Everolimus-eluting Bioresorbable Vascular Scaffold Research Articles

Ten-year clinical outcomes of everolimus- and biolimus-eluting coronary stents vs. everolimus-eluting bioresorbable vascular scaffolds—insights from the EVERBIO-2 trial

BackgroundBioresorbable vascular scaffolds (BVSs) have been developed as a potential solution to mitigate late complications associated with drug-eluting metallic stents (DESs) in percutaneous coronary intervention for coronary artery disease. While numerous studies have compared BVSs to DESs, none have assessed clinical outcomes beyond 5 years.ObjectivesThis study aimed to compare the 10-year clinical outcomes of patients treated with BVSs vs. DESs.MethodsThe EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) is a single-center, assessor-blinded, randomized controlled trial that enrolled 240 patients allocated in a 1:1:1 ratio to receive BVSs, everolimus-eluting stents, or biolimus-eluting stents (BESs). Clinical follow-up was scheduled for 10 years.ResultsClinical follow-up was completed in 222 patients (93%) at the 10-year mark. The rate of device-oriented composite events (DOCE) was 28% in the DES group and 29% in the BVS group (p = 0.72) at 10 years. Similarly, the rate of patient-oriented composite events (POCE) was 55% in the DES group and 49% in the BVS group (p = 0.43) at 10 years. Notably, the rate of myocardial infarction (MI) within the target vessel was 5% in the BVS group and 0% in the BES group (p = 0.04), while the rate of any MI was 10% in the BVS group and 2% in the BES group (p = 0.04). In addition, the rate of Academic Research Consortium (ARC) possible stent thrombosis was 3% in the BVS group and 0% in the DES group (p = 0.04).ConclusionsOver 10 years, the rates of clinical DOCE and POCE were similar between the BVS and DES groups but individual outcomes of stent thrombosis were higher (3%) in the BVS group compared to the DES group. Clinical Trial RegistrationClinicalTrials.gov, identifier (NCT01711931).

Impact of Selection Preference on Longer-Term Outcomes between Bioresorbable Vascular Scaffold versus Everolimus-Eluting Stent for True Lumen Tracking-Recanalized Chronic Total Occlusion.

Creation of sizable subintima during intervention for chronic total occlusions (CTO) could lead to the key selection preference of metallic stents rather than bioresorbable vascular scaffolds (BVS) and then possibly deviate the outcome comparisons in real-world studies. By including recanalized CTO with true lumen tracking, we tested if any selection preference remained and compared the outcomes between everolimus-eluting stent (EES) and BVS implantation.Among 211 consecutive CTO interventions with true lumen tracking from August 2014 to April 2018 when BVS was available, we compared the clinical and interventional features between 28 patients with BVS and 77 patients with EES implantation. With propensity score matching and a median follow-up of 50.5 (37.3-60.3) months, we further assessed 25 patients with BVS and 25 with EES for target vessel failure (TVF: cardiac death, target vessel myocardial infarction, and target lesion revascularization).Multivariate analyses showed that BVS was still favored in the presence of LAD CTO (odds ratio (OR) = 3.4, 95% confidence interval (CI) = 1.0-11.7) and an average scaffold/stent size ≥ 3 mm (OR = 10.5, 95% CI = 3.0-37.3). EES was preferred for lesions with a J-CTO score ≥ 3 (OR = 19.3, 95% CI = 3.4-110.8) and multivessel intervention necessary at index procedure (OR = 11.3, 95% CI = 1.9-67.3). With matched comparisons, the TVF-free survival of EES was better than that of BVS for CTO recanalization (P = 0.049 by log-rank test) at long-term follow-up.Even with true lumen tracking techniques, selection bias remained substantial when determining either device for CTO implantation. The matched comparison of outcomes suggested the unfavorable longer-term impacts of the first generation of BVS on CTO lesions.

Preclinical Evaluation of an Everolimus-Eluting Bioresorbable Vascular Scaffold Via a Long-Term Rabbit Iliac Artery Model.

