: mdl-30571502

RESUMO

Background Ticagrelor reduced cardiovascular death, myocardial infarction (MI), or stroke in patients with prior MI in PEGASUS-TIMI 54 (Prevention of Cardiovascular Events [eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke] in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin). MI can occur in diverse settings and with varying severity; therefore, understanding the types and sizes of MI events prevented is of clinical importance. Methods and Results MIs were adjudicated by a blinded clinical events committee and categorized by subtype and fold elevation of peak cardiac troponin over the upper limit of normal. A total of 1042 MIs occurred in 898 of the 21 162 randomized patients over a median follow-up of 33 months. The majority of the MIs (76%) were spontaneous (Type 1), with demand MI (Type 2) and stent thrombosis (Type 4b) accounting for 13% and 9%, respectively; sudden death (Type 3), percutaneous coronary intervention-related (Type 4a) and coronary artery bypass graft-related (Type 5) each accounted for <1%. Half of MIs (520, 50%) had a peak troponin ≥10x upper limit of normal and 21% of MIs (220) had a peak troponin ≥100× upper limit of normal. A total of 21% (224) were ST-segment-elevation MI STEMI. Overall ticagrelor reduced MI (4.47% versus 5.25%, hazard ratio 0.83, 95% confidence interval 0.72-0.95, P=0.0055). The benefit was consistent among the subtypes, including a 31% reduction in MIs with a peak troponin ≥100× upper limit of normal (hazard ratio 0.69, 95% confidence interval 0.53-0.92, P=0.0096) and a 40% reduction in ST-segment elevation MI (hazard ratio 0.60, 95% confidence interval 0.46-0.78, P=0.0002). Conclusions In stable outpatients with prior MI, the majority of recurrent MIs are spontaneous and associated with a high biomarker elevation. Ticagrelor reduces the MI consistently among subtypes and sizes including large MIs and ST-segment elevation MI. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01225562.

6.
J Bone Joint Surg Am ; 99(17): 1447-1452, 2017 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-28872526

RESUMO

BACKGROUND: In an earlier study with a 2-year follow-up of uncemented cups, we had reported low femoral-head penetration of vitamin E-infused highly cross-linked polyethylene liners (E1) compared with highly cross-linked liners without vitamin E (ArComXL). We studied the penetration rate of E1 compared with that of ArComXL, with a focus on changes occurring between 2 and 5 years after total hip arthroplasty. METHODS: In this randomized controlled study, we performed radiostereometric analysis of the penetration rate up to 5 years in 63 hips. RESULTS: During the total period of observation, the median proximal penetration for E1, 0.13 mm (mean, 0.11 mm [95% confidence interval (CI), 0.08 to 0.14 mm]), was lower than that for ArComXL, 0.20 mm (mean, 0.22 mm [95% CI, 0.17 to 0.26 mm]). The median proximal penetration rate between 2 and 5 years was 0.02 mm/yr (mean, 0.01 mm/yr [95% CI, 0.01 to 0.02 mm/yr]) for E1 and 0.04 mm/yr (mean, 0.04 mm/yr [95% CI, 0.03 to 0.05 mm/yr) for ArComXL. The corresponding median total (i.e., 3-dimensional resultant) penetration rates were 0.04 mm/yr (mean, 0.04 mm/yr [95% CI, 0.03 to 0.05 mm/yr]) for E1 and 0.07 mm/yr (mean, 0.08 mm/yr [95% CI, 0.06 to 0.10 mm/yr]) for ArComXL. CONCLUSIONS: From years 2 to 5, we observed increased penetration in both groups. The penetration rate was higher for ArComXL, resulting in more proximal and total penetration at 5 years than for E1. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.


