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Presented by: Nicolas Rodondi, MD, MAS, Reto Auer, MD, Patrick J. Devine, MD, Patrick G. O’Malley, MD, MPH, Daniel Hayoz, MD, Jacques Cornuz, MD, MPH
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1
The Impact of Carotid Plaque Screening on Motivation for Smoking Cessation
and Knowledge Retention About Atherosclerosis
Nicolas Rodondi, MD, MAS, Reto Auer, MD, Patrick J. Devine, MD, Patrick G. O’Malley, MD, MPH,
Daniel Hayoz, MD, Jacques Cornuz, MD, MPH
Consultation de Prévention Cardiovasculaire & Consultation des Lipides Policlinique Médicale Universitaire
Université de Lausanne
2
Background (1)
Controversy remains about who should be treated with medications for the primary prevention of CVD: the highest-risk patients should be identified to benefit/cost ratio of treatments
The determination of subclinical markers of ATS ability to identify individuals at risk for CVD outcomes:
– But the incremental values are often small1
Main candidates for identifying high-risk persons are 2 :– Carotid ultrasound to measure IMT and atherosclerotic plaques– EBCT to measure coronary artery calcification
1 PG O’Malley, Arch Intern Med 20062 NHLBI subclinical diseas working group 2004
3
Background (2) Little data are available on the health consequences of testing for
subclinical CVD: it is unknown whether the use of such testing would improve patient behavior 1,2.
Limited impact of biomedical risk assessment as an aid for smokingcessation 3:
1 PG O’Malley, Arch Intern Med 20062 P Greenland, JAMA 20033 R Bize, Cochrane Database 2005
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RCT of carotid US on smoking cessation at 6 months (n=153)
P value :
(A vs B+C [17.6%]) = 0.031
(A+B vs C) = 0.003
Bovet P et al., Prev Medicine 2002
Limitations• Population with low nicotine
dependence (mean daily cigarette use: 10/day)
• No biochemical validation of smoking cessation
• No standardized information on CV risk to the control group
6.35
22.2
0
5
10
15
20
25
(A) No US, noplaque shown
(B) US, noplaque shown
(C) US,plaque shown
%
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• These results require confirmation in western countries
• Little is known whether testing for subclinical CVD positively affects other aspects of patient behavior and control of other cardiovascular risk factors, such as adherence to:
- Medications- Lifesty interventions
Background (3)
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Pilot study before a large RCT: Objectives
To assess feasibility to study the impact of plaque screening in smokers
To assess the comprehension of ATS plaques in smokers
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Methods (1) : Design and participants
2-month observational pre-post pilot study conducted at the University Hospital of Lausanne, Switzerland.
30 first smokers recruited out of 90 responding to a single newspaper advertisement for a smoking-cessation study.
Eligible smokers had to smoke ≥10 cigarettes/ day and to be 40-70 years
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Methods (2): Intervention
All smokers underwent: smoking cessation counseling nicotine replacement therapy (or bupropion if intolerant) a carotid ultrasound a 7-minute PowerPoint educational tutorial on
atherosclerosis.
Carotid plaques were defined as a focal widening >50%relative to adjacent segment (as defined in the Rotterdamstudy)1 and as recommended by the US Task Force onnon-invasive atherosclerosis measurement 2
1 Oei HH, J Am Coll Cardiol 20022 Redberg RF, J Am Coll Cardiol 2003
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Methods (3) : Outcomes
Primary outcome:– Feasibility of studying the impact of carotid plaque
screening in smokers
Secondary outcomes:– Change in motivation for smoking cessation– 7-day point prevalence smoking abstinence at
2 months– Atherosclerosis (ATS) knowledge at 2 months (after
the tutorial on ATS)
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Pilot Study: Participant Characteristics (n=30)
Variable Mean (± SD) or %
Mean age [range], yr 51.7 ± 9.4 [40 – 70]
Women 43.3 %
Daily cigarette consumption 22.2 ± 9
Pack-year smoking history 38.3 ± 19.3
Previous attempts of smokingcessation
83.3 %
By attempters (n=25), number of previous attempts of smoking cessation
3.1 ± 2.2 [1-10]
Fagerström score 4.8 ± 2.3
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Smoking cessation at two months
Motivation for smoking cessation, 1-10
Pre
-scr
een
ing
72.7%
37.5%
Smoking cessation at 2 months, %
7.9
No plaque PlaqueNo plaque (n=8) Plaque (n=22)
Pre
-scr
een
ing
At
2 m
on
ths
At
2 m
on
ths
P = 0.10P = 1.0
P = 0.008
7.2
8.7
At
2 m
on
ths
At
2 m
on
ths
N Rodondi et al, Nicotine & Tobacco Research 2008
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Baseline At two months P
Stress Perceived 4-Item stress scale, 2.0 [0-5] 1.5 [0-3.5] 0.13range 0-16
Group without carotid plaques 1.0 [0-2.5] 2 [0-3.5] 0.66Group with carotid plaques 2.5 [1-5.5] 0.5 [0-3.5] 0.04
Anxiety, range 0-14, Prime-MD 4.0 [0-7.5] 2.0 [0-4.0] 0.01
Group without range carotid plaques 4.0 [2.0-5.5] 1.5 [0.5-4.0] 0.11Group with carotid plaques 3.5 [0-8.0] 2.0 [0-4.0] 0.04
Depression, range 0-27, Prime-MD 4.0 [2.0-6.5] 3.0 [0.5-4.5] 0.02
Group without range carotid plaques 6.0 [4.0-7.5] 3.5 [0.5-5.0] 0.08Group with carotid plaques 4.0 [2.0-6.0] 3.0 [1.0-4.5] 0.12
Potential harms of screening
Range 1-10, median [25%-75%]
N Rodondi et al, Nicotine & Tobacco Research 2008
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Knowledge Retention About Atherosclerosis
96% responded correctly to 80% of 10 multiple-choice questions regarding atheroslerosis knowledge: – at baseline – at two months
N Rodondi et al, Nicotine & Tobacco Research 2008
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Limitations
The increases in motivation at 2 months might be driven by the close follow-up and not by plaque screening. RCT needed !
As many smokers relapse to smoking after 2 months, 12 months of follow-up often necessary for long-term efficacy.
We could not exclude non-measured confounders or examine combinations of confounders in multivariate analyses, given our sample size.
Design of the ongoing RCT in 530 smokers
530 smokersaged 40-70 y
US of the carotids
C: Follow-up
Plaque
B: Follow-up
A: Follow-up
No plaque
No test
1° Outcome:Smoking cessation(validated by cotinine measurement)
2° Outcomes:Risk factor control: - LDL-C- BP- HbA1c (if diabetes)- CRP
R
Outcomesat 1 year
Outcomesat 1 year
Abbreviations: US: ultrasound, BP: blood pressure, CRP: C-reactive protein® = randomization
SupportThis clinical trial is supported by the Swiss National Foundation and the Swiss heart Foundation.
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Conclusions
Screening for carotid plaques may increase short- term motivation for smoking cessation, and might be an additional strategy to increase smoking quit rates.
The impact of screening for carotid plaques on long-term smoking cessation and control of other cardiovascular risk factors should be further examined in large randomized controlled trials:
– Ongoing Caross study in 530 smokers