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Surgery or Endovascular Therapy for Patients with Chronic Limb-threatening Ischemia Requiring Infrapopliteal Interventions
Kristina A. Giles, MD1, Alik Farber, MD, MBA2, Matthew T. Menard, MD3, Jeffrey J. Siracuse, MD, MBA4, Michael B. Strong3, Richard J. Powell, MD5.
1Maine Medical Center, Portland, ME, USA, 2Boston Medical Center, BOSTON, MA, USA, 3Brigham and Women's Hospital, Boston, MA, USA, 4Boston Medical Center, Boston, MA, USA, 5Dartmouth Hichcock Medical Center, Lebanon, NH, USA.

OBJECTIVE: The recent publications of randomized trials comparing open bypass surgery to endovascular therapy in CLTI patients, BEST-CLI and BASIL-2, have resulted in potentially contradictory findings. The trials differed significantly regarding anatomic disease criteria as well as their primary endpoints. We perform an analysis of BEST-CLI patients with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a more precise comparative study for BASIL-2.
METHODS: BEST-CLI patients in Cohort 1 (adequate saphenous vein conduit) who had significant infrapopliteal disease and underwent tibial level intervention were included. Patients were randomized to bypass or endovascular therapy with a stratification that included the presence or absence of infrapopliteal disease. The primary outcome was major adverse limb events (MALE) or all-cause death. MALE included any major limb amputation or major re-intervention.
RESULTS: A total of 665 patients were randomized to open tibial bypass(326) or tibial endovascular interventions(339). The primary outcome of MALE or all-cause death at 3 years was significantly lower after open bypass at 48.5% compared to 56.7%(p=0.0006)(Table/Figure). Mortality was similar between groups (35.5% open vs. 35.8% endovascular;p=0.24) whereas MALE events were lower after bypass (23.3% vs. 35.0%;p<0.0001) including major re-interventions (10.9% vs. 20.2%;p=0.0002). Freedom from amputation or all-cause death was similar (43.6% vs. 45.3%;p=0.12) however there was a trend toward lower amputation after bypass (13.5% vs. 19.3%;p=0.053). Perioperative (30-day) death was similar (2.5% vs 2.4%;p=0.93) as was 30-day MACE (5.3% vs 2.7%;p=0.12). Similar results were obtained in the as-treated analyses of the primary and secondary outcomes.
CONCLUSIONS: Among patients with suitable single segment great saphenous vein undergoing infrapopliteal intervention for critical limb ischemia, open bypass surgery had a lower incidence of major adverse limb events or death compared to endovascular intervention and similar amputation free survival. This supports the original conclusion of BEST-CLI favoring bypass surgery and continues to indicate contradictory findings in comparison to BASIL-2.
Table. 3-year outcomes after infrapopliteal open surgical bypass versus endovascular tibial interventions for patients with critical limb ischemia

All Patients(N=665)OPEN(N=326)ENDO(N=339)
N(%)3Yr.KM%N(%)3Yr.KM%N(%)3Yr.KM%HR(95% CI)[OPEN vs ENDO]p-value
MALE or All-Cause Death312(46.9%)52.7%136(41.7%)48.5%176(51.9%)56.7%0.69(0.56,0.85)0.0005
All-Cause Death204(30.7%)35.6%99(30.4%)35.5%105(31.0%)35.8%0.86(0.68,1.10)0.2390
Major Limb Amputation93(14.0%)16.5%37(11.3%)13.5%56(16.5%)19.3%0.67(0.45,1.01)0.0513
Major Re-intervention93(14.0%)15.7%30(9.2%)10.9%63(18.6%)20.2%0.44(0.28,0.68)0.0001
Minor Re-intervention186(28.0%)33.5%91(27.9%)32.9%95(28.0%)34.1%0.99(0.75,1.32)0.9553
Major Amputation or All-Cause Death256(38.5%)44.4%120(36.8%)43.6%136(40.1%)45.3%0.84(0.67,1.05)0.1216

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