Evaluation of the feasibility and efficacy of a coronary revascularization strategy by drug coated balloon

Abstract

Introduction

Percutaneous coronary revascularization (PCI) by drug eluting stenting (DES) still faces challenges such as complex revascularization procedures and stent (restenosis, thrombosis). The drug coated balloon (DCB) appears to be an attractive concept as no metallic material is left in the vascular wall. The SCRAP study found a satisfying efficacy profile with a 1-year MACE rate of 7.1% among patients who benefited from a stent-less coronary revascularization strategy (SLS). Uncertainties remain regarding the factors influencing the effectiveness and feasibility of this SLS.

Objective

We aimed to assess the prognostic role of LVEF in the occurrence of MACE at 3 years during a strategy of coronary revascularization by DCB. Secondary objectives were to evaluate the impact of clinical presentation and angiographic data on the occurrence of bailout stenting.

Method

983 unselected patients were prospectively and consecutively included between March 2019 and April 2020, and scheduled to benefit PCI at the La Rochelle Hospital Center. Patients without hemodynamic or rhythm instability were eligible for a SLS by DCB (n = 546). Otherwise, revascularization by DES was performed (n = 143). In the event of any iatrogenic coronary dissection, bailout stenting (BO-DES) was performed (n = 294). LVEF at admission and MACE at 3 years were collected. The clinical presentation leading to the PCI (acute or chronic coronary syndrome) was notified, as well as the angiographic data of the lesions.

Results

The overall MACE rate at 3-year follow-up was 15.1% (distribution shown in Fig. 1). In case of LVEF > 50%, the MACE were more frequent when the implantation of at least 1 stent was performed (15.7% vs. 9.2%; p = 0.007). No statistically significant difference was observed if LVEF was impaired, particularly when < 35% (42.3% if at least 1 stent was implanted vs. 36.8% if DCB-only; p = 0.71). The risk of BO-stenting was higher if the clinical presentation was an ACS (OR = 1.97; IC [1.26–3.07]), in case of a multi-vessel involvement (OR = 2.44; IC [1.64–3.63]) or a total treated lesion length (TTL) > 60 mm (OR = 1.64; IC [1.12–2.40]).

Conclusion

The LVEF remains an important prognostic factor in an all-comers population of patients requiring PCI. There was a lower rate of MACE occurrence when the LVEF was preserved. Furthermore the SLS appears to be applicable in patients with severely impaired LVEF as no manifest deleterious effect has been observed when LVEF was < 35%. Patients presenting with an ACS, a multi-vessel disease or a TTL > 60 mm were at higher risk of BO-stenting.