Outcomes of Drug-Coated Balloon Angioplasty vs. Conventional Balloon Angioplasty for Endovascular Treatment of Common Femoral Artery Atherosclerotic Disease

BackgroundAtherosclerotic disease of the common femoral artery (CFA), commonly associated with multilevel disease affecting the femoropopliteal segment, can cause claudication or contribute to critical limb ischemia. Although endovascular therapy for the management of peripheral arterial disease (PAD) has been increasingly utilized, its role in CFA lesions remains controversial. The aim of this study was to investigate the safety and efficacy of drug (DCB) vs non drug coated balloon angioplasty (BA) at the CFA segment.MethodsIn this two-center study, we identified 154 patients treated either with DCB (n = 47) or BA (n = 107) for CFA lesions. Hazard ratios (HR) and the respective 95% confidence interval (CI) were synthesized to examine the association between the two groups in terms of target lesion revascularization (TLR), limb loss, and major adverse limb event (MALE) at 12 and 24 months of follow up.ResultsThis real-world population included a high percentage of patients with critical limb ischemia (43%) and moderate to severe lesion calcification (75%). Adjunctive atherectomy was performed in 97.9% of DCB cases (N = 46/47) and 44.7% of BA cases (N = 51/114). The overall procedural success rate was 95% without any differences between the two groups. Post-angioplasty dissections were observed in 15 cases [DCB: 8.5% (N = 4/47) vs BA: 9.7% (N = 11/113); p = .81], while distal embolization occurred in one patient in the DCB group and one in the BA group (p = .52). Provisional stenting was more commonly necessary in BA vs. DCB cases (12.3% vs 2.13%, p = .044). Physiologic assessment during follow up demonstrated a better mean 2-year ABI for the DCB group (mean: 0.9; SD: 0.2) vs BA group (mean: 0.6; SD: 0.4), although statistical significance was not reached (p = .06). No difference between the two groups was detected in terms of freedom from TLR (DCB: 75.5% vs BA: 86.8%; HR: 1.31; 95% CI: 0.46–3.67; p = .61), freedom from limb loss (DCB: 83.8% vs BA: 83.6%; HR: 1.04; 95% CI: 0.36–2.99; p = .94) or freedom from MALE (DCB: 83.5% vs BA: 78%; HR: 0.73; 95% CI: 0.26–1.99; p = .53) at 24 m of follow up. However, at the end of follow up more deaths were observed in patients treated with BA than DCB (DCB: 14.9% vs BA: 31.7%; p = .03). Patients who required provisional stenting were at higher risk for limb loss 2 years after the initial procedure (multivariate: HR: 4.54; 95% CI: 1.09–18.85; p = .04).ConclusionsBoth DCB and non-DCB strategies are effective modalities for revascularization of patients with CFA lesions. Larger prospective studies are necessary to determine the relative benefit, if any, of drug-eluting technologies for the treatment of common femoral artery disease.     

The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions: A Randomized Controlled Trial

ObjectivesThe aim of this study was to investigate whether the addition of intravascular ultrasound (IVUS) guidance during femoropopliteal artery interventions reduced the rate of binary restenosis within 12 months compared with angiographic guidance alone.BackgroundIVUS is more accurate than angiography for assessment of vessel size and disease severity. Low-level studies suggest that the use of IVUS in femoropopliteal endovascular interventions improves outcomes, but currently, no level 1 evidence exists.MethodsThis was a prospective single-center trial of 150 patients undergoing femoropopliteal endovascular intervention, randomized (1:1) to guidance by angiography or angiography and IVUS. The primary outcome measure was freedom from binary restenosis, on duplex ultrasound, within 12 months. Secondary outcomes included clinically driven target lesion revascularization, disagreements in imaging findings between modalities, and changes in treatment caused by IVUS.ResultsFreedom from binary restenosis at 12 months was significantly higher in the IVUS group (72.4% vs 55.4%; P = 0.008). There was no significant difference between groups for clinically directed target lesion revascularization (84.2% and 82.4%; P = 0.776). Mean vessel diameter was significantly larger with IVUS (5.60 mm vs 5.10 mm; P < 0.001). A change in treatment occurred caused by IVUS in 79% of cases. Binary restenosis was lower in the IVUS group for cases treated with drug-coated balloons (9.1% vs 37.5%; P = 0.001).ConclusionsThe use of IVUS resulted in a significant reduction in the rate of restenosis after endovascular intervention. This is the first randomized controlled trial to demonstrate that IVUS improves outcomes in femoropopliteal interventions. This benefit may primarily relate to cases treated with drug-coated balloons. (Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?; ACTRN12614000006640)     

