Cardiovascular Disease, Myocardial Infarction
Conditions
Keywords
DAPT- Dual Antiplatelet Therapy, STEMI
Brief summary
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.
Detailed description
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.
Interventions
OTHER6 months DAPT
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.
OTHER12 months DAPT
Dual antiplatelet therapy will be continued till 12 months after enrollment in the study
Sponsors
Medtronic
Maasstad Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
STEMI patients between 18-85 years who underwent primary PCI with DES implantation.
Exclusion criteria
enrolment: * Intolerance to Aspirin, Prasugrel, Ticagrelor, Heparin, Bivalirudin, Zotarolimus or Everolimus. * Known bleeding diathesis or known coagulopathy. * Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization. * History of stent thrombosis * DES in main left coronary artery * Active bleeding, known bleeding diathesis or known coagulopathy. * Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization. * Oral anticoagulant therapy with Coumadin derivates * Malignancies or other comorbidity with a life expectancy of less than one year or that may result in protocol noncompliance * Pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net MACCE | 18 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 18 months | DAPT-STEMI: Stroke at 18 months after randomization. |
| ST following ARC | 2 days | Registry: ST following ARC definition at 2 days |
| All cause mortality, MI, Stroke, ST and bleeding | 2 days | Primary outcome of Registry: All cause mortality, MI, Stroke, ST and Bleeding(following BARC)at 2 days. |
| All cause mortality, MACCE, TIMI | 9 months | DAPT-STEMI: All cause mortality, any MI, stroke, stent thrombosis (ST) and major bleeding (TIMI) at 9 months after randomization |
| ST definite/probable | 9 months | DAPT-STEMI: ST definite/probable academic research consortium (ARC) definition at 9 months post randomization. |
| all cause mortality | 9 months | DAPT-STEMI: All cause mortality at 9 months after randomization. |
| Cardiac mortality | 9 months | DAPT-STEMI: Cardiac mortality at 9 months after randomization. |
| MI | 9 months | DAPT-STEMI: Any MI at 9 months after randomization. |
| Target vessel MI | 9 months | DAPT-STEMI: Target vessel MI at 9 months after randomization. |
| Bleeding | 9 months | DAPT-STEMI: Bleeding at 9 months after randomization. |
| All cause mortality | 18 months | DAPT-STEMI: All cause mortality at 18 months after randomization. |
| Target vessel revascularization | 9 months | DAPT-STEMI: Target vessel revascularization (TVR) at 9 months after randomization. |
| Target lesion revascularization | 9 months | DAPT-STEMI: Target lesion revascularization (TLR) at 9 months after randomization. |
| Target vessel failure | 9 months | DAPT STEMI: Target vessel failure (TVF) at 9 months after randomization. |
| Target lesion failure | 9 months | DAPT-STEMI: Target lesion failure (TLF), at 9 months after randomization. |
| net MACCE | 30days | 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. |
| Cardiac Mortality | 30 days | Registry: Cardiac Mortality at 30 days |
| All MI | 2 days | Registry: All MI at 2 days. |
| Bleeding BARC | 2 days | Registry: Bleeding (BARC) at 2 days |
| Bleeding (BARC) | 30 days | Registry: Bleeding (BARC) at 30 days |
| stroke | 9 months | DAPT-STEMI: Stroke at 9 months after randomization. |
Countries
Netherlands, Norway, Poland, Switzerland
Outcome results
None listed