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.

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. 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. The overall procedural success was 90%. Eight periprocedural complications occurred without any difference between the two groups (Turbo-Power™ + 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™ + 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™ + 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™ + DCB group vs 58.9% in the LA + BA group (p = .070). 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.

Giannopoulos S ，Kokkinidis DG ，Jawaid O ，Behan S ，Hossain P ，Alvandi B ，Foley TR ，Singh GD ，Waldo SW ，Armstrong EJ ... -  《-》

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

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. 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. 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. 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.

Kokkinidis DG ，Behan S ，Jawaid O ，Hossain P ，Giannopoulos S ，Singh GD ，Laird JR ，Valle JA ，Waldo SW ，Armstrong EJ ... -  《-》

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

Kokkinidis DG ，Hossain P ，Jawaid O ，Alvandi B ，Foley TR ，Singh GD ，Waldo SW ，Laird JR ，Armstrong EJ ... -  《-》

Network Meta-Analysis of All Available Regimens Based on Drug-Coated Balloon Angioplasty and Laser Atherectomy for Femoropopliteal In-Stent Restenosis.

Yu C ，Tang W ，Ren T ，Chen Q ，Lu R ，Gao Y ... -  《-》

Long-term outcomes with Jetstream atherectomy with or without drug coated balloons in treating femoropopliteal arteries: A single center experience (JET-SCE).

The long-term outcome of Jetstream atherectomy (JA) with or without adjunctive drug coated balloons (DCB) in a real-world setting remains unknown. We report 16-month target lesion revascularization (TLR) rates on patients treated for femoropopliteal (FP) artery disease with JA in a single center by one operator. From 1/1/12 to 8/24/16 a total of 311 procedures were performed with atherectomy by a single operator at a single center. Of these procedures, 75 met inclusion and exclusion criteria. This report evaluates the outcomes of these 75 patients treated at index and who were followed up to 16 months. The primary endpoint of the study was clinically driven TLR. Patients were stratified by the use of DCB (vs angioplasty (PTA)) post-JA. TLR was calculated by excluding bailout stenting as TLR. Survival analysis for TLR over time was plotted. 75 patients (49.3% male, mean age 68.0 years, 54.7% diabetes) with de novo or restenotic FP lesions whose symptoms were classified as Rutherford category I-V were enrolled. Adjunctive PTA was performed on 50 patients (26 de novo, 13 in-stent restenosis, 3 non-stent restenosis, 8 mixed lesions) and adjunctive DCB (LUTONIX® 24, IN.PACT® 1) on 25 patients (21 de novo, 1 in-stent restenosis, 2 non-stent restenosis, 1 mixed lesion) (p = 0.0249). There was no difference in the median treated length between the adjunctive PTA (15 cm) and DCB (10 cm) groups (p = 0.0530). The estimated freedom from TLR (fTLR) was significantly higher with atherectomy and adjunctive DCB compared to atherectomy with adjunctive PTA at 12 months (94.7% vs 68.0%, p = 0.002) and 16 months (94.4% vs 54%; p = 0.002). In a single center cohort of JA reflecting real-world practice, JA with DCB had a superior TLR rate up to 16-month follow-up when compared to JA with PTA in treating all comers FP arterial disease.

Shammas NW ，Shammas GA ，Jones-Miller S ，Shammas WJ ，Bou-Dargham B ，Shammas AN ，Banerjee S ，Rachwan RJ ，Daher GE ... -  《-》