Percutaneous lower extremity arterial interventions using primary balloon angioplasty versus cryoplasty: a randomized pilot trial

BackgroundTarget lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus cryoplasty (CRYO) in the treatment of de novo femoropopliteal disease has not been well defined in randomized trials.MethodsIn this prospective, 2-center randomized trial of PTA vs CRYO of femoropopliteal arteries, the primary endpoint of TLR was evaluated at 6 months. Secondary endpoints included the rate of bail out stenting because of suboptimal acute angiographic results (defined as a residual narrowing of ≥30% or type C or higher dissection) and target vessel revascularization (TVR). Major adverse events including death and amputations were recorded. A two sample t test was used to compare the two groups on the continuous variables. For categorical variables, cross tabular analysis was conducted with nonparametric tests (Chi Square and Fisher's Exact) used to test for significant differences.ResultsA total of 40 patients were included in the study. Of these 20 patients (24 vessels) were included in the PTA arm and 20 patients (26 vessels) in the CRYO arm. CRYO was performed at a predefined automated pressure of 8 atm. PTA was performed at a mean pressure of 9.57±1.34 atm (P=.001 compared to CRYO). TLR (10.5% vs. 15%, P=NS) and TVR (10% vs 25%, P=NS) were statistically similar between the PTA arm compared to the CRYO arm respectively. Bail out stenting was performed in 10/24 (41.7%) of vessels in the PTA arm and 10/26 (38.5%) of patients in the CRYO arm (P=NS).ConclusionIn this pilot randomized study of de novo femoropopliteal lesions, CRYO and PTA had the same TLR and TVR at 6 months in treating femoropopliteal de novo lesions. Also, bail out stenting was statistically similar between the 2 groups. Larger studies are needed to confirm these results.     

Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis (ROSTER)

Background

Various autopsy and intravascular ultrasound (IVUS) studies have shown neointimal proliferation as the main mechanism of in-stent restenosis (ISR) responsible for >95% of luminal narrowing while stent struts are not compressed. ISR of diffuse type has a high incidence of recurrence (up to 70%) after balloon angioplasty (PTCA). Tissue ablation with percutaneous rotational coronary atherectomy (PRCA) may be more efficacious compared to tissue compression or extrusion after PTCA for the interventional treatment of diffuse ISR.

Methods

The Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-Stent Restenosis (ROSTER) trial is a single-center, randomized trial comparing PRCA to PTCA (both with IVUS guidance) in the treatment of diffuse ISR in 200 patients. In the PRCA group (n = 100), rotablation was performed using a burr-to-artery ratio >0.7 followed by adjunctive balloon dilatation at low pressure (4-6 atm). In the PTCA group (n = 100), high-pressure (>12 atm) balloon dilatation was performed using an optimal size balloon. The study's primary end point was target lesion revascularization (TLR) at 9 months and secondary end points included clinical events at 1 year and angiographic restenosis in a substudy of the last 75 patients enrolled.

Results

Baseline clinical and angiographic variables were comparable between the 2 groups with similar procedural and angiographic success, but a higher rate of repeat stenting occurred in the PTCA group (31% vs 10%; P <.001). Although the angiographic acute luminal gain was similar between the 2 groups, IVUS analysis revealed lower residual intimal hyperplasia area after PRCA versus PTCA (2.1 ± 0.9 mm² vs. 3.3 ± 1.8 mm²; P = .005). At a mean follow-up of 12 ± 2 months, there were 2 deaths, 3 myocardial infarctions, and 3 coronary artery bypass graft procedures in each group. TLR incidence was 32% in the PRCA group and 45% in the PTCA group (P = .042), with a similar trend noted in the angiographic substudy.

Conclusion

The ROSTER trial for diffuse ISR revealed both PRCA and PTCA to be safe and effective, but PRCA resulted in less residual intimal hyperplasia, lower repeat stent use, and decreased TLR.     

Effect of Paclitaxel Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions on Mortality

