Everolimus-eluting Bioresorbable Vascular Scaffold Research Articles

Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials

Bioresorbable coronary stents might improve outcomes of patients treated with percutaneous coronary interventions. The everolimus-eluting bioresorbable vascular scaffold is the most studied of these stent platforms; however, its performance versus everolimus-eluting metallic stents remains poorly defined. We aimed to assess the efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with ischaemic heart disease treated with percutaneous revascularisation. We searched Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific sessions abstracts, and relevant websites for randomised trials investigating everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents published or posted between Nov 30, 2006, and Oct 12, 2015. The primary efficacy outcome was target lesion revascularisation and the primary safety outcome was definite or probable stent (scaffold) thrombosis. Secondary outcomes were target lesion failure (the composite of cardiac death, target-vessel myocardial infarction, or ischaemia-driven target lesion revascularisation), myocardial infarction, death, and in-device late lumen loss. We derived odds ratios (ORs) and weighted mean differences with 95% CIs, and calculated the risk estimates for the main outcomes according to a random-effects model. This study is registered with PROSPERO, number CRD42015026374. We included six trials, comprising data for 3738 patients randomised to receive percutaneous coronary intervention with either an everolimus-eluting bioresorbable vascular scaffold (n=2337) or an everolimus-eluting metallic stent (n=1401). Median follow-up was 12 months (IQR 9-12). Patients treated with bioresorbable vascular scaffolds had a similar risk of target lesion revascularisation (OR 0.97 [95% CI 0.66-1.43]; p=0.87), target lesion failure (1.20 [0.90-1.60]; p=0.21), myocardial infarction (1.36 [0.98-1.89]; p=0.06), and death (0.95 [0.45-2.00]; p=0.89) as those treated with metallic stents. Patients treated with a bioresorbable vascular scaffold had a higher risk of definite or probable stent thrombosis than those treated with a metallic stent (OR 1.99 [95% CI 1.00-3.98]; p=0.05), with the highest risk between 1 and 30 days after implantation (3.11 [1.24-7.82]; p=0.02). Lesions treated with a bioresorbable vascular scaffold had greater in-device late lumen loss than those treated with a metallic stent (weighted mean difference 0.08 [95% CI 0.05-0.12]; p<0.0001). Compared with everolimus-eluting metallic stents, everolimus-eluting bioresorbable vascular scaffolds had similar rates of repeat revascularisation at 1 year of follow-up, despite inferior mid-term angiographic performance. However, patients treated with a bioresorbable vascular scaffold had an increased risk of subacute stent thrombosis. Studies with extended follow-up in a larger number of patients are needed to fully assess the long-term advantages of everolimus-eluting bioresorbable vascular scaffolds. None.

Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease

BackgroundIn patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes.MethodsIn this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt–chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year.ResultsTarget-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, −0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13).ConclusionsIn this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt–chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.)

Abstract 14342: Relationship Between Peri-Strut Low Intensity Areas and Vascular Healing Response After Everolimus-Eluting Bioresorbable Scaffold Implantation: an Optical Coherence Tomography Study

