*Corresponding author email: [email protected]Symbiosis Group Symbiosis www.symbiosisonline.org www.symbiosisonlinepublishing.com A Cross Sectional Comparative Gender Base Study on Percutaneous Coronary Intervention Outcome in Pakistani Population Madiha Iqbal 1 *, Shamila Afshan 1 , Muhammad Rizwan Naeem 2 , Ahmad Shahbaz 3 and Waqar Batti 4 1 Biostatistician at Punjab institute of cardiology, Lahore, Pakistan 2 Cardiac Percussionist at Punjab institute of cardiology, Lahore, Pakistan 3 Assistant Professor of cardiac surgery at Punjab institute of cardiology, Lahore, Pakistan 4 Student of Biostatistics at Punjab University Lahore, Pakistan Journal of Clinical Trials in Cardiology Open Access Research Article Abstract Objective: To evaluate the risk factors, vessel intervened and the outcome of the Precutaneous Coronary Intervention with respect to gender. Materials & Methods: This Cross sectional comparative study included 200 consecutive patients of ischemic heart disease who underwent PCI, at Punjab Institute of Cardiology, Lahore Pakistan. Both males and females between 25-90 years of age were included and data was analyzed using SPSS 20s. p-value ≤ 0.05 was taken as significant. Results: Out of 200 patients, 160 were males and 40 were females. Women were older (54.25 ± 8.7 vs. 40.39 ± 10.29; p-value = 0.006) and had a higher mean body mass index (31.17 ± 5.93 vs. 28.33 ± 6.15; P value = 0.009) compared to men. Diabetes mellitus significantly (65.0% vs. 27.5%; p-value = 0.001), while family history of IHD (45% vs. 36.2%; P-value = 0.308) and Hyperlipidemia insignificantly (15% vs. 7.5%; p-value = 0.138) were more common in females than males. Presentation with unstable angina was insignificantly more frequent in females (40% vs. 33%; p-value = 0.527). Procedural success for PCI was less prevalent (80% vs. 94.4%; p-value = 0.004) as well as, in hospital mortality and adverse events were comparatively higher in females than males (mortality as 7.5% vs. 1.3%; p-value = 0.026), Shortness of breath(40.0% vs. 37.7%; p-value = 0.786), Other serious adverse event (12.5% vs. 1.3%; p-value = 0.001) and Minor bleeding (10% vs. 3.8%; p-value = 0.110). Conclusion: Diabetes, hyperlipidemia and outcome of PCI was more adverse in female as compare to male. Keywords: CAD: Coronary Artery Disease; PCI: Percutaneous Coronary Intervention; Angio: Angiography; ACS: Acute Coronary Syndrome Received: October 24, 2014; Accepted: March 27, 2015; Published: April 06, 2015 *Corresponding author: Madiha Iqbal, Biostatistician at Punjab institute of cardiology, Lahore, Pakistan, Tel: +03214269675; E-mail: madihabio- [email protected]Despite the fact that more women than men die from CAD in USA, and despite the established benefits of PCI in reducing fatal and nonfatal ischemic complications in patients with AMI and high risk ACS, only 33% i.e. one third of annual PCIs are performed in women in USA[4]. In addition, women experience greater delay to intervention and are referred for diagnostic catheterization less frequently than are men [4-7]. One possible explanation for the discrepancy in numbers of female patients referred for PCI versus male patients may be the widespread belief that women do not do as well as men after invasive coronary procedures [4,8,9]. But in late years it was found that women are referred for cardiac catheterization, revascularization rates and practices are similar to those of men [4,10-12]. Furthermore, others have suggested that with the advent of adjunctive pharmaco- therapy, smaller caliber catheters and wide spread use of intracoronary stents, the gender gap has been eliminated [4,9]. Studies have shown that PCI was judged to be a clinical success if there were angiographic success with no deaths, myocardial infarction or emergency CABG surgery and it is shown that 90% of all lesions were dilated successfully in both populations [13]. The recent studies have shown that outcome for PCI is different for women than men in that they have slightly higher events like myocardial infarction and death [14,15]. Gender differences in the clinical presentation and therapeutic options of cardiovascular diseases have been demonstrated all over the world. Under representation of women in clinical trials has been clearly demonstrated in the past. There appears to be no literature available from the Pakistani population with gender based analysis of background risk factors, diagnostic history, angiographic details, PCI and its outcomes as there exist differences in terms of healthcare facilities and patients’ access to these facilities. This study was undertaken to determine these factors in the population of patients presenting at Punjab institute Introduction Percutaneous Transluminal Coronary Angioplasty (PTCA), was introduced in 1977 and was considered a safe and effective method of myocardial revascularization in selected patients [1-3].
