Scandinavian Cardiovascular Journal

ISSN: 1401-7431 (Print) 1651-2006 (Online) Journal homepage: http://www.tandfonline.com/loi/icdv20

Gender differences and bleeding complications

after PCI on first and second generation DES.

Wojciech Wanha, Damian Kawecki, Tomasz Roleder, Aleksandra Pluta, Kamil

Marcinkiewicz, Beata Morawiec, Mariusz Kret, Tomasz Pawlowski, Grzegorz
Smolka, Andrzej Ochala & Wojciech Wojakowski

To cite this article: Wojciech Wanha, Damian Kawecki, Tomasz Roleder, Aleksandra Pluta,
Kamil Marcinkiewicz, Beata Morawiec, Mariusz Kret, Tomasz Pawlowski, Grzegorz Smolka,
Andrzej Ochala & Wojciech Wojakowski (2016): Gender differences and bleeding complications
after PCI on first and second generation DES., Scandinavian Cardiovascular Journal, DOI:
10.1080/14017431.2016.1219044

To link to this article: http://dx.doi.org/10.1080/14017431.2016.1219044

Accepted author version posted online: 29

Jul 2016.
Published online: 29 Jul 2016.

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 Gender differences and bleeding complications after PCI on first and second

generation DES.

Wojciech Wanha*1, Damian Kawecki*2, Tomasz Roleder1, Aleksandra Pluta1, Kamil

Marcinkiewicz1, Beata Morawiec2, Mariusz Kret3, Tomasz Pawlowski1, Grzegorz
Smolka1, Andrzej Ochala1, Wojciech Wojakowski1

* both authors contributed equally

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1. Third Division of Cardiology, Medical University of Silesia, Katowice, Poland.

2. Division of Cardiology, Medical University of Silesia, Zabrze, Poland.
3. Department of Cardiology, Specialistic Hospital, Tarnow, Poland.

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Corresponding author:

Wojciech Wańha, MD, PhD

3rd Division of Cardiology, Katowice
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Medical University of Silesia, Katowice

Ziołowa Str. 45, 40-635 Katowice, Poland
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Tel: +48 32 359 80 00; Fax: +48 32 202 87 54

Email: wojciech.wanha@gmail.com
 ABSTRACT:

Background: The aim of this study was to evaluate gender differences in the long-

term clinical outcomes and safety of patients treated with first- and second-generation

DES.

Methods: The Katowice-Zabrze Registry included 1916 consecutive patients treated

with either first or second-generation DES. We evaluated major adverse cardiac and

cerebral events (MACCE) [composite of death, myocardial infarction (MI), stroke

and target vessel revascularization (TVR)] at 12-month follow-up. Safety endpoint

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was bleeding complications and stent thrombosis.

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Results: Registry included [unstable angina (UA) 1500(78%), non-ST-segment

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elevation myocardial infraction (NSTEMI) 285(15%), ST-segment elevation

myocardial infraction/ left bundle branch block (STEMI/LBBB) 131(7%)]. There

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were 35.5% females and 64.5% males. Women were older and had higher prevalence

of comorbidities. Males more often had multivessel disease and higher Syntax score
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when comparable to females. We did not observed difference in acute and subacute
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stent thrombosis in our data, however, females had more in-hospital bleeding

complications. Univariable Cox regression analysis revealed that women had similar
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outcomes when compared to men in terms of a risk of death, myocardial infarction,

TVR, stroke and MACCE at 1-year follow-up. There were no differences between
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males and females in MACCE when first and second generation DES were analyzed

separately.

Conclusion: Despite higher risk profile, women treated with DES have similar

outcomes as males in 1-year follow-up. However there is, an increased risk of in-

hospital bleedings in women.

