Angioplasty For Critical Limb Ischemia Research Articles

End-stage renal disease patients undergoing angioplasty and bypass for critical limb ischemia have worse outcomes compared to non-ESRD patients: Systematic review and meta-analysis.

End-stage renal disease (ESRD) is associated with increased morbidity and mortality following lower extremity amputation for critical limb ischemia (CLI). Angioplasty and bypass are used in ESRD patients with CLI; however, the treatment of choice remains controversial. We compared the long-term outcomes in patients with CLI undergoing angioplasty or bypass to evaluate the differences between patients with ESRD and those without ESRD. Established databases were searched for observational studies comparing outcomes following bypass or angioplasty for CLI in patients with ESRD to those in non-ESRD patients. End points included survival, limb salvage, amputation-free survival (AFS), and primary and secondary patency at 1-year post-procedure. Pooled odds ratios (OR) with 95% confidence intervals (CI) were calculated using a random effect model. We included 20 studies with a total of 24,851 patients. ESRD patients compared to non-ESRD patients with CLI had significantly lower survival post-angioplasty (OR 0.51, 95% CI 0.36-0.72, p < .001) and post-bypass (OR 0.26, 95% CI 0.15-0.45, p < .001). ESRD patients had lower rates of limb salvage post-bypass (OR 0.33, 95% CI 0.21-0.53, p < .001) and post-angioplasty (OR 0.54, 95% CI 0.41-0.70, p < .001). AFS was significantly lower in ESRD patients compared to non-ESRD patients following angioplasty (OR 0.48, 95% CI 0.32-0.71, p < .001) and bypass (OR 0.28, 95% CI 0.16-0.47, p < .001) despite no significant differences in primary patency. ESRD patients had overall worse secondary patency post-angioplasty and/or bypass (OR 0.54, 95% CI 0.32-0.94, p=.03) compared to non-ESRD patients. A meta-analysis of four studies directly comparing survival in ESRD patients with CLI based on whether they underwent angioplasty or bypass showed no difference (OR 0.93, 95% CI 0.64-1.35, p=.69). ESRD patients have worse survival, limb salvage, and AFS outcomes following angioplasty and bypass for CLI compared to non-ESRD patients. Large randomized controlled trials comparing these two modalities of treatment in this patient population are needed for further clarity.

Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patient undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial

New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.

Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

A formal systematic review and study-level meta-analysis of randomized controlled trials investigating treatment of the infrapopliteal arteries with paclitaxel-coated balloons compared with conventional balloon angioplasty for critical limb ischemia (CLI) was conducted. Medical databases and online content were last screened in September 2019. The primary safety and efficacy endpoint was amputation-free survival defined as freedom from all-cause death and major amputation. Target lesion revascularization (TLR) constituted a secondary efficacy endpoint. Summary effects were synthesized with a random-effects model. Some 8 randomized controlled trials with 1,420 patients (97% CLI) were analyzed up to 1 year follow-up. Amputation-free survival was significantly worse in case of paclitaxel (13.7% crude risk of death or limb loss compared to 9.4% in case of uncoated balloon angioplasty; hazard ratio 1.52; 95% confidence interval: 1.12-2.07, p = .008). TLR was significantly reduced in case of paclitaxel (11.8% crude risk of TLR versus 25.6% in control; risk ratio 0.53; 95% confidence interval: 0.35-0.81, p = .004). The harm signal was evident when examining the high-dose (3.0-3.5μg/mm2) devices, but attenuated below significance in case of a low-dose (2.0 μg/mm2) device. Actual causes remain largely unknown, but non-target paclitaxel embolization is a plausible mechanism.

