ALEXANDRE CIAPPINA HUEB
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- Cost-Effectiveness Analysis for Surgical, Angioplasty, or Medical Therapeutics for Coronary Artery Disease 5-Year Follow-Up of Medicine, Angioplasty, or Surgery Study (MASS) II Trial(2012) VIEIRA, Ricardo D'Oliveira; HUEB, Whady; HLATKY, Mark; FAVARATO, Desiderio; REZENDE, Paulo Cury; GARZILLO, Cibele Larrosa; LIMA, Eduardo Gomes; SOARES, Paulo Rogerio; HUEB, Alexandre Ciappina; PEREIRA, Alexandre Costa; RAMIRES, Jose Antonio Franchini; KALIL FILHO, RobertoBackground-The Second Medicine, Angioplasty, or Surgery Study (MASS II) included patients with multivessel coronary artery disease and normal systolic ventricular function. Patients underwent coronary artery bypass graft surgery (CABG, n = 203), percutaneous coronary intervention (PCI, n = 205), or medical treatment alone (MT, n = 203). This investigation compares the economic outcome at 5-year follow-up of the 3 therapeutic strategies. Methods and Results-We analyzed cumulative costs during a 5-year follow-up period. To analyze the cost-effectiveness, adjustment was made on the cumulative costs for average event-free time and angina-free proportion. Respectively, for event-free survival and event plus angina-free survival, MT presented 3.79 quality-adjusted life-years and 2.07 quality-adjusted life-years; PCI presented 3.59 and 2.77 quality-adjusted life-years; and CABG demonstrated 4.4 and 2.81 quality-adjusted life-years. The event-free costs were $9071.00 for MT; $19 967.00 for PCI; and $18 263.00 for CABG. The paired comparison of the event-free costs showed that there was a significant difference favoring MT versus PCI (P<0.01) and versus CABG (P<0.01) and CABG versus PCI (P<0.01). The event-free plus angina-free costs were $16 553.00, $25 831.00, and $24 614.00, respectively. The paired comparison of the event-free plus angina-free costs showed that there was a significant difference favoring MT versus PCI (P=0.04), and versus CABG (P<0.001); there was no difference between CABG and PCI (P>0.05). Conclusions-In the long-term economic analysis, for the prevention of a composite primary end point, MT was more cost effective than CABG, and CABG was more cost-effective than PCI.
conferenceObject Evolution of ventricular function in patients with stable coronary artery disease submitted to on-pump or off-pump coronary artery bypass graft in MASS III trial(2012) STASZKO, K. F.; HUEB, W.; LIMA, E. G.; BISELLI, B.; GARZILLO, C. L.; PEREIRA, A. C.; HUEB, A. C.; REZENDE, P. C.; RAMIRES, J. A. F.; KALIL FILHO, R.Purpose: Ventricular function is a major determinant of prognosis in patients with coronary artery disease (CAD). Few data are available to assess the evolution of ventricular function among patients submitted to off-pump coronary artery bypas graft surgery (OPCAB). To compare the evolution of ventricular function in a long-term follow-up among patients with stable CAD submitted to OPCAB or On-Pump coronary artery bypass graft (ONCAB) Methods: Patients with stable CAD and preserved systolic left ventricular function were randomized to OPCAB or ONCAB and followed for 5 years. Patients who undergone a new evaluation of ventricular function in this follow-up were studied. Left ventricular ejection fraction (LVEF) was assessed by echocardiogram. Results: Of 308 patients randomized to OPCAB (n=155) or ONCAB (n=153), 91 had a new assessment of ventricular function by echocardiogram in a 5-year follow-up: 49 in ONCAB group and 42 in OPCAB group. In ONCAB group the initial and final mean of LVEF was respectively 59.85% and 56.16% (p=0.10). In