TCT-561 Long-term Outcome with Jetstream Atherectomy with or without Drug Coated Balloons in Treating denovo Femoropopliteal Arteries

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017

B232

Estimated regression coefficients Regression coefficient Characteristic

Estimate

Odds Ratio (95% CI)

Transfemoral access

0.505

1.66 (1.23 – 2.24)

p-value 0.001

RBBB

1.453

4.28 (2.87-6.38)

<0.001

LBBB without

1.068

2.91 (1.93-4.40)

<0.001

1.711

5.53 (4.27-7.18)

<0.001

bradycardia Bradycardia without LBBB LBBB and bradycardia

2.086

8.05 (5.14-12.60)

<0.001

2nd degree AV block

2.365

10.65 (5.80-19.53)

<0.001

CONCLUSION This PPM risk prediction model derived using NIS database is a simple tool that can estimate individual risk of PPM prior to TAVR procedure. The model displayed very good discrimination indices. CATEGORIES STRUCTURAL: Valvular Disease: Aortic

PERIPHERAL VASCULAR DISEASE AND INTERVENTIONS: DRUG-COATED BALLOONS

Abstract nos: 560 - 563 TCT-560 Paclitaxel-Eluting Balloon versus conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery. The ISAR-PEBIS randomized trial Theresa Wittmann,1 Salvatore Cassese,2 Philipp Groha,3 Birgit Steppich,3 Felix Voll,3 Martin Hadamitzky,3 Tareq Ibrahim,4 Sebastian Kufner,2 Karl Dewitz,3 Markus Kasel,3 Karl-Ludwig Laugwitz,5 Heribert Schunkert,3 Adnan Kastrati,3 Massimiliano Fusaro,2 Ilka Ott2 1 Schön Klinik München Schwabing, Munich, Germany; 2Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 3Deutsches Herzzentrum München, Munich, Germany; 4 Klinikum Rechts der Isar, Munich, Germany; 5Klinikum rechts der Isar TUM, Munich, Germany

TCT-561 Long-term Outcome with Jetstream Atherectomy with or without Drug Coated Balloons in Treating denovo Femoropopliteal Arteries Nicolas W. Shammas,1 Gail Shammas,1 Sue Jones-Miller,1 Bassel Bou Dargham,1 Andrew Shammas,2 Subhash Banerjee,3 Rayan Jo Rachwan,1 Ghassan Daher,1 W John Shammas1 1 Midwest Cardiovascular Research Foundation, Davenport, Iowa, United States; 2Midwest Cardiovascular Research Foundation, Bettendorf, Iowa, United States; 3UT Southwestern Medical Center/ VA North Texas Health Care System, Dallas, Texas, United States BACKGROUND 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 18-month target lesion revascularization (TLR) rates on patients treated for denovo femoropopliteal (FP) artery disease with JA in a single center by one operator. METHODS From 1/1/12 to 8/24/16 311 procedures were performed with atherectomy by a single operator at a single center. 77 procedures were excluded because they were performed with a non JA device or were infra-popliteal. The remaining procedures (n¼234) were performed in 81 patients (81 JA at index, 153 atherectomy procedures on follow-up). Of the 81 JA at index, adjunctive balloon angioplasty (PTA) was performed on 26 denovo lesions and adjunctive DCB on 23 denovo lesions (LUTONIXÒ 22, IN.PACTÒ 1). This report evaluates the 18-month outcome of the 49 patients with denovo disease. The primary endpoint of the study was clinically driven target lesion revascularization (TLR). Survival analysis for TLR over time was plotted. RESULTS There was no difference in the mean treated length between the adjunctive PTA (14.9  9.3 cm) and DCB (12.0  6.6 cm) groups (p¼0.1). The TLR rate was significantly reduced with atherectomy and adjunctive DCB compared to atherectomy with adjunctive PTA at 18 months (proportional rates: 94% vs 50% respectively; p¼0.0006). (figure)

BACKGROUND Paclitaxel-eluting balloon (PEB) angioplasty has superior efficacy as compared to conventional balloon angioplasty (BA) for de novo lesions of superficial femoral artery (SFA). Studies investigating the angiographic and clinical performance of PEB versus BA for in-stent restenosis (ISR) of SFA are limited. We performed a randomized trial to investigate angiographic and clinical performance of PEB versus BA for ISR of SFA. METHODS Patients with symptomatic ISR of SFA were randomly assigned to either PEB or BA at two centres in Munich, Germany. The primary endpoint was the percentage diameter stenosis (DS) at 6- to 8month follow-up angiography. Secondary endpoints were: the rate of binary restenosis at follow-up angiography, and target lesion revascularization (TLR), target vessel thrombosis, ipsilateral amputation, by-pass surgery of the affected limb and all-cause mortality at 24month follow-up. RESULTS A number of 70 patients were assigned to PEB (n¼36) or BA (n¼34). Overall, mean lesion length was 13967 mm and roughly one third of lesions were completely occluded at the time of index procedure. At control angiography the percentage DS (4433% versus 6533%, P¼0.01) and binary restenosis were significantly reduced with PEB versus BA (30% versus 59%, P¼0.03). At 24-month followup, PEB was associated with a significant reduction of TLR in comparison to BA (19% versus 50%, P¼0.007). There was no difference with respect to other outcomes of interest. CONCLUSION In patients with ISR of SFA, a percutaneous therapy with PEB as compared to BA has superior angiographic performance at 6-8 months and improved clinical efficacy up to 24-month follow-up. CATEGORIES ENDOVASCULAR: Peripheral Vascular Disease and Intervention

CONCLUSION In a single center cohort of JA reflecting real-world practice, JA with DCB had a superior TLR rate at 18 months follow-up when compared to JA with PTA in treating denovo femoropopliteal disease. CATEGORIES CORONARY: Drug-Eluting Balloons and Local Drug Delivery TCT-562 24 months outcomes of PACUS Trial: Randomized clinical trial to compare ultrasound enhanced delivery of Paclitaxel and DEB in patients with critical limb ischemia and femoral/popliteal disease Costantino Del Giudice,1 Roberto Gandini2 Universitè Paris Descartes, Paris, France; 2Policlinico Universitario di Tor Vergata, Rome, Rome, Italy 1