Early and Late Mortality Predictors in Patients with Acute Aortic Dissection Type B.

Background/Aim: Despite technological advances in diagnosis and treatment, in-hospital mortality with acute aortic dissection type B is still about 11%. The purpose of this study was to assess the risk factors for early and long-term adverse outcomes in patients with acute aortic dissection type B treated medically or with conventional open surgery. Methods: The present study included 104 consecutive patients with acute aortic dissection type B treated in our Center from January 1st, 1998 to January 1st, 2007. Patient demographic and clinical characteristics as well as in-hospital complications were reviewed. Univariate and multivariate testing was performed to identify the predictors of in-hospital (30-day) and late (within 9 years) mortality. Results: 92 (88.5%) patients were treated medically, while 12 (11.5%) patients with complicated acute aortic dissection type B were treated by open surgical repair. In-hospital complications occurred in 35.7% patients, the most often being acute renal failure (28%), hypotension/shock (24%), mesenteric ischemia (12%), and limb ischemia (8%). The in-hospital mortality rate was 15.7% and the 9-year mortality rate was 51.9%. Independent predictors of early mortality in patients with acute aortic dissection type B were uncontrolled hypertension (HR-20.69) and a dissecting aorta diameter >4.75 cm (HR-6.30). Independent predictors of late mortality were relapsing pain (HR-7.93), uncontrolled hypertension (HR-7.25), and a pathologic difference in arterial blood pressure (>20 mmHg) (HR-5.33). Conclusion: Knowledge of key risk factors may help with a better choice of treatment and mortality reduction in acute aortic dissection type B patients.

Dilemmas in the Choice of Adequate Therapeutic Treatment in Patients with Acute Pulmonary Embolism-From Modern Recommendations to Clinical Application.

Pulmonary thromboembolism is a very common cardiovascular disease, with a high mortality rate. Despite the clear guidelines, this disease still represents a great challenge both in diagnosis and treatment. The heterogeneous clinical picture, often without pathognomonic signs and symptoms, represents a huge differential diagnostic problem even for experienced doctors. The decisions surrounding this therapeutic regimen also represent a major dilemma in the group of patients who are hemodynamically stable at initial presentation and have signs of right ventricular (RV) dysfunction proven by echocardiography and positive biomarker values (pulmonary embolism of intermediate-high risk). Studies have shown conflicting results about the benefit of using fibrinolytic therapy in this group of patients until hemodynamic decompensation, due to the risk of major bleeding. The latest recommendations give preference to new oral anticoagulants (NOACs) compared to vitamin K antagonists (VKA), except for certain categories of patients (patients with antiphospholipid syndrome, mechanical valves, pregnancy). When using oral anticoagulant therapy, special attention should be paid to drug-drug interactions, which can lead to many complications, even to the death of the patient. Special population groups such as pregnant women, obese patients, patients with antiphospholipid syndrome and the incidence of cancer represent a great therapeutic challenge in the application of anticoagulant therapy. In these patients, not only must the effectiveness of the drugs be taken into account, but great attention must be paid to their safety and possible side effects, which is why a multidisciplinary approach is emphasized in order to provide the best therapeutic option.

Efficacy and safety of tirofiban-supported primary percutaneous coronary intervention in patients pretreated with 600 mg clopidogrel: results of propensity analysis using the Clinical Center of Serbia STEMI Register.

BACKGROUND: Studies with platelet glycoprotein IIb/IIIa receptor inhibitors (GPIs) showed conflicting results in primary percutaneous coronary intervention (PPCI) patients who were pretreated with 600 mg clopidogrel. We sought to investigate the short- and long-term efficacy and safety of the periprocedural administration of tirofiban in a largest Serbian PPCI centre. METHODS: We analysed 2995 consecutive PPCI patients enrolled in the Clinical Center of Serbia STEMI Register, between February 2007 and March 2012. All patients were pretreated with 600 mg clopidogrel and 300 mg aspirin. Major adverse cardiovascular events, comprising all-cause death, nonfatal infarction, nonfatal stroke, and ischaemia-driven target vessel revascularization, was the primary efficacy end point. TIMI major bleeding was the key safety end point. RESULTS: Analyses drawn from the propensity-matched sample showed improved primary efficacy end point in the tirofiban group at 30-day (OR 0.72, 95% CI 0.53-0.97) and at 1-year (OR 0.74, 95% CI 0.57-0.96) follow up. Moreover, tirofiban group had a significantly lower 30-day all-cause mortality (secondary end point; OR 0.63, 95% CI 0.40-0.90), compared with patients who were not administered tirofiban. At 1 year, a trend towards a lower all-cause mortality was observed in the tirofiban group (OR 0.74, 95% CI 0.53-1.04). No differences were found with respect to the TIMI major bleeding during the follow-up period. CONCLUSIONS: Tirofiban administered with PPCI, following 600 mg clopidogrel pretreatment, improved primary efficacy outcome at 30 days and at 1 year follow up without an increase in major bleeding.