Biodegradable poly (l-lactic acid) (PLLA), a bio safe polymer with a large elastic modulus, is widely used in biodegradable medical devices. However, because of its poor mechanical properties, a PLLA strut must be made twice as thick as a metal strut for adequate blood vessel support. Therefore, the mechanical properties of a drug-eluting metal-based stents (MBS) and a bioresorbable vascular scaffolds (BVS) were evaluated and their safety and efficacy were examined via a long-term rabbit iliac artery model. The surface morphologies of the MBSs and BVSs were investigated via optical and scanning electron microscopy. An everolimus-eluting (EE) BVS or an EE-MBS was implanted into rabbit iliac arteries at a 1.1:1 stent-to-artery ratio. Twelve months afterward, stented iliac arteries from each group were analyzed via X-ray angiography, optical coherence tomography (OCT), and histopathologic evaluation. Surface morphology analysis of the EE coating on the MBS confirmed that it was uniform and very thin (4.7μm). Comparison of the mechanical properties of the EE-MBS and EE-BVS showed that the latter outperformed the former in all aspects (radial force (2.75 vs. 0.162N/mm), foreshortening (0.24% vs. 1.9%), flexibility (0.52 vs. 0.19N), and recoil (3.2% vs. 6.3%). At all time points, the percent area restenosis was increased in the EE-BVS group compared to the EE-MBS group. The OCT and histopathological analyses indicate no significant changes in strut thickness. BVSs with thinner struts and shorter resorption times should be developed. A comparable long-term safety/efficacy evaluation after complete absorption of BVSs should be conducted.

Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice.

The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487-3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663-3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. ClinicalTrials.gov Identifier: NCT02601404, NCT04265443.

Comparison of post-procedural rise of cardiac biomarkers after implantation of an everolimus-eluting bioresorbable vascular scaffold versus everolimus-eluting metallic stent in patients with long/diffuse LAD disease

Objectives This study sought to evaluate the incidence and the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. Background A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury. Methods Prospective nonrandomized comparative study enrolled 52 patients with stable myocardial ischemia with diffuse/ long LAD lesion for either an everolimus-eluting bioresorbable vascular (BVS) scaffold (22 patients) or an EES (30 patients), 3 types of CB (creatine kinase (CK), creatine kinase-myocardial band (CK-MB), and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as CK rise >2 the upper limit of normal with CK-MB rise. Results Incidence of side branch occlusion (SBO) and any anatomic complications assessed by angiography was similar between the 2 treatment arms (SBO: Absorb: 4.5% vs. Xience: 6.7%, p=1; One PMI with acute instent thrombosis occurred in EES group. Dissection occurred in only 1 patient in BVS arm after stent implantation; this event was not associated with elevated cardiac biomarkers. One patient had PMI in BVS arm with no angiographic complications to explain it.

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.

Serial Baseline, 12-, 24-, and 60-Month Optical Coherence Tomography Evaluation of ST Segment Elevation Myocardial Infarction Patients Treated with Absorb Bioresorbable Vascular Scaffold

Data on long-term neointimal healing and neoatherosclerosis progression after primary percutaneous coronary intervention (PCI) with implantation of everolimus-eluting bioresorbable vascular scaffold (BVS) (ABSORB BVS 1.0, Abbott Vascular) are limited. The mechanisms underlying very late scaffold failure remain to be further elucidated. This study sought to assess healing pattern and presence of neoatherosclerosis. This was a single-center, prospective, longitudinal study with serial optical coherence tomography (OCT) assessment at baseline, 12, 24 and 60 months after PCI performed in 12 patients presenting with ST-segment elevation myocardial infarction (STEMI). The median follow-up was 59 months. The diameter stenosis increased from 7.11 ± 4.99% at 1-year to 21.00 ± 11.31% at 5 years, (p = 0.03), whereas minimum lumen diameter remained stable throughout the follow-up period, as assessed by angiography. Minimum and mean lumen area declined over the 5-year follow-up by 1.00 ± 1.57 mm2 and 1.75 ± 0.87 mm2, respectively; a significant decrease in minimum and mean lumen area in the first two years, was followed by stable luminal dimensions between 2 and 5 years of follow-up. The lumen eccentricity (0.85 ± 0.03) and asymmetry (0.43 ± 0.10) indexes showed no change over 60-month follow-up. The incidence of atherosclerosis was high both in the in-scaffold (IS) and out-scaffold (OS) regions consisting of calcifications (IS = 100%, OS = 92%, p = 0.99), macrophages (IS = 92% and OS = 67%, p = 0.31), neovascularization (IS = 75%, OS = 50%, p = 0.40). In conclusion, serial OCT imaging up to 5 years after implantation of BVS in STEMI indicated complete scaffold resorption, stable lumen area following period of neointima growth in the first two years after PCI and high incidence of neoatherosclerosis.

Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data.

Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.

Factors associated with long-term major adverse cardiac events of coronary bioresorbable vascular scaffold.

The long-term clinical outcomes after implantation of bioresorbable vascular scaffolds (BVS) in a real-world cohort were not well described. To identify factors associated with major adverse cardiovascular events (MACE) on long-term follow-up after implantation of BVS in patients undergoing elective percutaneous coronary intervention (PCI). This was an observational study based on a hospital registry of percutaneous coronary intervention. Participants were consecutive patients who underwent PCI and implanted with at least one everolimus-eluting BVS (Absorb®) in a single center between 2014 and 2017. Among the 170 cases analyzed (mean age 60.4 ± 10.7), a total of 203 Absorb BVS were implanted. MACE developed in 33 (19.4%) patients over a median follow-up period of 61months, including 9 (5.3%) deaths, 13 (7.6%) non-fatal myocardial infarction and 19 (11.2%) ischemia driven target vessel revascularization. Definite or probable stent thrombosis developed in 4 (2.4%) patients. In crude analysis, history of smoking and initial presentation of non-ST elevation-acute coronary syndrome (NSTE-ACS) were predictors of long-term MACE. In adjusted analysis, presentation with NSTE-ACS was an independent predictor of long-term MACE [adjusted odds ratio (OR) 4.52; 95% confidence interval (95% CI) 1.50 to 13.6, P = 0.007]. Among patients receiving implantation of ABSORB BVS, presentation with NSTE-ACS was an independent predictor of MACE after a median follow-up period of 61months. Future research is needed to confirm these findings and to determine the long-term safety of BVS in patients with NSTE-ACS.

Major adverse cardiovascular events after implantation of absorb bioresorbable scaffold: One-year clinical outcomes

Background/Aim: Bioresorbable vascular scaffold (BVS) represents a novel generation of intracoronary devices designed to be fully resorbed after healing of the stented lesion, delivering antiproliferative drug to suppress restenosis, providing adequate diameter of the coronary vessel and preserving the vascular endothelial function. It was supposed that BVS will reduce neointimal proliferation and that their late bioresorption will reduce the negative effects of traditional drug-eluting stents, including the late stent thrombosis, local vessel wall inflammation, loss of coronary vasoreactivity and the need for the long-term dual antiplatelet therapy. The purpose of this research was to investigate efficacy and safety of Absorb everolimus-eluting BVS implantation and the prevalence of major adverse cardiovascular events (MACE) at the mid-term follow-up. Methods: The study encompassed 42 patients selected for BVS implantation and fulfilling inclusion criteria - 37 male and 5 female - admitted to the Dedinje Cardiovascular Institute, Belgrade, Serbia over the one-year period (from January 2015 to January 2016) for percutaneous coronary intervention (PCI). Coronary vessel patency before and after stenting was assessed by the Thrombolysis in Myocardial Infarction flow (TIMI) grades. After the index PCI procedure with BVS all patients were clinically followed by regular (prescheduled or event-driven) visits during the next 12-month period. Results: In the intention-to-treat analysis, all Absorb BVS procedures were successful, without the need for conversion to other treatment modalities. The complete reperfusion (TIMI flow grade 3) after the intervention was established in 97.6 % of patients and 100 % of them achieved the TIMI flow grade ≥ 2. The presence of angina pectoris was reduced significantly by the BVS procedure: stable angina 57.1 % to 11.9 %, (p < 0.001) and unstable angina 31 % to 0 %, respectively (p < 0.001). After the one-year follow-up, the MACE rate was 11.9 %. Myocardial infarction occurred in 4.8 % and the need for PCI reintervention in 2.4 % of cases (not influenced by the gender or the age of patients). There were 4 cases of death (all patients were older and had lower values of left ventricular ejection fraction). Conclusion: The results of the current research demonstrated a high interventional success rate of the Absorb BVS implantation, followed by the early improvement of the anginal status. However, that was not translated into the favourable mid-term clinical outcomes, opening debate about the current status of Absorb BVS and the need for future refinements of stent design and implantation techniques.

