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Inflammation is known to play a crucial role in the development of coronary atherosclerosis and vascular healing after stenting. This study aimed to investigate the dynamic changes in inflammatory responses between XINSORB and TIVOLI scaffolds and their correlation with 3-year clinical outcomes. A total of 140 patients in the XINSORB group and 42 patients in the TIVOLI group were included in this prospective, single-center study, conducted in Shanghai tenth People's Hospital. Blood samples were collected at baseline, 24 h, 6 months, and 12 months after stent implantation to measure high sensitivity C-reactive protein (hsCRP), fibrinogen (FBG), white blood cell count (WBC), tumor necrosis factor (TNF), and interleukin-6 (IL-6). Receiver-operating characteristic curves and proportional hazards models were generated to evaluate the relationship between 24-h postoperative inflammatory indicators and 3-year patient-oriented composite endpoints (POCE). The levels of hsCRP, FBG, WBC, TNF, and IL-6 reached their peak levels 24 h after stenting and then gradually decreased to levels comparable to baseline at 6 and 12 months. During the 3-year follow-up, 11.4 % of the XINSORB cohort and 9.5 % of the TIVOLI cohort experienced POCE (P = 0.948). High levels of hsCRP and IL-6 24 h after the procedure were associated with clinical endpoints, and the combination of these two biomarkers improved the predictive ability of prognosis. There were no significant differences between the changes in the concentration of inflammatory biomarkers after XINSORB stents or drug-eluting stent implantation. Reduction in postoperative inflammatory levels may decrease the occurrence of clinical outcomes. This study provides insights into the dynamic changes of inflammatory responses and their correlation with clinical outcomes, which could have implications for the management of patients undergoing coronary stenting. The study has been registered on the official website of the China Clinical Trial Registry (ChiCTR1800014966). • Inflammation dynamics investigated in XINSORB and TIVOLI stents in coronary patients. • Elevated hsCRP and IL-6 levels linked to clinical endpoints at 3-year follow-up. • Study sheds light on inflammatory responses and long-term clinical outcomes in PCI. [ABSTRACT FROM AUTHOR]

This study sought to present an angiography-based computational model for serial assessment of superficial wall strain (SWS, dimensionless) of de-novo coronary stenoses treated with either bioresorbable scaffold (BRS) or drug-eluting stent (DES). A novel method for SWS allows the assessment of the mechanical status of arteries in-vivo, which may help for predicting cardiovascular outcomes. Patients with arterial stenosis treated with BRS (n = 21) or DES (n = 21) were included from ABSORB Cohort B1 and AIDA trials. The SWS analyses were performed along with quantitative coronary angiography (QCA) at pre-PCI, post-PCI, and 5-year follow-up. Measurements of QCA and SWS parameters were quantified at the treated segment and adjacent 5-mm proximal and distal edges. Before PCI, the peak SWS on the 'to be treated' segment (0.79 ± 0.36) was significantly higher than at both virtual edges (0.44 ± 0.14 and 0.45 ± 0.21; both p < 0.001). The peak SWS in the treated segment significantly decreased by 0.44 ± 0.13 (p < 0.001). The surface area of high SWS decreased from 69.97mm2 to 40.08mm2 (p = 0.002). The peak SWS in BRS group decreased to a similar extent (p = 0.775) from 0.81 ± 0.36 to 0.41 ± 0.14 (p < 0.001), compared with DES group from 0.77 ± 0.39 to 0.47 ± 0.13 (p = 0.001). Relocation of high SWS to device edges was often observed in both groups after PCI (35 of 82 cases, 41.7 %). At follow-up of BRS, the peak SWS remained unchanged compared to post-PCI (0.40 ± 0.12 versus 0.36 ± 0.09, p = 0.319). Angiography-based SWS provided valuable information about the mechanical status of coronary arteries. Device implantation led to a significant decrease of SWS to a similar extent with either polymer-based scaffolds or permanent metallic stents. [Display omitted] • Angiography-based superficial wall strain (SWS) is a new method for assessing the mechanical status of coronary arteries in-vivo. • Serial assessment of SWS of de-novo arteries treated with bioresorbable scaffold (BRS) or drug-eluting stent (DES) was performed. • At pre-PCI, the SWS in stenotic segments was significantly higher than at non-stenotic edges. • Following PCI, SWS in treated segments significantly decreased to a similar extent with BRS or DES, and remains low at long term in BRS group. Relocation of high SWS to device edges was observed in both groups. [ABSTRACT FROM AUTHOR]

