Absorb Bioresorbable Vascular Scaffold Implantation Research Articles

Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry

Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years. The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry. All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis. Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis. Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.

Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials

BackgroundThe long-term prognostic impact of IVUS findings following Absorb BVS implantation remains uncertain. This study aimed to identify the IVUS predictors of long-term clinical outcomes following ABSORB bioresorbable vascular scaffold (BVS) implantation from the pooled IVUS substudy cohorts of the ABSORB III and Japan trials. MethodsA total of 298 lesions in 286 patients were enrolled with 2:1 randomization to ABSORB BVS vs. cobalt-chromium everolimus-eluting stents. This sub-analysis included 168 lesions of 160 patients in the Absorb arm whose post-procedural quantitative IVUS were available. The primary endpoint of this analysis was device-oriented composite endpoint (DOCE) of target lesion failure, including cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The median follow-up duration was 4.9 [3.1–5.0] years. ResultsDuring follow-up, DOCE occurred in 10.1% of lesions treated with Absorb BVS. Among several post-procedural IVUS indices associated with DOCE, non-uniform device expansion (defined as uniformity index = minimum / maximum device area) (hazard ratio 0.47 per 0.1 increase [95%CI 0.28 to 0.77]; p = 0.003) and residual reference plaque burden (hazard ratio 4.01 per 10% increase [95%CI 1.50 to 10.77]; p = 0.006) were identified as independent predictors of DOCE by Cox multivariable analysis. ConclusionsNonuniform device expansion and substantial untreated residual plaque in reference segments were associated with long-term adverse events following BVS implantation. Baseline imaging to identify the appropriate device landing zone and procedural imaging to achieve uniform device expansion if possible (e.g. through post-dilatation) may improve clinical outcomes of BVS implantation. Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01751906 (ABSORB III); NCT01844284 (ABSORB Japan).

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.

The Absorb bioresorbable vascular scaffold in real-world practice: long-term follow-up of the AMC Single Centre Real World PCI Registry.

BackgroundBioresorbable scaffolds have been introduced to overcome the shortcomings of drug-eluting stents. Higher rates of device thrombosis, however, have been reported up to 3 years after implantation of the Absorb bioresorbable vascular scaffold (BVS). In the current article, we therefore report long-term clinical outcomes of the AMC Absorb Registry.Methods and resultsIn the AMC Absorb Registry, all patients who underwent a percutaneous coronary intervention with Absorb BVS implantation between 30 August 2012 and 5 August 2013 at the Amsterdam University Medical Centre—Academic Medical Centre were included. The composite endpoint of this analysis was target-vessel failure (TVF). The median follow-up of the study cohort of the AMC Absorb Registry was 1534 days. At the time of the cross-sectional data sweep the clinical status at 4 years was known in 124 of 135 patients (91.9%). At long-term follow-up, the composite endpoint of TVF had occurred in 27 patients. The 4‑year Kaplan-Meier estimate of TVF was 19.8%. At 4 years cardiac death had occurred in 4 patients (3.2%) and target-vessel myocardial infarction in 9 (6.9%) patients. Definite scaffold thrombosis occurred in 5 (3.8%) patients. We found 1 case of very late scaffold thrombosis that occurred at 911 days after device implantation in a patient who was not on dual anti-platelet therapy.ConclusionIn a patient population reflecting routine clinical practice, we found that cases of TVF continued to accrue beyond 2 years after Absorb BVS implantation.

Long-term outcomes after bioresorbable scaffold implantation in patients with coronary artery stenosis

Aim. The present study aimed to demonstrate the long-term outcomes after Absorb (Abbott Vascular, USA) everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in real-world patients with coronary artery disease.Methods. This trial involved the largest registry of Absorb BVS implantation in patients with coronary artery disease from Russia, and it was conducted between 2014 and 2018 (n = 500). Safety and efficacy parameters (target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation; major adverse cardiac and cardiovascular events, defined as a composite of cardiac death, myocardial infarction, target vessel revascularisation and stroke, stent thrombosis according to the Academic Research Consortium definition) were assessed over a period of 2 years after the index procedure. Results. Lesion treatment success was achieved in 98.51% (n = 594) of patients. In the 2 years after Absorb BVS implantation, long-term outcomes were assessed via phone calls. Only 9.8% (n = 49) of patients were lost to follow-up. The rates of target vessel failure and major adverse cardiac and cerebrovascular events were 11.6% (n = 58) and 12.6% (n = 63), respectively. Definite/probable stent thrombosis was observed in 3.2% (n = 16) of patients. Conclusion. Using an optimal implantation technique during Absorb BVS implantation in routine clinical practice leads to a high level of lesion treatment success. However, despite this, Absorb BVS use is associated with an increased risk of device-related adverse events, particularly stent thrombosis. Absorb BVS use in long and bifurcated lesions and BVS implantation in the distal segment of the coronary artery are independent predictors of stent thrombosis. In addition, Absorb BVS use in patients with a high functional class of angina and heart failure, multivessel coronary artery disease as well as BVS implantation in the distal segment of the coronary artery are independent predictors of device-related adverse events.Received 22 July 2019. Revised 1 October 2019. Accepted 14 October 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.