Objects: Peri-strut low intensity areas (PLIA) surrounding stent struts on optical coherence tomography (OCT) images has been histologically related to the delayed healing and inflammation, and have been previously associated with neointimal proliferation particularly in first generation drug-eluting stent era. However, the relationship between PLIA and bioresorbable vascular scaffolds (BRS) implantation remains to be clarified. Methods: Of 149 patients treated with the everolimus-eluting BRS at a single institution and followed-up for at least 6 months, 38 patients (50 lesions) underwent follow-up coronary angiography including OCT 11.0 ± 2.1 months after BRS implantation. All patients were prescribed lifelong aspirin (100mg/d) and prasugrel (10mg/d) for at least 6 months. The mean- and percent- neointimal area were evaluated by OCT. PLIA was defined as a peri-strut region with a homogenous lower intensity appearance than the surrounding tissue on OCT images without significant signal attenuation and was graded as follows:grade 0, no PLIA; grade 1, &lt;1 quadrant; grade 2, ≥1 but &lt;2 quadrants; grade 3, ≥2 quadrants but &lt;3 quadrants; and grade 4, ≥ 3 quadrants. Additionally, all patients were divided into two groups (PLIA+ group, N=35 and PLIA- group,N=15). Results: The frequency of any PLIA within the scaffold segment was 70.0% (35/50 scaffolds). Mean PLIA grade score was 0.72± 0.77 [Median value (interquartile range), 0.51 (0, 1.07)]. There were significant positive correlations between PLIA score and both mean- (R=0.55,p&lt;0.01) and percent- neointimal area (R=0.58,p&lt;0.01). Both mean- and percent- neointimal area were significantly higher in the PLIA+ group than in the PLIA- group (1.95±0.65 vs. 1.51±0.27 mm 2 , p&lt; 0.01 and 24.0±7.0 vs. 17.4±3.6 %, p&lt; 0.01, respectively).Furthermore, when lesions were divided in 3 groups (group of PLIA score 0, N=15; group of 0&lt;PLIA score&lt;1, N=20; group of 1 &lt; PLIA score, N=15), mean- and percent- neointima area were different among 3 groups (1.51±0.27 vs.1.66±0.39 vs.2.39±0.73 mm 2 , p&lt;0.01; 17.4±3.7 vs.21.6±5.0 vs. 27.4±8.1 %, p&lt;0.01). Conclusion: The presence and extent of PLIA after BRS implantation on OCT imaging appeared to be significantly associated with neointimal formation.

Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease: ABSORB China Trial

BackgroundThe everolimus-eluting bioresorbable vascular scaffold (BVS) is designed to achieve results comparable to metallic drug-eluting stents at 1 year, with improved long-term outcomes. Whether the 1-year clinical and angiographic results of BVS are noninferior to current-generation drug-eluting stents has not been established. ObjectivesThis study sought to evaluate the angiographic efficacy and clinical safety and effectiveness of BVS in a randomized trial designed to enable approval of the BVS in China. MethodsEligible patients with 1 or 2 de novo native coronary artery lesions were randomized to BVS or cobalt-chromium everolimus-eluting stents (CoCr-EES) in a 1:1 ratio stratified by diabetes and the number of lesions treated. Angiographic and clinical follow-up were planned at 1 year in all patients. The primary endpoint was angiographic in-segment late loss (LL), powered for noninferiority with a margin of 0.15 mm. ResultsA total of 480 patients were randomized (241 BVS vs. 239 CoCr-EES) at 24 sites. Acute clinical device success (98.0% vs. 99.6%; p = 0.22) and procedural success (97.0% and 98.3%; p = 0.37) were comparable in BVS- and CoCr-EES–treated patients, respectively. The primary endpoint of in-segment LL at 1 year was 0.19 ± 0.38 mm for BVS versus 0.13 ± 0.38 mm for CoCr-EES; the 1-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of BVS compared with CoCr-EES (pnoninferiority = 0.01). BVS and CoCr-EES also had similar 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization; 3.4% vs. 4.2%, respectively; p = 0.62) and definite/probable scaffold/stent thrombosis (0.4% vs. 0.0%, respectively; p = 1.00). ConclusionsIn the present multicenter randomized trial, BVS was noninferior to CoCr-EES for the primary endpoint of in-segment LL at 1 year. (A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population—ABSORB CHINA Randomized Controlled Trial [RCT]; NCT01923740)

Feasibility of 320-row multi-detector computed tomography angiography to assess bioabsorbable everolimus-eluting vascular scaffolds.

Coronary computer tomographic angiography (CCTA) for screening intra-arterial vessel disease is gaining rapid clinical acceptance in recent years, but its use for such assessments in metal-stented vessel segments is very limited due to blooming artifacts introduced by the metal. However, vessel segments treated by the polymeric everolimus-eluting bioresorbable vascular scaffolds (Absorb) are readily monitored for intravascular disease over time with CCTA. The data on the accuracy of multi-detector computed tomography (MDCT) in patients treated with Absorb is still sparse. Results on 5 Japanese case studies from ABSORB EXTEND are presented here. Five patients were treated with Absorb, and follow-up angiography was conducted at 8 to 14months as per routine site standard of practice. 320-row MDCT scan was performed within 1month before the angiography. By MDCT, all Absorb-treated lesions were clearly evaluated and restenosis were not observed. Minimal diameter and % diameter stenosis were similar between MDCT and quantitative angiography (2.07±0.13 vs. 2.03±0.06mm, P=0.86, and 22.5±5.0 vs. 21.5±4.5%, P=0.88, respectively). MDCT appears to be feasible and useful for evaluating lumen patency and vessel disease in segments implanted with Absorb at follow-up.