Safety and feasibility of bioabsorbable everolimus-eluting stents for patients with internal pudendal artery-related arteriogenic erectile dysfunction (PERFECT-ABSORB)

Abstract Background Obstructive pelvic arterial lesions are present in ∼70% of patients aged >50 years and having erectile dysfunction. The internal pudendal artery, with an average diameter of 2.5 mm, is the segment where ∼40% of pelvic obstructive lesions are located. Our prior experience showed a 40–50% binary restenosis rate for drug-eluting stents in internal pudendal artery. In this PERFECT-ABSORB study, we would like to assess the feasibility and safety of the bioresorbable everolimus-eluting vascular scaffolds (BVS), facilitated by intravascular optical coherence tomography (OCT), in patients with erectile dysfunction and concomitant internal pudendal artery stenoses. Methods This prospective, unblinded, single-arm, single-center study was a first-in-man proof-of-concept study. Patients with erectile dysfunction and obstructive pelvic arterial lesions (unilateral diameter stenosis ≥70% or bilateral stenoses ≥50%) in the internal pudendal arteries with reference vessel diameter ≥2.5 mm and ≤4.0 mm and a target-lesion length ≤30 mm in the pelvic computed tomographic (CT) angiography were recruited. All subjects underwent pelvic CT angiography, penile Doppler ultrasonography, and invasive pelvic angiography with OCT at baseline and 8 months after intervention. The primary endpoint is CT angiographic binary restenosis (≥50% lumen diameter stenosis) at 8 months. The secondary endpoints include sustained clinical success in erectile function (International Index for Erectile Function-5 [IIEF-5] score ≥22 or change in IIEF-5 ≥4 and without a later decline by ≥4) at 12 months. Results Eighteen patients were enrolled (mean age, 61.8±5.6 years; range, 52–71 years). The IIEF-5 score at baseline was 7.3±3.6, with a median duration of erectile dysfunction of 3 years. A total of 31 BVSs were implanted: seven patients were treated with one BVS, 9 patients with 2 BVSs, and 2 patients with 3 BVSs. All implanted BVSs were of 2.5 mm in diameter. Among the 17 patients undergoing 8-month follow-up pelvic CT angiography and invasive angiography (one not done due to colon cancer diagnosed later), binary CT angiographic restenosis developed in 7 (37%) of 19 lesions and 7 (41%) of 17 patients. After excluding those with lesions >30 mm (per-protocol analysis), binary CT angiographic restenosis developed in 5 (31%) of 16 lesions and 5 (36%) of 14 patients. Binary restenosis assessed by invasive angiography and OCT was the same as assessed by pelvic CT angiography. Among the 17 patients, 9 (53%) achieved sustained clinical success in erectile function 12 months following the procedure. All of them did not develop binary restenosis. Conclusions We for the first time demonstrated that BVS+OCT strategy for internal pudendal artery stenosis was safe and able to achieve 30% restenosis rate in lesions ≤30 mm in length. Compared to our prior experience, BVS+OCT strategy was associated with a numerically lower restenosis rate. Funding Acknowledgement Type of funding source: None

Bioresorbable scaffold versus drug coated balloon for treatment of in-stent-restenosis – long-term outcomes of the randomized ABSORB-ISR trial

