A prospective study of patients with refractory angina: outcomes and the role of high-sensitivity troponin T.

BACKGROUND: The predictors of cardiovascular events in patients with chronic refractory angina are limited. High-sensitivity cardiac troponin T (hs-cTnT) assays are biomarkers that may be used to determine the prognosis of patients with stable coronary artery disease. HYPOTHESIS: Hs-cTnT is a predictor of death and nonfatal myocardial infarction (MI) in patients with refractory angina. METHODS: We prospectively enrolled 117 consecutive patients in this study. A heart team ruled out myocardial revascularization feasibility after assessing recent coronary angiograms; evidence of myocardial ischemia served as an inclusion criterion. Optimal medical therapy was encouraged via outpatient visits every 6 months; plasma hs-cTnT levels were determined at baseline. The primary endpoint was the composite incidence of death and nonfatal MI. RESULTS: During a median follow-up period of 28.0 months (interquartile range, 18.0-47.5 months), an estimated 28.0-month cumulative event rate of 13.4% was determined via the Kaplan-Meier method. Univariate predictors of the composite endpoint were hs-cTnT levels and LV dysfunction. Following a multivariate analysis, only hs-cTnT was independently associated with the events in question, either as a continuous variable (hazard ratio per unit increase in the natural logarithm: 2.83, 95% confidence interval: 1.62-4.92, P < 0.001) or as a categorical variable (hazard ratio for concentrations above the 99th percentile: 5.14, 95% confidence interval: 2.05-12.91, P < 0.001). CONCLUSIONS: In patients with chronic refractory angina, plasma concentration of hs-cTnT is the strongest predictor of death and nonfatal MI. Notably, none of the outcomes in question occurred in patients with baseline plasma levels <5.0 ng/L.

Critical evaluation of screening questionnaires for obstructive sleep apnea in patients undergoing coronary artery bypass grafting and abdominal surgery.

BACKGROUND: Obstructive sleep apnea (OSA) is an independent risk factor for complications after surgery. However, OSA remains largely under recognized, and questionnaires designed to detect OSA have shown inconsistent results. Patients with cardiovascular diseases may not present with the typical symptoms of OSA. We therefore sought to compare the performance of screening questionnaires of patients referred for coronary artery bypass grafting (CABG) versus abdominal surgery (Abd surgery). METHODS: We studied 40 consecutive patients referred for CABG [29 men; age 56 ± 7 years; body mass index (BMI) 30 ± 4 kg/m(2)], and 41 referred to Abd Surgery matched for age, gender, and BMI (28 men; age 56 ± 8 years; BMI 29 ± 5 kg/m(2)). All patients were evaluated with validated questionnaires to predict OSA (STOP-Bang and Berlin), Epworth sleepiness scale (ESS) and full overnight polysomnography. RESULTS: The prevalence of OSA (apnea-hypopnea index ≥15 events/hour) in the CABG and Abd surgery groups was similar (52 and 41 %, respectively, p = 0.32). The Berlin questionnaire showed similar sensitivity (67 vs. 82 %, p = 0.17) but lower specificity in the CABG group (26 vs. 62 %, p = 0.02). The STOP-BANG questionnaire had a high sensitivity (90 vs. 94 %, p = 0.42) but low specificity (5 vs. 13 %, p = 0.25) in the CABG and Abd surgery groups, respectively. Patients referred for CABG slept less (323 [285-376] vs. 378 [308-415] minutes, p = 0.04) but had lower levels of daytime sleepiness than Abd surgery patients had (ESS, 6 ± 4 vs. 9 ± 5; p = 0.01, respectively). CONCLUSIONS: Presenting clinical characteristics of OSA are modulated by the population evaluated and may affect the performance of screening questionnaires.

Paper-filtered coffee increases cholesterol and inflammation biomarkers independent of roasting degree: a clinical trial.