OPCAB group the initial and final mean of LVEF was respectively 59.18% and 56.07 (p=0.17). Conclusion: There was no difference in the evolution of LVEF among patients with stable CAD randomized to ONCAB or OPCAB in a 5-year follow-up.conferenceObject EVOLUTION OF VENTRICULAR FUNCTION IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE SUBMITTED TO ON-PUMP OR OFF-PUMP CORONARY ARTERY BYPASS GRAFT IN MASS III TRIAL(2012) STASZKO, Kamila F.; HUEB, Whady; LIMA, Eduardo; BISELLI, Bruno; GARCIA, Rosa Maria Rahmi; VIEIRA, Ricardo D. O.; GARZILLO, Cibele Larrosa; PEREIRA, Alexandre Costa; HUEB, Alexandre Ciappina; REZENDE, Paulo Cury; CASELLA-FILHO, Antonio; RAMIRES, Jose; KALIL-FILHO, RobertoBackground Ventricular function is a major determinant of prognosis in patients with coronary artery disease (CAD). Few data are available to assess the evolution of ventricular function among patients submitted to off-pump coronary artery bypass graft surgery (OPCAB). Purpose To compare the evolution of ventricular function in a long-term follow-up among patients with stable CAD submitted to OPCAB or On-Pump coronary artery bypass graft (ONCAB) Methods Patients with stable CAD and preserved systolic left ventricular function were randomized to OPCAB or ONCAB and followed for 5 years. Patients who undergone a new evaluation of ventricular function in this follow-up were studied. Left ventricular ejection fraction (LVEF) was assessed by echocardiogram. Results Of 308 patients randomized to OPCAB (n=155) or ONCAB (n=153), 91 had a new assessment of ventricular function by echocardiogram in a 5-year follow-up: 49 in ONCAB group and 42 in OPCAB group. In ONCAB group the initial and final mean of LVEF was respectively 59.85% and 56.16% (p=0.10). In OPCAB group the initial and final mean of LVEF was respectively 59.18 % and 56.07 (p=0.17). Conclusion There was no difference in the evolution of LVEF among patients with stable CAD randomized to ONCAB or OPCAB in a 5-year follow-up. ACC Moderated Poster Contributions McCormick Place South, Hall A Monday, March 26, 2012, 9:30 a.m.-10:30 a.m. Session Title: Fresh CABG: Good for SIHD? Abstract Category: 3. Chronic CAD/Stable Ischemic Heart Disease: Therapy Presentation Number: 1208-409conferenceObject PERFORMANCE OF LEFT VENTRICULAR EJECTION FRACTION ON PATIENTS WITH STABLE MULTIVESSEL CORONARY DISEASE SUBMITTED TO MEDICINE, ANGIOPLASTY OR SURGERY: 10 YEARS FOLLOW-UPFROM MASS II TRIAL(2012) GARZILLO, Cibele L.; HUEB, Whady; LIMA, Eduardo Gomes; REZENDE, Paulo Cury; FAVARATO, Desiderio; SOARES, Paulo; HUEB, Alexandre Ciappina; STOLF, Noedir A. G.; RAMIRES, Jose; KALIL-FILHO, RobertoBackground Coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) are assumed as effective therapeutic options for the protection of the ischemic myocardium. However, it is not established if those procedures are effective for left ventricular ejection fraction (LVEF) preservation. In this setting, we evaluated the evolution of LVEF in patients with stable multivessel coronary disease, submitted to CABG, PCI or medical treatment (MT) alone, after ten years of follow-up. Methods Echocardiography was performed on patients participants of MASS II trial, previously to randomization for CABG, PCI or MT, and after 10 years. LVEF was measured by the biplane method (Simpson), when regional wall-motion abnormalities were present, or by the Teichholz method. Results After a follow-up of 10.32 (±1.43) years, 350 patients had LVEF reassessed: 108 patients on MT, 111 on CABG and 131 on PCI group. Main baseline characteristics and the occurrence of AMI were similar among the