Use Of Bioresorbable Vascular Scaffold Research Articles

837 COMPLETE MAGNESIUM BIORESORBABLE SCAFFOLD ABSORPTION AT 1-YEAR OF INTRACORONARY IMAGING FOLLOW UP

Abstract Background the development of bioresorbable scaffolds (BRSs) has been conceived as revolution in interventional cardiology for the prospective improvements in the treatment of coronary artery disease. However, metallic drug eluting stent (DES) demonstrated greater safety and efficacy than bioresorbable vascular scaffold (BVS) Absorb in dedicated trials culminating in the commercial withdrawal of Absorb device in 2017. Nevertheless, the progressive absorption of the scaffold and the restoration of physiological coronary artery characteristics attracted attention, so currently research on BRSs is in progress. Case presentation a 58-year-old woman was admitted in our department after an episode of typical angina at rest without significant troponin elevation. The electrocardiogram showed T wave inversion in lateral leads. Hypokinesia of distal septum and anterior wall and mildly reduced left ventricular ejection fraction (LVEF 50%) were observed on echocardiography. Her cardiovascular risk factors included obesity, arterial hypertension, dyslipidaemia, family history of ischemic heart disease and former smoking. Her past medical history was remarkable for chronic kidney disease (CKD EPI eGFR 50 ml/min) and previous connective tissue disease. Coronary angiography highlighted a critical stenosis in the middle segment of left anterior descending artery (LAD). Optical coherence tomography (OCT) imaging showed recanalized and organized throumbus and calcific plaques. After adequate predilatation and stent sizing by OCT, a 3×25 mm Magnesium-based BVS (Magmaris, Biotronik AG, Buelach, Switzerland) was implanted. OCT confirmed good expansion and apposition of the stent after postdilatation. Patient was discharged on dual antiplatelet therapy (DAPT) for 12 months, anti-remodeling cardiac and lipid-lowering therapy. One year later, the patient underwent and elective coronary angiography and OCT control showing a complete reabsorption of the Magmaris BVS with positive remodelling and luminal enlargement of the vessel. The patient was asymptomatic throughout the year with a good performance status. Conclusion The present case illustrates an example of imaging-based revascularization with BVS Magmaris and optimal intracoronary imaging result at 1 year follow up in agreement with the last available evidence. The last European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines on myocardial revascularization recommends the use of BVS only in the context of clinical controlled studies. However, encouraging results obtained and what expected from the current studies with Magmaris scaffolds, might change indications considering the potential benefit about the restoration of natural vasomotion, the reduced risk of neoatherosclerosis and the positive vascular remodelling following the scaffold absorption.

Very long-term follow-up of patients with coronary bifurcation lesions treated with bioresorbable scaffolds.

The data concerning the use of bioresorbable vascular scaffolds (BVS) in coronary bifurcation lesions are limited. The objective of the study was to evaluate the early and very long-term clinical outcomes of bifurcation stenting with ABSORB BVS. One hundred consecutive patients with coronary bifurcation lesions treated with BVS were included. A total of 124 BVS were implanted. Provisional side branch stenting was performed in 66 patients, distal main stenting in 14 patients, systematic T stenting in 2, and T with minimal protrusion (TAP) in 5 patients. Side branch ostial stenting was performed in additional 12 patients. The procedural success was achieved in 98% of patients. In long-term follow-up, the rate of cardiac death was 4.0%, target vessel myocardial infarction was 5.0%, and target vessel revascularization (TVR) was 11%. The cumulative incidence of definite/probable scaffold thrombosis (ST) was 2% at long-term follow-up. Comparison with the historical drug-eluting stents (DES) group revealed higher mortality and major adverse cardiac events rate in the ABSORB group. Stenting of coronary bifurcation lesions of low-to-moderate complexity with BVS was feasible with good acute performance and acceptable results. However, the risk of death and major adverse cardiovascular events was higher as compared with DES.

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

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

A systematic review and meta-analysis of bioresorbable vascular scaffolds for below-the-knee arterial disease.

