The Assocition of Gender With Qulity of Helth in Peripherl Arteril Disese Following Peripherl Vsculr Intervention Sudrshn Pudel, MD 1 ; Anwr Zitoun, MD 1 ; Sif Al-Njfi, MD 2 ; Ther Mus, MD 3 ; Susn Szpunr, PhD 1, Dwn Light, RN 1, Rjendr H. Meht, MD 4 ; Howrd S. Rosmn, MD 1 1 St John Hospitl nd Medicl Center, Detroit, Michign; 2 Rush University Hospitl, Chicgo, Illinois; 3 University of Kentucky, Lexington; nd 4 Duke Clinicl Reserch Institute, Durhm, North Crolin. ABSTRACT: Bckground. Women nd men hve similr prevlence of peripherl rteril disese (PAD). However, women re reported to hve more severe disese nd worse cludiction symptoms thn men. The ssocition of the gender-relted differences in PAD-specific helth sttus following peripherl vsculr intervention (PVI) hs not been previously evluted. Methods. We compred the clinicl responses of women nd men to PVI by prospectively obtining nswers to Peripherl Arteril Questionnire (PAQ) in 384 ptients t bseline nd up to 6-months follow-up post-pvi. We utilized the PAQ summry score of ptients physicl function, symptoms, socil function, nd qulity-of-life (QOL) scores to reflect ptients qulity of helth (QOH). Scores rnge from 0-100, with higher scores indicting better symptomtic nd functionl sttus. Results. Women (191, 49.7%) nd men (193, 50.3%) were eqully represented in our study. Prior to PVI, both groups hd similr QOH scores (36 ± 21 vs 34 ± 20, P = 0.49) for men nd women, respectively. Following PVI, there ws similr nd significnt improvement in QOH scores incresing to 60 ± 28 vs 58 ± 29 (P = 0.36) for men nd women, reflecting substntil clinicl improvement in both groups. Conclusion. In ptients undergoing PVI, women nd men hd similr QOH scores t bseline. There ws lso significnt nd similr improvement in QOH scores following PVI in both genders. These findings showed tht PVI hd similr effectiveness for improving QOH significntly nd eqully in both men nd women with symptomtic PAD. VASCULAR DISEASE MANAGEMENT 2017;14(10):E218-E224 Key words: peripherl rteril disese, Peripherl Arteril Questionnire, cludiction, qulity of helth Lower extremity peripherl rteril disese (PAD) ffects t lest 8.5 million Americns bove the ge of 40 yers. 1 Erlier studies hve suggested tht PAD is more common in men, but recent reports hve shown tht the prevlence of PAD in women is t lest the sme s in men, if not higher. 2,3 PAD results in significnt symptoms nd impirment in mbultory cpcity, leding to functionl disbility nd limittion in the ptient s qulity of life. 2 Specificlly, women with PAD hve fster functionl decline nd greter restriction of mobility thn men with PAD. 4 Women lso hve more severe nd complex disese process, nd they re t incresed risk for dverse outcomes following peripherl vsculr intervention (PVI). 5 In PAD revsculriztion trils, women re disproportiontely underrepresented, nd they ccounted for only third of tril prticipnts, with limited focus on gender-relted outcomes. 6,7 To the best of our knowledge, no study hs evluted the ssocition of gender with chnges in helth sttus following PVI. The im of our study is to exmine the gender-relted differences in PAD-relted helth sttus in ptients undergoing PVI for lower extremity PAD. METHODS Study popultion nd dt collection. The study popultion consisted of consecutive ptients who underwent PVI between Jnury 1, 2012 nd December 31, 2012 t St John Hospitl nd Medicl Center in Detroit, Michign. These dt re collected on n ongoing bsis s result of our prticiption in the multicenter qulity improvement registry, BMC2-VIC, tht involves 47 hospitls in Michign. Detils of the BMC2-VIC registry hve been described elsewhere. 