Professional Documents
Culture Documents
College of
Cardiology
Annual Scientific Sessions
2016
Key Trials
MARCH 29-31, 2014
WASHINGTON, DC
CONTENT
1. Non-Statin Therapies only After Lifestyle Interventions and Statins,
Says ACC Consensus Statement on LDL-reduction
2. Low-dose Statin Therapy Alone and in Combination to BP Lowering
Reduces Long-term CV Events in Intermediate-risk Population: HOPE
3 Trial
3. STEMI Patients More Younger & Obese in Recent Years
4. Vitamin D Supplementation Improves Cardiac Function in Chronic
Heart Failure: VINDICATE Trial
5. Evolocumab Lowers LDL-C Levels in Statin Intolerant Patients:
GAUSS-3 Trial
6. Evacetrapib Fails to Reduce Major CV Events in High Risk Patients:
ACCELARATE Trial
7. Aliskiren Not Beneficial in Patients with CHF: ATMOSPHERE Trial
8. Losmapimod Fails to Show Benefit in AMI Patients: LATITUDE-TIMI 60
Trial
9. Rate and Rhythm Control Equally Beneficial in Atrial Fibrillation
Post-Cardiac Surgery
10.
Prognostic Value of the Cardiac Non-Invasive Tests Results
Varies by Test Type and Patient Gender: PROMISE Trial
11.
Plaque Morphology in Stable CAD Patients Similar Irrespective
of Gender
12.
Breast Arterial Calcification Strongly Associated with Coronary
Artery Calcification
13.
Mobile-health Intervention Associated with Improvement in
Physical Activity: The Stepathlon Cardiovascular Health Study
14.
Deferred Stent Implantation Not Superior to Conventional PCI
in STEMI Patients: DANAMI 3-DEFER Trial
15.
Ischemic Postconditioning Added No Clinical Benefit Over
Conventional Primary PCI in STEMI: DANAMI 3-iPOST Trial
16.
CABG added to Medical Therapy Improves Long-Term Survival
and Prognosis vs. Medical Therapy Alone in Patients with Ischemic
Cardiomyopathy: STICH Trial
17.
Cryoablation Noninferior to Radiofrequency Ablation in
Paroxysmal Atrial Fibrillation: FIRE AND ICE Trial
18.
Lung Impedance Guided Treatment Superior to Routine
Treatment in CHF: IMPEDANCE - HF Trial
19.
Vagal Nerve Stimulation not Beneficial in Chronic Heart Failure:
INOVATE-HF Trial
20.
TAVR Comparable to SAVR in Intermediate-Risk Patients with
Severe Aortic-Valve Stenosis: PARTNER 2A Trial
21.
TAVR with SAPIEN 3 Preferred over Surgery in Treatment of
Intermediate-Risk Patients with Severe Aortic Stenosis
22.
TAVR with CoreValve Noninferior to Surgical AVR in Improving
Survival in Severe Aortic Stenosis Patients: The CoreValve High-Risk
Study
23.
Superiority of Bariatric Surgery plus Medical Therapy vs
Medical Therapy Alone in Obese/ Overweight Diabetes Patients
Sustained for 5 Years: STAMPEDE Trial
24.
Cell Therapy with Ixmyelocel-T may Improve Outcomes in
Patients with Ischemic HF: ixCELL-DCM Tria
Non-Statin Therapies only After Lifestyle Interventions and Statins,
Says ACC Consensus Statement on LDL-reduction
A latest expert consensus statement issued by the American College
of Cardiology recommends the use of lifestyle modifications and
statins before choosing non-statin drugs for low density lipoprotein
cholesterol (LDL-C) reduction for prevention of cardiovascular (CV)
events.
The 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin
Therapies for LDL-C Lowering in the Management of Atherosclerotic
Cardiovascular Disease (ASCVD) Risk was discussed at the American College
of Cardiology Scientific Sessions 2016. This statement is also endorsed by
the National Lipid Association (NLA).
This statement considered recently available trial evidence for non-statin
therapies such as ezetimibe, niacin and proprotein convertase
subtilisin/kexin
type
9
(PCSK-9)
inhibitors
for
formulating
the
recommendations. It provides response to 3 critical questions addressing the
following issues:
1. Patient populations in which non-statin therapies should be considered
2. Clinical situations in which non-statin therapies can be considered
(magnitude of LDL-reduction) and non-statin therapies to be considered for
statin intolerance
3. Particular non-statin agents and order of preference of these therapies
2016
(early
online
Placeb
o
4.8%
P value
5.7%
p < 0.001
1.1%
2.2%
5.8%
3.8%
p
p
p
p
p = 0.002
>
=
<
=
0.05
0.02
0.001
0.82
Thus, rosuvastatin was beneficial in a diverse population who did not have
CVD and who were at intermediate risk.
Results of the BP lowering analysis showed that the fixed-dose
combination of candesartan and HCTZ was not superior to placebo
in reducing CV events despite a 6/3 mmHg decrease in BP (Table 2)
Candesart
an + HCTZ
First co-primary outcome (composite of CV 4.1%
death/MI/stroke)
Second co-primary outcome (composite of 4.9%
CV
death/MI/stroke/resuscitated
cardiac
arrest/heart failure/revascularization)
Symptomatic hypotension
3.0%
Placeb
o
4.4%
P value
5.2%
p = 0.51
2.1%
p < 0.001
p = 0.40
P value
p = 0.005
p = 0.001
p
p
p
p
>
<
<
=
0.05
0.05
0.05
0.005
N
Engl
J
Med.
