Study of Anticoagulants low molecular weight heparin and Unfractionated heparin in the management of Non-St elevation Myocardial Infarction
Dr. Ruheena Yasmeen1, Dr. N. Krishna Reddy2, Dr. Marina. G. D’ Souza3, Dr. B. Swathi3,
Anas Abdul Waheed3, Katakam Chinmayee3, J. Vineeth Reddy3
1Department of Pharm. D (Pharmacy Practice), Nizam Institute of Pharmacy, Deshmukhi (V), Pochampally (M), Behind Mount Opera, Yadadri Bhuvanagiri (Dist)-508284, Telangana, India.
2Department of Cardiology, Durgabai Deshmukh Hospital, Vidya Nagar, Hyderabad.
3Bharat School of Pharmacy, Mangalpally (Village), Ibrahimpatnam (M), Ibrahimpatnam, Rangareddi (Dist), Hyderabad - 500 007 Telangana, India.
*Corresponding Author E-mail: ruheena.y786@gmail.com
ABSTRACT:
Introduction: MI is the leading cause of adult death in the United States (US). It is the predominant cause and responsible for more than 80% of CVD deaths in India. Objective: The objective of this study is to compare the effectiveness, adverse effects, mortality and safety profile of two anti-coagulants (LMWH & UFH) in the patients of acute coronary syndrome (NSTEMI). Methodology: A prospective observation study conducted on 70 adult patients at Durgabhai Deshmukh Hospital and Research Centre, Hyderabad on patients admitted for elective surgery for a period of six months. Results: Among 70 patients 56(80%) are males and 14 (20%) are females. Among all age groups major numbers of NSTEMI patients are seen in 51-60 years (30%). Among all patients 56 out of 70 patients i.e., 80% are with chest pain as chief complaint, 19 patients i.e., 27% are with sweating as chief complaint, 21 patients are with shortness of breath (SOB) as chief complaint i.e., 30% and 9 patients are with palpitations as chief complaint i.e., 13%. Among all patients 8 out of 70 patients suffered gastric bleeding i.e., 11.4% and 1 out of 70 patients suffered from intracranial bleeding i.e., 1.42%.Among all patients 9 patients out of 70 suffered with heart failure i.e., 12.85%, 22 patients out of 70 suffered with tachyarrhythmia i.e., 31.4%, and 13 patients suffered local bleeding i.e., 18.57%. Conclusion: From the study it is concluded that, patients with NSTEMI are given both the regimens i.e., low molecular weight heparin and un fractionated heparin and found that 27% more risk is observed in regimen 2 i.e., un fractionated heparin until the limited follow up that has done.
KEYWORDS: Anticoagulants, Unfractionated heparin, Myocardial Infarction.
INTRODUCTION:
Less commonly, myocardial ischemia can also arise if oxygen demand is abnormally increased, as may occur in severe ventricular hypertrophy due to hypertension, or the oxygen carrying capacity of blood is impaired, as in iron deficiency anemia. The term ischemic heart disease may be used to include all causes of myocardial ischemia. [1]
ACS are classified according to ECG changes into
1. ST segment elevation ACS (STEMI)
2. Non ST segment elevation ACS (NSTE ACS) which include necrotive myocytes into the blood stream. The cause of ACS in more than 90% of patients is rupture, fisses non–ST segment elevation myocardial infarction (NSTEMI) and unstable angina (UA).
Acute coronary syndrome arises from an unstable atheromatous plaque. The major feature of these lesions is the presence of overlying thrombus and associated inflammation of the vessel wall. Patients with acute coronary syndrome usually present with chest pain at rest and should be admitted to hospital for evaluation and treatment. The major difference in approach to these patients arises from whether the coronary artery involved is felt to be occluded or open. Patients with occluded coronary artery suffer myocardial damage, the extent of which is determined by duration and site of occlusion. The primary strategy for these patients is restoration of coronary flow with either thrombolysis or primary angioplasty. If the coronary artery is patent, however then therapy with thrombolysis is unnecessary and probably harmful, although angioplasty may still be appropriate. Once the vessel is open, for both groups of patients management then focuses on unstable coronary plaque and is therefore fundamentally similar.