Aim: To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique.Methods and Results: All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.8-1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25-0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8-38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length (p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up.Conclusion: Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions. [ABSTRACT FROM AUTHOR]

Purpose: We investigated whether optical coherence tomography (OCT)-guided bioresorbable vascular scaffolds (BVS) implantation can improve in-scaffold minimal lumen area (MLA) at 6-month compared with angiography guidance.Methods: The OPTICO BVS was a randomized, international multicenter, assessor blind, superiority trial comparing OCT- versus angiography-guided percutaneous coronary intervention (PCI) (1:1 allocation) in patients with coronary artery disease undergoing Absorb BVS 1.1 implantation. The primary endpoint was in-scaffold MLA at 6-month.Results: The trial was prematurely stopped on May 31, 2017 after enrollment of 38 of 270 planned patients (14%) following the retraction of the device in Europe. Patients were randomly assigned to OCT- (n = 19) or angiography-guided PCI (n = 19). Scaffold diameter (OCT 3.0 ± 0.3 mm vs. angiography 3.1 ± 0.3 mm, P = .333) and length (28.8 ± 13.6 mm vs. 23.8 ± 12.3 mm, P = .223) were comparable. There was no significant difference in in-scaffold MLA at 6 months (4.47mm2 vs. 5.08mm2, P = .692). Scaffold expansion at 6-month was significantly higher in the OCT-guided PCI as compared with angiography-guided PCI (84.5% vs. 76.5%, P = .010). There was no significant difference in clinical outcomes.Conclusions: Although in-scaffold MLA at 6-month did not differ between groups, scaffold expansion was improved following OCT- as compared with angiography-guided PCI. The findings of this study must be interpreted in view of the premature termination with inclusion of 14% of the initially planned study sample. [ABSTRACT FROM AUTHOR]

Background: data from clinical experiences with Absorb bioresorbable scaffold (BRS) in STEMI raised concerns among clinicians about the device safety because a noteworthy scaffold thrombosis (ScT) rate was reported at early and long-term follow-up. Nevertheless, pre-specified technical suggestions of how to perform an optimal BRS procedure in STEMI were lacking. In this study we sought to assess the 1-year results following a pre-specified BRS implantation strategy in ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI (pPCI).Methods: This is a prospective, multicenter study on 505 STEMI patients undergoing pPCI with Absorb following a dedicated implantation protocol. The primary end-point (a device oriented composite end-point (DOCE) of cardiac death, target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) within 30 days) was already reported. We here present DOCE, its singular components and ScT rates (secondary end-points) at 1-year.Results: According to the study protocol direct Absorb implantation was feasible in 47 (9.3%) patients while post-dilatation was performed in 468 (92.7%) cases. The hierarchical DOCE rate at 1-year was 1.2% (0.4% cardiac death, 0.4% TV-MI and 0.8% ID-TLR) versus 0.6% at 30-day. Two episodes (0.4%) of ScT (one probable subacute and one late definite) were reported. At 1-year, 99.2% patients were on dual antiplatelet therapy (95% with ticagrelor or prasugrel).Conclusions: A pre-specified Absorb implantation strategy in STEMI patients was associated with persistent low DOCE and ScT rates at 1-year. Longer term follow-up is needed to assess the role of this strategy on preventing very-late events (NCT02601781). [ABSTRACT FROM AUTHOR]

Background: The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis.Design: COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years.Conclusions: The prospective COMPARE ABSORB randomized trial (ClinicalTrials.govNCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis. [ABSTRACT FROM AUTHOR]

