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Cite this article: Safwan J, Hamwi H, Shamsedeen L, Sakr F, Cherfan M, et al. (2017) Evaluation of the Adherence to the Discharge Management for Secondary Prevention of Acute Coronary Syndrome in Lebanon. J Cardiol Clin Res 5(2): 1097.

*Corresponding author

Jihan Safwan, School of Pharmacy, Lebanese International University, Mousseitbe, Beirut, Lebanon, Tel: 961-3-643918; Fax: 961-1-306044; Email:

Submitted: 16 January 2017

Accepted: 04 February 2017

Published: 06 February 2017

Copyright© 2017 Safwan et al.

OPEN ACCESS

Keywords•Acute coronary syndrome•Secondary prevention•Post-discharge medications•Cardiovascular•Adherence

Research Article

Evaluation of the Adherence to the Discharge Management for Secondary Prevention of Acute Coronary Syndrome in LebanonJihan Safwan1*, Hana Hamwi1, Lama Shamsedeen2, Fouad Sakr1, Michelle Cherfan1, Marwan Akel1, Mariam Dabbous1, and Faraj Saade11School of Pharmacy, Lebanese International University, Lebanon2School of Pharmacy, Lebanese University, Lebanon

Abstract

Introduction: Acute coronary syndrome (ACS) remains a major cause of mortality worldwide due to recurrent cardiovascular events, which necessitates the use of secondary prevention medications. The objectives are to determine the individual and collective prescription rates of the guideline recommended medications for ACS and the factors associated with non-adherence.

Material and methods: This is a retrospective, multicenter, observational study conducted by clinical pharmacists on adult patients who were more than 18 years of age, of both sexes, diagnosed with ACS, and discharged alive from two Lebanese hospitals during the year 2013. Medical charts of 344 patients, who were admitted to the cardiac care unit, were reviewed.

Results: Out of 200 included patients, the discharge note showed that 95.5% received aspirin, 89.5% thienopyridine inhibitors, 75.5% beta blockers, 61.0% angiotensin converting enzyme inhibitors or angiotensin receptor blockers, 82.5% statins, and 40.0% the combination of all 5 agents. It has been noted that 28.33% of the non-adherent prescriptions had a reasonable explanation.

Conclusions: Despite the strong and unequivocal benefits of these agents, there is still a considerable adherence gap and opportunity for improvement. The role of the clinical pharmacist remains crucial in ensuring the adherence to the appropriate medications after ACS so that the best patient outcomes are maintained.

ABBREVIATIONS ACS: Acute Coronary Syndrome; UA: Unstable Angina; NSTEMI:

Non-ST-segment Elevation Myocardial Infarction; STEMI: ST-segment Elevation Myocardial Infarction; CAD: Coronary Artery Disease; USA: United States of America; ACC: American College of Cardiology; AHA: American Heart Association; BBs: Beta-Blockers; ACEIs: Angiotensin-Converting Enzyme Inhibitors; ARBs: Angiotensin II Receptor Blockers; DM: Diabetes Mellitus; HTN: Hypertension; CKD: Chronic Kidney Disease; CCU: Cardiac Care Unit; DL: Dyslipidemia; CHF: Congestive Heart Failure; CVD: Cardiovascular Diseases; TIA: Transient Ischemic Attack; COPD: Chronic Obstructive Pulmonary Disease; PUD: Peptic Ulcer Disease; GI: Gastrointestinal; SD: Standard Deviations; OR: Odds Ratio; CI: Confidence Interval; SPSS: Statistical Package for Social Sciences software; N: Number of Patients; OMT: Optimal Medical

Therapy; SAMI: Secondary prevention after Acute Myocardial Infarction

INTRODUCTIONThe term acute coronary syndrome (ACS) refers to any group

of clinical symptoms corresponding to an acute myocardial ischemia, and attributed to an obstruction of the coronary arteries. ACS covers multiple clinical conditions ranging from unstable angina (UA), to non-ST-segment elevation myocardial infarction (NSTEMI), to ST-segment elevation myocardial infarction (STEMI) [1,2]. The past 50 years have witnessed important scientific and medical advances in our understanding of coronary atherosclerosis, its diagnosis, and treatment. However, due to the exceptional pace of industrialization and urbanization, coronary artery disease (CAD) now accounts for approximately 30% of all deaths worldwide; the most common single cause of death


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among adults [3]. In the United States of America (USA) alone, an acute coronary event occurs approximately every 25 seconds and causes a death event every minute [4]. The epidemic of CAD is truly global, with more than 80% of the burden of this disease in the developing world [5]. CAD and its manifestation as ACS carry an immense personal, societal, and economic burden and is a major determining factor of morbidity and mortality among all races, ethnic groups, and cultures.

