Multizonal observational study conducted by clinical practitioners on evolocumab use in subjects with hyperlipidemia in Saudi Arabia and Kuwait: Results from the ZERBINI study.

OBJECTIVES: Dyslipidemia is a prevalent condition with significant morbidity and mortality across the world, including in the Arabian Gulf. The present study aimed to describe the characteristics of patients receiving evolocumab in clinical practice. METHODS: ZERBINI was a multi-country, observational, retrospective/prospective study of subjects receiving evolocumab as part of routine clinical management of their hyperlipidemia. This regional publication reports on adult participants from Saudi Arabia and Kuwait who have had ≥1 dose of evolocumab before enrollment and ≤6 months' prior exposure to evolocumab. Patient characteristics and treatment persistence data were collected in addition to baseline and follow-up data up to 12 months post-evolocumab initiation. RESULTS: Overall, 225 patients were included from two sites, Saudi Arabia (N = 155) and Kuwait (N = 70). Mean age was comparable across sites and most patients had baseline coronary artery disease and/or hypertension. Baseline LDL-C levels (mean ± SD 3.6 ± 1.4 mmol/L in Saudi Arabia, 3.1 ± 1.4 mmol/L in Kuwait) were reduced by approximately 57%-62% in the first 6 months after evolocumab initiation (1.5 ± 1.2 mmol/L in Saudi Arabia [n = 63], 1.2 ± 0.8 mmol/L in Kuwait [n = 28]). This decrease was maintained over the 12-month follow-up period. Most patients achieved ACC 2018 LDL-C goals (<1.8 mmol/L; 74.6% in Saudi Arabia, 93.1% in Kuwait) and ESC 2019 LDL-C goals (<1.4 mmol/L; 66.7% in Saudi Arabia, 75.9% in Kuwait) in the first 6 months after evolocumab initiation. Medication persistence with evolocumab was high (up to 90.7%). Evolocumab had a favorable safety profile and no treatment-emergent adverse events were observed at either site. CONCLUSION: Evolocumab is an effective lipid-lowering treatment in local populations. LDL-C goal achievement is increased when evolocumab is added to background lipid-lowering therapy with high tolerability and persistence. Long-term follow-up and large-scale data are needed to further support these observations.

Management of Diabetes and Hypertension within the Gulf Region: Updates on Treatment Practices and Therapies.

Cardiovascular disease (CVD) is a leading cause of death globally, driven by the high rates of risk factors, such as diabetes and hypertension. As the prevalence of these risk factors is particularly high in the Gulf region, better diagnosis and management of type 2 diabetes (T2D) and hypertension has the potential to dramatically reduce adverse cardiovascular outcomes for individuals in that part of the world. This article provides a summary of presentations made during the EVIDENT summit, a virtual symposium on Evidence in Diabetes and Hypertension, held in September 2021, including a review of the various guidelines for both T2D and hypertension, as well as recent findings relevant to the safety and efficacy for therapies relating to these conditions. Of relevance to the Gulf region, the risk of hypoglycaemia with sulfonylureas during Ramadan was reviewed. For the management of T2D, sulfonylureas have been a long-standing medication used to achieve glycaemic control; however, differences have emerged between early and later generations, with recent studies suggesting improvements in the safety profiles of late-generation sulfonylureas. For patients with hypertension, incremental therapy changes are recommended to reduce the risk of cardiovascular complications that are associated with increasing blood pressure. For first-line therapy, angiotensin-converting enzyme inhibitors (ACEi), such as perindopril, have been demonstrated to reduce the risk of cardiovascular and all-cause mortality. The addition of calcium channel blockers and diuretics to ACEi has been shown to be effective in patients with poorly controlled hypertension. The different renin-angiotensin-aldosterone system inhibitors are reviewed, and the benefit of combination therapies, including amlodipine and indapamide in patients with difficult-to-control hypertension, is investigated. The benefits of lifestyle modifications for these patients are also discussed, with important clinical considerations that are expected to inform patient management in daily clinical practice.

Disparity in ST-segment Elevation Myocardial Infarction Practices and Outcomes in Arabian Gulf Countries (Gulf COAST Registry).