Simple risk algorithm to predict serious bleeding in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: RISK-PCI bleeding score.

BACKGROUND: Bleeding is a potentially catastrophic complication after primary percutaneous coronary intervention (PPCI). It occurs most frequently within the first 30 days following the intervention. The aim of this study was to generate a simple and accurate risk model for the prediction of bleeding after PPCI. METHODS AND RESULTS: The training set included 2,096 patients enrolled in the RISK-PCI trial. The model was validated using a database of 961 patients enrolled in the ART-PCI trial. Bleeding was defined as type ≥3a bleeding according to the Bleeding Academic Research Consortium definition. Multivariate logistic regression was used to evaluate the predictors of outcome. A sum of weighted points for specific predictors was calculated to determine the final score. The model included 5 independent predictors of 30-day bleeding: gender (female); history of peptic ulcer; creatinine clearance at admission (<60 ml/min); hemoglobin at presentation (<125 g/dl); and Killip class >1 heart failure at admission. The model showed good discrimination and calibration for the prediction of bleeding in the derivation set (C-statistic, 0.79; goodness of fit, P=0.12) and in the validation set (C-statistic, 0.76; goodness of fit, P=0.37). Patients were classified into 3 risk classes and the observed incidence of 30-day bleeding of 1.0%, 3.5% and 10.7% corresponded to the low-, intermediate- and high-risk classes, respectively. CONCLUSIONS: A simple risk model was developed that has a reasonably good capacity for the prediction of 30-day bleeding after PPCI.

Sex-related analysis of short- and long-term clinical outcomes and bleeding among patients treated with primary percutaneous coronary intervention: an evaluation of the RISK-PCI data.

BACKGROUND: Unfavourable effect of female sex on short- and long-term clinical outcomes has been demonstrated in unselected ST-elevation acute myocardial infarction (STEMI) patients; the results are conflicting in patients who undergo primary percutaneous coronary intervention (PPCI). The objective of this substudy was to determine whether there are sex-related differences in the 30-day and 1-year clinical outcomes and bleeding after PPCI for STEMI. METHODS: We analyzed 2096 STEMI patients enrolled in the Risk Scoring Model to Predict Net Adverse Cardiovascular Outcomes After Primary Percutaneous Coronary Intervention (RISK-PCI) trial from February 2006 to December 2009. Composite efficacy end point comprised all-cause mortality, nonfatal infarction, and stroke. Safety end point was bleeding classified according to the Thrombolysis in Myocardial Infarction (TIMI) criteria. Net adverse cardiovascular events included composite efficacy end point and total bleeding. RESULTS: Women in our study were older and presented later than men. After adjustment for potential confounders, there was no difference between sexes with respect to the composite efficacy end point. A higher rate of total bleeding was observed in women (adjusted odds ratio [OR], 1.67; 95% confidence interval [CI], 1.07-2.61 at 30 days, adjusted OR, 1.63; 95% CI, 1.08-2.47 at 1 year) compared with men. Total bleeding was associated with increased mortality at 30 days (OR, 4.87; 95% CI, 2.79-8.47) and at 1 year (OR, 4.43; 95% CI, 2.79-7.02) after PPCI. CONCLUSIONS: We did not find a significant sex-related difference with respect to the composite efficacy end point. Women had a higher rate of total bleeding which was associated with increased short- and long-term mortality. Specific measures aimed at preventing bleeding in women might improve the prognosis of PPCI patients.

