Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes.

BACKGROUND: The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents. METHODS: We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up. RESULTS: At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002). CONCLUSIONS: In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).

Efficacy and safety of tenecteplase in Indian elderly STEMI patients from the Elaxim Indian Registry.

OBJECTIVE: To analyze the efficacy and safety of indigenous Tenecteplase in Indian elderly STEMI patients in a clinical setting. METHODS: Post-licensure, observational, prescription event monitoring (PEM) study. RESULTS: 2162 patients received weight-adjusted Tenecteplase injection. The data for elderly (> 60 years) and non-elderly (< or = 60 years) was identified, segregated and compared. Out of 2162 patients, 805 were elderly patients and 1357 were non-elderly. Clinically successful thromolysis was seen in 83.98% of elderly and 86% of non-elderly group (p = 0.22). There was no significant difference in percentage of patients reporting bleeding, stroke, intracranial hemorrhage, myocardial reinfraction, ventricular tachyarrhythmia between the groups. Mortality was significantly (p = < 0.0001) more in elderly (6.21%) than non-elderly (2.06%) patients. CONCLUSION: The indigenously developed Tenecteplase shows high efficacy and safety in its in-hospital use in Indian elderly patients with STEMI.

One-year clinical outcome of patients with nonvalvular atrial fibrillation: Insights from KERALA-AF registry.

BACKGROUND: We report patient characteristics, treatment pattern and one-year clinical outcome of nonvalvular atrial fibrillation (NVAF) from Kerala, India. This cohort forms part of Kerala Atrial Fibrillation (KERALA-AF) registry which is an ongoing large prospective study. METHODS: KERALA-AF registry collected data of adults with previously or newly diagnosed atrial fibrillation (AF) during April 2016 to April 2017. A total of 3421 patients were recruited from 53 hospitals across Kerala state. We analysed one-year follow-up outcome of 2507 patients with NVAF. RESULTS: Mean age at recruitment was 67.2 years (range 18-98) and 54.8% were males. Main co-morbidities were hypertension (61.2%), hyperlipidaemia (46.2%) and diabetes mellitus (37.2%). Major co-existing diseases were chronic kidney disease (42.1%), coronary artery disease (41.6%), and chronic heart failure (26.4%). Mean CHA2DS2-VASc score was 3.18 (SD ± 1.7) and HAS-BLED score, 1.84 (SD ± 1.3). At baseline, use of oral anticoagulants (OAC) was 38.6% and antiplatelets 32.7%. On one-month follow-up use of OAC increased to 65.8% and antiplatelets to 48.3%. One-year all-cause mortality was 16.48 and hospitalization 20.65 per 100 person years. The main causes of death were cardiovascular (75.0%), stroke (13.1%) and others (11.9%). The major causes of hospitalizations were acute coronary syndrome (35.0%), followed by arrhythmia (29.5%) and heart failure (8.4%). CONCLUSIONS: Despite high risk profile of patients in this registry, use of OAC was suboptimal, whereas antiplatelets were used in nearly half of patients. A relatively high rate of annual mortality and hospitalization was observed in patients with NVAF in Kerala AF Registry.

Prognostic value of soluble ST2 biomarker in heart failure patients with reduced ejection fraction - A multicenter study.

OBJECTIVE: To study the prognostic value of soluble Suppression of Tumorigenicity-2 (sST2) in heart failure patients with reduced ejection fraction (HFrEF). METHODS: In this prospective, observational, multicenter study, patients with heart failure (HF) and left ventricular ejection fraction (LVEF) <50% were included. Clinical evaluation and serum levels of sST2 were estimated at five time points during follow up. Study endpoint was the relationship of baseline and serial sST2 concentration in the blood to the composite endpoints of cardiac death and re-hospitalization for worsening of HF during one year follow up period. RESULTS: A total of 141 patients were enrolled. The mean age was 60±10.4years. At baseline evaluation, 49.6% patients were in New York Heart Association (NYHA) class III and 36.2% in class IV. Adverse events were observed in 57 patients (40.4%); 25 (17.7%) were re-hospitalized due to worsening of HF and 32 (22.7%) died due to cardiac causes. The median value of baseline sST2 was 46.36ng/ml (IQR 31.30-78.38). sST2 concentration at baseline was significantly higher among patients with adverse events in comparison to patients without adverse events (p=<0.001). Receiver operating characteristic curve (ROC) for baseline sST2 concentration identified 49ng/ml as optimal cut-off value to predict cardiac death and re-hospitalization, with a sensitivity and specificity of 72% and 75%, respectively. CONCLUSION: In patients with HFrEF, sST2 concentration at baseline as well as on serial testing was significantly correlated with cardiac death and re-hospitalization for worsening of HF.