The national practice guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) state that the goal of acute management of patients with ACS is to provide relief of ischemia and to prevent the recurrence of such events. In this regard, antiplatelet agents (aspirin and thienopyridine inhibitors), beta-blockers (BBs), angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs), and statins are individually effective in reducing secondary cardiovascular events, and even more effective when combined together [1,2].

Antiplatelets decrease platelet activation and aggregation which are essential steps in reducing vascular events and risk of death or recurrent myocardial infarction [1]. The use of a dual antiplatelet therapy with aspirin indefinitely and thienopyridine inhibitors for a pre-specified period depending on the selected interventional procedure is recommended for all ACS patients with no contraindications to these drugs [6-8]. BBs inhibit beta 1 adrenergic receptors in the myocardium and decrease myocardial contractility and heart rate, thereby reducing myocardial oxygen demand. The ACC/AHA guidelines state that therapy with oral BBs should be initiated within the first 24 hours after onset of ACS, in the absence of contraindications (class I recommendation) [9]. ACEIs or ARBs (for patients who cannot tolerate the former), should be administered orally within the first 24 hours to patients with left ventricular ejection fraction ≤ 40 %, heart failure, diabetes mellitus (DM), hypertension (HTN), or chronic kidney disease (CKD) (class I recommendation) and should be considered for administration to patients without these conditions (class IIa recommendation) [1]. These agents inhibit the renin angiotensin system and decrease ventricular remodeling, preserve ischemic preconditioning, decrease myocardial ischemia, or reduce sudden death [10-13]. Treatment with statins in patients stabilized after an ACS lowers the risk of death due to coronary heart disease, recurrent MI, stroke, and the need for coronary revascularization [1,2]. High intensity statins have been shown to decrease nonfatal clinical endpoints more than low intensity ones, independently from baseline cholesterol levels [14].

These drugs should be taken in combination after ACS if no contraindications exist, in order to have an estimated reduction in the relative risk of coronary heart disease mortality by 80% as compared to placebo [1,2]. Despite the recommendation for their long-term treatment use, there is evidence that these therapies are neither prescribed consistently when appropriate nor adhered to by patients [15-18].

Since limited studies have been published in Lebanon to clinically evaluate the adherence to guideline-recommended pharmacological agents after ACS, this study aims to review and document the current utilization of pharmacotherapy for the

secondary prevention of ACS in patients discharged from 2 major Lebanese hospitals along with the factors associated with non-adherence.

MATERIALS AND METHODSThis is a retrospective, multicenter, observational study in

a hospital setting, conducted by clinical pharmacists through the revision of medical records of the cardiac care unit (CCU) patients in two Lebanese hospitals, who were discharged alive after an admission for ACS. The institutional review board of the school of pharmacy at the Lebanese International University and research ethics committees of both Lebanese hospitals reviewed and approved the study protocol. The investigators performed this study in compliance with the Declaration of Helsinki. Due to the retrospective retrieval of the data, obtaining an informed consent was not necessary. This study offered no physical, psychological or social risks to the participants’ privacy, and their confidentiality was respected and abided by. Eligible patients were 18 years of age or older, of both sexes, admitted to the CCU, with a main diagnosis of ACS, and discharged alive. The only exclusion criterion was death during hospitalization.

