Short-term comprehensive cardiac rehabilitation after AMI is associated with reduced 1-year mortality: results from the OMEGA study.

BACKGROUND: The prognostic effect of early, comprehensive short-term cardiac rehabilitation on top of current, guideline-adjusted treatment of acute myocardial infarction has not sufficiently been evaluated. DESIGN: Prospective cohort study. METHODS: Within the OMEGA study population, the clinical course of 3560 patients still alive 3 months after acute myocardial infarction were evaluated by comparing patients who had attended to cardiac rehabilitation (70.6%) with those who did not. Total mortality and major adverse cerebrovascular and cardiovascular events, as well as non-fatal events, were evaluated within the time period of 4-12 months after hospital admission for acute myocardial infarction. The effect of cardiac rehabilitation on clinical events was estimated by using the propensity score method to adjust for confounding parameters in multivariate analysis. RESULTS: Patients participating in cardiac rehabilitation were younger, more often had acute revascularization, less often experienced non-ST-elevation myocardial infarction, and less often had a history of diabetes or cardiovascular events. Total mortality (OR 0.46, 95% CI 0.27-0.77) and major adverse cerebrovascular and cardiovascular events (OR 0.53, 95% CI 0.38-0.75) were significantly lower in the rehabilitation group. Subgroup analysis including major clinical characteristics also revealed significantly reduced rates of total death and major adverse cerebrovascular and cardiovascular events in the rehabilitation group. CONCLUSIONS: Attendance to early, comprehensive short-term cardiac rehabilitation programmes on top of current guideline-adjusted treatment of acute myocardial infarction is associated with a significantly improved 1-year prognosis.

Effects of 1-year treatment with highly purified omega-3 fatty acids on depression after myocardial infarction: results from the OMEGA trial.

OBJECTIVE: The effects of supplementation of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on prevalence and severity of depression were evaluated in patients after a myocardial infarction. METHOD: A cross-sectional evaluation (posttest-only design) within the prospective, randomized, controlled, multicenter OMEGA trial was performed in patients after myocardial infarction at 12 months' follow-up (N = 2,081; age, mean = 64 years; men, 76.7%; women, 21.8%) from April 2005 to June 2007. Patients received supplementation with ethyl esters 90 (460-mg EPA and 380-mg DHA) or placebo for 12 months. Depression was assessed with the Beck Depression Inventory-II (BDI-II); a BDI-II cutoff score of ≥ 14 was used as diagnosis of depression. RESULTS: When the total population was evaluated, no effects of EPA/DHA supplementation on depressive symptoms according to BDI-II score (mean [SD]) could be demonstrated: EPA/DHA (n = 1,046), 7.1 (6.9); placebo (n = 1,035), 7.1 (7.0); P = .7. The post hoc analyses of depressed patients with and without antidepressants revealed a tendency toward an antidepressant effect in patients with EPA/DHA supplementation as monotherapy: EPA/DHA (n = 125), 19.4 (5.8); placebo (n = 113), 19.9 (5.1); P = .07. However, in depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants, a clinically relevant antidepressant effect was demonstrated: EPA/DHA (n = 33), 20.9 (7.1); placebo (n = 29), 24.9 (8.5); P < .05. CONCLUSIONS: EPA/DHA supplementation in the total sample of patients after myocardial infarction had no effect on depressive symptoms. The clinically relevant antidepressant effect in the subgroup of depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants that was revealed in the post hoc analysis might provide a basis for a controlled, prospective trial of omega-3 augmentation of antidepressants in patients after myocardial infarction. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00251134.

Predictors of 1-year mortality in patients with contemporary guideline-adherent therapy after acute myocardial infarction: results from the OMEGA study.

