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1.
Am J Cardiol ; 88(10): 1097-102, 2001 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-11703951

RESUMO

This study describes the dose-exploration phase of the PRIDE trial, an investigation of the clinical pharmacology of higher dose eptifibatide in patients who underwent elective percutaneous coronary intervention (PCI). Outcomes of treatment with the platelet glycoprotein IIb/IIIa inhibitors were dependent upon proper dosing selection. In this multicenter, placebo-controlled clinical study, 127 patients were randomized 1:1:2:2 into 1 of the following treatment groups: placebo; eptifibatide as a 135 microg/kg bolus followed by a 0.75 microg/kg/min infusion; eptifibatide as a 180 microg/kg bolus with a 2.0 microg/kg/min infusion; or eptifibatide as a 250 microg/kg bolus with a 3.0 microg/kg/min infusion. Light transmission aggregometry was used to determine platelet aggregation in response to 20 microM adenosine diphosphate, and platelet receptor occupancy was also determined. Eptifibatide exhibited linear pharmacokinetics over the dose range studied. Inhibition of platelet aggregation was greater in samples collected in sodium citrate compared with those collected in D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone. The 180/2.0 dosing regimen achieved 90% inhibition of platelet aggregation immediately (5 minutes) and at steady state (8 to 24 hours). At 1 hour, mean inhibition of platelet aggregation was 80%. Eptifibatide exhibited dose-dependent pharmacodynamics that were dependent upon choice of anticoagulant. A 180 microg/kg bolus followed by a 2.0 microg/kg/min infusion at steady state achieved >80% inhibition of platelet aggregation. With the single-bolus regimen, however, there was an early loss of the inhibition of platelet aggregation before steady state was reached. Additional dose-exploration studies may further optimize eptifibatide dosing.


Assuntos
Doença das Coronárias/terapia , Peptídeos/farmacologia , Inibidores da Agregação Plaquetária/farmacologia , Agregação Plaquetária/efeitos dos fármacos , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Clorometilcetonas de Aminoácidos/farmacocinética , Angioplastia Coronária com Balão , Antitrombinas/farmacologia , Doença das Coronárias/mortalidade , Relação Dose-Resposta a Droga , Esquema de Medicação , Eptifibatida , Feminino , Humanos , Masculino , Taxa de Depuração Metabólica , Pessoa de Meia-Idade , Peptídeos/administração & dosagem , Peptídeos/farmacocinética , Inibidores da Agregação Plaquetária/farmacocinética
2.
Am Heart J ; 142(6): 982-8, 2001 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-11717601

RESUMO

BACKGROUND: The Simple and Effective Arterial Closure (SEAL) trial examined the safety and effectiveness of the Duett vascular sealing device (Vascular Solutions, Minneapolis, Minn) versus manual compression after diagnostic and interventional coronary procedures. We compared quality of life and initial hospitalization costs among patients treated with the Duett device versus manual compression. METHODS: Functional status was assessed with the Duke Activity Status Index (DASI) at 7 and 30 days after intervention. General health status was assessed with the Short Form (SF-36) at 30 days after intervention. Hospitalization costs were derived from the UB92 formulation of the hospital bill. RESULTS: There was a strong trend toward higher functional status in patients receiving treatment with the Duett device at 7 days both before (P =.04) and after (P =.08) adjustment for significant covariates. This difference was significant in the diagnostic group but not in the interventional group. No significant differences in quality of life between the Duett device and manual compression at 30 days were found. There was no significant difference in total hospitalization costs between treatment arms (P =.91). For interventional patients, mean total in-hospital costs were $10,167 in the Duett group and $10,225 in the manual compression group (P =.82). For diagnostic patients, mean hospitalization costs were $7784 and $7996 for the Duett device and manual compression groups, respectively (P =.72). Trends toward reduced recovery/observation room costs with the Duett device (P =.06) were found; this difference was significant in the diagnostic group ($198 vs $279, P =.02). CONCLUSIONS: The Duett sealing device was associated with significantly higher functional status at 7 days after the procedure in addition to shortened time to hemostasis and ambulation, with no associated increase in cost.