Iloprost treatment on top of infrapopliteal angioplasty accelerates wound healing in critical leg ischemia

Objectives This study aimed to examine the efficacy of the concomitant use of infrapopliteal drug-eluting balloon angioplasty and a medical treatment (iloprost) in the treatment of critical leg ischemia. Methods Eighty-seven patients that underwent infrapopliteal drug-eluting balloon angioplasty for critical leg ischemia were included in this retrospective study. For analyses, patients were allocated into one of the two groups: 55 patients that underwent drug-eluting balloon angioplasty alone (drug-eluting balloon Group), and 32 patients that received intravenous iloprost for one week after drug-eluting balloon (DEB-I Group). Demographic, perioperative and follow-up clinical data were extracted retrospectively and analyzed. Results Duration of hospitalization was significantly longer in the DEB-I group (9.7 vs. 3.1 days, p &lt; 0.001); however, the two groups were similar in terms of other clinical outcomes including early postoperative mortality, and primary patency, wound healing, reintervention, mortality, and amputation rates at one year ( p &gt; 0.05 for all). Primary patency was similar across groups. Wound healing occurred earlier in the DEB-I group when compared to drug-eluting balloon group, in the subgroup of patients with ischemic wound at baseline. Mean time to wound healing was 3.0 ± 0.6 and 4.4 ± 0.6 months in DEB-I and drug-eluting balloon groups, respectively ( p = 0.037). Conclusions Iloprost add-on treatment in patients undergoing drug-eluting balloon angioplasty for critical limb ischemia seems to have additional benefits, at least in terms of accelerated wound healing. Further large prospective studies are warranted.

Long term results after invasive treatment of critical limb ischemia

Surgical tibial bypass for critical limb ischemia is associated with significant morbidity, mortality, and graft failure, whereas percutaneous angioplasty and stenting has promising results. The objective of this study was the investigation of the long term results of below-knee percutaneous angioplasty for restoring straight inline arterial flow in patients with critical limb ischemia. The clinical and angiographic data of 281 consecutive patients with critical limb ischemia treated by PTA between 2008 and 2011 was evaluated in a prospective register. The aim of the revascularization was to achieve a straight inline flow to the wound with balloon angioplasty. Stent implantation was done in the case of recoil and flow limiting dissection. Primary end points were clinical success (relief of resting pain, healing of ulceration, limb survival) and major adverse events (death, myocardial infarction, major unplanned amputation, need for surgical revascularization, or major bleeding). Secondary end points were the angiographic result of the intervention, procedural data and consumption of angioplasty equipment. The impact of diabetic leg syndrome and the result of the angioplasty on the limb salvage was also investigated. We have analysed the impact of major amputation on long term mortality. Mean age of patients was 72.5 ± 10.6 years and the follow-up period was 40.8 ± 9.7 months. Technical success was reached in 255 (90.7%) of the patient's: 255 limbs straight inline flow with good angiographic result was restored to at least one tibial vessel. Balloon angioplasty, stent implantation and rotational atherectomy was performed in 278 (98.9%), 74 (26.3%) and 2 patients (0.7%). From clinical end points the rest pain was ceased in 56.6%, the ulcer and the gangrena was healed in 73.5% and 46.5%. The long term limb survival was 73.5%; 65.8% in diabetic and 89.6% in non-diabetic leg syndrome (p = 0.001). The major adverse events at long-term follow-up occured in 122 (43.8%) patients. Death occured in 57 (20.3%) of the patients during the long-term follow-up: 38 (13.5%) vs. 19 (6.8%) in diabetic vs. non-diabetic leg subgroup, respectively (p = 0.932). Long-term limb saving occured in 72.3% vs. 84.6% of the patients dependening the procedure was successful or unsuccessful (p = 0.225). Below-knee stent angioplasty for critical limb ischemia results in good clinical outcome, but the major adverse event rate is high. Diabetes mellitus is associated with a high rate of mortality and amputation. Orv. Hetil., 2017, 158(11), 418-425.

