Thomas Alexander

Systems of care for ST-elevation myocardial infarction in India

The prevalence of coronary artery disease and ST-elevation myocardial infarction (STEMI) are increasing in India. Although recent publications have focused on improving preventive measures in developing countries, less attention has been placed on the acute management of STEMI. Recent policy changes in India have provided new opportunities to address existing barriers but require greater investment and support in the coming years.

A System of Care for Patients With ST-Segment Elevation Myocardial Infarction in India: The Tamil Nadu–ST-Segment Elevation Myocardial Infarction Program

Importance Challenges to improving ST-segment elevation myocardial infarction (STEMI) care are formidable in low- to middle-income countries because of several system-level factors. Objective To examine access to reperfusion and percutaneous coronary intervention (PCI) during STEMI using a hub-and-spoke model. Design, Setting, and Participants This multicenter, prospective, observational study of a quality improvement program studied 2420 patients 20 years or older with symptoms or signs consistent with STEMI at primary care clinics, small hospitals, and PCI hospitals in the southern state of Tamil Nadu in India. Data were collected from the 4 clusters before implementation of the program (preimplementation data). We required a minimum of 12 weeks for the preimplementation data with the period extending from August 7, 2012, through January 5, 2013. The program was then implemented in a sequential manner across the 4 clusters, and data were collected in the same manner (postimplementation data) from June 12, 2013, through June 24, 2014, for a mean 32-week period. Exposures Creation of an integrated, regional quality improvement program that linked the 35 spoke health care centers to the 4 large PCI hub hospitals and leveraged recent developments in public health insurance schemes, emergency medical services, and health information technology Main Outcomes and Measures Primary outcomes focused on the proportion of patients undergoing reperfusion, timely reperfusion, and postfibrinolysis angiography and PCI. Secondary outcomes were in-hospital and 1-year mortality. Results A total of 2420 patients with STEMI (2034 men [84.0%] and 386 women [16.0%]; mean [SD] age, 54.7 [12.2] years) (898 in the preimplementation phase and 1522 in the postimplementation phase) were enrolled, with 1053 patients (43.5%) from the spoke health care centers. Missing data were common for systolic blood pressure (213 [8.8%]), heart rate (223 [9.2%]), and anterior MI location (279 [11.5%]). Overall reperfusion use and times to reperfusion were similar (795 [88.5%] vs 1372 [90.1%]; P = .21). Coronary angiography (314 [35.0%] vs 925 [60.8%]; P < .001) and PCI (265 [29.5%] vs 707 [46.5%]; P < .001) were more commonly performed during the postimplementation phase. In-hospital mortality was not different (52 [5.8%] vs 85 [5.6%]; P = .83), but 1-year mortality was lower in the postimplementation phase (134 [17.6%] vs 179 [14.2%]; P = .04), and this difference remained consistent after multivariable adjustment (adjusted odds ratio, 0.76; 95% CI, 0.58-0.98; P = .04). Conclusions and Relevance A hub-and-spoke model in South India improved STEMI care through greater use of PCI and may improve 1-year mortality. This model may serve as an example for developing STEMI systems of care in other low- to middle-income countries.

Protocol for a prospective, controlled study of assertive and timely reperfusion for patients with ST-segment elevation myocardial infarction in Tamil Nadu: the TN-STEMI programme

