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Introduction: There has been a marked paradigm shift in the treatment of symptomatic femoro-popliteal disease with a shift from open to endoluminal therapy. The consequence of this shift in therapy is poorly described. The aim of this study is to examine the clinical efficacy of this shift in treatment strategies.
Methods: A database of patients undergoing open (OPEN) and endoluminal (ENDO) intervention for TASC II C and D femoro-popliteal lesions between 1990 and 2010 was retrospectively queried. Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Factor analyses were performed using a Cox proportional hazard model for time dependent variables.
Results: 2593 limbs underwent either OPEN or ENDO treatment for symptomatic and anatomically advanced femoro-popliteal disease over the 20 year period (Table). There was a 2-fold rise in endovascular interventions between the first and second decade. In the first decade, 80% of the interventions were OPEN while in the second decade, 61% of the interventions were ENDO. There were equivalent co-morbidities in both groups and survival was also equivalent. Endoluminal therapy was more commonly performed on claudicants (Table). 30-day mortality was equivalent but major morbidity was higher in OPEN compared to ENDO. Cumulative patency was equivalent in both groups with a similar re-intervention rate. In contrast, clinical efficacy (freedom from recurrent symptoms, maintenance of ambulation and avoidance of major amputation) was significantly higher in the OPEN group. The presence of critical limb ischemia, diabetes, ESRD and poor tibial runoff were predictors of poor anatomic and functional outcomes in both groups.

TABLE 1	OPEN	ENDO	P-value
Number Limbs at Risk (n)	1416	1177	-
Male Gender (%)	58%	64%	0.05
Age	67+17	67+14	ns
Claudication (%)	50%	64%	0.05
Rest Pain / Tissue Loss (%)	50%	36%
30-day Mortality (%)	2%	1.5%	ns
All Cause 30-day Morbidity (%)	8%	3%	0.01
Re-intervention rate	27%	22%	ns
5-yr Clinical Efficacy (%)	91±3	68±4	0.01
5-yr Cumulative Patency (%)	72±7	74±5	ns

Conclusions: There has been a marked shift in treatment modality for advanced femoro-popliteal disease with a lowering of the symptomatic threshold for intervention over two decades likely spurred by the ease of ENDO. Although, peri-procedural and anatomic outcomes for both procedures are equivalent, it appears that open surgery continues to carry a superior long-term clinical efficacy.