Assuntos
Artroplastia de Quadril , Prótese de Quadril , Osteoartrite do Quadril/cirurgia , Polietileno , Desenho de Prótese , Vitamina E , Adulto , Idoso , Antioxidantes , Feminino , Fêmur , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Falha de Prótese , Análise Radioestereométrica , Fatores de Tempo , Adulto Jovem
7.
J Am Coll Cardiol ; 70(11): 1368-1375, 2017 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-28882235

RESUMO

BACKGROUND: Ticagrelor reduces ischemic risk in patients with prior myocardial infarction (MI). It remains unclear whether ischemic risk and the benefits of prolonged P2Y12 inhibition in this population remain consistent over time. OBJECTIVES: The study sought to investigate the pattern of ischemic risk over time and whether the efficacy and safety of ticagrelor were similar early and late after randomization. METHODS: The PEGASUS-TIMI (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis In Myocardial Infarction) 54 trial randomized patients with prior MI (median 1.7 years prior) to ticagrelor 90 mg, ticagrelor 60 mg, or placebo on a background of aspirin. The rates of cardiovascular (CV) death, MI, and stroke as well as TIMI major bleeding were analyzed at yearly landmarks (years 1, 2, and 3). RESULTS: A total of 21,162 patients were randomized and followed for 33 months (median), with 28% of patients ≥5 years from MI at trial conclusion. The risk of CV death, MI, or stroke in the placebo arm remained roughly constant over the trial at an ∼3% annualized rate. The benefit of ticagrelor 60 mg was consistent at each subsequent landmark (year 1 hazard ratio [HR]: 0.82; 95% confidence interval [CI]: 0.67 to 0.99; year 2 HR: 0.90; 95% CI: 0.74 to 1.11; and year 3 HR: 0.79; 95% CI: 0.62 to 1.00). TIMI major bleeding was increased with ticagrelor 60 mg at each landmark, but with the greatest hazard in the first year (year 1 HR: 3.22; year 2 HR: 2.07; year 3 HR: 1.65). CONCLUSIONS: Patients with a history of MI remain at persistent high risk for CVD, MI, and stroke as late as 5 years after MI. The efficacy of low-dose ticagrelor is consistent over time with a trend toward less excess bleeding. (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin [PEGASUS]; NCT01225562).


Assuntos
Adenosina/análogos & derivados , Infarto do Miocárdio/tratamento farmacológico , Terapia Trombolítica/métodos , Adenosina/administração & dosagem , Idoso , Causas de Morte/tendências , Relação Dose-Resposta a Droga , Eletrocardiografia , Feminino , Seguimentos , Saúde Global , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Taxa de Sobrevida/tendências , Ticagrelor , Fatores de Tempo , Resultado do Tratamento
8.
Cardiol J ; 24(6): 612-622, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28695975

RESUMO

BACKGROUND: The implementation of high-sensitivity cardiac troponin T (hs-cTnT) assays and a cutoff based on the 99th cTnT percentile in the evaluation of patients with suspected acute coronary syndrome has not been uniform due to uncertain effects on health benefits and utilization of limited resources. METHODS: Clinical and laboratory data from patients with chest pain or dyspnea at the emergency de¬partment (ED) were evaluated before (n = 20516) and after (n = 18485) the lowering of the hs-cTnT cutoff point from 40 ng/L to the 99th hs-cTnT percentile of 14 ng/L in February 2012. Myocardial infarction (MI) was diagnosed at the discretion of the attending clinicians responsible for the patient. RESULTS: Following lowering of the hs-cTnT cutoff point fewer ED patients with chest pain or dyspnea as the principal complaint were analyzed with an hs-cTnT sample (81% vs. 72%, p < 0.001). Overall 30-day mortality was unaffected but increased among patients not analyzed with an hs-cTnT sample (5.3% vs. 7.6%, p < 0.001). The MI frequency was unchanged (4.0% vs. 3.9%, p = 0.72) whereas admission rates decreased (51% vs. 45%, p < 0.001) as well as hospital costs. Coronary angiographies were used more frequently (2.8% vs. 3.3%, p = 0.004) but with no corresponding change in coronary interventions. CONCLUSIONS: At the participating hospital, lowering of the hs-cTnT cutoff point to the 99th percentile decreased admissions and hospital costs but did not result in any apparent prognostic or treatment benefits for the patients.

