Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

OBJECTIVE: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up. METHODS: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. RESULTS: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR. CONCLUSIONS: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.

Calcium Score Predicts Mortality After Revascularization in Critical Limb Ischemia.

PURPOSE: The calcium score is a measure of vessel wall calcification and has clinical applications when studied in different vascular beds. The presence of vascular calcification in the arteries of the lower limbs is very common in patients with peripheral arterial disease; however, its relationship with the postoperative outcomes in patients undergoing lower limb revascularization is still poorly studied. The aim of this study is to evaluate association between the calcium score of lower limbs and the postoperative outcomes in patients with peripheral arterial disease undergoing revascularization procedures. METHODOLOGY: We retrospectively analyzed 88 lower limb revascularization procedures in 72 patients with critical limb ischemia who had enhanced computed tomography for preoperative evaluation. The calcium score was calculated, from the angiographic phase of preoperative computed tomography, in the segments of the aorta, iliac, femoropopliteal, and infrapopliteal. It was also calculated the calcium score of the operated limb, and the total calcium score using a standardized method. The outcomes evaluated were the occurrence of acute myocardial infarction, amputation, patency, technical success, and death from any cause. Patients were followed up through a 12 month period. RESULTS: Among the 88 procedures performed, 31 (43.1%) lesions were classified as Trans-Atlantic Inter-Society Consensus Document II D. There were 66 (75%) endovascular procedures, 16 (18.2%) open surgery, and 6 (6.8%) hybrid interventions. No statistically significant relationship was found between the calcium score of the segments (aorta, iliac, femoropopliteal, infrapopliteal, the operated limb, and total calcium score) and the outcomes of acute myocardial infarction, amputation, patency, and technical success in any of the periods analyzed. The calcium score of the operated limb was higher in patients who died within 30 days and 6 months (6571 vs 2590.6; p=0.026) and (5227.8 vs 2335.3; p=0.036). CONCLUSION: A standardized calcium score calculation method with the angiographic phase of the computed tomography is feasible and reproducible. Higher values of the calcifications of the operated limb are related to a greater chance of death in the postoperative period. The calcium score of the operated limb can be considered as a marker of clinical severity and prognosis in this group of patients.