BACKGROUND: Predictors of long-term mortality after discharge after acute myocardial infarction (AMI) are well characterized. However, these established risk factors are based on data almost exclusively derived from older studies without consistent use of revascularization therapy and adjunctive therapy with statins, platelet inhibitors, beta-blockers and ACE inhibitors/ARBs. We therefore sought to investigate predictors of 1-year mortality in survivors of AMI treated with contemporary guideline-adherent therapy. METHODS AND RESULTS: We performed a retrospective analysis of 3,782 patients surviving acute ST-elevation and non ST-elevation myocardial infarction who were enrolled in the prospective, randomized, double-blind, controlled OMEGA trial with 104 German centers. The primary objective of the OMEGA study was to determine the effect of highly purified omega-3 fatty acid ethyl esters-90 on the rate of sudden cardiac death in patients surviving AMI and receiving current guideline-adherent treatment within the 1-year of follow-up. 80.8 % of the patients received early revascularization therapy. At discharge, 94.2 % of the patients received beta-blocker, 90.4 % ACE inhibitor/angiotensin receptor blocker, 94.3 % statin, 95.4 % aspirin and 88.4 % clopidogrel. During the 1-year follow-up 139 patients (3.7 %) died. Multivariate logistic regression analysis revealed the following independent predictors of 1-year mortality in decreasing order of importance: ejection fraction <45 % [odds ratio (OR) 2.28, 95 % confidence interval (CI) 1.53-3.41], age ≥70 years (OR 2.17, 95 % CI 1.42-3.32), no acute revascularization (OR 2.02, 95 % CI 1.33-3.08), prior stroke/transient ischemic attack (OR 1.90, 95 % CI 1.09-3.30), peripheral arterial disease (OR 1.86, 95 % CI 1.12-3.10), heart rate >85/min (OR 1.82, 95 % CI 1.23-2.71), chronic obstructive lung disease (OR 1.77, 95 % CI 1.01-3.10) and HDL cholesterol <40 mg/dl (OR 1.75, 95 % CI 1.15-2.67). CONCLUSIONS: In patients surviving AMI and treated with contemporary guideline-adherent therapy, 1-year mortality was low. Nevertheless, traditional risk factors such as ejection fraction <45 %, older age, no acute revascularization and comorbidities were the strongest predictors of long-term mortality supporting the findings from previous studies.

Predictors of one-year mortality after transcatheter aortic valve implantation for severe symptomatic aortic stenosis.

Transcatheter aortic valve implantation (TAVI) is already an accepted option to treat elderly patients with severe symptomatic aortic stenosis who are inoperable or at high surgical risk. However, short- and long-term mortality after TAVI remains an important issue, raising the need to further improve the technology of TAVI as well as to identify patients who will not benefit from TAVI. A total of 1,391 patients treated with TAVI at 27 hospitals were included in the German Transcatheter Aortic Valve Interventions - Registry. One-year follow-up data were available for 1,318 patients (94.8%), with a mean follow-up period of 12.9 ± 4.5 months. One-year mortality was 19.9%. Survivors and nonsurvivors showed multiple differences in patient characteristics, indications for interventions, preintervention and interventional characteristics, and postintervention events. A higher logistic European System for Cardiac Operative Risk Evaluation score was associated with higher 1-year mortality (p <0.0001). Cox proportional-hazards analysis revealed the following independent predictors of mortality: among preintervention findings: previous mitral insufficiency ≥II° (p = 0.0005), low-gradient aortic stenosis (p = 0.0008), previous decompensation (p = 0.0061), previous myocardial infarction (p = 0.0138), renal failure (p = 0.0180), previous New York Heart Association class IV (p = 0.0254), and female gender (p = 0.0346); among procedural factors: intraprocedural conversion to surgery (p = 0.0009), peri-intervention stroke (p = 0.0003), and residual aortic insufficiency ≥II° (p = 0.0022); and among postprocedural events: postintervention myocardial infarction (p = 0.0009) and postintervention pulmonary embolism (p = 0.0025). In conclusion, 1-year mortality after TAVI was 19.9% in this series. Patient characteristics and procedural as well as postintervention factors associated with mortality were identified, which may allow better patient selection and better care for these critically ill patients.

Usefulness of heart rate to predict one-year mortality in patients with atrial fibrillation and acute myocardial infarction (from the OMEGA trial).

In the setting of acute myocardial infarction and sinus rhythm, the heart rate (HR) has been demonstrated to correlate closely with mortality. In patients presenting with acute myocardial infarction and atrial fibrillation (AF) on admission, however, the prognostic relevance of the HR has not yet been systematically addressed. A post hoc subgroup analysis of the data from the OMEGA trial was conducted to analyze whether the admission HR determines the 1-year mortality in patients presenting with AF in the setting of acute myocardial infarction. Of 3,851 patients enrolled in the OMEGA study, 211 (6%) presented with AF on admission. This subgroup was dichotomized according to the admission HR (cutoff 95 beats/min). Multiple regression analysis revealed that an admission HR of ≥95 beats/min independently determined the 1-year mortality in patients with AF (odds ratio 4.69, 95% confidence interval 1.47 to 15.01; p = 0.01). In conclusion, this is the first study demonstrating that a high HR (≥95 beats/min) on admission in patients with AF and acute myocardial infarction is associated with an almost fivefold mortality risk.

