Efficacy and Safety of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Peripheral Artery Disease: A Single-Arm Meta-Analysis.

PURPOSE: This study aimed to evaluate the benefits and risks of patients with peripheral artery disease (PAD) treated with Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) by analyzing all the published studies on the clinical characteristics of patients with PAD. MATERIALS AND METHODS: PubMed, Embase, and the Cochrane Library were searched for relevant studies. Efficacy, safety, and basic characteristics were analyzed. RESULTS: Four studies were included in meta-analysis, including a total number of 155 patients with PAD. The pooled overall primary patency, freedom from target lesion revascularization (TLR), symptom resolution, and wound healing were 90%, 96%, 94%, and 86%, respectively. The pooled perioperative complication and all-cause mortality were 4% and 9%, respectively. Preoperative total occlusion was detected in 43 of 192 lesions (22%). The mean lesion length was 27.26 mm. In terms of comorbidities, the pooled percentage of hypertension, hyperlipidemia, diabetes mellitus, coronary artery disease, chronic kidney disease history, and smoking were 65%, 74%, 49%, 43%, 20%, and 57%, respectively. CONCLUSION: Among these studies, hypertension, hyperlipidemia, and diabetes mellitus were the most common comorbidities in patients with PAD. The Absorb everolimus-eluting BVS was safe and showed the favorable clinical outcomes in both patency and TLR, especially in infrapopliteal disease with heavy calcification. The conclusions of this meta-analysis still needed to be verified by more relevant studies with more careful design, more rigorous execution, and larger sample size.

Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice.

BACKGROUND: The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. METHODS: The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. RESULTS: Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487-3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663-3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. CONCLUSION: With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02601404, NCT04265443.

Impact of post-implantation time on bioresorbable vascular scaffold outcomes for type C versus non-type C coronary lesions: A longer-term study.

BACKGROUND: We have demonstrated that bioresorbable vascular scaffold (BVS) for ACC/AHA type C lesions was associated with higher risks of long-term target lesion revascularization (TLR) and target lesion failure (TLF). We determined the specific time after which higher risks of BVS for type C lesions are reduced in a longer-term follow-up. METHODS: We analyzed data of 457 patients (59 ± 12 years, 87% male) with 714 BVS implanted for 529 lesions and a median follow-up of 56.4 (48.6-62.6) months. Patients with BVS for at least one type C lesion (N = 177) at index intervention and all non-type C lesions (N = 280) were compared for TLF (cardiac death, target vessel myocardial infarction, TLR). We specified the interactions between the non-type C versus type C group and the event-free survival times dichotomized at 24, 30, 32, 33, 36, and 39 months respectively. RESULTS: The type C group had more multivessel disease (86% versus 65%, p < 0.001), left anterior descending artery treated (68% versus 53%, p = 0.002), intravascular imaging used (48% vs. 25%, p < 0.001), and BVS (2.3 ± 0.9 vs. 1.1 ± 0.3, p < 0.001) implanted with a longer total length (57 ± 21 vs. 29 ± 8 mm, p < 0.001). The TLR or TLF was higher (both log-rank p < 0.05) in the type C than in the non-type C group. However, the risks of TLR (hazard ratio: 3.6, 95% CI = 1.1-11.6) and TLF (hazard ratio: 3.8, 95% CI = 1.2-12.1) for type C lesions only remained higher until 24 months post-BVS implantation. CONCLUSION: BVS provides a longer-term advantage, particularly for type C lesions with the majority requiring long stenting.

Quality of life of patients with coronary heart disease treated with the bioresorbable vascular scaffold (ABSORB™): 2-year results from the GABI-R-registry.