Long-term clinical outcomes of direct absorb bioresorbable vascular scaffold implantation in acute coronary syndrome.

Preferred technique for bioresorbable vascular scaffold (BVS) implantation included high pressure predilation. Data about direct BVS implantation in acute coronary syndrome (ACS) patients are scarce. Analysis of 90 consecutive patients with acute myocardial infarction (MI) treated with primary PCI with Absorb deployment between 2013-2016 in a single center. In 45 patients, scaffolds were implanted in the direct technique, other 45 patients underwent Absorb deployment after balloon predilation. Follow-up was available in 100% of patients with mean duration of 32±11 months. No cardiac death or scaffold thrombosis were observed in both groups. In the direct group, no target lesion revascularization (TLR) was reported. In the predilation arm, TLR occurred in 4 (9%) patients (P=0.12). Target vessel revascularization (TVR) was observed in 1 (2%) case in the direct group and in 6 (13%) patients from the predilation group (P=0.11). Target vessel MI was reported in one patient from each group. In an intention to treat analysis, we observed significantly higher rates of TVR (15% vs. 2%; P<0.043) and TLR (10% vs. 0%; P=0.038) in the predilation arm. Kaplan-Meier survival analysis did not show significant differences in TLR, TVR and device oriented composite endpoint (a combination of cardiac death, target vessel MI and ischemia driven TLR) between patients treated with both methods. Direct Absorb implantation in patients with ACS may be feasible and safe.

Predictors of long-term adverse events after Absorb bioresorbable vascular scaffold implantation: a 1,933-patient pooled analysis from international registries.

The aim of this study was to investigate the predictors of long-term adverse clinical events after implantation of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS). We pooled patient-level databases derived from the large-scale ABSORB EXTEND study and five high-volume international centres. Between November 2011 and November 2015, 1,933 patients underwent PCI with a total of 2,372 Absorb BVS implanted. The median age was 61.0 (IQR 53.0 to 68.6) years, 24% had diabetes, and 68.2% presented with stable coronary artery disease. At a median follow-up of 616 days, MACE occurred in 93 (4.9%) patients, all-cause death in 36 (1.9%) patients, myocardial infarction in 47 (2.5%) patients, and target vessel revascularisation in 72 (3.8%) patients. Definite or probable scaffold thrombosis occurred in 26 (1.3%) patients. On multivariable logistic regression analysis, acute coronary syndromes (hazard ratio [HR] 2.79, 95% confidence interval [CI]: 1.47 to 5.29; p=0.002), dyslipidaemia (HR 1.43, 95% CI: 1.23 to 1.79; p=0.007), scaffold/reference diameter ratio >1.25 (HR 1.49, 95% CI: 1.18 to 1.88; p=0.001), and residual stenosis >15% (HR 1.67, 95% CI: 1.34 to 2.07; p<0.001) were independent predictors of MACE, whereas the use of intravascular imaging was independently associated with a reduction in MACE (HR 0.13, 95% CI: 0.06 to 0.28; p<0.001). Optimal Absorb BVS implantation and the use of intravascular imaging guidance are associated with lower rates of adverse events at long-term follow-up.