OBJECTIVE: The aim of this study was to compare the effects of medium light roast (MLR) and medium roast (MR) paper-filtered coffee on cardiovascular risk factors in healthy volunteers. METHODS: This randomized crossover trial compared the effects of consuming three or four cups (150 mL) of MLR or MR coffee per day for 4 wk in 20 healthy volunteers. Plasma lipids, lipoprotein(a) (Lp[a]), total homocysteine, and endothelial dysfunction-related inflammation biomarkers, serum glycemic biomarkers, and blood pressure were measured at baseline and after each intervention. RESULTS: Both roasts increased plasma total cholesterol, low-density lipoprotein-cholesterol, and soluble vascular cell adhesion molecule-1 (sVCAM-1) concentrations (10%, 12%, and 18% for MLR; 12%, 14%, and 14% for MR, respectively) (P < 0.05). MR also increased high-density lipoportein-cholesterol concentration by 7% (P = 0.003). Plasma fibrinogen concentration increased 8% after MR intake (P = 0.01), and soluble E-selectin increased 12% after MLR intake (P = 0.02). No changes were observed for Lp(a), total homocysteine, glycemic biomarkers, and blood pressure. CONCLUSION: Moderate paper-filtered coffee consumption may have an undesirable effect on plasma cholesterol and inflammation biomarkers in healthy individuals regardless of its antioxidant content.

Five-year follow-up of a randomized comparison between off-pump and on-pump stable multivessel coronary artery bypass grafting. The MASS III Trial.

BACKGROUND: Coronary artery bypass graft surgery with cardiopulmonary bypass is a safe, routine procedure. Nevertheless, significant morbidity remains, mostly because of the body's response to the nonphysiological nature of cardiopulmonary bypass. Few data are available on the effects of off-pump coronary artery bypass graft surgery (OPCAB) on cardiac events and long-term clinical outcomes. METHODS AND RESULTS: In a single-center randomized trial, 308 patients undergoing coronary artery bypass graft surgery were randomly assigned: 155 to OPCAB and 153 to on-pump CAB (ONCAB). Primary composite end points were death, myocardial infarction, further revascularization (surgery or angioplasty), or stroke. After 5-year follow-up, the primary composite end point was not different between groups (hazard ratio 0.71, 95% CI 0.41 to 1.22; P=0.21). A statistical difference was found between OPCAB and ONCAB groups in the duration of surgery (240±65 versus 300±87.5 minutes; P<0.001), in the length of ICU stay (19.5±17.8 versus 43±17.0 hours; P<0.001), time to extubation (4.6±6.8 versus 9.3±5.7 hours; P<0.001), hospital stay (6±2 versus 9±2 days; P<0.001), higher incidence of atrial fibrillation (35 versus 4% of patients; P<0.001), and blood requirements (31 versus 61% of patients; P<0.001), respectively. The number of grafts per patient was higher in the ONCAB than the OPCAB group (2.97 versus 2.49 grafts/patient; P<0.001). CONCLUSIONS: No difference was found between groups in the primary composite end point at 5-years follow-up. Although OPCAB surgery was related to a lower number of grafts and higher episodes of atrial fibrillation, it had no significant implications related to long-term outcomes. Clinical Trial Registration-URL: http://www.controlled-trials.com. Unique identifier: ISRCTN66068876.

Clinical profile of patients enroled in a cell therapy trial for severe coronary artery disease.

