Bioresorbable Vascular Scaffold Implantation Research Articles

The Absorb GT1 Bioresorbable Vascular Scaffold System - 5-Year Post-Market Surveillance Study in Japan.

The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available.Methods and Results: This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 [91.4%] lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations. Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.

Late acquired coronary aneurysm and restenosis after bioresorbable vascular scaffold implantation: a case report

Abstract Background Although the technology of bioresorbable vascular scaffold (BVS) aroused the peak of interest a few years ago and currently remains available only as part of experimental research, patients who have had BVS implanted should be still carefully monitored to detect possible long-term complications. Case summary We present the case of a 47-year-old man who had received BVS implantation for ST-segment elevation myocardial infarction. Six years later, computed tomography coronary angiography (CTCA) demonstrated in-segment restenosis in between two newly formed coronary aneurysms at the site of the implanted BVS. The patient received successful optical coherence tomography–guided percutaneous intervention with a new metallic drug-eluting stent implantation. Discussion Our case demonstrates that coronary aneurysms can be well characterized with CTCA and are often incidentally discovered as they cause no symptoms. The incidence of coronary aneurysm at the site of a previously implanted BVS is not defined, and little is known about the pathophysiology and evolution of these lesions. Therefore, the decision to proceed with conservative management or intervention must be tailored to the clinical conditions of the patient, the anatomy, the rapidity of growth, and the possible thrombotic burden.

Freedom From Stent Fracture–Related Complications of Vascular Longitudinal Remodeling in a Patient With Heart Failure and a Degraded Bioresorbable Vascular Scaffold

Because vascular geometric change during the long-term process of cardiac chamber remodeling in heart failure is usually unpredictable after coronary stenting, the risk of acquired metallic stent fracture can persist. This rare but possible complication could be minimized with the implantation of bioresorbable vascular scaffold because of its unique properties. Here, the authors report on 1 patient with heart failure who received optical coherence tomography evaluation between 3 and 3.5 years after bioresorbable vascular scaffold implantation. Measurement of the discernible struts of bioresorbable vascular scaffold provided evidence of coronary longitudinal remodeling without serious risk of complications related to metallic stent fracture resulting from cardiac remodeling.

Structural and Functional Evaluation of Coronary Arteries Treated With ABSORB Bioresorbable Vascular Scaffold at 5-Year Follow-Up

Although complete bioresorbable vascular scaffold (BVS) resorption has been demonstrated at 5-year follow-up, whether corresponding vasomotor function restoration occurs remains unknown. The objective was to simultaneously assess the structural healing response along with vasomotor responses at 5-year follow-up of BVS implantation. We studied consecutive patients treated with ABSORB-BVS at 5-year follow-up (n=31), who were recruited from a multicenter registry and were contacted to undergo a research protocol-driven repeat coronary angiogram involving intracoronary optical coherence tomography (OCT) and invasive coronary endothelial function testing. Epicardial endothelium-dependent vasomotion was defined as any vasodilatation after intracoronary acetylcholine (ACh), whereas endothelium-independent vasomotion was defined as any vasodilatation after intracoronary nitroglycerine (NTG), using quantitative coronary angiography. The mean implantation time point was 60.5 ± 4.6 months. OCT imaging demonstrated complete scaffold resorption in all patients. New coronary lesions (stenosis >50%) were found in 5 patients (16.1%), 3 of them underwent ad hoc percutaneous revascularization (9.7%). Intracoronary ACh (27 patients) and NTG testing (30 patients) was performed. Quantitative coronary angiography analysis demonstrated vasoconstriction after ACh administration and lack of response to NTG in BVS segments (mean lumen diameter=2.00 ± 0.61 mm at baseline vs 1.74 ± 0.70 mm post-ACh, p <0.001; 2.05 ± 0.54 mm at baseline vs 2.03 ± 0.50 mm post-NTG, p=0.69). OCT lumen analysis demonstrated similar vasoconstrictive responses to ACh (mean lumen area=5.31 ± 2.26 mm² at baseline vs 5.12 ± 2.55 mm² post-ACh, p=0.007) but had a vasodilatory response to NTG (5.96 ± 2.35 mm² at baseline vs 6.17 ± 2.55 mm² post-NTG, p<0.001). In conclusion, complete ABSORB-BVS resorption was demonstrated at 5-year follow-up. However, this healing response was associated with endothelium-dependent vasomotor dysfunction within the BVS segment.

