Indian Perspective on De-escalation from Dual Antiplatelet Therapy to Single Antiplatelet Therapy Study: A Knowledge, Attitude, and Practice Study among Indian Interventional Cardiologists.

BACKGROUND: Coronary artery disease (CAD) management is one of the most significant facets of interventional cardiology. Evidence from several clinical trials has redefined the drug management of CAD, including optimizing the duration of antiplatelet treatment regimens in the management of CAD, which is an intricate clinical issue. The available evidence indicates that East Asians have a higher bleeding risk. However, the Indian phenotype differs from that of East Asians, making this data confounding when applied to clinical decision-making among Indian patients. There is a need for a close understanding of Indian interventional cardiologists' perceptions of complex decision-making pertaining to antiplatelet agents among Indian CAD patients in real-world clinical settings. AIM: This Indian Perspective on De-escalation from Dual Antiplatelet Therapy to Single Antiplatelet Therapy (INDEPTH) study aims to assess the perspective of Indian interventional cardiologists regarding de-escalating from dual antiplatelet therapy (DAPT) to single antiplatelet therapy (SAPT), approach to decision-making, barriers, and related challenges in CAD management. METHODS: A cross-sectional knowledge, attitude, and practice (KAP) study survey was carried out among Indian interventional cardiologists practicing across different regions of India. A total of 209 responses were received. Descriptive statistics was used to summarize all the parameters. IBM Statistical Package for the Social Sciences (SPSS) statistics was used for biostatistical analysis. RESULTS: The study indicated that >90% of CAD patients received DAPT therapy immediately after percutaneous coronary intervention (PCI) (86.1%, p < 0.001). About 115 (55%) of the respondents reported using calculator-based scoring for evaluating bleeding risk in patients on DAPT therapy for the management of acute coronary syndrome (ACS) with post-PCI (p = 0.167). Regarding the usual duration of DAPT therapy post-ACS, nearly half of the respondents, 94 (45%), said that 6-12 months is the usual duration for DAPT therapy in post-ACS patients, followed by > 12 months 94 (45%) of the respondents; 17 (8.1%) of the respondents reported it is 3-6 months, and lastly up to 3 months as per four (1.9%) of the respondents (p < 0.001). A total of 128 (61%) of the respondents strongly believe that balancing bleeding with ischemic risk influenced the choice of antiplatelet agent when treating established CAD. As per interventional cardiologists surveyed, the perfect de-escalation time frame for Indian CAD patients with high bleeding risk (HBR) is up to 3 months (35.9%, p < 0.001), 6-12 months for medium bleeding risk (48.8%, p < 0.001), and >12 months for low bleeding risk (65.6%, p < 0.001). Regarding SAPT therapy, almost one-third of the respondents, 65 (31.1%), reported that they prescribed antiplatelet therapy other than aspirin in 20-40% of their SAPT-eligible patients. Furthermore, 69 (33%) of the respondents said that they preferred to prescribe clopidogrel in 50-75% of SAPT-eligible patients. While 64 (30.5%) prescribed in 25-50%, 53 (25.4%) prescribed in <25% and 23 (11%) of the respondents prescribed the drug in >75% of the SAPT-eligible patients. (p < 0.001). "Atorvastatin + clopidogrel" is the most preferred combination of SAPT primarily for the management of CAD among the majority of interventional cardiologists [33%, 95% confidence interval (CI): 1.97-2.24, p < 0.001]. The study respondents also indicated a need for Indian-specific guidelines on de-escalating from DAPT to SAPT in CAD management. CONCLUSION: The INDEPTH study indicated that the majority of CAD patients received DAPT immediately after PCI. The perfect de-escalation time frame for Indian CAD patients with "high-bleeding" risk is up to 3 and 6-12 months for "medium-bleeding" risk and >12 months for "low-bleeding" risk. One-third of respondents used clopidogrel as an antiplatelet agent in 50-75% of SAPT-eligible patients. Atorvastatin + clopidogrel is predominantly the most preferred combination of statin + SAPT for the management of CAD. Although the current international guidelines cover the Indian perspective to some extent, there is a need for Indian-specific guidelines on de-escalating from DAPT to SAPT.

Expert eValuation of Efficacy and Rationality of Vildagliptin "EVER-Vilda": An Indian Perspective.

Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor is effective in reducing HbA1c levels in patients with type 2 diabetes (T2DM) when administered as monotherapy, dual or triple combination therapy. In India, Vildagliptin is commonly prescribed in T2DM patients because it reduces mean amplitude of glycemic excursion (MAGE), has lower risk of hypoglycemia and is weight neutral. Early combination therapy with vildagliptin and metformin is effective and well-tolerated in patients with T2DM, regardless of age or ethnicity. In view of already existing data on vildagliptin and the latest emerging clinical evidence, a group of endocrinologists, diabetologists and cardiologists convened for an expert group meeting to discuss the role and various combinations of vildagliptin in T2DM management. This practical document aims to guide Physicians and Specialists regarding the different available strengths and formulations of vildagliptin for the initiation and intensification of T2DM therapy.

Clinical Decision Pathway for the Use of Fondaparinux in the Management of Acute Coronary Syndrome (ACS) in Hospitals with and Without Catheter Laboratories: An Expert Opinion from India.

The current recommendations by Indian experts who are focused on the challenges in the management of patients with acute coronary syndrome (ACS) in rural areas, due to limited catheterization (CATH) lab facilities and interventional cardiologist coverage across the country, are described. 120 cardiologist experts drafted recommendations during ten advisory board meetings conducted from April to May 2022. Experts framed statements based on experience, collective clinical judgment from practical experience, and available scientific evidence regarding ACS. The consensus positioned fondaparinux as highly useful in non-CATH-lab-based hospitals for patients diagnosed with non-ST elevation acute coronary syndrome (NSTE-ACS) and ST elevation acute coronary syndrome (STE-ACS) patients who cannot be shifted to percutaneous coronary intervention (PCI)-capable centres, or for patients who are thrombolysed at peripheral centres.

Management of American Heart Association/American College of Cardiology-Defined Stage 2 Hypertension by Cardiologists in India.

Uncontrolled hypertension is an important cardiovascular risk factor and therefore requires effective approaches to patient management. This study assessed approaches to the management of patients with Stage 2 hypertension by cardiologists in India. This was a retrospective, multicenter, observational, case-based questionnaire study. Data on demographic characteristics, risk factors associated with Stage 2 hypertension, use of antihypertensive medications, side effects, and approaches to education for 2,540 patients were extracted from questionnaire responses provided by 508 cardiologists. The study population of patients with Stage 2 hypertension had a mean age of 55.0 years. Most of the patients (62.6%) were aged 30 to 60 years and diabetes mellitus was the most prevalent comorbidity (48.9%). Triple antihypertensive therapy was being used by 760 patients, and 634 and 1,146 patients were receiving 4 and 5 different antihypertensive medications, respectively. Telmisartan, amlodipine, chlorthalidone, hydrochlorothiazide, spironolactone, metoprolol, and prazosin were the commonly prescribed drugs. Ankle edema (27.7%) was the most frequent side effect of therapy. Pharmacotherapy was supported by patient education and lifestyle modifications for better blood pressure control. The standardized approach to the collection and assessment of these contemporary data provides useful insights into the characteristics and treatment of patients with Stage 2 hypertension in India.

Effect of Amlodipine in Stroke and Myocardial infarction: A Systematic Review and Meta-analysis.

INTRODUCTION: Hypertension is a progressive cardiovascular condition arising from complex aetiologies. Progression is strongly associated with functional and structural abnormalities that lead to multi-organ dysfunction. Stroke and myocardial infarction are two of the major complications of hypertension in India. Various anti-hypertensive drugs, such as calcium channel blockers (CCBs), beta-blockers, diuretics, angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, have been the medications of choice for disease management and are known to be effective in reducing the complications of hypertension. CCBs, such as amlodipine, are also currently being used and proven to be effective, although their beneficial effects in the management of complications of hypertension like stroke and myocardial infarction (MI) have yet to be proven. Therefore, the aim of this systematic review was to evaluate the effect of amlodipine on stroke and MI in hypertensive patients. METHODS: A systematic search of English electronic databases was performed for studies with sufficient statistical power that were published between 2000 andl 30 August 2020, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. A total of 676 papers were screened, and 13 were found eligible to be included in the meta-analysis. Studies that included patients who suffered from MI or stroke and were under amlodipine treatment were included in the analysis. The odds ratio and the risk ratio of amlodipine compared to active control/placebo were noted from the studies and statistically analyzed. RESULTS: Amlodipine had a significant effect in reducing stroke and MI in hypertensive patients. Similar to results published in reports, this systematic review proved that the hazard ratio for amlodipine was < 1 for stroke (0.69-1.04) and MI (0.77-0.98), showing that amlodipine accounted for better prevention of stroke and MI. CONCLUSION: In the pooled analysis of data from 12 randomised controlled trials and one double-blinded cohort study measuring the effect of CCBs, we found that the CCB amlodipine reduced the risk of stroke and MI in hypertensive patients. Superior results for amlodipine were found in ten of the 13 studies included in this meta-analysis.