Assuntos
Técnicas Hemostáticas/instrumentação , Tempo de Internação/economia , Qualidade de Vida , Adesivos Teciduais , Adulto , Fatores Etários , Angioplastia Coronária com Balão , Cateterismo Cardíaco , Cateteres de Demora , Feminino , Artéria Femoral , Hemorragia/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Punções , Análise de Regressão , Fatores Sexuais , Resultado do Tratamento , Estados Unidos
3.
Circulation ; 103(21): 2572-8, 2001 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-11382726

RESUMO

BACKGROUND: The optimal level of platelet inhibition with a glycoprotein (GP) IIb/IIIa antagonist necessary to minimize thrombotic complications in patients undergoing a percutaneous coronary intervention (PCI) is currently unknown. METHODS AND RESULTS: Five hundred patients undergoing a PCI with the planned use of a GP IIb/IIIa inhibitor had platelet inhibition measured at 10 minutes, 1 hour, 8 hours, and 24 hours after the initiation of therapy with the Ultegra Rapid Platelet Function Assay (Accumetrics). Major adverse cardiac events (MACES: composite of death, myocardial infarction, and urgent target vessel revascularization) were prospectively monitored, and the incidence correlated with the measured level of platelet function inhibition at all time points. One quarter of all patients did not achieve >/=95% inhibition 10 minutes after the bolus and experienced a significantly higher incidence of MACEs (14.4% versus 6.4%, P=0.006). Patients whose platelet function was <70% inhibited at 8 hours after the start of therapy had a MACE rate of 25% versus 8.1% for those >/=70% inhibited (P=0.009). By multivariate analysis, platelet function inhibition >/=95% at 10 minutes after the start of therapy was associated with a significant decrease in the incidence of a MACE (odds ratio 0.46, 95% CI 0.22 to 0.96, P=0.04). CONCLUSIONS: Substantial variability in the level of platelet function inhibition is achieved with GP IIb/IIIa antagonist therapy among patients undergoing PCI. The level of platelet function inhibition as measured by a point-of-care assay is an independent predictor for the risk of MACEs after PCI.


Assuntos
Angioplastia Coronária com Balão , Cardiopatias/prevenção & controle , Inibidores da Agregação Plaquetária/uso terapêutico , Tirosina/análogos & derivados , Abciximab , Idoso , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais/uso terapêutico , Plaquetas/efeitos dos fármacos , Plaquetas/fisiologia , Estudos de Coortes , Eptifibatida , Feminino , Cardiopatias/induzido quimicamente , Humanos , Fragmentos Fab das Imunoglobulinas/efeitos adversos , Fragmentos Fab das Imunoglobulinas/uso terapêutico , Modelos Logísticos , Masculino , Análise Multivariada , Peptídeos/efeitos adversos , Peptídeos/uso terapêutico , Agregação Plaquetária/efeitos dos fármacos , Inibidores da Agregação Plaquetária/efeitos adversos , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Tirofibana , Tirosina/efeitos adversos , Tirosina/uso terapêutico
4.
Am Heart J ; 141(6): 964-70, 2001 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-11376311

RESUMO

BACKGROUND: The SHOCK Registry prospectively enrolled patients with cardiogenic shock complicating acute myocardial infarction in 36 multinational centers. METHODS: Cardiogenic shock was predominantly attributable to left ventricular pump failure in 884 patients. Of these, 276 underwent percutaneous coronary intervention (PCI) after shock onset and are the subject of this report. RESULTS: The majority (78%) of patients undergoing angiography had multivessel disease. As the number of diseased arteries rose from 1 to 3, mortality rates rose from 34.2% to 51.2%. Patients who underwent PCI had lower in-hospital mortality rates than did patients treated medically (46.4% vs 78.0%, P < .001), even after adjustment for patient differences and survival bias (P = .037). Before PCI, the culprit artery was occluded (Thrombolysis In Myocardial Infarction grade 0 or 1 flow) in 76.3%. After PCI, the in-hospital mortality rate was 33.3% if reperfusion was complete (grade 3 flow), 50.0% with incomplete reperfusion (grade 2 flow), and 85.7% with absent reperfusion (grade 0 or 1 flow) (P < .001). CONCLUSIONS: This prospective, multicenter registry of patients with acute myocardial infarction complicated by cardiogenic shock is consistent with a reduction in mortality rates as the result of percutaneous coronary revascularization. Coronary artery patency was an important predictor of outcome. Measures to promote early and rapid reperfusion appear critically important in improving the otherwise poor outcome associated with cardiogenic shock.


