Assessment of cardiovascular risk in a 3-year

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Transcript Assessment of cardiovascular risk in a 3-year

LIP
AFRI
Assessment of cardiovascular risk in a 3-yearcohort of HIV-infected patients of Sub-Saharan
origin living in France or Côte d’Ivoire and
starting antiretroviral therapy.
SP Eholié, K Lacombe, A Krain, Z Diallo, M
Ouiminga, P Campa, O Bouchaud, E Bissagnéné,
PM Girard
INTRODUCTION (1)
• HIV-infected patients of Sub-Saharan African
(SSA) origin are increasingly accessing
combination antiretroviral therapy (cART) in their
countries of origin and adoption;
• Cardiovascular disease (CVD) prevention and
treatment is of increasing importance with longer
life spans on cART;
•
Most studies on cardiovascular disease risk
(CVR) in HIV-infected patients on cART are
primarily Caucasian cohorts in resource rich
nations.
INTRODUCTION (2)
• The Data collection of Adverse Effects of Anti-HIV
Drugs Study (DAD) Cohort study group recently
published a CVR prediction equation for HIV infected
patients on cART;
•
The World Health Organization (WHO) and
International Society of Hypertension (ISH) developed
field based CVR prediction charts, based on the patients’
WHO region of origin. These charts do not take into
account HIV infection or cART use;
• The two CVR prediction equations were compared using
data from patients who participated in a three year
completed cohort of HIV infected patients of SSA origin
living in France or Côte d’Ivoire.
Objectives
1. To quantify the estimated 10 year
cardiovascular disease risk (CVR) in HIVinfected patients of Sub-Saharan origin starting
antiretroviral therapy.
2. To compare the differences in the 10 year
cardiovascular risks in the populations at the
two different countries of residence.
3. To compare the 10 year cardiovascular disease
risk as estimated by the DAD equation and the
field based WHO risk prediction charts.
PATIENTS AND METHODS
* Study design: Three year prospective, multi-center, multinational
longitudinal cohort study evaluating risk factors for the
development of antiretroviral associated lipodystrophy (LPD).
* Patients: Patients presenting to one of three University Hospital
Centers in Paris, France (Saint Antoine, Avicenne and Tenon) and
at the Treichville University Hospital in Abidjan, Côte d’Ivoire.
* Inclusion criteria: documented HIV infection, age ≥ 16 yrs, of
SSA origin, Karnofsky index ≥ 70, eligible to start cART in their
country of residence and informed consent to participate in the
study.
* Exclusion criteria: clinical signs of LPD, pregnancy, body mass
index (BMI) > 30 or < 16, fasting glucose of ≥ 6.1 mmol/l,
triglycerides of > 2.2 mmol/l or total cholesterol of > 5.5 mmol/l
end stage renal, liver or cardiac disease.
Study design
 Closed prospective cohort
 245 patients: Abidjan (176), Paris (69)
J0
M36
M12
Inclusion
01/05/2005 – 31/01/2007
M24
End of follow-up
February 2010
 Every 3 months: clinical + adherence monitoring
 Every 6 months: clinical + biological + adherence monitoring
 Every 12months: clinical + biological + adherence + insuline + dietétic
Methodology
Assessment of cardiovascular risk
* Framinghams’ Score:
age, presence or absence of diabete, presence or absence of
smoking, blood pressure categories and LDL cholesterol
(Wilson PWF ,Circulation 1998)
* Equation of DAD Study Group:
Framingham + exposure to indinavir, lopinavir and presence/absence
of abacavir in the current c-ART
(model used to estimate 12 months CV risk)
* 10 years Prediction of WHO/ISH CVR :
Sub regional epidemiological speficities + following risk factors: gender,
Systolic blood pressure, smoking, diabete type 2, Total cholesterol
PATIENTS AND METHODS
Calculating risk scores:
1.
The 10 year DAD cardiovascular disease risk (CVR) was calculated
using the DAD equation (Figure 1)
• Definition of cardiovascular disease (CVD): stroke, endarterectomy
of the carotid artery, any invasive coronary artery procedure,
myocardial infarction or death due to coronary heart disease.
Factors in DAD equation: age, sex, systolic blood pressure (SBP),
smoking status, family history of CVD, total and HDL cholesterol,
diabetes, IDV, LPV/r and ABC exposure (Figure 2).
DAD equation for the risk of CVD , CND or MI
PATIENTS AND METHODS
The 10 year WHO/ISH CVR was obtained by creating
a StataTM 10.0 based model of the risk prediction
charts (Figure 3).
CVR calculated for each
participant at baseline and at months 12, 24 and 36.
Definition of cardiovascular event: fatal or non-fatal
stroke or myocardial infarction.
Factors in WHO/ISH model: patient’s WHO African
sub-region, gender, age group, SBP, smoking status,
diabetes and total cholesterol. Patients younger than
40 years of age were put into the 40 – 49 age group.
RESULTS
BASELINE CHARACTERISTICS
Overall
(N=245)
Abidjan
(N=176)
Paris
(N=69)
LFU (n, %)
32 (13,1)
24 (13,6)
8 (11,9)
Age (mean SD)
36,2 (8,2)
35,6 (7,4)
37,8 (9,9)
Sex ratio
0,68
0,61
0,91
Delay for HIV diagnosis, month
s(med, IQR)
2,9 (1,7 – 10,0)
2,7 (1,7 – 7,1)
5,1 (2,1 – 32,0)
Stage C CDC (n,%)
48 (19,7)
36 (20,3)
12 (17,9)
BMI, kg/m2 (mean, SD)
21,4 (9,8)
20,5 (2,5)
23,8 (3,3)
CD4+ counts, mm3 (moy, SD)
144 (100)
124 (87)
195 (112)
Viral load log (moy, SD)
5,1 (0,9)
5,3 (0,8)
4,5 (0,9)
ART (n, %):
- NNRTI
- PI
- 3TC
- D4T
- AZT
173 (70,9)
58 (23,8)
201 (82,4)
121 (49,6)
63 (25,8)
158 (89,2)
10 (5,7)
174 (98,3)
121 (68,4)
49 (27,7)
15 (22,4)
48 (71,6)
27 (40,3)
0
14 (20,9)
Ten years cardiovascular risk diseases by cohort
DAD 10 year Cardiovascular Disease Risk, by cohort
0.06
0.05
Paris:
2.93%
CVR
0.04
Paris:
2.43%
0.03
P=0.6
0.02
0.01
0
Abidjan:
1.37%
6
12
p 0.3
p 0.01
p 0.003
p < 0.001
18
24
30
Abidjan:
2.45%
36
Visit (months)
Abidjan
IQR
Paris
P<0.001
Survival probability of patients with a fifty percent increase in
10-year DAD Cardiovascular Disease Risk (CVR)
0.75
0.60
0.45
0.30
0.15
0.00
0
Log-rank test: p = 0.2
1
2
Years of follow-up
Abidjan
3
Paris
There were no reported cases of cardiovascular disease (MI, CVA)
during the three years of follow up.
Ten-year estimated WHO/ISH cardiovascular disease risk in HIV
positive patients of Sub-saharan African origin on cART.
100
90
Percentage
80
70
60
50
40
30
20
10
0
9%
-2
20 9%
-1
10 %
10
<
9%
-2
20 9%
-1
10 %
10
<
9%
-2
20 9%
-1
10 %
10
<
9%
-2
20 9%
-1
10 %
10
<
Baseline
Month 12
Month 24
Visite
Abidjan
Paris
Month 36
CONCLUSION
•
•
•
•
The DAD CVR equation demonstrated a small but significantly
different risk of 10-year CVR before cART initiation between the
two study sites, becoming non significant at the end of follow up.
The WHO 10-year CVR prediction charts, while very applicable
in the field, gave less precise figures on 10 year CVR disease risk
and does not take into account HIV infection or cART.
As there were no reported cases of cardiovascular disease during
follow up, no determinants of CVR could be evaluated but
determinants such as country of residence and cART regimen
would be of interest.
More extensive follow up is needed to know which
cardiovascular prediction model would be most useful and
accurate for HIV patients of Sub-Saharan origin on cART.
ACKNOWLEDGEMENTS
* Coordinators and investigators of LIPO-AFRI study
* Physicians, nurses of Lipo-Afri study
* Patients involved in LIPO-AFRI study
* Dr Maryam Kassambara Sow
* Dr Elie Bankineza
* Fundation Bristol Myer Squibb, Program Secure the Future
Amesegnalehu
Thank you