TCT-518 Diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: Clinical outcomes of a subgroup analysis from an all-comers absorb registry

TCT-518 Diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: Clinical outcomes of a subgroup analysis from an all-comers absorb registry

TCT-545 Coronary artery vessel healing pattern short term and long term after implantation of the Everolimus-Eluting Bioresorbable Vascular Scaffold

TCT-545 Coronary artery vessel healing pattern short term and long term after implantation of the Everolimus-Eluting Bioresorbable Vascular Scaffold

Optical Coherence Tomography Findings in Bioresorbable Vascular Scaffolds Thrombosis.

Everolimus-eluting bioresorbable vascular scaffolds have been developed to improve late outcomes after coronary interventions. However, recent registries raised concerns regarding an increased incidence of scaffold thrombosis (ScT). The mechanism of ScT remains unknown. The present study investigated angiographic and optical coherence tomography findings in patients experiencing ScT. Fifteen ScT (14 patients, 79% male, age 59±10 years) occurred at a median of 16 days (25%-75% interquartile range: 1-263 days) after implantation. Early ScT (<30 days) occurred in 8 cases (53%). Possible causal factors in these patients included insufficient platelet inhibition in 2 cases and procedural factors (scaffold underexpansion, undersizing, or geographical miss) in 4 cases. No obvious cause could be found in 2 early ScT. In late (>1 month) and very late (>1 year) ScT (respectively, 5 and 2 cases), 5 scaffolds showed intimal neovessels or marked peristrut low-intensity areas. Scaffold fractures were additionally found in 2 patients, and scaffold collapse was found in 1 patient with very late ScT. Extensive strut malapposition was the presumed cause for ScT in 1 case. One scaffold did not show any morphological abnormality. Thrombectomy specimens were analyzed in 3 patients and did not demonstrate increased numbers of inflammatory cells. The mechanisms of early ScT seem to be similar to metallic stents (mechanical and inadequate antiplatelet therapy). The predominant finding in late and very late ScT is peristrut low-intensity area.

TCT-519 Feasibility and performance of everolimus-eluting bioresorbable vascular scaffolds (BVS) in long lesions (>25 mm): all-comers absorb registry with mid-term follow-up

TCT-519 Feasibility and performance of everolimus-eluting bioresorbable vascular scaffolds (BVS) in long lesions (>25 mm): all-comers absorb registry with mid-term follow-up

TCT-12 Impact of overlap on long-term clinical outcomes in patients undergoing everolimus-eluting bioresorbable vascular scaffolds implantation in routine clinical practice: insights from the European multicenter GHOST-EU registry

TCT-12 Impact of overlap on long-term clinical outcomes in patients undergoing everolimus-eluting bioresorbable vascular scaffolds implantation in routine clinical practice: insights from the European multicenter GHOST-EU registry

Experiences with the Absorb everolimus-eluting bioresorbable vascular scaffold in all comers: The St. Antonius hospital single centre registry

