target lesion revascularization
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In Vivo ◽  
2021 ◽  
Vol 36 (1) ◽  
pp. 416-423
Author(s):  
TATSUYA FUJINAMI ◽  
TAKASHI ASHIKAGA ◽  
KATSUYUKI HOSHINA ◽  
TARO SASAOKA ◽  
KEN KURIHARA ◽  
...  

VASA ◽  
2021 ◽  
Author(s):  
Michael Lichtenberg ◽  
Thomas Zeller ◽  
Peter Gaines ◽  
Michael Piorkowski

Summary: Background: The MIMICS-3D study aimed to assess the safety and effectiveness of the BioMimics 3D Vascular Stent System for the treatment of symptomatic femoropopliteal artery disease in a real-world patient population. Patients and methods: Consecutive participants who were scheduled for implantation of the BioMimics 3D stent were enrolled in the prospective, observational, multicenter study. The primary effectiveness outcome was freedom from clinically driven target lesion revascularization at 12 months and the primary safety outcome was a composite of major adverse events comprising death, major target limb amputation, or clinically driven target lesion revascularization at 30 days. Outcomes through 24 months are reported. Results: A total of 507 patients (70±10 years, 65.5% male sex) were enrolled and treated with the study stent. 24.0% had critical limb-threatening ischemia, lesion length was 127±92 mm, and 56.8% of lesions were totally occluded. The Kaplan-Meier (KM) estimate of freedom from clinically driven target lesion revascularization at twelve-months was 90.6% (95% CI: 87.9%–93.3%) and the 30-day primary safety outcome occurred in 1.2% (95% CI: 0.5%–2.7%) of participants. At 24 months, clinical improvement was achieved in 86.6% and the KM estimate of freedom from clinically driven target lesion revascularization was 82.8% (95% CI: 79.4%–86.4%). The KM estimate of freedom from loss of primary patency according to PSVR >2.4 was 78.6% (95% CI: 74.7%–82.4%). Survival distribution functions regarding primary patency were lower with long lesions (>150 mm; log-rank p<0.001) but did not differ significantly between participants with or without critical limb-threatening ischemia (log-rank p=0.07). Conclusions: Endovascular treatment of atherosclerotic femoropopliteal lesions with the BioMimics 3D Vascular Stent System is efficacious and safe in a real-world setting.


2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Botey Katamu Benjamin ◽  
Wenjie Lu ◽  
Zhanying Han ◽  
Liang Pan ◽  
Xi Wang ◽  
...  

Background. The revascularization of small vessels using drug-eluting stents remains challenging. The use of the drug-coated balloon is an attractive therapeutic strategy in de novo lesions in small coronary vessels, particularly in the diabetic group. This study aimed to assess the outcomes of DCB-only angioplasty in small vessel disease. Methods. A total of 1198 patients with small vessel disease treated with DCB-only strategy were followed. Patients were divided into the diabetic and nondiabetic groups. Clinical and angiographical follow-up were organized at 12 months. The primary endpoints were target lesion failure and secondary major adverse cardiac events. Results. There was a significantly higher rate of target lesion failure among diabetic patients compared to nondiabetic [17 (3.9%) vs. 11 (1.4%), P = 0.006 ], taken separately, the rate of target lesion revascularization significantly differed between groups with a higher rate observed in the diabetic group [9 (2%) vs. 4 (0.5%), P = 0.014 ]. Diabetes mellitus remained an independent predictor for TLF (HR: 2.712, CI: 1.254–5.864, P = 0.011 ) and target lesion revascularization (HR: 3.698, CI: 1.112–12.298, P = 0.033 ) after adjustment. However, no significant differences were observed between groups regarding the target vessel myocardial infarction (0.6% vs. 0.1%, P = 0.110 ) and MACE [19 (4.4%) vs. 21 (2.7%), P = 0.120 ]. Conclusion. Drug-coated balloon-only treatment achieved lower incidence rates of TLF and MACE. Diabetes is an independent predictor for target lesion failure and target lesion revascularization at one year following DCB treatment in small coronary vessels. We observed no significant differences between groups regarding MACE in one year.


Author(s):  
Chenyu Liu ◽  
Matthew Wolfers ◽  
Bint‐e Zainab Awan ◽  
Issa Ali ◽  
Adrian Michael Lorenzana ◽  
...  