AIMS AND OBJECTIVES: To compare the clinical profile of patients included in a clinical trial of autologous bone marrow cells as an adjunctive therapy to coronary artery bypass grafting with that of patients undergoing routine coronary artery bypass grafting. BACKGROUND: The therapeutic potential of autologous bone marrow cells has been explored in the treatment of severe coronary artery disease. There are few data regarding the clinical and socio-economic profile of patients included in clinical trials using bone marrow cell. DESIGN: Case-control study. METHOD: Sixty-seven patients (61 SD 9) years, 82% men) with multivessel coronary artery disease were divided into two groups: patients in the bone marrow cell group (n = 34) underwent incomplete coronary artery bypass grafting + intramyocardial injection of autologous bone marrow cells (lymphomonocytic fraction -2.0 (SD 0.2 x 10(8)) cells/patient) in the ischaemic, non-revascularised myocardium, whereas patients in the coronary artery bypass grafting group (n = 33) underwent routine bypass surgery. Demographics, socio-economic status, clinical and echocardiographic data were collected. Statistical analysis included the Fisher's exact test (categorical variables) and the Student's t-test (continuous variables). RESULTS: There were no significant differences between groups regarding age, gender, BMI, heart rate, blood pressure and echo data. There was a greater prevalence of obesity (65 vs. 33%; OR = 3.7 [1.3-10.1]), of previous myocardial infarction (68 vs. 39%; OR = 3.2 [1.2-8.8]) and prior revascularisation procedures (59 vs. 24%; OR = 4.5 [1.6-12.7]) in the autologous bone marrow cells group and of smokers in the coronary artery bypass grafting group (51 vs. 23%; OR = 3.5 [1.2-10.4]). CONCLUSIONS: Patients included in this clinical trial of autologous bone marrow cells for severe coronary artery disease presented a greater prevalence of myocardial revascularisation procedures, indicating a more severe clinical presentation of the disease. Fewer smokers in this group could be attributable to life style changes after previous cardiovascular events and/or interventions. RELEVANCE TO CLINICAL PRACTICE: The knowledge of the clinical profile of patients included in cell therapy trials may help researchers in the identification of patients that may be enroled in future clinical trials of this new therapeutic strategy.

[Informed consent as viewed by patients participating in cardiology drug trial]. / Entendimento do termo de consentimento por pacientes partícipes em pesquisas com fármaco na cardiologia.

BACKGROUND: In clinical tests, the Informed Consent is critical to preserve the ethics, but due to its high complexity level, it cannot be fully understood. This study assesses the Informed Consent as viewed by patients. OBJECTIVE: We addressed the issue of what do patients understand about the studies based on the IC. METHODS: We invited participants of outpatient clinical drug trials phase II, III and IV to answer a questionnaire with 29 questions, such as: why have you accepted to participate? Did you read the Informed Consent before signing it? By signing it, were you sure you have fully understood it? Eighty individuals (20 women and 60 men) showed up, from 106 patients. The variables of each question were considered as often as they appeared. The comparison of the averages among the groups was made by t tests of Student or Wilcoxon; and for associations, Chi-square or Likelihood Ratio, or Fisher's exact test. RESULTS: Ages averaged 58.7 +/- 9.3 years. Concerning their reasons to taking part in the survey, 66.2% pointed out their own benefit; 42.5%, for science's sake; 25.0% claimed they were doing so at their doctor's request; 50% did not understand the Informed Consent properly; and 32.9% did not read it, but signed it. Among those who were administered placebo after randomization (n = 47), 66.7% did not understand the meaning of the informed consent. A strong correlation between failure to understand the meaning of placebo with literacy level (p = 0,02) was verified, which is an evidence that the smaller is the literacy level, the smaller is the understanding level. CONCLUSION: The Informed Consent is poorly understood by patients and for some of them, trusting a doctor affected their decision in taking part in the clinical trial with drugs. Their literacy level also influenced their understanding of the term 'placebo'.

Entendimento do termo de consentimento por pacientes partícipes em pesquisas com fármaco na cardiologia / Informed consent as viewed by patients participating in cardiology drug trial / La comprensión del formulario de consentimiento por los pacientes que forman parte de investigaciones con fármaco en la cardiología

