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ABSTRACT: INTRODUCTION: Drug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES. MATERIALS AND METHODS: PubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported. RESULTS: Three RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall event-free survival (72.2 vs. 57.3 %; pooled RR = 1.26, 95 % CI = 1.10-1.44, p = 0.0006; NNT = 6.7). CONCLUSION: DES for focal infrapopliteal lesions significantly inhibit vascular restenosis and thereby improve primary patency, decrease repeat procedures, improve wound healing, and prolong overall event-free survival.
CardioVascular and Interventional Radiology 02/2013; · 2.09 Impact Factor
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ABSTRACT: PURPOSE: Application of metal stents is complicated by neointimal hyperplasia leading to vessel restenosis and reocclusion. Treatment options in cases presenting with complete occlusion of the stented segment and recurrent critical limb ischemia (CLI) are limited. We present the option of the subintimal/substent technique in dealing with occluded stents. METHODS: The study included patients presenting with recurrent CLI due to impaired blood flow as a result of complete occlusion of previously inserted metal stents and unsuccessful intraluminal crossing of the lesion via either the antegrade or retrograde approach. In these cases, crossing the occlusion through the subintimal/substent plane was attempted. Primary end points included technical success, safety of the procedure, clinical improvement, and limb salvage, while secondary end points were patient survival, primary patency, and vessel restenosis rates at 1-year follow-up. Study end points were calculated by Kaplan-Meier survival analysis. RESULTS: Between July 2006 and October 2011, a total of 14 patients (mean age 69.14 ± 12.59 years, 12 men) were treated with the substent technique and included in the analysis. Technical success rate was 85.71 % (12 of 14), with a total lesion length of 193.57 ± 90.78 mm. The mean occluded stented segment length was 90.21 ± 44.34 mm. In 10 (83.33 %) of 12 cases, a new stent had to be placed by the side of the old occluded one, while the remaining two cases (16.67 %) were treated only with balloon angioplasty. No serious adverse events were noted during the immediate postprocedural period. All successfully treated patients improved clinically. Estimated limb salvage was 90.9 %, and patient survival rate was 90.0 % at 1 year's follow-up. Primary patency was 45.50 % and vessel restenosis 77.30 %. CONCLUSION: Subintimal recanalization of occluded metal stents through the substent plane is a valuable alternative treatment option, especially in patients with recurrent CLI with few alternatives.
CardioVascular and Interventional Radiology 11/2012; · 2.09 Impact Factor
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ABSTRACT: PURPOSE: To report the long-term angiographic and clinical results in a series of below-the-ankle (BTA) angioplasty procedures and to present some biomechanical issues related to the unique anatomical geometry of the ankle. METHODS: We performed a retrospective analysis of BTA angioplasty procedures. Clinical end points included technical success, patient mortality, salvage of the treated foot, and repeat target lesion revascularization. Imaging end points included primary patency, binary restenosis of the target lesion at the 50 % threshold, and stent integrity (stent fracture, deformation, or collapse). Univariate subgroup analysis was performed. RESULTS: In total, 40 limbs in 37 patients (age 73.5 ± 8.2 years) with critical limb ischemia were included and 42 inframalleolar lesions (4.2 ± 1.4 cm) were analyzed. Technical success was achieved in 95.2 % (40 of 42). Provisional stent placement was performed in 45.2 % (19 of 42). Two patients died, and two major amputations occurred up to 3 years. At 1 year, overall primary vessel patency was 50.4 ± 9.1 %, lesion binary restenosis rate was 64.1 ± 8.3 %, and repeat intervention-free survival was 93.6 ± 4.3 % according to life table analysis of all treated lesions. Pairwise subgroup analysis showed that BTA self-expanding stents were associated with significantly higher restenosis and poorer primary patency compared to plain balloon angioplasty or sirolimus-eluting balloon-expandable stents. Significant deformation and/or fracture of balloon-expandable stents placed BTA were identified in five of 11. Dynamic imaging showed that the dorsalis pedis artery is kinked during foot dorsiflexion, whereas the distal posterior tibial artery is kinked during plantar flexion of the foot. CONCLUSION: BTA angioplasty for critical limb ischemia treatment is safe and feasible with satisfactory long-term results. BTA stent placement must be reserved for bailout indications.
