Association between post-balloon angioplasty dissection and primary patency in complex femoropopliteal artery disease: 2-year clinical outcomes of the AcoArt I trial

Objective To assess the association between post-balloon angioplasty dissection and the mid-term results of the AcoArt I trial evaluating complex femoropopliteal artery disease. Methods The outcome data for 144 patients from the AcoArt 1 trial were reanalysed. These patients were randomly divided into percutaneous transluminal angioplasty (PTA) and drug-coated balloons (DCB) groups. The primary endpoint was the primary patency (PP) rate and clinically-driven target lesion revascularisation at 24 months. Results After 24 months of follow-up, the PP rate of dissection cases in the PTA group was lower vs non-dissection cases. In patients receiving a bailout stent for dissection, the PP rate in the PTA group was lower vs the DCB group. Cox regression analysis showed that dissection decreased the PP rate; mild dissection reduced the PP rate as follows: 52%, PTA group and 19%, DCB group. With severe dissection, the PP rate reduction was as follows: 75%, PTA group and 73%, DCB group. Conclusions The mid-term follow-up showed that post-balloon angioplasty dissection reduced the PP rate in the PTA group but not in the DCB group. Additionally, in patients receiving a bailout stent for dissection, the DCB group had a better PP rate than the PTA group.

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Mid-term results and predictors of restenosis in patients undergoing endovascular therapy for isolated popliteal artery steno-occlusive disease

Imaging ◽

10.1556/1647.2020.00010 ◽

2021 ◽

Author(s):

Dat Tin Nguyen ◽

Patrik Bayerle ◽

Miklós Vértes ◽

Ákos Bérczi ◽

Edit Dósa

Keyword(s):

Popliteal Artery ◽

Cox Regression ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Cox Regression Analysis ◽

Stent Restenosis ◽

Percutaneous Transluminal ◽

Mid Term Results ◽

Crural Arteries

AbstractBackground and aimThere is only a limited number of major publications on the outcome of interventions for isolated popliteal artery stenosis. The purpose of this study was to report our results on mid-term patency and predictors of restenosis.Patients and methodsThis single-center retrospective study included 61 symptomatic patients (males, N = 33; median age, 65.1 years [IQR, 60.7–71.9 years]; Rutherford grade 4–6, N = 14) with at least two patent crural arteries, whose atherosclerotic stenoses/occlusions were treated with percutaneous transluminal angioplasty (PTA) or stenting (using self-expanding bare-metal Astron Pulsar stents) between 2011 and 2018.ResultsTwenty-six patients had PTA, while 35 underwent stenting. The median follow-up was 29 months (IQR, 10–47 months). The primary patency rates were not significantly different (P = 0.629) between PTA and stenting groups. Restenosis developed in nine patients (34.6%) in the PTA group, and in 12 (34.3%) in the stenting group. Restenotic lesions required re-intervention in nine cases (100%) in the PTA group, and in eight (66.7%) in the stenting group. Restenosis developed significantly less frequently (P = 0.010) in patients with a popliteal/P1 stent; the primary patency rates were also significantly better (P = 0.018) in patients with a popliteal/P1 stent when compared to popliteal/P2 plus multi-segment stents. Cox regression analysis identified lesion location as a predictor of in-stent restenosis (HR, 2.5; 95% CI, 1.2–5.5; P = 0.019).ConclusionStenting was not superior when compared to PTA (if selective stenting was not considered as loss of patency). Follow-up should be more thorough in patients undergoing popliteal/P2 or multi-segment stenting.

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Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial

Trials ◽

10.1186/s13063-021-05631-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Ulf Teichgräber ◽

Maja Ingwersen ◽

Stephanie Platzer ◽

Thomas Lehmann ◽

Thomas Zeller ◽

...