8,9 For this nlysis, ll ptients who underwent lower extremity PVI, nd whose dt were collected in the registry t our single center, were included. An on-site reserch coordintor collected dt on demogrphic nd clinicl chrcteristics, procedurl detils, tretments, nd outcomes of ptients undergoing PVI procedures. Rutherford clssifiction of chronic limb ischemi ws used for clinicl stging of peripherl rteril disese. This clssifiction hs 7 ctegories ctegory 0, symptomtic; ctegory 1, mild cludiction; ctegory 2, moderte cludiction; ctegory 3, severe cludiction; ctegory 4, rest pin; ctegory 5, minor tissue loss; nd ctegory 6, ulcertion or gngrene. 10 The dt were submitted electroniclly to the registry, nd copy of these dt Vsculr Disese Mngement Volume 14, No. 10, October 2017 E218
ws mintined t our institution. Similrly, our reserch nurse coordintors collected dt on helth sttus following PVI using the Peripherl Arteril Questionnire (PAQ). 11 This informtion ws collected prior to PVI nd t follow-up (up to 6 months) following intervention, using the sme questionnire. The dt were collected for totl of 502 ptients. Of those, 115 ptients hd cute limb ischemi nd were excluded from the current nlysis. Additionlly, 3 other ptients were excluded becuse informtion on gender ws missing for them. Thus, the study popultion consisted of 384 consecutive ptients with PAD who underwent PVI in the time period noted bove. As prt of prticiption in the BMC2-VIC registry, dt qulity nd the inclusion of consecutive procedures were ensured by d hoc queries, rndom chrt reviews, nd series of dignostic routines included in the dtbse. This study ws pproved by the institutionl review bord of the hospitl. Dt definitions nd endpoints. Peripherl vsculr intervention (PVI) ws defined s endovsculr intervention on n rtery in the orto-ilic, femoro-poplitel, nd below-knee rteril tree using wide rnge of interventionl devices t the discretion of the opertor. The PAQ is PAD-specific tool tht ssesses the helth sttus Tble 1. Bseline Chrcteristics of Study Popultion Ptients/Gender Age, men (SD) Men n=193 (50.3) 74.8 ± 10.1 Women n=191 (49.7) P Vlue 75.9 ± 11.4 0.29 Dibetes 106 (55.2) 95 (49.7) 0.28 Coronry rtery disese 122 (63.2) 110 (57.6) 0.26 Hypertension 187 (96.9) 181 (94.8) 0.29 Hyperlipidemi 179 (93.2) 163 (85.3) 0.01 Congestive hert filure 46 (23.8) 49 (25.7) 0.68 CVD/TIA 49 (25.5) 54 (28.3) 0.54 Atril fibrilltion 37 (19.2) 25 (13.2) 0.11 Fmily history of premture CAD 34 (17.9) 27 (14.2) 0.33 COPD 60 (31.1) 55 (28.9) 0.65 Renl filure on dilysis 14 (7.3) 11 (5.8) 0.56 Prior PVI procedure 105 (54.4) 98 (51.3) 0.54 Prior surgicl procedure 63 (32.6) 35 (18.3) 0.001 Current smoker 54 (28.0) 58 (30.4) 0.61 Former smoker 113 (58.5) 84 (44.0) 0.004 of PAD ptients over 4 weeks durtion prior to completing the questionnire. 11 The PAQ comprises 6 domins: physicl function, symptoms, symptoms stbility, tretment stisfction, socil function, nd qulity of life (QOL). Scores in ech domin rnge from 0-100; lower scores suggest worse functionl sttus, worse qulity of life, nd incresed frequency of symptoms. Six questions ddressed the physicl limittion domin, in which ptients rte the severity of restriction in different ctivities cused by PAD. These restrictions rnge from limittion in mild ctivities such s wlking round the house, to limittion only in more vigorous ctivities such s jogging. Three questions in the symptoms scle domin ddressed the frequency nd burden of cludiction nd ftigue, s well s rest or nocturnl pin, if present. Chnge of symptoms over 4-week period ws evluted by one question under symptoms stbility domin. QOL domin focused on PAD