Absorb Bioresorbable Scaffold Research Articles

Two-Year Outcomes for Patients with Non-ST-Elevation Acute Coronary Syndrome Treated with Magmaris and Absorb Bioresorbable Scaffolds in Large-Vessel Lesions.

The acute coronary syndrome (ACS) continues to be a fundamental indication for revascularization by percutaneous coronary intervention (PCI). Drug-eluting stent (DES) implantation remains a part of contemporary practice but permanent caging of the vascular structure with the metallic stent structure may increase the rate of device-related adverse clinical events. As an alternative to classic metallic DESs, the bioresorbable scaffolds (BRSs) have emerged as a temporary vascular support technology. We evaluated the mid-term outcomes of two generations of bioresorbable scaffolds-Absorb (Abbott-Vascular, Chicago, IL, USA) and Magmaris (Biotronik, Germany)-in patients with non-ST-elevation ACS. The study cohort consisted of 193 subjects after Magmaris implantation and 160 patients following Absorb implantation in large-vessel lesions. At 2 years, a significantly lower rate of a primary outcome (cardiac death, myocardial infarction, stent thrombosis) was observed with Magmaris (5.2% vs. 15%; p = 0.002). In addition, we observed a significantly lower rate of MI in the target vessel (2.6% vs. 9.4%; p = 0.009) and a lower rate of scaffold thrombosis (0% vs. 3.7%; p = 0.008). The TLF rate between the two groups was not significantly different. Magmaris demonstrated a good safety profile and more favorable clinical outcomes when compared to Absorb in patients with non-ST-elevation ACS.

Safety and efficacy of everolimus-eluting bioresorbable vascular scaffold for cardiac allograft vasculopathy (CART).

Cardiac allograft vasculopathy (CAV) is still the main drawback of heart transplantation (HTx) and percutaneous coronary intervention (PCI) is a palliative measure because of the high incidence of failure. This study aimed to investigate the safety and efficacy of bioresorbable scaffolds (BRSs) as potential novel therapeutic tool for the treatment of coronary stenoses in CAV. This is a multicenter, single-arm, prospective, open-label study (CART, NCT02377648), that included patients affected by advanced CAV treated with PCI and second-generation ABSORB BRS (Abbott Vascular). The primary endpoint was the incidence of 12-month angiographic in-segment scaffold restenosis (ISSR). Secondary endpoints were the incidence of major adverse cardiac events (MACEs) at 12- and 36-month follow-up and the incidence of ISSR at 36months. A paired intracoronary imaging analysis at baseline and follow-up was also performed. Between 2015 and 2017 35 HTx patients were enrolled and treated for 44 coronary lesions with 51 BRSs. The primary endpoint occurred in 13.5% of the lesions (5/37), with a cumulative ISSR rate up to 3years of 16.2% (6/37). Angiographic lumen loss was 0.40 ± 0.62mm at 12months and 0.53 ± 0.57mm at 36months. Overall survival rate was 91.4% and 74.3%, and MACEs incidence 14.2% and 31.4% at 12 and 36months, respectively. At the paired intracoronary imaging analysis, a significant increase of the vessel external elastic membrane area in the treated segment and some progression of CAV proximally to the BRS were detected. BRS-based PCI for the treatment of CAV is feasible and safe, with an ISSR incidence similar to what reported in retrospective studies with drug-eluting stents.

Everolimus-eluting bioresorabable scaffold system in the treatment of cardiac allograft vasculopathy: the cardiac allograft reparative therapy (CART) prospective multicentre pilot study

