Abstract
BackgroundDiabetes mellitus (DM) patients show higher rates of repeat revascularisation even in the era of modern drug-eluting stents (DES). The concept of bioresorbable scaffolds is becoming captivating, as it might allow for repeat interventions, prolonging the time span during which patients can be treated by percutaneous coronary intervention (PCI).AimsWe intend to evaluate the short- and long-term safety and efficacy of Absorb bioresorbable vascular scaffolds (Absorb BVS) in the treatment of coronary artery disease (CAD) in DM patients for any indication.MethodsThe ABSORB DM Benelux is an international prospective study in DM patients who have undergone PCI with ≥1 Absorb BVS. Major adverse cardiac events (MACE) at 1 year was the primary endpoint, defined as a composite of all-cause death, any myocardial infarction (MI) and ischaemia-driven target vessel revascularisation (TVR). Secondary endpoints were target lesion failure (TLF) and definite or probable scaffold thrombosis (ScT).ResultsBetween April 2015 and March 2017, 150 DM patients and 188 non-complex lesions were treated. Device implantation was successful in 100%. MACE occurred in 14 (9.5%) patients, with all-cause death occurring in 4 (2.7%), any MI in 6 (4.1%) and ischaemia-driven TVR in 7 (4.8%) respectively. TLF was reported in 11 (7.5%). Definite and probable ScT was observed in 2 (1.4%).ConclusionAbsorb BVS for treatment of anatomically low-risk patients with DM show acceptable safety and efficacy outcomes at 1 year. If these promising results are confirmed after a longer follow-up period, new-generation bioresorbable scaffolds combined with refinement of implantation techniques might open new horizons for CAD treatment in DM patients.Electronic supplementary materialThe online version of this article (10.1007/s12471-019-1293-7) contains supplementary material, which is available to authorised users.
Highlights
The incidence and prevalence of diabetes mellitus (DM) is increasing in both developed and developing countries [1, 2]
Absorb BVS for treatment of anatomically low-risk patients with Diabetes mellitus (DM) show acceptable safety and efficacy outcomes at 1 year. If these promising results are confirmed after a longer follow-up period, newgeneration bioresorbable scaffolds combined with refinement of implantation techniques might open new horizons for coronary artery disease (CAD) treatment in DM patients
The study was approved in February 2015, in accordance with the Declaration of Helsinki, by the Ethical Committees of each participating centre
Summary
The incidence and prevalence of diabetes mellitus (DM) is increasing in both developed and developing countries [1, 2]. Despite the major advances in percutaneous coronary intervention (PCI) with newer generations of drug-eluting stents (DES) accompanied by improved medical treatment, studies have continued to show a trend towards higher rates of major adverse cardiovascular events in DM patients compared to non-DM patients [7, 8]. The short-term results from the Absorb bioresorbable vascular scaffolds (Absorb BVS) clinical trial programs, at the time the study was designed, showed promising safety and efficacy outcomes for these devices, being non-inferior to those of the best-in-class durable polymer everolimus-eluting stents (EES) [9,10,11,12,13,14,15]. Aims We intend to evaluate the short- and long-term safety and efficacy of Absorb bioresorbable vascular scaffolds (Absorb BVS) in the treatment of coronary
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