|Year : 2021 | Volume
| Issue : 3 | Page : 161-168
Real-world experience of clinical management with antiplatelet and lipid-lowering therapy in post acute coronary syndrome patients in Indian setting
MS Hiremath1, SN Routray2, Sadanand R Shetty3, John F John4, Anil Damle5, Akshaya Pradhan6, Aniruddha Dharmadhikari7, Bhupen N Desai8, Mahesh V Abhyankar9, Santosh Revankar9
1 Department of Cardiology, Ruby Hospital, Pune, Maharashtra, India
2 Department of Cardiology, MKCG Medical College, Berhampur, Odisha, India
3 Department of Cardiology, Sadanand Healthy Living Center (P) Ltd., Kozhikode, Kerala, India
4 Department of Cardiology, Baby Memorial Hospital, Kozhikode, Kerala, India
5 Department of Cardiology, Damle Cardiac Centre, Dadar, Maharashtra, India
6 Department of Cardiology, Associate Professor, King George Medical University, Lucknow, India
7 Department of Cardiology, Shree Saibaba Heart Institute and Research Centre, Nashik, Maharashtra, India
8 Department of Cardiology, Desai Heart Care Clinic, Mumbai, Maharashtra, India
9 Scientific Services, USV Private Limited, Mumbai, Maharashtra, India
|Date of Submission||17-Jun-2021|
|Date of Acceptance||23-Sep-2021|
|Date of Web Publication||22-Dec-2021|
Dr. Mahesh V Abhyankar
USV Private Limited, Mumbai, Maharashtra
Source of Support: None, Conflict of Interest: None
Objective: The objective is to evaluate the pattern for use of triple-drug therapy (dual antiplatelet therapy [DAPT] and statin) in the management of patients with postacute coronary syndrome (ACS) and associated risk factors in Indian settings.
Materials and Methods: This was a retrospective multi-centric (n = 63), real-world, cross-sectional study which included patients (aged ≥18 years) diagnosed with an ACS, post-ACS patients from 3 months to 3 years, and receiving DAPT and lipid-lowering agents for ACS. Demographics, baseline characteristics, risk factors, medical history, and therapy details were retrieved from medical charts. Descriptive and comparative analysis for qualitative and quantitative variable was performed.
Results: A total of 1548 patients with a mean age of 57.4 years were included. Male preponderance was observed across all the age groups. A total of 973 patients were on triple-drug therapy, and the most common triple fixed-dose combination prescribed was rosuvastatin, clopidogrel, and aspirin, among all the groups (age-wise: 76.1%–88.6%; sex-wise: 78.5% and 79.2%; clinical status-wise: 75.7%–81.4%). The majority of patients with non-ST-segment elevation myocardial infarction (43.0%), ST-segment elevation myocardial infarction (42.7%), and unstable angina (40.8%) received triple-drug therapy for >6 to ≤12 months duration. Adverse effect observed in patients receiving triple-drug therapy were skin rash (n = 5), bleeding (n = 2), facial puffing (n = 2), and hematuria (n = 2). A total of 357 patients were undergone switch in DAPT therapy (prasugrel to clopidogrel or ticagrelor to clopidogrel).
Conclusion: DAPT and statin were the standard of care in majority of ACS patients. Triple fixed-dose combination therapy of aspirin, clopidogrel, and rosuvastatin was the most preferred choice of physicians, for optimal management post-ACS patient in Indian setting.
Keywords: Aspirin, clopidogrel, coronary, dual antiplatelet therapy, statin
|How to cite this article:|
Hiremath M S, Routray S N, Shetty SR, John JF, Damle A, Pradhan A, Dharmadhikari A, Desai BN, Abhyankar MV, Revankar S. Real-world experience of clinical management with antiplatelet and lipid-lowering therapy in post acute coronary syndrome patients in Indian setting. Heart India 2021;9:161-8
|How to cite this URL:|
Hiremath M S, Routray S N, Shetty SR, John JF, Damle A, Pradhan A, Dharmadhikari A, Desai BN, Abhyankar MV, Revankar S. Real-world experience of clinical management with antiplatelet and lipid-lowering therapy in post acute coronary syndrome patients in Indian setting. Heart India [serial online] 2021 [cited 2023 Feb 2];9:161-8. Available from: https://www.heartindia.net/text.asp?2021/9/3/161/333294
| Introduction|| |
The global burden of cardiovascular diseases (CVD) in the last two decades has revealed a drastic rise in the estimated prevalence and subsequent mortality and India is one major contributor for the increased mortality seen due to premature death and disability associated with CVDs. The overall observation from the Global Burden of Disease Study highlighted that the prevalence of ischemic heart disease and stroke have increased significantly in India and CVD contributed 28·1% of the total deaths in India. Therefore, urgent attention is required to improve the prognostic outcomes of various currently used treatment strategies. The incidence of acute coronary syndrome (ACS) in India is rising at an alarming rate, substantially contributing to the disease burden., ACS is associated with high rates of morbidity and mortality, and its management remains challenging despite advances in therapeutic treatment.