BACKGROUND: Numerous studies have reported clinical endpoints following coronary revascularization using bioresorbable vascular scaffolds (BVS), while information about the impact on health-related quality of life is sparse. In this analysis of the German-Austrian ABSORB RegIstRy, the 2 year results concerning quality of life development in a large cohort of patients treated with BVS were reported. METHODS: Data were collected at baseline as well as 30 days, 6 and 24 months after coronary revascularization using BVS. The EQ-5D score, EQ visual analogue scale (VAS) and Seattle Angina Questionnaire (SAQ) were determined for each time point. Patients were categorized according to the indication for coronary revascularization [acute coronary syndrome (ACS), stable angina pectoris (SAP), silent myocardial ischemia (SMI), or other]. Binary logistic regression analysis was performed to determine factors that predict above-average scores two years after implantation. RESULTS: Data from 1317 patients in 88 centres were included. Reasons for revascularization were: ACS (n = 643), SAP (n = 443), SMI (n = 52), and other (n = 179). Mean EQ-5D was significantly increased after six months, while a value comparable to baseline was found two years after implantation. EQ VAS and four of five dimensions of SAQ were significantly improved over baseline at all follow-up surveys. Particularly strong improvements were seen in SAQ scores angina frequency and quality of life. Binary regressions showed different statistically significant predictors in the respective models. CONCLUSIONS: Following coronary revascularization with BVS strong decrease in self-reported angina frequency and increase of self-reported quality of life were observed with continuous improvements over two years of follow-up. Trial registration ClinicalTrials.gov Identifier: NCT02066623.

Lesion impacts on long-term outcomes in patients implanted with bioresorbable vascular scaffold.

BACKGROUND: Bioresorbable vascular scaffold (BVS) had been implanted to several kinds of complex coronary lesions in real-world practice. We tested if long-term outcomes of BVS for complex lesions would be worse than that for relatively simple lesions. METHODS: We analyzed 457 patients (59 ± 12 years, 87% male) with 714 BVS implanted for their 529 lesions and median follow-up of 32.7 (26.8-39.3) months. Complex group (N = 284) was defined as those with BVS for acute coronary syndrome, chronic total occlusion, bifurcation/ostial lesions, instent restenosis/hybrid with metallic stents, diffuse lesions (overlapped by 2 BVS with each â‰§ 18 mm), venous graft/left main lesions, or lesions after rotablation. We compared their outcomes with the remaining 173 patients as non-complex group. RESULTS: The complex group had more chronic kidney disease (7% vs. 2%), multivessel disease (78% vs. 65%), use of intravascular imaging (40% vs. 23%), and more BVS (1.8 ± 0.9 vs. 1.1 ± 0.3) with longer total lengths (47 ± 22 vs. 29 ± 8 mm) implanted than non-complex group (all p < 0.05). However, the long-term target lesion revascularization (TLR) or target lesion failure (TLF) was similar (log rank p > 0.05) between the two groups. Multivariate Cox regression analyses showed BVS for ACC/AHA type C lesions was independently associated with higher risks of TLR (hazard ratio: 2.7, 95% CI = 1.1-6.6) and TLF (hazard ratio: 2.6, 95% CI = 1.1-6.3). CONCLUSION: Comparable outcomes were found between BVS for complex and non-complex lesion category. However, higher risks of TLR and TLF for type C lesions still suggested the prognostic impact of lesion complexity on long-term outcomes of BVS.

Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data.

Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.

Second generation, sirolimus-eluting, bioresorbable Tyrocore scaffold implantation in patients with ST-segment elevation myocardial infarction: Baseline OCT and 30-day clinical outcomes - A FANTOM STEMI pilot study.

BACKGROUND: There is paucity of data on acute performance of Fantom (REVA Medical, CA), a second generation sirolimus-eluting bioresorbable scaffold (BRS), in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention. The aim of this study was to evaluate safety and efficacy of the Fantom BRS in the acute setting of STEMI characterized by thrombogenic milieu. METHODOLOGY: Ten STEMI patients treated with a sirolimus-eluting Fantom BRS were enrolled into prospective, observational study. The scaffold sizing, positioning, and optimization were optical coherence tomography (OCT) guided. The primary end-point was the device-oriented composite endpoint (DOCE), additionally angiographic and OCT analysis were performed. RESULTS: The primary-end point, defined as DOCE, did not occur in any patient within the 30-day follow-up. The procedural and angiographic success rates were both 100%, there was no case of scaffold thrombosis, target lesion revascularization nor death. In QCA, an in-device minimum lumen diameter was 2.89 ± 0.24 mm and the residual diameter stenosis was 3.56 ± 3.17%. OCT revealed an incomplete scaffold apposition in five patients with an average of seven malapposed struts per scaffold and mean distance of 120 ± 30 µm. There was no proximal edge dissection, the distal edge dissection was recorded in one patient. CONCLUSIONS: This is the first pilot study evaluating safety and efficacy of the Fantom BRS, a second generation fully bioresorbable coronary scaffold, in STEMI patients undergoing primary PCI with OCT guidance. Fantom BRS showed adequate safety and efficacy in the acute 30-day angiographic, OCT, and clinical follow-up.

Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry.

Purpose: To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR (Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) registry. Materials and Methods: A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Results: Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. Conclusion: The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.

A case report of a recurrent early and late Bioresorbable vascular scaffold thrombosis: serial angiography and optical coherence tomography findings.

BACKGROUND: In bioresorbable vascular scaffolds (BVSs), there is some concern about a possible increase in the rate of scaffold thromboses (ScTs). Although several characteristics similarly contribute to the development of both early and late ScTs, there are also clearly different pathomechanisms between the two time-dependent types of thromboses, especially with BVSs. CASE PRESENTATION: We recently experienced a very rare case of a 69-year-old man who had recurrent early and late ScTs with somewhat differing pathomechanisms as assessed by optical coherence tomography (OCT). For the late ScT, OCT identified a scaffold dismantling in the same place that a peri-strut low intensity area (PLIA) was observed in the previous OCT finding. CONCLUSION: We report the management of an ScT in a case with findings such as a heterogeneous a BVS degradation, peri-strut low intensity area (PLIA), intraluminal scaffold dismantling, and under-sizing and/or stent malapposition observed in OCT.

[Influence of Thickness and Width of Bioabsorbable Vascular Stent on Local Hemodynamics].

The study reconstructed vascular model by the realistic Optical Coherence Tomography (OCT) data to investigate the influence of the local hemodynamics caused by different thickness and width of bioresorbable vascular scaffold (BRS) implantation in Left Anterior Descending (LAD) artery. The study explored the relationship between the stent structure and thrombus, and the result can provide a valuable reference for the optimal design of BRS.

The effect of elective implantation of the ABSORB bioresorbable vascular scaffold on coronary microcirculation: Serial assessment using the index of microcirculatory resistance.

INTRODUCTION: Stenting with metal stents can affect microcirculatory function. The impact of BVS on the microvascular network has not been studied. METHODS: A total of 30 patients with bifurcation disease of Medina (X,X,0) scheduled for elective PCI with the ABSORB BVS were studied. Pressure wire studies were performed before and after scaffold implantation and at a mean follow-up of 9 months. At each time point, FFR, IMR, and CFR were calculated using the thermodilution method. RESULTS: Following scaffold implantation, FFR change from pre-PCI, post-PCI and follow-up was 0.76, 0.92 and 0.91, respectively (P < 0.001 from pre to post-PCI and P = 0.91 from post-PCI to follow-up). There was a statistically significant improvement between pre- and post-procedural IMR (median 27.7 to 17.9, P = 0.02) and CFR (median 2.2 to 2.9, P = 0.02). Median IMR at follow-up (23.6) remained numerically lower than pre-procedure but this was not statistically significant (P = 0.05). Similarly, while median CFR at follow-up remained at post-procedural level (2.9), this effect did not reach statistical significance (P = 0.06). CONCLUSION: There is an immediate reduction in microvascular resistance after elective BVS implantation but this effect is not sustained long term.

The Current Literature on Bioabsorbable Stents: a Review.

PURPOSE OF REVIEW: The purpose of this review is to explore the evolution of the coronary stent, from the advent of bare-metal stents, to the newest adopted technology of bioresorbable vascular scaffolds (BVS) used in bioresorbable stents. To date, there have been conflicting data regarding the safety and efficacy of BVS stents, especially when compared to current-generation drug-eluting stents (DES). This review will cover the data that exist regarding current BVS stents, as well as the active clinical trials for future iterations of BVS. RECENT FINDINGS: The ABSORB BVS, the most widely circulated stent of its class, was promised to decrease rates of stent thrombosis and target vessel revascularization. Several randomized control trials, however, found the opposite to be true, with the ABSORB BVS demonstrating higher rates of thrombosis, target vessel revascularization, and even target lesion myocardial infarctions when compared to current-generation DES. These data caused the product to be pulled from all markets, leaving the field with uncertainty as to the role of BVS in coronary interventions. Coronary stents have evolved significantly from 1977, when they were first introduced. The original bare-metal stent was later fitted with a drug-eluting polymer, to prevent restenosis and thrombosis over time. Subsequent iterations of the stent attempted to further mitigate that risk by replacing the durable polymer to one that is bioresorbable. The final step in this progression was to create a stent that was fully bioresorbable, which Abbott did with the creation of their ABSORB BVS stent. The product, however, was found to perform poorly when compared to current-generation drug-eluting stents, with several trials showing high rates of stent thrombosis (ST), late stent thrombosis (LST), target-lesion myocardial infarction, and target vessel revascularization. Observational studies of BVS stents have proposed several mechanisms for their thrombogenicity, including higher stent-strut profiles leading to turbulent flow, low radial strength leading to strut disruption, and a higher propensity for neoatherosclerosis. Given the failure of the first-generation BVS stent, but the lingering desire for fully bioresorbable scaffolds, various manufacturers have proposed their solutions with new stents. Until data from their clinical trials emerge, it remains unclear whether fully bioresorbable stents will play any role in coronary interventions.