Two-year follow-up data from the STEPP-AMI study: A prospective, observational, multicenter study comparing tenecteplase-facilitated PCI versus primary PCI in Indian patients with STEMI.

BACKGROUND: A pharmacoinvasive strategy may alleviate the logistical and geographical barriers in timely reperfusion of ST-segment elevation myocardial infarction (STEMI), especially in a developing country like India. AIM: To assess the safety and efficacy of pharmacoinvasive strategy versus primary PCI in STEMI patients at 2 years. METHODS: Patients enrolled in STEPP-AMI, an observational, multicenter, prospective study of 200 patients presenting with STEMI, were followed up for 2 years. Group 'A' comprised of patients with pharmacoinvasive strategy (n=45), and patients who underwent primary PCI (n=155) formed group 'B'. Primary endpoint was composite of death, cardiogenic shock, reinfarction, repeat revascularization of the culprit artery, or congestive heart failure at 30 days, with follow-up till 2 years. RESULTS: The primary endpoint occurred in 11.1% and 17.8% in group A and in 3.9% and 13.6% in group B, at 30 days and 2 years, respectively (p=0.07, RR=2.87; 95% CI: 0.92-8.97 at 30 days and p=0.47, RR=1.31; 95% CI: 0.62-2.76). There was no difference in bleeding risk between groups, 2.2% in group A and 0.6% in group B ('p'=0.4). The infarct-related artery patency varied at angiogram; it was 82.2% in arm A and 22.6% in arm B ('p'<0.001). In group A, failed fibrinolysis occurred in 12.1%. CONCLUSION: A pharmacoinvasive strategy resulted in outcomes that were comparable with primary PCI at 2 years, suggesting it might be a viable option in India. Larger studies are required to confirm these findings.

Prospective study to evaluate safety and efficacy of Zotarolimus Eluting Stent (PSEZES) in patients with long coronary artery lesions.

BACKGROUND: Although the safety and effectiveness of Drug-Eluting Stents (DES) has been established extensively, reports on long term clinical outcome with angiographic findings in patients with long coronary artery lesions are not many. METHODS: In this single-center prospective registry of 100 patients, a total of 110 denovo long lesions (>20 mm) were treated with Resolute Zotarolimus Eluting Stent (R-ZES). The patients were followed up clinically at 3, 6 and 12 months and follow up coronary angiography was performed at 9-months. The primary end point was one year rate of target lesion failure (TLF) which is a composite of cardiac death, target lesion myocardial infarction or ischemia driven target lesion revascularization (TLR). The secondary end points included definite or probable stent thrombosis, 9-month angiographic restenosis and late lumen loss. RESULTS: The mean age of patients was 58.7 ± 9.50 years with prevalence of diabetes as high as 60%. The mean lesion length was 24.67 ± 4.87 mm with a mean reference vessel diameter of 2.85 ± 0.32 mm and 67.3% were Type C lesions (ACC/AHA classification). Two patients died during follow-up, of which one was non-cardiac death. One patient had target vessel myocardial infarction and five patients (4.5%) had ischemia driven TLR. The incidence of TLF was 6.36%. Binary restenosis was seen in 7 out of 93 lesions (7.5%). Median late lumen loss at 9 month was 0.22 mm. No stent thrombosis was noted in the study. CONCLUSION: Implantation of R-ZES in real-world patients with long coronary artery lesions is safe with comparable efficacy to what is observed in the treatment of less complex lesions.

Sex Differences in the Presentation, Diagnosis, and Management of Acute Coronary Syndromes: Findings From the Kerala-India ACS Registry.