The most important tool to help identify those patients in whom an artery is occluded is the ECG. The presence of ST elevation on the ECG correlates with the presence of occluded artery and is used to determine those patients who should receive thrombolysis or primary angioplasty. The presence of ST elevation on the ECG and ischemic chest pain is nearly always associated with myocardial damage confirmed by measurement of cardiac enzymes and plasma levels of troponin. These patients have therefore had an ST elevation MI (STEMI).
Patients without ST elevation on the ECG may still have myocardial damage due to temporary occlusion of vessel or emboli from the plaque related thrombus blocking smaller distal vessels and will have raised troponin values; these patients have had a non-ST elevation MI(NSTEMI). Patients without rise in troponin or cardiac enzymes and without ST elevation are defined as having unstable angina. [2]
METHODS AND MATERIALS:
Patients with NSTEMI are identified and enrolled in the study after taking their consent for willing to participate in the study.
1. Number of patients will be 70
2. A prospective observational study is done by follow up of patients and all the details regarding the study are collected from inpatient records, medication charts and consulting health care officials when needed.
3. All the information that is required for the study will be collected in the data collection forms designed as per our study requirements.
4. The data collected will be recorded and simple statistical tools involving data graphics are used in interpreting results.
5. Finally results are represented with various graphical diagrams.
6. Inclusion Criteria:
7. Patients presenting with acute Non - ST elevated myocardial infarction of either sex.
8. Eligible patients were men or non pregnant women at least 18 years of age with recent onset of angina at rest lasting at least 10 minutes.
9. Patients who presented within 24hrs of onset of chest pain with a NSTEMI.
Exclusion Criteria:
1. Patients with age < 15 years and > 80 years.
2. Patients with angina with an established precipitating cause (e.g., heart failure or tachy dysrhythmia), contraindications to anticoagulation, or a creatinine clearance rate of less than 30 ml per minute.
Primary assessment:
Heamodynamic changes in patients receiving IV Paracetamol
Secondary assessment:
Applications in the clinical parameters.
Data collection:
1. All the relevant and necessary data will be collected from.
2. Inpatient records at Cardiology department.
3. Lab reports, medication charts or prescriptions.
4. Communicating with health care professionals.
5. By regular follow up of the patient regarding for above stated data collection.
RESULTS AND DISCUSSION:
In the current clinical research study we have performed a prospective observational study regarding prescribing patterns involving NSTEMI patients who are admitted in cardiology department. This study was conducted solely at Durgabai Deshmukh Hospital under expertise doctor guidelines. Extensive study of 6 months has been done on 70 subjects and results have been interpreted. These results will probably help to evaluate the deviations of prescribing patterns from the standard. Day to day observation of each patient was done in medication charts, dosing schedules, prescriptions were analyzed based on their length of stay in the hospital.
The recorded data of each patient was entered in to a data collection form which is designed to meet our study requirements. Results have been displayed below based on our objectives of study using histograms, pie diagrams and bar graphs.
TABULAR REPRESENTATION:
Table 1: Number of patients according to age and gender:
|
Age |
Males |
Females |
Total |
|
30-40 |
7 |
2 |
9(13%) |
|
41-50 |
11 |
5 |
16(23%) |
|
51-60 |
18 |
3 |
21(30%) |
|
61-70 |
16 |
2 |
18(26%) |
|
71-80 |
4 |
2 |
6(9%) |
|
81-90 |
0 |
0 |
0(0%) |
|
TOTAL |
56(80%) |
14(20%) |
70 |
Fig1: Percentage of NSTEMI patients according to gender
Fig 2: Number of subjects according to their age
From the above table 1 it was concluded that, among 70 patients 56 are male i.e., (80%) and 14 are female (20%) as shown in (Fig.1).
Among all age groups major number of NSTEMI was seen in 51-60 years (30%) as shown in (Fig.2)
Table 2: Number of patients according to chief complaints:
|
S. No |
Chief Complaint |
Number of Subjects |
|
1. |
CHEST PAIN |
56 |
|
2. |
SWEATING |
19 |
|
3. |
SOB |
21 |
|
4. |
PALPITATION |
9 |
Fig.3 Number of patients according to chief complaints
From the above table 2 it was concluded that 56 out of 70 patients i.e., 80% are with chest pain as chief complaint, 19 patients i.e., 27% are with sweating as chief complaint, 21 patients are with shortness of breath (SOB) as chief complaint i.e., 30% and 9 patients are with palpitations as chief complaint i.e., 13% respectively.