Keyword(s):

Balloon Angioplasty ◽

De Novo ◽

Target Lesion ◽

Primary Patency ◽

Limb Amputation ◽

Current Standard ◽

Femoropopliteal Artery ◽

Randomized Controlled ◽

Link Type ◽

Artery Disease

Abstract Background Endovascular revascularization has established as the first-line therapy of femoropopliteal artery disease. Paclitaxel-coated balloon angioplasty proved to be superior to plain old balloon angioplasty (POBA) regarding prevention of restenosis and need for recurrent revascularization. Over the past years, paclitaxel was the only active drug to inhibit neointimal proliferation which could be processed to an appropriate balloon coating. The purpose of this study is to assess whether efficacy and safety of sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty. Methods This randomized controlled, single-blinded, multicentre, investigator-initiated noninferiority trial aims to enrol a total of 478 participants with symptomatic femoropopliteal artery disease of Rutherford category 2 to 4 due to de novo stenosis or restenosis. After pre-dilation, participants will be allocated in a 1:1 ratio to either sirolimus- or paclitaxel-coated balloon angioplasty. Post-dilation with the drug-coated balloon (DCB) used or standard balloon is mandatory in case ≥ 50%, and optional in case of ≥ 30% residual diameter stenosis. Bailout stenting with bare-metal nitinol stents should be conducted in case of flow-limiting dissection. Primary noninferiority endpoints are primary patency and the composite of all-cause mortality, major target limb amputation, and clinically driven target lesion revascularization at 12 months. Secondary outcomes are clinical and hemodynamic improvement, change in health-related quality of life, and safety throughout 60 months. Discussion Although concerns about long-term safety of paclitaxel-coated devices were not confirmed by recent patient-level data analyses, conflicting evidence contributed to a loss of confidence among patients and physicians. Therefore, sirolimus, known for a broader therapeutic range than paclitaxel, may serve as a welcome alternative. This will be justified if noninferiority of sirolimus-coated balloon angioplasty against the current standard of paclitaxel-coated balloon angioplasty can be demonstrated. Trial registration ClinicalTrials.govNCT04475783. Registered on 17 July 2020 EUDAMED No. CIV-20-11-035172, DRKS00022452

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One-year outcomes of drug-coated balloon treatment for long femoropopliteal lesions: a multicentre cohort and real-world study

BMC Cardiovascular Disorders ◽

10.1186/s12872-021-02127-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Xiaoxi Yu ◽

Xin Zhang ◽

Zhichao Lai ◽

Jiang Shao ◽

Rong Zeng ◽

...

Keyword(s):

Real World ◽

Cox Regression ◽

Ankle Brachial Index ◽

Primary Patency ◽

Critical Limb Ischaemia ◽

Limb Ischaemia ◽

Cox Regression Analysis ◽

Femoropopliteal Artery ◽

Kaplan Meier ◽

Multicentre Cohort

Abstract Background Drug-coated balloons (DCBs) have shown superiority in the endovascular treatment of short femoropopliteal artery disease. Few studies have focused on outcomes in long lesions. This study aimed to evaluate the safety and effectiveness of Orchid® DCBs in long lesions over 1 year of follow-up. Methods This study is a multicentre cohort and real-world study. The patients had lesions longer than or equal to 150 mm of the femoropopliteal artery and were revascularized with DCBs. The primary endpoints were primary patency, freedom from clinically driven target lesion revascularization (TLR) at 12 months and major adverse events (all-cause death and major target limb amputation). The secondary endpoints were the changes in Rutherford classification and the ankle brachial index (ABI). Results One hundred fifteen lesions in 109 patients (mean age 67 ± 11 years, male proportion 71.6%) were included in this study. The mean lesion length was 252.3 ± 55.4 mm, and 78.3% of the lesions were chronic total occlusion (CTO). Primary patency by Kaplan–Meier estimation was 98.1% at 6 months and 82.1% at 12 months. The rate of freedom from TLR by Kaplan–Meier estimation was 88.4% through 12 months. There were no procedure- or device-related deaths through 12 months. The rate of all-cause death was 2.8%. Cox regression analysis suggested that renal failure and critical limb ischaemia (CLI) were statistically significant predictors of the primary patency endpoint. Conclusion In our real-world study, DCBs were safe and effective when used in long femoropopliteal lesions, and the primary patency rate at 12 months by Kaplan–Meier estimation was 82.1%.

