Abstract
The limitations of the first-generation everolimus-eluting coronary bioresorbable vascular scaffolds (BVS) have been demonstrated in several randomized controlled trials. Little data are available regarding the outcomes of patients receiving hybrid stenting with both BVS and drug-eluting stents (DES). Of 3144 patients prospectively enrolled in the GABI-Registry, 435 (age 62 ± 10, 19% females, 970 lesions) received at least one BVS and one metal stent (hybrid group). These patients were compared with the remaining 2709 (3308 lesions) who received BVS-only. Patients who had received hybrid stenting had more frequently a history of cardiovascular disease and revascularization (p < 0.05), had less frequently single-vessel disease (p < 0.0001), and the lesions treated in these patients were longer (p < 0.0001) and more frequently complex. Accordingly, the incidence of periprocedural myocardial infarction (p < 0.05) and that of cardiovascular death, target vessel and lesion failure and any PCI at 24 months was lower in the BVS-only group (all p < 0.05). The 24-months rate of definite and probable scaffold thrombosis was 2.7% in the hybrid group and 2.8% in the BVS-only group, that of stent thrombosis in the hybrid group was 1.86%. In multivariable analysis, only implantation in bifurcation lesions emerged as a predictor of device thrombosis, while the device type was not associated with this outcome (p = 0.21). The higher incidence of events in patients receiving hybrid stenting reflects the higher complexity of the lesions in these patients; in patients treated with a hybrid strategy, the type of device implanted did not influence patients´ outcomes.
Highlights
A number of randomized controlled trials comparing the outcomes of drug eluting stents compared to first-generation everolimus-eluting coronary bioresorbable vascular scaffolds (BVS) have shown the limitations of this novel type of devices [1,2,3,4]
Of 3144 (4278 lesions) patients included in the German-Austrian ABSORB Registry (GABI-R) registry who received at least one BVS and whose two-years vital status was known, 2709 (3308 lesions) were treated with scaffolds only (BVS-only group) while 435 (970 lesions) were treated with at least one additional metallic stent
Patients in the hybrid group consistently showed characteristics compatible with a higher complexity: Glomerular filtration rate was lower (p < 0.05), the prevalence of prior PCI (p < 0.01), myocardial infarction (p < 0.01), multivessel disease (p < 0.0001), male sex (p < 0.05) were all higher in the hybrid group and there was a trend towards older age and higher diabetes prevalence in this group
Summary
A number of randomized controlled trials comparing the outcomes of drug eluting stents compared to first-generation everolimus-eluting coronary bioresorbable vascular scaffolds (BVS) have shown the limitations of this novel type of devices [1,2,3,4]. When compared with drug eluting stents (DES), the mechanical limitations of BVS, including thicker and wider struts, lower radial strength, and limited expansion capabilities [5,6] represent important limitations for the treatment of complex lesions, including ostial or calcific ones, bifurcations, and lesions in small vessels Supporting this concept, a number of post-hoc analyses have shown that this type of lesions represents predictors for BVS failure [7,8,9] unless a dedicated implantation technique is used [10,11]. Lesions in the left main, in by-pass grafts, and restenotic lesions have been excluded from the CE certification from the very beginning Based on these considerations, some authors have advocated for the use of a hybrid approach, which consists of limiting the use of BVS to settings in which the use of BVS is allowed (or considered to be safe) [12]. Of the clinical rationale supporting the use of hybrid stenting, this setting allows a direct head-to-head comparison of the outcomes of the device types independently of patientscharacteristics and clinical presentation
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