Assuntos
Angioplastia Coronária com Balão , Choque Cardiogênico/mortalidade , Choque Cardiogênico/terapia , Idoso , Canadá/epidemiologia , Feminino , Humanos , Masculino , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Estudos Prospectivos , Sistema de Registros , Análise de Sobrevida , Estados Unidos/epidemiologia
5.
J Interv Cardiol ; 14(2): 129-42, 2001 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-12053294

RESUMO

Glycoprotein (GP) IIb/IIIa inhibitors were developed to block platelet aggregation and potentially to abolish thrombus formation. Clinical trials have demonstrated that GP IIb/IIIa inhibitors are more potent antithrombotic agents than aspirin and heparin alone. GP IIb/IIIa inhibitors reduce short- and long-term complications of percutaneous revascularization. These agents also are effective as adjuncts to various treatment strategies for the management of patients with unstable angina (UA) or non-Q-wave myocardial infarction (NQMI). Furthermore, recent clinical trials with a small number of patients suggest that GP IIb/IIIa inhibitors in combination with low-dose fibrinolytics are safe and effective for the treatment of ST segment elevation myocardial infarction. The clinical trials of GP IIb/IIIa inhibitors summarized here examined different patient populations managed under different strategies. Moreover, these agents have different indications for clinical use and varying safety profiles.


Assuntos
Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Angina Instável/terapia , Angioplastia Coronária com Balão , Humanos , Infarto do Miocárdio/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto
6.
J Am Coll Cardiol ; 36(3 Suppl A): 1110-6, 2000 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-10985713

RESUMO

OBJECTIVES: We wished to assess the profile and outcomes of patients with ventricular septal rupture (VSR) in the setting of cardiogenic shock (CS) complicating acute myocardial infarction (MI). BACKGROUND: Cardiogenic shock is often seen with VSR complicating acute MI. Despite surgical therapy, mortality in such patients is high. METHODS: We analyzed 939 patients enrolled in the SHOCK Trial Registry of CS in acute infarction, comparing 55 patients whose shock was associated with VSR with 884 patients who had predominant left ventricular failure. RESULTS: Rupture occurred a median 16 h after infarction. Patients with VSR tended to be older (p = 0.053), were more often female (p = 0.002) and less often had previous infarction (p < 0.001), diabetes mellitus (p = 0.015) or smoking history (p = 0.033). They also underwent right-heart catheterization, intra-aortic balloon pumping and bypass surgery significantly more often. Although patients with rupture had less severe coronary disease, their in-hospital mortality was higher (87% vs. 61%, p < 0.001). Surgical repair was performed in 31 patients with rupture (21 had concomitant bypass surgery); 6 (19%) survived. Of the 24 patients managed medically, only 1 survived. CONCLUSIONS: There is a high in-hospital mortality rate when CS develops as a result of VSR. Ventricular septal rupture may occur early after infarction, and women and the elderly may be more susceptible. Although the prognosis is poor, surgery remains the best therapeutic option in this setting.


Assuntos
Sistema de Registros , Choque Cardiogênico/etiologia , Ruptura do Septo Ventricular/complicações , Idoso , Cateterismo Cardíaco , Procedimentos Cirúrgicos Cardíacos , Angiografia Coronária , Feminino , Mortalidade Hospitalar , Humanos , Balão Intra-Aórtico , Masculino , Infarto do Miocárdio/complicações , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/terapia , Revascularização Miocárdica , Prognóstico , Estudos Prospectivos , Choque Cardiogênico/mortalidade , Choque Cardiogênico/terapia , Terapia Trombolítica , Ruptura do Septo Ventricular/mortalidade , Ruptura do Septo Ventricular/terapia
7.
Am J Cardiol ; 85(2): 166-71, 2000 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-10955371

RESUMO

The influence of vessel size on clinical and angiographic outcomes after new device angioplasty has not been well documented. We reviewed clinical and angiographic outcomes of 2,044 patients undergoing new device angioplasty of native vessels enrolled in the New Approaches to Coronary Interventions (NACI) Registry. Quantitative angiography was performed using standard methods. Patients were divided into 3 groups according to reference vessel diameter (RVD) (<2.75, 2.75 to 3.25, and >3.25 mm). Patients with the smallest vessels had a higher incidence of diabetes (26% vs. 16%, p<0.01), multivessel disease (50% vs. 45%, p<0.01), left anterior descending coronary artery disease (61% vs. 39% p<0.01), and in general, more severe baseline lesion characteristics than patients with larger (>3.25 mm) vessels. Absolute baseline and final minimal lumen diameter (MLD) was also smaller in patients with RVD <2.75 mm despite similar final percent diameter stenosis. Although in-hospital events were similar, patients who underwent interventions in vessels <2.75 mm had an increased incidence of death (p<0.01), surgical revascularization (p<0.05), and target lesion revascularization (TLR) (p<0.01) at 1 year. Multivariate analysis by vessel size showed a stepwise increase in the risk of TLR by 1 year in patients with the smaller RVD (p = 0.0001) and the combined end point of 1 year death/Q wave-myocardial infarction/TLR (p = 0.02). Thus, despite similar early clinical events among patients undergoing new device angioplasty, patients who underwent treatment of smaller vessels had a significantly increased risk of major adverse clinical events and particularly TLR by 1 year after new device angioplasty of native coronary arteries.