9.
Acta Orthop ; 88(4): 363-369, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28375671

RESUMO

Background and purpose - Most registry studies regarding highly crosslinked polyethylene (XLPE) have focused on the overall revision risk. We compared the risk of cup and/or liner revision for specific cup and liner designs made of either XLPE or conventional polyethylene (CPE), regarding revision for any reason and revision due to aseptic loosening and/or osteolysis. Patients and methods - Using the Nordic Arthroplasty Register Association (NARA) database, we identified cup and liner designs where either XLPE or CPE had been used in more than 500 THAs performed for primary hip osteoarthritis. We assessed risk of revision for any reason and for aseptic loosening using Cox regression adjusted for age, sex, femoral head material and size, surgical approach, stem fixation, and presence of hydroxyapatite coating (uncemented cups). Results - The CPE version of the ZCA cup had a risk of revision for any reason similar to that of the XLPE version (p = 0.09), but showed a 6-fold higher risk of revision for aseptic loosening (p < 0.001). The CPE version of the Reflection All Poly cup had an 8-fold elevated risk of revision for any reason (p < 0.001) and a 5-fold increased risk of revision for aseptic loosening (p < 0.001). The Charnley Elite Ogee/Marathon cup and the Trilogy cup did not show such differences. Interpretation - Whether XLPE has any advantage over CPE regarding revision risk may depend on the properties of the polyethylene materials being compared, as well as the respective cup designs, fixation type, and follow-up times. Further research is needed to elucidate how cup design factors interact with polyethylene type to affect the risk of revision.


Assuntos
Artroplastia de Quadril/métodos , Prótese de Quadril , Desenho de Prótese , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Artroplastia de Quadril/instrumentação , Dinamarca/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Noruega/epidemiologia , Polietileno , Falha de Prótese , Sistema de Registros , Reoperação/estatística & dados numéricos , Fatores de Risco , Suécia/epidemiologia , Resultado do Tratamento , Adulto Jovem
10.
J Orthop Res ; 35(4): 760-767, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-26825861

RESUMO

In conventional Radiostereometric analysis (RSA) implants with attached tantalum markers are frequently used, which may be difficult to visualize. This problem can be avoided with model-based RSA (MBRSA), but it is uncertain if this method has the same precision as marker-based RSA. We evaluated the influence of cup design for the precision of MBRSA in four uncemented cups to study if the design had any influence on the precision. Stereo radiographs were analyzed postoperatively (double-examinations) and after 2 years (single examinations). The difference between the double-examinations was used to compute the precision for the methods and for each type of implant. Femoral head penetration and cup translation up to 2 years were compared using marker-based RSA as reference. The precision of proximal penetration and migration measurements did not differ between the methods for Trilogy, TMT and ABG. For Ringloc design a poorer precision was observed using MBRSA. Comparison between the methods regarding proximal penetration and cup migration at 2 years did not differ for three of the designs (p = 0.12-0.91). However, for the group with porous plasma sprayed surface (Ringloc) a significant difference between the methods was observed (ppenetration <0.01 and pmigration <0.01). Poorer precision, different penetration and migration values at 2 years for one of the designs indicate that the resolution of MBRSA might vary depending on surface coating and implant geometry. Therefore, we conclude that the resolution of MBRSA has to be studied for each type of basic cup design. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:760-767, 2017.


Assuntos
Artroplastia de Quadril , Cabeça do Fêmur/patologia , Prótese de Quadril , Desenho de Prótese , Análise Radioestereométrica/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Cabeça do Fêmur/fisiopatologia , Humanos , Pessoa de Meia-Idade , Modelos Teóricos , Imagens de Fantasmas , Reprodutibilidade dos Testes , Estudos Retrospectivos
11.
Hip Int ; 27(3): 251-258, 2017 May 12.
Artigo em Inglês | MEDLINE | ID: mdl-27886360

RESUMO

BACKGROUND: Bone impaction grafting is a biologically and mechanically appealing option in acetabular revision surgery, allowing restitution of the bone stock and restoration of the biomechanics. We analysed differences in proximal migration of the revision acetabular components when bone impaction grafting is used together with a cemented or an uncemented cup. PATIENTS AND METHODS: 43 patients (47 hips), revised due to acetabular loosening and judged to have less than 50% host bone-implant contact were included. The hips were randomised to either an uncemented (n = 20) or a cemented (n = 27) revision cup. Radiostereometry and radiography was performed postoperatively, at 3 and 6 months, 1, 2, 3, 5, 7, 10 and 13 and 17 years postoperatively. Clinical follow-up was performed at 1, 2 and 5 years postoperatively and thereafter at the same interval as in the radiographic follow-up. RESULTS: There were no differences in the base line demographic data between the 2 groups. At the last follow-up (17 years) 14 hips (10 cemented, 4 uncemented) had been re-revised due to loosening. 3 additional cups (1 uncemented and 2 cemented) were radiographically loose. There was a higher early proximal migration in the cemented cups. DISCUSSION: Cups operated on with cement showed a higher early migration measured with RSA and also a higher number of late revisions. The reason for this is not known, but factors such as inclusion of cases with severe bone defects, use of smaller bone chips and issues related to the impaction technique might have had various degrees of influence.