BackgroundMeta-analyses of randomized controlled trials have suggested an increased long-term mortality risk following femoropopliteal and infrapopliteal angioplasty using paclitaxel-coated devices. This study was conducted to evaluate long-term mortality after paclitaxel drug-coated balloon (DCB) and plain old balloon angioplasty (POBA) of infrapopliteal lesions in real-world practice.MethodsA retrospective mortality analysis of patients with at least 3 years of follow-up who underwent balloon-based endovascular therapy of infrapopliteal lesions was performed.ResultsOverall, 2,424 patients with infrapopliteal lesions were treated within the study period. Five hundred seventy-six patients fulfilled the study criteria. Of those, 269 patients were treated with uncoated devices without crossover to a paclitaxel-coated device during follow-up and 307 patients with DCB angioplasty. Mean (SD) follow-up was 46.48 (32.77) months. The mortality rate was 66.9% after POBA and 46.9% after DCB (P < .001). In the matched-pair cohort, 164 patients died after uncoated treatment (66.7%), and 119 in the DCB group died (48.4%; P < .001). There was no correlation between DCB length and mortality rate (P = .357). For the entire cohort, multivariate logistic regression analysis showed type of treatment (uncoated device vs DCB; P = .002), age (P < .001), stroke (P = .005), renal insufficiency (P = .014), and critical limb ischemia (P = .001) to be independent predictors of all-cause mortality. There was no significant difference in mortality among the paclitaxel exposure groups.ConclusionIn this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of infrapopliteal lesions.     

Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease

ObjectivesThe aim of this study was to assess safety outcomes of femoropopliteal drug-coated balloon (DCB) angioplasty using patient-level data from the Lutonix clinical program.BackgroundA recent systematic review and meta-analysis of heterogenous trials and summary-level data identified increased long-term mortality in patients treated with paclitaxel-coated balloons and stents.MethodsWe evaluated DCB angioplasty (n = 1,093) and uncoated balloon angioplasty (percutaneous transluminal angioplasty [PTA]) (n = 250) outcomes in LEVANT 1 (The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis), LEVANT 2 (Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries), and the LEVANT Japan Clinical Trial. Hazard ratios (HRs) were calculated with Cox proportional hazards modeling.ResultsThere were no significant differences in mortality rates between DCB angioplasty and PTA. The 5-year HR was 1.01 (95% confidence interval [CI]: 0.68 to 1.52) in the aggregated LEVANT trials. The 2-year HR after DCB angioplasty was 0.99 (95% CI: 0.25 to 3.95) in LEVANT 1, 1.40 (95% CI: 0.62 to 3.14) in LEVANT 2, and 0.32 (95% CI: 0.05 to 1.92) in the LEVANT Japan Clinical Trial. The 5-year HR was 1.60 (95% CI: 0.94 to 2.72) in LEVANT 2. Adverse events and causes of death were balanced, without clustering between DCB angioplasty and PTA. Patients who underwent paclitaxel or nonpaclitaxel reinterventions had higher survival rates than those who did not undergo reinterventions. Baseline covariates predicting mortality included, among others, age (HR: 1.03 per year; p < 0.0001), prior treatment of target lesion (HR: 1.67; p = 0.022), arrhythmia (HR: 1.65; p = 0.031), and diabetes (HR: 1.18; p = 0.047), without differences between the 2 arms. No dose-response relationship was identified when adjusted for key predictors of mortality.ConclusionsAnalyses of patient-level data identified no mortality differences between DCB angioplasty and PTA. Furthermore, the lack of dose-response relationships or clustering of causes of death argues against a causal relationship between paclitaxel and mortality. (LEVANT 1, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis [LEVANT 1], NCT00930813; Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries [LEVANT 2], NCT01412541; LEVANT 2 Continued Access Registry, NCT01628159; LEVANT Japan Clinical Trial, NCT01816412)     

Clinical Impact of Intravascular Ultrasound–Guided Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Lesions

BackgroundTreatment with a fluoropolymer-based drug-eluting stent (FP-DES has been widely applied to the contemporary femoropopliteal practice with durable outcomes. Nevertheless, the impact of intravascular ultrasound (IVUS) utilization on clinical outcomes after FP-DES implantation has not been determined.ObjectivesThis study aimed to investigate the impact of IVUS on 1-year clinical outcomes after FP-DES) implantation for femoropopliteal lesions in patients with symptomatic peripheral artery disease.MethodsAs a subanalysis of the CAPSICUM (contemporary outcomes after paclitaxel-eluting peripheral stent implantation for symptomatic lower limb ischemia with superficial femoral or proximal popliteal lesion) study, the present investigation analyzed 1,091 patients with symptomatic peripheral artery disease who underwent endovascular therapy with FP-DES for femoropopliteal lesions. One-year clinical outcomes were compared between patients treated with IVUS and those treated without IVUS after propensity score matching. The primary outcome measure was 1-year restenosis. The incidence of aneurysmal degeneration was also assessed.ResultsA total of 843 (77.2%) patients underwent IVUS-guided FP-DES implantation. After propensity score matching, the 1-year restenosis was not significantly different between the groups (11.5% [95% CI: 9.1%-14.0%] vs 15.5% [95% CI: 10.9%-20.1%]; P = 0.22). The frequency of aneurysmal degeneration at 1 year was significantly higher in the IVUS group than in the non-IVUS group (19.8% [95% CI: 16.3%-23.4%] vs 7.1% [95% CI: 3.3%-11.0%]; P < 0.001). IVUS use was associated with a lower restenosis risk in patients with chronic total occlusion but not in those without (P for interaction = 0.044).ConclusionsThe present study revealed that 1-year restenosis risk was not significantly different between the 2 groups, whereas the incidence of aneurysmal degeneration was significantly higher in the IVUS group.     