Keywords: percutaneous coronary intervention, drug eluting stents, gender, bleeding,

 INTRODUCTION

Large registries provide data which can be utilized to highlighted gender-related

differences in presentation, access to interventional treatment and long term outcomes

in patients with coronary artery disease (CAD). In a study conducted in Denmark by

Hvelplund A, et al, women who presented with acute myocardial infarction (MI) were

less often hospitalized and less likely to undergo percutaneous coronary intervention

(PCI) (1, 2). As well, women more often had microvascular disease as compared to
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men (3). Some studies showed that females have increased risk of major

cardiovascular adverse events and bleeding complications (4, 5), while others, suggest

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that after adjustments for comorbidities, females can have better long-term survival

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post PCI than man (6, 7). Yu, J et al noted that women presented with onset of

symptoms later than men, they were treated with medical management alone, they
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had a higher three-year rate of major adverse cardiac events (MACE) and bleeding.

However, after adjusting for baseline differences, female sex was an independent
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predictor of major bleeding complications after PCI (8). Even in light of

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comorbidities, microvascular diseases and or increased bleeding complications, a

clear rationlization for the observed treatment differences between genders was not
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explained. Stent technology has progressed from first generation DES (I-DES) to

second generation DES (II-DES). Both generational DES types are currently in use, it
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is possible that DES type could influence outcome observed between genders, treated

from this therapy. There is limited data, which assess the impact of DES types (I-DES

vs. II-DES) on PCI outcomes, in gender differences. We, therefore, examined the

incidence of death and Major Adverse Cardiovascular and Cerebrovascular Events

(MACCE) in men and females and compare DES-I vs. DES-II in both groups on 1-

year follow-up. The primary goal is to assess the implementation of the guidelines
 and evidence-based medicine into everyday clinical practice.

METHODS AND STUDY POPULATION:

The Katowice-Zabrze retrospective registry included 1916 consecutive patients

treated with either first- (paclitaxel, sirolimus eluting; 33.6%) or second-generation

(everolimus, zotarolimus, biolimus A9, 66.4%) DES. Briefly, baseline characteristics,

cardiac history, risk factors, medications, angiographic and procedural data were
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obtained and recorded. Angiographic data was collected on all patients undergoing

PCI and recorded in the cardiovascular information registry. Syntax score was

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calculated for all patients without prior CABG.

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The primary efficacy endpoint was a composite of MACCE, including as all-cause

death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR),

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and stroke. The secondary end- points were individual components of the primary

endpoint (all-cause death, MI, TVR, stroke) and in hospital bleeding. The safety of
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DES was defined as definite stent thrombosis (acute, subacute, late). TVR, definite
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stent thrombosis, acute, subacute, and late stent thrombosis were defined according to

the definitions of endpoints for clinical trials (9). Gastrointestinal bleeding was
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considered an end- point if it fulfilled criteria for type 3 or type 5 bleeding according

to proposed definitions (10). Data regarding long-term outcomes (MACCE and

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gastrointestinal bleeding) were obtained from the database of the National Health

Fund Service (Ministry of Health).

 STATISTICS:

Statistical analysis was performed using MedCalc Software (v.12 Belgium).

Quantitative variables are presented as mean ± standard deviation and median with

interquartile range (Q1 – Q3). Qualitative data is expressed as crude values and/or

percents. Between-group differences were assessed using Mann-Whitney U test for

quantitative variables and chi-square test for qualitative variables. Data distribution

was verified with Smirnov-Kolmogorov test. Kaplan-Meier curves were used to

present the unadjusted time-to-event data for investigated end-points. Additionally,

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multivariable modeling was performed using Cox proportional hazards method to

assess the adjusted association between all end-points and DES type. All tests were 2-

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tailed. P <0.05 was considered significant.

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RESULTS

Demographics, Comorbidities and chronic medications

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During 24 months between January 2009 to December 2010, 1916 patients were
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admitted with a final diagnosis unstable angina (UA) 1500 (78.2%), non-ST-segment

elevation myocardial infarction (NSTEMI) 285 (14.8%) and ST-segment elevation

myocardial infarction/left bundle branch block (STEMI/LBBB) 131(6.8%). There

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were 680 (35.5%) females and 1236 (64.5%) males. Females were older and had

higher prevalence of co-morbidities: hypertension, diabetes, chronic kidney disease,

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obesity but they were less often smokers. They also had less often a history of MI

and CABG in comparison to males. According to the clinical presentation, females

had higher blood pressure at admission. There were no differences across the

spectrum of GRACE risk score (Table 1). According to the medical treatments,

females received less often angiotensin converting enzyme inhibitors but they were
 more often administered angiotensin receptor blockers and calcium channel blockers.