Fundamento: Em ensaios clínicos, o Termo de Consentimento Livre e Esclarecido (TCLE) é fundamental para preservar a ética, mas pela sua complexidade ele pode não ser entendido completamente. Neste estudo, avaliamos o entendimento do TCLE pelo paciente. Objetivo: Abordamos a questão sobre o nível de compreensão dos pacientes em relação aos estudos baseados no Consentimento Informado. Métodos: Convidamos participantes de pesquisa ambulatorial fases II, III e IV, com fármacos, para responder um questionário estruturado com 29 questões, tais como: por que aceitou participar? Leu o TCLE antes de assinar? Ao assiná-lo, estava certo de tê-lo entendido? Oitenta indivíduos (20 mulheres e 60 homens) compareceram, num universo de 106 pacientes. As variáveis de cada questão foram consideradas por frequência de ocorrência. A comparação entre as médias entre os grupos foi realizada pelos testes t de Student ou Wilcoxon; e para associações, o Qui-quadrado ou Razão de Verossimilhança, ou teste exato de Fisher. Resultados: A média das idades foi de 58,7 ± 9,3 anos. Das motivações para participar da pesquisa, 66,2 por cento apontaram seu próprio benefício; 42,5 por cento, o bem da ciência; 25,0 por cento alegaram atender a um pedido de seu médico; 50 por cento não entenderam corretamente o TCLE; e 32,9 por cento sequer o leram, mas o assinaram. Dentre os que receberam placebo após a randomização (n = 47), 66,7 por cento não entenderam o significado deste termo. Houve forte correlação entre o não entender o significado de placebo com a escolaridade (p = 0,02), evidenciando que quanto menor o nível de instrução, menor este entendimento. Conclusão: O TCLE é pouco compreendido pelos pacientes e para alguns deles a confiança no médico teve impacto na decisão de participar do ensaio clínico com fármaco, havendo também influência do nível de instrução dos sujeitos no entendimento do termo "placebo".

Background: In clinical tests, the Informed Consent is critical to preserve the ethics, but due to its high complexity level, it cannot be fully understood. This study assesses the Informed Consent as viewed by patients. Objective: We addressed the issue of what do patients understand about the studies based on the IC. Methods: We invited participants of outpatient clinical drug trials phase II, III and IV to answer a questionnaire with 29 questions, such as: why have you accepted to participate? Did you read the Informed Consent before signing it? By signing it, were you sure you have fully understood it? Eighty individuals (20 women and 60 men) showed up, from 106 patients. The variables of each question were considered as often as they appeared. The comparison of the averages among the groups was made by t tests of Student or Wilcoxon; and for associations, Chi-square or Likelihood Ratio, or Fisher's exact test. Results: Ages averaged 58.7 ± 9.3 years. Concerning their reasons to taking part in the survey, 66.2 percent pointed out their own benefit; 42.5 percent, for science's sake; 25.0 percent claimed they were doing so at their doctor's request; 50 percent did not understand the Informed Consent properly; and 32.9 percent did not read it, but signed it. Among those who were administered placebo after randomization (n = 47), 66.7 percent did not understand the meaning of the informed consent. A strong correlation between failure to understand the meaning of placebo with literacy level (p = 0,02) was verified, which is an evidence that the smaller is the literacy level, the smaller is the understanding level. Conclusion: The Informed Consent is poorly understood by patients and for some of them, trusting a doctor affected their decision in taking part in the clinical trial with drugs. Their literacy level also influenced their understanding of the term "placebo".

Fundamento: En ensayos clínicos, el Formulario de Consentimiento Informado (FCI) es fundamental para que se preserve la ética, sin embargo por su complexidad él puede no comprenderse completamente. En este estudio, evaluamos la comprensión del FCI por parte del paciente. Objetivo: Abordamos la cuestión sobre el nivel de comprensión de los pacientes respecto a los estudios basados en el Consentimiento Informado. Métodos: Invitamos a los participantes de investigación clínica fase II, III y IV con fármacos para responder un cuestionario estructurado con 29 cuestiones, tales como: ¿Por qué aceptó participar?¿Leyó el FCI antes de firmarlo?¿Al firmarlo estaba seguro de haberlo entendido? Ochenta individuos (20 mujeres y 60 varones) comparecieron, en un total de 106 pacientes. Las variables de cada cuestión se llevaron a cabo por frecuencia de ocurrencia. La comparación entre los promedios entre los grupos se realizó mediante las pruebas t de Student o Wilcoxon; y para asociaciones, el Chi-cuadrado o Razón de Verosimilitud, o prueba exacta de Fisher. Resultados: El promedio de las edades fue de 58,7 ± 9,3 años. De las motivaciones para participar en la investigación, el 66,2 por ciento señaló su propio beneficio; un 42,5 por ciento, el bien de la ciencia; un 25,0 por ciento alegó atender a una petición de su médico; el 50 por ciento no comprendió correctamente el FCI; y un 32,9 por ciento tampoco leyó el formulario, pero lo firmó. Entre los que recibieron placebo tras la randomización (n = 47), un 66,7 por ciento no entendió el significado de este término. Hubo una fuerte correlación entre las personas que no entendían el significado de placebo con la escolaridad (p = 0,02), evidenciando que cuanto menor era el nivel de instrucción, menor era la comprensión. Conclusión: EL FCI es poco comprendido por los pacientes y para algunos de ellos la confianza en el médico tuvo impacto en la decisión de participar en el ensayo clínico con fármaco, habiendo...

