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

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://ichgcp.net/clinical-trials-registry/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.

© 2020 The Authors.

Figures

Fig. 1
Fig. 1
Cumulative incidence functions (CIF) for the Endpoints (a) Target Lesion Failure (TLF - composite of cardiac death, clinically driven target lesion revascularisation (TLR) or target vessel myocardial infarction (MI)), (b) Target Vessel Failure (TVF - composite of cardiac death, target vessel MI or clinically driven target vessel revascularization (TVR)), (c) major adverse cardiac events (MACE - composite of cardiac death, clinically driven TVR or MI) and (d) definite or probable Scaffold Thrombosis (ScT) by the definition of the Academic Research Consortium (ARC). Differences in cumulative incidence functions between the two groups were evaluated by Gray’s Test.

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Source: PubMed

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