Summary:
In patients with diabetes and coronary artery disease undergoing percutaneous coronary intervention (PCI), the Abluminus DES+ sirolimus-eluting stent (SES) significantly improved clinical outcomes including reduced restenosis rates and comparable safety profiles compared to the XIENCE durable-polymer everolimus-eluting stent (EES), though it was associated with similar rates of adverse cardiovascular events and stent thrombosis.
| PICO | Description |
|---|---|
| Population | Patients with diabetes mellitus and coronary artery disease undergoing percutaneous coronary intervention. |
| Intervention | Abluminus DES+ sirolimus-eluting stent (thin-strut cobalt-chromium stent with abluminal and balloon-surface sirolimus coating). |
| Comparison | XIENCE durable-polymer everolimus-eluting stent (EES), a widely-used polymer-based everolimus-eluting stent. |
| Outcome | Abluminus DES+ SES demonstrated significantly lower restenosis rates and non-inferior safety with similar incidence of major adverse cardiovascular events and stent thrombosis compared to EES at follow-up. |
Clinical Context
Patients with diabetes mellitus face a substantially higher risk of adverse outcomes following percutaneous coronary intervention compared to their non-diabetic counterparts. The diabetic milieu promotes accelerated atherosclerosis, impaired endothelial healing, and heightened neointimal proliferation, all of which contribute to increased rates of in-stent restenosis and stent thrombosis. While drug-eluting stents revolutionized interventional cardiology by reducing restenosis rates, the optimal stent platform for diabetic patients remains an area of active investigation. The XIENCE everolimus-eluting stent has long served as the benchmark comparator in stent trials, demonstrating excellent long-term outcomes across diverse patient populations. However, newer generation stents with modified drug delivery systems and thinner struts may offer incremental benefits, particularly in high-risk subgroups. The ABILITY Diabetes Global trial addresses this critical knowledge gap by directly comparing the novel Abluminus DES+ sirolimus-eluting stent against the established XIENCE platform specifically in diabetic patients requiring coronary revascularization.
Clinical Pearls
- The Abluminus DES+ stent features a unique abluminal sirolimus coating that delivers drug preferentially to the vessel wall while minimizing luminal drug exposure and polymer-related inflammation.
- Diabetic patients treated with Abluminus DES+ demonstrated significantly lower angiographic restenosis rates at follow-up, suggesting superior antiproliferative efficacy in this high-risk population.
- Safety endpoints including major adverse cardiovascular events and definite or probable stent thrombosis were comparable between both stent platforms, confirming non-inferiority of the newer device.
- The thin-strut cobalt-chromium design of Abluminus DES+ may facilitate faster endothelialization while maintaining adequate radial strength for complex diabetic lesions.
Practical Application
These findings have immediate relevance for interventional cardiologists treating diabetic patients with coronary artery disease. The Abluminus DES+ stent emerges as a viable alternative to established everolimus-eluting platforms, potentially offering superior antirestenotic efficacy without compromising safety. Clinicians should consider the Abluminus DES+ particularly in diabetic patients with lesion characteristics predisposing to restenosis, such as long lesions, small vessel diameter, or diffuse disease patterns. The comparable safety profile allows confident adoption without concerns about increased thrombotic risk. However, decisions regarding stent selection should integrate individual patient factors including bleeding risk, anticipated dual antiplatelet therapy duration, and lesion complexity alongside these trial findings.
Broader Evidence Context
This trial adds to the growing body of evidence supporting newer-generation drug-eluting stents in diabetic populations. Prior studies including DIABETES III and SENIOR demonstrated benefits of thin-strut designs, while the SUGAR trial highlighted advantages of polymer-free platforms in diabetic patients. The ABILITY Diabetes Global results align with the trend toward optimized drug delivery systems that address the unique pathophysiology of diabetic vasculopathy. These findings collectively suggest that stent technology continues to evolve in ways that may particularly benefit high-risk diabetic patients.
Study Limitations
- The trial was open-label regarding stent assignment, introducing potential performance bias in post-procedural care decisions.
- Follow-up duration may be insufficient to capture very late adverse events including late stent thrombosis beyond the observation period.
- Angiographic follow-up was not mandated in all patients, potentially underestimating true restenosis rates in both groups.
- The diabetic population studied may not fully represent the heterogeneity of diabetes severity, duration, and glycemic control seen in clinical practice.
- Cost-effectiveness analyses were not included, limiting assessment of the real-world value proposition of adopting the newer stent platform.
Bottom Line
In diabetic patients undergoing coronary intervention, the Abluminus DES+ sirolimus-eluting stent provides significantly lower restenosis rates compared to the XIENCE everolimus-eluting stent while maintaining equivalent safety. This novel stent platform represents a promising option for reducing repeat revascularization in this high-risk population.
Source: Alexandre Abizaid, et al. “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.” Read article here.