OBJECTIVES: The objective of this study is to describe contemporary management and 1-year outcomes of patients hospitalized with ST-segment elevation myocardial infarction (STEMI) in Arabian Gulf countries. METHODS: Data of patients admitted to 29 hospitals in four Gulf countries [Bahrain, Kuwait, Oman, United Arab Emirates (UAE)] with the diagnosis of STEMI were analyzed from Gulf locals with acute coronary syndrome (ACS) events (Gulf COAST) registry. This was a longitudinal, observational registry of consecutive citizens, admitted with ACS from January 2012 to January 2013. Patient management and outcomes were analyzed and compared between the four countries. RESULTS: A total of 1039 STEMI patients were enrolled in Gulf COAST Registry. The mean age was 58 years, and there was a high prevalence of diabetes (47%). With respect to reperfusion, 10% were reperfused with primary percutaneous coronary intervention, 66% with fibrinolytic therapy and 24% were not reperfused. Only one-third of patients who received fibrinolytic therapy had a door-to-needle time of 30 min or less. The in-hospital mortality rate was 7.4%. However, we noted a significant regional variability in mortality rate (3.8%-11.9%). In adjusted analysis, patients from Oman were 4 times more likely to die in hospital as compared to patients from Kuwait. CONCLUSIONS: In the Gulf countries, fibrinolytic therapy is the main reperfusion strategy used in STEMI patients. Most patients do not receive this therapy according to timelines outlined in recent practice guidelines. There is a significant discrepancy in outcomes between the countries. Quality improvement initiatives are needed to achieve better adherence to management guidelines and close the gap in outcomes.

Design and Rationale of Gulf locals with Acute Coronary Syndrome Events (Gulf Coast) Registry.

OBJECTIVES: To describe the risk profile, management and one-year outcomes of patients hospitalized with acute coronary syndrome (ACS) in the Gulf region of the Middle East. SUBJECTS AND METHODS: The Gulf locals with acute coronary syndrome events (Gulf COAST) registry is a prospective, multinational, longitudinal, observational, cohort-based registry of consecutive citizens, from the Gulf region of the Middle East, admitted from January 2012 to January 2013 to 29 hospitals with a diagnosis of ACS. Data entered online included patient demographics, cardiovascular risk profiles, past medical history, physical findings on admission, in-hospital diagnostic tests and therapeutic management, as well as one year outcomes. RESULTS: 3188 patients were recruited. The mean age was 60.4 ± 12.6years (range: 22-112), 2104 (66%) were males and 1084 (34%) females. The discharge diagnosis was ST-segment elevation myocardial infarction (STEMI) in 741 (23.2%), new-onset left bundle branch block myocardial infarction (LBBBMI) in 30 (0.9%), non-ST-segment elevation myocardial infarction (NSTEMI) in 1486 (46.6%) and unstable angina in 931 (29.2%). At hospital presentation, 2105 (66%), 1779 (55.8%), 1703 (53.4%) and 740 (23.2%) had history of hypertension, dyslipidemia, diabetes mellitus and active smoking, respectively. CONCLUSION: Patients with ACS in our region are young with very high risk profile. The Gulf COAST registry is an example of successful regional collaboration and will provide information on contemporary management of ACS in the region.

Adherence to ACC/AHA performance measures for myocardial infarction in six Middle-Eastern countries: association with in-hospital mortality and clinical characteristics.

BACKGROUND/OBJECTIVES: This study assesses adherence to performance measures for acute myocardial infarction (AMI) in six Middle-Eastern countries, and its association with in-hospital mortality. Few studies have previously assessed these performance measures in the Middle East. METHODS: This cohort study followed 5813 patients with suspected AMI upon admission to discharge. Proportions of eligible participants receiving the following performance measures were calculated: medications within 24 hours of admission (aspirin and beta-blocker) and on discharge (aspirin, beta-blockers, angiotensin converting enzyme inhibitors [ACEI], and lipid-lowering therapy), reperfusion therapy, and low-density lipoprotein (LDL) cholesterol measurement. A composite adherence score was calculated. Associations between performance measures and clinical characteristics were assessed using multivariate logistic regression. RESULTS: Adherence was above 90% for aspirin, reperfusion, and lipid-lowering therapies; between 60% and 82% for beta-blockers, ACEI, statin therapy, time-to-balloon within 90 minutes, and LDL-cholesterol measurement; and 33% for time-to-needle within 30 minutes. After adjustment, factors associated with high composite performance score (>85%) included Asian ethnicity (Odds Ratio, OR=1.3; p=0.01) and history of hyperlipidemia (OR=1.4; p=0.001). Factors associated with a lower score included atypical symptoms (OR=0.6; p=0.003) and high GRACE score (OR=0.6; p<0.001). Lower in-hospital mortality was associated with provision of reperfusion therapy (OR=0.54, p=0.047) and beta-blockers within 24 hours (OR=0.33, p=0.005). CONCLUSIONS: Overall adherence was lowest among the highest-risk patients. Lower in-hospital mortality was independently associated with adherence to early performance measures, comprising observational evidence for their effectiveness in a Middle East cohort. These data provide a focus for regional quality improvement initiatives and research.