Different types of bioresorbable vascular scaffolds (BVSs) have been developed and used in below-the-knee (BTK) arterial diseases. This is the first study reviewing and analyzing the literature on BVS treatment for BTK arterial disease. MEDLINE, Embase, and Cochrane were searched for studies published until October 21, 2019. The search, study selection, quality assessment, and data extraction were performed by 2 authors independently. Articles that studied the treatment of BTK arterial disease by using BVSs were eligible. Exclusion criteria were studies with a variant design (e.g. case reports <5 patients), non-BTK indications for BVS use, and nonhuman studies. Primary endpoint was 12-month primary patency. Secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, and amputation-free survival (AFS). Study quality was assessed by the Methodological Index for Non-randomized Studies score. Five studies representing 155 patients with 160 treated limbs met the inclusion criteria. Pooled 12-month primary patency per limb was 90% (143/160; 95% confidence interval [CI]: 0.84-0.95), freedom from CD-TLR 96% (124/130; 95% CI: 0.91-0.99), limb salvage rate 97% (156/160; 95% CI: 0.94-1.00), survival rate 90% (112/125; 95% CI: 0.82-0.96), and AFS rate 89% (110/125; 95% CI: 0.81-0.94). Subgroup analyses of included Absorb BVS studies showed similar results. All studies were assessed as moderate quality. This meta-analysis of case series showed good 12-month patency and clinical results with BVSs for BTK arterial disease, even in patients with multimorbidity and short but complex lesions. These results encourage a revival of this scaffold.

Absorb bioresorbable vascular scaffold outcomes following implantation with routine intravascular imaging guidance.

We sought to describe the outcomes of BVS use from a single-center experience in which scaffold implantation was guided by intravascular imaging (ultrasound and/or optical coherence tomography) to identify and treat mechanical factors potentially related to BVS failure. The Absorb bioresorbable vascular scaffold (BVS) has been associated with an unexpectedly high incidence of thrombosis. Between 11/2014 and 10/2016, 100 patients were treated with BVS. Intravascular imaging assessment before and after BVS implantation was performed in all cases. Mean age was 58.1 years; 88% were male, 31% had diabetes, and 28% presented with acute coronary syndromes. A total of 171 lesions in 141 vessels were treated with 190 BVS (mean 1.9 scaffolds/patient). Further intervention following intravascular imaging to optimize BVS implantation was required in 31% of patients. Procedure success was 100%. All patients completed a 1-year follow-up. The 1-year rate of target lesion failure was 4%, and there were no cases (0%) of scaffold thrombosis, myocardial infarction, or death. In this real-world experience, the use of intravascular imaging to guide BVS implantation was associated with a high 1-year event-free survival rate, with no scaffold thrombosis.

Bioresorbable Vascular Scaffolds-Dead End or Still a Rough Diamond?

Percutaneous coronary interventions with stent-based restorations of vessel patency have become the gold standard in the treatment of acute coronary states. Bioresorbable vascular scaffolds (BVS) have been designed to combine the efficiency of drug-eluting stents (DES) at the time of implantation and the advantages of a lack of foreign body afterwards. Complete resolution of the scaffold was intended to enable the restoration of vasomotor function and reduce the risk of device thrombosis. While early reports demonstrated superiority of BVS over DES, larger-scale application and longer observation exposed major concerns about their use, including lower radial strength and higher risk of thrombosis resulting in higher rate of major adverse cardiac events. Further focus on procedural details and research on the second generation of BVS with novel properties did not allow to unequivocally challenge position of DES. Nevertheless, BVS still have a chance to present superiority in distinctive indications. This review presents an outlook on the available first and second generation BVS and a summary of results of clinical trials on their use. It discusses explanations for unfavorable outcomes, proposed enhancement techniques and a potential niche for the use of BVS.

The impact of the use of bioresorbable vascular scaffolds and drug-coated balloons in coronary bifurcation lesions

BackgroundDespite the improvement in techniques and tools, coronary lesions involving a bifurcation are still challenging and the outcome with drug-eluting stents is not always optimal. The role of bioresorbable vascular scaffolds (BVS) and drug-coated balloons (DCB) in this setting has not been adequately investigated yet.ResultsFrom the databases of 6 italian centers with high proficiencies in newer technologies, we retrospectively collected all consecutive cases of coronary bifurcations managed or attempted with the implantation of at least one BVS in the main vessel and the use of one DCB in the side branch (SB). Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE) at the longest available follow-up. Fourty patients fulfilled the enrollment criterion, 22.5% had diabetes and 50% an acute coronary syndrome. Average syntax score was 15.04 ± 7.18, all lesions were de novo, and 27 patients (67.5%) had a type 1,1,1 Medina lesion. Twenty-three lesions (57.5%) involved the proximal left anterior-descending artery/first diagonal branch. Only 32.5% of patients underwent an intravascular imaging-guided angioplasty. Average lesion length was 21.4 mm in the main vessel and 11.49 mm in the SB. MV was always predilated and BVS received a postdilation in 100% of the cases. In 42.5% of the cases, the DCB was used during final kissing balloon inflation, and in no cases, a stent/BVS was required in the SB. Procedural success was achieved in 100% of the cases. After an average follow-up of 15.5 (± 11.5) months, we observed no MACE with only one case of target vessel revasularization (2.5%).ConclusionsManagement of coronary bifurcation lesions with the use of newer technologies including BVS and DCB seems feasible and effective at mid-term and long-term clinical follow-up.