Predictors and 3‐year outcomes of compromised left circumflex coronary artery after left main crossover stenting

BackgroundThere are few predictors of decreased fractional flow reserve (FFR) in the left circumflex coronary artery (LCx) after left main (LM) crossover stenting.ObjectivesWe aimed to determine the predictors for low FFR at LCx and possible treatment strategies for compromised LCx, together with their long‐term outcomes.MethodsAltogether, 563 patients who met the inclusion criteria were admitted to our hospital from February 2015 to November 2020 with significant distal LM bifurcation lesions. They underwent single‐stent crossover percutaneous coronary intervention (PCI) under intravascular ultrasound (IVUS) guidance with further LCx intervention based on the measured FFR.ResultsThe patients showed significant angiographic LCx ostial affection post‐LM stenting, but only 116 (20.6%) patients had FFR < 0.8. The three‐year composite major adverse cardiac events (MACE) rates were comparable between the high and low FFR groups (16.8% vs. 15.5; p = 0.744). In a multivariate analysis, low FFR at the LCx was associated with post‐stenting minimal luminal area (MLA) of LCx (odds ratio [OR]: 0.032, p < .001), post‐stenting LCx plaque burden (OR: 1.166, p < .001), poststenting LM MLA (OR: 0.821, p = .038), and prestenting LCx MLA (OR: 0.371, p = .044). In the low FFR group, those with compromised LCx managed with drug‐eluting balloon had the lowest three‐year MACE rate (8.1%), as compared to either those undergoing kissing balloon inflation (KBI) (17.5%) or stenting (20.5%) (p = 0.299).ConclusionUnnecessary LCx interventions can be avoided with FFR‐guided LCx intervention. Poststenting MLA and plaque burden of the LCx, and main vessel stent length are poststenting predictors of low FFR.     

Balloon Post-Dilatation Improves Long-Term Valve Performance After Balloon-Expandable Valve Implantation

BackgroundThe impact of balloon post-dilatation (BPD) on short- and long-term valve performance after Sapien 3 (S3) implantation is unknown. This study aimed to evaluate the impact of balloon post-dilatation (BPD) on short- and long-term valve performance after the implantation of S3.MethodsA total of 846 patients implanted with S3 from the OCEAN-TAVI registry were included in this study. The patients were divided into BPD and non-BPD groups. The clinical outcomes and valve functions were compared.ResultsThe BPD group included 173 (20.4%) patients and the non-BPD group comprised 673 (79.6%) patients. The prosthesis-patient mismatch (PPM) rates were significantly lower in the BPD group than in the non-BPD group before and after propensity score matching at in-hospital follow-up (before matching: 12 [7.1%] vs. 108 [16.3%], p = 0.002; after matching: 8 [6.3%] vs. 19 [14.8%], p = 0.027) and at 1-year follow-up (before matching: 14 [12.5%] vs. 112 [23.6%], p = 0.010; after matching: 9 [10.5%] vs. 19 [22.1%], p = 0.039). The rates of acute kidney injury, cardiac tamponade, and in-hospital cardiovascular death were significantly higher in the BPD group than in the non-BPD group (acute kidney injury: 22 [12.7%] vs. 33 [4.9%], p < 0.001; cardiac tamponade: 3 [1.7%] vs. 2 [0.3%], p = 0.028; in-hospital cardiovascular death: 4 [2.3%] vs. 3 [0.4%], p = 0.016). After matching, these clinical outcomes were similar between the BPD and non-BPD groups.ConclusionsThe BPD group demonstrated better short- and long-term valve performance. Caution is needed to avoid procedure-related complications in patients undergoing BPD.     

