Major Adverse Events In Patients Research Articles

Bleeding Risk and Major Adverse Events in Patients With Previous Ulcer on Oral Anticoagulation Therapy

Bleeding is the major concern for patients receiving oral anticoagulation therapy (OAT), especially those with histories of gastrointestinal ulcer. The aim of this study was to evaluate the efficacy and safety of OAT in patients with nonvalvular atrial fibrillation with histories of ulcer. A composite end point, including major adverse cardiac events or major bleeding, was compared between patients with AF with previous ulcers who were (OAT+; n = 200) and were not (OAT- n = 230) receiving OAT. During the follow-up period of 3.3 ± 2.7 years, 28 (14%) and 66 (29%) OAT+ and OAT- patients, respectively, had major adverse cardiac events (p = 0.001). Major bleeding occurred in 46 OAT+ patients (23%) and 25 OAT- patients (11%) (p = 0.001). There was no significant difference in the composite end point between OAT+ and OAT- patients (29% vs 36%, p = 0.08). The incidence of major bleeding was significantly lower, decreasing from 30% to 14%, when OAT began after endoscopic confirmation of ulcer healing (p = 0.02). OAT+ patients who achieved time in the therapeutic range ≥60% for international normalized ratio (2.0 to 3.0) demonstrated better cumulative survival free from the composite end point than OAT- patients (p = 0.01). In conclusion, OAT in patients with nonvalvular AF with histories of gastrointestinal ulcer made no difference in the composite end point compared to absence of OAT. In OAT+ patients, maintaining an optimal international normalized ratio reduced the composite end point, and the confirmation of ulcer healing reduced the incidence of bleeding.

Abstract 304: The Outcomes of Pre-Procedural Angiotensin Converting Enzyme Inhibitor Therapy in patients undergoing Percutaneous Coronary Intervention

Background: Post-procedural outcomes associated with the use of angiotensin converting enzyme inhibitors (ACEI) in patients undergoing percutaneous coronary intervention (PCI) have not been studied. We aimed to determine the association between ACEI use and adverse cardiovascular/ renal outcomes in these patients. Methods: We performed retrospective analysis of 15,485 consecutive patients who underwent percutaneous coronary intervention from January 1, 2000 to June 30, 2011. Primary outcome was the incidence of major adverse events (MAE) defined as a composite of mortality, post PCI renal dysfunction, myocardial infarction, and stroke during index hospitalization for PCI. Secondary outcome was the incidence of aforementioned components of MAE analyzed separately. Logistic regression and multivariate analyses were performed. Results: Of the patients undergoing PCI, 6,600 (43%) received pre-PCI ACEI and 8,885 (57%) did not. Patients on ACEI were more likely to be older (64.6 ± 10.9 years vs. 63.6 ± 12.1 years; p<0.0001), have diabetes (41% vs. 26%; p<0.0001), prior renal insufficiency (19% vs. 15%; p<0.0001) and ejection fraction less than 35% (9.6% vs. 7%; p<0.0001). There were no significant associations between pre-operative ACEI use and primary and secondary outcomes (table). Conclusion: Pre-operative ACEI use is not associated with major adverse events in patients undergoing PCI. Key Words: angiotensin converting enzyme inhibitor; percutaneous coronary intervention

Comparison of Frequency of Major Adverse Events in Patients With Atrial Fibrillation Receiving Bare-Metal Versus Drug-Eluting Stents in Their Coronary Arteries

In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with drug-eluting stent (DES) implantation, the available evidence from clinical trial data are inconclusive. We evaluated the safety and efficacy of the use of DESs versus bare-metal stents (BMSs) in a consecutive real-world cohort of patients with AF. Of 8,962 unselected patients with AF seen in our institution from 2000 through 2010, 833 (9%) had undergone percutaneous coronary intervention with stent implantation. BMSs were used for 678 patients (81%) and DESs for 155 (19%). During follow-up (median 688 days, interquartile range 1,114), all bleeding episodes, thromboembolism, and major adverse cardiac events (MACEs; i.e., death, acute myocardial infarction, target lesion revascularization) were recorded. Incidence of MACEs was similar in the 2 groups as was incidence of all-cause mortality. Results remained similar even after adjustment for age and other confounding factors. Factors independently associated with an increased risk of MACEs were older age (hazard ratio 1.024, 95% confidence interval 1.004 to 1.044, p = 0.02), implantation of stent during acute ST-segment elevation myocardial infarction (hazard ratio 1.81, 95% confidence interval 1.10 to 2.99, p = 0.02), and stent diameter (hazard ratio 1.09, 95% confidence interval 1.01 to 1.18, p = 0.03). Implantation of DESs was not significantly associated with a higher risk of major bleeding and we observed a similar ratio of serious events at follow-up after DES compared to BMS implantation. In conclusion, in our cohort, systematic use of DESs does not seem to be justified in most patients with AF because it was not associated with any clear advantage compared to BMSs.

