Among patients with acute and chronic coronary syndromes undergoing percutaneous coronary intervention (PCI), the novel Supreme healing-targeted drug-eluting stent (HT-DES) was as safe and effective as the standard durable polymer DES (DP-DES) over 12 months, according to the results from the PIONEER III trial .
Prof. Alexandra Lansky (Yale School of Medicine, USA) presented the primary results of the PIONEER III trial (NCT03168776), which aimed to demonstrate non-inferiority of the HT-DES compared with the standard DP-DES. She explained that the HT-DES emphasises early restoration of endothelial function in order to minimise chronic inflammation by 2 mechanisms: firstly, rapid drug delivery and polymer degradation and, secondly, an electro-grafted base layer that promotes endothelial migration and healing and protects the underlying metallic stent.
PIONEER III was a prospective, global, single-blind study conducted in 74 sites. Eligible subjects had chronic or acute coronary syndrome (no STEMI) with up to 3 de novo native lesions in up to 2 major vessels. The 1,632 participants were randomised 2:1 to receive HT-DES (n=1,088) or DP-DES (n=544). Average age was 64 years, 30% had diabetes, and 60% had a history of smoking. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically-driven target lesion revascularisation after 12 months.
The primary non-inferiority endpoint was met. Prof. Lansky noted that device performance was “excellent” in both arms, with >99% lesion success for both stents and no significant difference (P=0.62). At 12 months, the TLF was 5.4% in the HT-DES arm versus 5.1% in the DP-DES arm (risk difference 0.32%; 95% CI -1.87 to 2.5; P for non-inferiority=0.002). The Kaplan-Meier estimates of the TLF showed no significant difference between DP-DES and HT-DES: 5.0% and 5.3%, respectively (HR 1.05; 0.67–1.66; P=0.82). The components of the primary endpoint were not significantly different either:
- target vessel-related MI: 3.4% versus 4.1% (P=0.45);
- target lesion revascularisation: 2.3% versus 1% (P=0.06);
- cardiovascular death: 0.3% versus 0.8% (P=0.18).
Numerically, the secondary endpoint of cardiac death or target vessel MI was lower in the HT-DES group: 3.5% versus 4.6% (HR 0.76; 95% CI 0.46–1.25), but the difference was not statistically significant. Overall, there were no differences in stent thrombosis: 0.7% in both groups (P=1.00); although there was a numeric advantage for HT-DES for late stent thrombosis.
In conclusion, Prof. Lansky said the novel HT-DES is as safe and effective as the DP-DES, and that safety measures numerically favoured HT-DES. “Whether these early safety outcomes translate into significant clinical benefit will be assessed at 5-year follow-up.”
- Lansky A, et al. A Prospective Multicenter Randomized Controlled Trial Assessing the Safety and Efficacy of the BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System in Patients With Stable or Non-ST Elevation Acute Coronary Syndromes: Primary Endpoint Results of the PIONEER III Trial. LBS.05, AHA Scientific Sessions 2020, 13–17 Nov.
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