Dynamic regulation of MTHFR mRNA expression and C677T genotype modulate mortality in coronary artery disease patients after revascularization.

INTRODUCTION: A large body of evidence links plasma homocysteine (Hcy) concentrations and cardiovascular disease. A common MTHFR polymorphism (C677T) leads to a variant with reduced activity and associated with increased Hcy levels. Coronary surgery precipitates a significant and sustained increase in the blood concentrations of Hcy and elevated levels of plasma Hcy have been associated to saphenous vein (SV) graft disease after CABG. However, the effects of MTHFR genotypes in the incidence of cardiovascular events after CABG have not been investigated prospectively. Here, we investigate whether MTHFR gene variants are associated with an increased cardiovascular risk in individuals submitted to CABG. We also propose a molecular mechanism to explain our findings. METHODS: We performed MTHFR C677T genotypes in 558 patients with two or three vessel-disease and normal left ventricular function prospectively followed in the MASS II Trial, a randomized study to compare treatments for multivessel CAD and preserved left ventricle function. Follow-up time was 5 years. Survival curves were calculated with the Kaplan-Meier method, and evaluated with the log-rank statistic. We assessed the relationship between baseline variables and the composite end-point of death, myocardial infarction and refractory angina using a Cox proportional hazards survival model. Finally, using an ex-vivo organ culture we have reproduced the arterialization of SV implants by culturing human SV either under venous hemodynamic condition (flow: 5 mL/min; no pressure) or arterial hemodynamic condition (flow: 50 mL/min; pressure: 80 mm Hg) for 1 day. MTHFR gene expression was quantified by real time RT-PCR in 15 SV from different individuals in both experimental conditions. RESULTS: There were no significant differences among individuals within each genotype group for baseline clinical characteristics. A statistically significant association between the TT genotype, associated with increased serum levels of Hcy, and cardiovascular mortality after 5 years was verified (p=0.007) in individuals submitted to CABG surgery. In addition, MTHFR TT genotype was still significantly associated with a 4.4 fold increased risk in cardiovascular outcomes (p=0.01) even after adjustment of a Cox multivariate model for age, sex, hypertension, diabetes, LDL, HDL, triglycerides, and number of diseased vessels in this population. Finally, a significant reduction in MTHFR gene expression was demonstrated in human SV when submitted to an arterial hemodynamic condition (p=0.02). CONCLUSIONS: There is a dynamic regulation of MTHFR gene expression during the arterialization process of human saphenous vein grafts resulting in lower levels of gene expression when in an arterial hemodynamic condition. In addition, the C677T MTHFR functional variant is associated with a worse outcome in individuals submitted to CABG. Taken together, these data suggest an important role of Hcy metabolism in individuals after CABG.

Head-to-head comparison of dobutamine and adenosine stress real-time myocardial perfusion echocardiography for the detection of coronary artery disease.

