Coronary disease & ACSRandomised controlled trial
Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions in Sweden (INFINITY-SWEDEHEART): a single-blind, non-inferiority, registry-based, randomised controlled trial
- Randomised controlled trial
- single-blind
- non-inferiority
- registry-based
- 20 hospitals in Sweden
Authors' conclusion
Among patients with coronary artery disease, including those with acute coronary syndrome, treatment with the bioadaptor was non-inferior to contemporary DES, showing potential to mitigate non-plateauing device-related events and improving outcomes in patients undergoing PCI.
Study context
- Population
- Patients aged 18–85 years with chronic or acute coronary syndrome, indication for percutaneous coronary intervention (PCI), up to three de novo lesions, SwedenITT population
- Participants
- 2,399 patients
- Comparison
- DynamX bioadaptor vs zotarolimus-eluting drug-eluting stent (DES)
- Bioadaptorn = 1,201
- DESn = 1,198reference
- Primary endpoint
- Target lesion failure:
- CV death
- Target vessel MI
- Ischaemia-driven target lesion revascularisation
- Follow-up
- Up to 12 months
Primary result
Target lesion failure
Risk difference
−0.41%
95% CI −1.94 to 1.11
P < 0.0001 for non-inferiority
Events by treatment group
Bioadaptor vs DES
risk difference −0.41% (95% CI −1.94 to 1.11); P for non-inferiority < 0.0001
Non-inferiority margin 4.2 as printed, not drawn
As reported in the abstract
Secondary outcomes
| Outcome | Bioadaptor | DES | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Target lesion failure, landmark 6–12 months · Kaplan-Meier estimates | 0.3% | 1.7% | 0.19 (0.06–0.65) | P = 0.0079 | |
| Target vessel failure, landmark 6–12 months | 0.8% | 2.5% | 0.35 (0.16–0.79) | P = 0.011 | |
| Target lesion failure in ACS, landmark 6–12 months | 0.3% | 1.8% | 0.17 (0.04–0.74) | P = 0.018 | |
| 0.050.21520Hazard ratio (log scale) |
Safety
| Outcome | Bioadaptor | DES | difference in event rates (95% CI) | |
|---|---|---|---|---|
| Definite or probable device thrombosis | 0.7% | 0.5% | 0.16% (−0.50 to 0.83) | |
| −1−0.500.51Difference (linear scale) |
Original publication
Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions in Sweden (INFINITY-SWEDEHEART): a single-blind, non-inferiority, registry-based, randomised controlled trial. Lancet. Published 28 October 2024. doi:10.1016/s0140-6736(24)02227-x
Summarised from the published abstract; every number is checked against it