Trends in the Use of Evidence-based Therapies Early in the Course of Acute Myocardial Infarction and its Influence on Short Term Patient Outcomes.

AIM: To evaluate changes in management practices and its influence on short term hospital outcomes in patients with acute myocardial infarction (AMI) admitted during two different time periods, 2007 and 2004. METHODS AND RESULTS: We studied AMI patients from two acute coronary syndrome registries carried out in Kuwait in 2007 and 2004. We included 1872 and 1197 patients from the 2007 and 2004 registries, respectively. When compared with 2004, patients from the 2007 registry had similar baseline clinical characteristics. In 2007 compared to 2004, during the in-hospital period, patients with AMI received significantly more statins (94% vs. 73%%, p<0.0001), Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) (70% vs. 47%, p<0.001), and Clopidogrel (38% vs. 4%, p<0.001), while beta-blockers use dropped in 2007 compared to 2004 (63% vs. 68%, p=0.0066). The rates of in-hospital mortality and recurrent ischemia were significantly lower in the 2007 cohort compared with the 2004 cohort (for mortality 2.2% vs. 3.9%, P=0.0008, for recurrent ischemia 13.7% vs. 20.4%, P=0<0.0001).Higher utilization of angiotensin converting enzyme inhibitors, angiotensin receptor blockers and statins were the main contributors to the improved in-hospital mortality and morbidity. IN CONCLUSION: In the acute management of AMI, there was a significant increase in the use of statins, ACE inhibitors and Clopidogrel in 2007 compared to 2004. This was associated with a significant decrease in the in-hospital mortality and recurrent ischemia. Adherence to guidelines recommended therapies improved in-hospital outcomes.

In-hospital major clinical outcomes in patients with chronic renal insufficiency presenting with acute coronary syndrome: data from a Registry of 8176 patients.

OBJECTIVE: To assess the impact of chronic renal insufficiency (CRI) on in-hospital major adverse cardiac events across the acute coronary syndrome (ACS) spectrum. PATIENTS AND METHODS: From January 29, 2007, through July 29, 2007, 6 adjacent Middle Eastern countries participated in the Gulf Registry of Acute Coronary Events, a prospective, observational registry of 8176 patients. Patients were categorized according to estimated glomerular filtration rate into 4 groups: normal (>or=90 mL/min), mild (60-89 mL/min), moderate (30-59 mL/min), and severe CRI (<30 mL/min). Patients' characteristics and in-hospital major adverse cardiac events in the 4 groups were analyzed. RESULTS: Of 6518 consecutive patients with ACS, 2828 (43%) had mild CRI, 1304 (20%) had moderate CRI, and 345 (5%) had severe CRI. In CRI groups, patients were older and had a higher prevalence of hypertension, diabetes mellitus, and dyslipidemia. On admission, these patients had a higher resting heart rate and frequently had atypical and delayed presentations. Compared with the normal estimated glomerular filtration group, CRI groups were less likely to receive antiplatelet drugs, beta-blockers, angiotensin-converting enzyme inhibitors, and statins and were less likely to undergo coronary angiography. In-hospital heart failure, cardiogenic shock, and major bleeding episodes were significantly higher in all CRI groups. In multivariate analysis, mild, moderate, and severe CRI were associated with a higher adjusted odds ratio (OR) of death (mild: OR, 2.1; 95% confidence interval [CI], 1.2-3.7; moderate: OR, 6.7; 95% CI, 3.9-11.5; and severe: OR, 12.0; 95% CI, 6.6-21.7). CONCLUSION: Across the ACS spectrum, patients with CRI had a worse risk profile, had more atypical and delayed presentations, and were less likely to receive evidence-based therapy. Chronic renal insufficiency of varying stages is an independent predictor of in-hospital morbidity and mortality.