Abstract Background Cardiac allograft vasculopathy (CAV) is still the main drawback of heart transplantation (HTx) and percutaneous coronary intervention (PCI) is a palliative measure because of the high incidence of PCI failure. The bioresorbable scaffolds (BRS) could represent a potential novel therapeutic tool for the treatment of coronary obstructions in CAV. Purpose To investigates the effects of BRS implantation in CAV patients in a Nationwide prospective study. Methods Multicentre, single-arm, prospective, open-label study that included patients affected by advanced CAV treated with PCI and second-generation ABSORB BRS. The primary endpoint was the incidence of 12-month angiographic in-segment scaffold restenosis (ISSR). Secondary endpoints were the composite of cardiac death, myocardial infarction, and target lesion revascularisation at 12-and 36-month follow-up and the incidence of ISSR at 36 months. A paired analysis of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at baseline and follow-up was also performed. Results Between 2015–2017 35 HTx patients were enrolled and treated on 44 coronary lesions with 51 BRS. The primary endpoint occurred in 13.5% of the lesions (5/37), with a cumulative ISSR rate up to 3 years of 16.2% (6/37).Angiographic lumen loss was 0.40±0.62mm at 12 months and 0.53±0.57mm at 36 months. Overall survival was 91.4% and 74.3%, and MACEs 14.2% and 31.4% at 12 and 36 months, respectively. At the paired intracoronary imaging analysis a significant increase of the vessel external elastic membrane area in the treated segment of the BRS was described at the OCT, while some progression of CAV was detected proximally at the IVUS assessment. Conclusions BRS in CAV was feasible and safe, with an ISSR incidence similar to drug-eluting stents. For the first time, a positive remodeling was observed in HTx patients after PCI. Vessel enlargement and the lack of metallic stents may allow repeated PCI avoiding the vessel shrinkage caused by the addition of multiple metal layers, being CAV a complex clinical scenario with a high incidence of MACEs, mainly driven by PCI failure. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Partial funding by Abbott Vascular Italy

Thrombotic Left Main Coronary Artery Occlusion Treated With Bioresorbable Scaffold.

A 56-year-old man with a history of smoking presented with an extensive anterolateral ST-segment-elevation myocardial infarction (Killip class III) and moderate left ventricular (LV) systolic dysfunction. Emergency coronary angiograms revealed acute thrombotic occlusion of the unprotected left main coronary artery (LMCA) (Fig. 1A) and a dominant right coronary artery contributing to Rentrop grade 2 collateral circulation (Fig. 1B). We directed a guidewire into the left anterior descending coronary artery (LAD) and then, under optical coherence tomographic (OCT) imaging guidance, deployed a 3.5 × 28-mm Absorb bioresorbable vascular scaffold (Abbott Vascular; no longer commercially available) in the unprotected LMCA and LAD. Next, we dilated the vessels with a 3.5 × 20-mm noncompliant balloon. The good angiographic result indicated that patency had been achieved (Fig. 1C). With use of OCT, we confirmed the correct apposition of the scaffold (Fig. 2A), but also identified a small distal edge dissection in the LAD unsuitable for stenting, leaving the ostium of the left circumflex coronary artery caged by struts (Fig. 2B). At the patient's 40-month follow-up visit, his LV function had recovered, and a coronary angiogram confirmed that the treated unprotected LMCA-LAD remained patent (Fig. 1D). Optical coherence tomograms showed most of the struts to be adequately covered with neointima and in the process of being reabsorbed (Fig. 2C); they also showed no remaining scaffold struts or neointimal bridges at the ostium of the left circumflex coronary artery and other branches (Fig. 2D).To our knowledge, this is the first reported case of catastrophic acute thrombosis of an unprotected LMCA being treated with a bioresorbable scaffold. Acute myocardial infarction due to unprotected LMCA disease is rare, but it is also clinically catastrophic and associated with a high mortality rate even after successful revascularization.1 Despite the withdrawal of the Absorb bioresorbable scaffold from commercial sale,2 bioresorbable scaffolds in general are still an attractive therapeutic option for de novo lesions or spontaneous coronary artery dissections during percutaneous coronary interventions, particularly in young patients with less complex lesions.

Optimal dual antiplatelet therapy duration for bioresorbable scaffolds: an individual patient data pooled analysis of the ABSORB trials.

Compared with everolimus-eluting metallic stents, the Absorb bioresorbable scaffold (BRS) results in increased rates of myocardial infarction (MI) and scaffold thrombosis (ST) during its three-year bioresorption phase. It is unknown whether prolonged dual antiplatelet therapy (DAPT) duration might decrease the risk of ischaemic events. We sought to evaluate the impact of DAPT duration on ischaemic and bleeding outcomes following BRS implantation. We conducted an individual patient data pooled analysis from four ABSORB randomised trials and one prospective ABSORB registry. Study endpoints were MI, ST, bleeding, and death up to three-year follow-up. Propensity score-adjusted Cox regression analysis was used to account for baseline differences related to DAPT duration. The five ABSORB studies included 2,973 patients. DAPT use was 91.7%, 53.2%, and 48.0% at 1, 2, and 3 years, respectively. DAPT use within the first year after BRS implantation was associated with markedly lower risks of MI (adjusted hazard ratio [aHR] 0.17, 95% CI: 0.10-0.32; p<0.0001) and ST (aHR 0.08, 95% CI: 0.03-0.19; p<0.0001). Conversely, DAPT use between 1 and 3 years did not significantly affect the risk of MI (aHR 1.04, 95% CI: 0.70-1.55; p=0.84) or ST (aHR 0.86, 95% CI: 0.42-1.75; p=0.67). DAPT did not have major effects upon bleeding or death in either period. DAPT use during the first year after BRS implantation was strongly associated with lower risks of ST and MI. However, a benefit of ongoing DAPT use between 1 and 3 years after BRS implantation was not apparent.