We sought to determine the value of dobutamine versus adenosine real-time myocardial perfusion (MP) echocardiography for detecting coronary artery disease and the value of quantitative analysis of MP over electrocardiography, wall motion, and qualitative MP. We studied 54 patients by real-time MP echocardiography and coronary angiography. Replenishment velocity (beta) and an index of myocardial blood flow (A(n)xbeta) were derived from quantitative MP. During dobutamine stress, beta (1.7 +/- 0.7 vs 2.7 +/- 1.2; P < .001) and A(n)xbeta (2.2 +/- 1.0 vs 3.5 +/- 1.6; P < .001) reserves were lower in patients with coronary artery disease. The same was observed with adenosine for beta (1.7 +/- 0.8 vs 2.5 +/- 1.1; P < .001) and A(n)xbeta (1.9 +/- 0.7 vs 3.2 +/- 1.4; P < .001) reserves. Accuracy of electrocardiography, wall motion, qualitative MP, and quantitative MP were 61%, 76%, 76%, and 80% for dobutamine and 70%, 70%, 76%, and 80% for adenosine, respectively. Quantitative MP had incremental diagnostic value over other variables during dobutamine (chi(2) 23.7-38.4; P < .001) and adenosine (chi(2) 26.7-59.4; P < .001). In conclusion, dobutamine and adenosine real-time MP echocardiography hold similar accuracy for detecting coronary artery disease. Quantitative MP provides incremental diagnostic information over other variables.

Trimetazidine to reverse ischemia in patients with class I or II angina: a randomized, double-blind, placebo-controlled dobutamine-atropine stress echocardiography study.

AIMS: We sought to evaluate the effects of trimetazidine on ischemia induced by dobutamine-atropine stress echocardiography in patients with class I or class II angina. METHODS: In a randomized, double-blind, placebo-controlled study, 66 patients with proved coronary disease were subjected to dobutamine-atropine stress echocardiography. Ischemia was proved in 56 patients who were included in the study and who had been on standard maintenance medications (propranolol, aspirin and statin). They were randomized to placebo or trimetazidine, 20 mg three times daily for a 12-week period, when dobutamine-atropine stress echocardiography was repeated. RESULTS: Fifty-two patients (56.53+/-8.9 years old) completed the study. No differences were seen between groups at entry. Thirty patients had class I and 26 class II angina. At the end of the study, 42 had class I and 14 class II angina (P=0.01), owing to patients being in the trimetazidine arm. We did not observe any differences between groups either for onset time of ventricular ischemic dysfunction, or for wall-motion score index. Comparing variation at peak using the delta wall-motion score index, we observed no differences, but only a trend toward reduction favoring trimetazidine (P=0.09). CONCLUSION: We did not detect a significant anti-ischemic effect of trimetazidine in patients with mild angina, but there was a clear improvement in angina class.

Trimetazidine to reverse ischemia in patients with class I or II angina: a randomized, double-blind, placebo-controlled dobutamine–atropine stress echocardiography study / Trimetazidine to reverse ischemia in patients with class I or II angina: a randomized, double-blind, placebo-controlled dobutamine–atropine stress echocardiography study

Aims We sought to evaluate the effects of trimetazidine on ischemia induced by dobutamine–atropine stress echocardiography in patients with class I or class II angina. Methods In a randomized, double-blind, placebocontrolled study, 66 patients with proved coronary disease were subjected to dobutamine–atropine stress echocardiography. Ischemia was proved in 56 patients who were included in the study and who had been on standard maintenance medications (propranolol, aspirin and statin). They were randomized to placebo or trimetazidine, 20mg three times daily for a 12-week period, when dobutamine–atropine stress echocardiography was repeated. Results Fifty-two patients (56.53 ±8.9 years old) completed the study. No differences were seen between groups at entry. Thirty patients had class I and 26 class II angina. At the end of the study, 42 had class I and 14 class II angina (P =0.01), owing to patients being in the trimetazidine arm. We did not observe any differences between groups either for onset time of ventricular ischemic dysfunction, or for wall-motion score index.

Clinical judgment and treatment options in stable multivessel coronary artery disease: results from the one-year follow-up of the MASS II (Medicine, Angioplasty, or Surgery Study II).