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Malnutrition Affects Cholesterol Paradox in Coronary Artery Disease: a 41,229 Chinese Cohort Study

10.21203/rs.3.rs-266119/v1 ◽

2021 ◽

Author(s):

Bo Wang ◽

Jin Liu ◽

Shiqun Chen ◽

Ming Ying ◽

Guanzhong Chen ◽

...

Keyword(s):

Cox Regression ◽

Cox Model ◽

Cox Regression Analysis ◽

Coronary Syndrome ◽

Kaplan Meier ◽

All Cause Mortality ◽

Chinese Cohort ◽

Artery Disease

Abstract Background: Several studies found that baseline low LDL-C concentration was associated with poor prognosis in patients with acute coronary syndrome (ACS), which was called “cholesterol paradox”. Low LDL-C concentration may reflect underlying malnutrition, which was strongly associated with increased mortality. We objected to investigate the cholesterol paradox in patients with CAD and the effects of malnutrition.Method: A total of 41,229 CAD patients admitted to Guangdong Provincial People's Hospital in China were included in this study from January 2007 to December 2018, and divided into two groups (LDL-C < 1.8 mmol/L, n=4,863; LDL-C ≥ 1.8 mmol/L, n = 36,366). We used Kaplan-Meier method and Cox regression analyses to assess the association between LDL-C levels and long-term all-cause mortality and the effect of malnutrition. Result: In this real-world cohort (mean age 62.94 years; 74.94% male), there were 5257 incidents of all-cause death during a median follow-up of 5.20 years [Inter-quartile range (IQR): 3.05-7.78 years]. Kaplan–Meier analysis showed that low LDL-C levels were associated with worse prognosis. After adjusting for baseline confounders (e.g., age, sex and comorbidities, etc.), multivariate Cox regression analysis revealed that low LDL-C level (<1.8mmol/L) was not significantly associated with all-cause mortality (adjusted HR, 1.04; 95% CI, 0.96-1.24). After adjustment of nutritional status, risk of all-cause mortality of patients with low LDL-C level decreased (adjusted HR, 0.90; 95% CI, 0.83-0.98). In the final multivariate Cox model, low LDL-C level was related to better prognosis (adjusted HR, 0.91; 95% CI, 0.84-0.99).Conclusion: Our results demonstrate that the cholesterol paradox persisted in CAD patients, but disappeared after accounting for the effects of malnutrition.

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Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial

Vascular ◽

10.1177/17085381211013968 ◽

2021 ◽

pp. 170853812110139

Author(s):

Chuan-Jun Liao ◽

Sheng-Han Song ◽

Tan Li ◽

Yang Zhang and Wang-de Zhang

Keyword(s):

Randomized Controlled Trial ◽

Percutaneous Transluminal Angioplasty ◽

Controlled Trial ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Femoropopliteal Artery ◽

Randomized Controlled ◽

Artery Disease ◽

Percutaneous Transluminal ◽

Drug Coated Balloon

Purpose To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. Methods This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group ( n = 30) or percutaneous transluminal angioplasty group ( n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. Results Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. Conclusions The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

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Endovascular Reconstruction for Total Aorto–Iliac Occlusion

Journal of Endovascular Therapy ◽

10.1177/15266028211059908 ◽

2021 ◽

pp. 152660282110599

Author(s):

Gabriele Piffaretti ◽

Aaron Thomas Fargion ◽

Walter Dorigo ◽

Raffaele Pulli ◽

Michelangelo Ferri ◽

...

