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Everolimus-eluting Bioresorbable Vascular Scaffolds in Patients with Coronary Artery Disease: The ABSORB III trial.
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Everolimus-eluting Bioresorbable Vascular Scaffolds in Patients with Coronary Artery Disease: The ABSORB III trial Dean J. Kereiakes, MD, Stephen G. Ellis, MD, D. Christopher Metzger, MD, Ronald P. Caputo, MD, David G. Rizik, MD, Paul S. Teirstein, MD, Marc R. Litt, MD, AnnapoornaKini, MD, Ameer Kabour, MD, Steven O. Marx, MD, Jeffrey J. Popma, MD, Robert McGreevy, PhD, Zhen Zhang, PhD, Charles Simonton, MD and Gregg W. Stone, MD for the ABSORB III Investigators
Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. • Modest Consulting Fees • Significant Consulting Fees • Significant Consulting Fees • Significant Consulting Fees • Significant Consulting Fees • Significant Consulting Fees • Major Stock Shareholder/Equity • HCRI • Boston Scientific • Abbott Vascular • Svelte Medical Systems, Inc. • Janssen Research & Development LLC • Sanofi-Aventis U.S. LLC • Ablative Solutions, Inc. Affiliation/Financial Relationship Company
Absorb BVS Everolimus/PDLLA (1:1) matrix coating • 7 µm • Conformal coating • Controlled drug release similar to Xience CoCr-EES PLLA Backbone • Semi-crystalline • Circumferential sinusoidal rings connected by linear links • Strut thickness 150 µm • Platinum markers in each end ring Fully Bioresorbable
ABSORB III Study Design Prospective, multicenter, single blind, randomized 2:1 Absorb vs. Xience, in ~2000 patients Clinical Follow-up 4
Study Flow and Follow-up Randomized 2:1 N=2008 (ITT) ABSORB N=1322 Xience N=686 N=4 lost to follow-up N=6 withdrew consent N=6 lost to follow-up N=3 withdrew consent Xience N=677 ABSORB N=1312 12-month Follow-up 98.7% Complete 99.2% Complete
Primary Endpoint 1 Year TLF Non-inferiority margin = 4.5% 1-Year TLF ABSORB vs. Xience 7.8% (102/1313) vs. 6.1% (41/677) Difference = 1.7% [-0.5%, 3.9%] PNI = 0.007 % Difference (ABSORB - Xience)
Target Lesion Failure 100% 20% Absorb BVS (n=1322) Xience CoCr-EES (n=686) 80% 15% Diff [95% CI] = 1.7% [-0.5% to 3.9%] Psuperiority=0.16 60% 10% 7.7% TLF (%) 6.0% 40% 5% 0% 20% 0 1 2 3 4 5 6 7 8 9 10 11 12 13 0% 0 1 2 3 4 5 6 7 8 9 10 11 12 13 Months Post Index Procedure No. at Risk: Absorb 1322 1254 1230 1218 1196 Xience 686 661 651 643 634
1-Year TLF Components P=0.16 P=0.18 P=0.50 P=0.29
Device Thrombosis to 1 Year *One “definite ST” in the Absorb arm by ITT was in a pt that was treated with Xience
Summary and Conclusions (1) • ABSORB BVS was non-inferior to Xience CoCr-EES for TLF at 1 year (primary endpoint met) • TLF components (cardiac death, TV-MI, ID-TLR) were not significantly different between devices • Angina, all revascularization and ID-TVR were similar between devices • No statistically significant differences in device thrombosis were present
Summary and Conclusions (2) • The ABSORB III trial has demonstrated safety and efficacy of Absorb BVS at 1 year in patients with stable CAD and stabilized ACS • Longer term evaluation is ongoing to determine if ABSORB improves late outcomes compared to Xience