Assuntos
Acetábulo/cirurgia , Artroplastia de Quadril/métodos , Cimentos para Ossos , Transplante Ósseo/métodos , Previsões , Prótese de Quadril , Osteoartrite do Quadril/cirurgia , Acetábulo/diagnóstico por imagem , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Osteoartrite do Quadril/diagnóstico , Falha de Prótese , Radiografia , Análise Radioestereométrica , Reoperação , Estudos Retrospectivos
12.
Clin Orthop Relat Res ; 474(10): 2221-9, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27188836

RESUMO

BACKGROUND: Radiostereometry (RSA) measurements of early micromotion can predict later failure in hip and knee prostheses. In hip implants, RSA has been particularly helpful in the evaluation of composite-beam stem designs. The Spectron EF Primary stem (Smith & Nephew, London, UK) has shown inferior performance compared with its predecessors in both clinical studies and registry reports. Early RSA studies have shown somewhat greater subsidence for the Spectron EF Primary stem compared with the earlier Spectron EF, but still within boundaries considered to be safe. QUESTIONS/PURPOSES: Our primary research question was whether stem subsidence and rotation for this stem design measured with RSA at 2 years can predict later stem failure. A secondary question was whether high femoral stem offset and small stem sizes, both features specific to the Spectron EF Primary stem compared with its predecessors, are associated with stem failure rate. METHODS: Two hundred forty-seven hips (209 patients with median age 63 years [range, 29-80 years], 65% female, and 77% primary osteoarthritis) with a valid RSA examination at 2 years were selected from four different RSA studies (totaling 279 hips in 236 patients) in our department. The studies were primarily aimed at evaluating cup fixation, bone cement, and polyethylene types. All study patients received a cemented Spectron EF Primary stem. The selected hips had complete followup until stem failure, death, or the end of the followup period. Stem failure was defined as revision of a loose femoral stem or radiological failure with significant osteolysis in Gruen zones 2 to 6. Cox regression analyses were performed to evaluate if stem subsidence and rotation after 2 years, adjusted for age, sex, stem size, standard/high stem offset, and conventional/highly crosslinked polyethylene, could predict later clinical aseptic failure of the stem. We identified 32 stem failures (27 revisions, five radiological failures) at 14 years median followup (range, 3-18 years). Ten-year stem survival was 94% (95% confidence interval [CI], 90%-96%). RESULTS: Stem subsidence at 2 years (adjusted hazard ratio [HR], 6.0; 95% CI, 2.5-15; p < 0.001) and retrotorsion of the stem (adjusted HR, 1.7; 95% CI, 1.1-2.5; p = 0.018) were associated with later stem failure. Further risk factors were male sex (subsidence analysis HR, 6.9; p > 0.001), use of the two smallest stem sizes (HRsize 1, 8.0; p > 0.001, HRsize 2, 1 [reference], HRsize 3+, 0.06; p = 0.035), and the high offset option (HR, 3.1; p = 0.005). CONCLUSIONS: Stem subsidence and retrotorsion at 2 years can predict later failure in the Spectron EF Primary stem, consistent with earlier findings on composite-beam cemented stems. Small stem size and high-offset stems comprise the main group of underperforming stems. We recommend that premarket small-scale RSA studies be performed after any design change to a THA femoral component, because even seemingly minor design changes may unexpectedly result in inferior performance. LEVEL OF EVIDENCE: Level III, therapeutic study.