Long-term outcomes after bioresorbable scaffold implantation in patients with coronary artery stenosis

Aim. The present study aimed to demonstrate the long-term outcomes after Absorb (Abbott Vascular, USA) everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in real-world patients with coronary artery disease.Methods. This trial involved the largest registry of Absorb BVS implantation in patients with coronary artery disease from Russia, and it was conducted between 2014 and 2018 (n = 500). Safety and efficacy parameters (target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation; major adverse cardiac and cardiovascular events, defined as a composite of cardiac death, myocardial infarction, target vessel revascularisation and stroke, stent thrombosis according to the Academic Research Consortium definition) were assessed over a period of 2 years after the index procedure. Results. Lesion treatment success was achieved in 98.51% (n = 594) of patients. In the 2 years after Absorb BVS implantation, long-term outcomes were assessed via phone calls. Only 9.8% (n = 49) of patients were lost to follow-up. The rates of target vessel failure and major adverse cardiac and cerebrovascular events were 11.6% (n = 58) and 12.6% (n = 63), respectively. Definite/probable stent thrombosis was observed in 3.2% (n = 16) of patients. Conclusion. Using an optimal implantation technique during Absorb BVS implantation in routine clinical practice leads to a high level of lesion treatment success. However, despite this, Absorb BVS use is associated with an increased risk of device-related adverse events, particularly stent thrombosis. Absorb BVS use in long and bifurcated lesions and BVS implantation in the distal segment of the coronary artery are independent predictors of stent thrombosis. In addition, Absorb BVS use in patients with a high functional class of angina and heart failure, multivessel coronary artery disease as well as BVS implantation in the distal segment of the coronary artery are independent predictors of device-related adverse events.Received 22 July 2019. Revised 1 October 2019. Accepted 14 October 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.

Two-year clinical outcomes of the “Italian diffuse/multivessel disease absorb prospective registry” (IT-DISAPPEARS)

BackgroundLarge prospective studies on the use of bioresorbable vascular scaffolds (BVS) for diffuse coronary artery disease are lacking. IT DISAPPEARS is a large multicentre prospective registry investigating the short and long-term outcomes of everolimus-eluting BVS in patients with long coronary lesions and/or multivessel coronary artery disease (ClinicalTrials.gov: NCT02004730). We hereby report the 2-year outcomes of the registry. MethodsWe enrolled 1002 patients with complex lesions undergoing implantation of 2040 BVS with a prespecified technique including predilation, correct sizing, and postdilation with non-compliant balloons. The primary endpoint was the rate of device-oriented composite endpoint (DOCE), consisting of cardiac death, target vessel-related myocardial infarction (MI), and ischaemia-driven target lesion revascularization (TLR). Secondary endpoints included: 1) patient-oriented composite endpoint (POCE), consisting of all-cause mortality, all infarctions and all revascularisations; 2) definite/probable scaffold thrombosis. ResultsClinical presentation was an acute coronary syndrome in 59.8% of patients. Total BVS length implanted was 47 ± 22 mm. Postdilation of all scaffolds per patient was performed in 96.8%, while optimal implantation as per study guidelines was applied in 71.4%. Through 2-year follow-up, DOCE occurred in 9.5% of patients (cardiac death 0.6%, target vessel-related MI 5.3%, TLR 6.6%). The rate of POCE was 16.6% and of scaffold thrombosis 1.1%. Female gender, total length of coronary lesions, treatment of bifurcation lesions and use of 2.5 mm scaffolds were independent predictors of DOCE. ConclusionsThe 2-year results of IT-DISAPPEARS show that BVS may yield acceptable clinical outcomes in patients with complex coronary lesions when the implantation technique is appropriate.

Clinical Outcomes of Successful Revascularization of Chronic Total Coronary Occlusions with Bioresorbable Vascular Scaffolds: A Systematic Review.