Saddle embolism is associated with the major adverse events in patients with nonhigh-risk pulmonary embolism

In some patients with acute pulmonary embolism (PE), thrombi may lodge at the levels of bifurcation of the pulmonary trunk and extend into both main pulmonary arteries, forming so-called saddle embolism (SE). The aim of this study was to assess the incidence of SE and whether it is associated with an increased risk of complicated clinical course in patients with nonhigh-risk PE.

Lopinavir Plasma Concentrations and Serum Lipids in Therapy Naïve HIV-Patients: A Sub Analysis of the FREE Study

Antiretroviral therapy in HIV patients is known for its negative effect on the cardiovascular system. One of the major adverse events in patients on lopinavir is increasing lipids. Hyperlipidaemia together with chronic inflammation by HIV-infection itself makes these patients prone for cardiovascular diseases.The purpose of this study (a sub study within the FREE-study) was to determine if higher plasma lopinavir (LPV) concentrations lead to increase of serum lipids. Plasma drug concentrations were analysed up to week 24 in a prospective cohort of HIV antiretroviral therapy naive patients who started on a regimen of zidovudine, lamivudine and ritonavir-boosted lopinavir (FREE study). Prospectively we measured plasma lopinavir concentrations from baseline to week 24 in 72 naive HIV-patients starting on lopinavir (59 males and 13 females). A total of 210 samples were analysed, with at least 2 samples in every patient. Mean LPV trough concentration was 4.3 mg/L (± 2.1). The median intra-subject variation in LPV level was 38% (range 4% - 111%). Serum lipids were not correlated to LPV plasma concentrations possibly due to the wide intra-individual variability in LPV trough levels. Monitoring of plasma lopinavir and subsequent dose adjustment of LPV will not be useful to prevent hyperlipidaemia in HIV-patients treated with lopinavir.

Accuracy of an expanded early warning score for patients in general and trauma surgery wards

Early warning scores (EWS) may aid the prediction of major adverse events in hospitalized patients. Recently, an expanded EWS was introduced in the Netherlands. The aim of this study was to assess the relationship between this EWS and the occurrence of major adverse clinical events during hospitalization of patients admitted to a general and trauma surgery ward. This was a prospective cohort study of consecutive patients admitted to the general and trauma surgery ward of a university medical centre (March-September 2009). Follow-up was limited to the time the patient was hospitalized. Logistic regression analysis was used to assess the relationship between the EWS and the occurrence of the composite endpoint consisting of death, reanimation, unexpected intensive care unit admission, emergency surgery and severe complications. Performance of the EWS was analysed using sensitivity, specificity, predictive values and receiver operating characteristic (ROC) curves. A total of 572 patients were included. During a median follow-up of 4 days, 46 patients (8.0 per cent) reached the composite endpoint (two deaths, two reanimations, 17 intensive care unit admissions, 44 severe complications, one emergency operation). An EWS of at least 3, adjusted for baseline American Society of Anesthesiology classification, was associated with a significantly higher risk of reaching the composite endpoint (odds ratio 11·3, 95 per cent confidence interval (c.i.) 5·5 to 22·9). The area under the ROC curve was 0·87 (95 per cent c.i. 0·81 to 0·93). When considering an EWS of at least 3 to be a positive test result, sensitivity was 74 per cent and specificity was 82 per cent. An EWS of 3 or more is an independent predictor of major adverse events in patients admitted to a general and trauma surgery ward.

