Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial.

Rastan, Aljoscha; Krankenberg, Hans; Baumgartner, Iris; Blessing, Erwin; Müller-Hülsbeck, Stefan; Pilger, Ernst; Scheinert, Dierk; Lammer, Johannes; Beschorner, Ulrich; Noory, Elias; Neumann, Franz-Josef; Zeller, Thomas (2015). Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial. Journal of endovascular therapy, 22(1), pp. 22-27. International Society of Endovascular Specialists 10.1177/1526602814564386

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PURPOSE To investigate the 2-year technical and clinical results of primary nitinol stent placement in comparison with percutaneous transluminal angioplasty (PTA) in the treatment of de novo lesions of the popliteal artery. METHODS The ETAP study (Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions: balloon angioplasty vs. primary stenting; identifier NCT00712309) is a prospective, randomized trial that enrolled 246 patients (158 men; mean age 72 years) who were randomly assigned to receive a nitinol stent (n=119) or PTA (n=127) for lesions averaging 42.3 mm in length. The results of the primary study endpoint were published. Secondary outcome measures and endpoints included primary patency (freedom from duplex-detected target lesion restenosis), target lesion revascularization (TLR), secondary patency, changes in ankle-brachial index and Rutherford class, and event-free survival (freedom from target limb amputation, TLR, myocardial infarction, and death). RESULTS In total, 183 patients (89 stent and 94 PTA) were available for the 2-year analysis. The primary patency rate was significantly higher in the stent group (64.2%) than in the PTA group (31.3%, p=0.0001). TLR rates were 22.4% and 59.5%, respectively (p=0.0001). When provisional stent placement in the PTA arm was not considered as TLR and loss in patency, the differences prevailed between the study groups but were not significant (64.2% vs. 56.1% for primary patency, respectively; p=0.44). A significant improvement in ABI and Rutherford category was observed at 2 years in both groups. CONCLUSION In treatment of obstructive popliteal artery lesions, provisional stenting reveals equivalent patency in comparison to primary stenting. However, the 2-year results of this trial suggest the possibility of a shift toward higher patency rates in favor of primary stenting.

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Angiology

UniBE Contributor:

Baumgartner, Iris


600 Technology > 610 Medicine & health




International Society of Endovascular Specialists




Catherine Gut

Date Deposited:

03 Jul 2015 11:03

Last Modified:

03 Jul 2015 11:03

Publisher DOI:


PubMed ID:


Uncontrolled Keywords:

balloon angioplasty; occlusion; peripheral artery disease; popliteal artery; randomized trial; restenosis; stenosis; stent


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