Re-endothelialisation after Synergy stent and Absorb bioresorbable vascular scaffold implantation in acute myocardial infarction: COVER-AMI study

Background/aimsDrug eluting stent (DES) decrease the risk of restenosis by reducing the neointimal response. However, DES may impair strut coverage, and this has been associated with late stent/scaffold thrombosis. Bioresorbable vascular scaffold (BVS) may overcome the risk of stent/scaffold thrombosis when completely resorbed. The purpose of this randomised trial was to compare the arterial healing response in the short term, as a surrogate for safety and efficacy, between the metallic everolimus-eluting stent (Synergy; Boston Scientific, Marlborough, MA, USA) and the everolimus BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) in the particular setting of acute myocardial infarction (AMI). This pilot study sought to compare the neointimal response of metallic everolimus DES (Synergy) with polymeric everolimus BVS (Absorb) by optical coherence tomography (OCT) 3 months after an AMI.MethodsCOVER-AMI was a single-centre, single-blind, non-inferiority, randomised controlled trial. Patients with ST segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention were randomly allocated (1:1) to treatment with the Synergy DES or Absorb BVS. The primary endpoint was the 3-month neointimal response assessed as the percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima. The main secondary endpoint included the device-oriented composite endpoint according to the Academic Research Consortium definition.ResultsTwenty patients without clinical and/or angiographic complications (Synergy (n = 10) or BVS (n = 10); mean age 59.0 years; 20% female) were enrolled in our centre. The stent diameter was higher in the Synergy group (3.7 ± 0.4 mm vs 3.4 ± 0.4 mm in the BVS group, p = 0.01). At 3 months, no significant differences in angiographic lumen loss were observed between the everolimus DES and everolimus BVS (0.04 mm (IQR 0.00–0.07) vs 0.11 mm (IQR 0.04–0.31), p = 0.165). OCT analysis of 420 cross-sections showed that the total neointimal area and in-stent obstruction were lower in the Synergy group, while OCT analysis at the strut level (n = 3942 struts) showed that the rate of uncovered struts was lower in the BVS group.ConclusionsStenting of culprit lesions in the setting of STEMI resulted in a nearly complete arterial healing for both the Synergy and the BVS devices. Lower neointimal thickness and in-stent obstruction but a higher rate of uncovered struts were observed in the Synergy group. These findings provide the basis for further exploration in clinically oriented outcome trials.

The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial

Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58–1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52–1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19–0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.

Long-term outcome of first 300 implanted Absorb bioresorbable vascular scaffolds in an all-comers Middle East population

ObjectivesTo evaluate long-term clinical outcomes of the Absorb bioresorbable vascular scaffold (BVS) system (Abbott Vascular) in an all-comers Middle East population.MethodsThis prospective registry study included an initial set of patients with coronary lesions treated using Absorb BVS. Patients were followed for target vessel failure (TVF) including cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization.ResultsA total of 217 patients (age, 55 ± 11 years; male, 169) with 300 treated lesions were included (median follow-up, 36 months [range, 26–41 months]; complete follow-up, 201 patients). Diabetes mellitus and acute coronary syndrome were present in 50% and 57% of patients, respectively. TVF rate was 32/201 (15.9%), including cardiac death in 10 (5%), target vessel MI in 13 (6.5%), and target lesion revascularization in 22 patients (10.9%). Definite or probable device thrombosis occurred in 11/201 patients (5.5%). TVF was associated with heart failure, worse ejection fraction, multi-vessel BVS, multi BVS in lesion, and total BVS length >50 mm.ConclusionsLong-term outcome following Absorb BVS implantation in a population with high prevalence of high-risk and complex patients is acceptable, but heart failure, worse ejection fraction, and multi-vessel or long BVS implantation were associated with worse outcomes.

Predictors of early scaffold thrombosis: results from the multicenter prospective German-Austrian ABSORB RegIstRy.

In randomized clinical trials, the risk of thrombotic events with the absorb bioresorbable vascular scaffold (BVS) was significantly higher than with metallic drug-eluting stents. We evaluated predictors of scaffold thrombosis in the large-scale, multicenter German-Austrian ABSORB RegIstRy. 3178 patients with treatment of 4252 lesions using 5020 scaffolds were included. Follow-up rate at 6 months was 97.4%. Forty-five (1.42%) patients experienced definite/probable scaffold thrombosis during follow-up. Multiple regression analysis showed implantation of absorb BVS in bifurcation lesions [odds ratio (OR): 4.43; 95% confidence interval (CI): 1.69-11.59; P=0.0024] or treatment in the years 2013/2014 (OR: 1.88; 95% CI: 1.02-3.47; P=0.04) to be significant predictors of scaffold thrombosis. Excluding bifurcation lesions, the incidence of definite/probable scaffold thrombosis decreased from 1.8% (95% CI: 1.17-2.64%) in 2013/2014 to 0.89% (95% CI: 0.5-1.46%) in 2015/2016. In the latter period, absorb BVS were implanted more often in younger patients with less complex de novo lesions, and debulking devices and postdilatation were used more frequently. Between the two treatment periods, there was a significant reduction in myocardial infarction (2.73-1.24%, P<0.01; OR: 0.45; 95% CI: 0.26-0.77), definite/probable scaffold thrombosis (1.79-0.88%, P<0.05; OR: 0.49; 95% CI: 0.26-0.93), and target lesion failure and revascularization during follow-up. Improved procedural technique and more strict patient selection may explain a significant decrease in the absorb BVS thrombosis rates during the recruitment period of the large-scale German-Austrian ABSORB RegIstRy. In addition, treatment of bifurcation lesions was identified as an independent predictor of definite/probable scaffold thrombosis.

