ESC Congress 2016 - 22
clINIcAl TRIAl HIgHlIgHTs
designed to encourage patients with ACS to adopt a
heart-healthy lifestyle with current standard CR. The
primary outcome parameter was the SCORE at 18
months after randomization. In addition to age and gender, the SCORE risk function contains 3 modifiable risk
parameters (systolic blood pressure, total cholesterol,
and smoking status). Secondary outcome parameters
were quality of life, anxiety, and daily physical activity.
Intention-to-treat (ITT) and per-protocol (PP) analyses
(considered to include more motivated patients) were
performed.
The study comprised adult patients with a documented
ACS. Patients with heart failure, ejection fraction < 40%,
psychological or cognitive impairments, chronic obstructive pulmonary disease, and those in renal failure were not
permitted to enroll. Eligible participants were randomly allocated to 1 of 3 treatment regimens: standard CR plus 3 faceto-face (F) physical activity counseling sessions and 3 group
sessions (CR + F; n = 309) that included fitness training and
lifestyle counseling; standard CR care plus 5 to 6 telephone
(T) lifestyle counseling sessions (CR + T; n = 299); or standard
CR care (CR only; n = 306).
Participants were mean age 57 years; the majority
were men. Between 75-81% of patients had a prior percutaneous coronary intervention at baseline and 42-45%
were smokers prior to their ACS. The majority of patients
were receiving optimal medical treatment (eg, 70% were
receiving angiotensin-converting-enzyme inhibitors,
84% ß-blockers, and 97% statins). Almost all patients
(97%) were taking aspirin and 86% were prescribed
thienopyridines.
SCORE risk function at 18 months did not differ significantly for the 3 treatment arms on either ITT or PP analysis.
With respect to the individual modifiable factors of
SCORE, CR+F significantly (P < .001) improved total cholesterol (ITT analysis) compared with CR only and CR + T.
On the PP analyses: CR+F and CR+T significantly (P < .05)
decreased smoking and total cholesterol (CR + F, P < .001;
CR + T, P < .05), and improved quality of life (CR + F, P = .004;
CR + T, P = .04) compared with CR only. The percentage of
patients with 6 of 9 risk factors 'on target' at 18 months was
significantly (P = .004) greater and anxiety levels were lower
following CR+F treatment compared with CR-only (PP analysis). There were no differences in number of cardiac events
among the treatment arms at 18 months.
Neither of the extended CR programs added benefit
over standard CR with respect to the SCORE risk function
likely because most patients had reached the target levels for the modifiable SCORE risk factors by randomization, which was 6 weeks post ACS (ie, there was a ceiling
effect). PP analyses of the data revealed benefits for both
alternative protocols compared with standard CR only.
22
October 2016
Long-term Exposure to Even
Modestly Lower LDL-C and
SBP May Significantly Reduce
the Lifetime Risk of CVD
Written by Maria Vinall
Brian A. Ference, MD, MPhil, MSc, Wayne State
University, Cardiovascular Medicine, Detroit, Michigan,
USA, reported data showing that interventions that modestly lower low-density lipoprotein cholesterol (LDL-C)
and systolic blood pressure (SBP) have the potential
to reduce the cardiovascular (CV) risk with long-term
exposure.
The aim of this study was to evaluate the causal effect
of combined exposure to lower LDL-C and SBP associated with genetic polymorphisms on the risk of major
vascular events (MVEs) using a 2x2 factorial Mendelian
study design.
A total of 102,773 men and women aged 27 to 100
years who were enrolled in 14 prospective cohort or
case-control studies were included. The investigators
constructed a genetic LDL-C score based on 46 polymorphisms to naturally randomize individuals to higher or
lower cholesterol levels and a genetic SBP score based
on 33 polymorphisms to naturally randomize individuals to higher or lower SBP levels. The Mendelian randomization resulted in 4 groups (Figure 1).
Figure 1. 2x2 Factorial Mendelian Randomization
LDL-C Score
Naturally Randomize
Above Median
(reference)
Below Median
(Lower LDL-C)
SBP Score
SBP Score
Naturally Randomize
Naturally Randomize
Above Median
(reference)
Below Median
(Lower SBP)
Above Median
(reference)
Below Median
(Lower SBP)
Reference
Lower SBP
Lower LDL-C
Both Lower LDL-C
& Lower SBP
Lifetime risk of cardiovascular events
LDL-C, low-density lipoprotein cholesterol; SBP, systolic blood pressure.
Reproduced with permission from B Ference, MD, MPhil, MSc.
medicom-publishers.com/mcr
http://www.medicom-publishers.com/mcr
Table of Contents for the Digital Edition of ESC Congress 2016
Contents
ESC Congress 2016 - Cover1
ESC Congress 2016 - Cover2
ESC Congress 2016 - i
ESC Congress 2016 - ii
ESC Congress 2016 - Contents
ESC Congress 2016 - 2
ESC Congress 2016 - 3
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ESC Congress 2016 - 15A
ESC Congress 2016 - 15B
ESC Congress 2016 - 15C
ESC Congress 2016 - 15D
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ESC Congress 2016 - Cover3
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