From the BEASTARS registry, the 1-year primary patency rate after EVT with modern restenosis-inhibiting devices for in-stent restenosis (ISR)/reocclusion (ISO) lesions of the femoral popliteal artery was as high as 81%, but dropped to 42% at 3 years, indicating catch-up in the distant phase, according to a presentation by Dr. Kenji Suzuki, Tokyo Saisei Central at the Late Breaking Clinical Trial session of CVIT 2022.
Contemporary therapy of femoro-popliteal in-stent restenosis/occlusion high risk lesions: The BEASTARS Registry
Of the 3,635 patients who underwent EVT to the femoral popliteal artery enrolled in the BEASTARS registry since 2021 at seven centers in eastern Japan, 346 patients with a first ISR/ISO were included and analyzed in this study.
The mean age of patients was 74.5 years, 72% were male, 69% had diabetes, 72% smoked, 70% had chronic kidney disease, 35% had dialysis, 58% had coronary artery disease, 21% had cerebrovascular disease and 26% had heart failure. 12%, 13% and 2% had Rutherford class 4, 5 and 6, respectively.
The stents that resulted in ISR/ISO were 77% bare nitinol stent (BNS), 4% drug-coated stent (DCS), 5% covered stent (CS), 3% Inter Woven Stent (IWS), 11% DES, and the lesion site was SFA in 68%, SFA-Pop in 26%, and Pop in 6%. The mean lesion length was 187 mm, with ISO accounting for 35%, and the mean occlusion length was 237 mm. The proportion of calcified lesions was not high, with 25% bilateral and 13% unilateral calcification.
The mean diameter of the proximal reference was 5.5 mm, the mean diameter of the balloon used for pre-dilation was 5.3 mm, the percentages of semi-compliant, non-compliant, and scoring were 39%, 41%, and 12%, and the mean diameter of the balloon used for post-dilation was 5.8 mm, the percentages of semi-compliant, non-compliant, and scoring rates were 20%, 26%, and 1%, respectively. Final devices were POBA in 26%, BNS in 8%, IWS in 4%, DCS in 5%, CS in 10%, DES in 8%, and DCB in 36%. IVUS was also used in 62% of cases.
Primary patency rates at 1, 2, and 3 years for patients with DCS, DES, CS, and DCB, defined as restenosis-inhibiting devices, were 81%, 59%, and 42%, respectively, compared to 56%, 50%, and 42% for POBA and BNS, showing a large difference in 1-year patency rates, but this difference disappeared at 2-3 years.
The primary patency rate for ISR was 75% at 1 year, 62% at 2 years, and 52% at 3 years, while ISO had poor results at 62%, 44%, and 28%, respectively; BNS, IWS, and DCS were characterized by higher rates of ISO (32-33%) versus 50% for DES and CS.
Multivariate analysis showed that reference diameter (OR 0.68 [95%CI 0.49-0.94] p=0.02) and CTO (OR 1.77 [95%CI 0.95-3.28] p=0.07) were predictors of ISR/ISO, similarly reference diameter (OR 0.63 [95%CI 0.40-0.98] p=0.04) and CTO (OR 4.58 [95%CI 1.87-11.2] p<0.01).
Dr. Suzuki summarized, "Patients with ISR/ISO and lesion backgrounds are severe, and the use of restenosis control devices has been shown to improve short-term primary patency rates but catch up within 3 years.
※コンテンツには、国内で未承認、適応外の医療機器、医薬品、または効能・効果/用法・用量の情報を含む場合がありますが、未承認、適応外の使用を推奨するものではありません。
ご注意 当サイト内の全ての記事と動画の転載・転送はご遠慮ください。なお、法律上保護されたコンテンツの無許可の転載、複製、転用等は、当該コンテンツの権利者等から損害賠償請求その他の法的手続を申し立てられ、事案によっては処罰される可能性、また、故意にそれらを受け取った場合も同様の措置を受ける可能性がございます。ご不明な点がございましたら当社までご連絡ください。
おすすめ