three groups. There was no difference of LVEF either at the beginning (0.61 + 0.07, 0.61 + 0.08 e 0.61 + 0.09 respectively for PCI, CABG and MT, p=0.675) and the end of follow up (0.56 + 0.11, 0.55 + 0.11 e 0.55 + 0.12 respectively for PCI, CABG and MT, p=0.675). The impact of other variables over LVEF evolution, such as gender, age, diabetes and arterial pattern, were also analyzed, and no relevance was demonstrated. However, the presence of previous AMI (OR 2.50, 95% CI 1.40-4.45; p= 0.0007) and the occurrence of AMI during follow up (OR 2.73, 95% IC 1.25-5.92; p=0.005) were associated with an increased risk of developing LVEF < 45%. Also, AMI during follow-up was responsible for a greater reduction of LVEF (reduction delta of 18.29 ± 21.22% and 6.63 ± 18.91%, respectively for patients with and without AMI, p=0.001). Conclusion Thus, compared with PCI or CABG patients, patients in the medical group with unprotected coronary artery disease by mechanical revascularization without adverse cardiac events showed no differences in the left ventricular function after 10 years of follow up. Moreover, whatever of interventional therapeutic strategies applied, the left ventricular function remained unchanged in absence of MACE. ACC Moderated Poster Contributions McCormick Place South, Hall A Monday, March 26, 2012, 9:30 a.m.-10:30 a.m. Session Title: Fresh CABG: Good for SIHD? Abstract Category: 3. Chronic CAD/Stable Ischemic Heart Disease: Therapy Presentation Number: 1208-410- Effect of Complete Revascularization on 10-Year Survival of Patients With Stable Multivessel Coronary Artery Disease MASS II Trial(2012) VIEIRA, Ricardo D'Oliveira; HUEB, Whady; GERSH, Bernard J.; LIMA, Eduardo Gomes; PEREIRA, Alexandre Costa; REZENDE, Paulo Cury; GARZILLO, Cibele Larrosa; HUEB, Alexandre Ciappina; FAVARATO, Desiderio; SOARES, Paulo Rogerio; RAMIRES, Jose Antonio Franchini; KALIL FILHO, RobertoBackground-The importance of complete revascularization remains unclear and contradictory. This current investigation compares the effect of complete revascularization on 10-year survival of patients with stable multivessel coronary artery disease (CAD) who were randomly assigned to percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). Methods and Results-This is a post hoc analysis of the Second Medicine, Angioplasty, or Surgery Study (MASS II), which is a randomized trial comparing treatments in patients with stable multivessel CAD, and preserved systolic ventricular function. We analyzed patients who underwent surgery (CABG) or stent angioplasty (PCI). The survival free of overall mortality of patients who underwent complete (CR) or incomplete revascularization (IR) was compared. Of the 408 patients randomly assigned to mechanical revascularization, 390 patients (95.6%) underwent the assigned treatment; complete revascularization was achieved in 224 patients (57.4%), 63.8% of those in the CABG group and 36.2% in the PCI group (P = 0.001). The IR group had more prior myocardial infarction than the CR group (56.2% X 39.2%, P = 0.01). During a 10-year follow-up, the survival free of cardiovascular mortality was significantly different among patients in the 2 groups (CR, 90.6% versus IR, 84.4%; P = 0.04). This was mainly driven by an increased cardiovascular specific mortality in individuals with incomplete revascularization submitted to PCI (P = 0.05). Conclusions-Our study suggests that in 10-year follow-up, CR compared with IR was associated with reduced cardiovascular mortality, especially due to a higher increase in cardiovascular-specific mortality in individuals submitted to PCI.
