{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2022,4,1]],"date-time":"2022-04-01T10:07:12Z","timestamp":1648807632963},"reference-count":33,"publisher":"Index Copernicus","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pol Przegl Chir"],"published-print":{"date-parts":[[2017,4,30]]},"abstract":"<jats:p>Background: The aim of this review is to present the available clinical and surrogate endpoints that may be used in future studies performed in patients with peripheral artery occlusive disease (PAOD). Importantly, we describe statistical limitations of the most commonly used endpoints and offer some guidance with respect to study design for a given sample size. The proposed endpoints may be used in studies using surgical or interventional revascularization and\/or drug treatments. Methods: Considering recently published study endpoints and designs, the usefulness of these endpoints for reimbursement is evaluated. Based on these potential study endpoints and patient sample size estimates with different non-inferiority or tests for difference hypotheses, a rating relative to their corresponding reimbursement values is attempted. Results: As regards the benefit for the patients and for the payers, walking distance and the ankle brachial index (ABI) are the most feasible endpoints in a relatively small study samples given that other non-vascular impact factors can be controlled. Angiographic endpoints such as minimal lumen diameter (MLD) do not seem useful from a reimbursement standpoint despite their intuitiveness. Other surrogate endpoints, such as transcutaneous oxygen tension measurements, have yet to be established as useful endpoints in reasonably sized studies with patients with critical limb ischemia (CLI). Conclusions: From a reimbursement standpoint, WD and ABI are effective endpoints for a moderate study sample size given that non-vascular confounding factors can be controlled.<\/jats:p>","DOI":"10.5604\/01.3001.0009.9220","type":"journal-article","created":{"date-parts":[[2018,5,22]],"date-time":"2018-05-22T09:22:27Z","timestamp":1526980947000},"page":"39-48","source":"Crossref","is-referenced-by-count":0,"title":["Surrogate and clinical endpoints for studies in peripheral artery occlusive disease: Are statistics the brakes?"],"prefix":"10.5604","volume":"89","author":[{"given":"Matthias W.","family":"Waliszewski","sequence":"first","affiliation":[{"name":"Medical Scientific Affairs, B.Braun Melsungen AG, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ulf","family":"Redlich","sequence":"additional","affiliation":[{"name":"Klinikum Magdeburg, Magdeburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Victor","family":"Breul","sequence":"additional","affiliation":[{"name":"Medical Scientific Affairs, B.Braun Aesculap AG, Tuttlingen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00f6rg","family":"Tautenhahn","sequence":"additional","affiliation":[{"name":"Klinikum Magdeburg, Magdeburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"3689","reference":[{"key":"145790r1","doi-asserted-by":"crossref","unstructured":"Selvin E, Erlinger TPPrevalence of and risk factors for peripheral arterial diseasein the United States: results from the National Health and Nutrition ExaminationSurvey, 1999-2000. Circulation 2004; 110(6):738-43.","DOI":"10.1161\/01.CIR.0000137913.26087.F0"},{"key":"145790r2","doi-asserted-by":"crossref","unstructured":"Diehm C, Allenberg JR, Pittrow D, Mahn M, Tepohl G, Haberl RL, Darius H,Burghaus I, Trampisch HJ German Epidemiological Trial on Ankle BrachialIndex Study Group. Mortality and vascular