There were no differences in other peri– and post-procedural medical treatment in

both groups (Table 2).

Left ventricular function

Left ventricle ejection fraction (LVEF) values were available in 98,7% of all patients.

In general population LVEF was normal in 70% patients, moderately reduced (31-

50%) in 24% and severely (≤30%) reduced in 6% of patients. Males had lower LVEF
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values as compared to females (53 IQR45-59 vs. 55 IQR 50-60, p<0.001) (Table 1).

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Interventional treatment and reperfusion strategy

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Males had more often multivessel disease - three or more disease vessel (30.1% vs.
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21.9% p<0.001) and higher Syntax score comparable to female (16 IQR 9-25 vs. 13

IQR 7-20, p<0.001). Males were more frequently treated with II-DES and females
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were more frequently treated with I-DES (Table 3).

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In-Hospital and 30 days Outcomes:

There were a significantly higher rate of in-hospital bleedings requiring blood

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transfusion (1.7 % vs. 0.4%, p=0.005) and bleedings not requiring blood transfusion

(2.6 % vs. 0.8%, p=0.002) in females as compared to males (Figure 1). Moreover,
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women had longer hospitalization time compared to males (p<0.001). There were no

differences in the use of intra-aortic balloon pump (IABP), respiratory insufficiency

and cardiac arrest during hospitalization in both groups. Even so, we did not observe

differences in rates of acute and sub-acute stent thrombosis in males or females

(Table 4).
 12-month outcomes:

12-month follow up revealed that women had similar outcomes as men in terms of

death [HR=1.08 (95%CI 0.64–1.82), p=0.880), myocardial infarction [HR=0.72

(95%CI 0.47–1.09), p=0,149], TVR [HR=1.05; (95%CI 0.75–1.46), p=0.849], stroke

[HR=1.38 (95%CI, 0.43–4.41), p=0.792] and MACCE [HR=0.97 (95%CI, 0.75–

1.28), p=0.977]. Twelve month cumulative rate of late stent thrombosis did not differ

significantly between males and females (p=0.797). Survival probability at 12 months

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was presented using Kaplan-Meier curves stratified on males vs. females in Figure 2-

3. The rates of gastrointestinal bleeding were low and did not differ between groups

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(p=0.592) (Figure 4).

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Multivariate Cox regression analysis revealed that gender was not an independent risk

factor of death among CAD patients and DES users but chronic kidney disease,
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peripheral artery disease, ejection fraction lower than 50% and age over 65 years were

(Table 5). The comparisons of DES generational use in males and females showed
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that the cumulative rate of death did not differ significantly among I-DES vs. II-DES
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in males [HR= 1.1 (95%CI 0.61–2.14), p=0.658] and females [HR=0.93 (95%CI

0.37–2.32), p=0.885] (Figure 5). Moreover there were no differences in cumulative

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rate of MACCE between I-DES vs. II-DES in males [HR= 1.1 (95%CI 0.80–1.51),

p=0.538] and females [HR=0.91 (95%CI 0.60–1.39), p=0.669] (Figure 6).

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DISCUSSION

The present all-comer registry demonstrated some significant gender disparities with

regard to clinical and angiographic presentation of patients with ACS. Women had a

higher risk of adverse events, however, one year MACCE were equal in men and
 women. Importantly, there was a gender disparity in use of newer, more efficient

generation of DES.