Direct Absorb bioresorbable scaffold implantation in acute coronary syndrome.

Direct stent implantation is a preferred technique for primary percutaneous coronary intervention (PCI). For the deployment of a bioresorbable vascular scaffold (BVS), the current guidelines recommend aggressive predilatation. Data about direct BVS implantation in patients with acute coronary syndrome (ACS) are scarce. We sought to assess procedural characteristics and immediate outcomes of direct Absorb BVS implantation in ACS patients. A total of 91 patients with acute myocardial infarction (MI) requiring urgent coronary revascularisation were enrolled. Among them, 50 patients underwent an attempt of direct Absorb implantation. The control group consisted of 41 patients treated with PCI with BVS deployment after elective predilatation. In the direct group BVS deployment was successful in 91% of lesions, and in the remaining 9% of lesions direct implantation failed. In the control group scaffolds were successfully deployed after predilatation in 98% of lesions. In one case Absorb implantation failed even after balloon angioplasty. Type C lesions with severe tortuosity and angulation > 90° were associated with failure in direct Absorb deployment. Quantitative coronary analysis showed similar final percentages of diameter stenosis in the study and control groups. Flow analyses did not show significant differences between both methods. During hospitalisation no recurrent MI, scaffold thrombosis, or target lesion revascularisation was reported in either group. Direct Absorb implantation in ACS patients may be feasible in a suitable lesion anatomy.

Long-term safety of bioresorbable scaffolds: insights from a network meta-analysis including 91 trials.

The aim of this study was to investigate the long-term safety and efficacy of biodegradable scaffolds and metallic stents. We analysed a total of 91 randomised controlled trials with a mean follow-up of 3.7 years in 105,842 patients which compared two or more coronary metallic stents or biodegradable scaffolds and reported the long-term clinical outcomes (≥2 years). Network meta-analysis showed that patients treated with the Absorb bioresorbable vascular scaffold (BVS) had a significantly higher risk of definite or probable scaffold thrombosis (ScT) compared to those treated with metallic DES. The risk of very late ScT was highest with the Absorb BVS among comparators. Pairwise conventional meta-analysis demonstrated that the elevated risk of ScT with Absorb BVS compared to cobalt-chromium everolimus-eluting stents was consistent across the time points of ≤30 days (early), 31 days - 1 year (late) and >1 year (very late) ScT. In addition, target lesion failure rates were significantly higher in the Absorb BVS cohort, driven by both increased risk of target vessel myocardial infarction and ischaemia-driven target lesion revascularisation. Absorb BVS implantation was associated with increased risk of long-term and very late ScT compared to current-generation metallic DES. The risk of ScT occurred with a rising trend beyond one year.

TCT-168 TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold implantation for recovery of vascular function after successful Chronic Total Occlusion recanalization

Coronary vascular function of a chronic coronary total occlusion (CTO) immediately after recanalization is demonstrated to be poor. We aim to explore role of Ticagrelor vs. Clopidogrel in improving vascular function in this context. The TIGER BVS is a prospective, double-randomized, open-label, two

Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents

BackgroundAlthough previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion. ObjectivesThis study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling. MethodsIn the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements. ResultsThe relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. −1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling. ConclusionsExpansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281)

One-year outcomes after Absorb bioresorbable vascular scaffold implantation in routine clinical practice.