BackgroundData on procedural and clinical outcomes of the everolimus-eluting bioresorbable vascular scaffold (BVS, Abbott) in percutaneous coronary intervention in a real-world setting is limited. Early and mid-term clinical outcomes of the BVS in a real-world population were investigated in this single centre study. MethodsPatients treated with the BVS in the St. Antonius Hospital from April 2012 to February 2015 were included in a prospective single centre registry. Procedural success defined as <20% residual restenosis and 30-day and 6-month clinical outcome were investigated. Cumulative event rates were expressed using Kaplan−Meier method. ResultsA total of 108 patients were included in the study, including patients with ST-segment elevation myocardial infarction (STEMI) 18.5%, non-STEMI 22.2% and unstable angina 9.3%. In total 125 lesions were treated with the BVS, of which 48.8% B2/C type lesions including 19.2% bare metal or drugs-eluting in-stent restenosis. Procedural angiographic success was achieved in 99.2% of all patients. Clinical follow-up rate was 100% at 30-day and 87% at 6-month. The rate of cardiac death, target vessel revascularization and definite stent thrombosis was 0%, 0.9% and 0.9% at 30-day and 0.9%, 5.6% and 1.9% at 6-month. The composite end point of target lesion failure (Cardiac death, target lesion myocardial infarction MI and target lesion revascularization) was 1.9% at 30-day and 5.6% at 6-month, respectively. ConclusionsThe use of the BVS in a real-world setting demonstrated excellent procedural success and acceptable mid-term clinical outcomes. The rate of definite scaffold thrombosis was not dissimilar to other BVS registries.

Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German-Austrian ABSORB RegIstRy (GABI-R).

Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2-4years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects. The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German-Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5years). Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information.

Bioresorbable everolimus-eluting vascular scaffold in patients with ST-segment elevation myocardial infarction: Optical coherence tomography evaluation and clinical outcomes.

Bioresorbable vascular scaffold (BVS) implantation is a new, promising treatment method of coronary artery disease. Preliminary data in patients with stable angina are encouraging. However, the utility of BVS was not sufficiently evaluated in the setting of acute thrombotic lesions. The aim of this study was an optical coherence tomography (OCT) assessment of acute procedural result of the everolimus-eluting BVS implantation in patients with ST segment elevation myocardial infarction (STEMI) and evaluation of mid-term clinical outcomes. OCT examination was conducted in 23 STEMI patients who underwent primary angioplasty with BVS implantation. Off-line qualitative and quantitative coronary angiography and OCT analyses were performed by an independent core laboratory. Successful procedural and clinical results were achieved in 95.7% of patients, and device success was observed in all patients. In OCT evaluation, most of the struts (95.4 ± 7.96%) were well apposed, 4.6 ± 5.71% were classified as malapposed. The final minimum lumen diameter was 2.6 ± 0.35 mm, minimum scaffold area was 6.9 ± 1.54 mm² and final residual stenosis was 8.8 ± 24.37%. Edge dissections were found in 3 (7.7%) lesions. Median follow-up period was 229 (interquartile range 199-248) days. One myocardial infarction, due to sub-acute stent thrombosis, occurred in a patient who discontinued pharmacotherapy. The study shows that everolimus-eluting BVS implantation in STEMI is safe and feasible. The OCT evaluation confirmed excellent acute performance with appropriate scaffold expansion and low rate of malapposition.

Beyond the early stages: insights from the ASSURE registry on bioresorbable vascular scaffolds.

Bioresorbable vascular scaffolds (BVS) have been available on the European market since November 2011. The ASSURE registry aims to investigate the safety and efficacy of the Absorb everolimus-eluting bioresorbable vascular scaffold in a real-world setting. Patients with de novo coronary artery disease were consecutively enrolled at six German centres in this prospective registry. Outcomes were procedural success, cardiovascular death, myocardial infarction, and ischaemia-driven target lesion revascularisation (TLR). Angiographic parameters were assessed quantitatively and visual estimates of lesion dimensions were studied. One hundred and eighty-three patients were treated. In 128 (64.7%) lesions a complex ACC/AHA morphology was present. Procedural success was achieved in all patients. Acute gain was 1.54±0.51 mm, resulting in a final minimal lumen diameter (MLD), which met the baseline reference vessel diameter (RVD), although visual estimates overrated the RVD by 0.5±0.5 mm. Up to 12 months, one patient (0.5%) had died from gastrointestinal bleeding, three (1.7%) non-target vessel myocardial infarctions occurred, and five (2.8%) TLR had become necessary because of restenosis. One-year results suggest that bioresorbable vascular scaffolds for de novo coronary artery disease are associated with favourable clinical and functional outcomes in routine clinical practice despite a visually overestimated RVD.

