Prospective, randomized, open label trial of six vs. twelve months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction.

First generation DES (Drug Eluting Stents) have significantly reduced the
restenosis rates compared to the BMS 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 to1 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.

To test the hypothesis that 6 months DAPT after second generation DES
implantation in STEMI 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.

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.

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).

The study investigates a treatment strategy (6 months DAPT versus 12 months
DAPT).
In case the patient is randomised to the patientgroep, that will be treated
during 12 months with a combination of 2 antiplatelet drugs, there may be an
increased risk on bleedings.
In case the patient is randomised to the patientgrope, that after 6 months will
on ly be treated with one antiplatelet drug, there may be an increased risk on
thrombosis/cardiovascular complications.
See also section 10.4 of the protocol.

Burden for the patient:
It is possible that the patient has to come for an extra out-clinic visit for
the randomisation at 6 months. However it is also possible that this can be
combined with a routine out-clinic visit. Besides the patient will be
approached with a standard questionnaire three times during the course of the
study.