A Cross Sectional Comparative Gender Base Study on Percutaneous Coronary Intervention Outcome in
Pakistani PopulationMadiha Iqbal1*, Shamila Afshan1, Muhammad Rizwan Naeem2, Ahmad Shahbaz3 and Waqar Batti4
1Biostatistician at Punjab institute of cardiology, Lahore, Pakistan2Cardiac Percussionist at Punjab institute of cardiology, Lahore, Pakistan
3Assistant Professor of cardiac surgery at Punjab institute of cardiology, Lahore, Pakistan4Student of Biostatistics at Punjab University Lahore, Pakistan
Journal of Clinical Trials in Cardiology Open AccessResearch Article
AbstractObjective: To evaluate the risk factors, vessel intervened and the
outcome of the Precutaneous Coronary Intervention with respect to gender.
Materials & Methods: This Cross sectional comparative study included 200 consecutive patients of ischemic heart disease who underwent PCI, at Punjab Institute of Cardiology, Lahore Pakistan. Both males and females between 25-90 years of age were included and data was analyzed using SPSS 20s. p-value ≤ 0.05 was taken as significant.
Results: Out of 200 patients, 160 were males and 40 were females. Women were older (54.25 ± 8.7 vs. 40.39 ± 10.29; p-value = 0.006) and had a higher mean body mass index (31.17 ± 5.93 vs. 28.33 ± 6.15; P value = 0.009) compared to men. Diabetes mellitus significantly (65.0% vs. 27.5%; p-value = 0.001), while family history of IHD (45% vs. 36.2%; P-value = 0.308) and Hyperlipidemia insignificantly (15% vs. 7.5%; p-value = 0.138) were more common in females than males. Presentation with unstable angina was insignificantly more frequent in females (40% vs. 33%; p-value = 0.527). Procedural success for PCI was less prevalent (80% vs. 94.4%; p-value = 0.004) as well as, in hospital mortality and adverse events were comparatively higher in females than males (mortality as 7.5% vs. 1.3%; p-value = 0.026), Shortness of breath(40.0% vs. 37.7%; p-value = 0.786), Other serious adverse event (12.5% vs. 1.3%; p-value = 0.001) and Minor bleeding (10% vs. 3.8%; p-value = 0.110).
Conclusion: Diabetes, hyperlipidemia and outcome of PCI was more adverse in female as compare to male.
Received: October 24, 2014; Accepted: March 27, 2015; Published: April 06, 2015
*Corresponding author: Madiha Iqbal, Biostatistician at Punjab institute of cardiology, Lahore, Pakistan, Tel: +03214269675; E-mail: [email protected]
Despite the fact that more women than men die from CAD in USA, and despite the established benefits of PCI in reducing fatal and nonfatal ischemic complications in patients with AMI and high risk ACS, only 33% i.e. one third of annual PCIs are performed in women in USA[4]. In addition, women experience greater delay to intervention and are referred for diagnostic catheterization less frequently than are men [4-7].
One possible explanation for the discrepancy in numbers of female patients referred for PCI versus male patients may be the widespread belief that women do not do as well as men after invasive coronary procedures [4,8,9]. But in late years it was found that women are referred for cardiac catheterization, revascularization rates and practices are similar to those of men [4,10-12]. Furthermore, others have suggested that with the advent of adjunctive pharmaco- therapy, smaller caliber catheters and wide spread use of intracoronary stents, the gender gap has been eliminated [4,9]. Studies have shown that PCI was judged to be a clinical success if there were angiographic success with no deaths, myocardial infarction or emergency CABG surgery and it is shown that 90% of all lesions were dilated successfully in both populations [13].
The recent studies have shown that outcome for PCI is different for women than men in that they have slightly higher events like myocardial infarction and death [14,15].