TCTAP A-077 Two-year Imaging Results of the Absorb Bioresorbable Everolimus Eluting Vascular Scaffold with Planned Overlapping from the ABSORB EXTEND Optical Coherence Tomography Subgroup

TCTAP A-077 Two-year Imaging Results of the Absorb Bioresorbable Everolimus Eluting Vascular Scaffold with Planned Overlapping from the ABSORB EXTEND Optical Coherence Tomography Subgroup

Subacute thrombosis after primary percutaneous coronary intervention with bioresorbable vascular scaffold implantation

Everolimus-eluting bioresorbable vascular scaffold (BVS) is a promising new technology recently applied in the treatment of coronary artery lesions that might overcome the limitations of the currently used drug eluting stents. There were no scaffold thromboses reported in the first-in-human trials with BVS implantation. However, the current body of evidence on its safety and incidence of early thrombotic complications in the setting of acute coronary syndromes is still limited. We present the case of a 58-year-old male who was admitted to a coronary care unit due to typical (two-hour long) chest pain with electrocardiographic signs of anterior wall ST segment-elevation myocardial infarction. Coronary angiography revealed critical stenosis of the proximal left anterior descending artery (Fig. 1A). Subsequent primary angioplasty with manual aspiration thrombectomy, balloon predilatation, and implantation of BVS (ABSORB, 3.5/28 mm, 12 atm.) was performed, with good angiographic result (TIMI 3 flow) (Fig. 1B). Optical coherence tomography (OCT) confirmed good scaffold expansion and complete strut apposition (Fig. 1C–F). Further in-hospital course was uneventful and the patient was discharged after five days of hospitalisation. On the ninth day after BVS implantation he presented again with acute severe chest pain and anterior ST-segment elevation in electrocardiogram. The patient confirmed that he discontinued both antiplatelet drugs (aspirin and clopidogrel) after discharge. Repeat coronary angiography revealed a subacute scaffold thrombosis (Fig. 2A). Manual aspiration thrombectomy, abciximab infusion, and plain old balloon angioplasty was performed (Fig. 2B), with good final angiographic result (TIMI 3) (Fig. 2C). Echocardiography revealed an impaired left ventricular ejection fraction of 38%, compared to 50% directly after the primary index procedure. As there was appropriate scaffold expansion and strut apposition in OCT directly after the index procedure, the most likely cause of scaffold thrombosis was the cessation of antiplatelet therapy. Figure 2. A. Occlusion of the proximal left anterior descending artery in the place of bioresorbable vascular scaffold implantation (arrow); B. Plain old balloon angioplasty performed in the occluded left anterior descending artery; C. Good final angiographic result of the treatment of scaffold thrombosis (TIMI 3) Figure 1. A. Coronary angiography revealing critical stenosis of the proximal left anterior descending artery (arrow); B. Good angiographic result of primary angioplasty with bioresorbable vascular scaffold implantation (TIMI 3); C–F. Good scaffold expansion and complete strut apposition in optical coherence tomography A

Outcomes and Computed Tomography Scan Follow-Up of Bioresorbable Vascular Scaffold for the Percutaneous Treatment of Chronic Total Coronary Artery Occlusion

Everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in chronic total occlusion (CTO) could provide theoretical advantages at follow-up compared with metallic stents. This study aimed to assess the feasibility of BVS use for the percutaneous treatment of CTO by analyzing clinical outcomes and patency at midterm follow-up. From February 2013 to June 2014, 42 patients with 46 CTOs were treated by BVS implantation. Once the guidewire reached the distal lumen, all the occluded segments were predilated. Postdilation was performed in all patients. A multislice computed tomography was scheduled for all patients at 6months. The mean age was 58 ± 9years, 41 (98%) were men and 14 (33%) diabetic. The target vessel was predominantly the left anterior descending artery (22, 48%). According to the Japanese-CTO score, 21 CTOs (46%) were difficult or very difficult. Most cases were treated with an anterograde strategy (34 lesions, 74%). A hybrid procedure with a drug-eluting stent at the distal segment was the applied treatment in 7 CTOs (15%). The mean scaffold length was 43 ± 21mm. Technical success was achieved in 45 lesions (98%),and 1 patient (2.4%) presented a non-Q periprocedural myocardial infarction. Re-evaluation was obtained in all patients at 6 ± 1months. Two re-occlusions and a focalrestenosis were identified. After 13 ± 5months of follow-up, there were 2 repeat revascularizations (4.8%). Neither death nor myocardial infarction was documented. In conclusion, BVS for CTO seems to be an interesting strategy with a high rate of technical success and low rate of cardiac events at midterm follow-up in selected patients.

