Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-Year outcomes.

BACKGROUND: Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in-stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2-year outcomes. METHODS: This was a dual-center retrospective cohort study that compared patients with FP-ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2-year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. RESULTS: One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty-six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p < .0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p < .001) and cutting balloons (61% vs. 6%, p < .001). Bail-out stenting rates were lower in the LA + DCB group (32% vs. 57%, p = .008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34-0.9, p = .027) for the composite outcome of 2-year TLR or restenosis. The 12-month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24-month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. CONCLUSIONS: The combination of DCB + LA was associated with decreased rates of bail-out stenting and improved 2-year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP-ISR are needed.

Turbo-Power™ Laser Atherectomy Combined with Drug-coated Balloon Angioplasty is Associated with Improved One-Year Outcomes for the Treatment of Tosaka II and III Femoropopliteal In-stent Restenosis.

BACKGROUND: Femoropopliteal (FP) artery in-stent restenosis (ISR) is associated with high rates of re-intervention and occlusion. The combined use of laser atherectomy (LA) with balloon angioplasty (BA) is superior to conventional balloon angioplasty (BA). Drug-coated balloons (DCBs) when combined with LA have provided additional efficacy for the treatment of FP-ISR. The aim of this study was to investigate the combination of DCB + LA with the recently approved Turbo-Power™ (Spectranetics Inc., Colorado Springs, CO, USA) LA device. METHODS: This was a dual-center retrospective study enrolling 78 consecutive patients with Tosaka type II (n = 18) or III (n = 60) FP-ISR. The lesions were treated with either Turbo-Power™ LA followed by DCB (n = 27) or with other LA devices followed by plain BA (LA + BA; n = 51) from 2015 to 2017. A Cox regression analysis was performed to examine the association between the two groups in terms of target lesion revascularization (TLR) and occlusion rates over a follow up period of 12 months. Kaplan-Meier survival curves were estimated and compared with the log-rank test. RESULTS: The overall procedural success was 90%. Eight periprocedural complications occurred without any difference between the two groups (Turbo-Power™â€¯+ DCB: 7.4% vs LA + BA: 11.8%, p = .7). The 12-month KM estimates for freedom from TLR were 90.9% in the Turbo-Power™â€¯+ DCB group vs 55.7% in the LA + BA group (p = .005). Among Toasaka III lesions, the 12 m-KM survival estimates for freedom from TLR were 88.9% in the Turbo-Power™â€¯+ DCB group vs 54.2% in the LA + BA group (p = .009). The 12 m-KM estimates for freedom from re-occlusion were 89.0% in the Turbo-Power™â€¯+ DCB group vs 58.9% in the LA + BA group (p = .070). CONCLUSIONS: Turbo-Power™ laser atherectomy combined with DCB exerted synergistic mechanism of actions and improved 12-month TLR rates for the treatment of complex FP-ISR lesions.

How To Assess a Claudication and When To Intervene.

PURPOSE OF THE REVIEW: Peripheral artery disease (PAD) affects close to 200 million people worldwide. Claudication is the most common presenting symptom for patients with PAD. This review summarizes the current diagnostic and treatment options for patients with claudication. Comprehensive history and physical examination in order to differentiate between claudication secondary to vascular disease vs. neurogenic causes is paramount for initial diagnosis. Ankle-brachial index is the most commonly used test for screening and diagnostic purposes. Treatment consists of four different approaches, which are best utilized in combination: non-pharmacological treatment for claudication improvement, pharmacological treatment for claudication improvement, pharmacological treatment for secondary risk reduction, and interventional treatment for claudication improvement. RECENT FINDINGS: Cilostazol is the only Food and Drug Administration (FDA)-approved agent for symptomatic treatment of claudication. Supervised exercise programs provide the maximum benefit for claudication improvement, but home-based exercise programs are an alternative. High-intensity statins and an antiplatelet agent should be prescribed to all patients with PAD. Angiotensin-converting-enzyme inhibitors can provide additional risk reduction, especially in patients with diabetes or hypertension. Rivaroxaban of low dosage (2.5 mg twice daily) in combination with aspirin further decreases cardiovascular risk, but this reduction comes at the cost of higher bleeding risk. Peripheral artery disease (PAD) is a form of atherosclerotic disease that affects hundreds of millions of people worldwide-one of its most common manifestations is intermittent claudication (IC), which results from insufficient blood flow to meet the metabolic demands of an affected extremity. This paper reviews the current literature regarding the workup, diagnosis, diagnostic modalities, treatment options, and management of intermittent claudication.

Acute and Midterm Outcomes of Antegrade vs Retrograde Crossing Strategies for Endovascular Treatment of Iliac Artery Chronic Total Occlusions.