Rationale and design of the on-treatment PLAtelet Reactivity-Guided Therapy Modification FOR ST-Segment Elevation Myocardial Infarction (PLATFORM) randomized trial.

OBJECTIVES: The present trial aims at examining whether antiplatelet regimen modification, guided by assessment of the on-treatment platelet reactivity, might result with clinical benefit in moderate to high-risk patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). BACKGROUND: High platelet reactivity has been associated with an increased rate of ischemic events after PCI. Recent large trials did not show a clinical benefit of platelet reactivity-guided therapy modification in acute coronary syndrome patients treated by PCI. METHODS: PLATFORM is an investigator-initiated, prospective, randomized, parallel-group, controlled clinical trial. Approximately 632 STEMI patients with intermediate to high-risk (RISK-PCI score >3) clinical features undergoing PPCI will be randomly allocated to treatment modification or standard therapy. Low responders to aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel will receive 180 mg ticagrelor for 1 year. The primary end-point is the time to the first composite major adverse cardiovascular events (MACE) including death, nonfatal infarction, stroke, or immediate target vessel revascularization. Key safety end-point is the rate of TIMI major bleeding unrelated to coronary artery bypass graft surgery. Our secondary end-points are individual components of MACE, definite stent thrombosis, total bleeding, and the need for blood transfusions. Patients will be followed-up at 30 days and at 1 year after PPCI. CONCLUSION: PLATFORM will determine whether the platelet reactivity-guided use of ticagrelor in combination with 200 mg aspirin, compared with standard antiplatelet regimen, improves clinical outcome in moderate to high-risk STEMI patients undergoing PPCI. CLINICAL TRIAL REGISTRATION: U.S. National Institutes of Health (NIH) at www.clinicaltrials.gov. ClinicalTrials.gov Identifier: NCT01739556, and Current Controlled Trials at www.controlledtrials.com. International Standard Randomized Controlled Trial Number ISRCTN83081599.

Usefulness of the RISK-PCI score to predict stent thrombosis in patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a substudy of the RISK-PCI trial.

Stent thrombosis (ST) is an important cause of death after primary percutaneous coronary intervention (pPCI). This substudy aimed at evaluating the usefulness of the RISK-PCI score, originally developed for the prediction of 30-day major adverse cardiovascular events, to predict the occurrence of ST after pPCI. We analyzed 1972 consecutive patients who underwent pPCI with stent implantation between February 2007 and December 2009. Early ST (EST), late ST (LST), and cumulative 1-year ST (CST) were the predefined end points. Definite, probable, and possible ST were included. Models discrimination and calibration to predict ST was tested using receiver-operating characteristics curves and the goodness-of-fit (GoF) test. Sensitivity analyses and 1000-resample bootstrapping were used to evaluate the model's performance. The rates of EST, LST, and CST were 4.6, 1.4, and 6.0 %, respectively. Compared with controls, the cumulative ST group was associated with much higher rates of adverse clinical outcomes at 30-day follow-up (adjusted odds ratio (OR) for death 6.45, adjusted OR for major bleeding 4.41) and at 12-month follow-up (adjusted OR for death 7.35, adjusted OR for major bleeding 4.56). Internal validation confirmed a reasonably good discrimination and calibration of the RISK-PCI score for the prediction of EST (area under the curve (AUC) 0.71, GoF 0.42), LST (AUC 0.69, GoF 0.36), and CST (AUC 0.70, GoF 0.22) after pPCI. ST after pPCI is associated with adverse 30-day and 1-year clinical outcomes. We conclude that the risk of ST could be accurately assessed using the RISK-PCI score, which might help in deciding upon measures aimed at preventing adverse prognosis.

Impact of high post-loading platelet aggregation on 30-day clinical outcomes after primary percutaneous coronary intervention. The antiplatelet regimen tailoring after primary PCI (ART-PCI) trial.