Gender differences in the clinical presentation and therapeutic options of cardiovascular diseases have been demonstrated all over the world. Under representation of women in clinical trials has been clearly demonstrated in the past. There appears to be no literature available from the Pakistani population with gender based analysis of background risk factors, diagnostic history, angiographic details, PCI and its outcomes as there exist differences in terms of healthcare facilities and patients’ access to these facilities. This study was undertaken to determine these factors in the population of patients presenting at Punjab institute
was introduced in 1977 and was considered a safe and effective method of myocardial revascularization in selected patients [1-3].
Page 2 of 6Citation: Naeem MR, Iqbal M, Shahbaz A, Batti W, Afsha S (2015) A Cross Sectional Comparative Gender Base Study on Percutaneous Coronary Intervention Outcome in Pakistani Population. J Clin Trial Cardiol 2(2): 1-6.
A Cross Sectional Comparative Gender Base Study on Percutaneous Coronary Intervention Outcome in Pakistani Population
of cardiology hospital, Lahore. By recognizing the presence of these factors, we can predict the PCI outcome of patients, if a high outcome rate is reported from this study then it demands that all necessary steps should be taken to prevent any adverse outcome in these patients in future.
Data Collection Procedure This cross sectional comparative hospital based study of
200 consecutive patients of coronary artery disease undergoing angioplasty between the age group 25 to 90 years were selected from angiography department of Punjab Institute of cardiology, Lahore over a period of 6 months from 1st Jan 2014 to 31st June 2014.
Patients fulfilling the criteria of diagnosis of Acute Coronary Syndromes (ACS) defined according to the guidelines of the European Society of Cardiology (ESC) and American College of Cardiology (ACC) [16] who underwent primary, elective, emergent coronary angioplasty were included.
Before angioplasty procedure the purpose of this study was explained and informed consent was obtained from each interested patient. A Performa (Annexure I) was used for data collection, which include parameters of study. Risk factors, New York Heart Association (NYHA) class [17], diabetes (fasting glucose > 126 mg/dl or on treatment), hypertension (systolic blood pressure > 140/90 mmHg or on treatment), hyperlipidaemia (fasting total cholesterol > 240 mg/dL (6.21 mmol/L) or on treatment), smoking ( ≥ 1 cigarette per day),
Angiography details and PCI results were collected for each patient. In-hospital, outcome were concluded on achievement of successful and unsuccessful PCI procedure according to the ACC/AHA Guidelines for Percutaneous Coronary Intervention [18].
Unsuccessful PCI procedure related complications included (Shortness of breath defined as NYHA class[17], Plain Old Balloon Angioplasty (POBA) only, major and minor bleeding ( bleeding was defined according to (REPLACE-2) criteria[19] and other serious adverse event i.e. stroke defined as National Institutes of Health Stroke Scale (NIHSS) [20] , ventricular fibrillation defined as presence of irregular ondulations of varying contour and amplitude (atrial rate 60-100 bpm or ventricular rate 400-600 bpm)[21] and heart attack defined as the left ventricular ejection fraction LVEF ≤ 35%)[22] were recorded from hospital stay. Aspirin, clopidogrel, β-blocker, ACE inhibitor, statin were prescribed at the time of discharge from hospital.
Data was analyzed by using SPSS (Statistical Package for Social Sciences) Version 20.0 for Window. Mean ± S.D was given for quantitative variables. Frequencies, percentages and graphs were given for qualitative variables. Chi square test and Fisher exact test (if cell frequency was less than 5) was applied to observe the association of the qualitative variables with gender, while for quantitative variable independent t-test was applied. Multinomial logistic regression was used to determine the influence of predictors on PCI outcome with respect to gender. Level of significance will be considered ≤ 5%. All tests applied were two tailed.
Risk Factors Male(n=160) Female(n=40) P-value
NYHA class1-2 132(82.5%) 34(85%)
0.2633-4 26(16.25%) 6(15%)
Age 40.39 ± 10.29 54.25 ± 8.7 0.006
Body mass Index 28.33 ± 6.15 31.17 ± 5.93 0.009
Diabetes 44(27.5%) 26(65.0%) 0.001
Treatment for diabetes(OHA/Insulin) 40(25.0%) 26(65%) 0.001
STEMI: ST Segment Elevation Myocardial Infarction; NSTEM: Non ST Segment Elevation Myocardial Infarction
Page 3 of 6Citation: Naeem MR, Iqbal M, Shahbaz A, Batti W, Afsha S (2015) A Cross Sectional Comparative Gender Base Study on Percutaneous Coronary Intervention Outcome in Pakistani Population. J Clin Trial Cardiol 2(2): 1-6.