Keyword(s):

Cox Regression ◽

Aortic Surgery ◽

Primary Patency ◽

Secondary Patency ◽

Infrarenal Aorta ◽

Technical Success ◽

Total Occlusion ◽

Cox Regression Analysis ◽

Iliac Bifurcation

Objectives: To analyze outcomes following endovascular treatment of total occlusion of the infrarenal aorta and aorto–iliac bifurcation in a multicenter Italian registry. Methods: It is a multicenter, retrospective, observational cohort study. From January 2015 to December 2018, 1306 endovascular interventions for aorto–iliac occlusive disease were recorded in the vascular registry. For this analysis, only patients treated for total occlusion of the infrarenal aorta and aorto–iliac bifurcation were included. Early (<30 days) primary outcomes of interest were technical success and mortality. Late major outcomes were primary and secondary patency and freedom from conversion to open aortic surgery. Results: A total of 54 (4.1%) patients met the inclusion criteria. Total percutaneous revascularization was possible in 41 (75.9%) patients and hybrid (endo plus open) intervention in 13 (24.1%) patients. The kissing-stent-graft technique was used in 45 (83.3%) cases, covered endovascular reconstruction of the aortic bifurcation (CERAB) in 5 (9.2%), and a unibody endograft deployed in 4 (7.4%). Technical success was 98.1% (n = 53). There were no episodes of intraoperative or perioperative vessel rupture. Conversion to open surgery was not necessary, and there were no in-hospital deaths. The median patient follow-up time was 16 months (interquartrile range [IQR], 6-27). The estimated primary patency rate was 95.8% ± 0.03 (95% confidence interval [CI]: 85.5-98.9) at 1 year, 91.4% ± 0.05 (95% CI: 76.2-97.2) at 2 years, and 85 ± 0.08 (95% CI: 64.5-94.6) at 3 years. Cox regression analysis demonstrated that sex (hazard ratio [HR]: 0.96; 95% CI: 0.15-6.23, p = 0.963), extent of the occlusion (HR: 0.28; 95% CI: 0.05-1.46, p = 0.130), calcium score (HR: 1.88; 95% CI: 0.31-11.27, p = 0.490), or type of endovascular reconstruction (HR: 0.80; 95% CI: 0.13-5.15, p = 0.804) did not affect primary patency. Secondary patency was 95.5% ± 0.04 (95% CI: 78.4-99.2) at 3 years. No patients required late conversion to open surgical bypass. Conclusions: Endovascular reconstruction for total occlusion of the infrarenal aorta and aorto–iliac bifurcation was successful using a combination of percutaneous and hybrid revascularization techniques. Estimated patency rates at 3 years of follow-up are promising and are unaffected by the extent of occlusion or type of revascularization.

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Directional atherectomy versus balloon angioplasty in segmental femoropopliteal artery disease: Two-year follow-up with color-flow duplex scanning

Journal of Vascular Surgery ◽

10.1016/s0741-5214(95)70267-9 ◽

1995 ◽

Vol 21 (2) ◽

pp. 255-269 ◽

Cited By ~ 64

Author(s):

Dammis Vroegindeweij ◽

Alexander V. Tielbeek ◽

Jacob Buth ◽

François P.G. Schol ◽

Wim C.J. Hop ◽

...

Keyword(s):

Balloon Angioplasty ◽

Duplex Scanning ◽

Color Flow ◽

Femoropopliteal Artery ◽

Directional Atherectomy ◽

Artery Disease

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High-Serum Angiopoietin-Like Protein 3 Levels Associated with Cardiovascular Outcome in Patients with Coronary Artery Disease

International Journal of Hypertension ◽

10.1155/2020/2980954 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Ming-Chun Chen ◽

Bang-Gee Hsu ◽

Chung-Jen Lee ◽

Ji-Hung Wang

Keyword(s):