BACKGROUND: Patients with high post-loading platelet aggregation (PPA) are at increased risk of stent thrombosis and death after primary percutaneous coronary intervention (pPCI). The objective of the present trial was to examine whether high PPA is associated with adverse clinical outcomes in pPCI patients whose therapy was modified in accordance with PPA. METHODS: We analyzed 961 consecutive pPCI patients who underwent pPCI between February 2008 and June 2011. High PPA was defined as PPA >50%, 24h after the loading dose. Patients with high PPA were treated with aspirin 300 mg, clopidogrel 150 mg or ticlopidine 500 mg for 30 days. The co-primary efficacy and safety end points at 30 days were major adverse cardiovascular events (MACE) and major bleeding. RESULTS: We detected high PPA to clopidogrel and aspirin in 44.4% and 16.5% of patients, respectively. The rates of 30-day MACE (adjusted OR 1.76, 95% CI 1.05-2.97), definite subacute stent thrombosis (DSST, adjusted OR 2.15, 95% CI 1.09-4.22) and nonfatal infarction (adjusted OR 3.99, 95% CI 1.57-10.13) were higher in patients with high PPA to clopidogrel compared with responders. High PPA to aspirin was not associated with an adverse 30-day clinical outcome. Compared with high PPA patients who were not tailored, a significantly better outcome with respect to the primary end point was observed in the tailored group (OR 0.42, 95% CI 0.19-0.93). CONCLUSION: High PPA to clopidogrel was an independent predictor of 30-day adverse events after pPCI. Among high PPA patients, tailoring was associated with an improved primary outcome.

Predicting 30-day major adverse cardiovascular events after primary percutaneous coronary intervention. The RISK-PCI score.

BACKGROUND: Identification of patients at risk for major adverse cardiovascular events (MACE) might help selecting candidates for aggressive treatment or early discharge after primary percutaneous coronary intervention (pPCI). METHODS: The RISK-PCI is an observational trial of 2096 consecutive patients who underwent pPCI between 2006 and 2009, randomly allocated to derivation and validation sets with a set ratio of 80% to 20%. Thirty-day MACE comprising death, nonfatal reinfarction and stroke was the primary end point. Multivariable logistic regression was used to determine the independent predictors of outcome. A sum of weighted points for specific predictors was calculated to define the final score. RESULTS: The RISK-PCI score comprised 12 independent predictors of 30-day MACE, with a graded 125-fold increase in the primary end point with increasing risk score from ≤ 1 to ≥ 15. The model showed good discrimination and calibration for the prediction of 30-day MACE (c-statistic 0.83, goodness-of-fit p = 0.72) and 30-day death (c-statistic 0.87, goodness-of-fit p = 0.56). Bootstrapping with 1000 resample confirmed the stability of the model's performance. Patients were classified into risk classes, with the observed incidence of 30-day MACE of 1.9, 5.9, 13.3 and 39.4% in the low, intermediate, high and very high-risk classes, respectively. An 18-fold graded increase in the primary end point was observed between patients in a low risk class and those in a very high risk class. CONCLUSION: We derived a novel risk model to predict 30-day MACE after pPCI, which might help clinician decide the most appropriate treatment in accordance with the patient's risk profile.

Incidence, predictors, and 30-day outcomes of new-onset atrial fibrillation after primary percutaneous coronary intervention: insight into the RISK-PCI trial.

OBJECTIVES: Limited data exist about the prognostic significance of new-onset atrial fibrillation (AF) after contemporary primary percutaneous coronary intervention (pPCI). The objective of this study was to identify the incidence and predictors of new-onset AF and associated adverse 30-day outcomes in AF patients who underwent pPCI. METHODS: We analyzed 2096 patients undergoing pPCI after pretreatment with 600 mg clopidogrel. Composite 30-day major adverse cardiovascular events were the primary end point. A logistic regression model was developed to identify risk factors for the occurrence of AF and prediction of its impact on 30-day outcomes. RESULTS: AF occurred in 6.2% of patients. Older age, Killip >1 heart failure at admission, systolic blood pressure of greater than 100 mmHg at admission, creatinine clearance greater than 60 ml/min, preprocedural infarction-related artery occlusion and postprocedural thrombolysis in myocardial infarction flow less than 3 were identified as independent predictors of the occurrence of AF. Rates of 30-day major adverse cardiovascular events [adjusted odds ratio (OR) 2.39, 95% confidence interval (CI): 1.47-3.87] and 30-day death (adjusted OR 2.67, 95% CI: 1.46-4.89) were higher in AF patients compared with patients without AF. A trend toward higher rate of ischemia-driven target vessel revascularization was observed in the AF group (adjusted OR 2.61, 95% CI: 0.82-8.39, P=0.10). CONCLUSION: New-onset AF after pPCI is associated with adverse 30-day outcomes. Accurate prediction of AF after pPCI might help deciding a more aggressive treatment approach aimed at preventing the adverse prognosis of these patients.