Italian Diffuse/Multivessel Disease ABSORB Prospective Registry (IT-DISAPPEARS). Study design and rationale.

The Absorb Bioresorbable Vascular Scaffold System (Absorb BVS) is an everolimus-eluting bioresorbable vascular scaffold able to provide temporary scaffolding and antiproliferative drug delivery for the treatment of coronary artery disease. This temporary scaffolding could be the true feature to overcome the limitations of the conventional metallic stents. A growing body of evidence worldwide is supporting its implementation into daily practice as being associated with comparable results as the second-generation everolimus-eluting stent. However, these pieces of evidence come from 'studies in which the majority of the patients had low-risk stenoses', whereas patients with more complex coronary artery disease could benefit the most from the Absorb BVS technology. The aim of the IT-DISAPPEARS is to investigate the procedural and clinical performance of the Absorb BVS in patients with long (>24 mm), single-vessel coronary disease or with multivessel disease. At least 50 centers across the Italian territory will enroll 1000 patients with either stable or acute coronary syndromes. Follow-up will end up at 5 years. Primary endpoint will be the cumulative hierarchical incidence of major adverse cardiac events at 1 year, defined as: cardiac death, nonfatal target vessel myocardial infarction, or clinically driven target lesion revascularization. The efficacy as well as safety parameters will be evaluated along with a detailed evaluation of the dual antiplatelet therapy duration/interruption. The IT-DISAPPEARS could provide the first evidence worldwide concerning the performance of Absorb BVS in patients with high-risk diffuse coronary disease.

THROMBOSIS AFTER BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION: ANGIOGRAPHIC AND OCT FINDINGS

Everolimus-eluting Bioresorbable Vascular Scaffolds (BVS) have been developed to improve late outcomes after percutaneous coronary interventions. Recent registries in all-comer patients raised concerns regarding a potential increase in the incidence of in-scaffold thrombosis (ST). To gain further

Comparison of Everolimus- and Biolimus-Eluting Coronary Stents With Everolimus-Eluting Bioresorbable Vascular Scaffolds

BackgroundThe first CE-approved bioresorbable vascular scaffold (BVS) is effective at treating simple lesions and stable coronary artery disease, but it has yet to be assessed versus the best-in-class drug-eluting stents (DES). ObjectivesThis study sought to compare the performance of a BVS with that of everolimus-eluting stents (EES) and biolimus-eluting stents (BES) in all-comer patients. MethodsThe EVERBIO II (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II) trial was a single-center, assessor-blinded study of 240 patients randomly assigned in a 1:1:1 ratio to EES, BES, or BVS. The only exclusion criterion was a reference vessel diameter >4.0 mm, which precluded treatment with BVS. The primary endpoint was angiographic late lumen loss (LLL) at 9 months. Secondary endpoints included patient-oriented major acute coronary events (MACE) (death, myocardial infarction [MI], and any revascularization), device-oriented MACE (cardiac death, MI, and target lesion revascularization), and stent thrombosis at the 9-month clinical follow-up. ResultsFollow-up angiography was performed in 216 patients (90.7%) at 9 months. In-stent LLL was similar between patients treated with BVS (0.28 ± 0.39 mm) and those treated with EES/BES (0.25 ± 0.36 mm; p = 0.30). Clinical outcomes were similar at 9 months: the patient-oriented MACE rate was 27% in BVS and 26% in the EES/BES group (p = 0.83) and the device-oriented MACE rate was 12% in BVS and 9% in the EES/BES group (p = 0.6). ConclusionsNew-generation metallic DES (EES/BES) were not superior to BVS in terms of angiographic LLL and clinical outcomes. (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents [EVERBIO II]; NCT01711931)