Below-The-Knee Angioplasty for Critical Limb Ischemia: Results of a Series of 157 Procedures and Impact of the Angiosome Concept

To evaluate the long-term clinical results of below-the-knee percutaneous transluminal angioplasty (BTK-PTA) with or without stenting, in patients with critical limb ischemia (CLI), and to determine factors affecting clinical results including the role of the angiosome concept. All patients undergoing primary BTK-PTA from January 2007 to December 2011 were included. Primary patency, assisted patency, limb salvage, survival, and wound healing were assessed using the Kaplan-Meier method. Predictors of patency, limb salvage, survival, and wound healing, including the role of the angiosome theory, were determined using multivariate models. A total of 157 procedures were performed in 139 patients with CLI (Rutherford IV 10.8%; Rutherford V-VI 89.2%). Mean age was 74.2years and 68.3% were men; 60% had diabetes and 31% renal insufficiency. PTA was confined to the infrapopliteal segment alone in 53.5% of cases. Technical success was 87.9%. Stents were placed in 42.6% of cases. The mean follow-up was 14.7months (range, 1-67months). Four-year primary and secondary patency were 51% and 61%, respectively. Limb salvage at 4years was 68.8%. Complete wound healing was 52% at 4years. Positive predictors of survival were the absence of renal insufficiency (P<0.0001) and technical success (P=0.029). Target vessel occlusion of >50% was a negative predictor of limb salvage (P=0.0072). Positive predictors of wound healing were technical success (P=0.0067), the absence of renal insufficiency (P<0.0001) and continuity between a leg artery and a foot artery (P=0.02). BTK-PTA can be performed with favorable long-term results in patients with limited longevity. Secondary interventions may be necessary to maintain target vessel patency. In our experience, the angiosome concept had no impact on clinical success.

Results of isolated infrapopliteal percutaneous transluminal angioplasty for critical limb ischemia in high-risk diabetic patients.

Infrapopliteal occlusive arterial lesions mostly characterize diabetic patients arteriopathy. Diabetic patients are prone to multiple comorbidities that make them candidates for low-invasive therapeutic options. The aim of this study was to evaluate the safety of infrapopliteal angioplasty in high-risk diabetic patients. We undertook a study (retrospective study of a prospectively collected database) of all infrapopliteal endovascular revascularizations performed for critical limb ischemia in high-risk (≥3 major comorbidities) diabetic patients in our institution between 2008 and 2010. Study end points were safety, technical success rate, healing rate, overall 1-year survival, primary patency, secondary patency and limb salvage rates. A total of 101 high-risk diabetic patients (160 arterial lesions: 94 stenosis and 66 occlusions) underwent infrapopliteal endovascular surgery. No major adverse cardiovascular or cerebrovascular event was recorded within 30 days. Two major adverse limb events (two thromboses requiring major amputation) and seven minor adverse events were recorded. Technical and healing rates were, respectively, 83% and 78%. The 1-year survival, primary patency, secondary patency and limb salvage rates were, respectively, 86%, 67%, 83% and 84%. Infrapopliteal angioplasty can be considered as a safe and feasible option for high-risk diabetic patients with critical limb ischemia.

Three-year clinical outcome after infrapopliteal angioplasty for critical limb ischemia in hemodialysis patients with minor or major tissue loss.

Among hemodialysis (HD)-dependent patients with critical limb ischemia (CLI), Endovascular therapy (EVT) of isolated infrapopliteal lesions improves limb salvage. Accordingly, we sought to determine the outcomes of this group of patients based on the extent of tissue loss at baseline. From 2004 to 2011, 449 consecutive HD patients with CLI had ischemic wounds and underwent EVT for isolated infrapopliteal lesions. The "minor tissue loss" (MI) group was confirmed by 340 HD patients with wounds located distal to the metatarsophalangeal joints, and the "major tissue loss" (MA) group included 109 HD patients with wounds that extended beyond this point. The two groups were compared for limb salvage and amputation free survival (AFS) rates by Kaplan-Meier analysis. There was no significant difference in the percentage of diabetic patients (MI: 76.5 vs. MA: 75.2%). The percentage with direct flow to the wound site was lower in the MA group than in the MI group (MI: 63.5 vs. MA: 45.9%, P < 0.01). After EVT the MI group had a significantly better limb salvage rate (MI: 83.7 vs. MA: 71.2% at 3 years, P < 0.01), and AFS rate (MI: 44.1 vs. MA: 29.1% at 3 years, P < 0.01) compared to the MA group. EVT is an efficient treatment for HD patients with minor tissue loss, achieving >80% limb salvage rates at 3 years. However, AFS rates in all HD patients with tissue loss are <50% at 3 years, making their prognosis poor.

