Among patients with acute and chronic coronary syndromes undergoing PCI, the new Supreme healing-targeted drug-eluting stent (HT-DES) was as safe and effective as the standard durable polymer DES (DP-DES) according to the 12 month results from the PIONEER III trial.
Prof. Alexandra Lansky (Yale University, USA) presented the primary results of the PIONEER III trial, which aimed to demonstrate non-inferiority of the new HT-DES compared with the standard DP-DES, most commonly from XIENCE/Promus . The HT-DES is supported by a cobalt chromium outer surface, followed by a biostable electro-grafted base layer that promotes endothelial migration and healing and protects the underlying metallic stent from chronic corrosion and ion leaching, and top-coated with biodegradable polymer coating with sirolimus, with 90% drug elution by 28 days.
The primary objective of the PIONEER III trial was to compare the safety and efficacy of the Supreme biodegradable coronary stent in patients with up to 3 coronary lesions with either the XIENCE or Promus durable polymer coronary stents. PIONEER III was a prospective, global, multicentre, single blind study (n= 1,632) from 74 sites. Enrolment was largely open to all-comers; eligible subjects had chronic or acute coronary syndrome (no STEMI) with up to 3 de novo native lesions in up to 2 major vessels. Clinical follow-up took place in-hospital and at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years. Participants were randomised 2:1 to receive HT-DES (n=1,088) or DP-DES (n=544). The patient baseline characteristics were well balanced between the arms, with an average age of 64 years, 30% with diabetes, and 60% with a history of smoking.
The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel-related myocardial infarction, and clinically-driven target lesion revascularisation. There was a powered secondary endpoint of TLF from 1-5 years by landmark analysis. Key secondary endpoints were device success, cardiovascular outcomes, target vessel-related myocardial infarction, target lesion revascularization, and stent thrombosis.
Device performance was excellent in both arms, with >99% lesion success for both stents, and no significant differences between the 2 stents. The primary non-inferiority endpoint was met. The TLF at 12 months was 5.4% in the HT-DES arm (57/1057), versus 5.1% (27/532) in the DP-DES arm (risk difference 0.32%; 95% CI -1.87 to 2.5; P=0.002). In the Kaplan-Meier estimates of the TLF primary endpoint, there was no significant difference between the groups (5.0% for DP-DES vs 5.3% for HT-DES; HR 1.05; 95% CI 0.67-1.66; P=0.82). Secondary endpoints showed that the Kaplan-Meier event rate was not significantly different between the 2 arms for target vessel related myocardial infarction (3.4% vs 4.1%; P=0.45), target lesion revascularisation (2.3% vs 1%; P=0.06), or cardiovascular death (0.3% vs 0.8%; P=0.18). There was also no difference between the arms for composite secondary outcomes, such as cardiac death with target vessel MI (HR 0.76; 95% CI 0.46-1.25; P=0.27). Overall, there were no differences in stent thrombosis, with both stents having 0.7% (P=1.00); although there was a numeric advantage for HT-DES for late stent thrombosis.
In conclusion, among patients with acute and chronic coronary syndromes undergoing PCI, the Supreme HT-DES was as safe and as effective as the standard durable DES.
- 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, Virtual AHA Scientific Sessions 2020, 13-17 Nov.