Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus

The aim of this study was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO) after Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold (BVS) implantation. The thicker strut of metallic stents potentially contributes to a higher incidence of SBO. We performed a post-hoc angiographic assessment of 1,209 side branches in 435 patients enrolled in the ABSORB-EXTEND single-arm trial (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions), in comparison with 682 side branches in 237 patients treated with the everolimus-eluting metallic stent (EES) in the SPIRIT (A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) first and II trials. Any visible side branches originating within the device implantation site or the 5-mm proximal and distal margins were included in the angiographic assessment. The SBO was defined as a reduction in Thrombolysis In Myocardial Infarction flow grade 0 or 1. Post-procedural SBO was observed in 73 side branches (6.0%) in BVS group and 28 side branches (4.1%) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital myocardial infarction (6.5% in SBO group vs. 0.5% in non-SBO group, p < 0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (odds ratio: 2.09; 95% confidence interval: 1.18 to 3.68). By stratified analysis, BVS demonstrated a higher incidence of post-procedural SBO compared with EES only in small side branches with a reference vessel diameter ≤0.5 mm (10.5% vs. 3.9%, p = 0.03 between the groups, p for interaction = 0.08). Bioresorbable vascular scaffold was associated with a higher incidence of post-procedural SBO compared with EES. This effect was more pronounced with small side branches with a reference vessel diameter ≤0.5 mm. (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions: NCT01023789).

Muramatsu T ，Onuma Y ，García-García HM ，Farooq V ，Bourantas CV ，Morel MA ，Li X ，Veldhof S ，Bartorelli A ，Whitbourn R ，Abizaid A ，Serruys PW ，ABSORB-EXTEND Investigators ... -  《-》

1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials.

Muramatsu T ，Onuma Y ，van Geuns RJ ，Chevalier B ，Patel TM ，Seth A ，Diletti R ，García-García HM ，Dorange CC ，Veldhof S ，Cheong WF ，Ozaki Y ，Whitbourn R ，Bartorelli A ，Stone GW ，Abizaid A ，Serruys PW ，ABSORB Cohort B Investigators ，ABSORB EXTEND Investigators ，SPIRIT FIRST Investigators ，SPIRIT II Investigators ，SPIRIT III Investigators ，SPIRIT IV Investigators ... -  《-》

Comparison of in vivo acute stent recoil between the bioresorbable everolimus-eluting coronary scaffolds (revision 1.0 and 1.1) and the metallic everolimus-eluting stent.

The ABSORB cohort A trial using the bioresorbable everolimus-eluting scaffold (BVS revision 1.0, Abbott Vascular) demonstrated a slightly higher acute recoil with BVS than with metallic stents. To reinforce the mechanical strength of the scaffold, the new BVS scaffold (revision 1.1) with modified strut design was developed and tested in the ABSORB cohort B trial. This study sought to evaluate and compare the in vivo acute scaffold recoil of the BVS revision 1.0 in ABSORB cohort A and the BVS revision 1.1 in ABSORB cohort B with the historical recoil of the XIENCE V® everolimus-eluting metal stent (EES, SPIRIT I and II). In the ABSORB cohort B trial, 101 patients with one or two de-novo lesions were enrolled at 10 sites. In ABSORB cohort A, 27 patients treated with a BVS 1.0 were analyzed and compared with EES. Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon at the highest pressure (X) and mean lumen diameter of the stent immediately after the last balloon deflation (Y). Acute percent recoil was defined as (X - Y)/X and expressed as a percentage. Out of 101 patients enrolled in the ABSORB cohort B trial, 88 patients are available for complete analysis of acute recoil. Absolute recoil of BVS 1.1 (0.19 ± 0.18 mm) was numerically higher than metallic EES (vs. 0.13 ± 0.21 mm) and similar to BVS 1.0 (0.20 ± 0.21 mm) but the differences did not reach statistical significance (P = 0.40). The acute percent recoil demonstrated the same trend (EES: 4.3% ± 7.1%, BVS 1.0: 6.9% ± 7.0%, BVS 1.1: 6.7% ± 6.4%, P = 0.22). In the multivariate regression model, high balloon/artery ratio (>1.1) (OR 1.91 [1.34-2.71]) was the predictive for high absolute recoil (>0.27 mm) while (larger) preprocedural MLD was protective (OR 0.84 [0.72-0.99]). The stent/scaffold type was not a predictor of acute recoil. The average in vivo acute scaffold recoil of the BVS 1.1 is slightly higher than the metallic EES. However, the scaffold/stent type was not predictive of high acute recoil, while implantation in undersized vessels or usage of oversized devices might confound the results.

Onuma Y ，Serruys PW ，Gomez J ，de Bruyne B ，Dudek D ，Thuesen L ，Smits P ，Chevalier B ，McClean D ，Koolen J ，Windecker S ，Whitbourn R ，Meredith I ，Garcia-Garcia H ，Ormiston JA ，ABSORB Cohort A and B investigators ... -  《-》

The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial.

The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up. Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent. The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 - minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected. Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p < 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p = 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037). BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281).

Suwannasom P ，Sotomi Y ，Ishibashi Y ，Cavalcante R ，Albuquerque FN ，Macaya C ，Ormiston JA ，Hill J ，Lang IM ，Egred M ，Fajadet J ，Lesiak M ，Tijssen JG ，Wykrzykowska JJ ，de Winter RJ ，Chevalier B ，Serruys PW ，Onuma Y ... -  《-》

Incidence and Potential Mechanism(s) of Post-Procedural Rise of Cardiac Biomarker in Patients With Coronary Artery Narrowing After Implantation of an Everolimus-Eluting Bioresorbable Vascular Scaffold or Everolimus-Eluting Metallic Stent.

This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury. In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2× the upper limit of normal with creatine kinase-myocardial band rise. Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002). There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281).

Ishibashi Y ，Muramatsu T ，Nakatani S ，Sotomi Y ，Suwannasom P ，Grundeken MJ ，Cho YK ，Garcia-Garcia HM ，van Boven AJ ，Piek JJ ，Sabaté M ，Helqvist S ，Baumbach A ，McClean D ，de Sousa Almeida M ，Wasungu L ，Miquel-Hebert K ，Dudek D ，Chevalier B ，Onuma Y ，Serruys PW ... -  《-》