Antithrombotic therapy in Diabetes management

Antithrombotic therapy
in diabetes
2023 ESC Guidelines for the management of
cardiovascular disease in patients with diabetes
Bianca Rocca, MD, PhD, FESC
Associate Professor of Pharmacology
Catholic University School of Medicine
Rome, Italy August 26th, 2023

Antithrombotic therapy in patients with diabetes:
new evidence on efficacy and safety
ü Patients with no history of symptomatic atherosclerotic cardiovascular disease
(ASCVD) or revascularization
2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes
www.escardio.org/guidelines
(European Heart Journal; 2023 – doi:10.1093/eurheartj/ehad192)

Low-dose acetylsalicylic acid (ASA) versus placebo in diabetes patients with no history
of symptomatic ASCVD: evidence from the ASCEND, placebo-controlled trial
Similar benefit vs. risk in different 5-year risk groups
of diabetes paitents
No increase in dementia and/or death during the
mean of 9.1 (IQR 8-10.3) years of follow-up in 15,427
diabetes patients
Events per 5000 Person-year NNT 90 NNH 104
Ratio 0.86
NNT: number needed to treat
NNH: number needed to harm
ASA Placebo Rate ratio
(95% CI)
Dementia outcomes
(N=7714) (N=7713)
No. (%) with event
NNT 74 NNH 114
P value
0.11
Ratio 0.65
Broad dementia
Narrow dementia
548 (7.1%) 589 (7.8.%) 0.91 (0.81, 1.02)
0.89 (0.75, 1.06)
0.91 (0.81, 1.01)
0.98 (0.90, 1.06)
0.96 (0.90, 1.02)
254 (3.3%)
618 (8.0%)
283 (3.7%)
674 (8.7%)
NNT 163 NNH 334
Ratio 0.48
Broad dementia or
discharge to care home
Death without broad
dementia
Death or broad
dementia
1205 (15.6%) 1223 (15.9%)
1753 (22.7%) 1821 (23.6%)
0.75 1 1.25 1.5 ASA Pl ASA Pl ASA Pl ASA Pl ASA Pl ASA Pl
< 5% 5% to 10% >10%
Favours Favours
ASA Placebo Estimated 5-year risk of serious vascular events at baseline
Parish S et al, EHJ 2022; 43: 2010-19 Serious vascular events
CV death
Non-fatal major bleeding
Fatal major bleeding
20
Redrawn from Bowman et al, NEJM 2018;

Recommendations for patients with diabetes without a history of
symptomatic atherosclerotic cardiovascular disease or revascularization
Recommendation Class Level
In adults with T2DM without a history of symptomatic ASCVD or revascularization, ASA
(75–100 mg o.d.) may be considered to prevent the first severe vascular event, in the IIb A
absence of clear contraindications*.
* High risk of bleeding due to gastrointestinal haemorrhage or peptic ulcer within the previous 6
months, active hepatic disease (such as cirrhosis, active hepatitis), or history of ASA allergy.

revised and new evidence on efficacy and safety
ü Patients with acute (ACS), chronic (CCS) coronary syndromes and/or
symptomatic lower extremity arterial disease (LEAD) with no indications for
long-term oral anticoagulation (OAC)

Ticagrelor vs. placebo added to low-dose ASA in 19,220 DM patients with documented
CAD and with no MI or stroke: the benefit did not outweigh the increase in
TIMI major and intracranial bleeding
MI, stroke or cardiovascular death TIMI major bleeding
8.5%
7.7%
HR: 0.90 (95% CI, 0.81-0.99)
P=0.04
HR: 2.32 (95% CI, 1.82-2.94)
P<0.001
NNT/NNH
ratio
NNT: 125 NNH: 83.3
2.2%
1.0%
1.5
Months since randomization
Months since randomization
Intracranial Haemorrhage:
2023 ES
0.5% placebo, 0.7% ticagrelor, P=0.005
Steg et al. NEJM 2019; 381:1309-20