CardioVascular and Interventional Radiology 11/2012; · 2.09 Impact Factor
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ABSTRACT: Background: A well-established method to preserve failing synthetic arteriovenous grafts (AVGs) dialysis accesses is percutaneous transluminal angioplasty (PTA). Nevertheless, the one-year primary patency rate following PTA is approximately 25%. This study was designed to compare the angiographic and clinical outcomes following stent-graft insertion versus angioplasty and/or bare metal stenting (BMS) of recurrently failing AVGs, because of anastomotic and/or venous outflow stenoses. Methods: Self-expanding stent-grafts were deployed for the treatment of failing AVGs in case of recurrent stenosis after treatment with conventional angioplasty or bail-out BMS. Regular angiographic follow-up was scheduled every two months the first six months and every three months thereafter. Data from previous procedures on the same treatment site were retrieved from our database. Primary patency was defined as a functioning graft with a patent treatment site without angiographic restenosis >50% and without any subsequent repeat procedures. Outcome data were analyzed by Kaplan-Meier analysis. Results: In total, 35 patients previously treated with angioplasty and/or BMS for the treatment of recurrent significant AVG stenosis (group PTA), underwent stent-graft placement of the same treatment site (group SG). Of those, 20 patients had undergone angioplasty and 15 bail-out BMS. Mean lesion length was 4.8±1.7cm. Primary patency was significantly improved in the SG group (Hazard Ratio [HR] = 0.2 [95% CI= 0.11-0.36], P=.0001) by log-rank test. The estimated six and 12-month patency rates were 76.9% vs. 25.7%, and 61.4% vs. 8.6% for groups SG and PTA respectively, (P<.0001). Conclusions: Stent-graft placement significantly improves primary patency of anastomotic and venous outflow stenoses in recurrently failing prosthetic arteriovenous grafts.
Journal of nephrology 05/2012; · 1.65 Impact Factor
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ABSTRACT: To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG).
The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1 ± 14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures).
Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006).
PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.
Journal of Endovascular Therapy 04/2012; 19(2):263-72. · 2.86 Impact Factor
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ABSTRACT: INTRODUCTION: There are no cost-utility data about below-the-knee placement of drug-eluting stents. The authors determined the cost-effectiveness of infrapopliteal drug-eluting stents for critical limb ischemia (CLI) treatment. METHODS: The event-free individual survival outcomes defined by the absence of any major events, including death, major amputation, and target limb repeat procedures, were reconstructed on the basis of two published infrapopliteal series. The first included spot Bail-out use of Sirolimus-eluting stents versus bare metal stents after suboptimal balloon angioplasty (Bail-out SES).The second was full-lesion Primary Everolimus-eluting stenting versus plain balloon angioplasty and bail-out bare metal stenting as necessary (primary EES). The number-needed-to-treat (NNT) to avoid one major event and incremental cost-effectiveness ratios (ICERs) were calculated for a 3-year postprocedural period for both strategies. RESULTS: Overall event-free survival was significantly improved in both strategies (hazard ratio (HR) [confidence interval (CI)]: 0.68 [0.41-1.12] in Bail-out SES and HR [CI]: 0.53 [0.29-0.99] in Primary EES). Event-free survival gain per patient was 0.89 (range, 0.11-3.0) years in Bail-out SES with an NNT of 4.6 (CI: 2.5-25.6) and a corresponding ICER of 6,518 (range 1,685-10,112 ). Survival gain was 0.91 (range 0.25-3.0) years in Primary EES with an NNT of 2.7 (CI: 1.7-5.8) and an ICER of 11,581 (range, 4,945-21,428 ) per event-free life-year gained. Two-way sensitivity analysis showed that stented lesion length >10 cm and/or DES list price >1000 were associated with the least economically favorable scenario in both strategies. CONCLUSIONS: Both strategies of bail-out SES and primary EES placement in the infrapopliteal arteries for CLI treatment exhibit single-digit NNT and relatively low corresponding ICERs.