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.

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.

P79 FIRST GENERATION BIORESORBABLE VASCULAR SCAFFOLD VS NEXT GENERATION BIORESORBABLE VASCULAR SCAFFOLD: SINGLE CENTER, LONG–TERM FOLLOW UP EXPERIENCE

Abstract Background Previous randomized controlled trials demonstrated a higher rate of stent thrombosis with first generation (Absorb; Abbott Vascular, USA) bioresorbable vascular scaffold (BVS) implantation as compared with second–generation drug–eluting stent. Currently, with limited indications, others next generation BVS (NGB) are available (Magmaris; Biotronik AG, Switzerland and DESolve; Elixir Medical Corporation, USA). Real world long–term outcomes of such devices are limited. Methods and Results In our center from 27/09/2012 to 28/08/2018 in a cohort of 277 patients, a total of 259 BVS and 191 NGB (120 Magmaris and 71 DESolve) devices were implanted. The primary efficacy endpoint was a combined end point of target–lesion revascularization (TLR) and target lesion myocardial infarction (TLMI) the primary safety endpoint was scaffold thrombosis (ScT). At a median follow–up, of 83 months (interquartile range–IQR, 61–91 months) for BVS, and 48 months (IQR, 41–53.5 months) and 64.5 months (IQR, 58.5–69 months) for Magmaris and DESolve respectively, TLR/TLMI occurred in 17 patients (10.5%) in the BVS group and 4 patients (3.5%) in the NGB group (p value= 0.03), ScT occurred in 5 patient (3.1%) and 1 patient (0.9%), p–value=0.23, respectively. Median time of ScT occurrence in the BVS group was 12.5 months (IQR 9.75–16.75), ScT in the NGB group occurred after patient’s suspension of dual antiplatelet therapy 3 months later from the implantation date. Conclusion In a single center real world setting, the use of NGB appear safer compared to BVS at long–term follow–up.

Effects of aggressive predilatation, sizing, and postdilatation strategy for coronary bioresorbable vascular scaffolds implantation.

The results of the recent Amsterdam Investigator-Initiated Absorb Strategy All-Comers trial showed that the predilatation, sizing, and postdilatation (PSP) technique did not lower the long-term rates of scaffold thrombosis and adverse events. We evaluated the impact of aggressive PSP bioresorbable vascular scaffold (BRS) implantation on the short- and long-term clinical outcomes. From June 2014 to December 2016, 150 patients with BRS implantation were enrolled and received successful percutaneous coronary intervention (PCI), of whom 104 received aggressive PSP technique (high-pressure predilatation and lesion preparation in addition to the traditional PSP technique). Short- and long-term outcomes were compared. All patients underwent successful PCI and BRS implantation with final Thrombolysis in Myocardial Infarction grade 3 flow. The baseline and procedure characteristics were similar in both groups. Debulking techniques were used in 13 (8.7%) patients. Intracoronary imaging modalities were used in 73 (48.7%) patients. After BRS implantation, no adverse events were observed within 30 days in both groups. During the mean follow-up period of 2.98 ± 0.77 years, 12 (8.0%) patients experienced major adverse cardiovascular events (MACEs), including one cardiovascular death (0.6%), three nonfatal myocardial infarction (2.0 %), and 11 target-vessel revascularization (7.3 %). Multivariate Cox regression analysis showed that aggressive PSP remained an independent protective factor for MACEs. Moreover, the use of intracoronary imaging and rotablation atherectomy was associated with better clinical outcomes. Lesion preparation by aggressive PSP in BRS implantation was associated with better long-term clinical outcomes.

