Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in “Real-World” Practice - PANDA III
The goal of the trial was to assess the safety and efficacy of a novel sirolimus-eluting (SES) bioabsorbable stent (BuMA) compared with an existing sirolimus-eluting bioabsorbable stent (Excel).
Contribution to the Literature: The PANDA III trial showed that a novel bioabsorbable SES (BuMA) is noninferior to Excel bioabsorbable SES for clinical outcomes at 1 year.
Chinese patients with coronary artery disease (CAD) were randomized in a 1:1 fashion to either BuMA (n = 1,175) or Excel (n = 1,175).
- Total number of enrollees: 2,338
- Duration of follow-up: 1 year
- Mean patient age: 61 years
- Percentage female: 29%
Other salient features/characteristics:
- Percentage smokers: 37%
- Percentage with diabetes: 24%
- Prior percutaneous coronary intervention (PCI): 12%
- Percentage with stable angina: 15%, unstable angina: 50%
- SYNTAX score: 15.8
- Lesion number (mean): 1.3, number of stents: 1.7
- Total stent length per patient (mean): 31.3 mm
- Reference vessel diameter (mean): 2.75 mm
- Age ≥18 years
- Symptomatic CAD or silent ischemia, or acute coronary syndrome (ACS), and qualifies for PCI
- ≥1 coronary artery stenosis of ≥50% with visually estimated reference vessel diameter ≥2.5 mm and ≤4.0 mm
- Known allergy to contrast and/or device or study medications (PLA, PLGA, sirolimus, aspirin, clopidogrel, stainless steel, cobalt chromium alloy, etc.)
- Planned surgery within 6 months after the index procedure
- Participation in another investigational clinical trial that has not reached its primary endpoint
The primary outcome, target-lesion failure at 1 year, for BuMA vs. Excel, was 6.4% vs. 6.4%, p for noninferiority = 0.0003, p for superiority = 0.95.
- Cardiovascular death: 1.2% vs. 1.3%, p = 0.85
- Target-vessel myocardial infarction: 4.3% vs. 4.9%, p = 0.48
- Ischemia-driven target-lesion revascularization: 1.9% vs. 1.2%, p = 0.18
- Procedure success: 95.1% vs. 94.7%
- Any revasccularization: 4.5% vs. 2.9%, p = 0.05
- Definite/probable stent thrombosis: 0.5% vs. 1.3%, p = 0.048
The results of this trial indicate that a novel bioabsorbable SES is noninferior to Excel bioabsorbable SES for clinical outcomes at 1 year. There was a lower risk of stent thrombosis at 1 year with the novel stent, but a higher risk of all-cause revascularization (numerically higher ischemia-driven target-lesion revascularization as well). Longer-term follow-up data are awaited.
Both the stents in this study are bioabsorbable SES stents. The BuMA stent is PLGA-based and has an electro-grafting base layer between the polymer and stent strut securing adhesion of the PLGA coating. Sirolimus is completely eluted within 30 days, and the PLGA polymer is completely absorbed within 3 months. On the other hand, the Excel stent is PLA-based. It elutes sirolimus completely within 180 days, and the PLA polymer is completely absorbed within 6-9 months. Neither of these stents is currently available in the United States, but adds to the growing body of literature with bioabsorbable stent platforms.
Xu B, Gao R, Yang Y, et al. Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial. J Am Coll Cardiol 2016;67:2249-58.
Presented by Dr. Bo Xu at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2015), San Francisco, CA, October 14, 2015.
Keywords: Acute Coronary Syndrome, Angina Pectoris, Chromium Alloys, Coronary Artery Disease, Coronary Stenosis, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Polymers, Sirolimus, Stainless Steel, Stents, Thrombosis, Ticlopidine, Transcatheter Cardiovascular Therapeutics
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