Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial.

BACKGROUND: Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce. The aim of this trial was to assess whether the use of ticagrelor alone, compared with ticagrelor plus aspirin, could reduce the incidence of clinically relevant bleeding events without an accompanying increase in major adverse cardiovascular or cerebrovascular events (MACCE). METHODS: In this randomised, placebo-controlled, double-blind clinical trial, patients aged 18 years or older with an acute coronary syndrome who completed the IVUS-ACS study and who had no major ischaemic or bleeding events after 1-month treatment with dual antiplatelet therapy were randomly assigned to receive oral ticagrelor (90 mg twice daily) plus oral aspirin (100 mg once daily) or oral ticagrelor (90 mg twice daily) plus a matching oral placebo, beginning 1 month and ending at 12 months after percutaneous coronary intervention (11 months in total). Recruitment took place at 58 centres in China, Italy, Pakistan, and the UK. Patients were required to remain event-free for 1 month on dual antiplatelet therapy following percutaneous coronary intervention with contemporary drug-eluting stents. Randomisation was done using a web-based system, stratified by acute coronary syndrome type, diabetes, IVUS-ACS randomisation, and site, using dynamic minimisation. The primary superiority endpoint was clinically relevant bleeding (Bleeding Academic Research Consortium [known as BARC] types 2, 3, or 5). The primary non-inferiority endpoint was MACCE (defined as the composite of cardiac death, myocardial infarction, ischaemic stroke, definite stent thrombosis, or clinically driven target vessel revascularisation), with an expected event rate of 6·2% in the ticagrelor plus aspirin group and an absolute non-inferiority margin of 2·5 percentage points between 1 month and 12 months after percutaneous coronary intervention. The two co-primary endpoints were tested sequentially; the primary superiority endpoint had to be met for hypothesis testing of the MACCE outcome to proceed. All principal analyses were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03971500, and is completed. FINDINGS: Between Sept 21, 2019, and Oct 27, 2022, 3400 (97·0%) of the 3505 participants in the IVUS-ACS study were randomly assigned (1700 patients to ticagrelor plus aspirin and 1700 patients to ticagrelor plus placebo). 12-month follow-up was completed by 3399 (>99·9%) patients. Between month 1 and month 12 after percutaneous coronary intervention, clinically relevant bleeding occurred in 35 patients (2·1%) in the ticagrelor plus placebo group and in 78 patients (4·6%) in the ticagrelor plus aspirin group (hazard ratio [HR] 0·45 [95% CI 0·30 to 0·66]; p<0·0001). MACCE occurred in 61 patients (3·6%) in the ticagrelor plus placebo group and in 63 patients (3·7%) in the ticagrelor plus aspirin group (absolute difference -0·1% [95% CI -1·4% to 1·2%]; HR 0·98 [95% CI 0·69 to 1·39]; pnon-inferiority<0·0001, psuperiority=0·89). INTERPRETATION: In patients with an acute coronary syndrome who had percutaneous coronary intervention with contemporary drug-eluting stents and remained event-free for 1 month on dual antiplatelet therapy, treatment with ticagrelor alone between month 1 and month 12 after the intervention resulted in a lower rate of clinically relevant bleeding and a similar rate of MACCE compared with ticagrelor plus aspirin. Along with the results from previous studies, these findings show that most patients in this population can benefit from superior clinical outcomes with aspirin discontinuation and maintenance on ticagrelor monotherapy after 1 month of dual antiplatelet therapy. FUNDING: The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and the Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. TRANSLATION: For the Mandarin translation of the abstract see Supplementary Materials section.

Central venoplasty in AV (Arteriovenous) fistula dysfunction a palliative endovascular approach.

The ultimate treatment of chronic kidney disease is renal transplant. Patients with CKD who need temporary haemodialysis have to have indwelling catheters. The catheters used are either temporary or permacath (A permacath is a piece of plastic tubing very similar to jugular catheter used for haemodialysis). The issues with these catheters are stenosis of central vein especially subclavian. Central venous stenosis leads to impairment in optimal dialysis. We report two cases of central venous stenosis in which patients presented with pain and oedema of the arm. Venogram showed totally occluded right subclavain vein and left innominate vein. Venoplasty was done which on followup showed a normalization of arm and resumption of dialysis through AV fistula. .

Estimating risk of atherosclerotic cardiovascular diseases in non-atherosclerotic Pakistani patients: Study conducted at National Institute of Cardiovascular Diseases, Karachi, Pakistan.

