Absorb BVS Research Articles

The COBRA II (COmplex Bifurcation lesions: RAndomized comparison of a fully bioresorbable modified-T stenting strategy versus bifurcation reconstruction with a dedicated self-expanding stent in combination with bioresorbable scaffolds) study: Final 5-year follow-up

BackgroundIn order to advocate further research in bioresorbable scaffold (BVS) technology we report the final 5-year outcomes of the COBRA II study, the only randomized controlled trial (RCT) performed to investigate the safety, feasibility, and performance of Absorb BVS (Abbott Vascular) in true coronary bifurcations. MethodsCOBRA II was a prospective single-center RCT. Fifteen patients with true coronary bifurcation lesions were randomized to bifurcation treatment with self-expanding biolimus-eluting Axxess bifurcation device (Biosensors International) combined with additional bioresorbable everolimus-eluting Absorb BVS in the bifurcation branches on (Axxess group) or to 2-stent mod-T stenting technique with Absorb BVS (mod-T group). Optical coherence tomography was performed post-procedure and at 30-months. The primary endpoint was change in minimal luminal area (MLA) on OCT from baseline to 30-months. ResultsFifteen patients with coronary bifurcation lesions were randomized to the Axxess group (n = 8) or Modified-T group (n = 7). At 30 months, MLAs were significantly smaller than post-procedure in the majority of bifurcation segments treated with BVS due to neointima formation, while MLAs in the proximal Axxess segment remained stable (primary endpoint).Five-year clinical follow-up was available for all patients. Only 1 major adverse cardiac event occurred; a patient underwent target lesion revascularization at 30 months in the Axxess group. There were no cases of cardiac death, spontaneous MI, or stent/scaffold thrombosis. ConclusionsIn this small RCT bifurcation study, BVS luminal dimensions were significantly smaller at 30 months, with acute strut discontinuities and late Intraluminal dismantling frequently observed, although acceptable clinical outcomes were noted at 5 years.

Bioresorbable Vascular Scaffolds: A Disappearing Technology, But Should We Let It Vanish?

Absorb bioresorbable vascular scaffolds were designed to overcome the limitations imposed by drug-eluting stents; however, the Absorb BVS showed a 2% very late thrombosis rate. Suboptimal implantation technique has been proposed as a mechanism for the higher BVS thrombosis rate; one posthoc analysis suggested adequate pre- and postdilation in addition to proper sizing could reduce BVS thrombosis rates by 70%. This case acts as a proof of concept demonstrating advantages of BVS, namely, the ability to image the target vessel non-invasively and revascularize percutaneously or surgically if required. We advocate continued research and development in this technology given the attractive advantages, particularly in younger patients who are likely to require future coronary intervention and imaging.

TCT-60 The Impact of Implantation Techniques in Absorb BVS and Xience EES on Lesion-Oriented Outcomes at Complete 5-Year Follow-Up—An AIDA Trial QCA Substudy

TCT-60 The Impact of Implantation Techniques in Absorb BVS and Xience EES on Lesion-Oriented Outcomes at Complete 5-Year Follow-Up—An AIDA Trial QCA Substudy

ОТДАЛЁННЫЕ РЕЗУЛЬТАТЫ КОРРЕКЦИИ ПРОТЯЖЕННЫХ ПОРАЖЕНИЙ КОРОНАРНЫХ АРТЕРИЙ С ПРИМЕНЕНИЕМ БИОДЕГРАДИРУЕМЫХ СОСУДИСТЫХ СКАФФОЛДОВ