PURPOSE: To examine whether an antegrade or retrograde crossing strategy for treatment of iliac artery chronic total occlusions (CTOs) is associated with differences in procedural or midterm outcomes. MATERIALS AND METHODS: A dual-center retrospective cohort study was conducted in 168 patients (mean age 66.4±10.6 years; 116 men) treated for CTOs in 110 common iliac arteries (CIA), 52 external iliac arteries (EIA), and 26 combined CIA/EIAs. Logistic regression models were developed to determine the association between crossing strategy and procedural complications, 1- and 3-year target lesion revascularization (TLR), and major adverse limb events (MALE). Results are presented as the odds ratio (OR) and 95% confidence interval (CI). RESULTS: An initial antegrade strategy was more common for EIA CTOs (p<0.005), and an initial retrograde strategy was more often used in CIA (p<0.005) and combined CIA/EIA (p<0.005) CTOs. Crossover to an alternate approach was required in 27.6% of initial antegrade attempts and 9.6% of initial retrograde attempts. EIA CTOs were the most likely lesions to be treated successfully with the initial attempt (either strategy). In all, 123 (65.4%) lesions were successfully crossed with a final retrograde approach and 65 with a final antegrade approach. Overall target lesion success was high for both groups (95.1% vs 93.2%, p=0.456). Lesions treated with a final retrograde approach were shorter (75.3±34.9 vs 87.6±31.3 mm, p=0.005) and were more likely to be treated with a reentry device (34.2% vs 9.2%, p<0.001) and with balloon-expandable stents (39.2% vs 17.7%, p=0.005). The final antegrade approach was associated with a lower risk of target lesion complications (OR 0.07, 95% CI 0.01 to 0.81, p=0.034). The two crossing approaches were associated with similar estimates of 1- and 3-year TLR and MALE. CONCLUSION: A final antegrade approach was associated with lower rates for complications but the 2 approaches were similar in terms of lesion success, TLR, and MALE. The EIA CTOs were more likely to be treated with an antegrade approach and more likely to be crossed successfully with the initial approach irrespective of the crossing direction.

Long-term outcomes after re-entry device use for recanalization of common iliac artery chronic total occlusions.

OBJECTIVE: To examine the impact of re-entry device (RED) use on 1- and 5-year outcomes after endovascular treatment of common iliac artery (CIA) chronic total Occlusions (CTOs). BACKGROUND: There are not enough data regarding the long-term safety and efficacy of RED. METHODS: We performed a two-center retrospective study of 115 patients (140 lesions) undergoing CIA CTO endovascular intervention between 2006 and 2016. Baseline characteristics and long-term outcomes were described. A Cox proportional hazard model was developed to determine if REDs were associated with target lesion revascularization (TLR) or major adverse limb events (MALE) after 1 and 5 years. RESULTS: Among 140 lesions, 43 (31%) required use of a RED. The mean age was 63.9 years and the majority (n = 80) of patients were male. An antegrade crossing approach and treatment of restenotic lesions were less common in the RED group (10% vs. 29%, P < .05 and 0% vs. 21%, P < .05, respectively). There were no significant differences in Rutherford class, pre-procedure ABI, or patient presentation. The procedural complication rates were similar between the two groups. The 1- and 5-year TLR rates for lesions treated with re-entry device vs. standard approaches were 11% vs. 9%; P = 0.8 and 29% vs. 29%; P = 0.9 respectively. The 1 and 5-year MALE rates for lesions treated with re-entry device were 5% vs. 6%; P = 0.8 and 11% vs. 11%; P = 0.9 respectively. CONCLUSIONS: This retrospective analysis found that recanalization of CIA occlusions using a RED is safe and is associated with long-term clinical outcomes similar to that of standard crossing techniques.

Midterm Outcomes After Endovascular Intervention for Occluded vs Stenosed External Iliac Arteries.

PURPOSE: To evaluate the association between a chronic total occlusion (CTO) and long-term outcomes among patients undergoing endovascular intervention to the external iliac artery (EIA). METHODS: A 2-center retrospective study was conducted of 331 patients (mean age 64.7±12.7 years; 221 men) who underwent endovascular intervention for 481 EIA atherosclerotic lesions between 2006 and 2016. A quarter of the lesions (115, 23.9%) were CTOs. The majority of patients (184, 60.9%) were treated for claudication; 172 (38%) lesions were TransAtlantic Inter-Society Consensus type C or D. Target lesion revascularization (TLR) and major adverse limb event (MALE) rates were compared between lesions with or without an EIA CTO. A Cox proportional hazard model was subsequently developed to determine baseline variables associated with long-term outcomes after successful endovascular intervention of stented EIAs; outcomes are presented as the hazard ratio (HR) and 95% confidence interval (CI). RESULTS: The mean lesion length was longer (84 vs 50 mm, p<0.001) among patients treated for CTOs. While overall the target lesion failure rates were very low (2.8%), vessel perforation (2.7% vs 0.3%, p=0.02) and distal embolization (2.7% vs 0.9%, p=0.02) were more common in the CTO group. Among 377 successfully crossed and stented lesions (93 CTOs), the overall 1-year primary patency was 78% and secondary patency was 92%. One-year and 5-year TLR rates were 8.2% and 15.4%, respectively. CTO intervention was associated with higher 5-year TLR rates in the unadjusted analysis (HR 1.72, 95% CI 1.00 to 2.56, p=0.050), but the association did not remain significant after multivariable adjustment. CONCLUSION: Intervention to EIA CTOs is associated with increased intraprocedural complexity but with similar midterm outcomes, including high patency and low rates of TLR to 5 years.

Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis.

PURPOSE: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). METHODS: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. RESULTS: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). CONCLUSION: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.