Early outcome of magnesium bioresorbable scaffold implantation in acute coronary syndrome-the initial report from the Magmaris-ACS registry.

OBJECTIVES: The Magmaris-ACS Registry is the first assessment of the Magmaris implantation in the acute coronary syndrome (ACS) population. BACKGROUND: Bioresorbable vascular scaffolds (BRS), the newest coronary stent technology, was developed to overcome the limitations of the metallic drug-eluting stents (DES). Current promising data of the Magmaris in patients with stable angina have encouraged to validate the second generation BRS in ACS indications. METHODS: The study population consisted of the consecutive patients who underwent PCI with the Magmaris BRS in the settings of ACS. Patients with ST-segment elevation myocardial infarction were excluded from enrolment. Baseline demographic and angiographic characteristics, as well as 30-day and 6-month clinical, follow up were prospectively analyzed. RESULTS: Fifty patients were enrolled at mean age 62.9 ± 8.4 years (unstable angina-52% and non-ST-segment myocardial infarction [NSTEMI]-48%). Treated fifty-one de novo lesions were located in LAD (37%), LCx (14%), and RCA (49%), respectively. Angiographic success in the target lesion was 100%. One case of recurrent ischemia was observed a day after the index procedure, due to the significant distal edge dissection a regular metallic DES overlapping Magmaris was implanted. No other in-hospital events occurred (procedural success 98%). Six-Month follow up showed none device-oriented endpoints such as cardiac mortality, target vessel myocardial infarction or target vessel revascularization. None early scaffold thrombosis was reported. CONCLUSION: The use of the Magmaris BRS in non-ST elevation ACS patient is associated with a procedural safety and promising early angiographic and clinical outcomes. Long-term follow-up and further evaluation in large prospective randomized controlled trials are needed.

MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design.

AIM: Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular healing response following BRS implantation tend to superiority as compared to metallic drug-eluting stent in ST-segment elevation myocardial infarction (STEMI) patients. We sought to compare the in-stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12-month angiographic follow-up in the setting of patients with STEMI treated by primary PCI. STUDY DESIGN: This is an investigator-driven, prospective, multicenter, randomized, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end-point is the in-stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12-month angiographic follow-up. Besides, patient-oriented combined endpoint of all-cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device-oriented endpoint of cardiac death, target vessel (TV)-MI and TVR at 1 year will be also evaluated. Clinical follow-up will be scheduled yearly up to 5 years. CONCLUSION: This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.

Absorb GT1 Bioresorbable Vascular Scaffold System　- 1-Year Post-Marketing Surveillance in Japan.

BACKGROUND: The Japan post-marketing surveillance (PMS) for the Absorb GT1 bioresorbable vascular scaffold (BVS) mandated an intracoronary imaging-guided implantation technique.Methods and Results:We enrolled 135 patients who were planned to undergo PCI with THE Absorb GT1. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a noncompliant balloon to minimize final diameter stenosis were recommended. The primary endpoint was the scaffold thrombosis rate at 3 months. All patients successfully received at least 1 Absorb GT1 at the index procedure and completed 1-year follow-up. All 139 lesions were predilatated: cutting/scoring balloon and noncompliant balloon were used in 48 (34.5%) and 58 (41.7%) lesions, respectively. Post-dilatation was performed in 137 (98.5%) lesions with mean high pressure of 18.8 atm. Optical coherence tomography (OCT) was used in 127 of 139 (91.4%) lesions, and revealed 56.7% of lesions had incomplete scaffold apposition (ISA) but only in 1.89% in the per strut analysis. All patients received adenosine diphosphate receptor antagonist at discharge, and 132 (97.8%) patients continued therapy through the year. No definite/probable scaffold thrombosis, cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization was reported up to 1 year follow-up. CONCLUSIONS: Appropriate OCT-guided BVS implantation may prevent incomplete strut apposition, thereby reducing the risk of target lesion failure and scaffold thrombosis.