Materials and methods. Over the period of 2013 to 2018, endovascular correction of long (more than 25 mm) coronary artery lesions was performed on 80 patients in RSPC “Cardiology”, Minsk. Randomly the patients were divided into 2 groups: experimental group (EG) (n = 40) – endovascular correction with bioresorbable everolimus-eluting vascular scaffold Absorb BVS, and control group (CG) (n = 40) – endovascular correction with everolimus-eluting metallic stent Xience V/ Xience Pro. During further observations we estimated the development of death outcomes (from any reasons and from heart diseases), cases of acute myocardial infarction, incidence of revascularization due to target lesion patency failure, as well as a combined endpoint (all death cases + cases of acute myocardial infarction+ revascularization due to target lesion patency failure). The information about the presence or absence of negative outcomes was collected during the observation via a telephone contact with the patient or their relatives. Results. In the mean long-term observational period of 86.5 months (interquartile range from 77.0 to 93.0 months) after percutaneous intervention (PCI) total death cases were registered in 7.5% cases for the experimental group and in 5% cases for the control group (CG) (p = 1.00). The combined endpoint (death + myocardial infarction + target lesion revascularization) was registered in 17.5% cases for EG and in 15% cases for CG (p = 1.00). Kaplan-Meier analysis did not reveal statistical signif icance between the study groups (p = 0.78). Conclusion. Long lesion correction with biodegradable vascular scaffolds shows similar long-term clinical results in comparison with everolimus-eluting stents. The combined endpoint risk (all death cases + myocardial infarction + revascularization due to target lesion failure) statistically did not differ in long-term period between both groups.

Tungsten disulfide nanotubes enhance flow-induced crystallization and radio-opacity of polylactide without adversely affecting in vitro toxicity

Treatment of vascular disease, from peripheral ischemia to coronary heart disease (CHD), is poised for transformation with the introduction of transient implants designed to “scaffold” regeneration of blood vessels and ultimately leave nothing behind. Improved materials could expand the use of these devices. Here, we examine one of the leading polymers for bioresorbable scaffolds (BRS), polylactide (PLA), as the matrix of nanocomposites with tungsten disulfide (WS2) nanotubes (WSNT), which may provide mechanical reinforcement and enhance radio-opacity. We evaluate in vitro cytotoxicity using vascular cells, flow-induced crystallization and radio-opacity of PLA-WSNT nanocomposites at low WSNT concentration. A small amount of WSNT (0.1 wt%) can effectively promote oriented crystallization of PLA without compromising molecular weight. And radio-opacity improves significantly: as little as 0.5 to 1 wt% WSNT doubles the radio-opacity of PLA-WSNT relative to PLA at 17 keV. The results suggest that a single component, WSNT, has the potential to increase the strength of BRS to enable thinner devices and increase radio-opacity to improve intraoperative visualization. The in vitro toxicity results indicate that PLA-WSNT nanocomposites are worthy of investigation in vivo. Although substantial further preclinical studies are needed, PLA-WSNT nanocomposites may provide a complement of material properties that may improve BRS and expand the range of lesions that can be treated using transient implants. Statement of significanceBioresorbable Scaffolds (BRSs) support regeneration of arteries without permanent mechanical constraint. Poly-L-lactide (PLLA) is the structural material of the first approved BRS for coronary heart disease (ABSORB BVS), withdrawn due to adverse events in years 1-3. Here, we examine tungsten disulfide (WS2) nanotubes (WSNT) in PLA to address two contributors to early complications: (1) reinforce PLLA (enable thinner BRS), and (2) increase radiopacity (provide intraoperative visibility). For BRS, it is significant that WSNT disperse, remain dispersed, reduce friction and improve mechanical properties without additional chemicals or surface modifications. Like WS2 nanospheres, bare WSNT and PLA-WSNT nanocomposites show low cytotoxicity in vitro. PLA-WSNT show enhanced flow-induced crystallization relative to PLA, motivating future study of the processing behavior and strength of these materials.