Assuntos
Angioplastia/instrumentação , Vasos Coronários/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento
9.
Am Heart J ; 139(6): 1046-53, 2000 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-10827386

RESUMO

BACKGROUND: Prompt restoration of Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow improves survival in patients with acute ST-segment elevation myocardial infarction (MI). Fibrinolytic therapy fails to restore TIMI 3 flow within 90 minutes in 40% to 50% of patients. Because the results of percutaneous coronary intervention (PCI) for MI seem to be improving, a reevaluation of the role of PCI after fibrinolytic therapy for MI appears to be warranted. METHODS AND RESULTS: Data from all 9 randomized controlled trials (including new data from 4 trials) of rescue percutaneous transluminal coronary angioplasty (PTCA) versus conservative therapy after fibrinolytic therapy (1456 patients), 4 contemporary registries of PCI in this setting (977 patients), and other germane studies are reviewed. PTCA after failed fibrinolysis (TIMI 0 to 1 flow) appears to reduce early severe heart failure (3. 8% vs 11.7%, P =.04) and improve survival over 1 year in patients with moderate to large MI (92% vs 87%, P =.001) and possibly reduces early repeat MI (4.3% vs 11.3%, P =.08). Assessment of the possible benefit of PTCA for TIMI 2 flow is hampered by the small number of patients randomly assigned. Repeat MI may be decreased and left ventricular functional recovery enhanced. PTCA early after successful fibrinolysis is nearly always technically successful and may reduce repeat MI and hospital length of stay. However, it must be recalled that randomized trials from the 1980s suggested increased mortality rates with PTCA after restoration of TIMI 2 to 3 flow with fibrinolysis. Data from contemporary randomized studies of stents and glycoprotein IIb/IIIa inhibitors suggest that PCI as performed today may yield better results than those reviewed. CONCLUSIONS: These data suggest a probable benefit of rescue PTCA in several distinct scenarios and that the pivotal mid-1980s studies suggesting no benefit or harm for PTCA after fibrinolytic therapy may no longer be relevant. The role of mechanical intervention in the treatment of patients treated in these settings should be reassessed.


Assuntos
Angioplastia Coronária com Balão , Fibrinolíticos/uso terapêutico , Infarto do Miocárdio/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Terapia Trombolítica , Idoso , Eletrocardiografia , Tratamento de Emergência , Feminino , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/prevenção & controle , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Estudos Retrospectivos , Prevenção Secundária , Taxa de Sobrevida , Terapia Trombolítica/mortalidade , Falha de Tratamento
11.
J Ark Med Soc ; 96(9): 340-1, 2000 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-10705682

RESUMO

Among the multiple etiologies for congestive heart failure in patients with end-stage renal disease, the contribution of hemodialysis fistulas to the myocardial work load is often overlooked. We recently cared for a patient with high-output cardiac failure from an arteriovenous fistula and review the features and pathophysiology of this condition.


Assuntos
Fístula Arteriovenosa/complicações , Insuficiência Cardíaca/etiologia , Fístula Arteriovenosa/fisiopatologia , Ecocardiografia , Humanos , Falência Renal Crônica/complicações , Masculino , Pessoa de Meia-Idade
13.
J Ark Med Soc ; 97(6): 202-4, 2000 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-12876825

RESUMO

UNLABELLED: Serial serum troponin I and CK-MB measurements were obtained for 36 patients presenting to the emergency department with a confirmed diagnosis of acute myocardial infarction (AMI). For each patient, the normalized percentage of maximum troponin I concentration (%max TropI) was plotted vs. the time from the maximum value to obtain a kinetic decay plot. The linear correlation plots of the--Log (%max TropI) vs. time were compared. Patients with uncomplicated AMI (n = 31) showed linear correlation coefficients (CC) above 0.97 (mean CC = 0.991). Patients with AMI complicated by recurrent myocardial infarction (n = 5) documented by corroborate clinical findings, electrocardiographic abnormalities and/or abnormal CK-MB results showed linear correlation coefficients (CC) less than 0.97 (mean CC = 0.763). Using a cutoff value of CC = 0.97, both patient groups were completely separated and re-infarction or extension of infarction was predicted with 100% accuracy, sensitivity and specificity. CONCLUSION: Kinetic modeling of troponin I decay in patients with AMI correctly differentiates patients with complicated vs. non-complicated courses.