Long-term outcomes after treatment of in-stent restenosis using the Absorb everolimus-eluting bioresorbable scaffold

BackgroundEarly studies evaluating the performance of bioresorbable scaffold (BRS) Absorb in in-stent restenosis (ISR) lesions indicated promising short-term to mid-term outcomes.AimsTo evaluate long-term outcomes (up to 5 years) of patients...

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 &lt; 0.001) and unstable angina 31 % to 0 %, respectively (p &lt; 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 role of optical coherence tomography guidance in scaffold versus stent optimization

BackgroundOptical coherence tomography showed a great ability to identify adverse features during percutaneous coronary intervention with drug-eluting stents and resulted in better clinical outcomes. The study aimed to assess the impact of optical coherence tomography on intraoperative decision-making during implantation of Absorb bioresorbable scaffolds versus everolimus drug-eluting stents.ResultsWe performed an observational study that included 223 consecutive patients post optical coherence tomography-guided implantation of either Absorb bioresorbable scaffolds (162 patients) or everolimus drug-eluting stents (61 patients). We studied the influence of optical coherence tomography on intraoperative decision-making during implantation of bioresorbable scaffolds versus drug-eluting stents by analyzing the total rate of optical coherence tomography-dependent modifications in each device.After satisfactory angiographic results, the total rate of required intervention for optical coherence tomography detected complications was significantly higher in the bioresorbable scaffolds arm compared to drug-eluting stents arm (47.8% versus 32.9%, respectively; p = 0.019). The additional modifications encompassed further optimization in the case of device underexpansion or struts malapposition, and even stenting in the case of strut fractures, or significant edge dissection.ConclusionsCompared to drug-eluting stents, Absord scaffold was associated with a significantly higher rate of optical coherence tomography-identified intraprocedural complications necessitating further modifications. The study provides some hints on the reasons of scaffolds failure in current PCI practice; it offers a new insight for the enhancement of BRS safety and presents and adds to the growing literature for successful BRS utilization.

Four-year results of the AIDA trial: comparison of Absorb bioresorbable scaffold with Xience everolimus-eluting metallic stent in daily clinical practice

Abstract Aims Absorb bioresorbable scaffold (BRS) related events were noticed between 1 and 3 years – the approximate time of active scaffold bioresorption. This resulted in the recommendation for 3 year DAPT after Absorb BRS implantation. We aimed to evaluate the safety and efficacy of the Absorb BRS in comparison with Xience everolimus-eluting stent (EES) at 4 years follow-up in large unselected population. In addition, we aimed to assess the value of prolonged DAPT against scaffold thrombosis. Methods AIDA was an investigator-initiated, non-inferiority, multicenter, randomized, all-comers trial. Target vessel failure (a composite of cardiac death, target-vessel myocardial infarction and target-vessel revascularization) and device thrombosis at 4-year follow-up are the primary focus of this analysis. During the trial recommendation for DAPT was changed to up to 3-years post Absorb BVS implantation. Whether this adaption influenced the results after Absorb BVS will be assessed. Results Between August 2013 and December 2015, 1,845 patients were enrolled, of whom 924 were randomized to treatment with Absorb BRS and 921 to Xience EES. The baseline characteristics in the two study arms were well balanced. Of all patients, 18% had diabetes mellitus, more than 50% presented with ACS and the median SYNTAX score was 11. In the Absorb BRS arm, 97% of lesions were predilated and in 74% post-dilatation was performed. Four-year clinical outcomes are currently being adjudicated by an independent clinical event committee. The results will be available at EuroPCR 2020. Conclusions Absorb BRS is associated with higher rates of scaffold thrombosis throughout 3-year of follow-up. The performance of Absorb BRS beyond 3-years, in comparison with the Xience EES, in a large unselected population will be presented. (ClinicalTrials.gov Identifier: NCT01858077) Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

ImpaCt of an Optimal Implantation Strategy on Absorb Long-Term Outcomes: The CIAO Registry

AimTo compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique. Methods and resultsAll 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. ConclusionOur 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.

