PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study.
OBJECTIVE
To evaluate if stent placement is superior to percutaneous transluminal angioplasty (PTA) in the treatment of chronic symptoms in short femoropopliteal arterial lesions.


METHODS
One hundred fifty-four limbs in 141 patients who ranged in age from 39 to 87 years (mean age, 67 years) were randomized to PTA (n = 77) versus PTA followed by implantation of Palmaz stents (n = 77). Inclusion criteria were patients with intermittent claudication (n = 108, Society of Vascular Surgery/International Society of Cardiovascular Surgery [SVS-ISCVS] categories 1-3) or chronic critical limb ischemia (n = 46 with either ischemic rest pain [category 4] or minor tissue loss [category 5]), short stenosis or occlusion (lesion length < or = 5 cm), and at least one patent run-off vessel at angiography. Follow-up included clinical assessment, measurement of ankle/ brachial index (ABI), color duplex ultrasound, and/or angiography at 6 or 12 months. Angiographic follow-up between 12 and 36 months was available in 46 limbs (29.9%).


RESULTS
In the PTA group, initial technical success was achieved in 65 of 77 limbs (84%) versus 76 of 77 (99%) limbs in the stent group (chi2 value = 0.009). Overall, major complications occurred in 3.9% (n = 6); n = 4 in the PTA group compared to n = 2 in the stent group. There was no difference between groups of treatment: hemodynamic/clinical success at 1 and 2 years in the PTA group was 72% and 65% versus 77% and 65% in the stent group (Gehan P value = .26). The cumulative 1- and 2-year angiographic primary patency rates were 63% and 53%, respectively, for both groups. The secondary 1- and 2-year angiographic patency rates were 86% and 74% in the PTA group versus 79% and 73% in the stent group (P = .5).


CONCLUSIONS
After stent placement, the primary success rate was significantly higher than after PTA. However, 1-year angiographic and clinical/hemodynamic success was not improved.
Cejna
M
M
Department of Angiography and Interventional Radiology, University Clinics of Vienna, Austria.
Thurnher
S
S
Illiasch
H
H
Horvath
W
W
Waldenberger
P
P
Hornik
K
K
Lammer
J
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000628:therapy*; D007511:Ischemia / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery; D011183:Postoperative Complications; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome