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PIONEER III trial: Drug-eluting stents comparable

Presented by
Prof. Alexandra Lansky, Yale School of Medicine, USA
AHA 2020
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 [1].

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.”

    1. 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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