Antiplatelet therapy is the standard treatment for the prevention of short-and long-term atherothrombotic events in patients with ACS. The dual antiplatelet therapy (DAPT) with aspirin and the platelet adenosine diphosphate (P2Y12) receptor inhibitors such as clopidogrel, prasugrel, or ticagrelor are standard of care for CVD patient., In patients with ACS (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]), DAPT should be given for at least 6–12 months and prolonged DAPT use beyond initial 6–12 months in patients with ACS (NSTEMI or STEMI) treated with coronary stent implantation. Thus, overall DAPT should be continued for up to 1 year after ACS in revascularized and medically managed ACS patients.,
In patients with a low ischemic risk (such as uncomplicated percutaneous coronary intervention [PCI] for stable coronary artery disease) or high bleeding risk, a short course (3–6 months) DAPT is reasonable.
In patients with a high ischemic risk and acceptable bleeding risk, extending DAPT might improve outcomes.
Therapeutic interventions with cholesterol-lowering agents such as statins is another preventive measure in patients with ACS. For secondary prevention of medically managed ACS, it is advised to treat with routinely prescribed DAPT for 12 months and a high-intensity statin. Statin helps in reducing subsequent coronary events by 25%–30%, and immediate initiation of statin therapy in hospitals post-ACS have shown to improve adherence to medication. In addition, a study by Steely et al. demonstrated that patients with postoperative myocardial infarction receiving DAPT in combination with statin therapy had improved survival (79%) compared with those receiving noncombination or no therapy (69%), suggesting association between increased mortality and absence of the combination of antiplatelet and statin therapy.
This real-world study was aimed to evaluate the pattern for use of triple-drug therapy (DAPT and statin) in the clinical management of post-ACS patients and its associated risk factors in Indian settings.
| Materials And Methods|| |
Study design and ethics
This was a retrospective, non-comparative, non-randomized, multi-centric real-world cross-sectional study conducted at 63 tertiary care centers across India. The study was based on the individual experience of DAPT and lipid-lowering therapy prescribed in ACS patients.
The study was conducted in accordance with the ethical principles that are consistent with the Declaration of Helsinki, the International Conference on Harmonization-Good Clinical Practices, and the applicable legislation on noninterventional studies. The study protocol was approved by an Independent Ethics Committee.
Inclusion and exclusion criteria
All the patients of either sex, aged 18 years and above with diagnosis of ACS, post ACS patients from 3 months to 3 years duration, and patients who were receiving DAPT and lipid-lowering treatment for ACS, were included in this study. ACS patient who had surgery (including PCI) or hospitalization within the last 3 months were excluded from the study.
Information on baseline characteristics, risk factors, medical history, clinical status, and received medical therapies were retrieved from the patient's medical records available at hospital/clinics and entered into case report forms.
The primary endpoint was to determine the different patterns of DAPT and lipid-lowering drugs prescribed in the clinical management of post-ACS patients. The secondary endpoints were to assess the clinical status of ACS, risk factors, comorbidities, and physician's global evaluation of efficacy and tolerability for triple-drug therapy.
Data were analyzed using Statistical Package for The Social Sciences (SPSS) software, version 23.0 (Armonk, NY: IBM Corp). Qualitative data were presented as number and percentages, while quantitative data were presented as mean (standard deviation) or median (range). Comparison of quantitative and qualitative variables between the groups was done using Mann–Whitney U test and Chi-square test, respectively. A P < 0.05 was considered statistically significant.
| Results|| |
Patient demographics and clinical characteristics at baseline
A total of 1548 ACS patients were studied retrospectively. The most common comorbid conditions were hypertension (90.1%), followed by type-2 diabetes mellitus (54.7%) and heart failure (36.3%). Smoking (44.9%) was the most reported risk factor associated with ACS followed by excess of salt intake (41.6%), sedentary lifestyle (36.8%), obesity (32.8%), and stress (32.0%) [Table 1]. Smoking was highest (62.2%, P < 0.001) in men diagnosed with ACS; however, salt consumption was more common in women (56.0%, P < 0.001). Among the total patients, 529 patients had STEMI, 535 patients had NSTEMI and 374 patients had unstable angina. Overall, thrombolysis and PCI or CABG were performed in 20.2% and 66.5% of patients, respectively [Table 1]. Triple-drug therapy of rosuvastatin, clopidogrel, and aspirin was the most commonly used fixed-dose combination (FDC) (77.4%) in ACS patients followed by FDC of atorvastatin, clopidogrel, and aspirin (22.6%). According to sex, an FDC of rosuvastatin, clopidogrel, and aspirin was the most common fixed triple-drug combination used in both men (78.5%) and women (79.2%) [Figure 1]a. Overall, 357 (23.0%) patients had switch to DAPT in the past.
