Midterm outcomes from the TALON Registry: treating peripherals with SilverHawk: outcomes collection.
OBJECTIVE
To determine midterm clinical outcomes among patients with lower extremity peripheral arterial disease who underwent revascularization with catheter-based plaque excision (PE).


METHODS
Between August 2003 and February 2005, 19 institutions participating in the observational, nonrandomized, multicenter TALON registry enrolled 601 consecutive patients (353 men; mean age 70+/-11, range 36-98) with 1258 symptomatic lower extremity atherosclerotic lesions (748 limbs) treated by plaque excision with the SilverHawk catheter. Approximately 50% of the patients had diabetes, and nearly one third of the procedures were indicated for Rutherford ischemia category > or =4. Mean lesion lengths above and below the knee, respectively, were 62.5+/-68.5 mm (interquartile range [IQR], 20.0-80.0) and 33.4+/-42.7 mm (IQR 15.0-37.5). The primary endpoints of the study were target lesion revascularization (TLR) at 6 and 12 months.


RESULTS
The device achieved < or =50% residual diameter stenosis in 94.7% of lesions; procedural success was 97.6%. Nearly half (41.9%) of the procedures involved PE of > or =2 lesions. Nearly three quarters (73.3%) of the lesions did not require adjunctive therapy, and stent placement following PE occurred in only 6.3% of lesions. The 6- and 12-month rates of survival free of TLR were 90% and 80%, respectively. Rates of TLR were similar among patients with diabetes (11%) and without diabetes (9%). In the multivariate analysis, significant predictors of TLR at 6 months were a history of MI or coronary revascularization (HR 5.49, 95% CI 1.87 to 16.10, p=0.0008), multiple (> or =2) lesions (HR 1.37, 95% CI 1.11 to 1.70, p=0.0019), and increasing Rutherford category (HR 1.84, 95% CI 1.28 to 2.65, p=0.0003). Lesion length >50 mm was associated with a 2.9-fold increased risk for TLR (HR 2.88, 95% CI 1.18 to 7.01, p=0.012); lesion length >100 mm was associated with a 3.3-fold increase in TLR (HR 3.32, 95% CI 1.15 to 9.56, p=0.016).


CONCLUSIONS
In patients undergoing revascularization for lower extremity atherosclerotic disease, catheter-based PE achieves favorable procedural success and avoids the need for repeat revascularization at midterm follow-up. These findings support PE as a primary endovascular therapy for patients undergoing lower extremity arterial revascularization.
Ramaiah
Venkatesh
V
Arizona Heart Hospital, Phoenix, USA.
Gammon
Roger
R
Kiesz
Stefan
S
Cardenas
Joseph
J
Runyon
John Paul
JP
Fail
Peter
P
Walker
Craig
C
Allie
David E
DE
Chamberlin
Jack
J
Solis
Maurice
M
Garcia
Lawrence
L
Kandzari
David
D
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D002406:Catheterization, Peripheral / Q000295:instrumentation; D018572:Disease-Free Survival; D005260:Female; D005263:Femoral Artery / Q000473:pathology / Q000601:surgery; D005500:Follow-Up Studies; D006801:Humans; D007083:Iliac Artery / Q000473:pathology / Q000601:surgery; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016491:Peripheral Vascular Diseases / Q000628:therapy*; D011150:Popliteal Artery / Q000473:pathology / Q000601:surgery; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012042:Registries; D012086:Reoperation; D012107:Research Design; D016909:Tibial Arteries / Q000473:pathology / Q000601:surgery; D013997:Time Factors; D016896:Treatment Outcome