Everolimus-eluting Bioresorbable Vascular Scaffold Research Articles

Everolimus-eluting Bioresorbable Vascular Scaffold Implantation in Real World and Complex Coronary Disease: Procedural and 30-day Outcomes at Two Australian Centres

The Absorb BVS is a new generation of coronary stent designed to provide coronary arteries with mechanical support of a temporary nature, following balloon angioplasty. Clinical trials of the device have shown promising results thus far, however concern surrounds the deliverability of the device in real-world and complex coronary disease, and the possible higher incidence of early scaffold thrombosis when compared to conventional metallic drug-eluting stents. Implantation of the Absorb BVS was attempted in 152 lesions in 100 patients at two Sydney teaching hospitals, as part of a prospective registry. Lesions treated reflected a wide spectrum of real-world disease. Young patient age, long lesion length and involvement of the mid-portion of the left anterior descending artery were the strongest factors likely to influence the decision to use the Absorb BVS over conventional metallic stents. There were no restrictions on the lesion length, or on the number of lesions or vessels treated. Type C lesions made up 37% of all lesions treated with 64% of these being long lesions (>20mm). The Absorb BVS was successfully implanted in 98.8% of cases. Post-dilatation was performed in 95% of scaffolds. Peri-procedural non-ST elevation myocardial infarction occurred in four cases. Scaffold thrombosis did not occur in any patient at 30 days follow-up. There was no death, or need for target lesion revascularisation in-hospital or at 30 days. High rates of procedural success were achieved with minimal complications with use of the Absorb BVS in real-world coronary disease, including complex disease. These results suggest that the reduced deliverability of the device can be largely overcome by meticulous lesion preparation, and that early scaffold thrombosis may be minimised through scaffold post-dilatation.

CRT-102 Everolimus-Eluting Bioresorbable Vascular Scaffold Use in Acute Coronary Syndromes: Initial Clinical Experience from South Western Canada

Contemporary studies have established encouraging clinical outcomes for the everolimus-eluting bioresorbable vascular scaffold (BVS) ABSORB™ in patients with stable coronary artery disease (CAD). There is limited data on its use in patients presenting with acute coronary syndromes (ACS). We aimed

CRT-701 Clinical Outcomes Of Overlapping Absorb BVS For The Treatment Of Long Coronary Lesions: Data From The Italian RAI Multicenter Registry

BMS and DES overlap is associated with impaired clinical outcomes at long-term follow-up, whereas data on the impact of overlap with overlapping everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) are scant. We report the procedural and mid-term clinical outcomes in a cohort of patients

Clinical utility of optical coherence tomography (OCT) in the optimisation of Absorb bioresorbable vascular scaffold deployment during percutaneous coronary intervention

The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) represents an important advance in percutaneous coronary intervention (PCI) technology. With increasing use of BVS, it is important to understand its expansion characteristics to ensure optimal scaffold deployment. Optical coherence tomography (OCT) has been shown to improve detection of intraprocedural complications compared with conventional intravascular imaging modalities. This study aimed to determine whether or not OCT, post successful angiographic BVS implantation, influenced decision making with regard to the need for further scaffold optimisation. Consecutive patients undergoing OCT-guided BVS implantation from August 2012 to March 2013 were reviewed to determine if further intervention was required to optimise BVS implantation, based on OCT performed after what was deemed to be an optimal angiographic result. Nineteen patients with 29 scaffolds were analysed. Mean age was 53.7, with 84% male. There was a range of lesion types with 12 (63%) type A and seven (37%) type B or C. Of 29 scaffolds analysed, 28% required further intervention after OCT review, three (37.5%) due to scaffold malapposition and five (62.5%) due to scaffold underexpansion. Despite achieving angiographic success in all BVS implantations, further optimisation was required in over a quarter of patients on the basis of OCT findings.