TCT-391: Red Blood Cell Transfusion and Long-term Major Adverse Events in Patients Undergoing Percutaneous Coronary Interventions, Results from A Large Prospective Multicenter Registry – the STENT Group

TCT-391: Red Blood Cell Transfusion and Long-term Major Adverse Events in Patients Undergoing Percutaneous Coronary Interventions, Results from A Large Prospective Multicenter Registry – the STENT Group

Myocardial Scar Visualized by Cardiovascular Magnetic Resonance Imaging Predicts Major Adverse Events in Patients With Hypertrophic Cardiomyopathy

Myocardial Scar Visualized by Cardiovascular Magnetic Resonance Imaging Predicts Major Adverse Events in Patients With Hypertrophic Cardiomyopathy

Fcγ receptor IIIb polymorphism and use of glucocorticoids at baseline are associated with infusion reactions to infliximab in patients with rheumatoid arthritis

ObjectiveInfusion reaction is a major adverse event in patients with rheumatoid arthritis (RA) treated with infliximab. The possible factors including Fcγ receptor (FcγR) polymorphism associated with the development of infusion...

Evaluation of Global Registry of Acute Cardiac Events and Thrombolysis in Myocardial Infarction scores in patients with suspected acute coronary syndrome

Purposes We aimed to evaluate the Global Registry of Acute Cardiac Events (GRACE) and Thrombolysis in Myocardial Infarction (TIMI) scores in patients with suspected but not proven acute coronary syndrome (ACS). Basic procedures We conducted a secondary analysis of data from the RATPAC trial. Standardized data were collected from 2263 patients presenting to 6 emergency departments with suspected but not proven ACS. Patients were followed up by record review and postal questionnaire at 30 and 90 days after recruitment to identify major adverse events, defined as death, emergency revascularization, life-threatening arrhythmia, hospitalization for ACS, or nonfatal acute myocardial infarction (AMI). Main findings Data were available for 2243 patients (mean age, 54.5 years; 58% male). The major adverse event rate was 43 (2%) of 2243 after 30 days and 62 (3%) of 2243 after 90 days. The c statistics for 30-day events were 0.717 (95% confidence interval [CI], 0.698-0.735) for GRACE and 0.682 (95% CI, 0.662-0.701) for TIMI. The corresponding 90-day c statistics were 0.726 (95% CI, 0.707-0.745) for GRACE and 0.693 (95% CI, 0.674-0.712) for TIMI. The c statistic for patient age alone was 0.656 for 30-day events and 0.689 for 90-day events. Principal conclusions The GRACE and TIMI scores are little better than age alone as predictors of major adverse events in patients with suspected but not proven ACS, and thus add little to prognostic assessment of such patients.

Early Antiplatelet Therapy in Coronary Artery Bypass Grafting a Calculated Benefit

Studies have demonstrated that antagonists of platelet activity, including aspirin and clopidogrel, reduce the risk of major adverse events in patients with acute coronary syndromes. Although antiplatelet agents also convey an increased risk of bleeding, particularly in patients proceeding to coronary artery bypass graft surgery, in most cases, the benefits of early initiation of antiplatelet therapy outweigh the risks. The purpose of this review is to distinguish perceived and actual risk versus the benefit associated with early antiplatelet therapy to help clinicians make informed decisions on using these agents in an acute setting where patients may require coronary artery bypass grafting.

Myocardial Scar Visualized by Cardiovascular Magnetic Resonance Imaging Predicts Major Adverse Events in Patients With Hypertrophic Cardiomyopathy

We sought to establish the prognostic value of a comprehensive cardiovascular magnetic resonance (CMR) examination in risk stratification of hypertrophic cardiomyopathy (HCM) patients. With annual mortality rates ranging between 1% and 5%, depending on patient selection, a small but significant number of HCM patients are at risk for an adverse event. Therefore, the identification of and prophylactic therapy (i.e., defibrillator placement) in patients with HCM who are at risk of dying are imperative. Two-hundred forty-three consecutive patients with HCM were prospectively enrolled. All patients underwent initial CMR, and 220 were available for clinical follow-up. The mean follow-up time was 1,090 days after CMR. End points were all-cause and cardiac mortality. During follow-up 20 of the 220 patients died, and 2 patients survived sudden cardiac death due to adequate implantable cardioverter-defibrillator discharge. Most events (n = 16) occurred for cardiac reasons; the remaining 6 events were related to cancer and accidents. Our data indicate that the presence of scar visualized by CMR yields an odds ratio of 5.47 for all-cause mortality and of 8.01 for cardiac mortality. This might be superior to classic clinical risk factors, because in our dataset the presence of 2 risk factors yields an odds ratio of 3.86 for all-cause and of 2.20 for cardiac mortality, respectively. Multivariable analysis also revealed the presence of late gadolinium enhancement as a good independent predictor of death in HCM patients. Among our population of largely low or asymptomatic HCM patients, the presence of scar indicated by CMR is a good independent predictor of all-cause and cardiac mortality.