CardioVascular and Interventional Radiology 03/2012; · 2.09 Impact Factor
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Journal of Endovascular Therapy 02/2012; 19(1):20-2. · 2.86 Impact Factor
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ABSTRACT: Endovascular procedures have evolved to the mainstream treatment of choice for revascularization of infrapopliteal obstructive disease, especially in patients suffering from critical limb ischemia and multiple comorbidities. However, standard balloon angioplasty is limited by the potential of a suboptimal acute outcome due to elastic recoil and/or flow-limiting dissection, followed by neointimal hyperplasia and progressive vascular restenosis even in the case of bare-metal stent use. Drug-eluting stents and drug-coated balloons are emerging endovascular technologies with the promise of significant inhibition of vessel restenosis and improved clinical outcomes. The current review outlines the drug-eluting properties of those instruments and summarizes the currently available clinical data. The authors critically appraise the current status and also provide a glimpse of the near future of endovascular below-the-knee treatments.
Expert Review of Medical Devices 01/2012; 9(1):85-94. · 2.63 Impact Factor
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ABSTRACT: Percutaneous catheter-directed intra-arterial thrombolysis is a safe and effective method of treating acute and subacute lower limb ischemia, as long as accurate patient selection and procedural monitoring are ensured. Although larger, controlled trials are needed to establish the role of PTDs in ALI, mechanical thrombectomy could currently be applied combined with lytic infusion in selected cases where rapid recanalization is required or as a stand-alone therapy when the administration of thrombolytic agents is contraindicated.
CardioVascular and Interventional Radiology 09/2011; 34(6):1123-36. · 2.09 Impact Factor
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ABSTRACT: The purpose of this article is to report the results of a prospective single-center study analyzing the long-term clinical and angiographic outcomes of subintimal angioplasty (SIA) for the treatment of chronic total occlusions (CTOs) of the femoropopliteal artery.
Patients with severe intermittent claudication or critical limb ischemia (CLI) were enrolled in the study. All lesions were treated with SIA and provisional stenting. Primary end points were technical success, patient survival, limb salvage, lesion primary patency, angiographic binary restenosis (>50%), and target lesion revascularization (TLR). Regular clinical and angiographic follow-up was set at 6 and 12 months and yearly thereafter. Study end points were calculated with life-table survival analysis. Proportional-hazards regression analysis with a Cox-model was applied to adjust for confounding factors of heterogeneity.
Between May 2004 and July 2009, 98 patients (105 limbs, patient age 69.3±9.9 years) were included in the study. Technical success rate was 91.4% with a lesion length of 121±77 mm. Limb-salvage and survival rates were 88.7% and 84.1% at 3 years, respectively. After 12, 24, and 36 months, primary patency was 80.1%, 42.3%, and 29.0%, angiographic binary restenosis was 37.2%, 68.6%, and 80.0%, and TLR was 84.8%, 73.0%, and 64.5%, respectively. CLI was the only adverse predictor for decreased primary patency (hazard ratio [HR] 0.36; 95% confidence interval [CI] 0.16-0.80, p=0.012), whereas significantly less restenosis was detected after spot stenting of the entry and/or re-entry site (HR 0.31; 95% CI 0.10-0.89, p=0.01 and HR 0.20; 95% CI 0.07-0.56, p=0.002, respectively).
Subintimal angioplasty is a safe and effective revascularization technique for the treatment of CTOs of the femoropopliteal artery. Provisional stenting may have a role at the subintimal entry or true lumen re-entry site.
CardioVascular and Interventional Radiology 08/2011; 35(3):483-90. · 2.09 Impact Factor
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ABSTRACT: To present a large single-center retrospective study investigating the safety and efficacy of the StarClose extravascular closure device in achieving hemostasis after antegrade or retrograde femoral artery catheterization during peripheral angioplasty procedures.