impct on ptients enjoyment of life, stisfction with their current symptoms, nd psychologic well-being. Socil functioning domin evluted the PAD burden on ptients bilities to prctice their hobbies, visit fmilies nd friends, nd perform dily household chores. The summry score reflects the verge scores of the domins of physicl limittion, symptoms, socil functioning, nd qulity of life. In our study, we utilized the PAQ summry score Ptients/Gender Men n=193 (50.3) Women n=191 (49.7) P Vlue Lesion loction Above knee only b 81 (42.3) 94 (50.2) 0.11 Below knee only c 45 (23.6) 31 (16.6) 0.95 Above nd below knee d 67 (35.1) 62 (33.2) 0.72 Rutherford ctegory 0 0 0 1 0 0 2 2 (1.1) 0 3 80 (43.2) 74 (40.4) 4 41 (22.2) 61 (33.3) 5 59 (31.9) 43 (23.5) 6 3 (1.6) 5 (2.7) CAD = coronry rtery disese; COPD = chronic obstructive pulmonry disese; CVD/TIA = cerebrovsculr disese/trnsient ischemic ttck; PVI = peripherl vsculr intervention; SD = stndrd devition. Vlues re men ± SD nd n (%). b Ilic or femorl rtery lesions. f c Poplitel rtery or below-knee rtery lesions. d Both bove-knee nd below-knee lesions in sme ptient. Vsculr Disese Mngement Volume 14, No. 10, October 2017 E219
to represent the qulity of helth (QOH) of the ptients. The PAQ hs been vlidted ginst different helth sttus questionnires in ptients with PAD who underwent PVI. 12 The chnges in PAQ scores fter revsculriztion hve been shown to reflect substntil sensitivity of the PAQ to clinicl improvement. 11 The primry outcome of interest for this study ws the difference in the chnge in QOH scores following PVI between men nd women. The chnge score ws described s the difference between the bseline PAQ summry score pre-pvi nd up to 6 months post-pvi. Sttisticl nlysis. Descriptive sttistics were clculted to chrcterize the study group. Continuous vribles were described s the men with stndrd devition (SD) or medin with rnge. Ctegoricl vribles were described s frequency distributions. Men nd medin domin nd overll PAQ scores were computed. The differences in scores t ech time period (bseline, post-pvi) between men nd women were ssessed using Student t-test or the Mnn-Whitney U test (if the dt were skewed). The difference in the chnge in scores over time ws compred between men nd women using the Mnn-Whitney U test. All dt were nlyzed using SPSS version 24.0, nd P vlue of 0.05 or less ws considered to indicte sttisticl significnce. RESULTS Demogrphics nd clinicl history. Of the 384 ptients, hlf were women (n = 191, 49.7%) nd of similr ge compred with men, s shown in Tble 1. The prevlence of comorbid conditions such s dibetes, coronry rtery disese, hypertension, congestive hert filure, chronic obstructive pulmonry disese, nd tril fibrilltion ws similr in both groups. Hyperlipidemi ws less common in women. Also, women were less likely to hve prior peripherl surgicl revsculriztion. Rte of current smoking ws similr in the 2 groups, but men were more likely to be former smokers. Above-knee-only intervention ws performed slightly more in women thn men (50% vs 42%), but the difference ws not sttisticlly significnt. Over 99% of our study ptients hd severe cludiction (Rutherford clss 3), rest pin (Rutherford clss 4), or minor tissue loss (Rutherford clss 5). Rutherford clssifiction did not differ between genders, indicting similr severity of PAD. Post-PVI cre nd medictions. There ws no significnt difference in the use of dul nti-pltelet therpy, cilostzol, sttins, β-blockers, nd ngiotensin-converting enzyme (ACE) inhibitors between the 2 groups, s shown in Tble 2. However, women were more likely to receive dditionl vsodiltors, including nitrtes nd ngiotensin receptor blockers (ARBs). Women were less frequently on wrfrin, likely reflection of lower rtes of tril fibrilltion in women in our study popultion. Ptient eduction upon dischrge regrding the benefits of smoking cesstion nd regulr exercise ws similr in both groups. Technicl success, which ws defined s vsculr ccess, deployment of device(s), nd 30% dimeter residul stenosis fter revsculriztion, 9 ws slightly better in women compred with mn (95.7% vs 89.9%). The rtes of complictions both t 30 dys nd t 1 to 6 months were similr between the 2 groups (Appendix 1 nd 2). Tble 2. Prescribed Medictions, Technicl Success, nd Eduction Upon Dischrge Dischrge Men Women P Vlue Medictions Aspirin 182 (94.3) 178 (93.2) 0.65 DAPT 171 (88.6) 171 (89.5) 0.77 Clopidogrel 177 (91.7) 181 (94.8) 0.23 Prsugrel 5 (2.6) 3 (1.6) 0.48 β blockers 140 (72.5) 133 (69.6) 0.53 ACEIs 111 (57.5) 100 (52.4) 0.31 ARBs 23 (11.9) 37 (19.4) 0.04 Sttins 161 (83.4) 150 (78.5) 0.22 Clcium chnnel blockers 65 (33.7) 77 (40.3) 0.18 Nitrte 25 (13.0) 41 (21.5) 0.03 Cilostzol 14 (7.3) 13 (6.8) 0.86 Wrfrin 26 (13.5) 13 (6.8) 0.03 Technicl success 170 (89.9) 176(95.7) 0.03 Eduction upon dischrge Exercise (Yes) 157 (81.3) 151 (80.3) 0.79 Smoking (Yes) 193 (100) 188 (100) -- ACEIs = ngiotensin-converting enzyme inhibitors; ARBs = ngiotensin II receptor blockers; DAPT = dul ntipltelet therpy. ASA + one of the following (clopidogrel or prsugrel). QOH t bseline nd following PVI. The overll nlysis of PAQ scores showed 3 notble findings. First, both groups hd similr bseline scores in ll PAQ domins (Tble 3). Second, QOH scores following PVI incresed substntilly, from 35.9 ± 21.0 nd 34.4 ± 20 t bseline to 60.2 ± 27.8 nd 57.5 ± 29.0 t follow-up for men nd women, respectively, (Tble 3 nd Figure). These lrge improvements in the post-pvi QOH scores reflect significnt clinicl improvement in both groups. Third, both groups benefited eqully (Tble 4). This importnt finding suggests tht women derived equl clinicl benefit from the procedure. We next evluted the individul domins. Women nd men hd substntil nd sttisticlly significnt improvement in ll PAQ scores, except in tretment stisfction domin. The physicl function score doubled in both men nd women, incresing to 50.4 ± 35.7 nd 45.1 ± 32.4, respectively, while symptoms scores incresed significntly, indicting lessening of cludiction. The stbility score lso incresed in both groups, suggesting tht the improvements in cludiction symptoms were sustined. Socil function scores improved, indicting the ptients were ble to engge more in socil ctivities nd hobbies. In tretment stisfction domin, the scores Vsculr Disese Mngement Volume 14, No. 10, October 2017 E220
Tble 3. The PAQ Domins nd the Summry Score in Both Groups t Bseline nd Post-PVI Men Figure. Chnge in Qulity of Helth From Bseline to Post-PVI decresed in women but did not chnge in men. Overll QOH score improvement ws lrge in women nd men, ppropritely reflecting significnt clinicl improvement in both groups. For reders unfmilir with the PAQ questionnire, we describe the PAQ scoring in one study ptient in n ttempt to mke it esier to correlte PAQ scores with ptient clinicl symptoms. A 78-yer-old womn ws slightly limited wlking round the house nd modertely limited with her household chores. She hd episodes of rest pin nd cludiction every dy, nd she woke t lest once every night due to pin. Her summry score t bseline ws 25. After intervention in right femorl, poplitel, nd peronel rteries, she hd no limittion with wlking round the house or with her household chores. She hd cludiction less thn once week nd woke from sleep with leg pin less thn once week. Her summry