Assuntos
Infarto do Miocárdio/diagnóstico , Troponina I/sangue , Creatina Quinase/sangue , Creatina Quinase Forma MB , Humanos , Isoenzimas/sangue , Infarto do Miocárdio/sangue , Recidiva , Estudos Retrospectivos
14.
J Thromb Thrombolysis ; 9(1): 5-12, 2000 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-10590183

RESUMO

Thrombin activity has been implicated as a mechanism for failed reperfusion and reocclusion following thrombolysis. Aggregating platelets provide a phospholipid surface on which prothrombin is cleaved to form thrombin. We examined markers of thrombin generation and activity in patients enrolled in a randomized, placebo-controlled, dose escalating trial of the platelet glycoprotein IIb-IIIa inhibitor eptifibatide (Integrilintrade mark) administered concomitantly with tissue plasminogen activator for the treatment of myocardial infarction. Measurements were obtained at baseline, at 90 minutes, and at 6, 12, and 24 hours after starting therapy. Eptifibatide inhibited platelet aggregation in response to 20 microM ADP. Levels of fibrinopeptide A (FPA), thrombin-antithrombin complexes (TAT), and prothrombin fragment 1.2 (F1.2) were not lower in patients treated with eptifibatide than in the control group. In the course of dose escalation, two groups of patients received the same 135 microg/kg bolus of eptifibatide, one with and one without a heparin bolus. FPA levels were dramatically lower in the heparin-treated patients. Levels of FPA, TAT, and F1.2 were not higher in patients with than in those without recurrent ischemia, or in patients without than in those with Thrombolysis in Myocardial Infarction (TIMI) grade 3 angiographic flow at 90 minutes. These data suggest that thrombin generation and activity persist following thrombolysis, despite inhibition of platelet aggregation, and that treatment with inhibitors of thrombin activity may be required even when glycoprotein IIb-IIIa inhibitors are used.


Assuntos
Infarto do Miocárdio/tratamento farmacológico , Peptídeos/uso terapêutico , Inibidores da Agregação Plaquetária/uso terapêutico , Agregação Plaquetária/efeitos dos fármacos , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/farmacologia , Trombina/efeitos dos fármacos , Terapia Trombolítica , Estudos de Coortes , Método Duplo-Cego , Eptifibatida , Feminino , Fibrinopeptídeo A/efeitos dos fármacos , Fibrinopeptídeo A/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Peptídeos/administração & dosagem , Trombina/biossíntese , Trombina/metabolismo
15.
Control Clin Trials ; 20(6): 601-19, 1999 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-10588300

RESUMO

This multicenter, prospective randomized trial was designed to test the hypotheses that percutaneous coronary intervention (PCI) is a safe and effective alternative to coronary artery bypass grafting (CABG) for patients with refractory ischemia and high risk of adverse outcomes. As a comparison of revascularization strategies, the trial specifically allows surgeons and interventionists to use new techniques as they become clinically available. After 42 months of this 72-month trial, 17,624 patients have been screened and 2022 met eligibility requirements: 341 have been randomized to either CABG or PCI, and the remaining 1681 are being prospectively followed in a registry. The 3-year overall survival of patients in the registry and randomized trial is comparable. To enhance accrual into the randomized trial, site visits were conducted, a few low-accruing hospitals were put on probation and/or replaced, eligibility criteria were reviewed at annual meetings of investigators, and the accrual period was extended by 1 year. These data demonstrate that a prospective randomized trial and registry of coronary revascularization for medically refractory high-risk patients is feasible.


Assuntos
Ponte de Artéria Coronária , Isquemia Miocárdica/terapia , Revascularização Miocárdica , Fatores Etários , Idoso , Angina Instável/complicações , Baixo Débito Cardíaco/complicações , Estudos de Viabilidade , Seguimentos , Humanos , Balão Intra-Aórtico , Isquemia Miocárdica/cirurgia , Seleção de Pacientes , Estudos Prospectivos , Recidiva , Sistema de Registros , Reoperação , Fatores de Risco , Taxa de Sobrevida , Resultado do Tratamento
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