Assuntos
Artroplastia de Quadril/instrumentação , Fêmur/cirurgia , Articulação do Quadril/cirurgia , Prótese de Quadril , Desenho de Prótese , Falha de Prótese , Adulto , Idoso , Idoso de 80 Anos ou mais , Artroplastia de Quadril/efeitos adversos , Fenômenos Biomecânicos , Feminino , Fêmur/diagnóstico por imagem , Fêmur/fisiopatologia , Articulação do Quadril/diagnóstico por imagem , Articulação do Quadril/fisiopatologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Análise Radioestereométrica , Medição de Risco , Fatores de Risco , Rotação , Fatores de Tempo , Resultado do Tratamento
13.
Heart ; 102(12): 926-33, 2016 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-26928408

RESUMO

OBJECTIVES: To evaluate 90-day cardiovascular outcome in patients after myocardial infarction (MI) in relation to different subtypes of atrial fibrillation (AF) and MI. METHODS: We studied 155 071 hospital survivors of MI between 2000 and 2009 in Swedish registries. AF subtypes were defined according to history of AF and in-hospital ECG recordings. Clinical outcomes were evaluated with multivariable Cox models. RESULTS: AF was documented in 24 023 (15.5%) cases. The AF subtypes were new-onset AF with sinus rhythm at discharge (3.7%), new-onset AF with AF at discharge (3.9%), paroxysmal AF (4.9%) and chronic AF (3.0%). The event rate per 100 person-years for the composite cardiovascular outcome (all-cause mortality, MI or ischaemic stroke) was 90.9 in patients with any type of AF versus 45.2 in patients with sinus rhythm, adjusted hazard ratio with 95% CI (HR) 1.28 (1.19 to 1.37). There were no significant differences in the composite cardiovascular outcome between AF subtypes. AF was associated with higher risk of mortality, HR 1.59 (1.41 to 1.80), reinfarction, HR 1.14 (1.05 to 1.24), and ischaemic stroke, HR 2.29 (1.92 to 2.74), respectively. In subgroup analysis, AF was associated with a higher risk of composite cardiovascular outcome in the non-ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI) cohort, HR 1.24 (1.13 to 1.36) and HR 1.34 (1.21 to 1.48), respectively, with p value for interaction=0.23. CONCLUSIONS: AF is common in the setting of MI and is associated with a higher risk of composite cardiovascular outcome and the individual components; mortality, reinfarction and ischaemic stroke, respectively. No major difference in outcome was observed between AF subtypes. No difference in outcome for AF was observed between the NSTEMI and STEMI cohort.


Assuntos
Fibrilação Atrial/epidemiologia , Infarto do Miocárdio sem Supradesnível do Segmento ST/epidemiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Fibrilação Atrial/terapia , Isquemia Encefálica/epidemiologia , Causas de Morte , Comorbidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Prognóstico , Modelos de Riscos Proporcionais , Recidiva , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Acidente Vascular Cerebral/epidemiologia , Suécia/epidemiologia , Fatores de Tempo
14.
EuroIntervention ; 12(9): 1108-1116, 2016 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-26573973

RESUMO

AIMS: Despite recommendations in recent guidelines for a routine invasive strategy for non-ST-segment elevation acute coronary syndrome (NSTE-ACS), long-term data on the implementation of treatment strategies in clinical practice are not available. Our aim was to provide long-term data on the implementation of a routine invasive strategy in NSTE-ACS in clinical practice. METHODS AND RESULTS: In the SWEDEHEART registry, data from 204,092 consecutive NSTE-ACS patients admitted between 1996 and 2007 were recorded. The use of the routine invasive strategy, retrospectively defined as coronary angiography (and subsequent revascularisation) within three days after admission, increased from 3.8% in the period 1996-1998 to 37.4% in the period 2005-2007. The largest absolute increase in the use of this strategy was observed in low-risk patients, while a similar relative increase was observed in all risk categories. The use of the selective invasive strategy, defined as coronary angiography later than three days after admission or none at all, decreased from 96.2% in the period 1996-1998 to 62.5% in the period 2005-2007. In the total population, there was a gradual decrease in three-year all-cause mortality, from 29.1% in the period 1996-1998 to 23.9% in the period 2005-2007. CONCLUSIONS: There has been an increase in the use of a routine invasive strategy in NSTE-ACS patients over the course of 12 years in Sweden. There was a decrease in three-year mortality over the same time course.


