Coronary disease & ACSRandomised controlled trial
Abluminus DES+ sirolimus-eluting stent versus everolimus-eluting stent in patients with diabetes and coronary artery disease (ABILITY Diabetes Global): results from a multicentre, randomised controlled trial
- Randomised controlled trial
- multicentre
- prospective
- open-label
- non-inferiority
- 74 sites in 16 countries
Authors' conclusion
In patients with diabetes undergoing PCI, the Abluminus DES+ SES was not non-inferior to the XIENCE EES, resulting in higher rates of ischaemia-driven target-lesion revascularisation and target lesion failure at 12-month follow-up. Event rates between 12 and 24 months were similar between groups.
Study context
- Population
- Adults with type 1 or type 2 DM undergoing percutaneous coronary intervention (PCI) for ≥1 de novo coronary lesion due to chronic coronary syndrome or NSTE-ACS2,931 (96.7%) completed follow-up
- Participants
- 3,032 adults
- Comparison
- Abluminus DES+ sirolimus-eluting stent (SES) vs XIENCE everolimus-eluting stent (EES)
- Abluminus DES+ SESn = 1,514
- XIENCE EESn = 1,518reference
- Primary endpoint
- Coprimary: ischaemia-driven target-lesion revascularisation (non-inferiority margin 2.8%) and target-lesion failure (CV death, target-vessel MI or ischaemia-driven TLR; margin 3.0%)
- Follow-up
- 12 months
Primary result
Ischaemia-driven target-lesion revascularisation
Absolute risk difference
2.7%
95% CI 1.3–4.1
P = 0.44 for non-inferiority
Events by treatment group
As reported in the abstract
Further findings
| Outcome | Abluminus DES+ SES | XIENCE EES | absolute risk difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Target-lesion failure (coprimary) · 12 months · non-inferiority not met (margin 3.0%) · per-protocol analysis | 9.7% | 6.2% | 3.5% (1.5–5.5) | P for non-inferiority = 0.68 | |
| 95% CI | 8.4-11.5 | 5.3-7.8 | |||
| −50510Difference (linear scale) |
Target-vessel MI · 12 months
95% CI Abluminus DES+ SES 4.1-6.5 · XIENCE EES 2.4-4.3
All-cause death · 12 months
95% CI Abluminus DES+ SES 2.8-4.8 · XIENCE EES 2.5-4.4
| Outcome | Abluminus DES+ SES | XIENCE EES | Estimate | P value |
|---|---|---|---|---|
| CV death · 12 months | 2.9% | |||
| 95% CI | 2.1-3.9 | Not reported in the abstract |
- Target-lesion failure (coprimary): lower bound of 95% CI excluded zero
Target-vessel MI · 12 months
- More frequent with Abluminus DES+ SES
CV death · 12 months
- No significant difference
All-cause death · 12 months
- No significant difference
Coprimary endpoints, ITT · 24 months
- Results consistent at 24 months in ITT analysis; no significant differences in 12–24-month landmark analyses
- intention-to-treat
Original publication
Summarised from the published abstract; every number is checked against it