Background Both drug‐coated balloon (DCB) angioplasty and conventional plain balloon angioplasty (PBA) can be implemented to treat hemodialysis dysfunction. The present study aims to compare the safety and efficacy of these 2 approaches by conducting a meta‐analysis of available randomized controlled trials. Methods and Results PubMed, Cochrane Library, and Embase databases were queried from establishment to January 2021. A total of 18 randomized controlled trials including 877 and 875 patients in the DCB and PBA groups, respectively, were included in the present meta‐analysis. Target lesion primary patency, circuit patency, target lesion revascularization, and mortality were pooled. Odds ratios (ORs) were reported with 95% CIs. Publication bias was analyzed with funnel plot and Egger test. Target lesion primary patency was higher among patients who underwent DCB (OR, 2.93 [95% CI, 2.13–4.03], P <0.001 at 6 months; OR, 2.47 [95% CI, 1.53–3.99], P <0.001 at 1 year). Also, the DCB group had a higher dialysis circuit patency at 6 months (OR, 2.42; 95% CI, 1.56–3.77 [ P <0.001]) and 1 year (OR, 1.91; 95% CI, 1.22–3.00 [ P =0.005]). Compared with the PBA group, the DCB group had lower odds of target lesion revascularization during follow‐up (OR, 0.43 [95% CI, 0.23–0.82], P =0.001 at 6 months; OR, 0.74 [95% CI, 0.32–1.73], P =0.490 at 1 year). The OR of mortality was comparable between 2 groups at 6 months (OR, 1.18; 95% CI, 0.42–3.33 [ P =0.760]) and 1 year (OR, 0.93; 95% CI, 0.58–1.48 [ P =0.750]). Conclusions Based on evidence from 18 randomized controlled trials, DCB angioplasty is superior to PBA in maintaining target lesion primary patency and circuit patency among patients with dialysis circuit stenosis. DCB angioplasty also reduces target lesion revascularization with a similar risk of mortality compared with PBA.


2021 ◽  
pp. 152660282110570
Author(s):  
Jean-Baptiste Dexpert ◽  
Daniel Hayoz ◽  
Rolf P. Engelberger ◽  
Caroline Krieger ◽  
Marie-Antoinette Rey Meyer ◽  
...  

Purpose: Percutaneous transluminal angioplasty (PTA) with conventional plain old balloon (POBA) and/or drug-coated balloon (DCB) is the primary intervention to treat peripheral artery stenoses. However, acute dissections during the procedure and potential for future target lesion revascularization remain procedural complications. The purpose of this study was to assess the acute and 12-month outcomes in patients who underwent novel vessel preparation with longitudinal, controlled-depth micro-incisions prior to PTA. Materials and Methods: Patients with symptomatic lower extremity peripheral arterial disease with a Rutherford class of 2 to 6 and >70% de novo stenosis of the superficial femoral or popliteal arteries were included in this retrospective study. Patients with thrombotic or embolic lesions, restenosis, or in-stent restenosis were excluded. The FLEX Vessel Prep System (FLEX VP) was used to prepare the vessel prior to PTA by creating micro-incisions at the target lesion. The FLEX VP was followed by POBA or paclitaxel DCB. Results: The study included 65 patients. Lesion characteristics were 90% median stenosis (range = 70%–100%), 75.4% mild-to-severe calcifications, and 33.8% occlusion rate, and median lesion length was 196 (range = 10–480) mm. Following vessel preparation, 82.1% of the patients had low severity dissection or no flow-limiting dissection. The provisional stent rate postprocedure was 16.9%, with a median stent length of 60 mm. The freedom from target lesion revascularization (FFTLR) in 63 evaluable patients at 6 and 12 months was 98.4% and 93.7%, respectively. Freedom from amputation was 100%. Conclusion: In this real-world/all-comers patient population with long, stenotic lesions across the calcification spectrum, vessel preparation with longitudinal micro-incisions prior to PTA was associated with low dissection rate, low dissection severity, low stent implantation, and high FFTLR with the absence of amputation at 12 months relative to published reports in long-lesion cohorts. These results support vessel preparation via micro-incisions.


Angiology ◽  
2021 ◽  
pp. 000331972110434
Author(s):  
Prakash Krishnan ◽  
Arthur Tarricone ◽  
Allen Gee ◽  
Serdar Farhan ◽  
Haroon Kamran ◽  
...  