|Figure 1: Distribution of triple fixed dose combination of DAPT and statin. Distribution of triple FDC according to (a) sex-wise, (b) age group-wise, (c) clinical status-wise, and (d) treatment-wise. ACS: Acute coronary syndrome; DAPT: Dual antiplatelet therapy; NSTEMI: Non-ST-elevation myocardial infarction; STEMI: ST-elevation myocardial infarction; UA: Unstable angina|
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Majority of patients belonged to the age group of >40 to ≤60 years (n = 894). More than 60% of patients were on fixed triple-drug therapy across all the age groups (61.9%–76.0%) with FDC of rosuvastatin, clopidogrel, and aspirin being the most common (76.1%–88.6%) [Table 2] and [Figure 1]b. Majority of patients from ≤40 years (36.4%), >40 to ≤60 years (42.3%) and >60 years (46.1%) groups received triple-drug therapy for 6–12 months duration; while respective 4.5%, 19.0% and 20.0% of patients received triple-drug therapy for >12 months [Table 2]. Smoking was more common in patients of the age group ≤40 years (60.0%). A significantly increasing trend was observed in the prevalence of excess of salt intake (P < 0.001) from the youngest age group (≤40 years, 30.0%) to the oldest one (>60 years, 51.5%). Family history of ACS was prevalent risk factor observed in the youngest age group (≤40 years; P = 0.010) as compared to other age groups.
Clinical status wise observations
Overall, 41.9% of NSTEMI patients, 38.6% of STEMI, and 30.1% of unstable angina patients had sedentary lifestyle indicating a significant association between a sedentary lifestyle and NSTEMI patients (P = 0.002). Salt intake was more common (45.7%) in patients diagnosed with unstable angina. Overall rosuvastatin, clopidogrel, and aspirin were the most common fixed triple-drug therapy in NSTEMI (80.6%), STEMI (75.7%), and unstable angina (81.4%) (P = 0.177) patients [Figure 1]c. Patients with left anterior descending (3.9%), left circumflex (0.3%), left main coronary artery (4.2%), multiple vessel disease (32.2%), and single-vessel disease (52.0%) had triple FDC therapy. A total of 54 patients (7.4%) with a combination of different types of clinical status had triple fixed therapy. The proportion of patients that switched DAPT in past was significantly higher among NSTEMI patients than those with STEMI and with unstable angina (P = 0.011) [Table 3].
Majority of patients from NSTEMI (71.4%) and STEMI (67.0%) groups received triple-drug therapy for >3 to ≤12 months' duration while those with unstable angina (40.8% and 32.9%) received triple-drug therapy for >6 to ≤12 months and beyond 1 year [Table 3].
Treatment wise observation
In DAPT switched patients, smoking (53.5% vs. 42.5%), sedentary lifestyle (52.7% vs. 32.1%), and stress (40.1% vs. 29.7%) were the most common risk factors observed compared to unchanged DAPT patients, respectively (P < 0.001). Overall, 78.8% and 78.1% of patients were receiving triple FDC of rosuvastatin, clopidogrel, and aspirin in switched DAPT group and unchanged DAPT group, respectively [Figure 1]d.
Angiographic findings are depicted in [Figure 2]. In NSTEMI and unstable angina, single-vessel disease (44.9% and 35.2%), while in STEMI group, multiple vessel disease (37.9%) were the most common angiographic observations.
|Figure 2: Angiographic finding. LAD: Left anterior descending; LCx: Left circumflex; LM: Left main coronary artery; NSTEMI: Non-ST-elevation myocardial infarction; STEMI: ST-elevation myocardial infarction; UA: Unstable angina. Others: Inferior wall myocardial infarction|
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Patients' response for efficacy evaluation was similar between patients with unchanged DAPT therapy and those with switched DAPT in past. Overall, physician global evaluation of efficacy showed majority of patients from both the groups (switched DAPT, 97.8% and unchanged DAPT, 97.5%) on a good to excellent scale. However, the tolerability scale assessment showed that significantly higher proportion of patients from switched DAPT group responded positively (good to excellent) than unchanged DAPT group (98.3% vs. 86.7%, P < 0.001) [Figure 3]a and [Figure 3]b.