Assuntos
Síndrome Coronariana Aguda/cirurgia , Angina Instável/cirurgia , Angiografia Coronária/tendências , Infarto do Miocárdio sem Supradesnível do Segmento ST/cirurgia , Intervenção Coronária Percutânea/tendências , Sistema de Registros , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/epidemiologia , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Angina Instável/diagnóstico por imagem , Angina Instável/epidemiologia , Causas de Morte , Comorbidade , Diabetes Mellitus/epidemiologia , Feminino , Humanos , Hipertensão/epidemiologia , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Mortalidade , Análise Multivariada , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio sem Supradesnível do Segmento ST/epidemiologia , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Suécia/epidemiologia , Tempo para o Tratamento
15.
J Bone Joint Surg Am ; 97(16): 1366-71, 2015 Aug 19.
Artigo em Inglês | MEDLINE | ID: mdl-26290088

RESUMO

BACKGROUND: Highly cross-linked polyethylene infused with vitamin E (E-poly) was developed to increase oxidative resistance without affecting mechanical properties. We evaluated this type of polyethylene in a randomized clinical study that used radiostereometric analysis. Our objective was to compare the early-term femoral head penetration of an E-poly liner with that of a heat-treated polyethylene liner, ArComXL. We hypothesized that the clinical outcome at two years following total hip arthroplasty would be unaffected by the choice of polyethylene. METHODS: In this prospective study, sixty-one patients (seventy hips) with noninflammatory hip osteoarthritis and a median age of fifty-eight years were randomized to receive either an implant with an E-Poly or a heat-treated highly cross-linked polyethylene liner. The patients were followed for two years and evaluated at three time points (three months, one year, and two years). RESULTS: The median proximal penetration in the E-poly group increased from 0.04 mm at three months to 0.06 mm at two years of follow-up. Corresponding values for the ArComXL group were 0.03 mm and 0.10 mm. In both groups, significantly increased penetration was observed between three months and two years (E-poly, p = 0.02; ArComXL, p < 0.001), but between one and two years, the increase was significant only in the control group (E-poly, p = 0.23; ArComXL, p = 0.002). CONCLUSIONS: The femoral head penetration of E-poly was very low at two years. Whether the increase observed between three months and two years was caused by creep, deformation, wear, or a combination of these cannot be determined by our study. There were no significant differences observed in femoral head penetration rates between E-poly and ArComXL. Currently, the theoretical advantages of E-poly remain to be confirmed.


Assuntos
Artroplastia de Quadril/métodos , Cabeça do Fêmur/efeitos dos fármacos , Desenho de Prótese , Amplitude de Movimento Articular/fisiologia , Vitamina E/farmacologia , Idoso , Artroplastia de Quadril/efeitos adversos , Feminino , Seguimentos , Prótese de Quadril , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/diagnóstico por imagem , Osteoartrite do Quadril/cirurgia , Medição da Dor , Polietilenos/química , Estudos Prospectivos , Falha de Prótese , Análise Radioestereométrica , Recuperação de Função Fisiológica , Medição de Risco , Índice de Gravidade de Doença , Estatísticas não Paramétricas , Fatores de Tempo
16.
J Am Coll Cardiol ; 62(14): 1231-1238, 2013 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-23933541

RESUMO

OBJECTIVES: The purpose of this study was to examine the extent of change in troponin T levels in patients with non-ST-segment elevation myocardial infarction (NSTEMI). BACKGROUND: Changes in cardiac troponin T (cTnT) levels are required for the diagnosis of NSTEMI, according to the new universal definition of acute myocardial infarction. A relative change of 20% to 230% and an absolute change of 7 to 9 ng/l have been suggested as cutoff points. METHODS: In a clinical setting, where a change in cTnT was not mandatory for the diagnosis of NSTEMI, serial samples of cTnT were measured with a high-sensitivity cTnT (hs-cTnT) assay, and 37 clinical parameters were evaluated in 1,178 patients with a final diagnosis of NSTEMI presenting <24 h after symptom onset. RESULTS: After 6 h of observation, the relative change in the hs-cTnT level remained <20% in 26% and the absolute change <9 ng/l in 12% of the NSTEMI patients. A relative hs-cTnT change <20% was linked to higher long-term mortality across quartiles (p = 0.002) and in multivariate analyses (hazard ratio: 1.61 [95% confidence interval: 1.17 to 2.21], p = 0.004), whereas 30-day mortality was similar across quartiles of relative hs-cTnT change. CONCLUSIONS: Because stable hs-TnT levels are common in patients with a clinical diagnosis of NSTEMI in our hospital, a small hs-cTnT change may not be useful to exclude NSTEMI, particularly as these patients show both short-term and long-term mortality at least as high as patients with large changes in hs-cTnT.


