ESC Congress 2017 In Review – Focus on CAD&ACS - 13
ESC Congress 2017
Late-Breaking Science
In Review
CAD & ACS
VALIDATE-SWEDEHEART Trial
Results
Written by Toni Rizzo
Patients with Primary Endpoint Event (%)
Figure 1. Primary Endpoint: Death, MI, or Major Bleeding at 180 Days
15.0
12.5
10.0
7.5
Bivalirudin
Heparin
5.0
HR 0.95
95% CI, 0.83-1.10
P = .54
2.5
0.0
30
60
90
120
150
180
2628
2607
2605
2585
Time since Randomisation (days)
Bivalirudin 3004
Heparin
3002
2758
2733
2727
2698
2693
2665
2656
2639
MI, myocardial infarction.
From The New England Journal of Medicine, Erlinge D et al, Bivalirudin versus
Heparin Monotherapy in Myocardial Infarction, EPub 28 August 2017. Copyright
© 2017 Massachusetts Medical Society. Reprinted with permission from
Massachusetts Medical Society.
At 180 days, there were no significant differences
between the groups in mortality (HR, 1.05; 95% CI, 0.78 to
1.41; P = .76), MI (HR, 0.84; 95% CI, 0.60 to 1.19; P = .33),
or bleeding events (HR, 1.00; 95% CI, 0.84 to 1.19; P = .98).
Figure 2 shows the bleeding event rates at 30 and 180 days.
Figure 2. Bleeding Event Rates at 30 and 180 Days
Bivalirudin
Heparin
30 Days
9
180 Days
NS
8
Bleeding Event Rates, %
Bivalirudin was compared with heparin without planned
use of glycoprotein IIb/IIIa inhibitors (GPI) for patients
with acute coronary syndrome (ACS) in multiple studies [Cavender MA, Sabatine MS. Lancet. 2014]. Prior
studies differed in the use of prerandomisation heparin, post-percutaneous coronary intervention (PCI),
bivalirudin infusion, and use of potent P2Y12 inhibitors
[Shahzad A et al. Lancet. 2014; Han Y et al. JAMA.
2015; Schulz S et al. Eur Heart J. 2014]. The aim of the
VALIDATE-SWEDEHEART trial [NCT02311231], presented
by David Erlinge, MD, PhD, Skane University Hospital,
Lund University, Lund, Sweden, was to compare bivalirudin with heparin in patients with ACS (either ST-segment
elevation myocardial infarction [STEMI] or non-ST-segment elevation myocardial infarction [NSTEMI]).
In this open-label, registry-based trial, 3,005 patients
with STEMI and 3,001 with NSTEMI scheduled for urgent
PCI were randomised before the procedure to treatment
with bivalirudin (0.75 mg/kg IV bolus followed by 1.75 mg/kg
per hour infusion) or unfractionated heparin (70-100 U/kg
IV bolus). The use of potent P2Y12 inhibitors was required
for all the patients prior to PCI. GPI use was not planned.
PCI was performed, predominantly with radial artery
access. The primary endpoint was the composite of
death, MI, or major bleeding events at 180 days.
The SWEDEHEART healthcare registry was used for
screening, enrolment, randomisation, case report forms,
and follow-up. Study nurses phoned the patients at days
7 and 180 to register bleeding and MI events [Erlinge D
et al. Am Heart J. 2014].
Prior to PCI, the majority of patients were treated
with ticagrelor (94.9%) and the remaining patients were
treated with prasugrel, or cangrelor. A total of 25 of 29
Swedish PCI centres participated in the trial. The study
included 47.8% of all patients in Sweden presenting at
enrolling hospitals with an initial diagnosis of STEMI or
NSTEMI planned for PCI. Bailout GPIs were used in 2.4%
of the bivalirudin group and 2.8% of the heparin group.
After randomisation, 0.6% of patients in the bivalirudin group and 0.4% of patients in the heparin group
crossed over to the other treatment group.
At 180 days, the rate of death, MI, or major bleeding events was not significantly different between the
bivalirudin and heparin groups (HR, 0.96; 95% CI, 0.83
to 1.10; P = .54; Figure 1) [Erlinge D et al. N Engl J Med.
2017].
7
6
NS
NS
5
4
NS
NS
3
NS
2
1
0
NS
NS
0.1 0.1
3.3 3.8
1.8 1.8
5.1 5.6
BARC 2
BARC 3 BARC 5 BARC 2, 3 & 5
5.7 6.0
3.1 2.9 0.2 0.1
BARC 2
BARC 3 BARC 5 BARC 2, 3 & 5
8.6 8.6
BARC, Bleeding Academic Research Consortium.
Reproduced with permission from D Erlinge, MD, PhD.
Definite stent thrombosis occurred significantly more
often in the heparin versus bivalirudin group at 30 days
(P = .03) but was not significantly different at 180 days
(P = .09). In a prespecified subgroup analysis of the primary endpoint, there was no significant interaction for
Official Peer-Reviewed Highlights From ESC Congress 2017
13
Table of Contents for the Digital Edition of ESC Congress 2017 In Review – Focus on CAD&ACS
Contents
ESC Congress 2017 In Review – Focus on CAD&ACS - Cover1
ESC Congress 2017 In Review – Focus on CAD&ACS - Cover2
ESC Congress 2017 In Review – Focus on CAD&ACS - 1
ESC Congress 2017 In Review – Focus on CAD&ACS - 2
ESC Congress 2017 In Review – Focus on CAD&ACS - Contents
ESC Congress 2017 In Review – Focus on CAD&ACS - 4
ESC Congress 2017 In Review – Focus on CAD&ACS - 5
ESC Congress 2017 In Review – Focus on CAD&ACS - 6
ESC Congress 2017 In Review – Focus on CAD&ACS - 7
ESC Congress 2017 In Review – Focus on CAD&ACS - 8
ESC Congress 2017 In Review – Focus on CAD&ACS - 9
ESC Congress 2017 In Review – Focus on CAD&ACS - 10
ESC Congress 2017 In Review – Focus on CAD&ACS - 11
ESC Congress 2017 In Review – Focus on CAD&ACS - 11A
ESC Congress 2017 In Review – Focus on CAD&ACS - 11B
ESC Congress 2017 In Review – Focus on CAD&ACS - 11B
ESC Congress 2017 In Review – Focus on CAD&ACS - 11C
ESC Congress 2017 In Review – Focus on CAD&ACS - 12
ESC Congress 2017 In Review – Focus on CAD&ACS - 13
ESC Congress 2017 In Review – Focus on CAD&ACS - 14
ESC Congress 2017 In Review – Focus on CAD&ACS - 15
ESC Congress 2017 In Review – Focus on CAD&ACS - 16
ESC Congress 2017 In Review – Focus on CAD&ACS - 17
ESC Congress 2017 In Review – Focus on CAD&ACS - 18
ESC Congress 2017 In Review – Focus on CAD&ACS - 19
ESC Congress 2017 In Review – Focus on CAD&ACS - 20
ESC Congress 2017 In Review – Focus on CAD&ACS - Cover3
ESC Congress 2017 In Review – Focus on CAD&ACS - Cover4
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