Impact of the combined left ventricular systolic and renal dysfunction on one-year outcomes after primary percutaneous coronary intervention.

BACKGROUND: The aim of this study was to assess the impact of combined left ventricular systolic dysfunction (LVSD) and renal dysfunction (RD) on 1-year overall mortality and major adverse cardiovascular events (MACEs) (comprising cardiovascular death, nonfatal renfarction, target vessel revascularization, and nonfatal stroke) in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (pPCI). METHODS: One thousand three hundred ninety eight patients with first myocardial infarction, undergoing pPCI were divided into four groups according to the presence of LVSD (ejection fraction [EF] <40%) and/or baseline RD (estimated glomerular filtration rate <60 mL/min per m(2)): Group I (no LVSD and no RD); Group II (LVSD, no RD); Group III (RD, no LVSD); Group IV (LVSD + RD). RESULTS: One-year mortality rates in Groups I, II, III, and IV were 2.6%, 15.2%, 10.6%, and 34.2% and 1-year MACE rates were 5.7%, 19.5%, 17.1% and 35.7%, respectively. Patients in Groups II, III, and IV had an increased probability of 1-year overall mortality and MACE as compared to Group I. Overall mortality: Group II HR 2.1 (95% CI 1.1-4.2); Group III HR 2.1 (95% CI 1.1-4.1); Group IV HR 4.8 (95% CI 2.4-9.4); MACE: Group II HR 2.2 (95% CI 1.1-4.2); Group III HR 2.2 (95% CI 1.1-4.3); Group IV HR 5.1 (95% CI 2.6-10.1). The LVSD-RD combination was the strongest independent predictor for 1-year outcomes. CONCLUSIONS: The LVSD-RD combination is associated with an approximately five-fold increase in 1-year overall mortality and MACE after pPCI. The evaluation of the renal function in patients with LVSD represents a simple method which enables a more precise stratification of the risks related to the occurrence of adverse events in long-term patient follow-up.

Prognostic significance of the occurrence of acute heart failure after successful primary percutaneous coronary intervention.

BACKGROUND: Acute heart failure (AHF) has an adverse impact on short- and long-term outcomes in patients with acute ST-elevation myocardial infarction (STEMI). The aims of the present study were to determine independent predictors for the occurrence of AHF during hospitalization and to assess the impact of AHF on 30-day and 1-year outcomes in patients with STEMI who were successfully treated with primary percutaneous coronary intervention (pPCI). METHODS AND RESULTS: The study included 1,074 consecutive patients with STEMI who had no signs of heart failure (HF) at admission (Killip class I) and were treated with successful pPCI. Successful PPCI was defined as postprocedural TIMI 3 grade flow. Acute HF developed in 11.1% patients during hospitalization, which was predominantly mild to moderate (Killip classes II and III). Independent predictors for the occurrence of AHF were: anterior infarction, peak creatinine-kinase (CK) > 2,000 U/L and 3-vessel coronary disease. 30-day and 1-year mortality rates were significantly higher in patients with AHF compared to patients without AHF. AHF during hospitalization was an independent predictor of 30-day mortality (hazard ratio [HR] 10.5) and 1-year mortality (HR 4.4). CONCLUSION: Even after successful pPCI, the occurrence of AHF during hospitalization remains an independent predictor of 30-day and 1-year mortality.

Echocardiographic study of early left ventricular remodeling in highly trained preadolescent footballers.