Analysis of available angiographic data demonstrated that there were some gender

differences in terms of the complexity coronary atherosclerotic lesions. Similar to

Stefanini at all. (11) we noted that males despite younger age have more complex

coronary lesions measured by Syntax Score. In addition they reported no differences

in TVR, and stent thrombosis between males and females in two years follow up after

DES implantation. The same angiographic outcomes have been demonstrated after
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PCI with sirolimus eluting stent (12) or paclitaxel eluting stent (5) implantation,

analysed separately. Shammas et al. (13) evaluate differences for males and females

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treated with everolimus-eluting stents and paclitaxel-eluting stents. At 2-year follow-

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up, there was no difference in target lesion revascularization, cardiac death and stent
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thrombosis. Results from Scandinavian Organization for Randomized Trials with

Clinical Outcome (SORT OUT IV and V) also did not observe gender differences in
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patients treated with first or second generation DES (14). There is only one study,
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which compared DES generation in females. Giustino et al. (15) investigated the

safety and efficacy of II-DES vs. I-DES in women undergoing complex PCI. The use

of II-DES was associated with lower 3-year risk of MACE, target lesion
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revascularization and stent thrombosis. However stent thrombosis was more apparent

in the very-late period (>1 year).

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The outcomes after coronary revascularization are improving. Nowadays mainly

II-DES are used during PCI, they are characterized by thinner struts, more

biocompatible polymer coating (often biodegradable). They are more flexibility and

deliverability and have smaller more thickness struts compared to I-DES.

While, females have more frequently narrower, more tortuous vessels, more
 comorbidity and females sex has been reported to be predictive of in-stent restenosis

(16) the II-DES are better choice. II-DES are associated with lower risk of restenosis,

stent thrombosis, and a lower risk of death compared with I-DES (17, 18) in general

population.

In this present study despite the lack of differences in antiplatelet therapy there still

was an increased risk of in-hospital bleeding, requiring blood transfusion in women.

Bleeding is the most common non-ischemic complication observed post PCI (19), and
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red blood cell transfusion is associated with an increased risk of CV events (20).

Moreover according to the ACUITY trial (21) major bleeding is associated with

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higher ischemia, and stent thrombosis compared to patients without major bleeding

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and is an independent predictor of 30-day mortality. Therefore, those patients need an

individualized antiplatelet therapy approach to decrease thrombotic events without

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increasing bleeding (22, 23). Choosing the best vascular approach during PCI can

significantly reduce the risk of bleeding. Radial access is associated with significant
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reduction in major bleeding and need for blood PCI transfusions (8). Data from other
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studies demonstrated a strong association between gender differences and increased

risk of bleeding complications in patients with CAD, who were managed invasively.
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Birkemeyer et al. (24) indicated that women with STEMI more often had major

bleeding than men in short and long term follow up. Similar results were observed by
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Conne at al. (25) in MI patients. He examined the incidence of the bleeding event

within 1-year post PCI according to GUSTO and BARC definitions. In his study

women were associated with higher risks of post-PCI GUSTO bleeding (9.1% vs.

5.7%) and post-discharge BARC bleeding (39.6% vs. 27.9%). We examined the

incidence of the gastrointestinal bleeding event within 1-year post PCI and did not

observe any differences between both groups. But in contrast results from the
 HORIZONS- AMI Trial illustrated that women have almost a two-fold risk of

bleeding compared with men either in short-term as well as long-term follow-up.(8).

CONCLUSION:

Women presenting with coronary artery disease tend to be older and had more

co-morbidities. In women, the risk of bleeding post PCI is significantly higher when

compared with men. Despite the higher risk profile, women treated with either type of
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DES are not at increased risk of death or MACCE at 1-year follow-up or stent

thrombosis, as compared to men.

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STUDY LIMITATIONS:
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Patients were not randomized as to a choice of stent implantation (DES first or second

generation), so there was no balance between I-DES and II-DES. There was no
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information on drugs used before admission to hospital, especially those with a

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known impact on bleeding (e.g., VKA, NOAC). There was no information about the

duration of medication (example patients taking clopidogrel) after PCI.

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ACKNOWLEDGEMENTS
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No

DECLARATON OF INTEREST SATEMENT

The authors report no conflicts of interest. The authors alone are responsible for the

content and writing of this article.

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 Figure Legends:

Figure 1. In hospital follow up - bleeding complications in Females and Males.

Figure 2. Kaplan-Meier curves for all-cause mortality in Females and Males.

Figure 3. Kaplan-Meier curves for MACCE in Females and Males.

