RESUMO
The NIsoldipine in COronary artery disease in LEuven (NICOLE) study investigates (1) whether nisoldipine, a dihydropyridine calcium antagonist, reduces the progression of minor coronary arterial lesions in the long term, and (2) whether it reduces the restenosis rate after successful percutaneous transluminal coronary angioplasty (PTCA). The NICOLE study is a single-center, randomized, double-blind trial in 826 patients, who underwent a successful PTCA. Nisoldipine 40 mg coat-core or placebo was started the morning after the procedure and continued for 3 years. All coronary arterial segments were measured on preprocedural angiogram and on the second follow-up angiogram at 3 years. On the first follow-up angiogram at 6 months only the dilated segments were measured. Although the study is still ongoing until the primary end point is reached, we report in this study the angiographic restenosis data as well as the clinical events observed at 6-month follow-up. The per-protocol population consisted of 646 patients. Restenosis, defined as a > or =50% loss of the initial gain (National Heart, Lung, and Blood Institute criterion IV) occurred in 49% and 55% of the 308 nisoldipine-treated and the 338 placebo-treated patients, respectively (p = NS). At follow-up, the rates of death and myocardial infarction were low and similar in both groups, but in the nisoldipine group, less patients required early coronary angiography (18% vs 26%, p = 0.006) and subsequent revascularization procedures (32% vs 41%, p = 0.057). Thus, nisoldipine did not significantly reduce the angiographic restenosis rate after PTCA, but reduced the number of repeat revascularization procedures, which may be due to its antianginal action.
Assuntos
Angioplastia Coronária com Balão , Bloqueadores dos Canais de Cálcio/uso terapêutico , Doença das Coronárias/terapia , Nisoldipino/uso terapêutico , Angiografia Coronária , Doença das Coronárias/diagnóstico por imagem , Preparações de Ação Retardada , Progressão da Doença , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , RecidivaRESUMO
To defray the escalating costs of coronary stenting, we handmade a balloon-expandable, stainless steel stent, which after experimental evaluation, was implanted in 156 patients undergoing PTCA complicated by a major dissection. The procedural success rate was 98%. The in-hospital course was characterized by a 1.3% cardiopulmonary mortality and a 4.5% nonfatal myocardial infarction rate, while emergency bypass surgery and early repeat PTCA were necessary in only one patient each (0.6%). Clinical 6-mo follow-up in 150 patients revealed no deaths and no myocardial infarctions, and the event-free survival rate was 82%. Six-month control angiography was performed in 93.3% of eligible patients and revealed a restenosis rate of 20%.
Assuntos
Angioplastia Coronária com Balão , Doença das Coronárias/terapia , Stents , Dissecção Aórtica/etiologia , Angioplastia Coronária com Balão/efeitos adversos , Constrição Patológica , Aneurisma Coronário/etiologia , Angiografia Coronária , Desenho de Equipamento , Humanos , Recidiva , Resultado do TratamentoRESUMO
BACKGROUND: Earlier angiographic studies have suggested that calcium antagonists may prevent the formation of new coronary lesions and the progression of minimal lesions. Conversely, a meta-analysis suggested that these drugs may increase cardiovascular mortality and morbidity in patients with coronary heart disease. OBJECTIVE: To investigate whether nisoldipine retards the progression of coronary atherosclerosis or reduces the occurrence of clinical events. DESIGN AND SETTING: The NICOLE study (NIsoldipine in COronary artery disease in LEuven) is a single centre, randomised, double blind, placebo controlled trial with coronary angiography at baseline, six months, and three years of follow up. PATIENTS: 826 patients who had undergone successful coronary angioplasty were randomised to nisoldipine 40 mg once daily or placebo. The intention to treat and per protocol population consisted of 819 and 578 patients, respectively. RESULTS: In the per protocol population, 625 of the nisoldipine treated and 655 of the placebo treated patients (NS) showed angiographic progression in at least one coronary arterial segment, defined as an increase in diameter stenosis of > or = 13%. The average minimum luminal diameter of the non-dilated lesions decreased by 0.163 mm and 0.167 mm in the nisoldipine and placebo groups, respectively (NS). The respective numbers of new lesions detected were 7 and 13 (NS). In the intention to treat population, the rates of death, stroke, and acute myocardial infarction were similar in both treatment groups. However, nisoldipine use was associated with fewer revascularisation procedures and thus the percentage of patients with any clinical event was lower (44.6% v 52.6%, p = 0.02). CONCLUSIONS: Nisoldipine has no demonstrable effect on the angiographic progression of coronary atherosclerosis or the risk of major cardiovascular events but its use is associated with fewer revascularisation procedures.