score postintervention improved to 86. DISCUSSION The tretment of PAD is imed t reducing crdiovsculr risk, incresing functionl performnce, nd improving helth sttus. Women PAQ domin Bseline Follow-up P Vlue Bseline Follow-up P Vlue Physicl function 24.6 ± 24.9 50.4 ± 35.7 <0.0001 22.4 ± 22.3 45.1 ± 32.4 <0.0001 Symptoms 36.2 ± 25.9 66.6 ± 31.5 <0.0001 33.2 ± 24.6 60.1 ± 33.7 <0.0001 Symptom stbility 33.7 ± 23.9 55.9 ± 24.9 <0.0001 35.6 ± 24.3 53.7 ± 24.5 <0.0001 Tretment stisfction 81.7 ± 21.3 77.9 ± 25.0 0.06 82.7 ± 20.3 76.9 ± 26.0 0.008 Socil function 44.7 ± 32.7 62.7 ± 34.8 <0.0001 42.6 ± 31.1 61.2 ± 34.9 <0.0001 Qulity of life 38.3 ± 24.1 61.5 ± 29.1 <0.0001 38.2 ± 23.5 60.5 ± 29.1 <0.0001 Summry score 35.9 ± 21.0 60.2 ± 27.8 <0.0001 34.4 ± 20.2 57.5 ± 29.0 <0.0001 PAQ = peripherl rteril questionnire; PVI = peripherl vsculr intervention. Vlues re men ± stndrd devition. Abbrevitions: PVI, peripherl vsculr intervention; QOH, qulity of helth. QOL is emerging s n importnt mesurble outcome for ptients undergoing peripherl interventions. 11,12 In generl, ssessing PADrelted helth sttus provides insights into the effects of tretment on ptients nd my help guide the need for further therpy. Moreover, ssessment of helth sttus following PVI hs become even more relevnt in the current er where PVI hs emerged s common initil therpy for symptomtic PAD, 13 15 while supervised exercise therpy continues to remin underutilized. Prior PAD studies evluted gender disprities in mortlity nd morbidity following revsculriztion. These studies indicte tht mong ptients undergoing PVI, women hve higher djusted rtes of procedurl bleeding nd vsculr ccess site complictions. 5,16 Also, severl studies hve demonstrted higher rtes nd severity of PAD, worse qulity of life, nd worse physicl function in women compred with men with PAD. 17,18 However, no study s of yet hs ssessed gender differences in PAD-relted helth sttus following PVI. In contrst to previous studies, our study of post-pvi helth sttus demonstrted tht women hd similr PAD-specific helth sttus s reflected by similr QOH scores t bseline. The recently published Ptient-centered Outcomes Relted to Tretment Prctices in Peripherl Arteril Disese Investigting Trjectories (PORTRAIT) study by Roumi et l elegntly ssessed the differences in helth sttus between men nd women with symptomtic peripherl rteril disese upon their first presenttion to vsculr specilty clinic by using the peripherl rteril questionnire. 19 They reported tht women hd poorer bseline helth sttus when compred with men. However, the PORTRAIT study included younger ptient cohort with less severe disese thn tht of our cohort. Over 70% of PORTRAIT ptients hd only mild-to-moderte disese with Rutherford clss < 2, while 99% of prticipnts in our study hd Rutherford clss > 3. Moreover, over hlf of our ptients hd rest pin or tissue loss, while none of the PORTRAIT ptients did. Overll, the PORTRAIT included ptients with milder PAD mnged mediclly, while ptients from our study hd more dvnced disese tht necessitted vsculr intervention. These differences Vsculr Disese Mngement Volume 14, No. 10, October 2017 E221
