LB-11
Revascularization Strategies in Patients with Peripheral Arterial Disease Involving the Femoropopliteal Arteries: A Pooled Analysis of Individual Patient Data
Presenter
Serdar Farhan, MD, Mount Sinai Hospital, New York, NY
Serdar Farhan, MD1, Birgit Vogel, MD1, Florian Enzmann2, Patrick Bjorkman3, Haroon Kamran, M.D., FSCAI4, Samantha Sartori, PhD5, Klaus Linni6, Maarit Venermo7, Daphne Van der Veen8, Herve Muossali6, Roxana Mehran, M.D., MSCAI9, Michel MPJ Reijnen8, Marc Bosiers10 and Prakash Krishnan, M.D.9, (1)Mount Sinai Hospital, New York, NY, (2)Department of Cardiac, Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria, Innsbruck, Austria, (3)Department of Vascular Surgery, Helsinki University Hospital, Helsinki, Finland, Helsinki, Finland, (4)NYU Grossman School of Medicine, Brooklyn, NY, (5)Icahn School of Medicine at Mount Sinai, New York City, NY, (6)Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria., Salzburg, Austria, (7)Department of Vascular Surgery, Helsinki University Hospital, Helsinki, Finland., Helsinki, Finland, (8)Department of Surgery, Rijnstate, Arnhem, and Multi-Modality Medical Imaging Group, TechMed Centre, University of Twente, Enschede, the Netherlands, Enschede, Netherlands, (9)Icahn School of Medicine at Mount Sinai, New York, NY, (10)A.Z. Sint-Blasius Hospital, Kroonveldlaan 50, Dendermonde 9200, Belgium, Dendermonde, Belgium
Keywords: Peripheral Artery Disease (PAD) and Superficial Femoral Artery (SFA)
Background
Women are underrepresented in clinical trials on peripheral artery disease (PAD). No adequately powered study exists to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease in women.
Methods
A literature search identified 6 randomized controlled trials comparing EVT with stent implantation (bare-metal, drug-eluting, or covered stent) versus BSx (vein or prosthetic material) in patients with symptomatic PAD involving the femoropopliteal segment. Principal investigators of 5 RCTs agreed to pool individual patient data. The primary endpoint was major adverse limb events (MALE), a composite of all-cause death, major amputation, or re-intervention of the target limb. Other endpoints included amputation-free survival (AFS), the individual components of MALE, and primary patency. Early complications were defined as a composite of any bleeding, infection, or all-cause death within 30 days of the procedure.
Results
Of a total of 639 patients investigated 185 (29.0%) were females. Baseline and procedural characteristics were comparable between patients randomized to EVT vs BSx. At 2 years, there was no significant difference in the incidence of MALE between EVT and BSx in women and men (40.6% vs 42.1%, p=0.764; hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.57-1.52 for women and 39.7% vs 34.4%, p=0.963; HR 0.98, 95% CI 0.69-1.39 for men, P
int=0.963). Similarly, there were no differences in AFS, individual components of MALE and primary patency between EVT and BSx regardless of sex. EVT compared to BSx was associated with a significantly lower rate of early complications at 30-days (8.7% versus 25.9.6%, p=0.002 in women and 5.9% versus 21.5%, p<0.001 in men; P
int=0.770) and significantly shorter hospital stay in both women and men (3.7±5.7 vs 7.2±4.3 days, p<0.001 and 2.8±3.2 versus 7.4±5.1, p<0.001).
Conclusions
The findings of this pooled analysis of individual patient data support the efficacy and safety of EVT with stent implantation as an alternative to BSx in patients with symptomatic PAD involving the femoropopliteal segment regardless of sex.