morbidity in older adults withasymptomatic versus symptomatic peripheral artery disease. Circulation2009,120(21):2053-61.","DOI":"10.1161\/CIRCULATIONAHA.109.865600"},{"key":"145790r3","doi-asserted-by":"crossref","unstructured":"Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASCII Working Group. Inter-Society Consensus for the Management of PeripheralArterial Disease (TASC II). J Vasc Surg 2007;45 Suppl S:S5-67.","DOI":"10.1016\/j.jvs.2006.12.037"},{"key":"145790r4","doi-asserted-by":"crossref","unstructured":"Diehm N, Pattynama PM, Jaff MR, Cremonesi A, Becker GJ, Hopkins LN,Mahler F, Talen A, Cardella JF, Ramee S, van Sambeek M, Vermassen F, BiaminoG. Clinical endpoints in peripheral endovascular revascularization trials: acase for standardized definitions. Eur J Vasc Endovasc Surg 2008;36(4):409-19.","DOI":"10.1016\/j.ejvs.2008.06.020"},{"key":"145790r5","doi-asserted-by":"crossref","unstructured":"Diehm N, Diehm C, Kalka C, Dick F. Peripheral endovascular revascularizationtrials: high noon for uniform reporting standards. Acta Chir Belg2008;108(4):382-5.","DOI":"10.1080\/00015458.2008.11680246"},{"key":"145790r6","unstructured":"Sullivan EJ. Clinical trial endpoints. U.S. Food and Drug Administration. www.fda.gov\/downloads\/Training\/ClinicalInvestigatorTrainingCourse\/UCM283378.pdf, accessed: February 18, 2015."},{"key":"145790r7","doi-asserted-by":"crossref","unstructured":"Fleming TR, Powers JH. Biomarkers and surrogate endpoints in clinical trials.Stat Med 2012;31(25):2973-84.","DOI":"10.1002\/sim.5403"},{"key":"145790r8","doi-asserted-by":"crossref","unstructured":"Jensen LP, Lep\u00e4ntalo M, Fossdal JE, R\u00f8der OC, Jensen BS, Madsen MS, GrenagerO, Fasting H, Myhre HO, Baekgaard N, Nielsen OM, Helgstrand U, SchroederTV. Dacron or PTFE for above-knee femoropopliteal bypass. a multicenterrandomised study. Eur J Vasc Endovasc Surg 2007;34(1):44-9.","DOI":"10.1016\/j.ejvs.2007.01.016"},{"key":"145790r9","doi-asserted-by":"crossref","unstructured":"Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena--Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C;EXCITE ISR Investigators. Randomized Controlled Study of Excimer LaserAtherectomy for Treatment of Femoropopliteal In-Stent Restenosis: InitialResults From the EXCITE ISR Trial (EXCImer Laser Randomized ControlledStudy for Treatment of FemoropopliTEal In-Stent Restenosis). JACC CardiovascInterv. 2015;8(1 Pt A):92-101.","DOI":"10.1016\/j.jcin.2014.09.009"},{"key":"145790r10","doi-asserted-by":"crossref","unstructured":"Meijer WT, Hoes AW, Rutgers D, Bots ML, Hofman A, Grobbee DE. Peripheralarterial disease in the elderly: The Rotterdam Study. Arterioscler ThrombVasc Biol 1998;18(2):185-92.","DOI":"10.1161\/01.ATV.18.2.185"},{"key":"145790r11","doi-asserted-by":"crossref","unstructured":"Belch JJ, Bell PR, Creissen D, Dormandy JA, Kester RC, McCollum RD, MizushimaY, Ruckley CV, Scurr JH, Wolfe JH. Randomized, double-blind, placebo-controlledstudy evaluating the efficacy and safety of AS-013, a prostaglandinE1 prodrug, in patients with intermittent claudication. Circulation1997;95(9):2298-302.","DOI":"10.1161\/01.CIR.95.9.2298"},{"key":"145790r12","doi-asserted-by":"crossref","unstructured":"Redlich U, Xiong YY, Pech M, Tautenhahn J, Halloul Z, Lobmann R, Adolf D,Ricke J, Dudeck O. Superiority of transcutaneous oxygen tension measurementsin predicting limb salvage after below-the-knee angioplasty: a prospectivetrial in diabetic patients with critical limb ischemia. Cardiovasc InterventRadiol 2011;34(2):271-9.","DOI":"10.1007\/s00270-010-9968-x"},{"key":"145790r13","doi-asserted-by":"crossref","unstructured":"Cao