Coronary artery perforation after bioresorbable scaffold implantation treated with a new generation covered stent\u2014OCT insights

BackgroundCoronary artery perforation is a rare but potentially lethal complication of percutaneous coronary intervention (PCI) with an associated mortality of 7–17%. We report the case of coronary artery perforation complicating Absorb bioresorbable vascular scaffold (BVS) implantation and the associated technical challenges with managing this life-threatening complication.Case reportA 46-year-old male was referred to our institution and underwent PCI with an Absorb bioabsorbable vascular scaffold (BVS) to a proximal LAD long segment bifurcation lesion. Following pre-dilation and deployment of the 3.5 × 28 mm Absorb BVS, high pressure post-dilation of the distal scaffold was complicated by a large, Ellis type III coronary perforation with no flow to the distal LAD beyond the rupture, and associated with a large pericardial effusion confirmed on bedside transthoracic echocardiogram (TTE). The insult was temporised with prolonged balloon inflation within the Absorb BVS immediately proximal to the site of perforation, permitting urgent insertion of a pericardial drain. After deflation of the balloon, a 3.0 × 21 mm BeGraft covered stent was deployed across the perforation, restoring normal LAD flow and abolishing the perforation. Cardio-pulmonary resuscitation was not required and the patient remained conscious throughout the procedure. TTE demonstrated normal left ventricular function and the patient was discharged 3 days later. Repeat angiography at 3 months showed patent stents with TIMI III flow, and optical coherence tomography (OCT) showed good expansion and apposition of the proximal Absorb BVS and BeGraft. The patient has remained well 4 years after PCI with no major cardiovascular events.ConclusionThe utility of bioresorbable scaffold technology remains controversial although meticulous implantation techniques are associated with improved clinical outcomes. Adoption of the Pre-dilatation, Sizing and Post-dilatation (‘PSP’) method of BVS implantation with routine aggressive vessel preparation and scaffold optimization however may contribute to a higher risk of vessel perforation. The case emphasises the importance of accurate sizing of the vessel with intracoronary imaging and demonstrates the value of newer generation covered stents with single-layer design and slimmer crossing profile producing improved deliverability and procedural success.

Dissections after bioresorbable vascular scaffold implantation in the POLAR ACS Registry.

IntroductionPercutaneous coronary intervention (PCI) is a common method of treatment for patients with coronary artery disease. One of the most common complications during the PCI procedure is coronary artery dissection. It usually requires an additional action to assure the patency of the treated vessel.AimThe aim of the publication is to describe the occurrence of coronary artery dissection after bioresorbable vascular scaffold (BVS) implantation. This selected type of PCI procedure is especially interesting because precise target vessel measurement before BVS implantation is required for optimal determination of scaffold size.Material and methodsBased on angiographic data gathered in the POLAR ACS Registry, we assessed the frequency of dissections, their localization, and severity. Based on data regarding patients’ demographic, clinical status, and details regarding treatment strategy, the factors that could have an influence on the dissection occurrence were identified.ResultsA group of 100 patients included in the analyses. Group A consisted of 9 patients. This group was defined as patients in whom the significant dissection occurred after the BVS implantation. Group B comprised 91 patients. Both groups were very similar according to demographic data. The frequency of predilatation was similar; post-dilatation was performed more often in group A but without statistical significance. The presence of calcification in the target lesion was an independent factor of dissection during the index PCI procedure.ConclusionsThe occurrence of significant dissection can be effectively treated, and the good angiographic results of this treatment immediately after the initial procedure translate into good clinical results in longer follow-up.

299 3-Year results of STEMI patients treated with a pre-specified BVS implantation strategy: BVS SYTEMI strategy-it long term

Abstract Aims Data on Absorb bioresorbable vascular scaffold (BVS) use in patients presenting with ST-segment elevation myocardial infarction (STEMI) are limited. Furthermore, Absorb studies including STEMI patients lacked a prespecified implantation technique to optimize BVS deployment. To assess the 3-year clinical outcomes STEMI patients undergoing primary percutaneous coronary intervention (pPCI) with a pre-specified BVS implantation strategy. Methods and results BVS STEMI STRATEGY-IT (NCT02601781) included 505 STEMI patients undergoing pPCI with BVS following a dedicated implantation protocol. Device-oriented composite endpoint [(DOCE) cardiac death, ischemia-driven target lesion revascularization (ID-TLR) and target vessel myocardial infarction (TV-MI)] and scaffold thrombosis (ScT) at 3-year were evaluated. A subgroup analysis was performed on patients in whom dual antiplatelet therapy (DAPT) was continued 36 months after pPCI (‘longer-term DAPT’), and outcomes of this cohort compared to the remaining population (‘shorter-term DAPT’: <36 months) are also reported. Three-year DOCE and ScT rates were low (2.4% and 1.0%, respectively). In 319 (63.2%) patients DAPT was continued 36 months after pPCI. DOCE rate was significantly lower in the longer- compared to shorter-DAPT group (HR: 0.29; 95% CI: 0.1–0.9; P = 0.03), driven by a lower rate of TV-MI (0% vs. 2.2%, P = 0.018). Significantly lower rate of ScT was observed in longer-DAPT group (0% vs. 2.7%, P = 0.007). Conclusions In STEMI patients undergoing pPCI, a strategy of optimized BVS implantation technique is associated with favourable DOCE and ScT rates at 3 year. DAPT extension up to 36 months further improves long-term clinical outcomes.

Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice - results from the European Absorb Consortium.

To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population. Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

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.

Reduction of Lipid-Core Burden Index in Nonculprit Lesions at Follow-Up after ST-Elevation Myocardial Infarction: A Randomized Study of Bioresorbable Vascular Scaffold versus Optimal Medical Therapy.

Background Non-flow-limiting nonculprit lesions (NCL) that contain a large lipid-rich necrotic core (nonculprit lipid-rich plaques (NC-LRP)) are most likely to cause recurrent acute coronary syndrome after ST-elevation myocardial infarction (STEMI). Near-infrared spectroscopy (NIRS) detects LRPs using the maximum 4 mm lipid-core burden index (maxLCBI4 mm). Few data are available regarding NIRS-guided therapy of these NC-LRPs, which are a potential target for preventive stenting. Bioresorbable vascular scaffold (BVS) provides local drug delivery and could facilitate plaque passivation after resorption. This study sought to assess the safety of BVS implantation in NC-LRPs and its efficacy in reducing maxLCBI4 mm at 2-year follow-up after STEMI. Methods and Results In total, 33 non-flow-limiting NCLs from 29 STEMI patients were included in this study. Of these, 15 were LRPs and were randomly assigned to either the BVS + optimal medical therapy (OMT) arm (group 1; N = 7) or the OMT arm (group 2; N = 8). At baseline, there were no differences in plaque characteristics between groups (fractional flow reserve: 0.85 ± 0.04 vs. 0.89 ± 0.06; diameter stenosis (DS): 43.4 ± 8 vs. 40.1 ± 10.7%; plaque burden 54.98 ± 5.8 vs. 49.76 ± 8.31%; and maxLCBI4 mm 402 [348; 564] vs. 373 [298; 516]; p=NS for all comparisons between groups 1 and 2, respectively). Seven BVSs were implanted 3 ± 1 days after STEMI in six patients, without complications. At angiographic follow-up (712 [657; 740] days), a significant and similar reduction of maxLCBI4 mm was observed in both groups, with a median change of 306 [257; 377] in group 1 vs. 300 [278; 346] in group 2 (p=0.44). DS was significantly lower in group 1 vs. group 2 (19.8 ± 7 vs. 41.7 ± 13%, p=0.003), while plaque burden remained unchanged in both groups. Overall survival was 100%, target lesion failure was 13%, and stent thrombosis was 0%. Conclusions BVS + OMT and OMT appear as similarly safe and effective in reducing maxLCBI4mm in NC-LRPs at 2-year follow-up after STEMI.

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).

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.

Long-term clinical results of biodegradable vascular scaffold ABSORB BVS™ using the PSP-technique in patients with acute coronary syndrome.