Table 3: Number of patients with major complications:
|
S. No |
Complication |
Number |
|
1. |
GI BLEEDING |
8 |
|
2. |
IC BLEEDING |
1 |
Fig.4 Number of patients with major complications
From the above table 3 it was clear that 8 out of 70 patients suffered gastric bleeding i.e., 11.4% and 1 out of 70 patients suffered from intracranial bleeding i.e., 1.42% respectively
Table 4: Number of patients with minor complications:
|
S. No |
Complication |
Number |
|
1. |
HEART FAILURE |
9 |
|
2. |
TACHYARRTHYMIA |
22 |
|
3. |
LOCAL BLEEDING |
13 |
Fig. 5 Number of patients with minor complications.
From the above table it is clear that 9 patients out of 70 suffered with heart failure i.e., 12.85%, 22 patients out of 70 suffered with tachyarrhythmia i.e., 31.4%, and 13 patients suffered local bleeding i.e., 18.57% respectively
Table 5: Number of patients with complications in both regimens:
|
S. No |
Complications |
Regimen 1 |
Regimen 2 |
|
1. |
GI BLEEDING |
3 |
5 |
|
2. |
IC BLEEDING |
0 |
1 |
|
3. |
HEART FAILURE |
4 |
5 |
|
4. |
TACHYARRTHYMIA |
10 |
12 |
|
5. |
LOCAL BLEEDING |
4 |
9 |
|
|
TOTAL |
21 |
32 |
Fig. 6 Number of patients with complications.
RELATIVE RISK:
Rate per 1000
22/33*1000 = 6.363636
32/37*1000 = 8.64864
Relative risk = 6.363636 / 8.64864
= 0.7357
1-0.7 = 0.27
i.e., 0.27*100 = 27%
From the above study it is concluded that 21 out of 33 suffered with complications by administering low molecular weight heparin (regimen 1) and 32 out of 37 suffered with complications by administering un fractionated heparin (regimen 2) and it is concluded that 27% risk is more observed in regimen 2 than regimen 1 until the limited follow up that has been done.
DISCUSSION:
In previous studies, paracetamol was compared with the other antipyretic and analgesic drugs and also they have conducted studies in post operative women, patients with other comorbid conditions and the changes in blood pressure were seen. In our study we have taken single drug therapy. Patients included were only with fever and pain conditions.
CONCLUSION:
In this study we evaluate the common prescribing patterns in NSTEMI patients. We also see the deviations from the prescribing patterns, the reasons for the deviation. The following points have been established in our study that among 70 patients 56(80%) are males and 14 (20%) are females, all age groups major numbers of NSTEMI patients are seen in 51-60 years (30%). among all patients 56 out of 70 patients i.e., 80% are with chest pain as chief complaint, 19 patients i.e., 27% are with sweating as chief complaint, 21 patients are with shortness of breath (SOB) as chief complaint i.e., 30% and 9 patients are with palpitations as chief complaint i.e., 13%, all patients 8 out of 70 patients suffered gastric bleeding i.e., 11.4% and 1 out of 70 patients suffered from intracranial bleeding i.e., 1.42%, all patients 9 patients out of 70 suffered with heart failure i.e., 12.85%, 22 patients out of 70 suffered with tachyarrhythmia i.e., 31.4%, and 13 patients suffered local bleeding i.e., 18.57% . From the above study it is concluded that 21 out of 33 suffered with complications by administering low molecular weight heparin (regimen 1) and 32 out of 37 suffered with complications by administering un fractionated heparin (regimen 2) and it is concluded that 27% risk is more observed in regimen 2 than regimen 1 until the limited follow up that has been done.
REFERENCES:
1. Marc Cohen, M.D., Christine Demers, M.D., Enrique P. Gurfinkel, M.D., Alexander G.G. Turpie, M.D., Gregg J. Fromell, M.D., Shaun Goodman, M.D., Anatoly Langer, A Comparison of Low-Molecular-Weight Heparin with Unfractionated Heparin for Unstable Coronary Artery Disease, 1997 Aug: 337.447-452.