Purpose: This analysis of a consecutive series of bioresorbable vascular scaffolds (BVS) implanted for complex chronic total occlusions (CTOs) was done to evaluate the potential of this device to avoid a permanent full metal jacket with drug-eluting stents.Patients: We analyzed 52 young patients (50.8 ± 8.3 years) for the BVS group, and additionally we followed a subgroup of 17 patients where DES were combined with BVS mainly because severe calcification at the lesion site (hybrid group).Results: BVS were successfully implanted in 69 of 70 patients. An average of 3.17 BVS were used per lesion in the BVS group, with a CTO length of 28 ± 20 mm, and a reference diameter of 2.92 ± 0.34 mm, 69% were J-CTO ≥ 2. The retrograde approach was used in 38%. The device length was 79 ± 25 mm with 3.65 ± 0.34 mm final balloon diameter. In the hybrid group BVS was used to cover the distal segment beyond the actual occlusion predominantly in LAD lesions. Patients were discharged with dual antiplatelet therapy prescribed for 12 months. At 12 months, no patient had died or experienced an acute myocardial infarction. Angiography or MSCT follow-up available in 67% showed no reocclusion within 12 months. The target revascularization was 7% at 12 months. Two patients experienced a late non-acute reocclusion at 17 and 19 months.Conclusions: The implantation of BVS for long complex CTOs was feasible with no stent thrombosis despite the high complexity of lesions and multiple BVS implanted. The lack of mechanical strength may lead to the need for focal reintervention, but still the long-term burden of full metal jacketed vessels could be avoided. [ABSTRACT FROM AUTHOR]

Background: Little is known about the long term development of the tissue bridges covering the struts of bioresorbable vascular scaffold (BVS) at the side branches (SB) ostium. This study aims at assessing the resorption process of jailed SB after BVS implantation.Methods: We performed both Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) analysis of 7 patients enrolled in the ABSORB Cohort B trial at our center. Orifice SB area and mean thickness of tissue bridge covering SB were calculated from 2D assessment. The number of SB orifice compartments separated by BRS struts was analysed by using 3D OCT reconstruction.Results: At 5years follow-up, no struts could be identified. Between 3 and 5years, both lesion-level and cross section-level OCT findings showed a significant increase in Mean lumen area (MLA) (4.67±1.66mm2 vs. 5.57±1.57mm2; p=0.04) as well as Minimum Lumen Area (MinLA) (5.98±1.98mm2 vs. 6.73±1.87mm2; p=0.04). Moreover, eccentricity index showed a significant reduction between 3 and 5years (0.28±0.35mm2 vs. 0.16±0.06mm2; p=0.04). We identified a total of 3 SBs ostia in the segments treated with BVS. Between 3 and 5years follow-up in all SB analysed, we detected a decrease of mean tissue bridge thickness and an increase of calculated SBs area.Conclusions: In our serial OCT, a significant decrease of tissue bridge formation together with SB orifice area enlargement from 3 to 5year follow-up has been proved. [ABSTRACT FROM AUTHOR]

Background/purpose: The clinical performance of bioresrobable scaffolds (BRSs) in bifurcation lesion is not well investigated so far and information can currently mostly be gleaned from the results of bench testing. The present analysis evaluates the technical feasibility of BRS use in this type of lesion and its mid-term clinical outcome.Methods/materials: Consecutive patients with bifurcation lesions treated with at least one everolimus-eluting BRS were enrolled. Procedural success was defined as successful delivery and deployment of at least one BRS and a residual diameter stenosis ≤30%. The primary endpoint (major adverse cardiac events, MACE) included death due to cardiac cause, clinically driven percutaneous or surgical target lesion revascularization (TLR), and any myocardial infarction at the 12-month follow-up.Results: A total of 28 patients were eligible for this evaluation. Median age was 67 (52-73) years and in 46.4% (13/28) an acute coronary syndrome was present. The procedural success rate was 97.1% (33/34). The 1-year Kaplan Meier event rates for MACE, target lesion revascularization, and scaffold thrombosis were 16.1%, 12.1%, and 8.1%, respectively. Half of these patients discontinued the antiplatelet therapy prematurely.Conclusions: The results for BRS use in bifurcation lesions are not in line with previous studies investigating primarily simple lesions. The impaired outcomes are most likely related to the early stage of BRS use and an exacerbated risk of scaffold thrombosis due to premature discontinuation of the antiplatelet therapy. Hypothesis generated from this investigation has to be proven in further studies.Summary: Technical feasibility of everolimus-eluting bioresorbable scaffold implantation in bifurcation lesion and the clinical mid-term outcomes were evaluated in a real world scenario. Technical success rate was high; however the clinical results were not in line with previous studies investigating primarily simple lesions. The impaired outcomes were mostly driven by an exacerbated risk of scaffold thrombosis due to premature discontinuation of the antiplatelet therapy. [ABSTRACT FROM AUTHOR]