Revascularization of chronic total occlusions (CTO) with percutaneous coronary intervention is associated with favorable long-term clinical and echocardiographic outcomes. Whether bioresorbable vascular scaffolds (BVS) would be advantageous in the treatment of CTO is unknown as patients with these lesions were generally excluded from large BVS randomized trials. We performed a systematic review, which sought to summarize known data on mid- to long-term clinical outcomes for BVS in CTO. We searched MEDLINE, EMBASE, clinicaltrials.gov, and the Cochrane Library through April 2018 to look for studies on implantation of BVS in CTO. Outcomes of interest included myocardial infarction, cardiac death, all-cause mortality, major adverse cardiac events (MACE), vessel restenosis, scaffold thrombosis, and target lesion revascularization. A total of 13 articles met the inclusion criteria for analysis. All studies were observational with a total number of patients of 1,077. Only two studies included comparator groups which retrospectively compared BVS with drug-eluting stents (DES). The studies had variable size (21 to 537) and follow-up duration (3–23 months). The review showed favorable outcomes for BVS implantation in CTO with the reported incidence of MACE ranged from 0% to 6.7% with no significant differences between BVS and DES groups in double arm studies. Although data on the use of first-generation BVS in CTO are sporadic and limited by small sample observational studies, available evidence is promising and suggests of acceptable outcomes comparable with second generation DES. Further investigation with randomized clinical trials and use of newer generation scaffolds is required.

One-year clinical performance of ABSORB bioresorbable vascular scaffold in patients presenting with acute coronary syndromes: Results from the RAI registry.

To report 1-year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population. BVS use has rapidly extended to high-risk patients as those presenting with ACS. To date limited data have been reported on BVS performance in ACS patients. RAI is a multicenter, prospective registry that included 1,505 patients treated with at least 1 successful BVS implantation. A subgroup analysis on ACS patients was performed and the 1-year outcomes of this cohort compared to the remaining stable coronary artery disease (SCAD) population are reported here. Coprimary endpoints were target-lesion revascularization (TLR) and scaffold thrombosis (ScT) at 1-year follow-up. Fifty-nine percent of the patients presented with ACS, of whom 36.5% with ST-elevation myocardial infarctions. ACS patients were significantly younger, with a better cardiovascular risk profile, a lower rate of multivessel disease, chronic total occlusion or in-stent restenosis and a lower Syntax score. Predilation and postdilation were performed in 97.4% and in 96.5% of cases, respectively. No differences were noted in terms of TIMI 3 final flow, but acute gain was greater in ACS compared to SCAD group (P < 0.001). At one-year follow-up no differences were found in terms of TLR (3.3% vs. 3.3%, P = 0.98), and device-oriented composite end-point (4.3% vs. 3.4%, P = 0.4) between ACS and SCAD groups. The rate of definite/probable ScT was numerically higher in ACS vs. stable CAD patients (1.3% vs. 0.8%, P = 0.2). Our data suggest that the use of BVS in ACS patients is associated with a numerically higher rate of ScT compared to SCAD population numerically higher, but without statistical significance.

TCT-217 Stenting of Coronary Bifurcation Lesions with Bioresorbable Everolimus-Eluting Scaffolds- longterm outcome from Poznan Bifurcation-Absorb Registry

The data concerning the use of bioresorbable vascular scaffolds(BRS) in coronary bifurcation lesions are limited. Given the complexity of the procedure and the potential risk of side branch (SB) complications or occlusion after BRS implantation, it is imperative to evaluate the efficacy and long-

Appropriate use criteria for optical coherence tomography guidance in percutaneous coronary interventions : Recommendations of the working group of interventional cardiology of the Netherlands Society of Cardiology.

IntroductionOptical coherence tomography (OCT) enables detailed imaging of the coronary wall, lumen and intracoronary implanted devices. Responding to the lack of specific appropriate use criteria (AUC) for this technique, we conducted a literature review and a procedure for appropriate use criteria.MethodsTwenty-one of all 184 members of the Dutch Working Group on Interventional Cardiology agreed to evaluate 49 pre-specified cases. During a meeting, factual indications were established whereupon members individually rated indications on a 9-point scale, with the opportunity to substantiate their scoring.ResultsTwenty-six indications were rated ‘Appropriate’, eighteen indications ‘May be appropriate’, and five ‘Rarely appropriate’. Use of OCT was unanimously considered ‘Appropriate’ in stent thrombosis, and ‘Appropriate’ for guidance in PCI, especially in distal left main coronary artery and proximal left anterior descending coronary artery, unexplained angiographic abnormalities, and use of bioresorbable vascular scaffold (BVS). OCT was considered ‘Rarely Appropriate’ on top of fractional flow reserve (FFR) for treatment indication, assessment of strut coverage, bypass anastomoses or assessment of proximal left main coronary artery.ConclusionsThe use of OCT in stent thrombosis is unanimously considered ‘Appropriate’ by these experts. Varying degrees of consensus exists on the appropriate use of OCT in other settings.Electronic supplementary materialThe online version of this article (10.1007/s12471-018-1143-z) contains supplementary material, which is available to authorized users.