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial

ObjectivesThe study sought to compare short-term outcomes in patients with femoropopliteal artery calcification receiving vessel preparation with intravascular lithotripsy (IVL) or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) for symptomatic peripheral artery disease.BackgroundEndovascular treatment of calcified peripheral artery lesions is associated with suboptimal vessel expansion and increased complication risk. Although initial results from single-arm studies with IVL have been reported, comparative evidence from randomized trials is lacking for most devices in the presence of heavy calcification.MethodsThe Disrupt PAD III (Shockwave Medical Peripheral Lithoplasty System Study for PAD) randomized trial enrolled patients with moderate or severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA prior to DCB or stenting. The primary endpoint was core lab–adjudicated procedural success (residual stenosis ≤30% without flow-limiting dissection) prior to DCB or stenting.ResultsIn patients receiving IVL (n = 153) or PTA (n = 153), procedural success was greater in the IVL group (65.8% vs. 50.4%; p = 0.01) and the percentage of lesions with residual stenosis ≤30% (66.4% vs. 51.9%; p = 0.02) was greater in the IVL group, while flow-limiting dissections occurred more frequently in the PTA group (1.4% vs. 6.8%; p = 0.03). Post-dilatation (5.2% vs. 17.0%; p = 0.001) and stent placement (4.6% vs. 18.3%; p < 0.001) were also greater in the PTA group. The rates of major adverse events (IVL: 0% vs. PTA: 1.3%; p = 0.16) and clinically driven target lesion revascularization (IVL: 0.7% vs. PTA: 0.7%; p = 1.0) at 30 days were comparable between groups.ConclusionsIVL is an effective vessel preparation strategy that facilitates definitive endovascular treatment in calcified femoropopliteal arteries in patients with peripheral artery disease. (Shockwave Medical Peripheral Lithoplasty System Study for PAD [Disrupt PAD III]; NCT02923193)     

Comparison of intravascular ultrasound to contrast-enhanced 64-slice computed tomography to assess the significance of angiographically ambiguous coronary narrowings

The efficacy of contrast-enhanced multislice computed tomography (MSCT) for assessment of ambiguous lesions is unknown. We compared both quantitative coronary angiography (QCA) and MSCT to the gold standard for a significant stenosis-minimum luminal area (MLA) by intravascular ultrasound (IVUS)-in 51 patients (64 +/- 10 years old, 19 men) with 69 angiographically ambiguous, nonleft main lesions. The MSCT was performed 17 +/- 18 days before IVUS analysis. Overall diameter stenosis by QCAwas 51.0 +/- 9.8%; 39 of 51 patients (76%) eventually underwent revascularization (38 by percutaneous coronary intervention and 1 by coronary artery bypass graft). By univariate analysis, minimum luminal diameter, MLA, lumen visibility by MSCT, and minimum luminal diameter by QCA were significant predictors of MLA by IVUS 相似文献   

IVUS-Guided Wiring Improves the Clinical Outcomes of Angioplasty for Long Femoropopliteal CTO Compared with the Conventional Intraluminal Approach

Aims: This study aimed to assess the clinical efficacy of intravascular ultrasound (IVUS)-guided intraplaque wiring for femoropopliteal (FP) chronic total occlusion (CTO).Methods: This single-center, retrospective, observational study was performed at the Japanese Red Cross Kyoto Daini Hospital. From March 2013 to June 2017, a total of 75 consecutive patients (mean age: 75.4 ± 8.5 years; 59 males), who underwent endovascular treatment (EVT), having 82 de novo FP-CTO lesions, were enrolled in this study. Eleven of the lesions that met the exclusion criteria were excluded, and the remaining 71 lesions were divided into the IVUS-guided wiring group (n = 34) and non-IVUS-guided wiring group (n = 37). Primary patency, defined as a peak systolic velocity ratio of < 2.4 on duplex ultrasonography, and freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months were the primary outcomes.Results: The mean lesion length was 21.6 ± 8.9 cm. The frequencies of primary patency and freedom from CD-TLR were significantly higher in the IVUS-guided wiring group than in the non-IVUS-guided wiring group (70.0% vs. 52.2%, p = 0.045; 83.9% vs. 62.8%, p = 0.036, respectively). The complete clinically true lumen angioplasty rate was also higher in the IVUS-guided wiring group than in the non-IVUS-guided wiring group (91.1% vs. 51.3%, p < 0.001, respectively). The clinically true and false wire passage rates were respectively 97.3% and 2.7% in the IVUS-guided wiring group.Conclusion: IVUS-guided wiring improves the clinical outcomes of EVT for FP-CTO by achieving a high clinically true lumen wire passage rate.     