The five key guideline-recommended therapies of interest were aspirin, thienopyridine inhibitors, ACEI/ARBs, BBs, and statins. For the purpose of the present analysis, patients were divided into two subsets as either receiving all 5 agents at discharge or not. The primary endpoint was to assess the percentage of the individual and collective discharge prescription of aspirin, thienopyridine inhibitors, ACEI/ARBs, BBs, and statins. The secondary points were to examine the presence of a medical reason behind the non-adherence to any of the 5 key recommended medications and evaluate patients’ characteristics associated with the collective use of these agents.

Demographic and clinical data were collected from the electronic medical records. In addition to the main discharge diagnosis for hospital admission (UA, NSTEMI, or STEMI), the following variables were identified: age at hospital admission, sex, tobacco use, allergy to any of the 5 medications, concomitant diseases (HTN, dyslipidemia [DL], arrhythmias, congestive heart failure [CHF], cardiovascular diseases [CVD] or CAD, second or third degree heart block, stroke, history of transient ischemic attack [TIA], DM, asthma, chronic obstructive pulmonary disease [COPD], peptic ulcer disease [PUD], gastrointestinal [GI] bleeding, CKD, renal artery stenosis, active liver disease, and cancer), previous medications, vital signs, labs, intervention performed, and discharge medications.

Statistical analysis included calculation of frequencies and percentages for discrete variables, and means, standard deviations (SD), minimum and maximum values for continuous variables. Bivariate analysis was then performed; relationship between categorical variables whether dichotomous or multinomial qualitative variables were examined using Pearson’s Chi square or Fisher’s exact tests when normal or abnormal distribution was assumed, respectively. Comparison of continuous quantitative variables was analyzed using student (independent) T-test when applicable. Odds ratio (OR) was calculated with a 95% confidence interval (CI).Binary logistic regression was performed to identify patient characteristics independently associated with the




collective use of the 5 evidence-based agents using the forward selection method. Based on the results of the bivariate analysis, the candidate variables with a P-value less than 0.2 were checked for any association with the 5-drug combination therapy use at discharge. Statistical analysis was performed using the Statistical Package for Social Sciences software (SPSS) version 20.0 and two-tailed P-value less than 0.05 was considered to indicate statistical significance.

344 patients screened

144 excluded

38 due to lack of medical records

77 due to non-ACS final diagnosis

29 due to death during

hospitalization

200 included in analysis

Figure 1 Patients’ randomization.

RESULTSA total of 344 patients were initially screened, of which 144

patients were excluded due to lack of medical records, final diagnosis other than ACS, or death during hospitalization (Figure 1). For the primary outcome, data was analyzed based on the medications dispensed during the last day of hospitalization. Baseline demographic and clinical characteristics are shown in Table (1).

The most commonly documented risk factors of the patients’ presentation at the time of an ACS event admission are shown in Table (2). It should be noted that data about tobacco use was missing for 36 (18%) patients.

A total of 80 ACS patients (40%) received all 5 guideline-recommended classes of pharmacological agents at discharge. These patients were more in the middle age group defined as 46 to 64 years (P-value, 0.028), smokers (P-value, 0.028), having comorbidities such as HTN (P-value, 0.01), CAD (P-value, 0.042), and DL (P-value, 0.004).

Approximately, 80% of the patients had a previous CVD, 34% endocrine (DM), 7% renal (CKD), 6.5% GI (PUD, GI bleeding), 5% respiratory (asthma, COPD), 2% cancer, and 0.5% hepatic (active liver disease). None of the patients had a history of renal artery

Table 1: Baseline demographic and clinical characteristics.

Characteristics All patients, N= 200

Patients receiving 5-drug combination therapy at discharge, N=80

Patients not receiving 5-drug combination therapy at discharge, N=120

P-value

Age, N (%)

≤45 27 (13.5) 7 (8.8) 20 (16.7) 0.108

46 to 64 101 (50.5) 48 (60) 53 (44.2) 0.028

65 to 79 56 (28) 21 (26.2) 35 (29.2) 0.653

≥80 16 (8) 4 (5) 12 (10) 0.202

Mean [SD] 60.3 [13.6] 60 [10.8] 61 [15.2] 0.751

Gender, N (%) Male 133 (66.5) 55 (68.8) 78 (65) 0.582

Allergy▼, N (%) Present 2 (1) 1 (1.25) 1 (0.8) 0.772

Type of ACS, N (%)