Figure 4. Kaplan-Meier curves for gastrointestinal bleeding in Females and Males.

Figure 5. Kaplan-Meier curves for all-cause mortality in Females and Males (I-DES

vs. II-DES).

Figure 6. Kaplan-Meier curves for MACCE in Females and Males (I-DES vs. II-
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DES).

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 Table 1. Patients characteristics, risk factors and clinical presentation according to the
gender.
Male Female
p
n=1236 (64.5%) n= 680 (35.5%)
Demographic data
Age, [yrs], median (IQR) 60 (55-69) 67 (60-71) <0.001
BMI [kg/m2], median (IQR) 28 (26-31) 30 (26-33) <0.001
Discharge diagnosis
UA, n (%) 966 (78.1) 534 (78.5) 0.914
NSTEMI, n (%) 177 (14.3) 108 (15.8) 0.358
STEMI/LBBB, n (%) 93 (7.5) 38 (5.5) 0.108
CAD history
Previous MI, n (%) 617 (49.9) 298 (43.8) 0.011
Previous PCI, n (%) 701 (56.7) 363 (53.3) 0.160
Previous CABG, n (%) 296 (23.9) 102 (15.0) <0.001
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CAD risk factors

Hypertension, n (%) 1015 (82.1) 628 (92.3) <0.001
Dyslipidaemia, n (%) 808 (65.3) 456 (67.0) 0.456

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CKD, n (%) 163(13.1) 168(25.7) <0.001
Anaemia, n (%) 137(11.0) 80(11.7) 0,708
Diabetes mellitus, n (%)
Smoking, n (%)
Family history, n (%)
Concomitant disease
376(30.4)
346 (27.9)
338(31.3)
TE 341(50.1)
118 (17.3)
240(35.2)
<0.001
<0.001
0.090
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Cancer, n (%) 66(5.3) 51(7.5) 0.073
COPD, n (%) 83 (6.7) 34 (5.0) 0.136
PAD, n (%) 150 (12.1) 68 (10.0) 0.159
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CAD,n (%) 67(5.4) 47(6.9) 0.222

Obesity, n (%) 245(19.8) 196(28.8) <0.001
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Length of hospital stay (day), median

(IQR)
5 (3-6) 6 (4-7) <0.001
LVEF, n (%)
< 30% 91(7.3) 22(3.2) <0.001
30-50% 316(25.5) 138(20.2) 0.012
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> 50% 814(65.8) 511(75.1) <0.001

LVEF, median (IQR) 53(45-59) 55(50-60) <0.0001
Laboratory (on admission)
2 77.4(60.0-
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GFR [ml/min/1,73 m ], median (IQR) 85.5(69.9-96.1) <0.001

90.1)
Creatinine [µmol/L], median
83.9(53.0-79.5) 70.0(70-97.2) <0.001
(IQR)
Haemoglobin, [g/dl], median (IQR) 13.5(12.6-
14.5(6.1-15.3) <0.001
14.4)
Clinical status on admission
HR, [bpm], mean±SD 70.5±12.8 72.7±15.4 <0.001
SBP, [mmHg], median (IQR) 140.0(120-
130.0(120-145) <0.001
150)
CCS, n (%)
II 339(32.2) 198(29.1) 0.167
 III-IV 837(67.7) 482 (70.8)
GRACE score >140, n (%) 89(7.2) 47(6.9) 0.868

IQR-interquartile range; BMI- body mass index; UA- unstable angina; NSTEMI-
non-ST-segment elevation myocardial infarction, STEMI- ST-segment elevation
myocardial infarction; MI- myocardial infarction; PCI- percutaneous coronary
intervention; CABG- coronary artery bypass graft; CAD- coronary artery disease;
CKD- chronic kidney disease stage; COPD- chronic obstructive pulmonary
disease; PAD- peripheral artery disease; LVEF- left ventricular ejection fraction;
GFR- glomerular filtration rate; HR- heart rate; SBP- systolic blood pressure;
GRACE- Global Registry of Acute Coronary Events
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Table 2.Drug Therapy according to the gender.

