ABSORB Japan: 3 -year Clinical and Angiographic Results of a Randomized trial Evaluating the Absorb Bioresorbable Vascular Scaffold vs. Metallic Drug-eluting Stent in de novo Native Coronary Artery Lesions Ken Kozuma, Kengo Tanabe, Takeshi Kimura on behalf of the ABSORB Japan Investigators.
Study Design Patients with up to 2 de novo target lesions in separate native coronary arteries with a lesion length of ≤ 24 mm and a maximal diameter of ≥ 2. 5 mm to ≤ 3. 75 mm Randomized 2: 1 BVS N=266 Co. Cr-EES N=134 Tx. with single study device Diameter: 2. 5, 3. 0. 3. 5 mm Length: 8, 12, 18, 28 mm Post 1 M 6 M 12 M 13 M 2 Y 3 Y 4 Y 400 125 400 5 Y Y* Clinical FU Imaging Angiogram 400 OCT 1 125 at 3‐‐‐year: Clinical f/u 125 (Subrandomized) Angiographic f/u at 3‐‐‐year: 96. 5% • PI: Takeshi Kimura, Kyoto University 87. 3% QCA Corelab: Beth Israel Deaconess Medical Center, Inc. , Angiographic Core Lab, • • Boston Sponsor: Abbott Vascular
Clinical Summary Of Key Clinical and QCA Outcomes Co. Cr‐‐‐EES BVS P‐‐‐value (134 Pa. Dents) TLF 1. 6% (4) 1. 6% (2) 1. 00 ‐‐‐ Cardiac Death 0. 0% (0) 1. 00 ‐‐‐ Target Vessel MI 0. 4% (1) 0. 0% (0) 1. 00 1. 6% (4) BVS 0. 4% (1) (266 Pa. Dents) 1. 6% (2) Co. Cr‐‐‐EES 0. 0% (0) (134 Pa. Dents) TLF 8. 9% (23) 5. 5% (7) 0. 23 ‐‐‐ Cardiac Death 0. 4% (1) 0. 0% (0) 1. 00 ‐‐‐ Target Vessel MI 5. 4% (14) 3. 1% (4) 0. 31 ‐‐‐ ID‐‐‐TLR 7. 0% (18) 3. 9% (5) 0. 23 Definite/Probable ST 2‐‐‐ 3 Years (266 Pa. Dents) 3. 6% (9) 1. 6% (2) 0. 35 ‐‐‐ ID‐‐‐TLR Definite/Probable ST 0‐‐‐ 3 Years In-device MLD 1. 00 P‐‐‐value 1. 00 Pre Post 13 Months 3 Years BVS 0. 96± 0. 33 mm 2. 42 ± 0. 38 mm 2. 23 ± 0. 47 mm 2. 04 ± 0. 63 mm Co. Cr-EES 0. 99± 0. 36 mm 2. 64 ± 0. 40 mm 2. 48 ± 0. 53 mm 2. 40 ± 0. 56 mm 0. 42 <0. 0001 P-value
Relevance of the trial • • • The 2 -year results of Absorb III and Absorb Japan showed a relatively high incidence of TLF in Absorb compared to XIENCE. – Comparable safety and effectiveness was observed in ABSORB Japan between both study arms from 2 to 3 years, with low incremental TLF rates reported for BVS (1. 6%) and Co. Cr-EES (1. 7%) due to predominant to increases in ID-TLR. At 3 -years, the question of great interest among interventional cardiologists is whether the slope of the scaffold thrombosis curve will decrease after 2 years. – Compared to the prior year, only 1 VLST occurred between 2 and 3 years, on day 810 and in a BVS-treated lesion with visibly high restenosis. Few studies have demonstrated long-term clinical and serial angiographic outcomes of Absorb BVS in a randomized fashion both at 13 -month and 3 -year. The 3 -year angiographic appearance would similarly be unique as this time-point is around the time of full scaffold resorption. – Late lumen loss of BVS at 3 years was within clinically acceptable range (< 0. 4 mm), and consistently with that observed in ABSORB II and consistent with the low ID-TLR rates reported within 2 -3 years.
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