The Influence of Implantation Techniques on Lesion-Oriented Outcomes in Absorb BVS and Xience EES Lesions Treated in Routine Clinical Practice at Complete Three-Year Follow-Up - AIDA Trial QCA Substudy

It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel failure and device thrombosis. In this explorative AIDA trial QCA substudy, we sought to investigate the influence of implantation techniques on lesion-oriented outcomes in both the Absorb BVS and Xience EES arm at complete 3-year follow-up. The current analysis includes 2152 study lesions treated with at least one study device, of which the baseline angiogram was suited for offline QCA analysis, including Dmax analysis. The lesion-oriented composite outcome (LOCE) of this analysis was a composite of definite device thrombosis, target lesion revascularization and target-vessel myocardial infarction. In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151. In Xience EES, LOCE had occurred more frequently in incorrectly sized devices according to device diameter/RVD matching; 2.2% (4/187) in correctly sized devices versus 7.1% (63/911) in incorrectly sized devices (p = 0.014). In this AIDA trial QCA substudy, rates of LOCE were significantly lower in Xience EES treated lesions in which devices were correctly sized according to the definitions of device diameter/RVD matching.

Four-Year Follow-Up of Absorb BVS Compared to Xience EES in Daily Clinical Practice Shows Continued Accrual of Events

Percutaneous revascularization of chronic total occlusions (CTOs) is known for the high technical complexity. Considering the constant increase in CTO procedures, subsequent peri-procedural complications will rise too, thus they need to be promptly recognized and evaluated for their potential risk of clinical sequelae. We report the case of a newly described complication during trans-septal retrograde CTO intervention: a septal collateral artery dissection due to endothelial avulsion.

Acute Mechanical Performance of Magmaris vs. DESolve Bioresorbable Scaffolds in a Real-World Scenario.

Background: After the bioresorbable PLLA-based vascular scaffold (Absorb BVS) was taken from the market due to its high adverse event rates, a magnesium-based scaffold (Magmaris) was introduced.Objective: To compare the acute performance of the sirolimus-eluting magnesium alloy Magmaris scaffold with that of the novolimus-eluting PLLA-based DESolve scaffold in terms of appropriate scaffold deployment using optical coherence tomography (OCT).Methods and Results: Data from the final OCT pullback of 98 patients were included (19 Magmaris, 79 DESolve) and analyzed at 1-mm intervals. The following indices were calculated: mean and minimal area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. OCT showed a minimum lumen area for Magmaris vs. DESolve of 6.6 ± 1.6 vs. 6.0 ± 1.9 (p = 0.06). Scaffolds with residual area stenosis >20% were predominantly seen in the DESolve group (15.8 vs. 46.8%; p = 0.01). The mean eccentricity index did differ significantly (0.74 ± 0.06 vs. 0.63 ± 0.09; p < 0.001). No fractures were observed for Magmaris scaffolds, but 15.2% were documented for DESolve BRS (p < 0.001). Incomplete scaffold apposition area was significantly higher in the DESolve group (0.01 ± 0.02 vs. 1.05 ± 2.32 mm2; p < 0.001).Conclusion: This is the first study to compare the acute mechanical performance between Magmaris and DESolve in a real-world setting. The acute mechanical performance of Magmaris BRS seems to be superior to that of DESolve BRS, whereas OCT showed a good acute mechanical performance for both BRS in terms of generally accepted imaging criteria.

Two-year clinical performance of Absorb BVS compared to Xience EES in ST-segment elevation myocardial infarction: a pooled analysis of AIDA and COMPARE-ABSORB trials