Effectiveness of Amlodipine on Blood Pressure Control in Hypertensive Patients in India: A Real-World, Retrospective Study from Electronic Medical Records.

BACKGROUND: The effectiveness of amlodipine has been reported in clinical trials in India. However, real-world data on the effectiveness of amlodipine in India is limited. OBJECTIVE: To provide real-world evidence regarding the effectiveness of amlodipine as monotherapy or in combination with other antihypertensive drugs (AHDs) in Indian patients with essential hypertension. METHODS: Electronic medical record data of adult patients who were diagnosed with essential hypertension (≥ 140/90 mmHg) and were prescribed amlodipine as monotherapy or add-on therapy were retrospectively analyzed. Patients were classified based on the number of AHD classes prescribed on initiation of amlodipine. Change in systolic (SBP) and diastolic (DBP) blood pressure from baseline was the primary endpoint. Evaluation of proportion of patients who achieved treatment goals as per 2018 European Society of Cardiology/European Society of Hypertension guidelines was the secondary endpoint. Readings were obtained before initiating amlodipine and after at least a month of therapy with amlodipine. RESULTS: Among the 462 included patients, the majority (90.7%) were on amlodipine monotherapy or amlodipine + 1AHD. Mean (95% confidence interval [CI]) change in the amlodipine monotherapy group was: SBP (- 12.1 [- 14.9, - 9.3] mmHg) and DBP (- 7.5 [- 8.9, - 6.1] mmHg) and mean (95% CI) change in the amlodipine + 1AHD group was: SBP (- 17.8 [- 21.0, - 14.6] mmHg) and DBP (- 9.5 [- 11.0, - 8.0] mmHg) (P < 0.001 for all). SBP and DBP goals were achieved by 31.4% and 42.9% of patients on amlodipine monotherapy and by 38.9% and 51.8% of patients on amlodipine + 1AHD, respectively. Among patients aged ≤ 45 years, mean (95% CI) change in the amlodipine monotherapy group was: SBP (- 11.7 [- 16.0, - 7.4] mmHg; P < 0.001) and DBP (- 7.2 [- 9.7, - 4.7] mmHg; P < 0.001) and mean (95% CI) change in the amlodipine + 1AHD group was: SBP (- 14.6 [- 21.9, - 7.3] mmHg; P < 0.05) and DBP (- 10.6 [- 14.8, - 6.4] mmHg; P < 0.01). SBP and DBP goals were achieved by 35.4% and 33.8% of patients on amlodipine monotherapy and by 48.0% and 56.0% of patients on amlodipine + 1AHD, respectively. Among patients aged ≥ 65 years, mean (95% CI) change in the amlodipine monotherapy group was: SBP (- 13.9 [- 20.2, - 7.6] mmHg; P < 0.01) and DBP (- 8.5 [- 11.4, - 5.7] mmHg; P < 0.001) and mean (95% CI) change in the amlodipine + 1AHD group was: SBP (- 22.4 [- - 28.8, - 16.0] mmHg; P < 0.001) and DBP (- 10.8 [- 14.0, - 7.6] mmHg; P < 0.001). SBP and DBP goals were achieved by 25.5% and 13.7% of patients on amlodipine monotherapy and by 29.8% and 14.0% of patients on amlodipine + 1AHD. CONCLUSION: Amlodipine prescribed as monotherapy or add-on therapy during routine clinical practice significantly reduced BP in ≤ 45- and ≥ 65-year-old Indian patients with mild to moderate hypertension, emphasizing that amlodipine may be a good candidate for BP control in Indian patients with essential hypertension in these age groups.

Proposed low-density lipoprotein cholesterol goals for secondary prevention and familial hypercholesterolemia in India with focus on PCSK9 inhibitor monoclonal antibodies: Expert consensus statement from Lipid Association of India.