MI prevention in extended (> 12 months), mid- or short-term (= or < 6 months) vs.
12-month dual antiplatelet therapy (DAPT): a network meta-analysis of 79,073
patients from randomized controlled trials
ASA
ASA
P2Y12 inhibitor
0.5 1 1.5 2
Major Bleeding [Relative Risk, 95% CI]
Khan SU et al. Circulation. 2020;142:1425-36 (European Heart Journal; 2023 – doi:10.1093/eurheartj/ehad192)

patients with diabetes
www.escardio.o
93/eurheartj/ehad192)

Recommendations for antithrombotic therapy in patients with diabetes
and ACS or CCS without indications for long-term oral anticoagulation
Recommendations Class Level
ASA at a dose of 75–100 mg o.d. is recommended in patients with diabetes and
previous MI or revascularization (CABG or stenting).
I
I
A
A
Low-dose ASA (75–100 mg o.d.) is recommended in patients with CKD and ASCVD.
In patients with diabetes and symptomatic LEAD, antiplatelet therapy is recommended. I
I
A
B
Clopidogrel is recommended as an alternative in case of ASA intolerance.
Adding very low-dose rivaroxaban to low-dose ASA for long-term prevention of serious
vascular events should be considered in patients with diabetes and CCS or symptomatic IIa B
PAD without high bleeding risk.
CKD: chronic Kidney disease; PAD: peripheral arterial disease

ü Patients with symptomatic ASCVD and/or revascularization with an indication
for long-term OAC

Triple (TAT) vs. dual (DAT) antithrombotic therapy on Stent Thrombosis
and Myocardial Infarction: meta-analysis of randomized trials
Stent Thrombosis
TAT duration
6 months
~2 months (median)
1, 6 or 12 months
3 months (DES)
Myocardial Infarction
Gargiulo G et al
EHJ 2019; 40,
3757-67

Recommendations for antithrombotic therapy in patients with diabetes
and ACS or CCS and/or post-PCI requiring long-term oral anticoagulation
In patients with AF and receiving antiplatelet therapy, eligible for anticoagulation, and
without a contraindication, NOACs are recommended in preference to a VKA.
In patients with ACS or CCS and diabetes undergoing coronary stent implantation and
having an indication for anticoagulation, triple therapy with low-dose ASA, clopidogrel,
and an OAC is recommended for at least 1 week, followed by dual therapy with an
OAC and a single, oral, antiplatelet agent.
I A
I A
having an indication for anticoagulation, prolonging triple therapy with low-dose ASA,
clopidogrel, and an OAC should be considered up to 1 month if the thrombotic risk
outweighs the bleeding risk in the individual patient.
IIa C
having an indication for anticoagulation, prolonging triple therapy with low-dose ASA,
clopidogrel, and an OAC up to 3 months may be considered if the thrombotic risk
outweighs the bleeding risk in the individual patient.
IIb C

ü Patients with ASCVD and/or revascularization with an indication for long-term
OAC
ü Increasing safety by preventing gastrointestinal bleeding while on single or
combined antithrombotic drug(s)

Preventing major gastrointestinal bleeding to increase safety and net therapeutic
efficacy of antithrombotic drugs alone or in combination
1,713,183 patients on OAC, without and
with PPIs Follow-up: 1,161,989 person-years
Capsule endoscopy procedures in 1,092 post-PCI patients
randomized to DAPT, clopidogrel + placebo or ASA + placebo
Upper GI bleeding
Gastric or
small
SAPT-ASA vs. Clopi
RR (95% CI)
SAPT vs DAPT RR
(95%CI)
P P
intestinal
injury
0.96
(0.91-1.02)
0.18 0.95
(0.92-0.98)
0.02
Han Y et al., JACC 2022;79:116-28
Ray WA et al., JAMA 2018; 320:2221-30

Recommendations for gastric protection in patients with diabetes taking
antithrombotic drugs
When antithrombotic drugs are used in combination, proton pump
inhibitors are recommended to prevent gastrointestinal bleeding.
When a single antiplatelet or anticoagulant drug is used, proton pump
inhibitors should be considered to prevent gastrointestinal bleeding,
considering the bleeding risk of the individual patient.
When clopidogrel is used, omeprazole and esomeprazole are not
recommended for gastric protection.
I A
IIa A
III B

Thank you…

Antithrombotic therapy in Diabetes management

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