OBJECTIVE: To assess ten-year and lifetime estimated cardiovascular disease risks in non-atherosclerotic subjects. METHODS: This cross-sectional study was carried out at the National Institute of Cardiovascular Disease, Karachi, from July 2014 to March 2015, and comprised male and female subjects with multi-ethnic background, aged 20-79 years and having non-atherosclerotic disease. SPSS 22 was used for data analysis. RESULTS: Of the 437 participants, 174(39.8%) were men and 263(60.2%) were women. The overall mean age was 42.65±11.45 years. The mean age of men was 43.3±12.1 years and that of women was 42.2±10.8 years. Moreover, ten-year and lifetime risk assessment rates were higher in men (50[28.2%] and 86[49.4%] respectively) compared to women (28[10.6%] and 84[31.9%], respectively). CONCLUSIONS: Urdu-speaking Pakistanis were found to be at higher risk from atherosclerotic cardiovascular disease.

Burden Of Atherosclerosis Risk Among Different Ethinicity: A Hidden Health Challenge.

BACKGROUND: Atherosclerosis risk and incidence of developing chronic cardiovascular conditions vary greatly between ethnic groups in South Asian population. To evaluate different ethnic groups in Pakistan, population based study was conducted at Karachi, the largest metropolitan city of Pakistan; to assess ten years and lifetime estimated cardiovascular disease risks without preexisting cardiovascular disease in Pakistani subjects by using Pooled Cohort Risk equation (calculator) as per American College of Cardiology (ACC) and the American Heart Association (AHA) 2013 guidelines. METHODS: For the study, consecutive subjects (n=437) with multi-ethnic background, aged 20-79 years and having non-atherosclerotic disease were enrolled at site of National Institute of Cardio-Vascular Diseases (NICVD), Karachi, Pakistan. RESULTS: Within each ethnic group and overall, the risk of developing atherosclerosis was common in all ethnic groups especially Urdu speaking are mostly at the high with all the factors above the borderline values, followed by Punjabis and Pathans that may point toward associated higher risk for prevalence of cardiovascular disease. These ethnic groups showed increased prevalence of dyslipidemia, obesity, and much greater abnormalities asunique risk. Although there are differences in these altered factors but the changes in lifestyle, urbanization, genetic profile and physiological makeup are the main reasons that could be a trigger to increase cardiovascular events. CONCLUSIONS: The present study provides the first evidence and may serve as useful guidance to calculate the estimated risk both 10 years and lifetime in the non-atherosclerotic Pakistani population with different ethnic background.

Prognostic Significance of Electrocardiography, Echocardiography, and Troponin in Patients Admitted With Non-ST Elevation Myocardial Infarction.

BACKGROUND: Non-ST segment elevation myocardial infarction (NSTEMI) is a clinical condition characterized by typical symptoms of myocardial ischemia along with electrocardiographic changes and a positive value of troponin. After presentation in the emergency department, these patients have their troponin I value and electrocardiography done. Echocardiography (echo) should also be performed on these patients. This study was conducted to determine the prognostic significance of ECG, echo, and troponin. METHODS: This observational study was conducted at a tertiary care cardiac hospital on 221 diagnosed patients of NSTEMI. Electrocardiography was performed to see any particular resting ECG findings and the peak values of cardiospecific troponin were analyzed for associations with major adverse events after a six-month period of follow-up. On echo, the left ventricular ejection fraction was divided into two categories: left ventricular ejection fraction (LVEF) <40% and LVEF >40%. RESULTS:  The most frequent finding on presenting ECG was ST depression in anterior leads (V1-V6) in 27.6%. Median troponin I at presentation was 3.2 ng/dl and the median ejection fraction was 45%. The overall all-cause mortality rate at six months was observed to be 8.6%; re-infarction in 5%, re-hospitalization in 16.3%, and heart failure in 25.3% were observed. However, mortality was higher for patients with baseline ECG findings of A-fib, generalized ST-depression, poor R-wave progression, Wellens sign, and T-wave inversion in inferior; the mortality rate was also relatively higher among patients with poor LVEF (<30%). CONCLUSION: ECG and echo were prognostically significant and with the combined incidence of adverse events. However, troponin lacks prognostic significance at six months.

Characteristics of Patients Presenting with COVID-19 from Balochistan Province and Lessons Learnt.