Early changes in ventricular repolarization after thrombolytic therapy in patients with acute myocardial infarction as indicators for prediction of epicardial coronary artery reperfusion.

OBJECTIVES: To investigate the relationship between early T-wave inversion after thrombolytic therapy and the likelihood of successful epicardial coronary reperfusion. SUBJECTS AND METHODS: Thrombolytic therapy was given to 195 patients with ST segment elevation due to acute anterior myocardial infarction (AMI). Coronary angiography was performed. Receiver operating characteristic (ROC) curve (grade of sensitivity versus false positive) was calculated using likelihood ratio method to identify the ideal cut-off values of the ventricular repolarization variables. RESULTS: Predictive indices showed 80% sensitivity, 83% specificity, 81% accuracy, 88% positive predictive value and 71% negative predictive value for early T-wave inversion after thrombolytic therapy. A good concordant agreement was noted between the data of coronary angiography and early T-wave inversion in the infarct-related ECG leads after thrombolysis (kappa coefficient kappa= 0.876). Stepwise multivariate analysis revealed that early T-wave inversion after thrombolytic therapy of AMI was significantly associated with a history of preinfarction angina, residual infarct-related coronary artery stenosis >50%, short time to thrombolytic therapy <90 min, and evening time for occurrence of thrombolysis (p < 0.05). The ROC curve data analysis showed that early T-wave inversion amplitude after AMI had 87% sensitivity and 84% specificity for predicting successful reperfusion, with an ideal cut-off value of 7.2 mm, while time of T-wave inversion had 80% sensitivity and 79% specificity, with an ideal cut-off value of 120 min. CONCLUSION: The data indicate that early inversion of T wave after AMI is a statistically significant independent variable in predicting successful epicardial coronary thrombolysis status.

Predictive accuracy of tissue Doppler imaging for assessment of noninfarct myocardial region in patients with acute myocardial infarction.

OBJECTIVES: To investigate the value of pulsed tissue Doppler imaging (TDI) in order to predict significant coronary artery stenosis supplying the noninfarct region in patients after acute anterior myocardial infarction. SUBJECTS AND METHODS: Transthoracic echocardiography and coronary angiography were performed on 220 patients with acute anterior myocardial infarction. The TDI-derived variables of the mitral valve annulus in the noninfarct region, systolic velocity (Sm), early diastolic velocity (Em) and late diastolic velocity (Am), were estimated in centimeters per second, and the Em/Am ratio was calculated. RESULTS: Predictive indices revealed that the impaired TDI-derived variables, Sm, Em, Am and the Em/Am ratio, were an indicator for predicting significant coronary stenosis in the noninfarct region. Multivariate analysis revealed that the impaired Sm and Em velocities were significantly associated with age of the patients, coronary collaterals and infarct-related artery stenosis (p < 0.05). Receiver-operating characteristic curve data of TDI-derived variables for prediction of significant coronary stenosis revealed that the cut-off values of Sm, Em, Am and Em/Am ratio were 7.2 cm/s, 6.4 cm/s, 12.1 cm/s and 0.56, respectively. The kappa coefficient value indicated that there was an agreement between coronary angiography and the TDI-derived variables Sm, Em, Am and Em/Am ratio in noninfarct regions (kappa = 0.770, 0.731, 0.693 and 0.679, respectively). There was a significant correlation between the severity of coronary artery stenosis (independent variable) and impaired Sm and Em/Am ratio (dependent variables), y = 11.5 - 0.05x, r = -0.902, (p < 0.05), and y = - 0.14x + 1.87, r = -0.754, (p < 0.05), respectively. CONCLUSION: TDI can be used to identify patients with significant stenosis of the coronary arteries supplying the noninfarct region and consequently may be helpful in considering patients for coronary angiography in the early postinfarction period.