A Challenging Case of Bifurcation Lesion in Left Anterior Descending Artery: Managed Successfully with Everolimus-Eluting Bioresorbable Vascular Scaffold and Kissing Balloon Technique under Optical Coherence Tomography Guidance

A 54-year-old Indian male patient was presented to our hospital with the complaints of chest pain since 1-day prior to admission. He was diagnosed, elsewhere, with anterior-wall myocardial infarction and was treated with tenecteplase. Subsequently, he was referred to us for the management of postinfarction angina. He was a known case of hypertension and had no family history of coronary artery disease. Echocardiogram demonstrated hypokinesia of anterolateral wall with normal left ventricular function. Angiography revealed a single vessel disease-99% stenosis in the mid-segment of left anterior descending (LAD) coronary artery with significant narrowing at the proximal site of diagonal 1 (D1) branch. An optical coherence tomography-guided percutaneous coronary intervention to the LAD-D1 bifurcation lesion was performed successfully using ABSORB bioresorbable vascular scaffold (Abbott Vascular, USA) and kissing balloon angioplasty. No postprocedural complication was observed and the patient was discharged the next day. Clinical evaluation at 1-year follow-up was satisfactory.

Early (before 6 months), late (6-12 months) and very late (after 12 months) angiographic scaffold restenosis in the ABSORB Cohort B trial

The long-term follow-up of the first-in-man ABSORB Cohort B trial showed that angiographic binary restenosis can occur early, late or very late after implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS). Since the mechanical support of the scaffold decreases during bioresorption, the mechanism of in-segment restenosis (ISR) of the Absorb BVS might be different from that of metallic stents. The objective of the current analysis was to review the multimodality imaging of cases with binary restenosis to elucidate the mechanism of ISR after Absorb BVS implantation. The ABSORB Cohort B trial enrolled 101 patients with a maximum of two de novo coronary lesions. At the three-year imaging and clinical follow-up, there were six cases of in-segment binary restenosis: two early ISR (<6 months), one late ISR (6-12 months) and three very late ISR (>12 months). Three of these ISR cases seemed to be induced by anatomical or procedural factors. In the other three cases, intravascular imaging (IVUS/OCT) demonstrated that the main mechanism of restenosis was significant intra-scaffold tissue growth, while the structural circularity and diameter of the scaffold were not affected. Early and late restenosis after implantation of the Absorb bioresorbable scaffold could be related to anatomical or procedural factors. In this small cohort of patients late or very late restenosis seems to be attributed to pure intra-scaffold tissue growth without extrinsic encroachment of the scaffold.

Optical coherence tomography evaluation of overlapping everolimus-eluting bioresorbable vascular scaffold implantation guided by enhanced stent visualization system

In a porcine model, implantation of overlapping everolimus-eluting bioresorbable vascular scaffolds (BVS, Abbott Vascular, Santa Clara, California) resulted in delayed strut coverage and higher neointimal response [1] that might lead to important clinical consequences (scaffold thrombosis; in-scaffold restenosis). According to this, any effort to minimize BVS overlap area and the number of overlapping struts is desirable. A bench testing in an in vitro phantom model has shown how to minimize BVS overlap utilizing the platinum markers located at each BVS edge, where the ideal overlap should be achieved when BVS edge markers positioned at 90° to each other, causing the majority of the overlapped struts to be positioned in the cell area between the struts [2]. In the same paper [2], authors stated that trying to intentionally achieve a minimum overlap is highly difficult and that the correct positioning of the BVS markers is practically unachievable during conventional PCI. In fact, the achievement of minimum BVS overlap in daily clinical practice may be difficult mainly because BVS edge markers are poorly visible at normal fluoroscopy. Therefore, the risk of “geographical miss” or long overlap remains high. Enhanced stent visualization (ESV) system guidance has beenwell validated during conventional stent implantation [3]. ESV systems might significantly improve

OCT Assessment of the Long-Term Vascular Healing Response 5 Years After Everolimus-Eluting Bioresorbable Vascular Scaffold

