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

Vascular ◽  
2020 ◽  
pp. 170853812095494
Author(s):  
AbdulRahman Dia ◽  
Joseph M Venturini ◽  
Rohan J Kalathiya ◽  
Stephanie Besser ◽  
Jeremy Raider Estrada ◽  
...  
Keyword(s):  
Clinical Status ◽  
Limb Ischemia ◽  
Arterial Disease ◽  
Primary Patency ◽  
Target Vessel ◽  
Recent Trial ◽  
Bioresorbable Vascular Scaffold ◽  
Scaffold Thrombosis ◽  
Vascular Scaffold

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.

Three-Year Results of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Infrapopliteal Arteries

2018 ◽  
Vol 25 (6) ◽  
pp. 694-701 ◽  
Author(s):  
Ramon L. Varcoe ◽  
Shannon D. Thomas ◽  
Andrew F. Lennox
Keyword(s):  
Duplex Ultrasound ◽  
Primary Patency ◽  
Tissue Loss ◽  
Lesion Length ◽  
Bioresorbable Vascular Scaffold ◽  
Binary Restenosis ◽  
Antiplatelet Medication ◽  
Scaffold Thrombosis ◽  
Vascular Scaffold

Purpose: To investigate the midterm performance of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) for the treatment of symptomatic infrapopliteal atherosclerotic disease. Methods: A single-center study prospectively enrolled 48 symptomatic patients (mean age 82.1±8.0 years; 27 men) between September 2013 and February 2018 to evaluate the Absorb everolimus-eluting BVS system in distal popliteal and tibial lesions. Mean lesion length was 20.1±10.8 mm. Following predilation, up to 2 BVS were implanted in target lesions in 55 limbs. Clinical and duplex ultrasound follow-up was performed at 1, 3, 6, 12, 24, 36, and 48 months to determine 30-day morbidity and midterm Kaplan-Meier estimates of binary restenosis, clinically-driven target lesion revascularization (CD-TLR), amputation, and mortality. Results: Seventy-one scaffolds were implanted to treat 61 lesions. Technical success was achieved in all patients, with no amputation, death, or target limb bypass surgery within 30 days of the index procedure. There was 1 early thrombotic occlusion of 2 BVS in a previously anticoagulated patient not given antiplatelet medication after the procedure. During a mean follow-up of 24.0±15.3 months, 11 (23%) patients died; the remaining 37 were available for follow-up. Binary restenosis (50%–75%) was detected in 6 (8%) scaffolds. Primary patency estimates at 12, 24, and 36 months were 92.2%, 90.3%, and 81.1%; freedom from CD-TLR estimates were 97.2%, 97.2%, and 87.3% at the same time points. No late scaffold thrombosis has been observed. The majority of the 55 limbs (51, 93%) were clinically improved; 4 (7%) were unchanged. Thirty-six (92%) of 39 limbs treated for tissue loss achieved complete wound healing, with no major amputation (limb salvage 100%). Conclusion: Midterm follow-up demonstrates excellent safety, patency, and freedom from CD-TLR rates using the Absorb bioresorbable vascular scaffold below the knee.

scholarly journals First Bioresorbable Vascular Scaffold Implantation in Patients with Acute Coronary Syndrome in the Republic of Macedonia

PRILOZI ◽  
2015 ◽  
Vol 36 (2) ◽  
pp. 147-155
Author(s):  
Jorgo Kostov ◽  
Jelka Davceva-Pavlovska ◽  
Sasko Kedev
Keyword(s):  
Acute Coronary Syndrome ◽  
Clinical Symptoms ◽  
High Rate ◽  
Target Vessel ◽  
Lumen Area ◽  
Bioresorbable Vascular Scaffold ◽  
Coronary Syndrome ◽  
Timi Flow ◽  
Scaffold Thrombosis