P1, Eckstein HH, De Rango P, Setacci C, Ricco JB, de Donato G, Becker F,Robert-Ebadi H, Diehm N, Schmidli J, Teraa M, Moll FL, Dick F, Davies AH,Lep\u00e4ntalo M, Apelqvist J. Chapter II: Diagnostic methods. Eur J Vasc EndovascSurg 2011; 42 Suppl 2:S13-32.","DOI":"10.1016\/S1078-5884(11)60010-5"},{"key":"145790r14","doi-asserted-by":"crossref","unstructured":"Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Ruckley CV,Raab GM; BASIL Trial Participants. Bypass versus Angioplasty in Severe Ischaemiaof the Leg (BASIL) trial: A survival prediction model to facilitate clinicaldecision making. J Vasc Surg 2010;51(5 Suppl):52S-68S","DOI":"10.1016\/j.jvs.2010.01.077"},{"key":"145790r15","doi-asserted-by":"crossref","unstructured":"Bahmer FA (1999) Wound measurement made truly simple by point counting.Arch Dermatol 135(8):991-2","DOI":"10.1001\/archderm.135.8.991-a"},{"key":"145790r16","doi-asserted-by":"crossref","unstructured":"Bosch JL, van der Graaf Y, Hunink MG. Health-related quality of life after angioplastyand stent placement in patients with iliac artery occlusive disease: results of a randomized controlled clinical trial. The Dutch Iliac Stent TrialStudy Group. Circulation 1999;99(24):3155-60.","DOI":"10.1161\/01.CIR.99.24.3155"},{"key":"145790r17","doi-asserted-by":"crossref","unstructured":"Simpson EL, Kearns B, Stevenson MD, Cantrell AJ, Littlewood C, Michaels JA.Enhancements to angioplasty for peripheral arterial occlusive disease: systematicreview, cost-effectiveness assessment and expected value of informationanalysis. Health Technol Assess 2014;18(10):1-252.","DOI":"10.3310\/hta18100"},{"key":"145790r18","doi-asserted-by":"crossref","unstructured":"Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G,Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloonfor the prevention of femoropopliteal restenosis) trial for femoropoplitealrevascularization: first-in-human randomized trial of low-dose drug-coatedballoon versus uncoated balloon angioplasty. JACC Cardiovasc Interv2014;7(1):10-9.","DOI":"10.1016\/j.jcin.2013.05.022"},{"key":"145790r19","doi-asserted-by":"crossref","unstructured":"Kleber FX, Schulz A, Waliszewski M, Hauschild T, B\u00f6hm M, Dietz U, CremersB, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronaryarteries after balloon angioplasty. Clin Res Cardiol 2015;104(3):217-25","DOI":"10.1007\/s00392-014-0775-2"},{"key":"145790r20","unstructured":"Hirsch AT, Haskal ZJ, Hertzer NR, et al. Lower ankle\/brachial index, as calculatedby averaging the dorsalis pedis and posterior tibial arterial pressures,and association with leg functioning in peripheral arterial disease. Circulation2006;113(11):e463\u2013e654."},{"key":"145790r21","doi-asserted-by":"crossref","unstructured":"McDermott MM, Liu K, Greenland P, Guralnik JM, Criqui MH, Chan C, PearceWH, Schneider JR, Ferrucci L, Celic L, Taylor LM, Vonesh E, Martin GJ, ClarkE. Functional decline in peripheral arterial disease: associations with the anklebrachial index and leg symptoms. JAMA 2004;292(4):453-61.","DOI":"10.1001\/jama.292.4.453"},{"key":"145790r22","doi-asserted-by":"crossref","unstructured":"Micari A, Cioppa A, Vadal\u00e0 G, Castriota F, Liso A, Marchese A, Grattoni C,Pantaleo P, Cremonesi A, Rubino P, Biamino G. 2-year results of paclitaxel--eluting balloons for femoropopliteal artery disease: evidence from a multicenterregistry. JACC Cardiovasc Interv 2013;6(3):282-9.","DOI":"10.1016\/j.jcin.2013.01.128"},{"key":"145790r23","doi-asserted-by":"crossref","unstructured":"Waliszewski M, Rittger H. Surrogate and clinical endpoints in interventionalcardiology: are statistics the brakes? Ther Adv Cardiovasc Dis. 2016;10(5):314-26.","DOI":"10.1177\/1753944716656150"},{"key":"145790r24","doi-asserted-by":"crossref","unstructured":"Carman TL, Fernandez BB Jr. Contemporary management of peripheral arterialdisease: II. Improving walking distance and quality of life. Cleve Clin JMed 2006;73 Suppl 4:S38-44.","DOI":"10.3949\/ccjm.73.Suppl_4.S38"},{"key":"145790r25","unstructured":"NICE guidance MTG1 2010. SeQuent Please balloon catheter for in-stent coronaryrestenosis. December 2010. http:\/\/www.nice.org.uk\/guidance\/MTG1"},{"key":"145790r26","doi-asserted-by":"crossref","unstructured":"Al-Qaisi M, Nott DM, King DH, Kaddoura S. Ankle Brachial Pressure Index(ABPI): An update for practitioners. Vasc Health Risk Manag 2009;5: 833\u2013841.","DOI":"10.2147\/VHRM.S6759"},{"key":"145790r27","unstructured":"Peacock JM, Keo HH, Duval S, Baumgartner I, Oldenburg NC, Jaff MR, HenryTD, Yu X, Hirsch AT (2011) The incidence and health economic burden ofischemic amputation in Minnesota, 2005-2008.Prev Chronic Dis 8(6):A141."},{"key":"145790r28","doi-asserted-by":"crossref","unstructured":"Brosh D, Higano ST, Lennon RJ, Holmes DR Jr, Lerman A. Effect of lesionlength on fractional flow reserve in intermediate coronary lesions. Am HeartJ 2005;150(2):338-43.","DOI":"10.1016\/j.ahj.2004.09.007"},{"key":"145790r29","doi-asserted-by":"crossref","unstructured":"Young DF, Cholvin NR, Roth AC. Pressure drop across artificially induced stenosesin the femoral arteries of dogs. Circ Res 1975;36(6):735-43.","DOI":"10.1161\/01.RES.36.6.735"},{"key":"145790r30","unstructured":"Sherman FS. Viscous Flow. 1990. McGraw-Hill."},{"key":"145790r31","doi-asserted-by":"crossref","unstructured":"Matsumura JS1, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, SchultzGA, Scheinert D, Rocha-Singh KJ. The United States StuDy for EvalUating EndovasculaRTreAtments of Lesions in the Superficial Femoral Artery and ProximalPopliteal By usIng the Prot\u00e9g\u00e9 EverfLex NitInol STent SYstem II (DURABILITYII).J Vasc Surg 2013;58(1):73-83.","DOI":"10.1016\/j.jvs.2012.12.066"},{"key":"145790r32","doi-asserted-by":"crossref","unstructured":"Warner LM, Sch\u00fcz B, Aiken L, Ziegelmann JP, Wurm S, Tesch-R\u00f6mer C,Schwarzer R. Interactive effects of social support and social conflict on medicationadherence in multimorbid older adults. Soc Sci Med 2013;87:23-30.","DOI":"10.1016\/j.socscimed.2013.03.012"},{"key":"145790r33","unstructured":"NICE technology appraisal guidance TA223: Cilostazol, naftidrofuryl oxalate,pentoxifylline and inositol nicotinate for the treatment of intermittent claudicationin people with peripheral arterial disease. May 2011. http:\/\/www.nice.org.uk\/guidance\/ta223 -end of text"}],"container-title":["Polish Journal of Surgery"],"original-title":[],"link":[{"URL":"https:\/\/ppch.pl\/gicid\/pdf\/01.3001.0009.9220","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ppch.pl\/gicid\/pdf\/01.3001.0009.9220","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,10,18]],"date-time":"2019-10-18T08:59:00Z","timestamp":1571389140000},"score":1,"resource":{"primary":{"URL":"https:\/\/ppch.pl\/gicid\/01.3001.0009.9220"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,4,30]]},"references-count":33,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2017,4,30]]}},"URL":"https:\/\/doi.org\/10.5604\/01.3001.0009.9220","relation":{},"ISSN":["0032-373X","2299-2847"],"issn-type":[{"value":"0032-373X","type":"print"},{"value":"2299-2847","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,4,30]]}}}