conferenceObject IMPACT OF METABOLIC SYNDROME ON THE OUTCOME OF PATIENTS WITH STABLE CORONARY ARTERY DISEASE SUBMITTED TO DIFFERENT TYPES OF TREATMENT: 10-YEAR FOLLOW-UP OF THE MASS II STUDY(2012) LIMA, Eduardo Gomes; HUEB, Whady; GARCIA, Rosa Maria Rahmi; VIEIRA, Ricardo D. O.; GARZILLO, Cibele Larrosa; PEREIRA, Alexandre Costa; HUEB, Alexandre Ciappina; REZENDE, Paulo Cury; CASELLA-FILHO, Antonio; RAMIRES, Jose; KALIL-FILHO, RobertoBackground Metabolic syndrome (MetS) is understood as a condition that promotes atherosclerosis and confers an additional risk of adverse cardiovascular events in patients with coronary artery disease. The prognosis of this syndrome in this subset of patients in a long term follow up is inconclusive. Objective Evaluate the impact of metabolic syndrome on cardiac death in patients with symptomatic chronic multivessel coronary artery disease. Methods Patients randomized in MASS II study submitted to coronary artery bypass graft (CABG), angioplasty (PCI) or medical treatment (MT) were evaluated for the presence of MetS and followed prospectively for 10 years. We evaluated the incidence of overall and cardiac death in this period. Results Criteria for MetS were fulfilled in 283 patients of 583 (54%) randomized to three therapeutic strategies. The presence of MetS, was associated with an increased cardiac related death in studied population. During a 10-year follow-up, the probability cardiac mortality free survival was significantly different among patients in the 2 groups (MetS = 81,6% × non-MetS = 91,3% P=0.004). Stratifying patients with MetS by therapeutic approach we identify a statistical difference in cardiac death free survival comparing interventional approaches (CABG and PCI) to MT: 82,4% for CABG; 86,2% for PCI and 75,9% for MT (P=0,003). Besides, there is a group with best prognosis: patients without MetS submitted to CABG presenting 98,7% of patients free of cardiac death in a 10-year follow-up. Conclusion MetS confers high rates of cardiac death in patients with stable coronary artery disease irrespective of therapeutic strategy used. In patients with MetS, interventional approaches (PCI or CABG) seem to confer more protection against cardiac death in a 10-year follow-up. ACC Moderated Poster Contributions McCormick Place South, Hall A Monday, March 26, 2012, 11:00 a.m.-Noon Session Title: DES and Drugs: Decisions in Diabetics Abstract Category: 3. Chronic CAD/Stable Ischemic Heart Disease: Therapy Presentation Number: 1209-477- Cancer-related deaths among different treatment options in chronic coronary artery disease: results of a 6-year follow-up of the MASS II study(2012) VIEIRA, Ricardo D.; PEREIRA, Alexandre C.; LIMA, Eduardo G.; GARZILLO, Cibele L.; REZENDE, Paulo Cury; FAVARATO, Desiderio; HUEB, Alexandre C.; GERSH, Bernard J.; RAMIRES, Jose A. F.; HUEB, WhadyIntroduction The primary end points of randomized clinical trials evaluating the outcome of therapeutic strategies for coronary artery disease (CAD) have included nonfatal acute myocardial infarction, the need for further revascularization, and overall mortality. Noncardiac causes of death may distort the interpretation of the long-term effects of coronary revascularization. Materials and methods This post-hoc analysis of the second Medicine, Angioplasty, or Surgery Study evaluates the cause of mortality of patients with multivessel CAD undergoing medical treatment, percutaneous coronary intervention, or surgical myocardial revascularization [coronary artery bypass graft surgery (CABG)] after a 6-year follow-up. Mortality was classified as cardiac and noncardiac death, and the causes of noncardiac death were reported. Results Patients were randomized into CABG and non-CABG groups (percutaneous coronary intervention plus medical treatment). No statistical differences were observed in overall mortality (P = 0.824). A significant difference in the distribution of causes of mortality was observed among the CABG and non-CABG groups (P = 0.003). In the CABG group, of the 203 randomized patients, the overall number of deaths was 34. Sixteen patients (47.1%) died of cardiac causes and 18 patients (52.9%) died of noncardiac causes. Of these, seven deaths (20.6%) were due to neoplasia. In the non-CABG group, comprising 408 patients, the overall number of deaths was 69. Fifty-three patients (77%) died of cardiac causes and 16 patients (23%) died of noncardiac causes. Only five deaths (7.2%) were due to neoplasia. Conclusion Different treatment options for multivessel coronary artery disease have similar overall mortality: CABG patients had the lowest incidence of cardiac death, but the highest incidence of noncardiac causes of death, and specifically a higher tendency toward cancer-related deaths. Coron Artery Dis 23:79-84 (C) 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.