Assuntos
Eletrocardiografia , Infarto do Miocárdio/sangue , Troponina T/sangue , Idoso , Idoso de 80 Anos ou mais , Unidades de Cuidados Coronarianos , Diagnóstico Diferencial , Feminino , Seguimentos , Mortalidade Hospitalar/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Suécia/epidemiologia
17.
Int J Cardiol ; 168(4): 3594-8, 2013 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-23727105

RESUMO

BACKGROUND: We wanted to evaluate predictors of direct admittance to a coronary care unit (CCU) and predictors of death in patients with suspected acute coronary syndromes (ACS). METHODS: During 2004-2007, all consecutive prehospitally triaged patients with suspected ACS were prospectively included. Prehospital and emergency data were collected at point of care. Data from medical records, ECG-, echocardiography- and laboratory databases was collected retrospectively. RESULTS: In all, 2757 patients were included. Out of these 858 were directly admitted to the CCU or cath/lab. Predictors for direct admittance to the CCU were ST-segment elevation on the initial ECG; odds ratio (OR) 46.11, left bundle branch block; OR 3.30, ongoing symptoms; OR 2.90, current smoking; OR 2.18 and ST-segment depression; OR 2.05. Independent predictors for 1-year mortality were cardiogenic shock; OR 14.40, increasing age OR (per year) 1.08, diabetes; OR 2.09 and chronic heart failure; OR 1.67. ST-segment elevation was associated with a lower 1-year mortality rate; OR 0.52. CONCLUSIONS: Among patients with a suspected ACS, prehospital ECG-signs indicating an acute coronary occlusion were not only a predictor for direct admission to acute coronary care but also a predictor for increased survival. To improve future outcome in acute ischemic heart diseases we must find and treat not only the STEMI's but also the high-risk NSTEMIs that otherwise would have a poor prognosis.


Assuntos
Oclusão Coronária/diagnóstico , Oclusão Coronária/mortalidade , Eletrocardiografia/mortalidade , Serviços Médicos de Emergência/métodos , Triagem/métodos , Idoso , Idoso de 80 Anos ou mais , Oclusão Coronária/fisiopatologia , Eletrocardiografia/tendências , Serviços Médicos de Emergência/tendências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Triagem/tendências
18.
Int J Cardiol ; 166(1): 141-6, 2013 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-22071042

RESUMO

OBJECTIVES: To describe the differences in characteristics and outcome between two consecutive series of patients admitted to hospital with chest pain in a 20-year perspective. Particular emphasis is placed on changes in outcome in relation to the initial electrocardiogram (ECG). SUBJECTS: In the two periods, 1986-1987 and 2008, all patients with chest pain admitted to the study hospitals in Gothenburg, Sweden, were included. RESULTS: Five thousand and sixteen patients were registered in a period of 21 months in 1986-1987 and 2287 patients were registered during 3 months in 2008. In a comparison of the two time periods, the age of chest pain patients was not significantly different (mean age 60.1 ± 17.8 years in 1986-1987 and 59.8 ± 19.1 years in 2008, p=0.50). There was a lower prevalence of previous angina pectoris, congestive heart failure and current smoking in the second period, whereas a history of acute myocardial infarction, hypertension and diabetes mellitus had become more prevalent. The use of cardio-protective drugs increased and ECG changes indicating acute myocardial ischemia on admission to hospital decreased. Length of hospitalisation was reduced from a median of 5 days to 3 days (p<0.0001). A significant decrease in 30-day and 1-year mortality was found (3.8% in 1986-1987 vs 2.0% in 2008 and 9.9% vs 6.3% respectively, p<0.0001 for both comparisons). CONCLUSIONS: During a period of 20 years, the characteristics and outcome of patients admitted to hospital with chest pain changed. The most important changes were a lower prevalence of ECG signs indicating acute myocardial ischemia on admission, shorter hospitalisation time and a lower 30-day and 1-year mortality.


Assuntos
Dor no Peito/diagnóstico , Dor no Peito/terapia , Coleta de Dados/tendências , Admissão do Paciente/tendências , Adulto , Idoso , Idoso de 80 Anos ou mais , Dor no Peito/epidemiologia , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade
19.
J Am Coll Cardiol ; 60(16): 1581-98, 2012 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-22958960
20.
Eur Heart J ; 33(20): 2551-67, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22922414
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