Bioresorbable vascular scaffolds for percutaneous treatment of chronic total coronary occlusions: a meta-analysis.

BACKGROUND: BRS represent a new approach to treating coronary artery disease. Beneficial properties of BRS regarding the restoration of vasomotility after resorption make them attractive devices in CTO revascularization. However, experience in this setting is limited. METHODS: We systematically searched Medline, Scholar, and Scopus for reports of at least 9 patients with CTO undergoing BRS implantation. Patients' and procedural characteristics were summarized. The primary outcome of interest was target lesion revascularization (TLR). Pooled estimates were calculated using a random-effects meta-analysis. The study protocol was registered in PROSPERO (CRD42017069322). RESULTS: Thirteen reports for a total of 843 lesions with a median follow-up of 12 months (IQR 6-12) were included in the analysis. At short-term, the summary estimate rate of TLR was 2.6% (95% CI: 1 to 4%, I2 = 0%, P = 0.887) while at mid to long-term it was 3.8% (95% CI: 2 to 6%, I2 = 0%, P = 0.803). At long-term follow-up (≥12 months), the summary estimate rate of cardiac death was 1.1% (95% CI: 0 to 2%, I2 = 0%, P = 0.887). The summary estimate rates of scaffold thrombosis and clinical restenosis were respectively 0.9% (95% CI: 0 to 2%, I2 = 0%, P = 0.919) and 1.8% (95% CI: 0 to 4%, I2 = 0%, P = 0.448). Finally, the summary estimate rate of target vessel revascularization was 6.6% (95% CI: 0 to 11%, I2 = 0%, P = 0.04). CONCLUSIONS: Implantation of BRS in a population with CTO is feasible, although further longer-term outcome studies are necessary.

Guided de-escalation of DAPT in acute coronary syndrome patients undergoing percutaneous coronary intervention with BVS implantation: a post-hoc analysis from the randomized TROPICAL-ACS trial.

To investigate the safety and efficacy of an early platelet function testing (PFT)-guided de-escalation of dual antiplatelet treatment (DAPT) in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) with bioresorbable vascular scaffolds (BVS). Early DAPT de-escalation is a new non-inferior alternative to 12-months DAPT in patients with biomarker positive ACS treated with stent implantation. In this post-hoc analysis of the TROPICAL-ACS trial, which randomized 2610 ACS patients to a PFT-guided DAPT de-escalation (switch from prasugrel to clopidogrel) or to control group (uniform prasugrel), we compared clinical outcomes of patients (n = 151) who received a BVS during the index PCI. The frequency of the primary endpoint (cardiovascular death, myocardial infarction, stroke or BARC ≥ 2 bleeding) was 8.8% (n = 6) in the de-escalation group vs. 12.0% (n = 10) in the control group (HR 0.72, 95% CI 0.26-1.98, p = 0.52) at 12 months. One early definite stent thrombosis (ST) occurred in the control group (day 19) and 1 possible ST (sudden cardiovascular death) in the de-escalation group (day 86), both despite prasugrel treatment and in a background of high on-treatment platelet reactivity assessed at day 14 after randomization (ADP-induced platelet aggregation values of 108 U and 59 U, respectively). A PFT-guided DAPT de-escalation strategy could potentially be a safe and effective strategy in ACS patients with BVS implantation but the level of platelet inhibition may be of particular importance. This hypothesis-generating post-hoc analysis requires verification in larger studies with upcoming BVS platforms.

Immune-inflammatory response after bioresorbable vascular scaffold implantation in patients with acute myocardial infarction with ST elevation in a long-term perspective.