conferenceObject Evolution of left ventricular ejection fraction in patients with multivessel coronary heart disease submitted to 3 therapeutic strategies: 10 years follow-up(2012) GARZILLO, C. L.; HUEB, W.; LIMA, E. G.; REZENDE, P. C.; FAVARATO, D.; SOARES, P. R.; HUEB, A. C.; STOLF, N. A. G.; RAMIRES, J. A. F.; KALIL FILHO, R.Background: Coronary artery bypassgraft (CABG) and percutaneous coronary intervention (PCI) are assumed aseffective therapeutic options for the protection of the ischemic myocardium. However, it is not established if those procedures are mandatory for leftventricular ejection fraction (LVEF) preservation. In this setting, weevaluated the evolution of LVEF in patients with chronic multivessel coronary- heart disease, submitted to CABG, PCI or medical treatment (MT) alone, after afollow-up of ten years. Methods: Echocardiography wasperformed on patients participants of MASS II trial, previously to randomizationfor CABG, PCI or MT, and after 10 years. LVEF was measured by the biplanemethod (Simpson) preferably, but on obligatory basiswhen regional wall-motion abnormalities were present, or alternatively by the Teichholz method. Results: After afollow-up of 10,32 (±1.43)years, 350 patients had LVEF reassessed: 108 patientson MT, 111 on CABG and 131 on PCI group. Main baseline characteristics and theoccurrence of AMI were similar among the three groups. There was no difference of LVEF either at the beginning (0,61 + 0,07, 0,61 + 0,08 e 0,61 +0,09 respectively for PCI, CABG and MT, p=0,675) and the end of follow up (0,56+ 0,11, 0,55 + 0,11 e 0,55 + 0,12 respectively for PCI,CABG and MT, p=0,675). The impact ofother variables over LVEF evolution, such as gender, age, diabetes and arterial pattern, were also analyzed, and no relevance was demonstrated. However, the presence of previous AMI (OR 2.50, 95% CI 1.40- 4.45; p= 0.0007) and theoccurrence of AMI during follow up (OR 2.73, 95% IC 1.25-5.92; p=0,005) were associated with an increased risk of developing LVEF < 45%. Also, AMIduring follow-up was responsible for a greater reduction of LVEF (reductiondelta of 18,29 ± 21,22% and 6,63 ± 18,91%, respectively for patients with andwithout AMI, p=0.001). Conclusion: In this study, the evolution of ventricular function on patients of MT-group, with unprotected coronary heart disease, was similar to those withme-chanical revascularization, either by PCI or CABG. Besides, irrespective ofthe therapeutic strategy applied, the occurrence of AMI was responsible for agreater decrease of LVEF.- Hypotheses, rationale, design, and methods for prognostic evaluation of cardiac biomarker elevation after percutaneous and surgical revascularization in the absence of manifest myocardial infarction. A comparative analysis of biomarkers and cardiac magnetic resonance. The MASS-V Trial(2012) HUEB, Whady; GERSH, Bernard J.; REZENDE, Paulo Cury; GARZILLO, Cibele Larrosa; LIMA, Eduardo Gomes; VIEIRA, Ricardo D'Oliveira; GARCIA, Rosa Maria Rahmi; FAVARATO, Desiderio; SEGRE, Carlos Alexandre W.; PEREIRA, Alexandre Costa; SOARES, Paulo Rogerio; RIBEIRO, Expedito; LEMOS, Pedro; PERIN, Marco A.; STRUNZ, Celia Cassaro; DALLAN, Luis A. O.; JATENE, Fabio B.; STOLF, Noedir A. G.; HUEB, Alexandre Ciappina; DIAS, Ricardo; GAIOTTO, Fabio A.; COSTA, Leandro Menezes Alves da; OIKAWA, Fernando Teiichi Costa; MELO, Rodrigo Morel Vieira de; SERRANO JUNIOR, Carlos Vicente; AVILA, Luiz Francisco Rodrigues de; VILLA, Alexandre Volney; PARGA FILHO, Jose Rodrigues; NOMURA, Cesar; RAMIRES, Jose A. F.; KALIL FILHO, RobertoBackground: Although the release of cardiac biomarkers after percutaneous (PCI) or surgical revascularization (CABG) is common, its prognostic significance is not known. Questions remain about the mechanisms and degree of correlation between the release, the volume of myocardial tissue loss, and the long-term significance. Delayed-enhancement of cardiac magnetic resonance (CMR) consistently quantifies areas of irreversible myocardial injury. To investigate the quantitative relationship between irreversible injury and cardiac