Abstract Background: The term acute coronary syndrome (ACS) refers to any group of clinical symptoms compatible with acute myocardial ischemia. These high-risk manifestations of coronary atherosclerosis are important causes of the use of emergency medical care and hospitalization. We evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ACS. Methods and results: The present investigation was a prospective, single-centre study. Clinical outcomes were reported at the 30-day, 6-month, 1 year and 2 years follow-up. The procedural success was 100.0%. After the BVS implantation a TIMI flow 3 was achieved in all 15 patients and the postprocedure percentage diameter stenosis was 16.4 ± 8.6%. No patients had angiographically visible residual thrombus at the end of the procedure. Optical coherence tomography (OCT) analysis was performed in 8 patients (53.3%) and showed that the post-procedure mean lumen area was 7.86 ± 1.81 mm2, minimum lumen area 5.51 ± 1.58 mm2. At the 30-day, 6-month, 1 year (15 patients) and 2 years follow-up (5 patients) target-lesion failure rate was 0%. Non-target vessel revascularization and target vessel myocardial infarction were not reported. No cases of cardiac death or scaffold thrombosis were observed. Conclusion: BVS implantation in patients presenting with ACS appeared feasible, with high rate of final TIMI-flow 3 and good scaffold apposition.

scholarly journals PERCUTANEOUS CORONARY INTERVENTION WITH BIORESORBABLE VASCULAR SCAFFOLD VERSUS MINIMALLY INVASIVE OFF-PUMP BYPASS SURGERY: 30-DAYS FOLLOW UP

2018 ◽  
Vol 7 (3) ◽  
pp. 56-64 ◽  
Author(s):  
K. M. Vakkosov ◽  
V. I. Ganjukov ◽  
S. V. Ivanov ◽  
O. L. Barbarash ◽  
L. S. Barbarash
Keyword(s):  
Coronary Artery ◽  
Cardiovascular Events ◽  
Coronary Intervention ◽  
Target Vessel ◽  
Bioresorbable Vascular Scaffold ◽  
Target Vessel Revascularization ◽  
Percutaneous Coronary ◽  
Vascular Scaffold ◽  
Artery Disease

Aim. To assess the comparative 30-day effectiveness of percutaneous coronary intervention (PCI) with bioresorbable vascular scaffold (BVS) versus minimally invasive direct coronary artery bypass (MIDCAB) for left anterior descending coronary artery disease.Methods. 130 patients with significant (≥70%) LAD disease were recruited in the study. Patients were randomized either to PCI with BVS (n = 65) or MIDCAB (n = 65). The groups of patients were comparable in baseline demographic, clinical and angiographic parameters. The endpoints included adverse cardiovascular events (all-cause mortality, myocardial infarction, stroke, target vessel revascularization) and scaffold thrombosis and were measured on day 30 after the indexed intervention.Results. At 30-day follow-up, there were no significant differences in the incidence of the adverse cardiovascular events between the study groups (0% MIDCAB vs. 3.1% PCI, р = 0.151), myocardial infarction (0% vs. 3.1%, p = 0.151), target vessel revascularization (0% vs. 1.5%, p = 0.32) and scaffold (graft) thrombosis (0% vs. 1.5%, p = 0.32).Conclusion. PCI with BVS and MIDCAB in patients with stable coronary artery disease and isolated left anterior descending lesions demonstrated comparable outcomes at 30-days follow-up.

scholarly journals Efficacy and safety of bioresorbable vascular scaffold Absorb: 6-month outcomes of GABI-R: Russia registry

2019 ◽  
Vol 23 (1S) ◽  
pp. 26
Author(s):  
A. A. Prokhorikhin ◽  
E. I. Fartakov ◽  
D. U. Malaev ◽  
A. A. Boykov ◽  
S. V. Oidup-Ool ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Conflict Of Interest ◽  
Target Vessel ◽  
Efficacy And Safety ◽  
Bioresorbable Vascular Scaffold ◽  
Target Vessel Revascularization ◽  
Coronary Syndrome ◽  
Scaffold Thrombosis ◽  
Artery Disease