OBJECTIVES: This study examined the predictive power of clinical judgment in the incidence of cardiovascular end points in a group of individuals with multivessel coronary artery disease (CAD) followed up in the MASS II (Medicine, Angioplasty, or Surgery Study II). BACKGROUND: There is still no consensus on the best treatment for patients with stable multivessel CAD and preserved left ventricular function. METHODS: Preferred treatment allocation was recorded for each of the 611 randomized patients in the MASS II trial before randomization. We have divided our sample according to physician-guided decision and randomization result into two categories: concordant or discordant. The incidence of the points of cardiac death, myocardial infarction, and refractory angina was compared between concordant and discordant patients. RESULTS: The number of concordant individuals was 292 (48.2%), and this number was not different between the three studied treatments (p = 0.11). A significant difference (p = 0.02) was disclosed because of an increased incidence of combined end point events in discordant patients. In the multivariate Cox hazard model, clinical judgment was a powerful predictor of outcome (p = 0.01) even after adjustment for other covariates. The main subgroup explaining this difference was a significant shift toward a worse outcome in the subgroup of discordant patients who underwent percutaneous coronary intervention (PCI) (p = 0.003). CONCLUSIONS: Angiographic variables were more often used in making clinical decisions regarding PCI than clinical variables, and the only independent predictor of concordance status in the PCI group was the number of diseased vessels (p = 0.01). Our data are a reminder that physician judgment remains an important predictor of outcomes.

Effect of glycoprotein IIIa PlA2 polymorphism on outcome of patients with stable coronary artery disease and effect of smoking.

A polymorphism of glycoprotein IIb/IIIa has been associated with myocardial infarction and restenosis after percutaneous coronary intervention. The influence on outcome and the interaction of the Pl(A1) genotype with classic risk factors for coronary artery disease (CAD) were characterized in patients with chronic CAD followed prospectively for 3 years. Pl(A1) genotypes were assessed in 592 patients enrolled in the Medical, Angioplasty, or Surgery Study II, a randomized trial comparing treatments for patients with CAD and preserved left ventricular function. The incidence of the composite end point of cardiac death, myocardial infarction, and refractory angina requiring revascularization were determined in each genotype group. Risk was assessed with the Cox proportional-hazards model. The clinical characteristics and treatment of each genotype were similar. Although the composite end point tended to be more common in patients with the Pl(A2) allele, only smokers with the Pl(A2) allele had a significantly increased incidence of the composite end point (p = 0.01). Moreover, a 2.2-fold increased risk was apparent in smokers with the Pl(A2) allele (p = 0.03). Thus, taken together, these data provide support for the interaction effect between smoking and the Pl(A1) gene variant. Smokers with the Pl(A2) polymorphism of platelet glycoprotein IIIa are at greater risk for subsequent cardiac events in stable coronary disease.

The medicine, angioplasty, or surgery study (MASS-II): a randomized, controlled clinical trial of three therapeutic strategies for multivessel coronary artery disease: one-year results.

OBJECTIVES: We sought to evaluate the relative efficacies of three possible therapeutic strategies for patients with multivessel coronary artery disease (CAD), stable angina, and preserved ventricular function. BACKGROUND: Despite routine use of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI), there is no conclusive evidence that either one is superior to medical therapy (MT) alone for the treatment of multivessel CAD. METHODS: The primary end point was defined as cardiac mortality, Q-wave myocardial infarction (MI), or refractory angina requiring revascularization. All data were analyzed according to the intention-to-treat principle. RESULTS: A total of 611 patients were randomly assigned to either a CABG (n = 203), PCI (n = 205), or MT (n = 203) group. The one-year survival rates were 96.0% for CABG, 95.6% for PCI, and 98.5% for MT. The rates for one-year survival free of Q-wave MI were 98% for CABG, 92% for PCI, and 97% for MT. After one-year follow-up, 8.3% of MT patients and 13.3% of PCI patients underwent to additional interventions, compared with only 0.5% of CABG patients. At one-year follow-up, 88% of the patients in the CABG group, 79% in the PCI group, and 46% in the MT group were free of angina (p < 0.0001). CONCLUSIONS: Medical therapy for multivessel CAD was associated with a lower incidence of short-term events and a reduced need for additional revascularization, compared with PCI. In addition, CABG was superior to MT for eliminating anginal symptoms. All three therapeutic regimens yielded relatively low rates of cardiac-related deaths.