April
2nd,
2016
(early
online
publication).
doi:10.1056/NEJMoa1600176
N Engl J Med. April 2nd, 2016 (early online publication). doi:
10.1056/NEJMoa1600175
N Engl J Med. April 2nd, 2016 (early online publication). doi:
10.1056/NEJMoa1600177
-24.11
0.255
6.07
<0.001
-2.49
0.002
-2.09
0.043
P
valu
e
Aliskiren
vs.
Enalapril
(HR)
P
valu
e
0.97
-1.02
0.20
0.23
1.01
0.80
0.36
0.85
0.28
0.65
0.86
0.12
1.12
1.10
1.04
0.42
0.69
0.46
*The Kansas City Cardiomyopathy Questionnaire (KCCQ) score was evaluated with the use of a repeated-measures
analysis with the baseline value as a covariate and treatment, dose stratum, NYHA class, and visit as factors and a
visit-by-treatment interaction; a score of 0 was used in patients who died. Scores were available at 12 months for
1811 patients in the combination-therapy group, for 1796 in the aliskiren group, and for 1804 in the enalapril group.
2016
(early
online
publication)
DOI:
Pvalue
0.76
5.1
4.4
0.96
0.76
7.1
0.11
without AF for the previous 30 days were 93.8% in the rate-control group and
97.9% for those in rhythm control group while 84.2% and 86.9% did not have
AF from discharge to 60 days.
Thus rate control and rhythm control fared equally in terms of
hospitalization for AF after cardiac surgery. In the light of these results,
choosing either of these strategies should depend on the individual patient
and physician preferences.
New Engl J Med. April 4th,
10.1056/NEJMoa1602002
2016
(early
online
publication)
doi:
4th
2016
(early
online
publication).
2nd,
2016
(early
online
publication).
> 0 increased from 28% to 55% to 79%, respectively, among the age
groups (P <0.0001). All BAC variables were significantly predictive
of the CAC score. In multivariable model, odds ratio for CAC >0 was
3.2 for BAC 4 to 12, 2.0 for age, and 2.2 for hypertension. The
sensitivity, specificity, positive and negative predictive values, and
accuracy of BAC >0 for CAC >0 were 63%, 76%, 70%, 69%, and 70%,
respectively.
The agreements of FRS risk categories with CAC and BAC risk categories
were 57% for CAC and 55% for BAC; the agreement was 47% for PCE risk
categories for CAC and 54% by BAC. BAC >0 had area under the curve of
0.73 for identification of women with CAC >0 which was equivalent
to both FRS (0.72) and PCE (0.71). BAC >0 increased the area under
the curve curves for FRS (0.72 to 0.77; p = 0.15) and PCE (0.71 to
0.76; p = 0.11) for the identification of high-risk (4 to 12) CAC. When
the analysis included 33 women with established CAD, BAC >0 was
significantly additive to both FRS (p = 0.02) and PCE (p = 0.04) for high-risk
CAC.
The study data thus indicates that it is reasonable to recommend further risk
assessment of BAC-positive women, preferably with a gated CAC scan, with
subsequent adjustment or institution of therapy as indicated by the CAC
score.
J Am Coll Cardiol Img. April 2nd,
doi:10.1016/j.jcmg.2015.10.022.
2016
(early
online
publication).
3rd,
2016
(early
online
publication).
publication).
3rd,
2016
(early
online
publication).
DOI:
4th,
2016
(early
online
publication)
DOI:
2016
(early
online
publication):
doi:
2016
(early
online
publication)
at 2 years
SAVR Group
18.0%
11.3%
p Value
0.45
0.38
6.4%
0.83
2nd,
2016
(early
online
publication).
DOI:
sub-group:
The one year outcomes in this population were compared with those for
intermediate-risk patients treated with surgical valve replacement in the
PARTNER 2A trial using a prespecified propensity score analysis to account
for between-trial differences in baseline characteristics. In a propensity-score
analysis which included 963 patients treated with SAPIEN 3 TAVR and 747
with surgical valve replacement, TAVR appeared to be both, non-inferior
(pooled weighted proportion difference of 9.2%; p < 0.0001) and
superior (9.2%; p < 0.0001) to surgical valve replacement for the
primary composite outcome of mortality, stroke, and moderatesevere aortic regurgitation. TAVR was also superior to surgery for
individual outcomes of death (52%; p= 00003) and stroke (35%;
p=00038).
Further long-term, prospective randomized trials are warranted to confirm
these findings before they can be extended to intermediate- or low-risk
patient populations.
Lancet.
April
3rd,
2016
(early
online
DOI: http://dx.doi.org/10.1016/S0140-6736(16)30073-3
publication).
p Value
<0.0001
0.04
0.07
The incidence of stroke at 30 days and at 1 year was lower with TAVR vs.
SAVR (4.9% vs. 6.2% [at 30 days]; 8.8% vs. 12.6% [at 1 year]). The
incidence of stroke (including major stroke) and MACE at 3 years
was also lower with TAVR vs. SAVR (Table 2).
Table 2: Incidence of stroke and MACE in the study groups at 3 years
Outcome
TAVR
SAVR
p Value
Stroke
12.6%
19.0%
0.034
MACE
40.2%
47.9%
0.03
2016
(Early
Online
Publication).
Lancet.
April
4th,
2016
(Early
http://dx.doi.org/10.1016/S0140-6736(16)30137-4
Online
Publication).