Bioresorbable Vascular Scaffold in the Midportion of the Left Anterior Descending Artery for Cardiac Allograft Vasculopathy in a Cardiac Transplant Patient

In an era when cardiac transplant patients are surviving more immediate issues of rejection and infection, the prevalence of more chronic issues such as cardiac allograft vasculopathy (CAV) is rising. This case describes a man 20 years after cardiac transplant with his first presentation of CAV. Acute myocardial infarction was diagnosed on the basis of symptoms and biochemical markers and on coronary angiography, and he was found to have a critical stenosis of the midportion of the left anterior descending artery. It was elected to treat this percutaneously with a fully bioresorbable vascular scaffold (BVS) because of the diffuse nature of the disease process. This was successfully performed with optical coherence tomography guidance. The use of BVS in CAV has not been well studied. This is one of few case reports describing the use of BVS in CAV.

Very Late Restenosis of a BVS Implanted in a Degenerated Saphenous Vein Graft

The use of bioresorbable vascular scaffolds (BVS) in aortocoronary grafts has been scarcely reported in the literature, with some isolated cases [(1–3)][1] and a unicentric series of 6 cases [(4)][2]. In pivotal trials, saphenous vein grafts (SVGs) were also excluded, and have been poorly

Everolimus-eluting bioresorbable vascular scaffold implantation to treat saphenous vein graft disease, single-center initial experience.

Recent studies have shown favorable outcomes with everolimus-eluting bioresorbable vascular scaffold (BVS) in patients with stable coronary artery disease. Data on the use of BVS in saphenous vein graft disease (SVG) is currently lacking. A total of 10 consecutive patients (13 lesions, including 6 in-stent restenosis) who underwent BVS for SVG disease between May 2013 and June 2015 at a tertiary care institution were included. Median follow-up period was 874 (720-926) days. One patient had scaffold thrombosis (ScT) 15 months after implantation, which was treated medically. Another patient had target lesion revascularization (TLR) in two different lesions, where BVS was used to treat in-stent restenosis. The composite endpoint of TLR, ScT, target vessel myocardial infarction, and cardiac death, was reached in two patients CONCLUSIONS: This first real-world data on the use of the ABSORB™ BVS in patients with SVG disease shows that its implantation is technically feasible. The observed rate of target lesion revascularization was similar to those observed with drug-eluting stents in similar settings. Larger studies are required to better define the optimal use of BVS to treat SVG disease.

BRS implantation in long lesions requiring device overlapping: myth or reality?

Dealing with bioresorbable vascular scaffolds (BVS) implantation in long lesions requiring device overlapping in this particular moment might seem a little provocative for several reasons. First, most studies testing BVS have focused on their safety and efficacy profile in simple patients with simple lesions. Second, ABSORB II did not meet its primary endpoint, while ABSORB III showed a higher rate of target vessel-myocardial infarction (TV-MI) at 2 years. Third, data on porcine model showed that overlapping zone has delayed but greater neointimal proliferation with consequent higher risk for scaffold thrombosis in the short-term and of in-scaffold restenosis in the long-term. Fourth, recently published data showed higher risk of TVF in patients treated with ≥60 mm BVS. Given all these premises, it may seem right to put aside this technology, while it may seem inappropriate to hypothesize the use of BVS in long lesions. The aim of the present review is precisely to critically review the available evidences regarding BVS with particular regard to overlapping BVS in order to understand whether this technology has a future per se and especially in long coronary lesions requiring overlap.