Transcatheter aortic valve implantation in patients with "porcelain" aorta (from a Multicenter Real World Registry).

The presence of severe atherosclerosis of the ascending aorta, and its extreme form the "porcelain" aorta, is associated with a worse clinical outcome in patients undergoing surgical aortic valve replacement. Percutaneous transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis can overcome this problem: 1,374 TAVI procedures were performed at 27 hospitals in 147 patients (10.7%) with and 1,227 (89.3%) without a porcelain aorta. The mean reported prevalence of a porcelain aorta at the hospitals was 7.8% ± 14.8% (range 0% to 70%). Diabetes mellitus (46.3% vs 33.2%, p = 0.00018), chronic obstructive pulmonary disease (43.5% vs 22.2%, p <0.0001), and peripheral arterial obstructive disease (34.7% vs 20.0%, p <0.0001) were more prevalent in patients with a porcelain aorta. In patients with a porcelain aorta, coronary ischemia occurred more often (2.0% vs 0.1%, p <0.0001), with a tendency toward a greater stroke rate (5.5% vs 2.8%, p = 0.08), greater in-hospital death rate (10.9% vs 8.1%, p = 0.24), and greater death or stroke rate (14.4% vs 10.2%, p = 0.12). On multivariate analysis, the presence of a porcelain aorta was not associated with in-hospital death (odds ratio 1.36, 95% confidence interval 0.72 to 2.55, p = 0.3441) nor in-hospital death or stroke (odds ratio 1.50, 95% confidence interval 0.81 to 2.47, p = 0.2207). In conclusion, in this real-world TAVI registry, a "porcelain" aorta was diagnosed in almost every tenth patient. Although differences were found in its frequency among the participating hospitals, the presence of a porcelain aorta was not associated with in-hospital death or stroke.

Correction of aortic regurgitation after transcatheter aortic valve implantation of the Medtronic CoreValveTM prosthesis due to a too-low implantation, using transcatheter repositioning.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) has been introduced for the treatment of severe symptomatic aortic stenosis in patients not suitable for surgical valve replacement. However, a potential problem of TAVI is the development of severe aortic insufficiency after valve implantation due to a too-low implantation of the valve. METHODS: Since August 2008, a total of 33 TAVI procedures using the 18 Fr Medtronic CoreValve ReValving system has been performed at the authors' institution. RESULTS: Severe post-implantation aortic regurgitation occurred in three patients (9%), due to a too-low implantation. Two of these patients underwent a catheter-based repositioning of the valve using a standard snare; the third patient declined any further intervention. Both repositioning procedures were uneventful, with no significant residual regurgitation. CONCLUSION: Severe aortic regurgitation after TAVI with the Medtronic CoreValve system is not uncommon. If the valve is implanted too low, a catheter-based valve repositioning may be the method of choice to resolve the problem.

OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction.

BACKGROUND: There is no randomized, double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline-adjusted treatment of acute myocardial infarction. METHODS AND RESULTS: OMEGA is a randomized, placebo-controlled, double-blind, multicenter trial testing the effects of omega-3-acid ethyl esters-90 (1 g/d for 1 year) on the rate of sudden cardiac death in survivors of acute myocardial infarction, if given in addition to current guideline-adjusted treatment. Secondary end points were total mortality and nonfatal clinical events. Patients (n=3851; female, 25.6%; mean age, 64.0 years) were randomized in 104 German centers 3 to 14 days after acute myocardial infarction from October 2003 until June 2007. Acute coronary angiography was performed in 93.8% and acute percutaneous coronary intervention in 77.8% of all patients. During a follow-up of 365 days, the event rates were (omega and control groups) as follows: sudden cardiac death, 1.5% and 1.5% (P=0.84); total mortality, 4.6% and 3.7% (P=0.18); major adverse cerebrovascular and cardiovascular events, 10.4% and 8.8% (P=0.1); and revascularization in survivors, 27.6% and 29.1% (P=0.34). CONCLUSIONS: Guideline-adjusted treatment of acute myocardial infarction results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up, which could not be shown to be further reduced by the application of omega-3 fatty acids. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251134.