Our aim was to report one-year outcomes of Absorb bioresorbable scaffold implantation under real-world conditions in an all-comers population of patients with high proportions of complex lesions. Patients undergoing Absorb 1.1 implantation were included in a single-centre, prospective, all-comers registry. The primary outcome was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction (MI), or clinically driven target lesion revascularisation (TLR). A total of 319 patients received 604 Absorb BVS in 406 lesions. Of note, 24.8% of patients had diabetes and 49.5% presented with an acute coronary syndrome. A total of 51% of lesions were type B2/C. The reference vessel diameter and lesion length were 2.9±0.5 and 21.2±16.8 mm, respectively. The one-year cumulative rate of TLF was 4.9%. Rates of cardiac death, target vessel MI and TLR were 0.9%, 1.3% and 4.2%, respectively. The cumulative one-year rate of definite/probable scaffold thrombosis was 1.3%, with all events occurring within 30 days. These data suggest that twelve-month clinical outcomes of Absorb use in "real-world" unselected patients with high proportions of complex lesions are reasonably good.

Первый случай имплантации биорезорбируемого стентирующего каркаса Absorb при остром коронарном синдроме у ребенка со сложным врожденным пороком сердца

Первый случай имплантации биорезорбируемого стентирующего каркаса Absorb при остром коронарном синдроме у ребенка со сложным врожденным пороком сердца

Effect of the Endothelial Shear Stress Patterns on Neointimal Proliferation Following Drug-Eluting Bioresorbable Vascular Scaffold Implantation: An Optical Coherence Tomography Study

This study sought to investigate the effect of endothelial shear stress (ESS) on neointimal formation following an Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) implantation. Cumulative evidence, derived from intravascular ultrasound–based studies, has demonstrated a strong association between local ESS patterns and neointimal formation in bare-metal stents, whereas in drug-eluting stents, there are contradictory data about the effect of ESS on the vessel wall healing process. The effect of ESS on neointimal development following a bioresorbable scaffold implantation remains unclear. Twelve patients with an obstructive lesion in a relatively straight arterial segment, who were treated with an Absorb BVS and had serial optical coherence tomographic examination at baseline and 1-year follow-up, were included in the current analysis. The optical coherence tomographic data acquired at follow-up were used to reconstruct the scaffolded segment. Blood flow simulation was performed on the luminal surface at baseline defined by the Absorb BVS struts, and the computed ESS was related to the neointima thickness measured at 1-year follow-up. At baseline, the scaffolded segments were exposed to a predominantly low ESS environment (61% of the measured ESS was <1 Pa). At follow-up, the mean neointima thickness was 113 ± 45 μm, whereas the percentage scaffold volume obstruction was 13.1 ± 6.6%. A statistically significant inverse correlation was noted between baseline logarithmic transformed ESS and neointima thickness at 1-year follow-up in all studied segments (correlation coefficient range −0.140 to −0.662). Mixed linear regression analysis between baseline logarithmic transformed ESS and neointima thickness at follow-up yielded a slope of −31 μm/ln(Pa) and a y-intercept of 99 μm. The hemodynamic microenvironment appears to regulate neointimal response following an Absorb BVS implantation. These findings underline the role of the ESS patterns on vessel wall healing and should be taken into consideration in the design of bioresorbable devices.

Phenomenon of elongated struts: Is optical coherence tomography accurate enough to analyze scaffold area?

A team of Prof. Serruys during 2009–2012[1–10] published some results of multi-modality imaging studies within ABSORB (a bioabsorbable everolimus-eluting coronary stent system for patients with single de novo coronary artery lesions) trial. The first two publications[1,2] of the first generation Absorb BVS (bioresorbable vascular scaffold) reported few observations made at 6and 24month follow-ups using different imaging modalities: 1) complete bioresorption; 2) physiologically or pharmacologically induced vasomotion, and 3) between 6 and 24 months, late lumen enlargement with plaque media regression without pathological remodeling has been established. The second generation of Absorb BVS [4] (n = 101 with two subgroups: B1 — clinical and imaging follow-up at 6 and 24 months, n = 45, and B2 — follow-up at 12 and 36 months, n = 56; NCT00856856), with changes in the design platform and manufacturing process, fully remediated this mechanical deficiency so that the scaffold area (SA) was found to be unchanged at 6 and 12 months by 1-mm analysis of optical coherence tomography (OCT) [6–8]. Struts that were recognizable on OCT at 24 months showed signs of bioresorption accompanied by unexplained increase in mean scaffold area (see Fig. 1) compared with baseline (0.54 ± 1.09 mm on intravascular ultrasound, p = 0.003; 0.77 ± 1.33 mm in OCT, p = 0.016) [2,8]. An accuracy of OCT for assessment of SA requires further studies. Three years post-procedure after Absorb BVS implantation, biodegrading struts become more pliable and soft causing deformation with smoothing and elongation of struts in remodeling artery wall with accumulation of proteoglycan, and extracellular matrix as well as cellular recomposition of the tissue environment [3,9,10]. The essential mechanisms of the elongated strut phenomenon remain unknown, taking into account increase in scaffold area and signs of biodegradation [9]. Particularly, percentage of the hyperechogenicity area [5], a more sensitive parameter to measure degradation of polymeric material, decreased from a baseline value of 25.3% to 20.4% at 6 months and to 13.8% at 24 months. By our courtesy, there are four probable scenarios to explain a phenomenon of elongated struts (see Fig. 1):