Acute mechanical performance of bioresorbable scaffolds compared with everolimus-eluting stents under optical coherence tomography guidance

Objective The aim was to compare the acute mechanical performance of the ABSORB bioresorbable scaffold (BRS) with the everolimus-eluted stents (EES) after optical coherence tomography (OCT)-guided deployment. Background The intrinsic differences in biomechanical properties between BRS and EES and the thicker BRS struts can affect the BRS acute mechanical performance in terms of scaffold expansion and struts apposition. Materials and methods The authors compared the acute mechanical performance of 245 scaffolds with that of 82 everolimus-eluted EES. All scaffolds/stents were deployed under OCT guidance. OCT was used to assess the following acute mechanical performance indices: residual area stenosis, device underexpansion, struts malapposition, edge dissection whether covered or uncovered, and strut fracture. Results Two hundred forty-five scaffolds implanted in 162 patients in the BRS arm were compared with 82 stents implanted in 61 patients in the EES arm. Final OCT acquisitions showed no statistically significant difference in the acute mechanical performance indices between both arms, in terms of residual area stenosis, device underexpansion, struts malapposition, and struts fracture. The only significant difference was noted in the higher rates of both covered and uncovered edge dissections in the BRS arm. Conclusion Under OCT guidance, there was no significant difference in the acute mechanical performance of BRS vs EES, apart from higher rates of both covered and uncovered edge dissections in the BRS arm.

Medium-Term Bioresorbable Scaffold Outcomes Utilising Data From an Australian Clinical Quality Registry

Bioresorbable scaffolds (BRS) are a novel technology in coronary intervention. However, recent trials demonstrate higher rates of device failure compared to contemporary drug-eluting stents. This study sought to utilise a clinical quality registry to assess the medium-term safety of the Abbott Absorb BRS (Abbott Vascular, Santa Clara, CA, USA), in an Australian context. A prospective, observational study of 192 BRS percutaneous coronary interventions (PCI) compared to 31,773 non-BRS PCIs entered in the Victorian Cardiac Outcomes Registry from 2013 to 2017. The main outcome measure was patient-oriented composite endpoint (POCE) events comprising all-cause mortality, any myocardial infarction (MI), and any revascularisation. Bioresorbable scaffolds patients (mean age 61.6±10.5 years, 79% male) were younger, had less comorbidity, less prior PCI, fewer ST elevation myocardial infarction (STEMI) presentations, lower rates of multi-lesion disease and more adjuvant devices compared to non-BRS PCI (all p<0.01). All-cause mortality was 2.1%, myocardial infarction (MI) 2.1%, scaffold thrombosis 3.1% and any revascularisation 14.1% (mean follow-up 27.4±8.9 months). POCE events occurred in 11.5% at 1 year and 16.9% at 2 years, comparable to pooled-trial data. Multivariate predictors of POCE were >1 scaffold used (odds ratio [OR] 4.6, 95% confidence interval [CI] 1.9-11.4, p<0.01) and scaffold diameter ≤2.5 mm (OR 3.3, 95% CI 1.4-7.6, p=0.02). Over 95% guideline adherence was achieved in six of eight patient selection criteria and four of six device deployment criteria. In an Australian setting, BRS were used in non-complex patients. Most guidelines for use were adhered to and outcomes were comparable to pooled trial data. Clinical quality registries are effective in assessing novel treatments and technologies when potential safety concerns develop.

P5615A randomised study comparing FFR-guided paclitaxel-coated balloon angioplasty vs. drug-eluting bioresorbable scaffolds with 9 months invasive follow-up