Inferior ST-Elevation Myocardial Infarction Associated with Takotsubo Cardiomyopathy.

Takotsubo cardiomyopathy (TCM) is usually characterized by transient left ventricular apical ballooning. Due to the clinical symptoms which include chest pain, electrocardiographic changes, and elevated myocardial markers, Takotsubo cardiomyopathy is frequently mimicking ST-elevation myocardial infarction in the absence of a significant coronary artery disease. Otherwise an acute occlusion of the left anterior descending coronary artery can produce a typical Takotsubo contraction pattern. ST-elevation myocardial infarction (STEMI) is frequently associated with emotional stress, but to date no cases of STEMI triggering TCM have been reported. We describe a case of a female patient with inferior ST-elevation myocardial infarction complicated by TCM.

Severe aortic regurgitation after percutaneous transcatheter aortic valve implantation: on the importance to clarify the underlying pathophysiology.

Severe symptomatic aortic stenosis in a 90-year-old man was treated with percutaneous aortic valve implantation (TAVI) with a 29-mm CoreValve Revalving system. Following implantation, severe aortic regurgitation occurred. Echocardiography showed a small paravalvular and a huge valvular leakage, probably due to one malfunctioning valve leaflet. Concerning this pathophysiology, a further TAVI was performed using a second 29-mm CoreValve Revalving system, as a "valve-in-valve" implantation.

Reperfusion therapy for acute ST-elevation and non ST-elevation myocardial infarction: what can be achieved in daily clinical practice in unselected patients at an interventional center?

BACKGROUND: In the year 2000 a new definition of acute myocardial infarction (AMI) was introduced, now differentiating ST segment elevation AMI (STEMI) from non-ST segment elevation AMI (NSTEMI). The characterization of AMI patients according to this definition is still incomplete. METHODS AND RESULTS: 888 consecutive AMI patients at a single interventional center were included: 493 (55.5%) STEMI and 395 (44.5%) NSTEMI patients. Median age of STEMI patients was four years lower compared to NSTEMI patients (62.8 versus 66.6 years, P<0.001). STEMI patients more often presented in cardiogenic shock (11.0% versus 2.0%, P<0.001) and after pre-hospital resuscitation (4.9% versus 0.8%, P<0.001). Catheterization was performed in 98.4% of STEMI and in 95.9% of NSTEMI patients (P<0.001). The circumflex artery was more often the culprit lesion in NSTEMI patients compared to STEMI patients (58.3% versus 48%, P=0.003). They also showed significantly more often a 3 vessel disease (41.4% versus 29.9%, P=0.002). Out of STEMI patients 10.1% were treated with medical therapy only compared to 27.2% of NSTEMI patients (P<0.001). Whereas PCI was performed more often in STEMI patients (84.3% versus 57.8%, P<0.001), CABG was used more often in NSTEMI patients (21.6% versus 9.1%, P<0.001). In-hospital death was 8.7% in STEMI compared to 4.8% in NSTEMI patients (P<0.001). CONCLUSIONS: In clinical practice STEMI and NSTEMI seem to occur with similar frequency. Invasive strategies were applied in a high percentage in both groups, however with different therapeutic consequences. In-hospital mortality was twice as high in STEMI compared to NSTEMI patients.

Incidence and clinical impact of right bundle branch block in patients with acute myocardial infarction: ST elevation myocardial infarction versus non-ST elevation myocardial infarction.

BACKGROUND: Both left bundle branch block and right bundle branch block (RBBB) have been associated with increased inhospital and long-term mortality in patients with acute ST elevation myocardial infarction (STEMI). However, the prognostic role of RBBB in acute non-ST elevation myocardial infarction (NSTEMI) is not well known. Therefore, the aim of the study was to evaluate the incidence and clinical impact of RBBB in patients with NSTEMI compared to patients with STEMI. METHODS: From the German prospective multicenter registry "Maximal Individual Therapy of Acute Myocardial Infarction" (MITRA PLUS), 6,403 consecutive patients with NSTEMI and 20,233 patients with STEMI were analyzed. Patients with left bundle branch block were excluded. The median follow-up time for NSTEMI was 378 days and for STEMI 479 days. RESULTS: A total of 455 (7.1%) patients with NSTEMI and 894 (4.4%) patients with STEMI presented with RBBB on admission. In general, RBBB patients were older, more often had comorbidities, and less often received short-term inhospital treatment according to guidelines. In STEMI, RBBB patients had higher peak enzyme levels and lower left ventricular ejection fraction (LV-EF) than patients without BBB. Right bundle branch block in STEMI was associated with an increased inhospital and long-term mortality. In NSTEMI, however, peak enzyme levels and LV-EF were similar in both groups with and without RBBB. Right bundle branch block in NSTEMI was not independently associated with a worse outcome. CONCLUSIONS: Unlike RBBB in STEMI, RBBB in NSTEMI is not an independent predictor of inhospital and long-term mortality.