Percutaneous transluminal angioplasty for critical limb ischemia in very elderly diabetic patients

In diabetic subjects, new less invasive therapies for critical limb ischemia (CLI) are available to obtain limb salvage. One of these is the percutaneous transluminal angioplasty (PTA), a minor surgical intervention which allows obtaining an effective revascularization, avoiding the traditional major surgery and its post-operative complications. Our case report regards a 94-year-old woman with CLI due to critical obstruction (stage IV according to Leriche's classification) of superficial femoral and popliteal arteries and infrapopliteal arteries that should have been treated by the left limb amputation considering her age, severe co-morbidities, and poor compliance. Instead of this quite common approach, our team treated the patient with PTA. This led to very good outcomes, above all in terms of pain control. PTA is able to avoid major surgery, lower intra and post-operative risks, reduce length of hospital stay, and preserve functional autonomy. Therefore, this procedure should be taken into account also for frail very elderly diabetic patients with peripheral artery disease (PAD).

Prognosis of Critical Limb Ischemia in Hemodialysis Patients After Isolated Infrapopliteal Balloon Angioplasty: Results From the Japan Below-the-Knee Artery Treatment (J-BEAT) Registry

To evaluate the long-term clinical results after isolated infrapopliteal balloon angioplasty for critical limb ischemia (CLI) in end-stage renal disease patients on hemodialysis. Between April 2004 and October 2010, 406 CLI consecutive patients (275 men; mean age 71±11 years) who underwent balloon angioplasty for primary treatment of isolated infrapopliteal artery lesions in 465 limbs were enrolled in a multicenter, non-randomized registry. The patients were classified into 2 groups, those on hemodialysis (242 patients with 283 limbs) and those not (164 patients with 182 limbs), for a retrospective comparative study of clinical outcomes [target extremity revascularization (TER), major amputation (MA), and survival] at an average 3.4±1.9 years. Freedom from TER at 5 years was lower in the hemodialysis patients (48.3% vs. 65.4% in non-hemodialysis patients, p<0.001); 9.9% of hemodialysis patients had undergone bypass surgery in contrast to 3.8% of non-hemodialysis patients (p=0.011). Freedom from MA was 77.1% in hemodialysis patients and 85.1% in non-hemodialysis patients at 5 years (p=0.058). Hemodialysis patients had significantly poorer survival (24.3% vs. 48.0%, p<0.001) and MA-free survival (20.8% vs. 42.9%, p<0.001) than non-hemodialysis patients at 5 years. Multivariate predictors of MA or all-cause death were non-ambulatory status (p<0.001), gangrene (p=0.036), and higher C-reactive protein levels (p=0.048). Although hemodialysis patients have a higher TER rate compared to the general population, the long-term limb salvage rate after balloon angioplasty for isolated infrapopliteal lesions is acceptable; nevertheless, the MA-free survival rate is very low.

SS3. Infrapopliteal Angioplasty for Critical Limb Ischemia: Results at 5-year Follow-up

SS3. Infrapopliteal Angioplasty for Critical Limb Ischemia: Results at 5-year Follow-up

The Influence of Glycemic Control on the Prognosis of Japanese Patients Undergoing Percutaneous Transluminal Angioplasty for Critical Limb Ischemia