Abstract Background Elimination of a permanent metallic stent from standard PCI techniques is desirable since mid- and longterm adverse reactions are attributed to an intracoronary foreign body. Purpose To investigate two “metal-free” PCI techniques using either drug-coated balloons (DCB) or bioresorbable scaffolds (BRS) in stable coronary artery disease regarding their safety and efficacy (NCT02607241) and clinical course. Methods 59 patients (table 1) were prospectively randomized for elective PCI of de novo stenosis with either BRS implantation (N=28) or with DCB only angioplasty (N=31). The DCB only arm was treated by a previously implemented protocol including sequential balloon predilations and repetitive FFR (fractional flow reserve) measurements. Stenting was deferred if FFR was &gt;0.80 and in the absence of flow-limiting dissections after final DCB dilatation. All BRS were post-dilated using a non-compliant balloon. All BVS were post-dilated (non-compliant balloon). Optical coherence tomography (OCT) was performed during index procedure and at 9-month f/u. Results Both groups were well balanced without significant differences in clinical characteristics (table 1). Procedural success was achieved in 89.3% in the BRS and 77.4% in the DCB group. Parameter of quantitative coronary angiography are shown in the table 2. The predefined primary end point (efficacy) net luminal gain was significantly larger in the DCB group (noninferiority t-Test, margin: 0.2mm, 80% power). Accordingly, the secondary endpoint late lumen loss indicated with −0.20±0.73 vessel enlargement at the stenotic site in the DCB group at 9-month f/u. Target lesion failure during 9-month f/u occurred much more in the BRS group (14.3% (N=4) vs. 3.2% (N=1), p=0.180) but did not reach significance in this small sample size. In detail, there were 2 scaffold thrombosis despite OCT-guided index procedure in the BRS group with subsequent myocardial infarction, and 2 restenosis in the BRS vs. 1 restenosis in the DCB group requiring repeat target lesion revascularization. Due to safety concerns of BRS and the worldwide recall of Absorb BRS the study was prematurely terminated. Conclusion Our data add evidence for FFR-guided “DCB only” PCI as an attractive, safe and feasible alternative by showing a favorable longterm course contrary to the late lumen loss of conventional coronary stents. The Absorb BRS is potentially harmful with a high percentage of target lesion failure including scaffold thrombosis despite OCT-guided implantation and should be avoided.

P2809Comparison between treatment of “established” versus complex “off-label” coronary lesions with Absorb bioresorbable scaffold implantation: results from the GABI-R registry

Abstract Objectives The purpose of this study was to compare the clinical outcomes of patients treated with bioresorbable scaffold (BRS) for off-label versus approved indications. Background The BRS promised some advantages in terms of complete biodegradation, however, the implication of BRS for off-label indications is not well described. Methods The short- and long-term outcome after implantation of a bioresorbable scaffold system (ABSORB, Abbott Vascular, USA) was evaluated in the prospective, non-interventional, multicenter real-world German-Austrian ABSORB RegIstRy (GABI-R). Results A total of 3,188 patients were enrolled. Patients were divided into two groups: on-label BRS use (33.0%) and off-label use (66.9%) if at least one off-label use criteria was met. The incidence of scaffold thrombosis in confirmed cases was significantly higher in off-label group (1.36% vs. 0.57%, p=0.04; OR 2.41 (95% CI: 1.00–5.82) with also a trend towards higher myocardial infarction rate (2.39% vs. 1.42%, p=0.077; OR 1.70 (95% CI: 0.95–3.03) and cardiovascular death (1.27% vs. 1.14%, p=0.76, OR 1.11 (95% CI: 0.56–2.21) at 6 months follow up. Clinical outcome at 6 months Total Off-label On-label p-value* OR (95%-CI) Patients with 6m FU record 99.0% 99.0% 99.1% 0.82 0.92 (0.43–1.95) Confirmed cardiovascular death 1.22% 1.27% 1.14% 0.76 1.11 (0.56–2.21) Confirmed non-cardiovascular death 0.22% 0.14% 0.38% 0.18 0.37 (0.08–1.66) Cause unknown 0.22% 0.28% 0.09% 0.29 2.97 (0.36–24.73) Hospitalisation 27.5% 27.9% 26.7% 0.51 1.06 (0.89–1.27) MI 2.07% 2.39% 1.42% 0.07 1.70 (0.95–3.03) ARC definite scaffold thrombosis 1.10% 1.36% 0.57% 0.04 2.41 (1.00–5.82) TLF 2.70% 3.00% 2.09% 0.13 1.45 (0.89–2.37) TVF 3.98% 4.31% 3.32% 0.18 1.31 (0.88–1.95) MACE 4.33% 4.64% 3.70% 0.22 1.27 (0.87–1.85) Values are mean ± standard deviation (SD) or number and percentage (n, %). *Comparison between off-label and on-label use. The p-values are from Chi-squared test or Mann-Whitney-Wilcoxon test. ARC, academic research consortium; FU, follow up; MACE, major adverse cardiac events; PCI, percutaneous coronary intervention; TLF, target lesion failure; TVF, target vessel failure. Kaplan-Meyer curve stent thrombosis Conclusions The off-label use of BRS compared to confirmed indications appears to be associated with a higher rate of clinical endpoints considering more complex lesions and higher morbidity in this patients' group. Acknowledgement/Funding This research was supported by a grant from Abbott Vascular.

Absorb Bioresorbable Scaffolds—Out of the Woods After 3 Years?

Absorb Bioresorbable Scaffolds—Out of the Woods After 3 Years?