BACKGROUND: Rates of atherosclerotic cardiovascular disease (ASCVD) are strikingly high in India compared to Western countries and are increasing. Moreover, ASCVD events occur at a younger age with only modest hypercholesterolemia, most commonly with low levels of high-density lipoprotein cholesterol. The course of ASCVD also appears to be more fulminant with higher mortality. OBJECTIVE: In light of these issues, the Lipid Association of India (LAI) endeavored to develop revised guidelines with more aggressive low-density lipoprotein cholesterol (LDL-C) goals in secondary prevention and for patients with familial hypercholesterolemia compared to guidelines in the United States and other countries. METHODS: Owing to the paucity of clinical outcomes data in India, it was necessary to place major emphasis on expert opinion as a complement to randomized placebo-controlled data generated mostly in non-Indian cohorts. To facilitate this process, the LAI conducted a series of 19 meetings among 162 lipid specialists in 13 cities throughout India over a period of 11 months before formulating this expert consensus statement. RESULTS: The LAI recommends an LDL-C goal <50 mg/dL in all patients in secondary prevention or very high-risk primary prevention but proposes an optional goal ≤30 mg/dL in category A extreme-risk patients (eg, coronary artery disease + familial hypercholesterolemia) and a recommended goal ≤30 mg/dL in category B extreme-risk patients [coronary artery disease + (1) diabetes and polyvascular disease/≥3 major ASCVD risk factors/end organ damage, or (2) recurrent acute coronary syndrome within 12 months despite LDL-C <50 mg/dL, or (3) homozygous familial hypercholesterolemia]. CONCLUSIONS: More aggressive LDL-C goals are needed for prevention of ASCVD in India, as described in this expert consensus statement. Use of statins and ezetimibe needs to increase in India in combination with improved control of other ASCVD risk factors. Proprotein convertase subtilisin kexin type 9 inhibitors can improve LDL-C goal achievement in patients with refractory hypercholesterolemia.

Vascular Disease in Young Indians (20-40 years): Role of Dyslipidemia.

Dyslipidemia is an established risk factor for cardiovascular disease (CVD). Atherosclerosis begins early in life as suggested by "fatty streaks" observed in coronaries of healthy organ donors aged 20-29 years. Premature occurrence of coronary heart disease (CHD) in Indians, increases the risk for young individuals. Management of Dyslipidemia in the young Indian poses several challenges. In this article we provide in-depth review of prevalence, guidelines' perspective and expert comments on management of Dyslipidemia in the young (20-40 years) Indian.

Percutaneous transvenous mitral commissurotomy: immediate and long-term follow-up results.

Percutaneous transvenous mitral commissurotomy has emerged as an effective nonsurgical technique for the treatment of patients with symptomatic mitral stenosis. This report highlights the immediate and long-term follow-up results of this procedure in an unselected cohort of patients with rheumatic mitral stenosis from a single center. It was performed in a total of 4,850 patients using double balloon in 320 (6.6%), flow-guided Inoue balloon technique in 4,374 (90.2%), and metallic valvulotome in 156 (3.2%) patients. Their age range was 6.5-72 years (mean, 27.2 +/- 11.2 years) and 1,552 (32%) patients were under 20 years of age. Atrial fibrillation was present in 702 (14.5%) patients. No patient was rejected on the basis of echocardiographic score using the Wilkins criteria. Echocardiographic score of > or = 8 was present in 1,632 (33.6%) patients, of which 103 (2.1%) had densely calcified (Wilkins score 4+) valve. A detailed clinical and echocardiographic (two-dimensional, continuous-wave Doppler and color-flow imaging) assessment was done at every 3 months for the first year and at 6-month interval thereafter. The procedure was technically successful in 4,838 (99.8%) patients but optimal result was achieved in 4,408 (90.9%) patients with an increase in mitral valve area (MVA) from 0.7 +/- 0.2 to 1.9 +/- 0.3 cm(2) (P < 0.001) and a reduction in mean transmitral gradient from 29.5 +/- 7.0 to 5.9 +/- 2.1 mm Hg (P < 0.001). The mean left atrial pressure decreased from 32.1 +/- 9.8 to 13.1 +/- 6.2 mm Hg (P < 0.001). Although there was no statistically significant difference in the MVA achieved between de novo and restenosed valves (1.9 +/- 0.3 and 1.8 +/- 0.2 cm(2), respectively; P > 0.05), or between noncalcific and calcific valves (2.0 +/- 0.3 and 1.8 +/- 0.2 cm(2), respectively; P > 0.05), on the whole MVA obtained after percutaneous transvenous mitral commissurotomy was less in restenosed and calcific valves. Ten (0.20%) patients had cardiac tamponade during the procedure. Mitral regurgitation appeared or worsened in 2,038 (42%) patients, of which 68 (1.4%) developed severe mitral regurgitation. Urgent mitral valve replacement was carried out in 52 (1.1%) of these patients. Data of 3,500 patients followed over a period of 94 +/- 41 months (range, 12-166 months) revealed MVA of 1.7 +/- 0.3 cm(2). Elective mitral valve replacement was done in 34 (0.97%) patients. Mitral restenosis was seen in 168 (4.8%) patients, of which 133 (3.8%) were having recurrence of class III or more symptoms. Thus, percutaneous transvenous mitral commissurotomy is an effective and safe procedure with gratifying results in high percentage of patients. The benefits are sustained in a majority of these patients on long-term follow-up. It should be considered as the treatment of choice in patients with rheumatic mitral stenosis of all age groups.