Earlier surgery is associated to reduced postoperative morbidity in ileocaecal Crohn's disease: Results from SURGICROHN – LATAM study

BackgroundEarly surgical resection is an emerging concept for patients with ileocaecal Crohn's disease (CD). The aim of this study was to compare postoperative outcomes after ileocaecal resections between patients with luminal and complicated CD.MethodsA retrospective analysis of patients operated for ileocaecal CD during an 8-year period in ten tertiary referral academic centres from Latin America was performed. Patients were allocated into 2 groups: those operated for early (luminal) disease (Early Crohn's Disease -ECD-) and for complications of CD (Complicated Crohn's disease -CCD-). A comparative analysis was performed regarding short-term outcomes of surgery, considering overall postoperative complications as main outcome.Results337 patients were included in the analysis, 60 (17.80%) in the ECD group. Smoking and exposure to perioperative biologic drugs were more prevalent in CCD group. CCD patients had increased requirement of urgent surgery (26.71 vs. 15%, p = 0.056), longer operative time (164.25 vs. 90.53 min, p< 0.01), lower rates of primary anastomosis (90.23 vs. 100%, p = 0.012), increased rate of overall postoperative complications (33.21 vs. 16.67%, p = 0.013), more reoperations (13.36 vs. 3.33%, p = 0.026), and higher rates of major anastomotic fistulas and hospital stay. On multivariable analysis, smoking (p = 0.001,95%CI: 2.59–32.11), operative time (p = 0.022,95%CI:1–1.02), associated procedures (p = 0.036,95%CI:1.09–15.72) and intraoperative complications (p = 0.021,95%CI:1.45–92.31) were independently related to presenting postoperative complications.ConclusionEarly (luminal) ileocaecal resections were associated to lower rates of overall postoperative complications. Proper timing for surgery, avoiding delays in surgical indication can impact postoperative outcomes.     

What Is an Appropriate Reference Standard in the Quantitation of Plaque Surface Area by Intravascular Coronary Ultrasound?

We reevaluate the predictive accuracy of intravascular ultrasound (IVUS)-derived per cent plaque area stenosis (PAS) in significant coronary lesions (CLs) with or without proximal and distal reference vessel area adjustment. IVUS is valuable in defining moderate CL severity (30 to 70%) in left main (LM) or non-left main (NLM) coronaries using minimum luminal area (MLA) of ≤5.9 and ≤4 mm², respectively. Despite a strong correlation with severe CLs, PAS (≥ 70% for NLM and ≥67% for LM) remains underutilized because of confusion about an appropriate reference standard. We studied 120 patients with symptomatic moderate CLs (74 NLM, 46 LM) who underwent IVUS. In-lesion and adjusted PAS were derived by subtracting MLA from in-lesion and proximal or distal reference''s external elastic membrane (EEM) area, respectively, divided by corresponding EEM area multiplied by 100. In-lesion PAS was correlated with MLA cutoffs of ≤5.9 and ≤7.5 mm² for LM and ≤4 mm² for NLM. Adjusted PAS strongly correlated with in-lesion PAS irrespective of reference segment (proximal reference, r = 0.879, p < 0.001; distal reference, r = 0.833, p < 0.001; mean proximal and distal reference, r = 0.896, p < 0.001). Considering MLA of ≤4 mm² (for NLM) and ≤5.9 mm² (for LM), in-lesion PAS of ≥70 and ≥67%, respectively, explained the majority of severe CLs but the sensitive LM MLA cutoff of ≤7.5 mm² showed higher predictive accuracy. Based on results, both in-lesion PAS and adjusted PAS can be used interchangeably and correlate strongly with MLA.     

Comparative 12-Month Outcomes of Drug-Coated Balloon Versus Non-Drug-Coated Balloon Revascularization Strategy in Chronic Limb-Threatening Ischemia: Results From the XLPAD Registry

BackgroundEndovascular therapy is often the preferred first treatment option for chronic limb threatening ischemia (CLTI) patients. Drug coated balloons (DCB) reduce restenosis rates compared to percutaneous transluminal angioplasty (PTA), however DCB use has not been studied systematically in patients with CLTI. Thus, the optimal treatment option for these complex lesions remains controversial.MethodsWe report on 327 patients with CLTI treated either with DCB (n = 105) or non-DCB (n = 222) for femoropopliteal disease. Data were retrieved from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851). Two DCB types were used at the discretion of the operator: Lutonix® (BARD Peripheral Vascular, Inc., Tempe, AZ, USA) and IN.PACT AdmiralTM (Medtronic, Santa Rosa, CA, USA). Odds ratios and the respective 95% confidence interval were synthesized to examine the association between the two groups in terms of all-cause mortality, target limb repeat endovascular or surgical revascularization, target vessel revascularization (TVR), major and minor amputation at 12 months of follow up.ResultsThe mean lesion length was 150.0 mm (SD:123.2) and 151.2 mm (SD:108.3) for the DCB and non-DCB group respectively. No difference between the two groups was detected in terms of all-cause mortality (2.86%vs2.7%,p = .94), target limb repeat endovascular or surgical revascularization (16.19%vs12.61%,p = .25), TVR (16.19%vs.11.71%,p = .26) or minor amputation (15.24%vs10.81%,p = .25) at 12 months of follow up. Although a higher incidence of 12 months major amputation was observed in the DCB group (11%vs.4%,p = .01), after adjusting for several risk factors the odds of major amputation were not statistically different between the DCB and non-DCB groups (OR:1.54;95%CI:0.53–4.51;p = .43).ConclusionsBoth DCB and non-DCB strategies are effective modalities for revascularization of patients with CLTI. No differences were identified between the DCB and non-DCB group in terms of late outcomes during 12 months of follow up.     