We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm2 [1.65, 9.0], with complete healing for 45 patients by 20 months. The Wagner score of this subgroup decreased by an average of 3.4 ± .9 points. Supera stents can be used together with other endovascular therapies and are a safe and effective treatment modality for CLTI.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
G Oliveira Campos ◽  
L Leite ◽  
M Santos ◽  
L Paiva ◽  
E Jorge ◽  
...  

Abstract Introduction Although percutaneous coronary intervention (PCI) for ostial or midshaft lesions in left main (LM) disease has shown similar results as compared with coronary artery bypass grafting (CABG), distal LM bifurcations are associated with an increase in procedural complexity and higher rates of target lesion revascularization. Several studies have investigated the optimal stenting strategy in patients with coronary bifurcation lesions and showed no benefit for systematic two-stent approach in comparison with provisional stenting. This is reflected in the current guidelines that recommend provisional stenting of the side branch as the preferred approach for most bifurcation lesions. However, there is still debate about the optimal strategy according to lesion location. Objectives This analysis aimed to compare the clinical outcomes of LM bifurcation PCI using a provisional strategy versus a two-stent strategy. Methods Retrospective, observational study including patients submitted to LM bifurcation (Medina 1,1,1) PCI between January 2010 and December 2019. Data was collected from the emergency department and hospitalization registries. Patients were divided according to the stenting approach. We made a global analysis including baseline clinical and angiographic data. The primary endpoint was target lesion failure (TLF), defined as the composite of myocardial infarction, cardiac death, and target lesion revascularization (TLR). Secondary endpoints included the individual components. Results A total of 106 patients were included (median age 74 [66–82], 79 (74.5%) males), 57 (53.8%) submitted to provisional stenting and 49 (46.2%) to a two-stent technique. Baseline characteristics were well matched (table 1). The mean SYNTAX score was 29.6±10.0 and LM stenosis grade was ≥70% in all lesions. Median follow-up was 26.6 [12.0–48.6] months. No differences were found regarding the primary endpoint (TLF in provisional stenting was 21.7% vs 21.4%, HR 2.432; 95% confidence interval, 0.472–12.450; p=0.233.). Although target lesion revascularization within the LM complex was numerically higher in the two-stent group (10.2% vs. 3.5%, p=0.245), the opposite was found in cardiac death (provisional group 10.5% vs. 4.3%, p=0.289). Conclusions Besides being a “simpler” technique, provisional stenting had no significant differences in outcomes compared to two-stent techniques. Without further evidence, revascularization strategies should primarily rely on operator expertise. FUNDunding Acknowledgement Type of funding sources: None.


Author(s):  
Wojciech Wańha ◽  
Jacek Bil ◽  
Rafał Januszek ◽  
Natasza Gilis-Malinowska ◽  
Tomasz Figatowski ◽  
...  

Background: Data regarding the use of percutaneous coronary intervention with drug-eluting balloons (DEB) versus thin-strut drug-eluting stents (thin-DES) for treating DES in-stent restenosis in everyday clinical practice is scarce. Our goal was to evaluate the efficacy and safety profile of DEB versus thin-DES in DES in-stent restenosis. Methods: Consecutive patients with DES in-stent restenosis who underwent percutaneous coronary intervention between 2008 and 2019 entered the multicenter DEB-DRAGON Registry with a follow-up of 3 years. Patients who received DEB at the index procedure (n=557, 49.9%) were compared with those who received thin-DES (n=560, 50.1%). Results: Analysis of the unmatched cohort revealed lower rates of target lesion revascularization (9.1% versus 13.6%; hazard ratio [HR], 0.58 [95% CI, 0.41–0.83], P =0.003), target vessel revascularization (11.8% versus 16.7%; HR, 0.62 [95% CI, 0.45–0.84], P =0.003) and device-oriented composite end point, defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction (12.7% versus 16.0%; HR, 0.69 [95% CI, 0.50–0.94], P =0.018) in the thin-DES group compared with the DEB group. The incidence of cardiac death, target vessel-myocardial infarction, and myocardial infarction were similar in both groups. However, after propensity score matching, there were no significant differences in target lesion revascularization (11.2% versus 11.2%; HR, 0.91 [95% CI, 0.55–1.51], P =0.707), target vessel revascularization (13.4% versus 14.2%; HR, 0.86 [95% CI, 0.55–1.36], P =0.523), and device-oriented composite end point (14.2% versus 14.2%; HR, 0.91 [95% CI, 0.58–1.42], P =0.667) between the thin-DES and DEB group, respectively. Conclusions: This analysis of a real-life registry revealed similar long-term outcomes of thin-DES and DEB in DES in-stent restenosis regarding target lesion revascularization, myocardial infarction, cardiac death, and device-oriented composite end point. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04415216.