UA 56 (28) 19 (23.8) 37 (30.8) 0.274

NSTEMI 74 (37) 27 (33.7) 47 (39.2) 0.437

STEMI 70 (35) 34 (42.5) 36 (30) 0.069▼: Allergy to any of the 5 drugsP-value less than 0.05 is considered significant Abbreviations: N: Number of patients; SD: Standard Deviation; ACS: Acute Coronary Syndrome; UA: Unstable Angina; NSTEMI: Non-ST-segment Elevation Myocardial Infarction; STEMI: ST-segment Elevation Myocardial Infarction

Table 2: Common risk factors.

Risk factors All patients, N= 200 (%)

Patients receiving 5-drug combination therapy at discharge,

N=80 (%)

Patients not receiving 5-drug combination therapy at discharge,

N=120 (%)P-value*

HTN 113 (56.5) 54 (67.5) 59 (49.2) 0.01CAD 110 (55) 51 (63.8) 59 (49.2) 0.042DM 68 (34) 32 (47) 36 (53) 0.144DL 42 (21) 25 (31.3) 17 (14.2) 0.004Tobacco use ‡ 108 (54) 50 (62.5) 58 (48.4) 0.028*P-value less than 0.05 is considered significant ‡: Data about tobacco use was missing for 36 patients of the 200 (18%)Abbreviations: N: Number of patients; %:Percentage; HTN: Hypertension; CAD: Coronary Artery Disease; DM: Diabetes Mellitus; DL: Dyslipidemia




stenosis. Out of the comorbidities, CVDs were the most common accounting for 59% of the cases. Out of the cardiovascular comorbidities, 56.5% of the patients had a previous history of HTN, 55% CAD, 21% DL, 13.5% CHF, 4.5% arrhythmia, 2.5% heart block, and 2.5% stroke. None of the patients had a history of TIA. Most of the patients were treated conservatively (56%) after admission to the CCU with ACS, 29.5% underwent PCI, 3% CABG, 10% were given fibrinolytics, and 1.5% were on both fibrinolytics and PCI.

The discharge prescription rates are described in Table (3). There was neither a clinical nor a statistical significant difference in the individual and collective prescription rates of the previously mentioned discharge medications, between the different types of ACS.

Upon discharge, 120 patients (60%) out of the 200 were not discharged on all the five agents. For this reason, it was reasonable to examine the presence of a reason behind the non-adherence, which was only available for 34 patients (28.3%) out of the 120 (Table 4). The reason for non-adherence varied between patients and is shown in Table (5).

Binary logistic regression was performed to identify patient characteristics that were independently associated with the collective use of the 5 evidence based agents (Table 6). The following characteristics were associated with more adherence to the 5-drug combination therapy: middle age category (OR, 1.91; 95% CI, 1.04-3.52; P, 0.038), diagnosis with STEMI (OR, 2.07; 95% CI, 1.10 to 3.95; P, 0.026), and co-morbidities including HTN (OR, 2.23; 95% CI, 1.18 to 4.21; P, 0.013), and DL (OR, 2.50; 95% CI, 1.177 to 5.35, P; 0.017).

The study evaluated the rates of exposure to 5 evidence-based drug therapies after hospital discharge for patients with ACS. It was found that 40 % of the patients received all 5 guideline-recommended classes of pharmacological agents at discharge in the first subset of 200 patients. Individual utilization rates for aspirin, thienopyridine inhibitors, ACE-I/ARBs, BBs, and statins at hospital discharge were 95.5 %, 89.5 %, 61 %, 75.5 %, and 82.5%, respectively. The present utilization rates of guideline-recommended pharmacological agents represent current medical discharge management of ACS in the region and serve as a baseline regional core measure performance.