|Figure 3: Physicians global evaluation of efficacy and tolerability (a: Switched DAPT and b: Unchanged DAPT). DAPT: Dual antiplatelet therapy|
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Adverse events such as skin rash (n = 5), bleeding (n = 2), facial puffing (n = 2), and hematuria (n = 2) were observed in patients receiving triple-drug therapy (n = 973).
| Discussion|| |
The present study evaluated the pattern for use of triple-drug therapy (DAPT and statin) in the clinical management of post ACS patients. Furthermore, the study assessed the clinical status of ACS and risk factors along with comorbidities such as hypertension, type-2 diabetes mellitus, stroke, heart failure, and recurrent ACS. The current therapeutic management to reduce ischemic event recurrence includes triple-drug therapy of DAPT and lipid-lowering agents.
In the present study, most of the patients (57.7%) were between >40 to ≤60 years of age and majority were men. A comparative study between elderly and young patients alluded that the prevalence of ACS increases exponentially from the age of 50 years. The male preponderance observed in this study is in accordance with the previous studies.,
The present study reported a higher prevalence of patients with NSTEMI than STEMI, which is in concordance with the Fassaa et al. study. However, nearly 3 million STEMI are estimated to occur in India per year, and Indian ACS registries have reported a wide range of clinical status, suggesting patients of ACS in India have a higher proportion of STEMI. The DAPT with aspirin and a P2Y12 inhibitor, such as clopidogrel has been considered key for the successful management of STEMI and NSTEMI to support primary PCI and fibrinolytic treatment strategies. In addition, a study by Steely et al. reported an improved 5-year survival in patients with myocardial infarction receiving combined statin and antiplatelet treatment postoperatively and demonstrated the efficacy of statin therapy in conjunction with antiplatelet therapy in reducing risk of mortality compared to those no therapy or noncombination therapy. Similarly, in concordance with this, the present study revealed that combined therapy of statin and DAPT (rosuvastatin, clopidogrel, and aspirin) was the most common fixed triple-drug therapy among NSTEMI, STEMI, and unstable angina patients.
The associated comorbidities and risk factors in patients with ACS increase the risk of recurrent ischemic and bleeding events. In the current study, the most predominant risk factor associated was smoking, which is in concordance with other Indian studies, followed by other risk factors which include excess of salt intake, sedentary lifestyle, obesity, stress, tobacco and alcohol consumption. In addition, smoking was the predominant risk factor among young patients (≤40 years). This result was in concordance with a previous study which found that smoking frequency in young patients was 58.9%. Smoking and alcohol abuse are significantly associated with STEMI, while patients with hypertension, stable angina or dyslipidemia are more prone to develop NSTEMI than STEMI. The present study showed hypertension and type 2 diabetes mellitus as the most commonly occurring comorbidities and also risk factors that showed significant association with ACS as reported in a study by Mohanan et al.
In the present study, patients received triple-drug therapy of DAPT and statin for a varied duration from <3 months to more than 1 year. The proportion of patients receiving triple-drug therapy for up to 1 year was higher than those receiving triple-drug therapy for more than 1 year. These observations suggest that majority of the study population could tolerate the triple-drug therapy for the duration of up to 1 year without any adverse events such as bleeding complications or ischemic events.
Poor adherence of patients to the polypharmacy approach for a long-term is a major obstacle in the management of CVD-associated risk factors. In general, the use of triple FDC in patients with CVD is associated with improved medication adherence for long duration and compliance that reduces overall pill burden and ultimately reduces the risk of recurrent cardiovascular events. Usually, patients with ACS are susceptible to cardiovascular death and nonfatal myocardial infarction; and lipid-lowering therapies can help to reduce the risk of these comorbidities. Compared to other statins, rosuvastatin, synthetic HMG-CoA reductase inhibitor available, has a higher capacity of reducing low-density lipoprotein cholesterol and therefore considered as a potent statin that can reduce the risk of cardiovascular mortality and myocardial infarction in patients with ACS. Various clinical trials support the early intensive rosuvastatin use in ACS patients was effective in improving 12-month outcomes and well-tolerated in ACS patients undergoing PCI.,, Further, a LUNAR study demonstrated the superiority of high dose rosuvastatin compared with high dose atorvastatin for lipid modification in ACS with similar safety and tolerability.