Abstract Introduction Bioresorbable vascular scaffolds (BVS) use appears theoretically attractive in patients presenting with ST-segment elevation myocardial infarction (STEMI) as acute lesions are generally composed of soft plaques, in which optimal BVS deployment and expansion is easier to achieve. Furthermore, those patients are generally younger and would benefit longer from the promise of vascular restoration therapy. Purpose In this patient level pooled analysis of two clinical trials, we evaluated the clinical outcomes of Absorb BVS versus Xience everolimus-eluting stent (EES) in STEMI patients at 2-year follow-up. Methods We performed an individual patient-level pooled analysis of the AIDA and COMPARE-ABSORB trials in which 3515 patient were randomly assigned to Absorb BVS (n=1772) or Xience EES (n=1743). Clinical outcomes in STEMI patients were analyzed by randomized treatment assignment cumulative through 2 years. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up. Results 350 (19.8%) STEMI patients were allocated to Absorb BVS versus 328 (18.8%) to Xience EES. The mean age of patient presenting with STEMI was 60 years old, 76.0% were males and 15.3% had diabetes mellitus. At 2-years target lesion failure occurred in 8.4% of BVS STEMI patients and 6.2% of EES STEMI patients (p=0.253). The 2-year rates of cardiac death (2.6% vs 1.6%, p=0.332), TV-MI (4.7% vs 2.5%) and TLR (6.8% vs 4.1%) were not significantly different. The 2-year incidence of definite device thrombosis was 4.7% in Absorb BVS versus 1.8% in Xience EES (p=0.045). Conclusion In the present patient-level pooled analysis of the AIDA and COMPARE-Absorb trials, BVS was associated with increased rates of device thrombosis in STEMI patients compared to Xience EES. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

Four-year results of the AIDA trial: comparison of Absorb bioresorbable scaffold with Xience everolimus-eluting metallic stent in daily clinical practice

Abstract Aims Absorb bioresorbable scaffold (BRS) related events were noticed between 1 and 3 years – the approximate time of active scaffold bioresorption. This resulted in the recommendation for 3 year DAPT after Absorb BRS implantation. We aimed to evaluate the safety and efficacy of the Absorb BRS in comparison with Xience everolimus-eluting stent (EES) at 4 years follow-up in large unselected population. In addition, we aimed to assess the value of prolonged DAPT against scaffold thrombosis. Methods AIDA was an investigator-initiated, non-inferiority, multicenter, randomized, all-comers trial. Target vessel failure (a composite of cardiac death, target-vessel myocardial infarction and target-vessel revascularization) and device thrombosis at 4-year follow-up are the primary focus of this analysis. During the trial recommendation for DAPT was changed to up to 3-years post Absorb BVS implantation. Whether this adaption influenced the results after Absorb BVS will be assessed. Results Between August 2013 and December 2015, 1,845 patients were enrolled, of whom 924 were randomized to treatment with Absorb BRS and 921 to Xience EES. The baseline characteristics in the two study arms were well balanced. Of all patients, 18% had diabetes mellitus, more than 50% presented with ACS and the median SYNTAX score was 11. In the Absorb BRS arm, 97% of lesions were predilated and in 74% post-dilatation was performed. Four-year clinical outcomes are currently being adjudicated by an independent clinical event committee. The results will be available at EuroPCR 2020. Conclusions Absorb BRS is associated with higher rates of scaffold thrombosis throughout 3-year of follow-up. The performance of Absorb BRS beyond 3-years, in comparison with the Xience EES, in a large unselected population will be presented. (ClinicalTrials.gov Identifier: NCT01858077) Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

Bioresorbable Coronary Scaffold Technologies: What's New?

To overcome the not negligible metallic drug-eluting stents adverse events rate, the polymeric or metallic bioresorbable scaffolds were designed to provide early drug delivery and mechanical support followed by complete resorption. However, the long-term evidence, focusing on the leading Absorb BVS technology, showed higher events compared with drug-eluting stents. This review discusses the lights and shadows of the current bioresorbable scaffolds according to their mechanical properties and biodegradation profile and suggests possible perspective on these technologies. Improved scaffold design and deployment techniques might mitigate early bioresorbable scaffolds risk enhancing the late benefit of complete resorption.

Two-year longitudinal evaluation of a second-generation thin-strut sirolimus-eluting bioresorbable coronary scaffold with hybrid cell design in porcine coronary arteries.