Although recent observations suggest a favorable initial healing process of the everolimus-eluting bioresorbable vascular scaffold (BVS), little is known regarding long-term healing response. This study assessed the in vivo vascular healing response using optical coherence tomography (OCT) 5 years after elective first-in-man BVS implantation. Of the 14 living patients enrolled in the Thoraxcenter Rotterdam cohort of the ABSORB A study, 8 patients underwent invasive follow-up, including OCT, 5 years after implantation. Advanced OCT image analysis included luminal morphometry, assessment of the adluminal signal-rich layer separating the lumen from other plaque components, visual and quantitative tissue characterization, and assessment of side-branch ostia "jailed" at baseline. In all patients, BVS struts were integrated in the vessel and were not discernible. Both minimum and mean luminal area increased from 2 to 5 years, whereas lumen eccentricity decreased over time. In most patients, plaques were covered by a signal-rich, low-attenuating layer. Minimum cap thickness over necrotic core was 155 ± 90 μm. One patient showed plaque progression and discontinuity of this layer. Side-branch ostia were preserved with tissue bridge thinning that had developed in the place of side-branch struts, creating a neo-carina. At long-term BVS follow-up, we observed a favorable tissue response, with late luminal enlargement, side-branch patency, and development of a signal-rich, low-attenuating tissue layer that covered thrombogenic plaque components. The small size of the study and the observation of a different tissue response in 1 patient warrant judicious interpretation of our results and confirmation in larger studies.

Feasibility of everolimus-eluting bioresorbable vascular scaffolds in patients with chronic total occlusion

ObjectiveThis study evaluates the feasibility of percutaneous coronary intervention with bioresorbable vascular scaffolds (BVSs) in chronic total occlusion (CTO) lesions. BackgroundEverolimus-eluting BVSs represent a new approach to treating coronary artery disease, but experience with CTO is limited. MethodsPatients with a previously diagnosed CTO who had been treated with BVS were included. Patients with unsuccessful CTO procedures and patients treated with drug-eluting stents were excluded. Difficulty of the CTO procedure was assessed by the J-score. ResultsA total of 23 patients were included. Mean age was 60.4±9.0years, 17.4% were female, 91.3% suffered from hypertension and 34.8% from diabetes. Mean J-score was 1.7±1.0. Median procedure time was 70min (54–85), mean contrast volume was 213.5mL (±94.2) and median fluoroscopy time was 19.1min (13.1–30.0). A total of 64 BVSs were implanted with a mean number of 2.8±1.0 BVSs per patient, a mean total BVS length of 64.8±24.2mm per lesion, and a mean BVS diameter of 3.1±0.2mm. Neither a scaffold-related dissection nor any other intra-procedural complication occurred. During a follow-up of 108 (79.5–214.5) days one in-scaffold thrombosis was noted 4days after the CTO procedure due to a lack of dual antiplatelet therapy. No further major adverse cardiac events occurred. ConclusionThese results suggest that BVS implantation in CTO lesions can be performed with good procedural success and reasonable clinical short-term outcome in highly selected cases.

Complex coronary artery bifurcation treatment utilizing everolimus-eluting bioresorbable vascular scaffolds and optical coherence tomography

Chan, William; Shah, Ashish; Džavík, Vladimír; Overgaard, Christopher B. Author Information

Satisfactory Angiographic and Clinical Outcomes with the Everolimus-Eluting BVS

New generation drug-eluting stents (DESs) are increasingly efficient and safe, while the ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS) is thought to reduce long-term complications, including neoatherosclerosis and very late stent thrombosis. The objective of the Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stent trial [EVERBIO II; NCT01711931] was to compare the efficacy of the BVS with the best-in-class new generation DESs.

TCT-637 Analysis of Quality of Life Decrements Associated with Changes in Angina Status in the ABSORB II Trial: First Randomized Comparison Between the Absorb™ Everolimus Eluting Bioresorbable Vascular Scaffold and the XIENCE™ Everolimus Eluting Stent

TCT-637 Analysis of Quality of Life Decrements Associated with Changes in Angina Status in the ABSORB II Trial: First Randomized Comparison Between the Absorb™ Everolimus Eluting Bioresorbable Vascular Scaffold and the XIENCE™ Everolimus Eluting Stent