Between January 2004 and October 2009, 1213 StarClose devices were implanted in 850 consecutive patients (598 men; mean age 65.8 ± 12.2 years) who underwent peripheral endovascular procedures. Femoral artery punctures included 625 (51.5%) retrograde and 588 (48.5%) antegrade accesses. The primary endpoints were hemostasis success, device failure, and major and minor complication rates up to 30 days.
A 6-F vascular sheath was used in the majority of cases [39 (3.2%) 7-F and 9 (0.7%) 8-F]. The device was applied more than once in the same femoral artery of 124 (10.2%) limbs during different angioplasty sessions. Overall hemostasis success was achieved in 1139 (93.9%) cases. In 237 (20.8%) of those, additional manual compression for <5 minutes was necessary due to immediate vessel oozing. The remaining 74 (6.1%) cases required prolonged standard manual compression because of hemostasis failure, including 13 (1.1%) failures to deliver the clip. Overall major and minor complication rates were 0.3% (4/1213) and 5.3% (64/1213), respectively.
The StarClose vascular closure device is safe and effective in achieving hemostasis during antegrade and retrograde peripheral angioplasty procedures.
Journal of Endovascular Therapy 06/2011; 18(3):435-43. · 2.86 Impact Factor
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Journal of Endovascular Therapy 02/2011; 18(1):43-5. · 2.86 Impact Factor
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ABSTRACT: To report the long-term outcomes of a single-center prospective study investigating primary placement of everolimus-eluting metal stents for recanalization of long infrapopliteal lesions compared to a matched historical control group treated with plain balloon angioplasty and provisional placement of bare metal stents in a bailout manner.
The study included 81 patients (63 men; mean age 71 years, range 45-85) suffering from critical limb ischemia (CLI) and angiographically proven long-segment (at least 1 lesion >4.5 cm) de novo infrapopliteal artery disease who underwent below-the-knee revascularization with either primary placement of everolimus-eluting stents (n = 47, 51 limbs, 102 lesions) or angioplasty and bailout bare metal stenting (n = 34, 36 limbs, 72 lesions). Clinical and angiographic follow-up was collected at regular time intervals. Primary clinical and angiographic endpoints included patient survival, major amputation-free survival, angiographic primary patency, angiographic binary restenosis (>50%), and overall event-free survival. Results were stratified according to endovascular treatment received. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity.
Baseline demographics were well matched. No significant differences were identified between the 2 groups with regard to overall 3-year patient survival (82.2% versus 65.7%; p = 0.90) and amputation-free survival (77.1% versus 86.9%; p = 0.20). Up to 3 years, lesions fully covered with everolimus-eluting stents were associated with significantly higher primary patency [hazard ratio (HR) 7.98, 95% CI 3.69 to 17.25, p < 0.0001], reduced binary restenosis (HR 2.94, 95% CI 1.74 to 4.99, p < 0.0001), and improved overall event-free survival (HR 2.19, 95% CI 1.16 to 4.13, p = 0.015) versus the matched historical control group.
Primary infrapopliteal everolimus-eluting stenting for CLI treatment significantly inhibits restenosis and improves long-term angiographic patency and overall patient event-free survival compared to balloon angioplasty and bailout bare metal stenting.
Journal of Endovascular Therapy 02/2011; 18(1):1-12. · 2.86 Impact Factor
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ABSTRACT: Optical coherence tomography (OCT) is a catheter-based imaging method that employs near-infrared light to produce high-resolution intravascular images. The authors report the safety and feasibility and illustrate common imaging findings of frequency-domain OCT (FD-OCT) imaging of the femoropopliteal artery in a series of 20 patients who underwent infrainguinal angioplasty.
After crossing the lesion of interest, OCT was performed with a dextrose saline flush technique with simultaneous obstructive manual groin compression. An automatic pullback FD-OCT device was employed (each scan acquiring 54 mm of vessel lumen in 271 consecutive frames). OCT images were acquired before and after balloon dilatation and following provisional stenting if necessary and were evaluated for baseline characteristics of plaque or in-stent restenosis (ISR), vessel wall trauma after angioplasty, presence of thrombus, stent apposition, and tissue prolapse. Imaging follow-up was not included in this study's protocol.