The first commercially available bioresorbable scaffold (BRS) had a strut thickness of 156 microns. As such, it had the potential for delivery challenges and higher thrombogenicity. The aim herein, is to evaluate biomechanical performance, pharmacokinetics and vascular healing of a novel thin strut (100 μm) sirolimus eluting BRS (MeRes-100, Meril Life Sciences, Gujarat, India) against the once clinically used BRS (Absorb BVS, Abbott, Santa Clara, CA) in porcine coronary arteries. Following device implantation, angiographic and optical coherence tomography (OCT) evaluation were performed at 45, 90, 180 days, 1 year and 2 years. Histological evaluation was per-formed at 30, 90 and 180 days. At 2 years, both lumen (MeRes-100 7.07 ± 1.82 mm² vs. Absorb BVS 7.57 ± 1.39 mm2, p = NS) and scaffold areas (MeRes-100 9.73 ± 1.80 mm² vs. Absorb BVS 9.67 ± 1.25 mm², p = NS) were comparable between tested and control scaffolds. Also, the late lumen area gain at 2 years was similar in both groups tested (MeRes-100 1.03 ± 1.98 mm² vs. Absorb BVS 0.85 ± 1.56 mm², p = NS). Histologic examination up to 6 months showed comparable healing and inflammation profiles for both devices. The novel sirolimus-eluting BRS with thinner struts and hybrid cell design showed similar biomechanical durability and equivalent inhibition of neointimal proliferation when compared to the first-ever Absorb BVS up to 2 years in normal porcine coronary arteries.

Bio-absorbable Cardiovascular Implants: Status and Prognosis

There are three major classes of cardiovascular implants that can benefit from biodegradable materials: coronary/peripheral stents, occluders for heart defects, and embolic devices. We review the progress made in these three device classes, and offer our own prognosis for where the technology needs to improve. Although there has been product withdrawals of an approved fully resorbable stent (Absorb BVS), we believe that metallic bioresorbable stents may have a role to play. Likewise, in the area of embolic devices, there is a need for a quick-acting, fully-degradable device that blocks certain blood vessels. Most of the push for bioabsorbable occluders will come from countries where there is a large incidence of heart defects, such as China and India.

The influence of implantation techniques on lesion oriented-outcomes in Absorb BVS and Xience EES lesions treated in routine clinical practice at complete three year follow-up: AIDA trial QCA substudy

It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel failure and device thrombosis. In this explorative AIDA trial QCA substudy, we sought to investigate the influence of implantation techniques on lesion-oriented outcomes in both the Absorb BVS and Xience EES arm at complete 3-year follow-up. The current analysis includes 2152 study lesions treated with at least one study device, of which the baseline angiogram was suited for offline QCA analysis, including Dmax analysis. The lesion-oriented composite outcome (LOCE) of this analysis was a composite of definite device thrombosis, target lesion revascularization and target-vessel myocardial infarction. In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151. In Xience EES, LOCE had occurred more frequently in incorrectly sized devices according to device diameter/RVD matching; 2.2% (4/187) in correctly sized devices versus 7.1% (63/911) in incorrectly sized devices (p = 0.014). In this AIDA trial QCA substudy, rates of LOCE were significantly lower in Xience EES treated lesions in which devices were correctly sized according to the definitions of device diameter/RVD matching.

СРЕДНЕСРОЧНЫЕ РЕЗУЛЬТАТЫ КОРРЕКЦИИ ПРОТЯЖЕННЫХ ПОРАЖЕНИЙ КОРОНАРНЫХ АРТЕРИЙ С ПРИМЕНЕНИЕМ БИОДЕГРАДИРУЕМЫХ СОСУДИСТЫХ СКАФФОЛДОВ