biomarkers, we will evaluate the extent of irreversible injury in patients undergoing PCI and CABG and relate it to postprocedural modifications in cardiac biomarkers and long-term prognosis. Methods/Design: The study will include 150 patients with multivessel coronary artery disease (CAD) with left ventricle ejection fraction (LVEF) and a formal indication for CABG; 50 patients will undergo CABG with cardiopulmonary bypass (CPB); 50 patients with the same arterial and ventricular condition indicated for myocardial revascularization will undergo CABG without CPB; and another 50 patients with CAD and preserved ventricular function will undergo PCI using stents. All patients will undergo CMR before and after surgery or PCI. We will also evaluate the release of cardiac markers of necrosis immediately before and after each procedure. Primary outcome considered is overall death in a 5-year follow-up. Secondary outcomes are levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis and systolic left ventricle dysfunction assessed by CMR. Discussion: The MASS-V Trial aims to establish reliable values for parameters of enzyme markers of myocardial necrosis in the absence of manifest myocardial infarction after mechanical interventions. The establishments of these indices have diagnostic value and clinical prognosis and therefore require relevant and different therapeutic measures. In daily practice, the inappropriate use of these necrosis markers has led to misdiagnosis and therefore wrong treatment. The appearance of a more sensitive tool such as CMR provides an unprecedented diagnostic accuracy of myocardial damage when correlated with necrosis enzyme markers. We aim to correlate laboratory data with imaging, thereby establishing more refined data on the presence or absence of irreversible myocardial injury after the procedure, either percutaneous or surgical, and this, with or without the use of cardiopulmonary bypass.
conferenceObject Impact of metabolic syndrome on the outcome of patients with stable coronary artery disease submitted to different types of treatment: 10-year follow-up of the MASS II study(2012) LIMA, E. G.; HUEB, W.; RAHMI, R.; VIEIRA, R. D. O.; GARZILLO, C. L.; PEREIRA, A. C.; HUEB, A. C.; REZENDE, P. C.; RAMIRES, J. A. F.; KALIL FILHO, R.Purpose: Metabolic syndrome (MetS) is understood as a condition that promotes atherosclerosis and confers an additional risk of adverse cardiovascular eventsin patients with coronary artery disease. The prognosis of this syndrome in this subset of patients in a long term follow up is inconclusive. Evaluate the impact of metabolic syndrome on cardiac death in patients with symptomatic chronic multivessel coronary artery disease. Methods: Patients randomized in MASS II study submitted to coronary artery bypass graft (CABG),angioplasty (PCI) or medical treatment (MT) were evaluated for the presence of MetS and followed prospectively for 10 years. We evaluated the incidence of overall and cardiac death in this period. Results: Criteria for MetS were fulfilled in 283 patients of 583 (54%) randomized to three therapeutic strategies. The presence of MetS was associated with an increased cardiac related death in studied population. During a 10-year follow- up, the probability cardiac mortality free survival was significantly different among patients in the 2 groups (MetS = 81,6% x non-MetS = 91,3% P=0.004). Stratifying patients with MetS by therapeutic approach we identify a statistical difference in cardiac death free survival comparing interventional approaches (CABG and PCI) to MT: 82,4% for CABG; 86,2% for PCI and 75,9% for MT(P=0,003). Besides, there is a group with best prognosis: patients without MetS submitted to CABG presenting 98,7% of patients free of cardiac death in a 10-year follow-up. Conclusion: MetS confers high rates of cardiac death in patients with stable coronary artery disease irrespective of therapeutic strategy used. In patients with MetS, interventional approaches (PCI or CABG) seem to confer more protection against cardiac death in a 10-year follow-up.