Twenty-seven obstructive lesions (18 cases of de novo atherosclerosis and 9 of ISR) of the femoropopliteal artery were imaged and 148 acquisitions were analyzed in total. High-resolution intravascular OCT imaging with effective blood clearance was achieved in 93.9%. Failure was mainly attributed to preocclusive proximal lesions and/or collateral flow. Mixed features of lipid pool areas, calcium deposits, necrotic core, and fibrosis were identified in all of the imaged atherosclerotic lesions, whereas ISR was purely fibrotic. After balloon angioplasty, OCT identified extensive intimal tears in all cases and one case of severe dissection that biplane subtraction angiography failed to identify.
Infrainguinal frequency-domain optical coherence tomography is safe and feasible and may provide intravascular high-resolution imaging of the femoropopliteal artery during infrainguinal angioplasty procedures.
CardioVascular and Interventional Radiology 12/2010; 34(6):1172-81. · 2.09 Impact Factor
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ABSTRACT: The purpose of this study was to investigate the immediate and long-term results of cryoplasty versus conventional balloon angioplasty in the femoropopliteal artery of diabetic patients. Fifty diabetic patients (41 men, mean age 68 years) were randomized to cryoplasty (group CRYO; 24 patients with 31 lesions) or conventional balloon angioplasty (group COBA; 26 patients with 34 lesions) of the femoropopliteal artery. Technical success was defined as <30% residual stenosis without any adjunctive stenting. Primary end points included technical success, primary patency, binary in-lesion restenosis (>50%), and freedom from target lesion recanalization. Cox proportional hazards regression analysis was performed to adjust for confounding factors of heterogeneity. In total, 61.3% (19 of 31) in group CRYO and 52.9% (18 of 34) in group COBA were de novo lesions. More than 70% of the lesions were Transatlantic Inter-Society Consensus (TASC) B and C in both groups, and 41.4% of the patients in group CRYO and 38.7% in group COBA suffered from critical limb ischemia. Immediate technical success rate was 58.0% in group CRYO versus 64.0% in group COBA (p = 0.29). According to 3-year Kaplan-Meier estimates, there were no significant differences with regard to patient survival (86.8% in group CRYO vs. 87.0% in group COBA, p = 0.54) and limb salvage (95.8 vs. 92.1% in groups CRYO and COBA, respectively, p = 0.60). There was a nonsignificant trend of increased binary restenosis in group CRYO (hazard ratio [HR] 1.3; 95% CI 0.6-2.6, p = 0.45). Primary patency was significantly lower in group CRYO compared with group COBA (HR 2.2; 95% CI 1.1-4.3, p = 0.02). Significantly more repeat intervention events because of recurrent symptoms were required in group CRYO (HR 2.5; 95% CI 1.2-5.3, p = 0.01). Cryoplasty was associated with lower primary patency and more clinically driven repeat procedures after long-term follow-up compared with conventional balloon angioplasty.
CardioVascular and Interventional Radiology 10/2010; 33(5):929-38. · 2.09 Impact Factor
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Journal of Endovascular Therapy 08/2010; 17(4):488-91. · 2.86 Impact Factor
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ABSTRACT: To present the 3-year angiographic and clinical results of a prospective registry investigating the performance of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs) for critical limb ischemia (CLI) treatment.
A single-center double-arm prospective registry included patients with CLI who underwent infrapopliteal revascularization with angioplasty and "bailout" use of an SES or BMS. Clinical and angiographic follow-up was scheduled at regular time intervals. Primary clinical and angiographic endpoints included mortality, limb salvage, primary patency, binary angiographic restenosis (ie, >50%), and clinically driven repeat intervention-free survival. Results were stratified according to stent type, and cumulative proportion outcomes were determined by Kaplan-Meier plots. Multivariable Cox proportional-hazards regression analysis was applied to adjust for confounding factors of heterogeneity.
