A uniquely-designed, sirolimus-eluting, bioresorbable stent was noninferior to an existing sirolimus-eluting stent for target lesion failure at 1 year, according to results from the PANDA III trial presented at the annual TCT Scientific Symposium.
In the prospective, randomized, multicenter trial, Bo Xu, MBBS, of Fu Wai Hospital, Beijing, and colleagues enrolled 2,348 patients with symptomatic CAD, silent ischemia or ACS from 46 centers. All patients were eligible for PCI.
The investigators randomized patients in a 1:1 ratio to treatment with a poly(lactic-co-glycolic acid) sirolimus-eluting stent (SES) incorporating an electro-grafting base layer (BuMA, SinoMed) or a polylactide SES (Excel, JWMS).
The primary endpoint was target lesion failure at 1 year, a composite endpoint consisting of cardiac death, target vessel MI or ischemia-driven target lesion revascularization. The study was powered for consecutive superiority and noninferiority analyses. Follow-up was conducted at 30 days, 6 months and 1 year.
At final follow-up, the primary endpoint was met in 6.4% of patients in theBuMA cohort and 6.4% of patients in the Excel cohort (difference, 0.06%; P for non-inferiority = .0003).
Comparable 1-year results were also observed with BuMA and Excel for each of the individual components of the target lesion failure endpoint:
- cardiac death, 1.2% vs. 1.3%; difference, -0.1% (HR = 0.93; 95% CI, 0.45-1.93);
- target vessel MI, 4.3% vs. 4.9%; difference, -0.6% (HR = 0.87; 95% CI, 0.60-1.27); and
- ischemia-driven target lesion revascularization, 1.9% vs. 1.2%; difference, 0.7% (HR = 1.57; 95% CI, 0.80-3.07).
With BuMA compared with Excel, however, the rates of definite/probable stent thrombosis at 1 year were 0.5% vs. 1.3%, respectively (P = .047) in the intention-to-treat group and 0.4% vs. 1.3% (P = .01) in the per-treatment evaluable group.
“In the multicenter randomized trial, the BuMA SES was noninferior to the Excel SES for the primary endpoint of target lesion failure at 1 year,” Bo said. “The PGLA polymer-based BuMA SES was associated with a lower incidence of stent thrombosis compared to the PLA-polymer-based Excel SES, consistent with the previous findings of enhanced strut coverage with this device.” - by Jennifer Byrne
Disclosures: The researchers report no relevant disclosures.
Reference: Xu B, et al. PANDA III: A Prospective Randomized Trial of Two Sirolimus-Eluting Bioresorbable-Polymer-Based Metallic Stents With Varying Elution and Absorption Kinetics. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.