Initial experience in the clinical use of everolimus-eluting bioresorbable vascular scaffold (BVS) in a single institution

We read with great interest the recent review article on bioresorbable vascular scaffolds by Bourantas et al. and wish to share our institution's experience with the use of the ABSORB bioresorbable vascular scaffold (BVS; Abbott Vascular, Santa Clara, California) [1]. There is currently limited published data on the use of BVS in routine clinical practice andwehaveundertaken a prospective evaluation of this novel device in our institution. All consecutive patients who underwent percutaneous coronary intervention (PCI) with intent for BVS implantation between July 2011 and September 2012were included in the analysis. All patients received dual anti-platelet therapyprior to PCI and this therapywascontinued for at least a year after implantation. This study fulfilled local ethical requirements and written informed consent was obtained from all patients. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. Once a suitable lesion was identified, the pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary analysis (QCA) using the Pie Medical CAAS QCA (quantitative coronary analysis) package in our Xcelera Workstations (Philips Medical Systems, Veenpluis, The Netherlands). Alternative vessel sizing was via the use of commercially available intravascular ultrasound (IVUS) or optical coherence tomography (OCT). A RVD of 2.0 to 3.8 mm and a lesion length of less than 28 mm were considered suitable for BVS (single or overlapping). The availableABSORBBVSwere2.5×18 mm,2.5×28 mm, 3.0×18 mm, 3.0×28 mm, 3.5×12 mm, 3.5×18 mm, or 3.5×28 mm in size. 6 Fr vascular access was used in all patients with a predominant radial access (77.1%). Mandatory predilation with balloon angioplasty using a balloon with a diameter of 0.5 mm smaller or equivalent to the intended BVS size was performed prior to BVS implantation. Device deployment was performed at a rate of ≤2 atm per 5 s up to 16 atm (rated burst pressure). Postdilation was with a non-compliant balloon with diameter≤0.25 mm beyond the implanted BVS if necessary to avoid scaffold damage. For longer lesions or edge dissections, overlapping scaffolds were used. A total of 35 consecutive patients with 41 lesions underwent attempted ABSORB BVS implantation during the study period. Baseline emographics, indications, procedure and quantitative coronary angiography details are summarized in Table 1. The mean age is 54.7± 11.2 years (range 36–86 years) and 85.7% of the patients (n=30) were male. Diabetes mellitus (type I or II) was present in 17.1% (n=6) of the study population. 51.4% of patients presented with an acute coronary syndrome including unstable angina, non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI). Overall, 45 BVS were successfully implanted in 33 (93.3%) patients (1.4 BVS/patient). Of the 41 lesions treated, the success rate was 100% (22/22) for the left anterior descending artery (LAD), 100% (11/11) for the right coronary artery (RCA), and 75% (6/8) for the left circumflex artery (LCX). Two patients had circumflex (LCX) stenosis not crossable by the BVS despite aggressive lesion preparation with multiple balloon predilations. An equivalent metallic drug eluting stent crossed without difficulty in both cases. The majority, 31 (75.6%), of lesions treated were complex (B2 or C). Pre-procedure RVD was assessed by QCA in 28 patients (80.0%), IVUS in 4 patients (11.4%), andOCT in 3 patients (8.6%). Themeanpre-procedural RVDwas 2.7±0.4 mm, diameter stenosiswas 77.7±13.0%, and lesion lengthwas 17.2±6.7 mm. Post-procedural RVD was 3.0±0.3 mmwith residual diameter stenosis of 2.4±2.0%.