Comparison of the Absorb bioresorbable vascular scaffold to the Xience durable polymer everolimus-eluting metallic stent in routine clinical practice: a propensity score-matched analysis from a multicenter registry

Abstract

IntroductionMost clinical trials related to bioresorbable vascular scaffold (BVS) technology are limited to a highly selected patient population.AimTo evaluate early and long-term clinical outcomes of the Absorb everolimus-eluting BVS compared to the everolimus-eluting metallic XIENCE V stent in routine clinical practice.Material and methodsThis is a multicenter, retrospective propensity score-matched comparative study, comprising 76 patients treated with a bare metal stents (BMS) and 501 with a XIENCE stent. Patients included in the study had stable and unstable angina and both types of myocardial infarction (STEMI and NSTEMI) as an indication for intervention and at least one significant de novo lesion in native coronary arteries. The primary endpoint was major adverse cardiovascular event (MACE), defined as death, myocardial infarction (MI), or target vessel revascularization (TVR).ResultsMedian follow-up was 400 days in both groups. After propensity score matching for patient baseline characteristics, only higher rate of predilatation, predominantly treated left anterior descending artery (LAD) and lower number of used stents in the BVS group remained statistically significant. After adjustment there was no difference in type of treated lesions. The MACE rate did not differ between BVS and drug-eluting stents (DES) groups (7.2% vs. 11.15%, respectively; p = 0.17). The TVR was 2.9% in both groups. Except in the periprocedural period, there were no deaths or MI in the BVS group. There was no stent thrombosis in either studied group.ConclusionsIn routine clinical practice throughout long-term follow-up, clinical outcomes of patients who successfully received the Absorb BVS did not differ from those of patients who received the Xience stent. Longer follow-up data are required to determine whether these findings will persist beyond one year.

Comparison of the everolimus-eluting bioresorbable vascular scaffold versus the everolimus-eluting metallic stent in real-world patients with ST-segment elevation myocardial infarction

“…Moreover, the resorption process with late lumen enlargement, restoration of normal vasomotion, shear stress, and cyclic strain could lead to plaque regression and reduction of late cardiovascular events [5,11,12]. Only one randomized trial [13] and a few studies [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] were designed to evaluate clinical outcomes in STEMI patients. Nevertheless, the mentioned studies were limited by small sample size or the highly selected nature of the study population.…”

Bioresorbable vascular scaffold: a step back thinking of the future

“…Of note, none of these studies was powered for this endpoint. The rates of target vessel myocardial infarction in these studies were in the range of 5.5–7.3%, again not outside a hypothetical confidence interval of the registries by Orlik et al [ 4 ] and Briede et al [ 6 ]. Finally, their rate of scaffold restenosis was in line with another registry recently published that reported in a similar cohort a rate of 6% at 2 years and 9% at 3 years [ 17 ].…”

“…Given the small sample size and fortunately low incidence of scaffold thrombosis, a comparison with the results of these larger trials is impossible. In the study by Orlik et al [ 4 ], no thrombosis was observed; in the study by Briede et al [ 6 ], only two such events had been observed at 2 years (1.1%). In the Absorb II trial, the rate of scaffold thrombosis was 1.5%; in the ABSORB III and AIDA trials the rates of scaffold thrombosis were 1.9% and 3.5%.…”

“…In this issue of the journal, Orlik et al [ 4 ] report 1-year clinical outcomes with the ABSORB BRS (Abbott, Santa Clara, USA) in 138 patients with coronary artery disease. The study design is observational, comparing clinical outcomes with everolimus-eluting bioresorbable scaffolds against those with everolimus-eluting metallic DES.…”

Designing Better Cardiovascular Stent Materials: A Learning Curve

“…[135,136] Compared to the XIENCE V stent, MACE rates for the Absorb BVS did not differ much at 400 days follow-up. [137] The 2-4 µm thick (EES) PDLLA polymer coating of the Absorb BVS releases 80% of the drug within 30 days and is an improvement from the Absorb 1.0, which included changes in polymer processing whereby polymer chains were aligned to slow the hydrolysis rate. [138] A comparison of the Absorb BVS and Magnitude-BRS revealed a lower % of embedded struts and higher % protruding and % uncovered struts on the Absorbs BVS (Figure 4c).…”