Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: Three-Year Results of the DEBATE-ISR Study.
OBJECTIVE
To report the 3-year safety and effectiveness outcomes from the prospective all-comers DEBATE-ISR study (ClinicalTrials.gov identifier NCT01558531) of symptomatic diabetic patients with femoropopliteal in-stent restenosis (ISR) undergoing treatment with paclitaxel-eluting balloons compared with historical diabetic controls.


METHODS
From January 2010 to December 2011, 44 consecutive diabetic patients (mean age 74±11 years; 32 men) were treated with drug-eluting balloons (DEBs) and enrolled in the study. The control group comprised 42 consecutive diabetic patients (age 76±7 years; 23 men) treated with conventional balloon angioplasty (BA) from 2008 to 2009.


RESULTS
No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Critical limb ischemia was present in the majority of patients. Tosaka class III ISR was observed in more than half of the patients. Mean lesion length was 132±86 and 137±82 mm in the DEB and BA groups, respectively (p=0.7). At 3-year follow-up, the rate of target lesion revascularization (TLR) was 40% in the DEB group vs 43% in the BA group (p=0.8); Kaplan-Meier analysis showed no significant differences in terms of freedom from TLR. The presence of a Tosaka class III occlusion was associated with a worse outcome in both study groups (odds ratio 3.96, 95% confidence interval 1.55 to 10.1, p=0.004).


CONCLUSIONS
Using DEBs for femoropopliteal ISR yielded similar results to BA in terms of TLR at 3-year follow-up. The treatment of more complex ISR lesions was associated with an increased rate of TLR, irrespective of the technology used.
Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
Simone
S
Grotti
Cardiovascular Department, San Donato Hospital, Arezzo, Italy francescoliistro@hotmail.com.
Francesco
F
Liistro
Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
Paolo
P
Angioli
Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
Kenneth
K
Ducci
Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
Giovanni
G
Falsini
Cardiovascular Department, San Donato Hospital, Arezzo, Italy Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy.
Italo
I
Porto
Diabetes Unit, San Donato Hospital, Arezzo, Italy.
Lucia
L
Ricci
Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
Giorgio
G
Ventoruzzo
Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
Filippo
F
Turini
Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
Guido
G
Bellandi
Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
Leonardo
L
Bolognese
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D003251:Constriction, Pathologic; D016638:Critical Illness; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D065386:Historically Controlled Study; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D019233:Retreatment; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
D002317:Cardiovascular Agents; D017239:Paclitaxel
diabetes; drug-coated balloon; femoropopliteal segment; in-stent restenosis; paclitaxel-eluting balloon; peripheral artery disease; popliteal artery; restenosis; stent; superficial femoral artery; target lesion revascularization