A Cross Sectional Comparative Gender Base Study on Percutaneous Coronary Intervention Outcome in Pakistani Population
ResultsThere were total 200 patients of which 160(80%) were
male and 40(20%) were females. The mean age of the patients was 50.32 ± 10.18 while women as compare to men were older. At base line women as compared to men, more frequently had diabetes, hyperlipidemia, obesity, Family history of premature CAD, smoking was significantly most prevalent risk factor seen in men. The trend towards high mean ESR was observed in women as shown in table 1. There is insignificant difference between stent implanted/deployed in both genders.
Single-vessel disease was present in 10(25%) of female patients whereas 28 (18.9%) of male patients. DVD was present in 9 (22.5%) female patients in comparison to 39 (26.4%) male patients. TVD was seen in 21(52.5%) female patients but in 81 (54.7%) male patients (P > 0.05).
In both women and men, LAD was the most commonly identified culprit vessel (95% and 97.4%), less common culprit vessel to be involved was LCX (72 and 70%) and RCA (80 and 75%) while least common was LMS (25 and 17.6%).
High incidence of procedure failure was noticed among females than men. The trend towards the in-hospital outcomes was also observed to be more frequent in women than men. Different diagnosis i.e. stable angina, unstable angina, STEMI and NSTEMI were found to be similar in men and women but the frequency of unstable angina and NSTEMI was more in female, women were more likely than men to have single-vessel disease.
The angiographic features are described in table 2. Women showed a relatively higher, but statistically insignificant, incidence of in-hospital complications, such as shortness of breath as 40% vs. 37.7%, minor bleeding 10% vs. 3.8% and other serious adverse event as (12.5% vs. 1.3%). In women two patients developed stroke after the procedure, 2 patients developed VF and one developed Heart attack. In men one patient developed VF and one patient developed stroke.
The results shows that the patients who were older age had hypertension, obesity, family history of CAD, prior MI and high mean ESR, poor EF and adverse outcome of PCI in female as compare to male and then who had hyperlipidemia, diabetes, high mean urea, more chance of adverse outcome of PCI in male as compare to female as shown in table 3,4.
DiscussionThe present study provides evidence that women as compare
to men were older; more diabetic and obese as compared to male. There is insignificantly difference in stent implanted in both gender. Women had more extensive CAD.
Women were found to be higher in hospital mortality rate as compare to men as (7.5% vs. 1.3%; p-value <0.026). The trend towards procedure failure was more commonly observed in women than men (20% vs. 5.6%; p-value<0.004).
Our results are comparable with literatures as study by Mehilli et al. [8] reported poor outcomes and a higher incidence of success rate and (82.5% vs. 88.8%) mortality (7.9% vs. 2.3%) after PCI in women with diabetes mellitus as compared to men.
As stated by National Heart, Lung, and Blood Institute PCI registry that female gender to be an independently predictor of in-hospital outcome [11].
Cowley et al. [1] and Bell et al. [11] estimated gender differences in patients undergoing PCI noted a significantly lower procedure success rate (60.3 vs. 66.2%) with higher adverse outcome (27 vs. 19.7%) and mortality (1.8 vs. 0.7%) in women in comparison with men. These findings are in contrast to present study due to the different age structure of these populations.
Angiographic detailGender
P-valueMale(n=160) Female(n=40)
Single vessel disease 28(18.9%) 10(25%) 0.39
Double vessel disease 39(26.4%) 9(22.5%) 1.00
Triple vessel disease 81(54.7%) 21(52.5%) 1.00
LAD 148(97.4%) 38(95%) 0.444
LMS 28(17.6%) 10(25%) 0.288
RCA 112(80.5%) 30(75%) 0.772
Circumflex 124(72.7%) 28(70%) 0.150
BMS implants 62(39.7%) 16(40%)
0.084DES implants 86(55.1%) 18(45%)
Both(BMS+DES) implants 8(5.1%) 6(15%)
Table 2: Angiographic characteristics.