Prehospital cardiac arrest: a marker for higher mortality in patients with acute myocardial infarction and moderately reduced left ventricular function: results from the MITRA plus registry.

BACKGROUND: According to the current guidelines for acute myocardial infarction, ventricular fibrillation during the acute phase of myocardial infarction is no indication for specific treatment like ICD implantation. Primary objective of our study was to evaluate the prognostic significance of cardiac arrest within the acute phase of myocardial infarction in patients with moderately reduced left ventricular function. METHODS AND RESULTS: From 1994 until 2004, we included 7111 patients with acute STEMI and an LVEF >30% from the MITRA plus registry who were discharged alive from hospital and had a complete follow up. We compared long term prognosis on total mortality in patients with and without prehospital cardiac arrest. 286 out of 7111 patients (4%) with moderately reduced LVEF >30% after STEMI had prehospital cardiac arrest and were discharged alive from hospital. In these patients, total mortality during a mean follow up of 13 months was 13.6% compared to 8.7% in patients without cardiac arrest, although patients with cardiac arrest were younger and had less risk factors. Higher mortality after cardiac arrest was independent from gender, risk factors and medical treatment. Only in patients with preserved LVEF >55% after STEMI, mortality was equal in patients with and without cardiac arrest. CONCLUSION: Prehospital cardiac arrest in the acute phase of STEMI is an independent risk indicator for higher mortality in patients with moderately reduced left ventricular function (LVEF 30-55%). To evaluate the prognostic impact of the implantation of an ICD in these patients, further investigation is needed.

Body mass index and effectiveness of reperfusion strategies: implications for the management of patients with ST-elevation myocardial infarction.

BACKGROUND: Fibrinolytic therapy has maximum dose limit in patients with ST-elevation myocardial infarction (STEMI). Consequently, obese patients receive lower dose of fibrinolytic per kg body weight compared to lower weight patients. Whether the relatively lower dose results in lower effectiveness of fibrinolytic agents versus primary percutaneous coronary interventions (PCI) in patients with higher body mass index (BMI) is not known. METHODS: We analyzed 7,630 STEMI patients receiving primary PCI (46%) or fibrinolysis (54%) < 24 hours of symptom onset from the MITRA PLUS registry. The relative effectiveness of the 2 reperfusion strategies on in-hospital death (adjusted with propensity scores) and bleeding were studied in 3 BMI groups: I-BMI 20-24.9 kg/m(2) (n = 2,277), II-BMI 25-29.9 kg/m(2) (n = 3,763), and III-BMI > or = 30 kg/m(2) (n = 1,590). RESULTS: BMI was inversely related to death, shock, stroke, and bleeding in patients treated with either reperfusion strategy. However, compared with primary PCI, fibrinolysis was associated with higher adjusted death with similar relative adjusted difference in all 3 groups (group I OR 1.69, 95% CI 1.19-2.44; group II OR 1.89, 95% CI 1.39-2.56; group III OR 1.85, 95% CI 1.08-3.22). CONCLUSIONS: Compared with primary PCI, fibrinolysis was associated with relatively similar higher risk of death in all 3 BMI groups. Whether the differences in death between fibrinolysis and primary PCI in the high-BMI categories can be reduced by higher fibrinolytic doses without increasing bleeding risks needs evaluation in future studies.

Impact of the body mass index on occurrence and outcome of acute ST-elevation myocardial infarction.