Prospective Validation that Vulnerable Plaque Associated with Major Adverse Outcomes Have Larger Plaque Volume, Less Dense Calcium, and More Non-Calcified Plaque by Quantitative, Three-Dimensional Measurements Using Intravascular Ultrasound with Radiofrequency Backscatter Analysis

Whether quantitative, two-dimensional, and three-dimensional plaque measurements by intravascular ultrasound with radiofrequency backscatter (IVUS/VH) are different between intermediate lesions with or without major adverse cardiovascular events (MACE) is unknown. IVUS/VH-derived parameters were compared in 60 patients with an intermediate coronary lesion (40–70 %) between lesions that did or did not result in MACE over 12 months. IVUS/VH measurements were done at the site of the minimal lumen area (MLA) and on a per-plaque basis, defined by 40 % plaque burden. Pre-specified, adjudicated MACE events occurred in 5 of 60 patients (8.3 %). MACE lesions had larger plaque burden (65 % vs. 53 %, p?=?0.004), less dense calcium (6.6 % vs. 14.7 %, p?=?0.05), and more non-calcified plaque, mostly fibrofatty kind (17.6 % vs. 10 %, p?=?0.02). Intermediate coronary lesions associated with MACE at 12 months have more plaque, less dense calcium, and more non-calcified plaque, particularly fibrofatty tissue by IVUS/VH.     

Comparison of Angiographic and Intravascular Ultrasound Vessel Measurements in Infra-Popliteal Endovascular Interventions: The Below-the-Knee Calibration Study

BackgroundEndovascular revascularization (ER) via percutaneous transluminal angioplasty (PTA) and stenting are viable options for revascularization in below-the-knee (BTK) peripheral arterial disease. Two-dimensional angiography has been the standard of practice for estimating vessel size and selecting treatment devices during ER. However, in other vascular territories, intravascular ultrasound (IVUS) offers better visualization of the lumen dimensions.PurposeTo compare angiographic and intravascular ultrasound reference vessel (lumen) measurements in below-the-knee peripheral artery interventions.MethodsTwenty consecutive patients were enrolled in the BTK Calibration study from 2 sites in the United States and Australia. Patients with at least one diseased segment in a native infra-popliteal artery (below-the-knee) and a clinical indication for endovascular therapy (EVT) were included with no limitations with regard to vessel diameter or lesion length. Digital subtraction angiography and IVUS imaging were collected pre- and post-PTA and images were sent to an independent core lab for standardized quantitative analysis of the normal-looking reference vessel dimensions when available. The results were presented as least square means with 95% confidence intervals and a p-value of < 0.05 was considered significant.ResultsThe overall (N = 19) mean reference vessel diameter for QVA was 2.98 ± 1.24 mm vs. 3.47 ± 0.72 mm for IVUS (mean difference was −0.50 mm, (95% CI: −0.80, −0.20; p = 0.14). As expected, in the proximal segments (N = 12), the mean reference vessel diameters were larger: for QVA, it was 3.17 ± 1.34 mm vs. 3.55 ± 0.76 mm in IVUS, (mean difference was −0.38 mm, (95% CI: -0.79, 0.03; p = 0.40); while in the distal segments (N = 7), mean reference vessel diameters were smaller: for QVA, it was 2.64 ± 1.06 mm vs. 3.33 ± 0.67 mm in IVUS, (mean difference was −0.69 mm, (95% CI: -1.04, 0.34; p = 0.17). We observed a greater degree of acute gain in cases where the treatment balloon size correlated with the IVUS measured reference size.ConclusionAngiography underestimates infrapopliteal reference vessel lumen size even when quantitatively assessed. Adjunctive IVUS imaging use in guiding BTK procedures could help ensure adequate sizing and possibly impact immediate post-procedure indices.     