Almost all the studies of athlete's heart have been carried out on adult and older adolescent players; hence the limited data on the cardiac response to exercise in the beginning of the active sports career in the youngest athletes. The study was designed to examine the physiological limits of left ventricle (LV) cavity size and wall thickness in elite footballers at the preadolescent age, it the beginning of the active sports career. Ninety-four highly trained male footballers (mean aged 12.85±0.84) competing in the Serbian Football League and 47 age-matched healthy male controls, aged 12-14, were enrolled in the study. All the echocardiographic findings were adjusted to BSA(-0.5), while left ventricle mass (LVM) was additionally adjusted to BSA(-1.5). Reference ranges were defined as values of 5-95th centile according to the mean values in both groups. The proportions of the footballers with LV dimensions outside expected ranges were additionally noted. The data indicate significant increases in absolute values of LV dimensions, aortic root size and left atrium (p<0.001) in preadolescent professional footballers compared with the values expected for age-matched controls, whereas there are no differences in absolute values of ventricular septal and posterior wall thickness, LV wall thickness and LVM (p>0.05). Upon body-size adjustments, significant increases were observed in all echocardiographic parameters (p<0.001). Our data indicate an early cardiac remodeling, already apparent in pre-adolescence, even after a short period of training.

Obstacles in the diagnostics and therapy of heparin-induced thrombocytopenia.

An immune-mediated, severe, acquired prothrombotic disorder, heparin-induced thrombocytopenia type II (HIT II) occurs in 0.5-5% of patients exposed to unfractionated heparin longer than 5-7 days. Arterial and venous thromboses are induced by HIT II in about 35-50% of patients. Typical death rate for HIT is about 29%, while 21% of HIT patients result in amputation of a limb. The trend towards the occurrence of HIT due to the administration of low molecular weight heparins (LMWH) taking ever conspicuous place in the standard venous thromboembolism (VTE) prophylaxis has been more frequently observed recently. It is considered that LMWH may cause HIT II in about 0.25-1%. The need for further modification of HIPA assays with LMWH has been imposed in the HIT laboratory diagnostics, heretofore overburdened with complexity. There are several constantly opposing problems arising in HIT laboratory diagnostics, one of which is that in a certain number of patients immunologic assays detect nonpathogenic antibodies (mainly IgM or IgA heparin-PF4 antibodies) while, on the other hand, the occurrence of HIT pathogenetically mediated by minor antigens (neutrophil-activating peptide 2 or interleukin 8) may be neglected in certain cases. The following factors play an important role in the interpretation of each laboratory HIT assays performed: 1. correlation with HIT clinical probability test, the best known of which is 4T'score, 2. the interpretation of the laboratory findings dependent on the time of the thrombocytopenia onset, as well as 3. the sensitivity and specificity of each test respectively. The HIT diagnostics in the presence of other comorbid states which may also induce thrombocytopenia, more precisely known as pseudo HIT (cancer, sepsis, disseminated intravascular coagulation, pulmonary embolism, antiphospholipid syndrome, etc), represents a specific clinical problem.

The long-term risk of stroke in patients with acute myocardial infarction complicated with new-onset atrial fibrillation.

BACKGROUND: The long-term risk of stroke after acute myocardial infarction (AMI) complicated with new-onset atrial fibrillation (AF) remains unclear. The aim of this study was to determine the long-term risk of AF and stroke in patients with AMI complicated with new-onset AF. METHODS: Patients with AMI complicated with new-onset AF (n = 260) and those without new-onset AF (n = 292) were followed for a mean of 7 years. All patients had sinus rhythm at hospital discharge. RESULTS: During the follow-up, AMI patients with new-onset AF had more frequent AF than those without new-onset AF (10.4% vs 2.7%, respectively; P < 0.0001). New-onset AF during AMI was a significant predictor of subsequent AF occurrence (the time elapsing between 2 consecutive R waves [RR] = 3.15, P = 0.004); but AF recurrence in follow-up (RR = 5.08, P = 0.001) and non-anticoagulation at discharge (RR = 0.29, P = 0.008) were independent predictors of stroke (Cox regression analysis). A period of 3.5 hours of AF within the first 48 hours of AMI was the high sensitivity cut-off level for the prediction of low long-term risk of stroke obtained by receiver operating characteristic analysis. Among patients who did not receive anticoagulants at discharge, the patients with short AF did not experience stroke and AF recurrence during follow-up, while those in the other group developed it (10.8%, P = 0.038 and 13.5%, P = 0.019, respectively). CONCLUSION: New-onset AF during AMI identifies the patients at long-term risk for stroke who may potentially benefit from anticoagulant therapy. Atrial fibrillation recurrence in follow-up was independently related to the development of stroke. However, for low-risk patients with AF (those with short AF occurring early in AMI) long-term anticoagulants might not be required.