Assuntos
Bloqueadores dos Canais de Cálcio/uso terapêutico , Doença da Artéria Coronariana/tratamento farmacológico , Nisoldipino/uso terapêutico , Bloqueadores dos Canais de Cálcio/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Estenose Coronária/prevenção & controle , Progressão da Doença , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Assistência de Longa Duração , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Nisoldipino/efeitos adversos , Acidente Vascular Cerebral/etiologiaRESUMO
One hundred two patients with evolving myocardial infarction of 6 hours' duration were given aspirin and intravenous heparin and randomly allocated to intravenous front-loaded, weight-adjusted rTPA administration over a 90-minute period (52 patients) or to two 15 mg doses of recombinant staphylokinase, 30 minutes apart (50 patients). Thrombolysis in Myocardial infarction (TIMI) perfusion grade 3 at 90 minutes was achieved in 68% (95% confidence interval, 55% to 81%) of patients treated with staphylokinase versus 57% (95% confidence interval, 43% to 72%) of patients treated with rTPA (p = not significant). Double-bolus staphylokinase was significantly more fibrin-specific than accelerated rTPA with residual fibrinogen at 90 minutes of 105% +/- 4.1% and 68% +/- 7.5%, respectively (p < 0.0001). Thirteen patients in each study group underwent angioplasty of the culprit coronary artery within the first 24 hours because of suboptimal recanalization (TIMI < 3). In the patients without prior coronary intervention, TIMI 3 at 24 hours was 100% after staphylokinase administration (n = 35) versus 79% after rTPA (n = 34) (p = 0.005). The distribution of inhospital events did not significantly differ between both groups. One patient receiving rTPA died in the hospital from ischemic stroke. Staphylokinase administration did not induce allergic reactions, but significant staphylokinase-neutralizing activity (> 5 micrograms/ml) and specific anti-staphylokinase IgG developed in 73% of patients after 2 weeks. Thus two 15 mg doses of staphylokinase induce early, complete, and sustained coronary artery patency at least as frequently as accelerated rTPA without associated fibrinogen degradation but with subsequent induction of circulating neutralizing antibodies.
Assuntos
Fibrinolíticos/uso terapêutico , Metaloendopeptidases/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Ativador de Plasminogênio Tecidual/uso terapêutico , Feminino , Fibrinogênio/efeitos dos fármacos , Fibrinolíticos/efeitos adversos , Fibrinolíticos/imunologia , Humanos , Injeções Intravenosas , Masculino , Metaloendopeptidases/efeitos adversos , Metaloendopeptidases/imunologia , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Ativadores de Plasminogênio/efeitos adversos , Ativadores de Plasminogênio/uso terapêutico , Estudos Prospectivos , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/imunologia , Proteínas Recombinantes/uso terapêutico , Ativador de Plasminogênio Tecidual/efeitos adversos , Grau de Desobstrução Vascular/efeitos dos fármacosRESUMO
BACKGROUND: Recombinant staphylokinase (STAR) was shown recently to offer promise for coronary arterial thrombolysis in patients with evolving myocardial infarction. The present multicenter randomized open trial was designed to assess the thrombolytic efficacy, safety, and fibrin specificity of STAR relative to accelerated alteplase (recombinant tissue-type plasminogen activator [RTPA]). METHODS AND RESULTS: One hundred patients with evolving myocardial infarction of < 6 hours' duration and with ST-segment elevation were allocated to accelerated and weight-adjusted RTPA over 90 minutes (52 patients) or to STAR (the first 25 patients to 10 mg and the next 23 patients to 20 mg given intravenously over 30 minutes). All patients received aspirin and intravenous heparin. The main end points were coronary artery patency and plasma fibrinogen levels at 90 minutes. Thrombolysis in Myocardial Infarction (TIMI) perfusion grade 3 at 90 minutes was achieved in 62% of STAR patients versus 58% of RTPA patients (risk ratio, 1.1; 95% CI, 0.76 to 1.5). With 10 mg STAR, TIMI grade 3 patency was 50% (risk ratio, 0.86; 95% CI, 0.54 to 1.4 versus RTPA); with 20 mg STAR, it was 74% (risk ratio, 1.3; 95% CI, 0.90 to 1.8 versus RTPA). Residual fibrinogen levels at 90 minutes were 118 +/- 47% (mean +/- SD) of baseline with STAR and 68 +/- 42% with RTPA (P < .0005). STAR therapy was not associated with an excess mortality or electric, hemorrhagic, mechanical, or allergic complications. However, patients developed antibody-mediated STAR-neutralizing activity from the second week after STAR treatment. As an addendum to the randomized study, 5 patients were given 40 mg STAR over 30 minutes, resulting in TIMI perfusion grade 3 at 90 minutes in 4 patients without fibrinogen breakdown (residual levels at 90 minutes of 105 +/- 8% of baseline). CONCLUSIONS: STAR appears to be at least as effective for early coronary recanalization as and significantly more fibrin-specific than accelerated RTPA in patients with evolving myocardial infarction.