In this real-world study, the physician's global evaluation of efficacy and tolerability of triple-drug therapy using DAPT and lipid-lowering agent in patients with ACS revealed that the majority of patients were in a good to excellent response. This triple-drug therapy mainly helps in plaque disruption, arterial thrombosis and helps to achieve target lipid and cholesterol levels. Statins are also known to benefit patients with ACS due to their pleiotropic effects that may inhibit different pathogenic pathways participating in the development of vulnerable plaque and in the pathogenesis of ACS., Despite the recommendations and benefits in ACS, statins still remain underutilized in many patients posthospitalization.
This study is limited by its retrospective and observational nature, and more studies need to be done to obtain conclusive results with the use of DAPT in combination with statin. In addition, a long-term follow-up study will be useful to validate the use of DAPT in combination with statin in these patients.
| Conclusion|| |
This real-world study revealed that majority of post-ACS patients in Indian setting were mainly prescribed with triple FDC of aspirin, clopidogrel, and statin (rosuvastatin/atorvastatin); rosuvastatin was preferred statin choice of the physicians. Most of the patients received triple-drug therapy of DAPT and statin for up to 1 year duration. Further, the physician's global evaluation of efficacy and tolerability along with safety profile revealed that the combination of DAPT and statins was effective and well-tolerated. Therefore, the use of triple FDC of DAPT and statin may improve treatment compliance and tolerability.
We would like to acknowledge Ms. Farida Hussain, Mr. Anuj Maheshwari, Mr. Deepak Mandhane and Ms. Annsusan Renji from USV Pvt Ltd for their assistance in carrying out the project. The medical writing support was provided by Dr. Tejal Vedak, and Ms. Ruchika Thale from Sqarona Medical Communications. We acknowledge Abiogenesis Clinpharm Private Limited for their services in the conduction of the real-world study.
Financial support and sponsorship
This project has been funded by USV Pvt Ltd.
Conflicts of interest
Dr. Mahesh Abhyankar and Dr. Santosh Revankar are employees of USV Pvt Ltd. All other authors have no other conflicts of interest to declare.
The study protocol was approved by an Independent Ethics Committee.
Being a subject expert Dr M S Hiremath has contributed in conceptualization of the study, suggestions, analysis and interpretation of study data. All named authors take the responsibility for this integrity of the work as a whole and have given their approval for this version to be published. The contents published herein represents the views and does not necessarily represent the views or opinions of USV Pvt Ltd. and/or its affiliates. The details published herein and intended for discrimination of educational, academic, and/or research purposes and are not intended as a substitute for professional medical advice, diagnostic or treatment.
Dr. A N S Varaprasad, Dr. A Vasantha Kumar, Dr. Abhay Kumar, Dr. Amit Kumar, Dr. Arun Gopi, Dr. Arun Mohanty, Dr Arvind Kumar Sharma, Dr. Arvind Kumar, Dr. Ashida, Dr. Avadhut Warake, Dr. B B Chanana, Dr. B Ramesh Babu, Dr. Bhanu Prakash, Dr. C G Sajeev, Dr. C Krishnakumar, Dr. Chaitanya Gokhale, Dr. Chandra Kant Mishra, Dr. Chetan Chouhan, Dr. Deepak S Shirsath, Dr. Sanjay Korde, Dr. Laxmidas Prabhudas Ganatra, Dr. Partho Protim Chowdhary, Dr. Ramesh R Modi, Dr. Fahad Merchant, Dr. J Nagaraju, Dr. K N Reddy, Dr. Kamlesh Ratilal Thakur, Dr. Krishnakant Sharma, Dr. Krishnakumar P, Dr. M Malleswara Rao, Dr. M R Syed, Dr. Madhu Kurapati, Dr. Manoj Durairaj, Dr. Manoj Ravi, Dr. Mohd Ahmad, Dr. Nagaraj Moorthy, Dr. Naresh Patwardhan, Dr. Nitin Annarupu, Dr. P K Dhar, Dr. Pankaj P Patil, Dr. Prabin Kumar Srivastava, Dr. Prashant Pawar, Dr. R K Prabhu, Dr. R Vimal Kumar, Dr. Rajiv Khanna, Dr. Ramesh Natrajan, Dr. Rohit Kapoor, Dr. R V Anand, Dr. S Arvind, Dr. S Prabhu, Dr. S Shanthi Jyothi, Dr. Samir Kubba, Dr. Sandip Fulpagare, Dr. Shahid Haider Warsi, Dr. Solanki Dharmesh Ramakant, Dr. Vinod Krishnan, Dr. Virendra C Chauhan, Dr. Vishwas Zade, Dr. Vivek Raj Singh.”
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]