OBJECTIVE OF THE STUDY: To test the hypothesis that 6 months DAPT (Dual anti-platelet therapy) after second generation DES (Drug Eluting Stent) implantation in STEMI (ST elevation Myocardial Infarction) is not inferior to 12 months DAPT in terms of clinical outcomes (composite endpoint of all-cause mortality, any MI, any revascularization, stroke and major bleeding at 18 months after randomization). The trial will incorporate two registers studying respectively the safety outcomes of Bivalirudin and Prasugrel combination and Bivalirudin and Ticagrelor combination at 2 and 30 days. Finally the trial design permits assessment of the clinical outcomes after primary PCI for treatment of STEMI with the new Resolute Integrity (Medtronic Santa Rosa Ca, USA) stent at 30 days and 6 months.
BACKGROUND OF THE STUDY: First generation DES (Drug Eluting Stents) have significantly reduced the restenosis rates compared to the BMS (Bare Metal Stents) but have raised concerns regarding higher rates and ongoing propensity for stent thrombosis. Based on these concerns current guidelines advocate dual antiplatelet therapy (DAPT, aspirin plus P2Y12 inhibitor) to be continued for up to 1 year after DES implantation. Large registries analyzing recent data now challenge these recommendations and suggest no increase in mortality or (late) stent thrombosis when DAPT is discontinued after 6 months. STUDY DESIGN: This is a prospective, randomized, open-label trial testing the hypothesis that 6 months DAPT after second generation drug eluting stent (DES) implantation in STEMI is not inferior to 12 months DAPT in terms of clinical outcomes. Patients with STEMI undergoing primary PCI will be enrolled at presentation. Only those patients who are event-free (death, MI, ST, TVR/TLR or unscheduled revascularization with DES in the first 6 months and stroke or bleeding requiring discontinuation of DAPT) and on DAPT at 6 months after primary PCI will be randomized (1:1 fashion) between single (aspirin) versus dual antiplatelet therapy (aspirin plus P2Y12) for an additional 6 months (up to 12 months after primary PCI) and assessed at 18 months post randomization. STUDY POPULATION: Patients between 18 and 85 years, presenting with STEMI undergoing PCI with DES implantation. INTERVENTION: Patients, who are event-free and stil on DAPT at 6 months after primary PCI will be randomized (1:1 fashion) between single (aspirin) versus dual antiplatelet therapy (aspirin plus P2Y12) for an additional 6 months (up to 12 months after primary PCI). PRIMARY STUDY PARAMETERS/OUTCOME OF THE STUDY: DAPT STEMI trial Composite endpoint of all cause mortality, any MI, any revascularization, stroke, ST and Bleeding (TIMI) (net MACCE) at 18 months after randomization. Registry Bivalirudin/Prasugrel and Bivalirudin/Ticagrelor All cause mortality, MI, Stroke, ST and bleeding (following BARC) at 2 and 30 days. Report Resolute Integrity Primary endpoint of DAPT-STEMI, at 30 days and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,100
Dual antiplatelet therapy will be stopped at randomisation to the 6 months DAPT group. Patients will be treated from 6 months onwards only with ASA.
Dual antiplatelet therapy will be continued till 12 months after enrollment in the study
VU medisch Centrum
Amsterdam, Netherlands
Amphia ziekenhuis
Breda, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Atrium MC Parkstad
Heerlen, Netherlands
Maasstadhospital
Rotterdam, Netherlands
Erasmus MC
Rotterdam, Netherlands
Haga Hospital
The Hague, Netherlands
Isala Clinics
Zwolle, Netherlands
Oslo University Hospital
Oslo, Norway
Amerykańskie Kliniki Serca
Bielsko-Biala, Poland
...and 6 more locations
Net MACCE
DAPT-STEMI trial: Composite endpoint of all cause mortality, any myocardial infarction (MI) , any revascularization, stroke and major bleeding (TIMI) (net MACCE) at 18 months after randomization
Time frame: 18 months
All cause mortality, MI, Stroke, ST and bleeding
Primary outcome of Registry: All cause mortality, MI, Stroke, ST and Bleeding(following BARC)at 2 days.
Time frame: 2 days
All cause mortality, MACCE, TIMI
DAPT-STEMI: All cause mortality, any MI, stroke, stent thrombosis (ST) and major bleeding (TIMI) at 9 months after randomization
Time frame: 9 months
ST definite/probable
DAPT-STEMI: ST definite/probable academic research consortium (ARC) definition at 9 months post randomization.
Time frame: 9 months
all cause mortality
DAPT-STEMI: All cause mortality at 9 months after randomization.