DISCUSSIONAlthough randomized controlled trials set the ‘gold standard’

for evaluating treatment efficacy, observational studies afford unique and valuable insights into treatment effectiveness and generalizability in routine practice [19,20]. In this regard, multiple registries have demonstrated the underuse of evidence-based medical therapies at discharge among patients with ACS, irrespective of geographic location [21-24]. But up till now, limited studies have been conducted in Lebanon. Only Taha et al., evaluated whether ACS patients in Lebanon have been discharged on optimal medical therapy based on the current ACC/AHA guidelines; this study has showed that discharge cardiac medications are prescribed at suboptimal rates, with 98.9% receiving aspirin, 89.1% dual antiplatelet therapy (aspirin + thienopyridine or ticagrelor), 90.5% BBs, 81.9% ACEI or ARB, and 89.8% statin [19].

Several studies have examined the proportion of hospitalized cardiac patients discharged on secondary prevention medications. Yetgin et al., evaluated the rates of key guideline-

Table 3: Discharge prescription rates of patients with ACS.

Prescribed Drug ACS UA NSTEMI STEMI P-Value*

Aspirin 95.50% 92.90% 95.90% 97.10% 0.50Thienopyridine In-hibitors 89.50% 82.10% 90.50% 94.30% 0.83

ACEIs/ARBs 61.00% 64.30% 58.10% 61.00% 0.547

BBs 75.50% 69.60% 78.40% 77.10% 0.45

Statins 82.50% 80.40% 79.70% 87.10% 0.44Combination of all 5 agents 40.00% 33.90% 36.50% 48.60% 0.18

*P-value less than 0.05 is considered significantAbbreviations: ACS: Acute Coronary Syndrome; UA: Unstable Angina; NSTE-MI: Non-ST-segment Elevation Myocardial Infarction; STEMI: ST-segment Elevation Myocardial Infarction; ACEIs/ARBs: Angiotensin Converting En-zyme In hibitors / Angiotensin Receptor Blockers; BBs: Beta Blockers

Table 4: Number of patients with explained non-adherence.

Non-adherence explained Yes NoPatients’ number out of 120 (%) 34 (28.3%) 86 (71.7%)

Abbreviations: %: Percentage

Table 5: Reasons behind not being discharged on one of the five-drug combination therapy.Drugs not prescribed Reason Number of patients

ACEI/ARBsHypotension 22

Hyperkalemia 1

BBs

Bradycardia 7Decompensated heart

failure 3

Heart block (second degree) 1

Statins Active liver disease 4

Thienopyridine inhibitors

GI bleeding 2Allergy 1

Aspirin GI bleeding 3Abbreviations: ACEI: Angiotensin Converting Enzyme Inhibitors; ARBs: Angiotensin Receptor Blockers; BBs: Beta Blockers; GI: Gastrointestinal

Table 6: Independent predictors of the 5-drugs combination therapy at discharge.Parameter OR 95 % CI P-value*

STEMI 2.07 1.10 − 3.95 0.026

Hypertension 2.23 1.18 − 4.21 0.013

Dyslipidemia 2.50 1.17 − 5.35 0.017Middle age category (46 to 64 years)

1.91 1.04 − 3.52 0.038

*P-value less than 0.05 is considered significantAbbreviations: OR: Odds Ratio; CI: Confidence Interval; STEMI: ST-segment Elevation Myocardial Infarction




recommended pharmacological agents after ACS in the Rijnmond Collective Cardiology Research registry in Netherlands; this research found that at discharge, 94% of patients received aspirin, 100% thienopyridine inhibitors, 80 % ACEI/ARBs, 87 % BBs, 96 % statins, and 65 % the combination of the 5 agents [21]. Bramlag et al., analyzed the proportion of patients being treated with optimal medical therapy (OMT) at hospital discharge in the German SAMI (Secondary prevention after Acute Myocardial Infarction) registry; this research found that 90 % of patients received aspirin, 70 % thienopyridine inhibitors, 81 % ACE-I/ARBs, 90 % BBs, 84 % statins, and 46 % all 5 drugs [22]. Yan et al., documented OMT use in 51.8% of patients in the Canadian ACS II registry (2002e3); they further documented an absolute increase of 23% over the previous Canadian ACS I registry (1999e2001) at which time 28.9% of patients received OMT (p < 0.001) [23]. A study of a nationwide registry of patients admitted to intensive care units for acute MI in France found that only 27% received ACEIs, antiplatelet agents, BBs, and statins at discharge [24].

