Five Years Outcomes and Predictors of Events in a Single-Center Cohort of Patients Treated with Bioresorbable Coronary Vascular Scaffolds.

Remzi Anadol,Tommaso Gori,Annika Mühlenhaus,Thomas Münzel,Alberto Polimeni,Ann-Kristin Trieb

doi:10.3390/jcm9030847

Abstract

Introduction: We report outcome data of patients treated with coronary bioresorbable scaffolds up to 5 years and investigate predictors of adverse events. Methods: Consecutive patients treated with at least one coronary bioresorbable scaffold (BRS, Abbott Vascular, Santa Clara, USA) between May 2012 and May 2014 in our center were enrolled. Clinical/procedural characteristics and outcome data at 1868 (1641–2024) days were collected. The incidence of scaffold thrombosis (ScT), restenosis (ScR), and target lesion failure (TLF) and their predictors were investigated using Kaplan–Meier and Cox regression analysis. Results: 512 consecutive patients and 598 lesions were included in the database. A total of 30 ScT, 42 ScR, and 92 TLF were reported. The rate of ScT was 3.6% in the first year, 2.2% in the second–third year, and 0.6% in the fourth–fifth year after implantation. The corresponding rates of ScR were 2.5%, 5.7%, and 1.1%. The corresponding incidence of TLF was 8.8%, 8.0%, 3.8%. Procedural parameters (vessel size, scaffold footprint) and the technique used at implantation (including predilation, parameters of sizing, and postdilation) were predictors of ScT and TLF in the first three years after implantation. In contrast, only diabetes was predictive of events between 4–5 years (HR 6.21(1.99–19.40), p = 0.002). Conclusions: After device resorption, the incidence of very late adverse events in lesions/patients implanted with a BRS decreases. Procedural and device-related parameters are not predictors of events anymore.

Highlights

We report outcome data of patients treated with coronary bioresorbable scaffolds up to 5 years and investigate predictors of adverse events
Separate analyses were performed for the following events which occurred within 1 year after implantation, between two and three years, and between four and five years after implantation: scaffold thrombosis, scaffold restenosis, and target lesion failure
The impact of the following variables on outcomes during the first year, 2–3 years, and 4–5 years after implantation was assessed in univariable Cox regression analysis: cardiovascular risk factors including age, gender, hypertension, diabetes, smoking, dyslipidemia, renal function, history of prior revascularization via percutaneous coronary intervention (PCI) or coronary by-pass (CABG), prior stroke/transient ischemic attack (TIA), and left ventricular ejection fraction (LVEF), clinical presentation during index procedure, treated vessel, and location of lesion, optimal implantation technique and its components, lesion characteristics, such as reference vessel diameter (RVD), minimum lumen diameter (MLD), sizing, scaled, and residual stenosis, MLD, length of scaffold, used antiplatelet medication, follow-up days

Summary

Introduction

We report outcome data of patients treated with coronary bioresorbable scaffolds up to 5 years and investigate predictors of adverse events. The Absorb bioresorbable coronary vascular scaffold (BRS) was the first of a new class of devices for the treatment of coronary artery disease This poly-(L)-lactide acid-based scaffold with a coating of everolimus was designed to resorb completely ≈3 years after implantation, limiting the complications associated with a permanent foreign body, including vascular inflammation and the loss of physiologic motion of the vessel. We and others previously described how the mechanical/physical characteristics of first-generation scaffolds may explain these associations [6,7] In these papers, consistent evidence was produced that the thicker struts of BRS might cause flow turbulence leading, in settings of incompletely expanded scaffolds (early device thrombosis) or malapposition (late thrombosis), to both platelet aggregation and neointima proliferation and to an increased risk of events. Consistent with this, a number of studies reported that an optimal implantation technique including pre- and postdilation to optimize expansion as well as correct lesion and scaffold selection markedly reduced this risk [13,14]

Methods

Results

Conclusion