Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R)

Myron Zaczkiewicz; Bastian Wein; Matthias Graf; Oliver Zimmermann; Johannes Kastner; Jochen Wöhrle; Riemer Thomas; Christian Hamm; Jan Torzewski; GABI-R Study Group

doi:10.1016/j.ijcha.2020.100501

Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R)

Int J Cardiol Heart Vasc. 2020 Mar 20:27:100501. doi: 10.1016/j.ijcha.2020.100501. eCollection 2020 Apr.

Authors

Myron Zaczkiewicz¹, Bastian Wein¹, Matthias Graf¹, Oliver Zimmermann¹, Johannes Kastner², Jochen Wöhrle³, Riemer Thomas⁴, Christian Hamm⁵, Jan Torzewski¹; GABI-R Study Group

Affiliations

¹ Cardiovascular Center Oberallgäu-Kempten, Kempten, Germany.
² Department of Cardiology, University of Vienna Medical School, Vienna, Austria.
³ Department of Internal Medicine II, University of Ulm, Ulm, Germany.
⁴ IHF GmbH - Institut für Herzinfarktforschung, Ludwigshafen, Germany.
⁵ Kerckhoff Heart and Thorax Center, Department of Cardiology, Benekestrasse 2-8, 61231 Bad Nauheim, Germany.

Abstract

Aims: The ABSORB bioresorbable vascular scaffold raised safety concerns due to higher rates of scaffold thrombosis (ScT) and adequate scaffold diameter and length for scaffold technology. Smaller scaffold diameter (SScD, 2.5 mm) was an infrequently quoted predictor of major adverse cardiac events (MACE). Therefore, we evaluated the impact of SScD compared to large scaffold diameter (LScD, ≥3 mm) of ≤18 mm device length on 2 year outcome in the all-comer real life GABI-R cohort.

Methods and results: We compared patients with implanted LScD (1341 patients) vs. SScD (444 patients) of ≤18 mm device length. Patients with LScD more often presented with ST-elevation myocardial infarction (35.8% vs. 20.6%, p < 0.0001) and single-vessel disease (50.6% vs. 36.5% p < 0.0001). After a 24 months follow-up, there was no difference in regard of MACE (9.66% vs. 12.31%, p = 0.14) or definite/probable ST (2.47% vs. 2.82%, p = 0.71). Despite no difference in target lesion revascularisations (TLR) (5.81% vs. 7.71%, p = 0.18), there was a higher need for target vessel revascularisation (TVR) in the SScD-group (11.57% vs. 7.51%, p < 0.05).

Conclusion: Compared to LScD, SScD of ≤18 mm device length demonstrated comparable safety in regard to MACE and ScT as well as efficacy in regard to TLR. Resorbable scaffold technology should not be restricted to large vessel diameters.

Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT02066623.

Keywords: ACS/NSTE-ACS, STEMI; BVS, bioresorbable vascular scaffold(s); Bioresorbable scaffolds; DES, drug-eluting-stent(s); IVUS, intravascular ultrasound; LScD, large scaffold diameter (≥ 3 mm); MACE, major adverse cardiac events; MI, myocardial infarction; NSTEMI, Non– ST-segment elevation myocardial infarction; OCT, optical coherence tomography; PCI, percutanous coronary intervention; PSP, predilatation, sizing, postdilatation; SA, Stable Angina; SScD, small scaffold diameter (2.5 mm); STEMI, ST-segment elevation myocardial infarction; ScT, Scaffold thrombosis; Stable angina; Stent thrombosis; TLF, target lesion failure; TLR, target lesion revascularization; TVF, target vessel failure; TVR, target vessel revascularization; UA, Unstable Angina.

Associated data

ClinicalTrials.gov/NCT02066623