Microparticles, vascular function and hypertension

To summarize the potential role of microparticles in hypertension and in cardiovascular diseases. Microparticles are submicron vesicles shed from the membrane in response to cell activation or apoptosis. Microparticles of different cellular origins are found in the plasma of healthy individuals and their circulating levels augment in patients with cardiovascular diseases. Recent studies demonstrate that circulating levels of microparticles originating from endothelial cells, which represent a small fraction of the overall pool of plasma microparticles, augment with increased endothelial dysfunction in patients with cardiovascular diseases. Therefore, endothelial microparticles constitute an emerging surrogate marker of endothelial dysfunction, with potential prognostic value for major adverse events in patients with cardiovascular diseases. In addition, microparticles of endothelial and other cellular origins are also potential biological effectors in inflammation, vascular injury, angiogenesis and thrombosis. In summary, circulating endothelial microparticles may serve not only as an index of arterial damage but also as a trigger of vascular repair.

Impact of an ICU Liaison Nurse Service on major adverse events in patients recently discharged from ICU

Aim To identify the effect of an ICU Liaison Nurse (LN) on major adverse events in patients recently discharged from the ICU. Methods Case–control study using a chart audit protocol to assess controls retrospectively and cases prospectively. Controls did not receive ICU-based follow-up care. Cases received at least three visits over 3 days from the ICU LN. The LN service operated 7 days/week 0800–1800. Data on a range of predictors and three major adverse events (unexpected death, surgical procedure needed, and transfer to a higher level of care) were collected using a purpose built audit form. Results A total of 388 patients (201 controls and 187 cases) were included in the study. Demographic and clinical characteristics were similar for both groups. A total of 165 major adverse events were identified in 129 patients. After controlling for all other potential predictors, patients who received the LN intervention were 1.82 times more likely to be transferred to a higher level of care ( P = 0.028) and 2.11 times more likely to require a surgical procedure ( P = 0.006). Surgical patients were 7.20 times as likely to require a surgical procedure ( P < 0.001). Conclusions Our results support the claim that ICU LN has a role in preventing adverse events. However as the control data was retrospective and the study was conducted at one site, other unknown factors may have influenced the results.

Coronary Stents and Chronic Anticoagulation

Case Presentation: A 76-year-old man was admitted with retrosternal chest pain. The ECG on admission showed inferolateral ST depression, and troponin levels were elevated, confirming the diagnosis of an acute coronary syndrome. The patient had a history of hypertension and aortic valve replacement with a metallic bileaflet valve 7 years before. He was being treated with warfarin and low-dose aspirin and had an international normalized ratio (INR) of 2.5. Coronary angiography revealed a long subocclusive lesion of the proximal right coronary artery. At that point, there was a question about the optimal treatment for this patient regarding the type of stent to be selected and the need for future combined antiplatelet and anticoagulation treatment. Oral anticoagulation was routinely used for coronary stent thrombosis prevention during the first era of stents.1 It has since been replaced by the combination of aspirin and a thienopyridine because studies have shown a definite advantage of the antiplatelet combination on coronary events2–4 and on reducing the risk of access-site bleeding complications. However, ≈5%5,6 of patients undergoing percutaneous coronary intervention (PCI) also present with an indication for oral anticoagulation therapy. In such cases, the type of stent selected; the use of oral anticoagulants, antiplatelets, or their combinations; the target INR; and the duration of treatment are essential considerations in relation to the risk of stent thrombosis/thromboembolic events and bleeding risk. With the introduction and widespread use of drug-eluting stents (DES) in recent years and given the necessity for longer duration of dual antiplatelet therapy, the issue of concurrent warfarin and antiplatelet therapy has become even more important. The existing guidelines do not offer a convincing solution to these issues. For acute coronary syndrome patients with an indication for anticoagulation, triple therapy (warfarin, aspirin, and clopidogrel) for the minimum time possible and a maintenance …