LAD: Left Anterior Descending Artery; LMS: Left Main Stump; RCA: Right Coronary Artery; BMS: Bare-Metal Stent; DES: Drug-Eluting Stent
Page 4 of 6Citation: Naeem MR, Iqbal M, Shahbaz A, Batti W, Afsha S (2015) A Cross Sectional Comparative Gender Base Study on Percutaneous Coronary Intervention Outcome in Pakistani Population. J Clin Trial Cardiol 2(2): 1-6.
A Cross Sectional Comparative Gender Base Study on Percutaneous Coronary Intervention Outcome in Pakistani Population
Carine and Andreas et al. [23] discussed in his study that hospital mortality was more frequent in women who underwent PCI as compare to men (14.8 and 10% vs. 4.8 and 4.5%) and was associated with an extensive CAD, the complication rate was found to be more common in women than men (13.4% vs. 8.85%) and procedure success in women was found to be (82.5%) as compare to men (88.7%). The main reason related to increased operative mortality in women undergoing PCI may be due to potential impact of referral bias on diagnostic effectiveness and clinical decision-making.
Ogita et al. [24] investigated the impact of gender on clinical outcomes and found women were significantly older, more likely to have dyslipidemia, and had significantly higher systolic blood pressure than men also compared the angiographic profiles of both gender and observed higher mortality (6.8% vs. 3.0%) among women than men after elective PCI.
Mandeep et al. [25] found similar mortality rate in men and women in patients who underwent PCI. Additionally, it failed to show any gender-related disparity in the mortality (4.4% vs. 2.8%) and procedure success (89% in women vs. 90% in men) after PCI. However, improvement in procedure success and adverse events in this study might be due to an increased utilization of intracoronary stents and different comorbid conditions in both genders.
Another study by Mazen et al. [26] established that female had similar coronary risk factors with more diabetes and hyperlipidemia as compare to male. Males were found to have multi vessels involvement and complex lesions than female. Female patients had lower rate of PCI procedures and lower number of stents implanted including drug eluting stents. The success rates were similar in both the sexes (99.2% vs. 98.4%), with relatively higher complication rate in the female group as compare to men (14.96% vs. 6.7%).
Our study with the contrast of Mazen et al. [26] study showed contradictory results, this disparity may be due to the small sample size as well as the bias in selection of women when
included may be the reason for the misconceptions regarding these findings in women.
Birkemeyer [27] and Younan et al. [28] examined that female were older than male, in another study women were noted to be older at the time of PCI procedure by Jibran [29] and Kreatsoulas et al. [30] present study demonstrated that females were characterized by older age.
As comorbid condition, diabetes was found to be more in females while less likely to be with past/present smokers in patients who underwent PCI with STEMI however, significantly more males were smokers by Kreatsoulas [30], Birkemeyer [27] and Jibran et al.[29].
Jibran et al. [29] and Birkemeyer et al. [27] found that hypertension was more in women than men who underwent PCI. Present study showed similar results.
Another study by Younan et al. [28] analyzed that male patients were found to have more frequent hypertension than female due to different sampling frame. This study showed different results.
Birkemeyer [27] and Younan et al. [28] evaluated that DES stent was with mild difference more deployed in male, according to the Krotin [31], and Younan et al. [28] found that more patients were treated for unstable angina. Our study showed same results.
Birkemeyer et al. [27] found higher procedural success rate in men (97% vs. 95%) and in-hospital mortality was significantly higher in females (10% vs 5%, p < 0.01). Another study by Jibran et al. [29] found insignificant differences in the short-term adverse event rate at 30 days in both female and male (stroke 0.7 and 0.9% and heart attack 0.5 and 1.7%), due to the improved optimal therapy present study showed similar results.
ConclusionWomen undergoing coronary angioplasty for acute coronary
syndrome are older at the time of presentation, have more co-morbid conditions like diabetes, smoking’s, lower procedural
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A Cross Sectional Comparative Gender Base Study on Percutaneous Coronary Intervention Outcome in Pakistani Population
success and higher rate of in hospital mortality and adverse events.
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