Coronary disease & ACSRandomised controlled trial
Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial
- Randomised controlled trial
- open-label
- non-inferiority
- international
- 52 hospitals in 18 countries
Authors' conclusion
Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis.
Study context
- Population
- Patients at high bleeding risk undergoing percutaneous coronary intervention (PCI) for acute or chronic coronary syndrome, receiving 1 month of DAPT then single antiplatelet therapy
- Participants
- 1,948 patients
- Comparison
- Biodegradable-polymer sirolimus-eluting stent vs durable-polymer zotarolimus-eluting stent
- Biodegradable-polymer sirolimus-eluting stentn = 969
- Durable-polymer zotarolimus-eluting stentn = 979reference
- Primary endpoint
- Composite of:
- Cardiac death
- MI
- Stent thrombosis
- Follow-up
- 1 year
Primary result
As reported in the abstract
Risk difference
0.2 percentage points
P < 0.0001
Events by treatment group
Original publication
Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial. Circulation. Published 25 August 2023. doi:10.1161/circulationaha.123.065448
Summarised from the published abstract; every number is checked against it