OBJECTIVE: With the spread of COVID-19 in Pakistan, Balochistan province with its unique problems of lowest literacy rates in the country, limited resources and a flail health care system is reporting an increasing number of cases of COVID-19. This study discusses the epidemiological and clinical characteristics of COVID-19 patients from the Balochistan province. STUDY DESIGN: Situation report Place and Duration of Study: The study was conducted in Balochistan province of Pakistan. The completion date for the study was April 30, 2020. METHODOLOGY: The data was retrieved from the daily situation report from the Health Department, Government of Balochistan. Descriptive statistics (proportions, mean ± SD) were used for data analysis. RESULTS: A total of 1136 patients were confirmed to have COVID-19. The highest rate was found in cases with ages >60 years. About 78% of COVID-19 cases were males and majority of the cases (78.56%)were asymptomatic. Out of these, 183 recovered and 16 died. The case fatality rate was 1.3%. CONCLUSION: COVID-19 cases and case fatality ratio is low in Balochistan. Whether this is due to inability to carry out more tests is still to be ascertained. Males and elderly are more affected and fatalities were higher in cases with co-morbid conditions. Balochistan having a weak healthcare system and with the majority of cases being asymptomatic, needs more stringent actions to practice social distancing to avoid further spread of COVID-19.

Pakistan Following Foot Prints of Developed World in Structural Interventions: Experience of Transcatheter Aortic Valve Implantation Reported First Time.

Background The aim of this study was to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) program in a Tertiary care hospital in Karachi, Pakistan. Methodology This study was conducted by interventional cardiology department of the National Institute of Cardiovascular Diseases (NICVD), Karachi from July 2015 to February 2020. All patients of severe aortic stenosis (AS) who underwent TAVI were included. Baseline characteristics, in-hospital course and one-month follow-up data were collected. Results This study included 100 consecutive patients with severe AS undergoing TAVI. Sixty-three (63.0%) patients were males and the mean age was 67.38 ± 10.73 years. Eighty-five (85%) patients were in the New York Heart Association (NYHA) class III-IV. Aortic valve mean gradient was 51.33±10.47 mmHg and 50% of patients had bicuspid aortic valves. Core valve was implanted in 86 (86%) and evolute-R aortic valve was implanted in 14 (14%) patients. TAVI was successfully done in 94% of patients. Post-deployment aortic valve mean gradient was 5.33±4.13 mmHg. Major vascular access site complications were noted in 14% and atrioventricular (AV) blocks were seen in 22% of cases. There was a significant difference in symptoms of patients before and after the procedure. Overall, eight (8%) patients expired during hospital stay. At one-month follow-up, 76% of patients were found to have no limitation of physical activities. Conclusions Results of this study showed that TAVI is a safe procedure in these high-risk patients and is an alternative to surgery for AS patients in the region.

Acute ST-Elevation Myocardial Infarction Before and During the COVID-19 Pandemic: What is the Clinically Significant Difference?

Background In the current coronavirus disease-2019 (COVID-19) pandemic, the pattern of hospital admissions for acute ST-elevation myocardial infarction (STEMI) is changing, and increased mortality and morbidity is being noted in these patients. Cardiac manifestations of COVID-19 are complex and include STEMI, myocarditis, myocardial injury, and cardiomyopathy. The objective of our study was to compare the data of patients with STEMI presenting in COVID-19 versus the non-COVID-19 era.  Methods We analyzed the clinical and angiographic characteristics of STEMI patients undergoing primary percutaneous coronary intervention (PCI) at our center. The primary outcome variables were admission rate for STEMI, mean total ischemic time (TIT), coronary artery disease burden, mean ejection fraction, and in-hospital mortality for three defined groups. Group A consisted of patients who underwent primary PCI from March through April 2020. Group B included patients who underwent primary PCI from January to February 2020. Group C consisted of patients who underwent primary PCI from March to April 2019. We then compared the data among the three groups and calculated any significant p-value (p<.001). Results In Group A, 1139 patients were admitted for primary PCI. The mean admission rate was 18.6 ± 4.36 admissions per day. There were 1535 patients in Group B and an admission rate of 26.01 ± 4.90 (p<.001 compared to Group A). In Group C, there were 1537 patients and an admission rate of 24.8 ± 4.55 (p<.001, compared to Group A). The mean TIT was 429.25±272.16 minutes for Group A, 359.78±148.04 minutes for Group B, and 346.75±207.31 minutes for Group C (p<.001). A higher mortality rate was noted in Group A (COVID-19 era) versus Group C (non-COVID-19 era; p<.001). Conclusions A lower admission rate, higher TIT, and higher mortality rates were noted in patients with acute STEMI during the COVID-19 pandemic compared to the pre-COVID era. During the COVID-19 pandemic, physicians should bear in mind that patients with STEMI have increased mortality and morbidity. Where possible, efforts should be made for timely management of these critical patients to decrease mortality.