Introduction Over the past two decades, India has witnessed a staggering increase in the incidence and mortality of ST-elevation myocardial infarction (STEMI). Indians have higher rates of STEMI and younger populations that suffer from it when compared with developed countries. Yet, the recommended reperfusion therapy with fibrinolysis and percutaneous coronary intervention is available only to a minority of patients. This gap in care is a result of financial barriers, limited healthcare infrastructure and poor knowledge and accessibility of acute medical services for a majority of its population. Methods and analysis This is a prospective, multicentre, ‘pretest/post-test’ quasi-experimental, community-based study. This programme will use a ‘hub-and-spoke’ model of an integrated healthcare network based on clusters of primary-care health clinics, small hospitals and large tertiary-care facilities. It is an ‘all-comers’ study which will enrol consecutive patients presenting with STEMI to the participating hospitals. The primary objectives of the study is to improve the use of reperfusion therapy and reduce the time from first medical contact to device or drug in STEMI patients; and to increase the rates of early invasive risk stratification with coronary angiography within 3–24 h of fibrinolytic therapy in eligible patients through changes in process of care. Outcomes will be measured with statistical comparison made before and after implementing the TN-STEMI programme. The estimated sample size is based on the Kovai Erode Pilot study, which provided an initial work on establishing this type of programme in South India. It will be adequately powered at 80% with a superiority margin of 10% if 36 patients are enrolled per cluster or 108 patients in three clusters. Thus, the enrolment period of 9 months will result in a sample size of 1500 patients. Ethics This study will be conducted in accordance with the ethical principles that have their origin in the current Declaration of Helsinki and ‘ethical guidelines for biomedical research on human participants’ as laid down by the Indian Council for Medical Research. All participating hospitals will still obtain local ethics committee approval of the study protocol and written informed consent will be obtained from all participants. Dissemination and results Our findings will be reported through scientific publications, research conferences and public policy venues aimed at state and local governments in India. If successful, this model can be extended to other areas of India as well as serve as a model of STEMI systems of care for low-income and middle-income countries across the world. Registration Trial is registered with Clinical trial registry of India, No: CTRI/2012/09/003002.

A prospective, observational, multicentre study comparing tenecteplase facilitated PCI versus primary PCI in Indian patients with STEMI (STEPP—AMI)

Objective To compare the efficacy of pharmacoinvasive strategy versus primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Primary PCI is the preferred treatment for STEMI, but it is not a feasible option for many. A pharmacoinvasive strategy might be a practical solution in the Indian context, although few empirical data exist to guide this approach. Methods This is a prospective, observational, multicentre pilot study. Two hundred consecutive patients with STEMI aged 18–75 years, presenting within 12 h of onset of symptoms and requiring a reperfusion strategy, were studied from five primary PCI capable centres in South India. Patients who opted for pharmacoinvasive strategy (n=45) formed group A. Group B consisted of patients treated with primary PCI (n=155). One patient was lost to follow-up at 1 year. The primary end point was a composite of death, cardiogenic shock, reinfarction, repeat revascularisation of a culprit artery and congestive heart failure at 30 days. Results The primary end point occurred in 11.1% in group A and in 3.9% in group B, p=0.07 (RR=2.87; 95% CI 0.92 to 8.97). The infarct-related artery patency at angiogram was 82.2% in group A and 22.6% in group B (p<0.001). PCI was performed in 73.3% in group A versus 100% in group B (p<0.001), and a thrombus was present in 26.7% in group A versus 63.2% in group B (p<0.001). Failed fibrinolysis occurred in 12.1% in group A. There was no difference in bleeding risk, 2.2% in group A versus 0.6% in group B, (p=0.4). Conclusions This pilot study shows that a pharmacoinvasive strategy can be implemented in patients not selected for primary PCI in India and hints at the possibility of similar outcomes. Larger studies are required to confirm these findings. Trial registration number Trial is registered with Clinical trial registry of India, CTRI number: REF/2011/07/002556.

Developing a STEMI system of care for low- and middle-income countries: the STEMI-India model.

Coronaryarterydisease(CAD)isamajorcontributortodeath and disability in India, and its overall prevalence hasrisen dramatically over the past 2 decades. Current datashowthat3%to4%ofIndiansinruralareasand8%to10%inurbanareashaveCAD[1].Furthermore,thepatientswithCAD in the Indian subcontinent appear to be at greater riskof acute presentations of CAD, present 5 years early withacute events, and demonstrate worse outcomes followingsuch events.Data about contemporary trends in ST-segment eleva-tion myocardial infarction (STEMI) patients come fromCREATE (Treatment and Outcomes of Acute CoronarySyndromes in India), a large clinical registry of acute coro-nary syndrome patients from 89 large hospitals in 10regions and cities across India [2]. Among the >20,000patients enrolled in CREATE, over 60% had STEMI, aproportion that is substantially higher than in NorthAmericanandEuropeanregistries[3,4].Thirty-fourpercentof the STEMI patients were 40 million people are pushed into massivedebts to access health care. The consequences of out-of-pocket payment for acute care can have a devastating ef-fect on poverty and rural indebtedness [5]. The scenario isprobablysimilarinmostlow-andmiddle-incomecountries(LMIC).Therefore,anySTEMIsystemofcaredevelopedforthese countries will have to be equitable and inclusive sothat this vulnerable population is not ignored.