Development and validation of a risk scoring model to predict net adverse cardiovascular outcomes after primary percutaneous coronary intervention in patients pretreated with 600 mg clopidogrel: rationale and design of the RISK-PCI study.

BACKGROUND: No comprehensive primary PCI (pPCI) risk model to predict net adverse cardiovascular events (NACE) has been reported with the use of clopidogrel 600 mg, which is now considered the standard loading dose. The primary hypothesis of the RISK-PCI trial is that an accurate risk prediction may be achieved by using clinical, angiographic, and procedural variables available at the time of intervention. METHODS: The present single-center, longitudinal, cohort study will include 1,750 consecutive patients with ST-elevation myocardial infarction (STEMI), undergoing pPCI after pretreatment with 300 mg aspirin and 600 mg clopidogrel. The primary end-points of the trial (NACE) include major adverse cardiovascular events (MACE) and major bleeding. A logistic regression model will be developed to predict 30-day and 1-year NACE after pPCI. A risk score derived from study set data will be validated using validation set data. RESULTS: Until June 1, 2008, 1,166 patients have been enrolled. Thirty-day follow-up is available in 1,007 patients. CONCLUSIONS: The RISK-PCI study is designed to develop an accurate risk scoring system, using variables available at the time of intervention, to predict long-term adverse outcomes after pPCI.

Clinical challenge: heparin-induced thrombocytopenia type II (HIT II) or pseudo-HIT in a patient with antiphospholipid syndrome.

Treatment of patients with heparin-induced thrombocytopenia type II (HIT II) and thrombosis in some cases that represents a clinical challenge, which, if unrecognized, may lead to treatment delay or disease progression with potentially lethal outcome. We present a case of a 19-year-old patient with antiphospholipid syndrome, factor V (FV) Leiden mutation in heterozygous state, and venous thromboembolism. The patient was subjected to intravenous infusions of unfractionated heparin (UFH), and 16 days after the beginning of the treatment, his condition worsened, with thrombocytopenia and extension of thrombosis. Whereas the patient had a high clinical score for HIT II, functional and antigenic assays for the presence of HIT antibodies were negative. After repeated negative functional and antigenic assays, pseudo-HIT was suspected and nadroparin was introduced, which resulted in further worsening of the clinical presentation. Disease remission, along with complete normalization of platelet count, was finally accomplished with the introduction of lepirudin. The presence of multiple comorbid states, such as antiphospholipid syndrome, can potentially make laboratory confirmation of disease more difficult in patients with HIT II. In our opinion, it is of great importance that HIT II diagnosis be primarily clinical and that laboratory test results are carefully interpreted, especially when HIT is indicated by high clinical score values.

Carvedilol increases copper-zinc superoxide dismutase activity in patients with acute myocardial infarction.

Balanced and coordinated antioxidant defence enzyme activities are of utmost importance for correct physiological function and for shielding against unwelcome pathological conditions. We determined the activities of copper-zinc superoxide dismutase (CuZnSOD), catalase, glutathione peroxidase and glutathione reductase in erythrocytes isolated from patients receiving different therapy (streptokinase alone or in combination with metoprolol or with carvedilol) for up to 168 hr after starting treatment for acute myocardial infarction. We observed increased CuZnSOD activity in erythrocytes isolated from patients treated with streptokinase-carvedilol (after 6, 24 and 168 hr) and in erythrocytes isolated from patients treated with streptokinase-metoprolol (after 24 hr). In addition, positive correlation between CuZnSOD and catalase activities was found in erythrocytes isolated from patients that received streptokinase-carvedilol after 168 hr. As metoprolol does not react directly with hydrogen peroxide, it would appear that combined streptokinase-metoprolol therapy exerted its effects primarily via by beta-blockade whereas combined streptokinase-carvedilol therapy appeared to function via both beta-blockade and direct antioxidant mechanisms.