Assuntos
Fibrinolíticos/uso terapêutico , Metaloendopeptidases/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Terapia Trombolítica , Ativador de Plasminogênio Tecidual/uso terapêutico , Angioplastia Coronária com Balão , Angiografia Coronária , Vasos Coronários/efeitos dos fármacos , Feminino , Fibrinogênio/análise , Fibrinolíticos/efeitos adversos , Humanos , Infusões Intravenosas , Masculino , Metaloendopeptidases/efeitos adversos , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Infarto do Miocárdio/diagnóstico por imagem , Estudos Prospectivos , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Fatores de Tempo , Ativador de Plasminogênio Tecidual/efeitos adversos , Grau de Desobstrução Vascular/efeitos dos fármacosRESUMO
To defray the escalating cost of coronary stenting, we handmade a balloon expandable coil stent with stainless steel wire. Preliminary comparison with the Palmaz-Schatz stent showed that, when implanted in porcine iliac arteries, there was no difference in immediate angiographic results or in the degree of foreign body reaction at 6 wk. Subsequently, a total of 73 stents were implanted in 52 patients, either as a bailout device (54%) or for suboptimal angiographic results (46%). All but two implantations were successful. The postprocedural regimen consisted of heparin 1,000 IU/hr, aspirin 250 mg daily, and ticlopidine 500 mg daily. In-hospital complications were limited to two groin hematomas, one necessitating blood transfusion. Importantly, stent thrombosis was not observed. While 6-mo follow-up is pending, we already conclude that a balloon expandable coil stent can be handmade easily at low cost and implanted safely in patients.
Assuntos
Cateterismo/instrumentação , Doença das Coronárias/terapia , Segurança de Equipamentos , Stents , Animais , Cateterismo/métodos , Angiografia Coronária , Vasos Coronários/patologia , Vasos Coronários/ultraestrutura , Modelos Animais de Doenças , Desenho de Equipamento , Seguimentos , Humanos , Stents/economia , SuínosRESUMO
The immediate safety and efficacy and the 6 month clinical and angiographic follow-up of a new fish-scale designed coronary coil stainless steel stent (Freedomª) was assessed by a prospective study. During 1995, 169 patients were treated on 177 vessels using 233 Freedom stents. Procedural indication for stenting was a bail-out situation in 79 vessels, a suboptimal angioplasty result in 62 vessels and a third restenosis after PTCA in 36 vessels. Procedural success was achieved in 170 vessels (96%); in 162 patients (96%). Subacute thrombotic occlusion occurred in one patient (0.6%). Acute myocardial infarction occurred in 7 patients (4.1%). Bleeding complications, necessitating blood transfusion occurred in 6 patients (3.6%). There were two non-stent related deaths. Recurrence of stent-related angina pectoris and/or a positive stress test occurred in 10 pts (6.4%). Elective control angiography at 6 months was performed in the first 85 patients. Stent restenosis of ³ 50% diameter stenosis was found in 14 patients (16.5%).