ESC Congress in Review - Main Edition 2019 - 25

ESC Congress 2019 In Review

impact in HIC. In line with the findings of the first report,
metabolic risk factors, including hypertension, high cholesterol, abdominal obesity, and diabetes, played a larger
role in causing deaths in HIC, compared with in LIC.
Authors of both studies acknowledged some limitations. Despite being the only study involving as many as
21 countries in a single cohort study, caution should be
exercised in generalising results to all countries. In particular, PURE does not include data from northwest Africa
or Australia; the number of participants from Europe and
the Middle East is modest; and data from LICs are predominantly from south Asia with a few African countries.
In conclusion, the major findings of the study were that
as country income increases, a higher proportion of deaths
and hospitalisations comes from non-communicable diseases compared with infectious diseases. Also, among
non-communicable diseases, the proportion of deaths
from cancer as compared with CVD increases. Secondly,
the higher rates of CVD and related deaths in poorer countries compared with richer countries occurs despite fewer
traditional CVD risk factors in poor countries. Thirdly, there
is an inverse association between use of hospital care and
effective medication versus deaths, suggesting that lower
quality healthcare may be responsible, at least in part, for
the higher mortality in poorer countries. Lastly, this data
can form the basis of informed policy decisions at the governmental level.
Replay presentation 1 on ESC365

Replay presentation 2 on ESC365

Stable Coronary Patients with
Diabetes Benefit from Aspirin/
Ticagrelor Despite Increased
Bleeding Risk
Written by Rachel Giles

The THEMIS trial, as well as the pre-specified THEMISPCI subanalysis, reported that diabetic patients with
stable coronary artery disease benefited from dual

aspirin/ticagrelor therapy, whether or not they had had
previous percutaneous coronary intervention (PCI).
However, patients experienced a greater risk of major
bleeding when ticagrelor was added to aspirin.
Presented during the first Hot Line session in 2 consecutive talks, and published simultaneously in the New
England Journal of Medicine and The Lancet, investigators Deepak L. Bhatt, MD, MPH, Brigham and Women's
Hospital and Harvard Medical School, Boston, MA, USA,
and Philippe Gabriel Steg, MD, Hospital Bichat-Claude
Bernard, Paris, France, reported the late-breaking clinical
trial results from The Effect of Ticagrelor on Health
Outcomes in Diabetes Mellitus Patients Intervention
Study [THEMIS; Bhatt DL et al. Lancet. 2019; Steg PG
et al. N Engl J Med 2019].
THEMIS enrolled over 19,000 patients with stable
coronary artery disease and type 2 diabetes, but without
a history of heart attack or stroke and randomised them
to receive either ticagrelor plus aspirin or a placebo plus
aspirin. The primary efficacy outcome was the composite of cardiovascular death, heart attack, or stroke. The
primary safety outcome was Thrombolysis in Myocardial
Infarction (TIMI) major bleeding. The median follow-up
was 39.9 months.
During that time, 736 of 9,619 patients (7.7%) taking
ticagrelor plus aspirin experienced cardiovascular death,
myocardial infarction, or stroke versus 818 of 9,601
patients (8.5%) taking placebo plus aspirin -a significant
10% reduction (P = .04; Table 14). However, patients on
this dual-antiplatelet therapy also experienced greater
risk of major bleeding (206 patients vs 100 patients) and
intracranial haemorrhage (70 patients vs 46 patients)
compared with placebo. The difference in intracranial
haemorrhages was driven by an increased number of
traumatic bleeds, most of them subdural, and not by
spontaneous or procedural bleeding.
In THEMIS-PCI, a pre-specified analysis that specifically looked at THEMIS patients with a history of previous PCI
that included stenting, compared with the overall THEMIS
population, investigators found even more favourable
benefits for patients taking ticagrelor plus aspirin.

Table 14. Full Data from the THEMIS Trial
Endpoint

Ticagrelor
(n = 9,619)

Control
(n = 9,601)

Statistics

Cardiovascular death, myocardial infarction, or stroke

736 (7.7%)

818 (8.5%)

HR, 0.90; 95% CI, 0.81 to 0.99; P = .04

Cardiovascular death

364 (3.8%)

357 (3.7%)

HR, 1.02; 95% CI, 0.88 to 1.18; P = .79

Myocardial infarction

274 (2.8%)

328 (3.4%)

HR, 0.84; 95% CI, 0.71 to 0.98; P = .029

Stroke

152 (1.6%)

192 (2.0%)

HR, 0.80; 95% CI, 0.64 to 0.99; P = .038

Major bleeding

206 (2.2%)

100 (1%)

HR, 2.32; 95% CI, 1.82 to 2.94; P < .001

70 (0.7%)

46 (0.5%)

HR, 1.71; 95% CI, 1.18 to 2.48; P = .005

Intracranial haemorrhage
CI, confidence interval; HR, hazard ratio.

Official Peer-Reviewed Highlights From ESC Congress 2019

https://esc365.escardio.org/Congress/ESC-CONGRESS-2019/Hot-Line-Session-5/202183-pure-contrasting-patterns-of-cardiovascular-disease-cancers-and-related-mortality-between-high-versus-low-middle-income-countries-in-21-countries https://esc365.escardio.org/Congress/ESC-CONGRESS-2019/Hot-Line-Session-5/202376-pure-impact-of-modifiable-risk-factors-on-cardiovascular-disease-and-mortality

ESC Congress in Review - Main Edition 2019

Table of Contents for the Digital Edition of ESC Congress in Review - Main Edition 2019