Coronary Artery Disease ◽

Coronary Artery ◽

Cox Regression ◽

High Serum ◽

Major Adverse Cardiovascular Events ◽

Cox Regression Analysis ◽

Reactive Protein ◽

Kaplan Meier ◽

Artery Disease

Background. Angiopoietin-like protein 3 (ANGPTL3) plays a pivotal role in lipid metabolism and angiogenesis, and there is growing interest regarding the association between ANGPTL3 and coronary artery disease (CAD). This study aims to investigate whether ANGPTL3 levels can be used to predict the future occurrence of major adverse cardiovascular events (MACEs) in patients with CAD. Methods. Overall, 90 patients with CAD were enrolled between January and December 2012. The study’s primary endpoint was incidence of MACEs. Patient follow-up was completed on June 30, 2017. Results. Following a median follow-up period of 54 months, 33 MACEs had occurred. Patients reporting MACEs had lower statin use (P=0.022) and higher serum C-reactive protein (P<0.001) and serum ANGPTL3 (P<0.001) levels than those without MACEs. Kaplan–Meier analysis revealed higher cumulative incidence of CV events in the high ANGPTL3 group (median ANGPTL3 level ≥ 222.37 ng/mL) than in the low ANGPTL3 group (log-rank P=0.046). Multivariable Cox regression analysis demonstrated that ANGPTL3 levels were independently associated with MACEs in patients with CAD (hazard ratio: 1.003; 95% confidence interval: 1.000–1.005; P=0.026) after adjusted for age, gender, and body mass index, classical risk factors, and potential confounders. Conclusions. Serum ANGPTL3 levels could serve as a biomarker for future occurrence of MACEs in patients with CAD.

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

Journal of Clinical Medicine ◽

10.3390/jcm9030847 ◽

2020 ◽

Vol 9 (3) ◽

pp. 847

Author(s):

Remzi Anadol ◽

Annika Mühlenhaus ◽

Ann-Kristin Trieb ◽

Alberto Polimeni ◽

Thomas Münzel ◽

...

Keyword(s):

Adverse Events ◽

Cox Regression ◽

Target Lesion ◽

Outcome Data ◽

First Year ◽

Cox Regression Analysis ◽

Kaplan Meier ◽

Scaffold Thrombosis ◽

Vascular Scaffolds ◽

Target Lesion Failure

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

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The association of nine amino acids with cardiovascular events in Finnish men in a 12-year follow-up study

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/clinem/dgab562 ◽

2021 ◽

Author(s):

Raimo Jauhiainen ◽

Jagadish Vangipurapu ◽

Annamaria Laakso ◽

Teemu Kuulasmaa ◽

Johanna Kuusisto ◽

...

Keyword(s):

Cardiovascular Disease ◽

Amino Acids ◽

Ischemic Stroke ◽

Amino Acid ◽

Cox Regression ◽

Cox Regression Analysis ◽

Increased Risk ◽

Artery Disease

Abstract Background and aims To investigate the significance of nine amino acids as risk factors for incident cardiovascular disease events in 9,584 Finnish men. Materials and Methods A total of 9,584 men (age 57.4±7.0 years, body mass index 27.2±4.2 kg/m 2) from the METSIM study without cardiovascular disease and type 1 diabetes at baseline were included in this study. A total of 662 coronary artery disease (CAD) events, 394 ischemic stroke events, and 966 cardiovascular disease (CVD, CAD and stroke combined) events were recorded in a 12.3-year follow-up. Amino acids were measured using nuclear magnetic resonance platform. Results In Cox regression analysis phenylalanine and tyrosine were significantly associated with increased risk of CAD and CVD events, and phenylalanine with increased risk of ischemic stroke after the adjustment for confounding factors. Glutamine was significantly associated with decreased risk of stroke and CVD events and nominally with CAD events. Alanine was nominally associated with CAD events. Conclusion We identified alanine as a new amino acid associated with increased risk of CAD and glutamine as a new amino acid associated with decreased risk of ischemic stroke. We also confirmed that phenylalanine and tyrosine were associated with CAD, ischemic stroke, and CVD events.

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