Cardiological Society of India: Position statement for the management of ST elevation myocardial infarction in India

Santanu Guha*, Rishi Sethi, Saumitra Ray, Vinay K. Bahl, S. Shanmugasundaram, Prafula Kerkar, Sivasubramanian Ramakrishnan, Rakesh Yadav, Gaurav Chaudhary, Aditya Kapoor, Ajay Mahajan, Ajay Kumar Sinha, Ajit Mullasari, Akshyaya Pradhan, Amal Kumar Banerjee, B.P. Singh, J. Balachander, Brian Pinto, C.N. Manjunath, Chandrashekhar Makhale, Debabrata Roy, Dhiman Kahali, Geevar Zachariah, G.S. Wander, H.C. Kalita, H.K. Chopra, A. Jabir, JagMohan Tharakan, Justin Paul, K. Venogopal, K.B. Baksi, Kajal Ganguly, Kewal C. Goswami, M. Somasundaram, M.K. Chhetri, M.S. Hiremath, M.S. Ravi, Mrinal Kanti Das, N.N. Khanna, P.B. Jayagopal, P.K. Asokan, P.K. Deb, P.P. Mohanan, Praveen Chandra, (Col.) R. Girish, O. Rabindra Nath, Rakesh Gupta, C. Raghu, Sameer Dani, Sandeep Bansal, Sanjay Tyagi, Satyanarayan Routray, Satyendra Tewari, Sarat Chandra, Shishu Shankar Mishra, Sibananda Datta, S.S. Chaterjee, Soumitra Kumar, Soura Mookerjee, Suma M. Victor, Sundeep Mishra, Thomas Alexander, Umesh Chandra Samal, Vijay Trehan

The impact of systems-of-care on pharmacoinvasive management with streptokinase: The subgroup analysis of the TN-STEMI programme

Objectives We evaluated the impact of implementation of the TN-STEMI programme on various characteristics of the pharmacoinvasive group by comparing clinical as well as angiographic outcomes between the pre- and post-implementation groups. Methods The TN-STEMI programme involved 2420 patients of which 423 patients had undergone a pharmacoinvasive strategy of reperfusion. Of these, 407 patients had a comprehensive blinded core-lab evaluation of their angiograms post-lysis and clinical evaluation of various parameters including time-delays and adverse cardio- and cerebro-vascular events at 1 year. Streptokinase was used as the thrombolytic agent in 94.6% of the patients. Results In the post-implementation phase, there was a significant improvement in ‘First medical contact (FMC)-to-ECG’ (11 vs. 5 min, p < 0.001) and ‘Lysis-to-angiogram’ (98.3 vs. 18.2 h, p < 0.001) times. There was also a significant improvement in the number of coronary angiograms performed within 24 h (20.7% vs. 69.3%, p < 0.001). The ‘Time-to-FMC’ (160 vs. 135 min, p = 0.07) and ‘Total ischemic time’ (210 vs. 176 min, p = 0.22) also showed a decreasing trend. IRA patency rate (70.2% vs. 86%, p < 0.001) and thrombus burden (TIMI grade 0: 49.1% vs. 73.4%, p < 0.001) were superior in this group. The MACCE rates were similar except for fewer readmissions (29.8% vs. 12.6%, p = 0.0002) and target revascularizations at 1 year (4.8% vs. none, p = 0.002) in the post-implementation group. Conclusion The implementation of a system-of-care (hub-and-spoke model) in the pharmacoinvasive group of the TN-STEMI programme demonstrated shorter lysis-to-angiogram times, better TIMI flow patterns and lower thrombus burden in the post-implementation phase.