Aim. To establish efficacy and safety of endovascular correction of long coronary lesion with biodegradable scaffolds in comparison with everolimus-eluting metallic coronary stents. Materials and methods. From 2013 to 2018 in Republican Scientific and Practical Centre «Cardiology», Minsk, endovascular correction of long (more than 25 mm) coronary artery lesions was performed on 80 patients. Randomly patients were divided into 2 groups: group 1 (n=40) – endovascular correction with the biodegradable everolimus-eluting vascular scaffold Absorb BVS, and group 2 (n=40) – endovascular correction with the everolimus-eluting metallic stent Xience V/Xience Pro. Results. In 12-month observational period there were no cases of death or myocardial infarction in both groups. One-year primary endpoint (death + myocardial infarction + target lesion failure) was 10% in group 1 (scaffolds BVS Absorb) and 8.75% in group 2 (Xience stents), 4 and 3 cases of target lesion failure accordingly (p&gt;0.05). As secondary endpoints there were 3 cases of target lesion revascularization registered and 4 cases of target vessel revascularization in each group, 5 cases of target vessel failure in group 1 and 4 cases in group 2 (p&gt;0.05). There was 1 case of confirmed and 1 case of probable scaffold thrombosis in group 1 (cumulative rate 5%), no cases of stent thrombosis in group 2 (p=0.49). Conclusion. Long lesion correction with biodegradable scaffolds shows similar one-year clinical and angiographic results in comparison with everolimus-eluting stents. Combined endpoint risk (all death cases + myocardial infarction + revascularization due to target lesion failure) statistically did not differ in one-year period in both groups.

Four-Year Follow-Up of Absorb BVS Compared to Xience EES in Daily Clinical Practice Shows Continued Accrual of Events

Four-Year Follow-Up of Absorb BVS Compared to Xience EES in Daily Clinical Practice Shows Continued Accrual of Events

Future Balloon-Expandable Stents: High or Low-Strength Materials?

Recent progress in material science allows researchers to use novel materials with enhanced capabilities like optimum biodegradability, higher strength, and flexibility in the design of coronary stents. Considering the wide range of mechanical properties of existing and newfangled materials, finding the influence of variations in mechanical properties of stent materials is critical for developing a practical design. The sensitivity of stent functional characteristics to variations in its material plastic properties is obtained through FEM modeling. Balloon-expandable coronary stent designs: Absorb BVS, and Xience are examined for artificial and commercial polymeric, and metallic materials, respectively. Standard tests including (1) the crimping process followed by stent implantation in an atherosclerotic artery and (2) the three-point bending test, have been simulated according to ASTM standards. In Absorb BVS, materials with higher yield stress than PLLA have similar residual deflection and maximum bending force to PLLA, which is not the case for Xience stent and Co-Cr. Moreover, elevated yield stress significantly reduces stent flexibility only in Xience stent. For both stents, with different degree of influence, an increase in yield or ultimate stress improves stent radial strength and stiffness and reduces arterial stress and plastic strain of stent, which consequently enhances the stent mechanical performance. Contrarily, yield or ultimate stress elevation increases stent recoil which adversely affects stent performance. Using high-strength materials has a double-edged sword effect on the stent performance and existing uncertainty in the precise estimate of stent mechanical properties adversely affects the reliability of numerical models' predictions.

Neoatherosclerosis - Long-Term Assessment of Bioresorbable Vascular Scaffold.

Although metallic stents improved the safety and efficacy of percutaneous coronary intervention (PCI), even the latest generation of drug-eluting stents (DES) is still limited by several factors. The limitations of DES are mainly related to the permanent metallic caging in vessel, chronic inflammatory response to the polymer and adverse effects of antiproliferative drug on endothelial tissue, leading to impaired physiological vasomotor response and late stent-related adverse events such as stent thrombosis and neoatherosclerosis. Bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular) was designed to overcome these drawbacks of DES by disappearing from the vessel wall. Absorb BVS, however, was withdrawn from the world market because of increased incidence of scaffold thrombosis compared with DES. Importantly, only very limited long-term post-BVS implantation data are available, especially with regard to neoatherosclerosis, which can lead to very late adverse events even after resorption of the scaffold. Therefore, the goal of this review was to highlight the mid to long term clinical outcomes published to date, and to describe the features of the intimal healing process and neoatherosclerosis in the 5 years following Absorb BVS implantation, mainly based on our previous study. This may provide important information on the pathophysiology of the scaffolded vessel for clinicians, and promote identification of future bioresorbable materials for PCI that will minimize the stimulus for neoatherosclerosis.