Abstract Background Observational studies showed promising results after treatment of coronary instent-restenosis (ISR) using the everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb®. Purpose We compared long-term outcomes after treatment of ISR with BVS versus the paclitaxel-eluting drug coated balloon (PE-DCB) SeQuent® Please, which is commonly used for treatment of ISR. Methods This was randomized-controlled trial of Absorb® BVS versus SeQuent® Please PE-DCB in an all-comers population with clinically relevant ISR. The patients were randomized in a 1:1 fashion. The angiographic primary endpoint was late lumen loss (LLL) at 9 months. Clinical follow-ups (FU) up to 48 months were conducted. Results Totally, 53 patients and lesions were enrolled. The mean age was 66.7±9.8 years, 23 (43.4%) had an acute coronary syndrome (ACS) and 16 (30.2%) were diabetic. PCI was successful in all patients. After 9 months, the mean LLL did not significantly differ between patients treated with BVS versus PE-DCB (median 0.41 (interquartile range (IQR) 0.15; 1.23)mm versus 0.27 (IQR 0.13; 0.66)mm, p=0.86). Moreover, mean lumen area on optical coherence tomography (OCT) did not significantly differ (median 5.47 (IQR 4.44; 7.69)mm2 versus 6.70 (IQR 5.00; 7.82)mm2, p=0.24). Rates of significant ISR (angiographic stenosis >70%) were similar with BVS versus PE-DCB (7 (30.4%) versus 6 (27.3%), p=0.81). The target vessel revascularization rates were 9 (33.3%) versus 9 (34.6%) using the BVS versus PE-DCB (p=0.72), also highlighted in the Figure below). No stent/ scaffold thrombosis occurred during FU. The study was prematurely stopped due to withdrawal of the Absorb® BVS in September 2017. Conclusions In this randomized pilot study, we found no significant difference in angiographic, OCT and clinical endpoints after treatment of ISR lesions using the Absorb BVS versus SeQuent® Please PE-DCB during long-term follow-up (≥48months). However, rates of target vessel revascularization were very high in both groups (>30%). TVR and TLF with BVS or PE-DCB for ISR Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott Vascular

Long-term follow-up of therapeutic efficacy of everolimus-eluting bioresorbable vascular scaffold in comparison to everolimus-eluting stent in treatment of chronic total occlusion guided by intracoronary imaging

BackgroundWe hypothesized that 1st generation everolimus-eluting bioresorbable vascular scaffold (BVS) stent associated with less complication and less restenosis rate than everolimus-eluting stent (EES) in chronic total occlusion (CTO) recanalization guided by intracoronary imaging. Therefore, we aimed to assess the safety and performance of BVS stent in CTO revascularization in comparison to EES guided by intracoronary imaging.Our prospective comparative cross-sectional study was conducted on 60 CTO patients divided into two groups according to type of stent revascularization: group I (EES group): 40 (66.7%) patients and group II (BVS group): 20 (33.3%) patients. All patients were subjected to history taking, electrocardiogram (ECG), echocardiography, laboratory investigation, stress thallium study to assess viability before revascularization. Revascularization of viable CTO lesion guided by intracoronary imaging using optical coherence tomography (OCT). Then, long-term follow-up over 1 year clinically and by multi-slice CT coronary angiography (MSCT). Our clinical and angiographic endpoints were to detect any clinical or angiographic complications during the follow-up period.ResultsAt 6 months angiographic follow-up, BVS group had not inferior angiographic parameters but without statistically significant difference (p = 0.566). At 12 months follow-up, there was no difference at end points between the two groups (p = 0.476).No differences were found at angiographic or clinical follow-up between BVS and EES.ConclusionThis study shows that 1st generation everolimus-eluting BVS is non-inferior to EES for CTO revascularization. Further studies are needed to clearly state which new smaller footprint BVS, faster reabsorption, magnesium-based less thrombogenicity, and advanced mechanical properties is under development. We cannot dismiss the efficacy and safety of new BVS technology.Trial registrationZU-IRB#2498/3-12-2016 Registered 3 December 2016, email: IRB_123@medicine.zu.edu.eg

Evolución de pacientes tratados con armazones coronarios bioabsorbibles liberadores de everolimus tras su disolución completa