Premature coronary artery disease in India: coronary artery disease in the young (CADY) registry

Background Coronary artery disease (CAD) occurs at younger age in India but only a limited number of studies have evaluated risk factors and management status. This is a multisite observational registry to assess risk factors and treatment patterns in young patients presenting with acute coronary syndrome (ACS) and stable ischemic heart disease (IHD). Methods We recruited 997 young patients (men <55, women <65 y) presenting with ACS or stable IHD successively at 22 centers across India. Details of baseline risk factors and management status were obtained. Descriptive statistics are reported. Results Mean age of participants was 49.1 ± 8y, 72% were men and 68% had ACS. Family history of CAD was in 50%, diabetes 44%, hypertension 49%, history of dyslipidemia 11%, smoking/tobacco use 39%, and sedentary habits in 20%. 1.3% had “possible familial hypercholesterolemia”. Metabolic risk factors (high BMI, diabetes and hypertension) were significantly greater in women (p < 0.01). Women were older at diagnosis of CAD and presented more often with non-ST elevation ACS. In the study cohort antiplatelet use was in 85%, beta-blockers 38%, statins 63% and ACE inhibitors/ARBs in 41% while in ACS patients it was 80.5%, 54.6%, 80.8% and 40.8%, respectively. 35.9% patients underwent percutaneous coronary intervention while coronary bypass surgery was performed in 10.4%. Conclusions Conventional risk factors including family history continue to play a pivotal role in premature CAD in Indians. Women have more of metabolic risk factors, present at a later age and have non-ST elevation ACS more often. There is a need to focus on improving use of evidence-based drug therapies and interventions.

Management of STEMI in low- and middle-income countries.

The authors report no relationships that could be construed as a conflict of Prehospital and initial management .. . . . . . . . . . . . . . . . 471 Patient delay ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 472 Emergency medical systems .. . . . . . . . . . . . . . . . . . . . . 472 In-hospital management ... . . . . . . . . . . . . . . . . . . . . . . . . . . . 477 interest. Diagnosis and risk assessment .. . . . . . . . . . . . . . . . . . . . . . . . . . . 477 From the *Division of Cardiovascular Medicine, Wexner Medical Center, The Ohio State University, Columbus, OH, USA; yDepartment of Cardiology, All India Institute of MediClinical examination .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 477 Risk assessment on initial presentation ... . . . . . . . . . . 479 ECG ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 479 Cardiac biomarkers .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 482 Echocardiography .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 486 Coronary angiography ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 486 cal Sciences, New Delhi, India; zKovai Medical CenTherapy .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 486

Metals in urine in relation to the prevalence of pre-diabetes, diabetes and atherosclerosis in rural India

Objective Diabetes and cardiovascular diseases are growing burdens in rural communities worldwide. We have observed a high prevalence of diabetes among rural farming communities in India and sought to evaluate the association of non-traditional risk factors, such as metals, with diabetes and other cardiometabolic risk factors in this community. Methods Anthropometric measurements, chemistries and carotid intima-media thickness were determined in 865 participants of the Kovai Medical Center and Hospital-Nallampatti Non-Communicable Disease Study-I (KMCH-NNCD-I, 2015), a cross-sectional study conducted in a farming village in South India. Urinary metal levels were determined by inductively couped plasma-mass spectrometry analysis and corrected to urinary creatinine level. Statistical analyses were performed to study the association between urinary metal levels and clinical parameters. Results 82.5% of the study population were involved in farming and high levels of toxic metals were detected in the synthetic fertilisers used in the study village. The prevalence of pre-diabetes, diabetes and atherosclerosis was 43.4%, 16.2% and 10.3%, respectively. On logistic regression analysis, no association of traditional risk factors such as body mass index, blood pressure and total cholesterol with disease conditions was observed, but urinary levels of metals such as arsenic, chromium, aluminium and zinc showed an association with diabetes, while arsenic and zinc showed an association with pre-diabetes and atherosclerosis. Conclusions Our data suggest a probable role of metals in the aetiology of diabetes and cardiovascular diseases in rural communities. Identifying and eliminating the causes of increased levels of these environmental chemicals could have a beneficial impact on the burden of non-communicable diseases in rural population.