Acute Angiographic and Intermediate-Term Clinical Results of Patients with Non-Left Main Coronary Bifurcation Lesions Treated with BVS by Jailed Semi-Inflated Balloon Technique and Provisional Side-Branch Stenting Strategy.

Background To evaluate the acute angiographic and intermediate-term clinical results of patients with non-left main (LM) coronary artery bifurcation disease (CABD) treated with BVS, as compared with those treated with DES, using the jailed semi-inflated balloon technique (JSIBT) for side branch (SB) protection and provisional stenting. Methods and Results Sixty-eight patients with non-LM CABD who had undergone provisional one-stent implantation with SB protection by JSIBT between January 2015 and December 2017 were retrospectively enrolled. Among them, 20 patients received Absorb BVS implantation and 48 patients received DES implantation. Patients in the BVS group were younger and had higher BMI, total cholesterol, low-density lipoprotein cholesterol, and hemoglobin but had lower serum creatinine and lower prevalence of prior PCI and MI. No SB balloon rupture/entrapment occurred in either group. The incidence of SB dissection/occlusion and SB in need of rewiring or stenting was rare in both groups and showed no significant difference between them. Postinterventional TIMI flow significantly increased in both groups. The intermediate-term clinical outcomes were good in terms of incidence of target lesion failure, target lesion revascularization, target vessel revascularization, myocardial infarction, and all-cause death in both groups. Conclusion The use of JSIBT for treating CABD with modern BVS can provide SB protection as similar as those with DES, even with higher incidence of acute SB dissection/occlusion. The immediate angiographic results and acute and intermediate-term clinical outcomes were also similar in both groups. Our study results demonstrate that JSIBT might be a safe and alternative SB protection tool for BVS in patients with complex CABD.

126Clinical outcomes at two years of the Absorb BRS vs. the Xience metallic DES in patients presenting with ACS vs. stable coronary disease - AIDA trial substudy

Abstract AIMS Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention, might lead to better outcomes when compared to conventional treatment. ACS patients (STE-ACS patients in particular) are generally younger, and most often have lesions with softer plaques, a lower plaque burden and less extensive coronary artery disease. In this pre-specified subgroup analysis of the AIDA trial, we evaluated the clinical outcomes of Absorb BVS versus Xience EES treated patients presenting with or without ACS. Methods and results This analysis includes the 2-year outcomes of all 1845 patients randomized in the AIDA trial subdivided by clinical presentation, a pre-specified subgroup analysis. We compared patients presenting with ACS with those presenting without ACS (ACS versus no-ACS patients). Patients presenting with ACS were further sub-categorized according to the presence or absence of ST-segment elevation at presentation (STE-ACS versus NSTE-ACS patients). Baseline status by clinical presentation was known in all patients, and 842 (45.6%) patients presented with ACS, 456 (25.2%) with STE-ACS and 377 (20.4%) with NSTE-ACS.The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; p=0.49) and in no-ACS patients (11.7% versus 10.7% respectively; p=0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7% respectively, p=0.03) as well as in no-ACS patients (2.4% versus 0.2% respectively; p=0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (p=0.80) and for the endpoint of definite or probable device thrombosis (p=0.17). Conclusions In ACS patients within AIDA, we found no difference in rates of target vessel failure between the Absorb BVS and Xience EES groups. Rates of definite or definite/probable device thrombosis were higher in the Absorb BVS group throughout all clinical presentations. No significant interaction between ACS and no-ACS patients and the occurrence of TVF Acknowledgement/Funding The AIDA trial was financially supported by an unrestricted research grant from Abbott Vascular.