The present study indicates that the individual use rates of these agents in ACS patients at discharge was encouraging, however the collective use was provided to less than half of the patients, leaving room for substantial improvement. Although initiation of evidence-based therapies after discharge is encouraging, numerous studies have documented the rapid decline in adherence to medications after hospitalization for ACS [20,25,26]. According to the American Research and Manufacturers of America, nonadherence has been described in one third of the patients who discontinue their medicine earlier than instructed, as well as, having almost 75% of adults not filling a new prescription or taking a lower dose [27]. In this regard, further research should be conducted to assess patient adherence to evidence based pharmacological therapies over time.

It is important to note that the absence of one of the 5 classes of pharmacological agents after ACS does not necessarily imply that the patients are not treated optimally. Practice guidelines recommend the use of these agents in all patients with ACS, unless contraindicated [1,28,29]. In the present study, 120 (60%) patients were not discharged on the 5-drug combination, of which, only 34 (28.3%) patients had a reasonable explanation for non-adherence. Reasons varied between, hypotension, bradycardia, hyperkalemia, heart failure, second degree heart block, active liver disease, gastrointestinal bleeding, and allergy. The largest discrepancies in the use of guideline medications appear to be by age, comorbidities, and index diagnosis. Those aged 46 to 64 years were more likely to receive the 5-drug combination. Patients with HTN or DL were more likely than patients with other comorbidities to receive the 5-drug combination. Patients diagnosed with STEMI were more likely to receive the combination therapy as compared to patients with NSTEMI or UA. Even though, STEMI was not significantly associated with adherence in the bivariate analysis, it became significant in the binary logistic regression analysis.

Several investigators have studied the determinants of the collective medication use after ACS [21,22]. The current report is compatible with prior work demonstrating that patients presenting with HTN, DL and STEMI were more likely to be given optimal medical treatment [21]. In a prospective

cohort observational study, Yetgin et al., reported that patients presenting with STEMI, HTN, hypercholesterolemia and those enrolled in the registry in an interventional center were more likely to be given optimal medical treatment [21]. In an observational cohort of patients admitted with MI, Birkhead et al., found that the proportion of patients not receiving secondary prevention drugs during hospitalization increased with age. There were 14.2% to 26% fewer patients using ACEIs, BBs, or statins in the age category ≥ 85 years compared with the younger group aged 55-64 years [30]. In a randomized clinical trial by Ho et al., it has been noted that during the year that follows ACS hospital discharge, adherence to medication regimens has been increased through collaboration between pharmacists, primary care providers, and/or cardiologists [31].

The study’s limitation lies in the relatively small sample size. As for the external validity of the results, the current study was conducted in only two hospitals, and thus the generalization of our findings to other jurisdictions should be done with caution. It would therefore be useful to conduct additional studies including hospitals from areas all-over Lebanon. Moreover it would also be beneficial to compare the management between institutions which can help them meet benchmarks of quality care.

CONCLUSIONPharmacological secondary prevention with aspirin,

thienopyridine inhibitors, ACEI/ARBs, BBs, and statins in patients after ACS has contributed substantially to reductions in cardiovascular morbidity and mortality [32]. Our results suggest that the proportion of full adherence remains suboptimal and every effort should be made to increase it. So, despite the strong and clear benefits of these agents, there is still a considerable adherence gap and opportunity for improvement. Future research should attempt to explain the differences in the use of these secondary prevention therapies by demographic factors, evaluate adherence and persistence, and determine cost-effective interventions to improve the use of the five secondary prevention therapies. Importantly, active research study enrollment will continue to provide essential data concerning regional performance and will potentially enhance hospital care quality.

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Safwan J, Hamwi H, Shamsedeen L, Sakr F, Cherfan M, et al. (2017) Evaluation of the Adherence to the Discharge Management for Secondary Prevention of Acute Coronary Syndrome in Lebanon. J Cardiol Clin Res 5(2): 1097.

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Evaluation of the Adherence to the Discharge Management for Secondary Prevention of Acute Coronary SAbstractAbbreviations IntroductionMaterials and Methods ResultsDiscussionConclusionReferencesFigure 1Table 1Table 2Table 3Table 5Table 6

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