Applicability and procedural success rate of bioresorbable ­vascular scaffolds for percutaneous coronary intervention in an all-comer cohort of 383 consecutive patients

Objectives The purpose of this study was to determine applicability and procedural success of bioresorbable vascular scaffolds (BVS) for percutaneous coronary intervention (PCI) in an all-comer cohort.Background BVS use in bifurcations and severely calcified lesions is not recommended, and a relatively large crossing profile may cause limitations. It is has never been studied how widely BVS can be applied in all-comer cohorts.Methods In 383 consecutive patients (acute coronary syndrome: 124, stable coronary disease 259), a BVS (Absorb) was used as first-line device unless any of the following contraindications were present: bifurcation with side branch >2.0 mm, reference diameter <2.5 mm or >4.0 mm, required device length <12 mm, in-stent stenosis, or contraindications to 6 months of DAPT. Patients and lesions were evaluated regarding suitability for BVS treatment, procedural success (successful BVS placement and residual stenosis <30%), and outcome.Results Of 588 lesions, 303 (52%) were unsuitable for BVS placement due to presence of a bifurcation (30% of unsuitable lesions), reference ­diameter >4.0 mm (13%) or <2.5 mm (12%), contraindication to 6 months DAPT (13%), in-stent stenosis (14%), and desired device length <12 mm (4%). If BVS use was attempted, procedural success with a scaffold was 95% (271/285). Crossing failure occurred in 14 cases (5%), affected lesions were significantly more calcified. After a mean follow-up period of 259 days, definite/probable scaffold thrombosis occurred in 1.1% of patients.Conclusions Approximately one-half of lesions in an all-comer population can successfully be treated with BVS. Crossing failure is rare.

Low major adverse cardiac event rates following bioresorbable vascular scaffold implantation: Impact of implantation technique on treatment outcomes

Background and objectiveStudies conducted across the world have reported that the rates of major adverse cardiac events (MACE) following the use of bioresorbable vascular scaffolds (BVS) are comparable to that noted with traditional drug eluting stents (DES). However, there is limited data on the immediate and medium-term clinical outcomes following the use of the Absorb BVS (Abbott Vascular, Santa Clara, SA) in the Indian context. This study was conducted to determine real-world evidence on the immediate and medium-term clinical outcomes in all patients undergoing percutaneous coronary intervention (PCI) with the Absorb BVS. MethodsData of all patients who were treated with Absorb BVS at our center were evaluated. Between December 2012 and October 2016, 142 patients underwent PCI with BVS. The MACE rates during hospitalization, at 30days, 3 months, 6 months after PCI, and every 6 months thereafter were the primary endpoints evaluated with median follow up of 13 months. ResultsMean age of the study participants was 53.7±11.8years. Intravascular ultrasound imaging was performed in 15.34% of patients. Predilatation and postdilatation were performed in 81.8% and 84.6% of scaffolds, respectively. There were no episodes of MACE during hospitalization. However, 1 BVS-related MACE was observed at the 1-month (0.7%) as well as at the ≥12 month (0.8%) follow up visits. At the 6- and 12-month follow up visits, 2 (1.5%) and 3 (2.5%) non-BVS-related MACEs, respectively, were recorded. ConclusionThe use of Absorb BVS in this real-world experience was associated with very good immediate and medium-term clinical outcomes.

Recommendations for the use of bioresorbable vascular scaffolds in percutaneous coronary interventions : 2017 revision.

BackgroundTo eliminate some of the potential late limitations of permanent metallic stents, the bioresorbable coronary stents or ‘bioresorbable vascular scaffolds’ (BVS) have been developed.MethodsWe reviewed all currently available clinical data on BVS implantation.ResultsSince the 2015 position statement on the appropriateness of BVS in percutaneous coronary interventions, several large randomised trials have been presented. These have demonstrated that achieving adequate 1 and 2 year outcomes with these first-generation BVS is not straightforward. These first adequately powered studies in non-complex lesions showed worse results if standard implantation techniques were used for these relatively thick scaffolds. Post-hoc analyses hypothesise that outcomes similar to current drug-eluting stents are still possible if aggressive lesion preparation, adequate sizing and high-pressure postdilatation are implemented rigorously. As long as this has not been confirmed in prospective studies the usage should be restricted to experienced centres with continuous outcome monitoring. For more complex lesions, results are even more disappointing and usage should be discouraged. When developed, newer generation scaffolds with thinner struts or faster resorption rates are expected to improve outcomes. In the meantime prolonged dual antiplatelet therapy (DAPT, beyond one year) is recommended in an individualised approach for patients treated with current generation BVS.ConclusionThe new 2017 recommendations downgrade and limit the use of the current BVS to experienced centres within dedicated registries using the updated implantation protocol and advise the prolonged usage of DAPT. In line with these recommendations the manufacturer does not supply devices to the hospitals without such registries in place.