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

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.

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 with ISR treated with the Absorb BRS.MethodsWe did an observational analysis of long-term outcomes of patients treated for ISR using the Absorb BRS (Abbott Vascular, Santa Clara, California, USA) between 2013 and 2016 at the Heart Centre Luzern. The main outcomes included a device-oriented composite endpoint (DOCE), defined as composite of cardiac death, target vessel (TV) myocardial infarction and TV revascularisation, target lesion revascularisation and scaffold thrombosis (ScT).ResultsOverall, 118 ISR lesions were treated using totally 131 BRS among 89 patients and 31 (35%) presented with an acute coronary syndrome. The median follow-up time was 66.3 (IQR 52.3–77) months. A DOCE had occurred in 17% at 1 year, 27% at 2 years and 40% at 5 years of all patients treated for ISR using Absorb. ScTs were observed in six (8.4%) of the cohort at 5 years.ConclusionsTreatment of ISR using the everolimus-eluting BRS Absorb resulted in high rates of DOCE at 5 years. Interestingly, while event rates were low in the first year, there was a massive increase of DOCE between 1 and 5 years after scaffold implantation. With respect to its complexity, involving also a more unpredictable vascular healing process, current and future BRS should be used very restrictively for the treatment of ISR.

One Ring to Revascularize Them All: Assessing The End Results of Coronary Bioresorbable Vascular Scaffolds as Revascularization Approach for Chronic Total Occlusions

Following the era of percutaneous coronary intervention (PCI), the occurrence of revascularization in chronic total occlusions (CTO) is correlated with positive and longstanding echocardiographic and clinical outcomes. The beneficial outcomes of bioresorbable vascular scaffolds (BVS) treatment to manage CTO are currently inconclusive, since patients presenting with CTO were frequently ruled out from a vast number of randomized clinical trials (RCTs) which assess BVS. This systematic review is aimed to review and recapitulate available reports on the clinical outcomes of CTO with BVS treatment. Available data in the Cochrane Library, EMBASE, MEDLINE, and, clinicaltrials.gov are being examined to gather investigations on BVS-treated CTO. Outcomes of concern involved vessel restenosis, scaffold thrombosis, target lesion revascularization, myocardial infarction, major adverse cardiac events (MACE), and all-cause mortality. Thirteen papers have met the criteria for inclusion. All papers were written based on observational studies cumulative population samples of 1,077. Two papers were found to involve retrospective comparison of drug-eluting stents (DES) group with BVS group. The investigations had varying group size and duration of follow-up. This review presented beneficial results for BVS-treated CTO. In double-arm studies, the recorded MACE incidence diverged from 0% to 6.7% with no notable differences between DES and BVS populations. While reports on the implantation of the first-generation BVS in CTO populations are infrequent and recruited only insufficient observational studies samples, the available data is promising. The data shows satisfactory results which are analogous to second-generation DES. However, additional investigation by means of RCTs and the application of more novel scaffolds is necessitated.

One Ring to Revascularize Them All: Assessing The End Results of Coronary Bioresorbable Vascular Scaffolds as Revascularization Approach for Chronic Total Occlusions

Following the era of percutaneous coronary intervention (PCI), the occurrence of revascularization in chronic total occlusions (CTO) is correlated with positive and longstanding echocardiographic and clinical outcomes. The beneficial outcomes of bioresorbable vascular scaffolds (BVS) treatment to manage CTO are currently inconclusive, since patients presenting with CTO were frequently ruled out from a vast number of randomized clinical trials (RCTs) which assess BVS. This systematic review is aimed to review and recapitulate available reports on the clinical outcomes of CTO with BVS treatment. Available data in the Cochrane Library, EMBASE, MEDLINE, and, clinicaltrials.gov are being examined to gather investigations on BVS-treated CTO. Outcomes of concern involved vessel restenosis, scaffold thrombosis, target lesion revascularization, myocardial infarction, major adverse cardiac events (MACE), and all-cause mortality. Thirteen papers have met the criteria for inclusion. All papers were written based on observational studies cumulative population samples of 1,077. Two papers were found to involve retrospective comparison of drug-eluting stents (DES) group with BVS group. The investigations had varying group size and duration of follow-up. This review presented beneficial results for BVS-treated CTO. In double-arm studies, the recorded MACE incidence diverged from 0% to 6.7% with no notable differences between DES and BVS populations. While reports on the implantation of the first-generation BVS in CTO populations are infrequent and recruited only insufficient observational studies samples, the available data is promising. The data shows satisfactory results which are analogous to second-generation DES. However, additional investigation by means of RCTs and the application of more novel scaffolds is necessitated.