In total, 103 patients were included in the analysis; 41 (75.6% with diabetes) were treated with a BMS (47 limbs; 77 lesions) and 62 (87.1% with diabetes) with an SES (75 limbs; 153 lesions). At 3 years, SES-treated lesions were associated with significantly better primary patency (hazard ratio [HR], 4.81; 95% CI, 2.91-7.94; P < .001), reduced binary restenosis (HR, 0.38; 95% CI, 0.25-0.58; P < .001), and better repeat intervention-free survival (HR, 2.56; 95% CI, 1.30-5.00; P = .006) versus BMS-treated ones. No significant differences were identified between SESs and BMSs with regard to overall 3-year patient mortality (29.3% vs 32.0%; P = .205) and limb salvage (80.3% vs 82.0%; P = .507).
Infrapopliteal application of SESs for CLI significantly improves angiographic long-term patency and reduces infrapopliteal vascular restenosis versus BMSs, thereby lessening the rate of clinically driven repeat interventions.
Journal of vascular and interventional radiology: JVIR 08/2009; 20(9):1141-50. · 1.81 Impact Factor
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ABSTRACT: To investigate the incidence, anatomical location, and clinical impact of fractures and/or compression of infrapopliteal balloon-expandable metal stents implanted for critical limb ischemia (CLI) treatment.
This prospective study included 63 CLI patients (45 men; mean age 71.3+/-9.5 years) who had been treated with infrapopliteal angioplasty and stent placement for 191 lesions in 84 limbs. In all, 369 stents (296 stainless steel and 73 cobalt-chromium alloy) were implanted; 239 were placed overlapping in tandem lesions. Mean length of the overall stented segment was 4.4+/-6.3 cm (range 1.6-14.0). Stents were located in the tibioperoneal (n = 34), anterior tibial (n = 195), posterior tibial (n = 63), and peroneal (n = 77) arteries. Follow-up consisted of digital subtraction angiography and infrapopliteal radiography imaging at 2 different angles. Evaluation of stents for the presence of fracture and/or compression was done after digital processing at the highest possible magnification. Stent fractures were defined according to published standards, whereas compression was classified as severe shape alteration and/or collapse of the stent mesh. Angiographic restenosis was based on a 50% threshold.
Mean follow-up was 15+/-11 months (range 6-60). Image analysis detected 1 (0.3%) severe stent fracture (complete separation and misalignment of stent struts) and 11 (3.0%) stent compressions. Infrapopliteal stent fracture and compressions were associated with increased artery restenosis [100% (12/12) versus 47.3% (169/357), p<0.001] and an increased rate of clinical deterioration and clinically-driven reinterventions [41.7% (5/12 limbs) versus 19.4% (14/72 limbs), p = 0.04]. The single fracture and most of the compressions were located in the distal third of the anterior tibial artery.
Stent fractures and compressions of infrapopliteal balloon-expandable metal stents are infrequent. However, they may be related to increased restenosis.
Journal of Endovascular Therapy 02/2009; 16(1):15-22. · 2.86 Impact Factor
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ABSTRACT: Minimally invasive infrapopliteal angioplasty procedures are becoming the gold standard for treatment of below-the-knee arterial disease. To date, sirolimus-eluting stents have shown significant promise in inhibiting restenosis of the infrapopliteal arteries and thereby reducing recurrent leg ischemia and repeat revascularization procedures. Longer self-expanding bare stents are available to better suit the diffuse nature of atherosclerosis usually associated with critical limb ischemia. Bioabsorbable stents for transient vessel scaffolding are an elegant endovascular concept, but positive data below the knee are still lacking. It remains to be answered whether bare or drug-eluting, balloon-expandable or self-expanding, or metal versus bioabsorbable stents will have a positive impact on limb salvage to support their primary use in below-the-knee endovascular treatment.
Journal of Endovascular Therapy 02/2009; 16 Suppl 1:I153-62. · 2.86 Impact Factor