A higher rate of bioresorbable vascular scaffold (BVS) thrombosis has been observed after device implantation compared to implantation of permanent metallic stents in recently published studies. The mechanism of BVS thrombosis is currently under debate. To assess whether the immune-inflammatory response after BVS implantation is a potential trigger of BVS thrombosis. The PRAGUE-19 study was an academic study that enrolled consecutive patients with ST-segment elevation myocardial infarction (STEMI) with the intention to implant a BVS. A laboratory sub-study included 49 patients with an implanted BVS (of which 38 underwent the complete 2-year follow-up) and 52 patients having an implanted permanent metallic stent as the control group (of which 30 underwent the complete 2-year follow-up). Samples for inflammatory markers [high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α)] were taken before BVS or stent implantation, on days 1 and 2 after device implantation and at 1 month and 2 years for a clinical control. The primary combined clinical endpoint of the sub-study (death, reinfarction or target vessel revascularization) occurred in 4.08% of the BVS group and 7.69% of the control group (p = 0.442) during the 2-year follow-up period, with overall mortality of 2.04% in the BVS group and 1.92% in the control group (p = 0.966). Definite BVS thrombosis occurred in one patient in the subacute phase; there was no late or very late thrombosis. Two definite stent thromboses were observed in the control group: one in the subacute phase and the other in the late phase. Baseline inflammatory marker levels did not differ between the groups. Lower levels of IL-6 and hs-CRP were observed in the BVS group compared to the control group (12.02 ± 5.94 vs. 15.21 ± 5.33 pg/ml; p < 0.01; 3952.9 ± 1704.75 ng/ml vs. 4507.49 ± 1190.01 ng/ml; p = 0.037, respectively) on days 1 and 2 (12.01 ± 6.31 vs. 13.85 ± 6.01 pg/ml; p = 0.089; 4447.92 ± 1325.31 ng/ml vs. 4637.03 ± 1290.99 ng/ml; p = 0.255, respectively). No differences in IL-6 or hs-CRP were observed after 1 month or 2 years in the clinical control. Levels of TNF-α did not differ between the groups in the early period after BVS or metallic stent implantation, nor during follow-up. The immune-inflammatory response is lower during the early phase after BVS implantation compared to that after metallic stent implantation, but the responses did not differ in the long term.

Implantation of bioresorbable vascular scaffold for the treatment of pudendal artery stenosis and erectile dysfunction.

Bioresorbable vascular scaffolds (BVS) have been designed to overcome long-term limitations of metallic drug-eluting stents including permanent metallic "caging" that might trigger late coronary adverse events. Here, we report for the first time a case of 72-year gentleman with previous coronary artery disease, treated by successful implantation of BVS (Absorb, Abbott Vascular) due to significant stenosis of internal pudenda artery and erectile dysfunction. After 2 years, BVS completely resorbed and there were no signs of pudendal artery restenosis on CT scan, whereas blood flow and sexual function improved.

Use of Bioresorbable Vascular Scaffold technology in treating coronary bifurcation lesions: A report about long-term clinical results and review of available literature.

INTRODUCTION: BVS proved safe in humans. ABSORB trials showed them performing similar to Drug Eluting Stents in simple coronary interventions. We assessed a registry of 63 patients with bifurcation lesions, treated by BVS and followed their outcomes up-to 5 years. METHODS: Patients who satisfied the inclusion criteria were included. Data about contact information, baseline characteristics, findings of coronary angiogram, details of their interventional treatment; short and long-term outcomes up till 5 years was collected. RESULTS: Acute feasibility of implantation in bifurcation was high (98 %). Rate of stent thrombosis, acute or sub-acute, was 3.1 %. Rate of re-intervention was 38 %. The average time for an event to occur was 1.6±0.8 years. Over 5 years, 56 % had developed MACE. Patients with MACE were more likely females, hypertensive, smokers, with acute presentations (p=NS), and diabetic (72 % vs 33 % non-diabetic; p=0.002). Patients treated with hybrid strategy of BVS and DES were more likely to develop MACE (64 % vs 49 % for others; P=ns). Patients treated by simple provisional stenting were less likely to develop MACE (45 % vs 60.5 %; p=ns). The average SYNTAX score of MACE patients was 27 vs 20; p=0.06). Diabetes was independently associated with MACE. Hypertension was of borderline statistical significance (2-sided Log rank for Hypertension p=0.06, for Diabetes p=0.01). DISCUSSION: The use of multiple stenting strategies to treat true bifurcation lesions using BVS is feasible with low rate of serious adverse events, albeit on the long run, the rate of re-intervention is high and stringent follow up is required (Tab. 7, Fig. 3, Ref. 37).