Obesity is a traditional risk factor for the development of cardiovascular disease. However, recent studies have described a better outcome of obese patients in the clinical course of acute coronary syndromes.We investigated the impact of the body mass index (BMI) on occurrence and outcome of acute ST-elevation myocardial infarction (STEMI). Data of 10 534 consecutive patients with STEMI of the German MITRA PLUS registry were analyzed, comparing international classes of the BMI (obesity: BMI >or= 30 kg/m(2), overweight: 25-29.9 kg/m(2), normal weight: 18.5-24.9 kg/m(2)).STEMI occurred at a younger age in obese patients. The obese patients with first STEMI were 3 years younger than the normal weight patients with first STEMI (62.5 vs 65.7 years, p <0.0001).After STEMI has occurred, the obese patients had the lowest hospital (6.0%) and long-term mortality (4.8%) of all compared BMI-groups. In a multivariate analysis, obesity compared to normal weight was associated with a trend of a reduced mortality without significance during the hospital course (OR 0.81, 95% CI 0.60-1.08) and with significance during follow-up (OR 0.56, 95% CI 0.40-0.79).In conclusion, our data show that obesity is a risk factor of a manifestation of STEMI at a younger age compared to normal weight patients. After STEMI has occurred, obesity is associated with a trend of a lower mortality during the following clinical course. Therefore, the focus of prevention should be the reduction of obesity and metabolic syndrome in young people, to avoid the early occurrence of STEMI by primary prevention.

Prognostic impact of acute beta-blocker therapy on top of aspirin and angiotensin-converting enzyme inhibitor therapy in consecutive patients with ST-elevation acute myocardial infarction.

The prognostic effect of beta-blocker treatment on ST-elevation acute myocardial infarction (STEMI) is controversially discussed in the era of reperfusion therapy. From the German multicenter registry Maximal Individual Therapy of Acute Myocardial Infarction PLUS (MITRA PLUS), 17,809 consecutive patients with STEMI treated with a guideline-recommended therapy with aspirin and an angiotensin-converting enzyme inhibitor were investigated; the prognostic effect of additional acute beta-blocker treatment was analyzed. Patients with cardiogenic shock were excluded. Of included patients, 77.6% received additional acute beta-blocker treatment and 22.4% did not. Patients with beta-blocker treatment were younger and more often received reperfusion therapy. Acute beta-blocker treatment was associated with a lower hospital mortality (univariate analysis 4.9% vs 10.8%, p <0.001; multivariate analysis odds ratio [OR] 0.70, 95% confidence interval [CI] 0.61 to 0.81). Acute beta blockade was significantly associated with a lower hospital mortality in patients without (OR 0.66, 95% CI 0.56 to 0.79) and with (OR 0.76, 95% CI 0.60 to 0.98) reperfusion therapy. The greatest benefit of acute beta-blocker treatment, measured by the number needed to treat to save 1 life, was found in patients with anterior MI, a heart rate > or =80 beats/min, no reperfusion therapy, female gender, and age > or =65 years. In conclusion, acute beta-blocker therapy in the clinical practice of treating patients with STEMI, in addition to aspirin and angiotensin-converting enzyme inhibitor therapy, was independently associated with a significant decrease in hospital mortality in patients with and without reperfusion therapy. High-risk patients with STEMI, such as elderly patients and patients without reperfusion therapy, showed a greater benefit of acute beta-blocker therapy than low-risk patients with STEMI.

Highly purified omega-3 fatty acids for secondary prevention of sudden cardiac death after myocardial infarction-aims and methods of the OMEGA-study.

INTRODUCTION: During the last decades a large body of data has been accumulated indicating omega-3 fatty acids to exert beneficial effects on the prognosis of patients with cardiovascular disease. Especially, omega-3 fatty acids are regarded to be effective in reducing the risk of sudden cardiac death after acute myocardial infarction. However, treatment of acute myocardial infarction and secondary prevention considerably have been improved within the past years including early revascularization by PCI, the routine use of beta-blockers, statins and ACE-inhibitors as well as cardiac rehabilitation for improving life style measures. To date, there exists no controlled randomized trial testing the prognostic effect of omega-3 fatty acids after acute myocardial infarction in a double blind regimen under the conditions of modern treatment of myocardial infarction. MATERIALS AND METHODS: The present study therefore evaluates the effect of highly purified omega-3 fatty acid ethylesters (omega-3-acid ethyl esters 90=Zodin) on the rate of sudden cardiac death within 1 year after acute myocardial infarction. Secondary endpoints are total mortality, non-fatal cardiovascular events, rhythm abnormalities in holter monitoring and depression score. RESULT AND CONCLUSION: The recruitment-period started in October 2003 and is expected to last until December 2006. The results of the study are therefore expected for the beginning of 2008, when all patients will have completed the 12-months follow up-period.