BACKGROUND: Previous literature from high-income countries has repeatedly shown sex differences in the presentation, diagnosis, and management of acute coronary syndromes (ACS), with women having atypical presentations and undergoing less aggressive diagnostic and therapeutic measures. However, much less data exist evaluating sex differences in ACS in India. OBJECTIVES: This study sought to evaluate sex differences in the diagnosis, management, and treatment of patients with ACS in Kerala, India. METHODS: The Kerala ACS Registry collected data from 25,748 consecutive ACS admissions (19,923 men and 5,825 women) from 125 hospitals in the Indian state of Kerala from 2007 to 2009. This study evaluated the association between sex differences in presentation, in-hospital management, and discharge care with in-hospital mortality and in-hospital major adverse cardiovascular events (defined as death, reinfarction, stroke, heart failure, or cardiogenic shock). RESULTS: Women with ACS were older than men with ACS (64 vs. 59, p < 0.001) and were more likely to have a history of previous myocardial infarction (16% vs. 14%, p < 0.001). Inpatient diagnostics and management and discharge care were similar between sexes. No significant differences between men and women in the outcome of death (odds ratio [OR]: 1.05, 95% confidence interval [CI]: 0.80 to 1.38) or in the composite outcome of death, reinfarction, stroke, heart failure, or cardiogenic shock (OR: 0.99, 95% CI: 0.79 to 1.25) were seen after adjustment for possible confounding factors. CONCLUSIONS: In Kerala, even though women with ACS were older and more likely to have previous myocardial infarction, there were no significant differences in in-hospital and discharge management, in-hospital mortality, or major adverse cardiovascular events between sexes. Whether these results apply to other parts of India or acute presentations of other chronic diseases in low- and middle-income countries warrants further study.

Hemianomalous pulmonary venous connection of the left lung surgically corrected.

Hemianomalous pulmonary venous connection is a rare congenital abnormality that leads to significant left-to-right shunt and complications related to that. Earlier surgical correction of this disorder was associated with the problem of stenosis at the anastomotic site with the left atrium. We describe the diagnosis of this abnormality in a 24-year-old woman and present the details of surgery to avoid the stenosis at the site of anastomosis.

Thrombectomy with rescue percutaneous thrombectomy catheter: our initial experience.

Plaque rupture and subsequent thrombus formation inside the coronary arteries has been known for years. Mechanical devices have been used for the extraction or dissolution of thrombus inside the coronary arteries. This report illustrates the use of the Rescue Percutaneous Thrombectomy Catheter in a right coronary artery loaded with thrombus. Following thrombectomy, the stenosis in the artery was well delineated. Successful balloon angioplasty was performed, which resulted in TIMI 3 flow and no distal embolization. Rescue Percutaneous Thrombectomy Catheter has been successfully used in the setting of acute myocardial infarction. The present case illustrates that the Rescue Percutaneous Thrombectomy Catheter can be used for removing thrombus even one month after acute myocardial infarction.

Aortoarteritis presenting as coarctation of aorta.

An interesting case of Aortoarteritis with clinical features simulating congenital coarctation of aorta (COA) is presented. Clinical pointers of differentiation of these conditions are discussed. Relevant literature is reviewed.

Complete heart block in rheumatoid arthritis.

A case of rheumatoid arthritis with complete AV heart block is reported. The relevant literature is briefly reviewed.

The first attack of acute rheumatic fever in childhood--clinical and laboratory profile.

One hundred consecutive cases of 'first attack' of acute rheumatic fever were studied. There were 52 males and 48 females, constituting 1.12% of total hospital admissions. Nearly 10% of children were below the age of 5 years, stressing the early onset of rheumatic fever in tropics. Only 47% gave a definite history of overcrowding at home. Sore throat was present in 67%, overt arthritis in 66%, carditis in 57%, arthralgia alone in 22% of which 45.45% had carditis. Small joint involvement was noticed in 23% of cases of which 73.91% had carditis. Only 33.33% had congestive cardiac failure. Ten per cent of children had chorea, while subcutaneous nodules were seen in 4% of cases, all of whom had associated carditis. Erythrocyte sedimentation rate (ESR) showed good correlation with clinical profile. Throat cultures were positive for beta hemolytic streptococci only in 12% of cases. Anti-streptolysin 'O' (ASO) titre showed significant titres on 68% of cases, anti-deoxyribonuclease "B" (ADN-B) in 69.32%, antibody to group A carbohydrate (ACHO) in 70.65%. ASO, ADN-B, and ACHO titres together gave 87.5% positivity while estimations in paired sera showed ASO 79.54%, ADN-B 82.27% and ASO, ADN-B together 99.92% significant titres. Study of blood groups showed A group children to be more vulnerable to rheumatic fever (37.5%) and rheumatic carditis (47.37%). Mortality in the present study was nil.