TCT-623 Procedural Results and Mid-Term Outcome of Percutaneous Coronary Interventions with Everolimus-eluting Bioresorbable Vascular Scaffolds: Evidence of a Learing Curve

Bioresorbable vascular scaffolds (BVS, Abbott Vascular, Santa Clara, California, USA) are new options for treatment of coronary stenoses. Due to a large crossing profile, the implantation procedure is more complex than for current metal stents. Thus, a learning curve might be present. We analyzed

TCT-235 Long-segment stenting (≥ 28 mm) with everolimus-eluting bioresorbable vascular scaffolds in patients with coronary artery disease

Everolimus-eluting bioresorbable vascular scaffolds (BVS, Abbott Vascular, Santa Clara, California, USA) are an upcoming technique in the interventional treatment of coronary artery disease. It is known that the total length of conventional metallic stents implanted is an independent predictor of

TCT-628 Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffolds in Complex Coronary Lesions

TCT-628 Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffolds in Complex Coronary Lesions

TCT-203 12-months Clinical Outcomes of Bioresorbable everolimus-eluting Vascular Scaffold for the Treatment of Chronic Total Occlusions: CTO ABSORB pilot study

The feasibility of using the BVS in chronic total occlusions (CTO) lesions is unknown. This study sought to assess the safety, performance and efficacy of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS), in percutaneous CTO revascularization, under guidance of imaging techniques

TCT-246 Feasibility and mid-term outcome of everolimus-eluting bioresorbable vascular scaffolds in diabetics

TCT-246 Feasibility and mid-term outcome of everolimus-eluting bioresorbable vascular scaffolds in diabetics

Lumen Gain and Restoration of Pulsatility After Implantation of a Bioresorbable Vascular Scaffold in Porcine Coronary Arteries

Using intravascular ultrasound (IVUS) and histomorphometry, this study sought to evaluate the potential of nonatherosclerotic porcine coronary arteries to undergo progressive lumen gain and a return of pulsatility after implantation with an everolimus-eluting bioresorbable vascular scaffold (BVS). Unique benefits such as lumen gain and restored vasomotion have been demonstrated clinically after treatment with BVS; however, a more rigorous demonstration of these benefits with a randomized clinical trial has not yet been conducted. Seventy nonatherosclerotic swine received 109 everolimus-eluting BVS and 70 everolimus-eluting metal stents randomized among the main coronary arteries. Arteries were evaluated in vivo by angiography and IVUS and post-mortem by histomorphometry at time points from 1 to 42 months. From 1 to 6 months, both BVS- and everolimus-eluting metal stent-implanted arteries demonstrated stable lumen areas (LAs). From 12 months to 42 months, there was a progressive increase in the LA of arteries implanted with a BVS as assessed by histomorphometry and IVUS. This lumen gain in the implanted segment corresponded to an increase in the reference vessel LA. Normalization in the in-segment LA (LA:reference vessel LA) was observed qualitatively by angiography and quantitatively by IVUS. Additionally, BVS-implanted arteries demonstrated restored in-segment pulsatility on the basis of IVUS assessment of the differences in the mid-scaffold area between end-diastole to end-systole. Starting at 12 months, BVS-implanted porcine coronary arteries underwent progressive lumen gain and showed restored pulsatility. These benefits demonstrated preclinically may translate into improvements in long-term clinical outcomes for patients treated with BVS compared with conventional drug-eluting stents.

1-Year Clinical Outcomes of Diabetic Patients Treated With Everolimus-Eluting Bioresorbable Vascular Scaffolds: A Pooled Analysis of the ABSORB and the SPIRIT Trials

The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Clinical outcomes of diabetic patients after BVS implantation have been unreported. This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047).

Early results following everolimus-eluting bioresorbable vascular scaffold implantation for the treatment of in-stent restenosis

We read with great interest the recent article by Grasso et al. [1] on the use of everolimus-eluting bioresorbable vascular scaffold (BVS) for the treatment of in-stent restenosis (ISR) and we would like to share our experience with the use of the ABSORB (BVS; Abbott Vascular, Santa Clara, California) for the treatment of this complex lesion subset.