A Patient-Level,Pooled Analysis of Mortality Rates With the Passeo-18 Lux Paclitaxel Drug-Coated Balloon in Peripheral Arterial Disease

BackgroundRecent meta-analyses have raised concerns about mortality with paclitaxel drug-coated balloons (DCB). This pooled, patient-level analysis of the BIOLUX P-I, P-II, and P-III studies was performed to evaluate the safety and efficacy of Passeo-18 Lux DCB.Materials and MethodsIndividual patient-level demographic, clinical, diagnostic, and procedural data from the BIOLUX P-I, BIOLUX P-II, and BIOLUX P-III studies were pooled in a common database. Clinical safety (all-cause mortality and cardiovascular mortality) and efficacy (any amputation, target lesion/vessel revascularization) were extracted. Cox proportional modeling was used to assess the effect of critical limb ischemia at the time of enrollment and the occurrence of new amputation as a time-dependent variable on mortality.ResultsA total of 1009 patients were included in the analysis. Sixty-six patients were treated with percutaneous transluminal angioplasty (PTA) and 943 underwent DCB angioplasty. The cumulative incidence of all-cause mortality did not differ between the groups (PTA 6.7%, DCB 6.7%, p = 0.65). The composite efficacy endpoint of freedom from any amputation and target lesion/vessel revascularization was superior in the DCB arm compared to PTA [PTA 28.8%, DCB 16.7%, p = 0.02]. Both in unadjusted and adjusted Cox proportional models (adjusted for critical limb ischemia and amputation), the use of DCB was not associated with any mortality at 1 year.ConclusionsOur patient-level analysis shows that overall, the use of the Passeo-18 Lux paclitaxel DCB in infrainguinal arteries was not associated with increased mortality at 1 year and reinforces the efficacy of DCB angioplasty in preventing amputation or the need for reintervention.     

Cilostazol reduces target lesion revascularization after percutaneous transluminal angioplasty in the femoropopliteal artery.

BACKGROUND: Although percutaneous transluminal angioplasty (PTA) is being widely used for the treatment of stenosis of peripheral arteries, the high in-stent restenosis rate (50-60%) in the femoropopliteal artery still remains an unsolved issue. Cilostazol is a unique antiplatelet drug that has vasodilatory effects and inhibits smooth muscle cell proliferation. METHODS AND RESULTS: A total of 141 consecutive patients scheduled for PTA in the femoropopliteal artery between September 1999 and April 2004 were retrospectively analyzed for the use of cilostazol. Target lesion revascularization (TLR) was defined as repeated PTA in patients who had a recurrence of symptoms with diameter stenosis >50% by angiography. Patient and lesion characteristics were similar between the cilostazol (+) and cilostazol (-) groups. Use of other medications was similar between the groups, except for ticlopidine, which was more frequently used in the cilostazol (-) than in the cilostazol (+) group (15% vs 61%, p<0.01). TLR was significantly reduced in the cilostazol (+) group (12% [8/68] vs 32% [23/73], p<0.01). CONCLUSIONS: Although this study was retrospective and nonrandomized, the results suggest that cilostazol reduces TLR after PTA in the femoropopliteal artery.     

Early Experience with Intravascular Ultrasound in Evaluating the Effect of Statins on Femoropopliteal Arterial Disease: Hypothesis-Generating Observations in Humans

The purpose of this study was to compare the vascular response seen with intravascular ultrasound (IVUS) at 1-year follow-up between statin-treated and non–statin-treated patients. Patients (n=10) undergoing percutaneous transluminal angioplasty (PTA) of the femoropopliteal artery were studied with IVUS immediately after PTA and at 1-year follow-up. In nondilated matched vascular segments, the change in lumen, vessel, and plaque volume was assessed. In balloon-dilated matched vascular segments, the change in lumen, vessel, and plaque area was assessed. A comparison was made between statin-treated (n=5) and non–statin-treated patients (n=5) in lumen, vessel, and plaque changes. At follow-up, both statin-treated and non–statin-treated patients showed a similar increase in plaque volume at the nondilated segment (+4% and +2%, respectively). In statin-treated patients the plaque volume increase was compensated by an increase in vessel volume (+2%), resulting in an increase in lumen volume (+1%). In non–statin-treated patients, on the other hand, the increase in plaque volume was associated with a decrease in vessel volume (–2%), resulting in a decrease in lumen volume (–4%). At the balloon-dilated segment a similar trend in changes of lumen, vessel, and plaque was encountered. Differences between both groups of patients were not statistically significant. Despite the nonsignificant nature of the observation, this small retrospective IVUS study may generate the hypothesis that statin therapy may contribute to superior long-term lumen dimensions by inducing positive vascular remodeling both in nondilated and balloon-dilated vascular segments.