Stavudine plasma concentrations and lipoatrophy

The objective of this study was to determine the correlation between plasma stavudine concentrations and lipoatrophy (LA), one of the major adverse events in patients on stavudine and one of the major reasons to discontinue stavudine. Plasma drug concentrations were retrospectively analysed in patients who were on a stavudine-containing regimen for at least 12 months. We defined two groups of patients: 21 patients with LA and 15 patients without LA or other stavudine-related side effects (i.e. neuropathy). We analysed stavudine concentrations in 212 plasma samples: 87 in the control group and 125 in the LA group, with a mean of four plasma samples per person (at least two a year). Demographics were comparable in LA patients and controls, except the duration of stavudine use, which was longer in the LA group: 55 versus 42 months in the control group. Overall, LA patients had higher drug exposure to stavudine when compared with the controls, and this was seen in the geometric concentration ratios (CRs), which were 0.978 and 0.741, respectively (P = 0.04), and also a higher percentage of CR values >1.0, representing a drug concentration above the normal population curve (46% versus 23%, P = 0.02). In addition, the duration of stavudine therapy was independently associated with LA (P = 0.05). In the multivariate analysis, both duration of stavudine (P = 0.05) and CR > 1.0 (P = 0.02) were independently correlated with LA. Monitoring of plasma stavudine concentrations can be useful to prevent stavudine-related LA.

Previous Restenosis As a Prognostic Indicator in New Conventional Stent Implantation at a Different Location

The aim was to determine whether data on restenosis of a previous stent are useful for predicting outcome in patients who need to undergo a second conventional stent implantation at a different location because of coronary disease progression. The study included 80 patients who, during 2000-2004, underwent a second conventional (i.e., not drug-eluting) stent implantation for de novo lesions at a different location to that of the previous stent. Major adverse cardiac events (MACE) were defined as death, non-fatal myocardial infarction, or the need for target lesion revascularization (TLR). One year after the second procedure, the cumulative incidence of MACE was significantly higher in patients who experienced significant restenosis of the previous stent than in those who did not (40.6% vs 12.5%, P=.004). Univariate predictors of MACE were: evidence of previous stent restenosis, previous myocardial infarction, and a small vessel (< or =2.75 mm). However, the only independent predictor (Cox regression) of a MACE was previous stent restenosis (hazard ratio 3.85, 95% confidence interval, 1.46-10.18; P=.007). At one year, the TLR rate was also higher in patients with previous stent restenosis (31.3% vs 8.3%; P=.008), in those with small vessels, and in diabetics. Previous stent restenosis and a small vessel were independent predictors of TLR. Restenosis of a previous stent is a strong predictor of major adverse events in patients undergoing a second conventional stent implantation at a different location because of coronary disease progression.

Major Adverse Events in Patients with Peripartum Cardiomyopathy – Clinical Profile and Risk Predictors

Major Adverse Events in Patients with Peripartum Cardiomyopathy – Clinical Profile and Risk Predictors

Relation of Right Ventricular Peak Systolic Pressure to Major Adverse Events in Patients Undergoing Cardiac Resynchronization Therapy

The degree to which increased right-sided heart pressures influence outcome in cardiac resynchronization therapy (CRT) is unclear. High right ventricular (RV) pressures may contribute to septal malpositioning, thus hindering effective resynchronization. We hypothesized that patients with high RV systolic pressures before CRT implantation would have poorer outcome. We evaluated echocardiograms, electrocardiograms, and clinical records from 75 consecutive patients with CRT. RV systolic pressure was calculated from the peak tricuspid regurgitant, time-velocity profile. The primary end point was a composite of mortality, cardiac transplantation, or need for a left ventricular assist device. Events were evaluated by Kaplan-Meier curves and Cox proportional hazard ratios. Patients grouped by RV systolic pressure divided at the median of 35 mm Hg were similar except for more renal insufficiency and RV dysfunction when RV systolic pressure was >35 mm Hg. Univariate analysis identified RV systolic pressure >35 mm Hg (hazard ratio [HR] 3.32), diabetes (HR 2.45), renal insufficiency (HR 3.52), atrial fibrillation (HR 3.07), use of nonamiodarone antiarrhythmic medications (HR 2.86), atrial pacing (HR 2.57), and prolonged PR interval (HR 1.009) as associated with poorer outcome. Normal sinus rhythm at implantation (HR 0.34), baseline left bundle branch block (HR 0.44), and beta-blocker use (HR 0.47) were associated with improved outcome. In a multivariable model, high RV systolic pressure (HR 3.71, 95% confidence interval 1.31 to 10.4), renal insufficiency (HR 3.18, 95% confidence interval 1.29 to 7.86), and atrial fibrillation (HR 4.22, 95% confidence interval 1.54 to 11.6) remained significant. In conclusion, despite resynchronization, patients with high RV pressures have significantly decreased survival after adjusting for significant contributing influences.