Male
Female
n=1236 p
n= 680 (35.5%)

D
(64.5%)
ASA, n (%) 1217 (98.4) 670 (98.5) 0.839
Clopidogrel, n (%)
IIb/IIIa inh., n (%)
Beta-blockers, n (%)
ACEI, n (%)
1218 (98.5)
66 (5.3)
1106 (89.4)
1013 (81.9)
TE 671 (98.6)
30 (4.4)
612 (90.0)
502 (73.8)
0.935
0.373
0.803
<0.001
EP
ARB, n (%) 120 (9.7) 110 (16.1) <0.001
Statins, n (%) 1163 (94.0) 627 (92.2) 0.077
Ca-blockers, n (%) 290 (23.4) 233 (34.2) <0.001
Prasugrel , n (%) 3 (0.2) 2 (0.3) 0.834
C

ASA- acetylsalicylic acid; ACEI- angiotensin converting enzyme inhibitors;

AC

ARB- angiotensin receptor blockers; Ca-blockers- calcium channel blockers

ST
JU
 Table 3. Angiographic and procedural data according to the gender.
Male Female
p
n=1236 (64.5%) n= 680 (35.5%)
SYNTAX score, (pts) 16 (9-25) 13 (7-20) <0.001
DES-I, n (%) 395 (31.9) 250 (36.7)
0.033
DES-II, n (%) 841 (68.0) 430 (63.2)
No. of vessels with significant stenosis,
n (%)
1 426(34.4) 289(42.5) <0,001
2 437(35.3) 242 (35,5) 0,958
3 373(30.1) 149(21.9) <0,001
Target vessel
Left main, n (%) 79(6.3) 46(6.7) 0.826
Left anterior desc, n (%) 623(50.4) 353(51.9) 0.559
Left circumflex, n (%) 240(19.4) 99(14.5) 0.009
Right coronary artery, n (%) 220(17.7) 160(23.5) 0.003
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Arterial bypass graft, n (%) 11(0.8) 0 0.031

Saphenous vein graft, n (%) 63(5.0) 22(3.2) 0.075
Extensive calcifications, n(%) 114 (9.2) 53 (7.7) 0.270
Stent thrombosis in culprit lesion, n(%) 6 (0.6) 2 (0.4) 0.551

D
Average stent diameter (mm) 3.0(2.7-3.5) 3.0(2.5-3.5) 0.627
Total stent length (mm) 23.0(16.0-28.0) 22.0(15.0-29.0) 0.261

TE
SYNTAX- synergy between percutaneous coronary intervention with taxus and
cardiac surgery; DES-I - first generation drug eluting stents; DES-II - second
generation drug eluting stents;
EP
C

Table 4. In hospital and long term follow up according to the gender.

Male Female
AC

p
n=1236 (64.5%) n= 680 (35.5%)
In-hospital adverse events
Acute stent thrombosis, n(%) 7(0.5) 3 (0.4) 0.974
Subacute stent thrombosis, n(%) 6(0.4) 1 (0.1) 0.436
Late stent thrombosis, n(%) 4(0.3) 1(0.1) 0.797
ST

IABP, n(%) 12(0.9) 6(0.8) 0.955

Respiratory insufficiency, n(%) 6(0.4) 5(.07) 0.706
Cardiac arrest, n(%) 12(0.9) 11(1.6) 0.305
JU

IABP- intra-aortic balloon pump

 Table 5. Multivariate analysis regression

P HR 95,0% CI
Male 0.348 0.767 0.44-1.31
CKD 0.007 2.059 1.28–3.69
Anaemia 0.334 1.342 0.73–2.49
DM 0.088 1.554 0.93–2.57
PAD 0.007 2.213 1.24–3.93
LVEF < 50% <0.001 6.138 2.99–12.58
Age > 65 yrs 0.004 2.385 1.32–4.28
Previous MI 0.723 1.100 0.65–1.86

CKD- chronic kidney disease; DM- diabetes mellitus; PAD- peripheral artery
disease; LVEF – left ventricular ejection fraction; MI – myocardial infarction
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D
TE
EP
C
AC
ST
JU