Coronary disease & ACSRandomised controlled trial
Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk
- Randomised controlled trial
- international
- single-blind
- non-inferiority
Authors' conclusion
Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes.
Study context
- Population
- Patients at high bleeding risk undergoing percutaneous coronary intervention (PCI), treated with 1 month of DAPT followed by single antiplatelet therapy
- Participants
- 1,996 patients
- Comparison
- Zotarolimus-eluting stent vs Polymer-free drug-coated stent
- Zotarolimus-eluting stentn = 1,003
- Polymer-free drug-coated stentn = 993reference
- Primary endpoint
- Safety composite of:
- Cardiac death
- MI
- Stent thrombosis
- Follow-up
- 1 year
Primary result
Cardiac death, MI or stent thrombosis
Risk difference
0.2 percentage points
one-sided 97.5% CI upper boundary 3.5
P = 0.01 for non-inferiority
Events by treatment group
As reported in the abstract
Secondary outcomes
Target-lesion failure (cardiac death, target-vessel MI or clinically indicated target-lesion revascularization), principal secondary outcome
- Target-lesion failure (cardiac death, target-vessel MI or clinically indicated target-lesion revascularization), principal secondary outcome: noninferiority margin 4.4
Original publication
Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. Published 12 February 2020. doi:10.1056/nejmoa1910021
Summarised from the published abstract; every number is checked against it