Background/purpose: The implantation of bioresorbable scaffolds (BVSs) is an emerging technique in the treatment of coronary lesions and implantation of BVSs is different than that of metallic drug-eluting stents, however, due to different mechanical properties. This investigation focused on procedural and mid-term results and was designed to evaluate whether there is evidence of a learning curve with BVSs and how it might influence the clinical outcome.Methods/materials: In an all-comers registry, the first 100 consecutive patients were compared with the second 100 patients. Target parameters were major adverse cardiac events (MACEs), including cardiac death, any myocardial infarction, and percutaneous or surgical target lesion revascularization (TLR). Target vessel failure (TVF) comprised cardiac death, target vessel myocardial infarction, and percutaneous or surgical target vessel revascularization (TVR).Results: Baseline characteristics were not significantly different. Post-dilatation was used significantly more often in the second group (23.8% vs. 50.5%, p<0.05) as was intravascular imaging (9% vs. 19%, p<0.05). In-hospital MACEs (2.0% for both groups) and median duration of hospital stay (4 (2-6)days) did not differ significantly. During a follow-up of 210 (155-369) or 200 (176-286)days (p=n.s.) for the first and second groups, respectively, MACE (11.2% vs. 1.1%, p<0.01), TVF (10.1% vs. 1.1%, p<0.01), and TVR (9.9% vs. 1.1%, p<0.05) rates were significantly lower in the second group.Conclusion: There is evidence of a learning curve. Post-dilatation is most probably associated with an improved clinical result and intravascular imaging might be useful for further improvement. [ABSTRACT FROM AUTHOR]

• Bioresorbable Scaffolds (BRS) present theoretical clinical benefit over non-resorbable coronary stent • Several BRS were tested with different timing of resorption according to their composition • Technological evolution in scaffold architecture could reduce time needed for full absorption [ABSTRACT FROM AUTHOR]

We report the long-term outcome of a case of "full plastic jacket" treatment consisting of three bioresorbable scaffolds to manage a subtotally occluded left anterior descending artery with associated severe bare metal in-stent restenosis. Angiography 36months' post procedure revealed an excellent result with negative fractional flow reserve result. Bioresorbable scaffolds may be an attractive option for in-stent restenosis due to the avoidance of an additional metallic layer, and this case is unusual regarding the total scaffold length used and long term angiographic follow-up. [ABSTRACT FROM AUTHOR]

Background: Due to the inherent limitations of current generation BVSs, complex coronary artery disease often contains BVS unsuitable segments. Our aim was to assess the feasibility of a hybrid approach using bioresorbable vascular scaffolds (BVSs) and drug-eluting stents (DESs) for the treatment of complex coronary artery lesions not suitable for a scaffolding only approach.Methods: A retrospective multicenter cohort analysis was performed on patients with complex de novo or in-stent restenosis lesions treated with a hybrid BVS (Absorb BVS, Abbott Vascular, Santa Clara, CA) and DES strategy. The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target-vessel myocardial infarction (MI) and target lesion revascularization (TLR).Results: A total of 98 patients (105 lesions) were treated with the hybrid strategy. Isolated long lesions in which either proximal or distal reference vessel diameters were not suitable for BVS were an indication in 36.2% (n=38) of cases. In contrast, 28% (n=29) of lesions treated with the hybrid strategy were bifurcations in which the side branch was predominantly treated with DES (n=28). DES bailout after BVS implantation was an indication in 21.9% (n=23 lesions). The rates of type B2/C and long lesions (>28mm) were 95.2% and 74.3% respectively. The mean total BVS and DES lengths implanted were 37.5±24.1mm and 25.0±14.7mm respectively. The rate of TLF in the overall cohort of patients (median follow-up 405days [interquartile range 189-658]) was 11.4% at 1-year. This was primarily driven by TLR (9.5%), with rates of cardiac death and target vessel MI of 2.1% and 1.4% respectively. No cases of definite or probable BVS/DES thrombosis occurred.Conclusion: In conclusion, the use of a hybrid BVS/DES strategy was feasible and associated with acceptable outcomes at 1-year, considering the length and complexity of lesions treated. Further, larger studies with longer follow-up are needed to confirm our findings. [ABSTRACT FROM AUTHOR]