Bioresorbable Scaffolds: Contemporary Status and Future Directions

Percutaneous coronary intervention, which is safe, effective, and timely, has become an important treatment for coronary artery diseases and has been widely used in clinical practice. However, there are still some problems that urgently need to be solved. Permanent vessel caging through metallic implants not only prevents the process of positive vessel remodeling and the restoration of vascular physiology but also makes the future revascularization of target vessels more difficult. Bioresorbable scaffolds (BRSs) have been developed as a potential solution to avoid the above adverse reactions caused by permanent metallic devices. BRSs provide temporary support to the vessel wall in the short term and then gradually degrade over time to restore the natural state of coronary arteries. Nonetheless, long-term follow-up of large-scale trials has drawn considerable attention to the safety of BRSs, and the significantly increased risk of late scaffold thrombosis (ScT) limits its clinical application. In this review, we summarize the current status and clinical experiences of BRSs to understand the application prospects and limitations of these devices. In addition, we focus on ScT after implantation, as it is currently the primary drawback of BRS. We also analyze the causes of ScT and discuss improvements required to overcome this serious drawback and to move the field forward.

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

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

Two-year follow-up of bioresorbable vascular scaffolds in severe infra-popliteal arterial disease

Objectives To assess the safety, efficacy, and durability of the Absorb bioresorbable vascular scaffold in predominantly complex, infra-popliteal lesions for the management of chronic limb ischemia at two-year clinical follow-up. Bioresorbable vascular scaffold are biodegradable scaffolds that provide short-term vascular support before undergoing intravascular degradation. A recent trial reported excellent 36-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb bioresorbable vascular scaffold. Methods This single-center, retrospective study evaluated the use of the Absorb bioresorbable vascular scaffold (everolimus impregnated poly-L-lactic scaffold) in patients with infra-popliteal peripheral arterial disease (PAD) with respect to safety (thrombosis and TIMI bleeding), technical success, and freedom from clinically driven target vessel failure at 24 months. Results 31 patients (51.6% male) with a median age of 67 years with predominantly advanced infra-popliteal disease were treated with 49 bioresorbable vascular scaffold in 41 vessels. The mean stenosis was 94% (80–100), with 49% of lesions being chronic thrombotic occlusions. No scaffold thrombosis or peri-procedural bleeding was observed. Procedural success was achieved in all patients; 93.5% of patients experienced freedom from clinically driven target vessel failure at 24 months, driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months and 87.1% at 24 months. All patients were alive at 12 and 24 months. Conclusions At 24 months, our study found that patients with predominantly advanced infra-popliteal PAD who were treated with Absorb bioresorbable vascular scaffold reported improved clinical status and a low and durable rate of clinically driven target vessel failure extending out to 24 months.

Five Years Outcomes and Predictors of Events in a Single-Center Cohort of Patients Treated with Bioresorbable Coronary Vascular Scaffolds

Introduction: We report outcome data of patients treated with coronary bioresorbable scaffolds up to 5 years and investigate predictors of adverse events. Methods: Consecutive patients treated with at least one coronary bioresorbable scaffold (BRS, Abbott Vascular, Santa Clara, USA) between May 2012 and May 2014 in our center were enrolled. Clinical/procedural characteristics and outcome data at 1868 (1641–2024) days were collected. The incidence of scaffold thrombosis (ScT), restenosis (ScR), and target lesion failure (TLF) and their predictors were investigated using Kaplan–Meier and Cox regression analysis. Results: 512 consecutive patients and 598 lesions were included in the database. A total of 30 ScT, 42 ScR, and 92 TLF were reported. The rate of ScT was 3.6% in the first year, 2.2% in the second–third year, and 0.6% in the fourth–fifth year after implantation. The corresponding rates of ScR were 2.5%, 5.7%, and 1.1%. The corresponding incidence of TLF was 8.8%, 8.0%, 3.8%. Procedural parameters (vessel size, scaffold footprint) and the technique used at implantation (including predilation, parameters of sizing, and postdilation) were predictors of ScT and TLF in the first three years after implantation. In contrast, only diabetes was predictive of events between 4–5 years (HR 6.21(1.99–19.40), p = 0.002). Conclusions: After device resorption, the incidence of very late adverse events in lesions/patients implanted with a BRS decreases. Procedural and device-related parameters are not predictors of events anymore.