This column alerts SIR members to abstracts that may have an impact on their practice and how they converse with referring clinicians. If you would like to suggest abstracts you feel should be included, email us at
gandhi@baptisthealth.net or
sganguli@mgh.harvard.edu.
Drug-coated balloon versus standard balloon for superficial femoral artery in- stent restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) trial.
Circulation. 2015 Dec 8;132(23):2230-6. doi: 10.1161/ CIRCULATIONAHA.115.017364. Epub 2015 Oct 7.
Krankenberg H, Tübler T, Ingwersen M, Schlüter M, Scheinert D, Blessing E, Sixt S, Kieback A, Beschorner U, Zeller T.
BACKGROUND: Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain.
METHODS AND RESULTS: One-hundred-nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at five German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57). Mean lesion length was 82.2±68.4 mm. Thirty-four (28.6 percent) lesions were totally occluded; 30 (25.2 percent) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary endpoint of recurrent in-stent restenosis assessed by ultrasound at 6 months was 15.4 percent (8 of 52) in the DCBA and 44.7 percent (21 of 47) in the POBA group (P=0.002). Freedom from target lesion revascularization was 96.4 percent vs. 81.0 percent (P=0.0117) at 6 months and 90.8 percent versus 52.6 percent (P<0.0001) at 12 months, respectively. At 12 months, clinical improvement by 1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBA patients (77.8 percent) and 23 of 44 POBA patients (52.3 percent; P=0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure related.
CONCLUSIONS: DCBA for superficial femoral artery in-stent restenosis is associated with less recurrent restenosis and a better clinical outcome than POBA without an apparent difference in safety.
Association of an endovascular-first protocol for ruptured abdominal aortic aneurysms with survival and discharge disposition.
JAMA Surg. 2015 Nov 1;150(11):1058-65. doi: 10.1001/ jamasurg.2015.1861.
Ullery BW, Tran K, Chandra V, Mell MW, Harris EJ, Dalman RL, Lee JT.
IMPORTANCE: Mortality after an open surgical repair of a ruptured abdominal aortic aneurysm (rAAA) remains high. The role and clinical benefit of ruptured endovascular aneurysm repair (rEVAR) have yet to be fully elucidated.
OBJECTIVE: To evaluate the effect of an endovascular-first protocol for patients with an rAAA on perioperative mortality and associated early clinical outcomes.
DESIGN, SETTING, AND PARTICIPANTS: Retrospective review of a consecutive series of patients presenting with an rAAA before (1997–2006) and after (2007–2014) implementation of an endovascular-first treatment strategy (i.e., protocol) at an academic medical center.
MAIN OUTCOMES AND MEASURES: Early mortality, perioperative morbidity, discharge disposition and overall survival.
RESULTS: A total of 88 patients with an rAAA were included in the analysis, including 46 patients in the preprotocol group (87.0 percent underwent an open repair and 13.0 percent underwent an rEVAR) and 42 patients in the intention-to-treat postprotocol group (33.3 percent underwent an open repair and 66.7 percent underwent an rEVAR; P=.001). Baseline demographics were similar between groups. Postprotocol patients died significantly less often at 30 days (14.3 percent vs. 32.6 percent; P=.03), had a decreased incidence of major complications (45.0 percent vs. 71.8 percent; P=.02), and had a greater likelihood of discharge to home (69.2 percent vs. 42.1 percent; P=.04) after rAAA repair compared with preprotocol patients. Kaplan-Meier analysis demonstrated significantly greater long-term survival in the postprotocol period (log-rank P=.002). One-, 3- and 5-year survival rates were 50.0 percent, 45.7 percent and 39.1 percent for open repair, respectively, and 61.9 percent, 42.9 percent and 23.8 percent for rEVAR, respectively.
CONCLUSIONS AND RELEVANCE: Implementation of a contemporary endovascular-first protocol for the treatment of an rAAA is associated with decreased perioperative morbidity and mortality, a higher likelihood of discharge to home, and improved long-term survival. Patients with an rAAA and appropriate anatomy should be offered endovascular repair as first-line treatment at experienced vascular centers.
32 IR QUARTERLY | SPRING 2016
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