Introduction and objectivesLong-term outcomes of unselected patients treated with bioresorbable vascular scaffold (BVS) implantation are lacking, especially for the period after complete dissolution of the BVS. This study sought to evaluate 5-year outcomes in patients treated with BVS in routine practice. MethodsConsecutive patients who underwent implantation of everolimus-eluting BVS during routine clinical practice at 2 high-volume centres in Germany were studied. The patients were followed-up for up to 5 years. The primary endpoints of interest were the composite of death, myocardial infarction and target lesion revascularization, as well as definite scaffold thrombosis. ResultsA total of 419 patients (mean age 66.6 ± 10.9 years; 31.5% had diabetes) were included, of whom 38.9% presented with an acute coronary syndrome. Of the 527 lesions treated, 49.0% were classified as complex and 13.1% were bifurcation lesions. At 5 years, the composite clinical endpoint occurred in 33.1% of patients and definite scaffold thrombosis occurred in 4.7%. Most definite scaffold thrombosis occurred within 2 years after BVS implantation. ConclusionsIn patients treated with BVS implantation in routine clinical practice the rates of adverse clinical events at 5 years were high, including a considerable incidence of scaffold thrombosis.

Outcomes after complete dissolution of everolimus-eluting bioresorbable scaffolds implanted during routine practice

Introduction and objectivesLong-term outcomes of unselected patients treated with bioresorbable vascular scaffold (BVS) implantation are lacking, especially for the period after complete dissolution of the BVS. This study sought to evaluate 5-year outcomes in patients treated with BVS in routine practice. MethodsConsecutive patients who underwent implantation of everolimus-eluting BVS during routine clinical practice at 2 high-volume centres in Germany were studied. The patients were followed-up for up to 5 years. The primary endpoints of interest were the composite of death, myocardial infarction and target lesion revascularization, as well as definite scaffold thrombosis. ResultsA total of 419 patients (mean age 66.6 ± 10.9 years; 31.5% had diabetes) were included, of whom 38.9% presented with an acute coronary syndrome. Of the 527 lesions treated, 49.0% were classified as complex and 13.1% were bifurcation lesions. At 5 years, the composite clinical endpoint occurred in 33.1% of patients and definite scaffold thrombosis occurred in 4.7%. Most definite scaffold thrombosis occurred within 2 years after BVS implantation. ConclusionsIn patients treated with BVS implantation in routine clinical practice the rates of adverse clinical events at 5 years were high, including a considerable incidence of scaffold thrombosis.

Procedural microvascular activation in long lesions treated with bioresorbable vascular scaffolds or everolimus-eluting stents: the PROACTIVE trial.

Significant platelet activation after long stented coronary segments has been associated with periprocedural microvascular impairment and myonecrosis. In long lesions treated either with an everolimus-eluting bioresorbable vascular scaffold (BVS) or an everolimus-eluting stent (EES), we aimed to investigate (a) procedure-related microvascular impairment, and (b) the relationship of platelet activation with microvascular function and related myonecrosis. Patients (n=66) undergoing elective percutaneous coronary intervention (PCI) in long lesions were randomised 1:1 to either BVS or EES. The primary endpoint was the difference between groups in changes of pressure-derived corrected index of microvascular resistance (cIMR) after PCI. Periprocedural myonecrosis was assessed by high-sensitivity cardiac troponin T (hs-cTnT), platelet reactivity by high-sensitivity adenosine diphosphate (hs-ADP)-induced platelet reactivity with the Multiplate Analyzer. Post-dilatation was more frequent in the BVS group, with consequent longer procedure time. A significant difference was observed between the two groups in the primary endpoint of ΔcIMR (p=0.04). hs-ADP was not different between the groups at different time points. hs-cTnT significantly increased after PCI, without difference between the groups. In long lesions, BVS implantation is associated with significant acute reduction in IMR as compared with EES, with no significant interaction with platelet reactivity or periprocedural myonecrosis.

Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry

Purpose: To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR (Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) registry. Materials and Methods: A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Results: Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. Conclusion: The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.

Mid-term outcomes of bioresorbable vascular scaffolds vs second-generation drug-eluting stents in patients with acute coronary syndromes: A systematic review and meta-analysis.

Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes. We searched PubMed, Embase, the Cochrane Library, Web of Science, and relevant web sites for studies with a follow-up of ≥ 1 years that studied percutaneous coronary interventions with BVS vs second-generation DES in acute coronary syndromes. A meta-analysis was performed with the software RevMan following the standards of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Five studies, 2 randomized controlled trials, and 3 observational studies, with a total of 1758 patients (BVS n = 917; DES n = 841) and a median follow-up duration of 24 months, were included. BVS, when compared with DES, resulted in higher rates of target lesion revascularization (TLR) (OR, 2.20; 95% CI, 1.12-3.64; P = .02) and stent/scaffold thrombosis (ST/ScT) (OR = 2.35, 95% CI: 1.13-4.89, P = .02). When TLR due to device thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR: 1.67, 95% CI: 0.73-3.82, P = .22). The risk for all-cause death (OR = 1.32 95% CI: 0.61-2.88, P = .48), cardiac death (OR = 1.29, 95% CI: 0.58-2.86 P = .52), target vessel myocardial infarction (OR = 1.50, 95% CI: 0.86-2.61, P = .15), and target lesion failure (OR = 1.34, 95% CI: 0.76-2.35, P = .31) did not differ between BVS and DES groups. At mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.

Comparison of percutaneous coronary intervention using bioresorbable vascular scaffold and minimally invasive direct coronary artery bypass for left anterior descending artery disease: 3-year clinical outcomes

Aim. Evaluates 3-year clinical outcomes of percutaneous coronary intervention (PCI) with bioresorbable vascular scaffold (BVS) versus minimally invasive direct coronary artery bypass (MIDCAB) surgery for the treatment of left anterior descending (LAD) lesions.Methods. In this single-center study were included 130 patients with stable angina and significant (≥70%) LAD disease. Patients were randomly assigned in a 1:1 ratio to PCI with everolimus-eluting bioresorbable vascular scaffold (Absorb) (n = 65) or MIDCAB (n = 65). The primary end-point was major adverse cerebrocardiovascular events (MACCE) and secondary was. Primary and secondary endpoints were, respectively, major adverse cerebro-cardiovascular events (MACCE) and target vessel failure at 3-year.Results.The groups of patients were comparable for all baseline demographic, clinical and angiographic parameters. The primary composite endpoint of MACCE through 3 years occurred in 16.9% of BVS patients and 9.2% of MIDCAB patients (p = 0.19). But 3-year any revascularization rates were higher with BVS (13.8% vs. 3.1%; p = 0.027). TVF was favor of the MIDCAB group (12,3% vs. 3,1%, p = 0.04), mainly triggered by high subsequent need for revascularization of the targeted vessel in the BVS group (9.2% vs. 1.5%; p = 0.05).Conclusion. At 3-year follow-up, PCI by BVS and MIDCAB in in patients with isolated LAD lesions yielded similar long-term outcomes regarding the primary composite clinical endpoint. The bioresorbable scaffold was associated with a higher incidence of reinterventions, TVF and TVR than the MIDCAB through 3 years of follow-up.

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

IntroductionDespite the withdrawal of the ABSORB bioresorbable vascular scaffold (BVS) from clinical use, continuous observation of BVS-treated patients is necessary. In the vast majority of clinical trials, patients with ST-segment elevation myocardial infarction (STEMI) were excluded from the analysis.AimTo compare the early and long-term outcomes of the BVS with the everolimus-eluting metallic stent (EES) in patients with STEMI.Material and methodsConsecutive patients treated with BVS or EES in our center were screened. For analysis, only patients with STEMI were enrolled. The primary endpoint was a comparison of the target lesion failure at 12 and 24 months. The secondary endpoints encompass occurrence of the patient-oriented cardiovascular endpoint (PoCE), stent thrombosis (ST), device, and procedural success.ResultsBetween 2012 and 2016, 2,137 patients were hospitalized for STEMI. Of these, 123 patients received the BVS (163 scaffolds; 151 lesions), whereas in 141 patients the EES (203 stents; 176 lesions) was implanted. The median follow-up was 931 ±514 days. The primary endpoint at 12 months occurred in 9.7% in the BVS group and in 8.5% in the EES group (hazard ratio (HR) = 2.61; 95% confidence interval (CI): 0.90–7.56; p = 0.076). At 24 months the incidence of the primary endpoint was 15.2% in the BVS group and 14.9% in the EES group (HR = 2.46; 95% CI: 0.85–7.07; p = 0.095). The rates of PoCE, ST, device, and procedural success were also comparable in both groups.ConclusionsSTEMI patients treated with the BVS showed statistically similar rates of primary and secondary endpoints compared with the EES.