The pre-existence of an acute coronary event predicts differences in biological parameters and clinical evolution among patients with longstanding stable angina.

BACKGROUND: To date, patients displaying stable angina with or without a previous acute coronary event have been grouped together and are offered nowadays, similar clinical approach. However, from clinical experience, increasing doubt exists whether they behave clinically in the same way. In the current study, we investigated whether differences might exist in the clinical, angiographic and biological parameters between these two distinct clinical presentations. METHODS: The cardiovascular risk factor profile, clinical evolution, angiographic data, white blood cell (WBC) count and plasma concentrations of lipids and fibrinogen were compared between two groups of patients with longstanding stable angina. The first group consisted of 160 subjects who had undergone myocardial infarction (MI) as the first manifestation of coronary artery disease (CAD) and had no further coronary event. The second group was composed of 226 subjects who had effort-induced angina but never experienced an acute coronary event. The mean period between the first CAD manifestation and entry into the study was 7+/-6 years for MI group and 7+/-4 years for patients with uneventful angina. RESULTS: MI patients displayed 8% higher WBC count (P=0.038), 20% higher fibrinogen (P=0.001), 12% lower HDL cholesterol (P=0.02), 8% lower apoA1 (P=0.005) and 46% higher lipoprotein (a) (P=0.005) than patients who presented an uneventful clinical course. Upon multivariate logistic regression analysis, fibrinogen (OR=1.14; 95% CI=1.08-1.28; P=0.033), lipoprotein (a) (OR=1.19; 95% CI=1.05-1.34; P=0.0036) and HDL cholesterol levels (OR=0.97; 95% CI=0.94-0.99; P=0.0095) remained independently associated with the pre-existence of MI. Patients with prior MI evolved more frequently towards clinically refractory angina (P=0.04). In addition, fibrinogen levels were independently associated with evolution to clinically refractory angina (OR=1.03; 95% CI=1.005-1.550; P=0.0448). CONCLUSIONS: Stable CAD patients with a prior MI differ from those who display an uneventful effort-induced angina in their biological profile and their evolution towards clinically refractory angina.

Relative cost comparison of treatments for coronary artery disease: the First Year Follow-Up of MASS II Study.

BACKGROUND: Prior comparisons of costs following CABG and PTCA have demonstrated higher initial costs after CABG but following PTCA, recurrent symptoms and repeat revascularization result in increased late costs and over time their costs equilibrate. The MASS II trial provides an opportunity to compare the costs of CABG and PTCA in addition to a strategy of medical therapy. METHODS: We studied the 611 patients of MASS II [Medical (203), Angioplasty (205), or Surgery (203) Study], a randomized study to compare treatments for multivessel CAD and preserved left ventricle function. The costs were: CABG 10,650.00 US dollars; PTCA 6400.00 US dollars; new AMI hospitalization AMI 2550 US dollars; angiography not followed-up of PTCA 1900.00 US dollars; and medication 1200.00 US dollars for medical, and 1000.00 US dollars for the other groups. We did adjustment for average event-free time, and angina-free proportion. The statistical analysis carried out was chi-square, t test, and analysis of variance. RESULTS: After 1 year, 49% Medical, 79% PTCA, and 88% CABG became angina-free; P<0.0001. There were 26 coronary angiograms (5 medical, 17 PTCA, and 4 CABG), 23 AMI (8 medical, 17 PTCA, and 6 CABG; P=0.03); PTCA was performed in 7 Medical, 17 PTCA, and 1 CABG, (P=0.0003), CABG was performed in 15 Medical, 8 PTCA, and zero CABG; P=0.002. The event-free and event and angina-free-costs in the first year were 2453.50 US dollars and 5006.32 US dollars for Medical; 10348,43 US dollars; and 13,099.31 US dollars for PTCA; and 12,404.21 US dollars and 14,095.09 US dollars for CABG group. An increase from expected costs of 317%, 77%, and 21%, respectively. CONCLUSIONS: PTCA effective costs were similar to CAGB costs, Medical treatment presented the lowest cost, and however, the greatest increment, and CABG presented the most stable costs.