<p><strong>Aim.</strong> The paper demonstrates the interim analysis of efficacy and safety after everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb implantation in “real-world patients” with coronary artery disease.</p><p><strong>Methods.</strong> A cohort of 500 consecutive patients who underwent percutaneous coronary intervention for stable chest pain or acute coronary syndrome with implantation of at least one BVS (Absorb, Abbott Vascular) and followed up by telephone interview and review of medical charts were included in a singlecenter, prospective, all-comers, first in Russia registry. The primary endpoint, target vessel failure, defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization and secondary endpoints, MACCE (composite of cardiovascular death, myocardial infarction, coronary artery bypass surgery, target vessel revascularization, stroke) and stent thrombosis, were assessed during 6-month follow-up.</p><p><strong>Results</strong>. A total of 500 patients with coronary artery disease (CAD) (stable CAD 54.4%, acute coronary syndrome 45.6%) and different amount of affected vessels (1 vessel CAD 40.8%, n = 204; 2-vessel CAD 32.8%, n = 164; 3-vessel CAD 26.4%, n = 132) received 664 scaffolds and 55 stents in 603 stenoses. Procedure success, defined as a residual stenosis less than 30% and TIMI 3 flow in target vessel at the end of procedure, was observed in 98.51% (n = 594). At the moment of 6-month follow-up 4.2% (n = 24) of patients were lost to contact. After 6 months, incidence of target vessel failure and MACCE was 4.2% (n = 21) and 5% (n = 25). The cumulative rate of definite/probable scaffold thrombosis was 1.6% (n = 8).</p><p><strong>Conclusion</strong>. The interim analysis of Gabi-R: Russia registry, the largest trial of BVS Absorb implantation in routine clinical practice, showed high procedural success and low incidence of adverse events during follow-up. However, a tendency to high incidence of scaffold thrombosis compared to drug-eluting stents can be observed. Considering the long-term results of randomized trials retrospective registries, safety in terms of BVS routine use is of big concern. Longterm 24-month data regarding safety endpoints are required to test the afore-mentioned suggestion. </p><p>Received 5 January 2019. Revised 28 March 2019. Accepted 29 March 2019.</p><p>Funding: The study did not have sponsorship.</p><p>Conflict of interest: Authors declare no conflict of interest.</p>

scholarly journals Early results with LifeStent implantation in RESILIENT and non-RESILIENT inclusion criteria patients

Vascular ◽  
2014 ◽  
Vol 23 (3) ◽  
pp. 225-233 ◽  
Author(s):  
Patrick A Stone ◽  
John E Campbell ◽  
Rashi Fischer ◽  
David Phang ◽  
Stephanie N Thompson ◽  
...  
Keyword(s):  
Tobacco Use ◽  
De Novo ◽  
Limb Ischemia ◽  
Arterial Disease ◽  
Primary Patency ◽  
Limb Loss ◽  
Endovascular Interventions ◽  
Early Results ◽  
Peripheral Arterial

The purpose of our study was to determine outcomes of patients receiving the LifeStent (Bard Peripheral Vascular, Tempe, AZ) for femoropopliteal peripheral arterial disease in real-world academic practice outside the limitations of an industry supported trial. All patients from 2009 to 2012 at our institution who received a LifeStent during endovascular interventions and had follow-up were included. Outcomes evaluated included patency and freedom from limb loss. A total of 166 limbs in 151 patients had the LifeStent implanted in de novo vessels (54% male; 68 ± 12 years). Eighty-percent of limbs did not meet RESILIENT criteria due to Rutherford category >3 (51%), TransAtlantic Inter-Society Consensus II classifications C/ D (51%), zero runoff vessels (6%), or stent location (17%). Primary patency rates were 81% at 6 months and 58% at 12 months with predictors for primary patency loss at 1 year including Rutherford category >3 (HR: 1.8 (95% CI: 1.0–3.1), p = 0.04), tobacco use (HR: 1.8 (95% CI: 1.0–3.3), p = 0.04), and no clopidogrel at discharge (HR: 3.2 (95% CI: 1.6–6.7), p < 0.01). A preintervention Rutherford category >3 predicted 24-month limb loss (HR, 16.0 (95% CI: 2.0–122.0), p < 0.01). The LifeStent is a viable option regardless of the TransAtlantic Inter-Society Consensus II classification; however, critical limb ischemia, current tobacco use, and absence of clopidogrel on discharge predict decreased patency on follow-up.

scholarly journals Long-term follow-up of therapeutic efficacy of everolimus-eluting bioresorbable vascular scaffold in comparison to everolimus-eluting stent in treatment of chronic total occlusion guided by intracoronary imaging

