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Rocha‐Singh, Krishna J.; Sachar, Ravish; DeRubertis, Brian G.; Nolte‐Ernsting, Claus C. A.; Winscott, John G.; Krishnan, Prakash; Scott, Eric C.; Garcia, Lawrence A.; Baeriswyl, Jean‐Luc; Ansel, Gary; Rosenfield, Kenneth; Zeller, Thomas
Catheterization and cardiovascular interventions, September 2021, 2021-09-00, 20210901, Letnik: 98, Številka: 3Journal Article
Background Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand‐alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high‐grade dissections necessitating provisional stent implantation. Objectives Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD. Methods REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8–36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12‐month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events. Results A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve‐month primary patency rate was 76.7% (66/86) and freedom from CD‐TLR rate was 92.6% (87/94). No device or procedure related deaths and one index‐limb major amputation were reported. Conclusions Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Vir: Osebne bibliografije
in: SICRIS
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