Time frame: 9 months
Cardiac mortality
DAPT-STEMI: Cardiac mortality at 9 months after randomization.
Time frame: 9 months
MI
DAPT-STEMI: Any MI at 9 months after randomization.
Time frame: 9 months
Target vessel MI
DAPT-STEMI: Target vessel MI at 9 months after randomization.
Time frame: 9 months
Bleeding
DAPT-STEMI: Bleeding at 9 months after randomization.
Time frame: 9 months
stroke
DAPT-STEMI: Stroke at 9 months after randomization.
Time frame: 9 months
Target vessel revascularization
DAPT-STEMI: Target vessel revascularization (TVR) at 9 months after randomization.
Time frame: 9 months
Target lesion revascularization
DAPT-STEMI: Target lesion revascularization (TLR) at 9 months after randomization.
Time frame: 9 months
Target vessel failure
DAPT STEMI: Target vessel failure (TVF) at 9 months after randomization.
Time frame: 9 months
Target lesion failure
DAPT-STEMI: Target lesion failure (TLF), at 9 months after randomization.
Time frame: 9 months
net MACCE
Primary endpoint of Report Resolute Integrity: Composite endpoint of all cause mortality, any myocardial infarction (MI) , any revascularization, stroke and major bleeding (TIMI) (net MACCE) at 30 days after randomization. Secondary endpoints of Report Resolute Integrity: Secondary endpoints of DAPT-STEMI at 30 days.
Time frame: 30days
All cause mortality, MI, Stroke, ST and bleeding
Primary outcome of registry: All cause mortality, MI,Stroke, ST and Bleeding (following BARC) at 30 days.
Time frame: 30 days
net MACCE
Primary endpoint of Report Resolute Integrity: Composite endpoint of all cause mortality, any myocardial infarction (MI) , any revascularization, stroke and major bleeding (TIMI) (net MACCE) at 6 months after randomization. Secondary endpoints of Report Resolute Integrity: Secondary endpoints of DAPT-STEMI at 6 monthss.
Time frame: 6 months
All cause mortality, MACCE, TIMI
DAPT-STEMI: All cause mortality, any MI, stroke, stent thrombosis (ST) and major bleeding (TIMI) at 18 months after randomization
Time frame: 18 months
ST definite/probable
DAPT-STEMI: ST definite/probable academic research consortium (ARC) definition at 18 months post randomization.
Time frame: 18 months
All cause mortality
DAPT-STEMI: All cause mortality at 18 months after randomization.
Time frame: 18 months
Cardiac mortality
DAPT-STEMI: Cardiac mortality at 18 months after randomization.
Time frame: 18 months
MI
DAPT-STEMI: Any MI at 18 months after randomization.
Time frame: 18 months
Target vessel MI
DAPT-STEMI: Target vessel MI at 18 months after randomization.
Time frame: 18 months
Bleeding
DAPT-STEMI: Bleeding at 18 months after randomization.
Time frame: 18 months
Stroke
DAPT-STEMI: Stroke at 18 months after randomization.
Time frame: 18 months
Target vessel revascularization
DAPT-STEMI: Target vessel revascularization (TVR) at 18 months after randomization.
Time frame: 18 months
Target lesion revascularization
DAPT-STEMI: Target lesion revascularization (TLR) at 18 months after randomization.
Time frame: 18 months
Target vessel failure
DAPT STEMI: Target vessel failure (TVF) at 18 months after randomization.
Time frame: 18 months
Target lesion failure
DAPT-STEMI: Target lesion failure (TLF), at 18 months after randomization.
Time frame: 18 months
ST following ARC
Registry: ST following ARC definition at 2 days
Time frame: 2 days
ST following ARC
Registry: ST following ARC definition at 30 days
Time frame: 30 days
All cause mortality
Registry: All cause mortality at 2 days
Time frame: 2 days
All cause mortality
Registry: All cause mortality at 30 days
Time frame: 30 days
Cardiac mortality
Registry: Cardiac Mortality at 2 days
Time frame: 2 days
Cardiac Mortality
Registry: Cardiac Mortality at 30 days
Time frame: 30 days
All MI
Registry: All MI at 2 days.
Time frame: 2 days
All MI
Registry: All MI at 30 days.
Time frame: 30 days
Target vessel MI
Registry: Target vessel MI at 2 days.
Time frame: 2 days
Target vessel MI
Registry: Target vessel MI at 30 days.
Time frame: 30 days
Bleeding BARC
Registry: Bleeding (BARC) at 2 days
Time frame: 2 days
Bleeding (BARC)
Registry: Bleeding (BARC) at 30 days
Time frame: 30 days
Stroke
Registry: Stroke at 2 days
Time frame: 2 days
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