2. Marc Cohen MD, D. White MB, DSce, W. Van, Mieghem MD - Randomized double-blind safety study of enoxaparin versus unfractionated heparin in patients with non-ST-segment elevation acute coronary syndromes treated with tirofiban and aspirin: The acute -2 study, 2002 Sep, 144(3): 470-477.
3. Navarsee E.P, De luca G, Castriota F, Kozinski M, Andreotti F, Buffon A, De Servi S, low molecular –weight heparins vs unfractionated heparin in the setting of percutaneous coronary intervention for NSTEMI: a meta analysis, 2011 oct 10, 1902-1915.
4. Eugene Braunwald, Elliott Antman M, John Beasley W, Robert Califf W, Melvin D Cheitlin, Judith S Hochman, Robert H Jones, Dean Kereiakes, Joel Kupersmith, Thomas N Levin, Carl J Pepine, John W Schaeffer, Earl E Smith III, David E Steward, Pierre Theroux, Raymond J Gibbons, Elliott M Antman, Joseph S Alpert, David P Faxon, Valentin Fuster, Gabriel Gregoratos, Loren F Hiratzka, Alice K Jacobs and Sidney C Smith Jr-lmwhvsufh in management of patients with unstable angina and non–ST-segment elevation myocardial infarction: 2002oct 7;2336-2337.
5. Gilles Montalescot, Claire Bal-dit-Sollier, Daniela Chibedi, Jean-Philippe Collet, Thierry Soulat, Miles Dalby, R.émi Choussat, Ariel Cohen, Michel Slama, Phillipe Gabriel Steg, Jean-Luc Dubois-Randé, Jean-Philippe Metzger, François Tarragano, Jean L Guermonprez, Ludovic Drouet. Comparison of effects on markers of blood cell activation of enoxaparin, dalteparin, and unfractionated heparin in patients with unstable angina pectoris or non–ST-segment elevation acute myocardial infarction: 2003, 91(8); 925–930.
6. Mushtaq Ahmed, Mohammad Tariq, Lubna Noor, Shahab Ud Din, Mohammad Hafizullah–Comparison of enoxaparin and dalteparin with ufh in NSTEMI: 2011 April, 23(3); 61-65.
7. Wayangankar SA, Roe MT, Chen AY, Gupta RS, Giugliano RP, Newby LK, de Lemos JA, Alexander KP, Sanborn TA, Saucedo JF-Trends in use of anti-thrombotic agents and outcomes in patients with non-ST-segment elevation myocardial infarction (NSTEMI) managed with an invasive strategy:2016 Jul-Aug;68(4):464-72
8. Chiara Melloni, W. Schuyler Jones, Jeffrey B. Washam, Victor Hasselblad, Stephanie B. Mayer, Sharif Halim, Sumeet Subherwal, Karen Alexander, David F. Kong, Brooke L. Heidenfelder, R. Julian Irvine, Liz Wing, Rowena J. Dolor-Antiplatelet and anticoagulant treatments for unstable angina/non-ST elevation myocardial infarction; 2013sep; 13(14); 172
9. Erlinge D, Omerovic E, Fröbert O, Linder R, Danielewicz M, Hamid M, Swahn E, Henareh L, Wagner H, Hårdhammar P, Sjögren I, Stewart J, Grimfjärd P, Jensen J, Aasa M, Robertsson L, Lundin A, Tödt T, Ioanes D, Råmunddal T, Kellerth T, Zagozdzon L, Götberg M -Bivalirudin versus Heparin Monotherapy in Myocardial Infarction;2017 Sep 21;377(12):1132-1142.
10. Moscucc M, Fox K.A.A. Christopher P. Cannon W. Klein José López-Sendón G. Montalescot K. White R.J. Goldberg- Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE):2003 Oct 1;1815–1823,
11. Montalescot G, Collet JP, Tanguy M., Ankri. A, Payot. L, Dumaine R, Choussat R, Beygui F, Gallois V, Thomas. D-Anti-Xa Activity Relates to Survival and Efficacy in Unselected Acute Coronary Syndrome Patients Treated With Enoxaparin: 2004 July; 3
Received on 17.07.2019 Modified on 15.08.2019
Accepted on 13.09.2019 © RJPT All right reserved
Research J. Pharm. and Tech. 2020; 13(7): 3151-3155.
DOI: 10.5958/0974-360X.2020.00557.0