OBJECTIVETo reveal the influence of preoperative factors on the prognosis of patients undergoing percutaneous transluminal angioplasty (PTA) for critical limb ischemia (CLI).RESEACH DESIGN AND METHODSWe recruited 278 Japanese patients who underwent PTA for CLI between 2003 and 2009. The outcome measures were mortality and major amputation. Cox proportional hazards regression analyses were performed.RESULTSThe prevalence of diabetes was 71%, and A1C was 7.0 ± 1.4%. The follow-up period was 90 ± 72 weeks, and 48 patients underwent major amputations and 89 died. The presence of diabetes in the whole population and A1C level in the diabetic population had no influence on morality; rather, mortality was associated with age (P = 0.007), impaired activities of daily living (P < 0.001), hemodialysis (P < 0.001), and albumin level (P = 0.010). In contrast, the presence of diabetes and A1C level had significant association with major amputation (P = 0.012 and P = 0.007, respectively). The quartile analysis showed that diabetic subjects with an A1C ≥6.8%, but not <6.8%, had a significantly higher risk of major amputation than nondiabetic subjects. The adjusted hazard ratio of diabetes with A1C ≥6.8% was 2.907 (95% CI 1.606–5.264) (P < 0.001).CONCLUSIONSDiabetes with poor glycemic control is associated with major amputation, but not mortality, in CLI patients undergoing PTA. Prognostic indicators seem somewhat different between survival and limb salvage in the population.

Six-month clinical outcomes after below-the-knee angioplasty for critical limb ischemia in patients on hemodialysis

To evaluate 6-month clinical outcomes after below-the-knee (BTK) angioplasty for critical limb ischemia (CLI) in patients on hemodialysis (HD). Subjects were 69 serial patients (81 limbs, 123 vessels) who underwent percutaneous transluminal angioplasty (PTA) for primary treatment of infrapopliteal lesions in CLI from June 2004 to December 2008. Subjects were classified into two groups for the comparative study of clinical outcomes: the patients on HD: the HD group (35 patients, 45 limbs, 71 vessels, 66±11years) and the patients not on HD: the non-HD group (34 patients, 36 limbs, 52 vessels, 69±9years). A non-randomized retrospective comparative study was conducted to obtain clinical outcomes at 6months. In clinical results at 6months, a higher percentage of tendency toward repeat PTA for the treated leg in the HD group (28.9 vs. 11.1%, p=0.059), but it was not statistically significant. There was no significant difference in the rate of major amputation (11.1 vs. 5.5%) between the two groups. However, the percentage of repeat PTA performed twice or more times (13.3 vs. 0%, p=0.031) and all-cause mortality (17.1 vs. 0%, p=0.012) in the HD group was significantly higher than in the non-HD group. The HD group had a significantly lower rate of freedom from all-cause mortality, major amputation, or repeat PTA in the 6-month follow-up compared to the non-HD group, with the HD group 51.4% and the non-HD group 85.3% (logrank test p=0.003). Although there are more HD patients requiring repeat revascularization compared to the general population, the 6-month outcomes of limb salvage after BTK angioplasty for CLI in HD patients were not significantly different from the general population.

Prospective Trial of Infrapopliteal Artery Balloon Angioplasty for Critical Limb Ischemia: Angiographic and Clinical Results

To evaluate the safety and efficacy of infrapopliteal percutaneous transluminal angioplasty (PTA) as a primary treatment of chronic critical limb ischemia in a prospective trial. Infrapopliteal PTA was performed on 72 limbs of 60 patients (mean age, 72 y; range, 38-92 y) and patients were followed for 12-24 months. The primary angiographic success rate for the stenoses was 84% (102 of 121) and that for the occlusions was 61% (41 of 67) with corresponding restenosis rates of 32% and 52% at follow-up angiography performed a mean of 10 months after primary PTA. The rate of major complications was 2.8% (access site pseudoaneurysms in two patients). The primary clinical success was 63% (45 of 72). A 48% cumulative primary patency rate, a 56% secondary patency rate, and a 80% cumulative limb salvage rate were registered at 18 months, as determined with use of Kaplan-Meier analysis. Lack of angiographic improvement at the site of the most severe ischemia and renal insufficiency (serum creatinine level > 130 micromol/L) were independent predictors of poorer long-term clinical results, as determined with use of Cox multiple regression analysis. Infrapopliteal PTA is a feasible primary treatment of chronic critical limb ischemia with moderate primary angiographic and clinical success, a low complication rate, and a cumulative limb salvage rate comparable with surgical techniques.