The PSP (predilatation, sizing, post-dilatation)-technique was developed to improve the prognosis of patients after bioresorbable vascular scaffold (BVS) implantation. In acute coronary syndrome (ACS) the use of BVS is particularly demanding and carries some potential risk regarding aggressive lesion preparation, proper vessel sizing due to spasm and thrombus inside the artery. The aim herein, was to determine the long-term results of BVS stenting in ACS patients depending on the scaffold implantation technique. The present study is a prospective, two-center study, which consisted of 182 patients who underwent percutaneous coronary intervention (PCI) with BVS (Absorb, Abbott Vascular, Santa Clara, California, USA) implantation for the ACS. All patients were divided into two groups. The first consisted of 52 patients treated with the PSP-technique (PSP group). The second group enrolled 130 patients treated with a non-PSP procedure (non-PSP group). The procedure was successful in all patients. The mean observation time was 28.8 ± 16.5 months (median 28.3 months, interquartile range 24.0 [17.0-41.0] months). It was found that target vessel failure (TVF) was consistently reduced in patients using the PSP-technique as compared with the non-PSP group (5.8% vs. 17.7%, p = 0.03). Moreover, PSP-technique was superior to non-PSP-technique concerning major adverse cardiac events (MACE) (3.7% vs. 22.3%, p = 0.02). Logistic regression analysis revealed that the use of PSP technique significantly decreased the risk of target vessel revascularization (odds ratio [OR] 0.11, p = 0.01), TVF (OR 0.28, p = 0.03) and MACE (OR 0.29, p = 0.02). The PSP-technique for BVS implantation improves long-term results and should also be recommended for newer generations of the bioresorbable scaffold.

Bioresorbable vascular scaffolds versus everolimus-eluting stents: a biomechanical analysis of the ABSORB III Imaging substudy.

The Absorb bioresorbable vascular scaffold (BVS) has high rates of target lesion failure (TLF) at three years. Low wall shear stress (WSS) promotes several mechanisms related to device TLF. We investigated the impact of BVS compared to XIENCE V (XV) on coronary WSS after device deployment. In the prospective, randomised, controlled ABSORB III Imaging study (BVS [n=77] or XV [n=36]), computational fluid dynamics were performed on fused angiographic and intravascular ultrasound (IVUS) images of post-implanted vessels. Low WSS was defined as <1 Pa. There were no differences in demographics, clinical risks, angiographic reference vessel diameter or IVUS minimal lumen diameter between BVS and XV patients. A greater proportion of vessels treated with BVS compared to XV demonstrated low WSS across the whole device (BVS: 17/77 [22%] vs XV: 2/36 [6%], p<0.029). Compared to XV, BVS demonstrated lower median circumferential WSS (1.73 vs 2.21 Pa; p=0.036), outer curvature WSS (p=0.026), and inner curvature WSS (p=0.038). Similarly, BVS had lower proximal third WSS (p=0.024), middle third WSS (p=0.047) and distal third WSS (p=0.028) when compared to XV. In a univariable logistic regression analysis, patients who received BVS were 4.8 times more likely to demonstrate low WSS across the scaffold/stent when compared to XV patients. Importantly, in a multivariable linear regression model, hypertension (beta: 0.186, p=0.023), lower contrast frame count velocity (beta: -0.411, p<0.001), lower post-stent residual plaque burden (beta: -0.338, p<0.001), lower % underexpanded frames (beta: -0.170, p=0.033) and BVS deployment (beta: 0.251, p=0.002) remained independently associated with a greater percentage of stented coronary vessel areas exposed to low WSS. In this randomised controlled study, the Absorb BVS was 4.8 times more likely than the XV metallic stent to demonstrate low WSS. BVS implantation, lower blood velocity and lower residual post-stent plaque burden were independently associated with greater area of low WSS.

BVS stent optimisation based on a parametric model with a multistage validation process

Developing new polymer-based bioresorbable vascular scaffolds (BVS) requires a new structural geometry, as these polymer materials are characterised by substantially lower stiffness than metallic alloys. Sufficient radial strength of the stent is essential, as insufficient vessel wall support can lead to a significant recoil (reduction of the vessel lumen) and can cause dangerous complications. To assess the stress development and deformation of the stent, finite element analysis (FEA) was used. First, a complex FEA of the inflation and crimping processes of a bioresorbable coronary stent was performed. An optimisation procedure based on the simplified parametric FE model was subsequently performed to obtain the optimal geometric parameters of the analysed structure. The objective of the optimisation was to maximise the vessel diameter after the BVS implantation. The optimisation procedure was based on automatic model-generating scripts, numerical analyses and implementation of genetic algorithms. Finally, a comparison of the parametric and complex models results was performed, as well as a final validation at several stages (structural studies, computational fluid dynamics (CFD) simulations and in vivo testing). The validation confirmed that the presented optimisation methodology represents a valid and useful tool for the stent design process.