TCT-178 Intravascular Ultrasound Predictors of Long-Term Outcomes Following ABSORB Bioresorbable Scaffold Implantation: A Pooled Analysis of the ABSORB III and ABSORB Japan Trials

TCT-178 Intravascular Ultrasound Predictors of Long-Term Outcomes Following ABSORB Bioresorbable Scaffold Implantation: A Pooled Analysis of the ABSORB III and ABSORB Japan Trials

TCT-7 Blinded Outcomes Assessment of Absorb Bioresorbable Scaffolds Implanted With Improved Technique: 2-Year Results From the ABSORB IV Randomized Trial

The ABSORB III trial demonstrated that following implantation of coronary bioresorbable vascular scaffolds (BVS), an excess of adverse events continued to accrue through 3 years of implantation (the time of their complete bioresorption), compared with metallic everolimus-eluting stents (EES).

Early strut protrusion and late neointima thickness in the Absorb bioresorbable scaffold: a serial wall shear stress analysis up to five years.

The aim of the study was to evaluate the effect of strut protrusion (SP) on wall shear stress (WSS) and neointimal growth (NG) one and five years after implantation of an Absorb bioresorbable vascular scaffold. Eight patients were selected from a first-in-man study. Following three-dimensional (3D) reconstruction of coronaries, WSS was quantified using Newtonian steady-flow simulation in each cross-section at 5° subunits (sectors) of the circumferential luminal surface. At one year, neointimal thickness (NT) was measured by optical coherence tomography (OCT) and correlated to WSS and SP post procedure. Median SP was 112.9 (90.8, 133.1) µm post implantation. Post procedure, a logarithmic inverse relationship between SP and post-implantation WSS (r=-0.425, p<0.001; correlation coefficients in a range from -0.143 to -0.553) was observed, whereas a correlation between baseline logarithm-transformed WSS (log-WSS) and NT (r=-0.451, p<0.001; correlation coefficients ranged from -0.140 to -0.662) was documented at one year. Mixed-effects analysis between baseline log-WSS and NT at follow-up yielded a slope of 30 µm/ln Pascal (Pa) and a y-intercept of 98 µm. As a result of NG, median flow area decreased from 6.91 (6.53, 7.48) mm2 post implantation to 5.65 (5.47, 6.02) mm2 at one-year follow-up (p=0.01) and to 5.75±1.37 mm2 at five-year follow-up (p=0.024). However, the vessel surface exposed to low WSS (<1 Pa) decreased significantly post procedure (42%) to one year (35.9%) and five years (15.2%) (p-overall <0.0001). SP disturbs laminar flow, creates regions of low WSS (<1.0 Pa) that are associated with NG and lumen area reduction. Low WSS post implantation reduced significantly at long-term follow-up. Thin struts with effective embedment would substantially reduce NG and accelerate homogenisation of WSS towards physiological values.

Impact of Absorb bioresorbable scaffold implantation technique on post-procedural quantitative coronary angiographic endpoints in ST-elevation myocardial infarction: a sub-analysis of the BVS STEMI STRATEGY-IT study.

The aim of the study was to evaluate the impact of bioresorbable vascular scaffold (BRS) implantation technique on post-procedural quantitative coronary angiography (QCA) parameters in ST-elevation myocardial infarction (STEMI). We assessed 442 STEMI patients who underwent BRS implantation in the BVS STEMI STRATEGY-IT study. Optimal BRS implantation was assessed using the PSP score, developed and validated in the GHOST-EU registry. We analysed post-implantation QCA parameters, including minimum lumen diameter (MLD) and maximum footprint, in patients with and without optimal BRS implantation, coded as maximum PSP score. Patients with optimal BRS implantation had higher post-procedural MLD and lower maximum footprint than those without. Multivariate analysis demonstrated that optimal BRS implantation was an independent predictor of high post-procedural MLD, defined as ≥2.4 mm for 2.5 or 3.0 mm BRS and ≥2.8 mm for 3.5 mm BRS. Thrombectomy before optimal BRS implantation showed a trend towards higher post-procedural MLD and lower maximum footprint. There was no relationship between optimal BRS implantation and device-oriented composite events at one year. Optimal BRS implantation, as assessed by PSP score, was associated with better post-procedural QCA parameters in STEMI. Thrombectomy before optimal BRS implantation might improve angiographic results in STEMI. Long-term follow-up is needed to analyse the relationship between QCA parameters and clinical outcomes after BRS implantation in STEMI patients.