VASA ◽  
2021 ◽  
pp. 1-9
Author(s):  
Mariya Kronlage ◽  
Christian Erbel ◽  
Michael Lichtenberg ◽  
Ulrike Heinrich ◽  
Hugo A. Katus ◽  
...  

Summary: Background: Traditionally endarterectomy has been considered as the gold standard technique for the treatment of common femoral artery (CFA) lesions. The aim of this study is to investigate the procedural safety and mid-term outcomes of minimal invasive Phoenix atherectomy for the treatment of CFA lesions. Patients and methods: Phoenix atherectomy was used for treatment of 61 consecutive, moderately to heavily calcified CFA lesions in 56 patients. Lesions were classified based on the CFA occlusive disease classification (Type I, II&III lesions). Primary endpoints were technical, procedural, and clinical success rate. Safety endpoints (vessel perforation, peripheral embolization) and clinically driven target lesion revascularization (TLR) were also assessed. Results: Of 61 CFA lesions, 58 (95%) exhibited at least moderate/severe calcification (PACSS3 in 38 (62%) and PACSS4 in 20 (33%) cases). Type III lesions were present in 30 (49%), type I/II lesions in 31 (51%) cases. Technical and procedural success was achieved in 30 (49%) and all 61 (100%) lesions, respectively with low complication rates (0% perforation, 2% embolization). Adjunctive treatment after atherectomy was performed using drug-coated balloon (DCB) in 35 (57%) and bail-out stenting in 6 (10%) cases. Target lesion revascularization (TLR) occurred in 4 (7%) cases during a mean follow-up duration of 11±7months. All patients exhibited clinical improvement at follow-up, showing mean Rutherford category reduction from 3.7±1.1 to 1.5±1.1 (p<0.001). Conclusions: The Phoenix device can be used for the effective endovascular treatment of CFA lesions, due to its reasonable safety profile and mid-term results.


Vascular ◽  
2021 ◽  
pp. 170853812110183
Author(s):  
Ottavia Borghese ◽  
Ciro Ferrer ◽  
Carlo Coscarella ◽  
Claudio Spataro ◽  
Nicolò Diotallevi ◽  
...  

Objective To report the results of a single-centre in the treatment of extensive aorto-iliac occlusive disease (AIOD) by the covered endovascular reconstruction of aortic bifurcation (CERAB) technique. Methods A retrospective analysis was conducted on data obtained from the review of medical charts of all consecutive patients treated with CERAB technique for AIOD between January 2016 and December 2019 in San Giovanni-Addolorata Hospital (Rome, Italy). Clinical examination, duplex ultrasound with ankle-brachial index measurement and contrast-enhanced computed tomography angiography were performed preoperatively. A clinical and ultrasound follow-up was carried out at one month and then half yearly after the intervention to evaluate patients’ clinical status, limb salvage, target lesion revascularization rate, primary and secondary patency rate. Results During the study period, 24 patients (14 men, 58.3%; 10 women, 41.7%; median age 59 years, range 37–79 years) underwent CERAB for AIOD (TASC II C 29.2%, TASC II D 70.8%). Indications for treatment were: intermittent claudication in 18 patients (75%) and critical limb ischemia in 6 (25%). Technical success was achieved in all cases. Perioperative minor complications occurred in three cases (12.5%). One patient reported an intraoperative iliac rupture requiring adjunctive covered stenting. Median hospital length of stay was two days (range 1–9). No patient died perioperatively nor at the last follow-up. At a median follow-up of 18 months (range 6–48 months), mean ankle-brachial index increased significantly (from 0.62 ± 0.15 before the procedure to 0.84 ± 0.18) ( P < 0.001) and target lesion revascularization rate was 12.5%. At two years, the limb salvage rate was 100%, and primary and secondary patency rates were 87.5% and 100%, respectively. Conclusion CERAB technique demonstrated to be effective at the mid-term follow-up with low rate of complications and short length of stay. Long-term results and more robust data are needed to affirm this technique as the first-line treatment for extensive AIOD. However, it could become the preferred option especially in fragile patients and during contemporary COVID-19 pandemic due to the current limitations in vascular and critical care bed capacity.


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