2020 ◽  
Vol 72 (1) ◽  
Author(s):  
Mohammad Abdallah Eltahlawi ◽  
Abdel-Aziz Fouad Abdel-Aziz ◽  
Abdel-Salam Sherif ◽  
Khalid Abdel-Azeem Shokry ◽  
Islam Elsayed Shehata
Keyword(s):  
Chronic Total Occlusion ◽  
Bioresorbable Vascular Scaffold ◽  
Total Occlusion ◽  
Intracoronary Imaging ◽  
Group I ◽  
Significant Difference ◽  
Vascular Scaffold ◽  
Long Term Follow Up

Abstract Background We hypothesized that 1st generation everolimus-eluting bioresorbable vascular scaffold (BVS) stent associated with less complication and less restenosis rate than everolimus-eluting stent (EES) in chronic total occlusion (CTO) recanalization guided by intracoronary imaging. Therefore, we aimed to assess the safety and performance of BVS stent in CTO revascularization in comparison to EES guided by intracoronary imaging. Our prospective comparative cross-sectional study was conducted on 60 CTO patients divided into two groups according to type of stent revascularization: group I (EES group): 40 (66.7%) patients and group II (BVS group): 20 (33.3%) patients. All patients were subjected to history taking, electrocardiogram (ECG), echocardiography, laboratory investigation, stress thallium study to assess viability before revascularization. Revascularization of viable CTO lesion guided by intracoronary imaging using optical coherence tomography (OCT). Then, long-term follow-up over 1 year clinically and by multi-slice CT coronary angiography (MSCT). Our clinical and angiographic endpoints were to detect any clinical or angiographic complications during the follow-up period. Results At 6 months angiographic follow-up, BVS group had not inferior angiographic parameters but without statistically significant difference (p = 0.566). At 12 months follow-up, there was no difference at end points between the two groups (p = 0.476). No differences were found at angiographic or clinical follow-up between BVS and EES. Conclusion This study shows that 1st generation everolimus-eluting BVS is non-inferior to EES for CTO revascularization. Further studies are needed to clearly state which new smaller footprint BVS, faster reabsorption, magnesium-based less thrombogenicity, and advanced mechanical properties is under development. We cannot dismiss the efficacy and safety of new BVS technology. Trial registration ZU-IRB#2498/3-12-2016 Registered 3 December 2016, email: [email protected]

Comparison of Results in Endovascular Interventions for Infrainguinal Lesions: Claudication versus Critical Limb Ischemia

2005 ◽  
Vol 71 (6) ◽  
pp. 474-480 ◽  
Author(s):  
Susan M. Trocciola ◽  
Rabih Chaer ◽  
Rajeev Dayal ◽  
Stephanie C. Lin ◽  
Naveen Kumar ◽  
...  
Keyword(s):  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Clinical Success ◽  
Ankle Brachial Index ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Arterial Disease ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Endovascular Interventions

This study analyzed clinical success, patency, and limb salvage after endovascular repair in patients treated for chronic limb ischemia presenting with claudication versus critical limb ischemia. Between October 2001 and August 2004, 115 patients (mean age 71) underwent endovascular treatment for infrainguinal arterial disease. Techniques included subintimal angioplasty and transluminal angioplasty with or without stents. Lesions were classified according to Transatlantic InterSociety Consensus. Follow-up (mean 11 months) included physical exam, ankle-brachial index, and duplex ultrasound. Patency rates were determined using Kaplan-Meier and compared by log-rank analysis. One hundred ninety-nine lesions were treated in 121 limbs using percutaneous techniques. Comorbidities were similar except higher rates of diabetes mellitus (67% vs 41%, P < 0.001) and chronic renal insufficiency (22% vs 7%, P < 0.05) were found in critical limb ischemia patients. Primary patency for claudicants was 100 per cent, 98 per cent, and 85 per cent at 3, 6, and 12 months and 89 per cent, 80 per cent, and 72 per cent for critical limb ischemia, respectively ( P = 0.06). Limb salvage was 91 per cent at 12 months for critical limb ischemia patients. Morbidity was similar between groups, and there was no perioperative mortality. Percutaneous intervention for both claudication and critical limb ischemia provides acceptable 12-month patency with limited morbidity.

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