Tble 4. The Chnge in Ech of the Six PAQ Domins nd the Summry Score PAQ domin Men Women P Vlue Physicl Function 20.8 (58.3) 20.8 (45.8) 0.65 Symptoms 33.3 (47.2) 25.0 (52.8) 0.31 Symptom Stbility Tretment Stisfction Socil Function 25.0 (50.0) 25.0 (50.0) 0.28 0.0 (41.7) 0.0 (33.3) 0.83 16.7 (56.3) 25.0 (58.3) 0.87 Qulity of Life 25.0 (45.8) 25.0 (47.9) 0.90 Summry Score 24.4 (41.1) 25.0 (44.3) 0.78 Abbrevitions: PAQ, peripherl rteril questionnire; PVI, peripherl vsculr intervention. Vlues re men ± stndrd devition. in demogrphics nd PAD severity were proportiontely reflected by differences in bseline PAQ scores: lower bseline PAQ scores indicting worse helth sttus (verge 30 to 40) due to severe disese in our study vs higher bseline scores (verge 40 to 60) consistent with milder disese nd better helth sttus in POR- TRAIT ptients. These bove noted differences help us explin the gender-relted disprities seen in PAQ scores nd helth sttus between the 2 studies. We believe tht gender-relted differences in helth sttus re more prominent in the milder form of PAD, s ssessed by the PORTRAIT study nd other erlier studies. However, s the disese progresses to dvnced stges, especilly in older ptients, these significnt gender-relted differences in helth sttus dispper, s elucidted in our study. Our study showed tht both men nd women benefited significntly from PVI. Prior to interventions, the ptients were significntly limited physiclly nd socilly, nd they hd poor QOH due to severe PAD. After intervention, there ws significnt improvement in symptoms, physicl nd socil function, nd overll QOH. Most PAQ domins incresed to 60%, demonstrting better nd improved helth sttus but lso indicting room for greter improvement, which is where future reserch should be directed. When the net increse in the scores ws compred with tht seen in men, women chieved similr improvements in QOH following intervention. This is n importnt finding, suggesting tht even in study popultion like ours with dvnced nd severe PAD, the benefits of PVI on helth sttus gined by women re significnt, nd this improvement is not impcted by gender. These findings will help the physicin explin the tretment pln nd outcome expecttions to ptients nd will help ptients mke decisions nd refine their expecttions regrding improvements in QOH following PVI. An interesting nd potentilly importnt finding of our study concerns stisfction of ptients with their cre. Despite significnt physicl nd socil limittions relted to their PAD, ptients reported very high stisfction with cre both pre-pvi (PAQ stisfction score 82) nd t follow-up post-pvi (PAQ score 78). This score ws substntilly higher thn ll other PAQ domins pre- nd post-pvi. Further, 2 other studies of PAD utilizing PAQ observed similr findings. 12,19 It is not immeditely cler why ptients with moderte or severe limittions from PAD would consistently be very stisfied with their cre. Possibilities might include optimism nd pprecition for personlized cre provided in specilized vsculr clinic 19 or with n intervention designed to improve cre. 12 An opposite hypothesis could be tht ptients my be frid of offending their physicins, even though the survey ws nonymous. We lso noted tht women hd lower rtes of prior surgicl procedures before the index PVI. This finding, when combined with dditionl use of nitrtes nd ARBs in women, might indicte tht women with symptomtic PAD were more likely to be mnged mediclly. It remins uncler if physicins tret women with PAD mediclly nd tend to defer revsculriztions, given reported higher rtes of procedurl complictions in this popultion. The design nd size of our study precludes us from deriving ny concrete conclusions in this regrd. Our study complements the prior vsculr literture nd dds to our understnding of the impct of gender on helth sttus in severe PAD requiring PVI. Gender-relted impct on helth sttus is more pronounced in the milder form of disese. However, s disese severity increses, the PAD-relted clinicl helth sttus is similr in men nd women. STUDY LIMITATIONS This is retrospective observtionl study with moderte smple size. Limittions of observtionl studies would pply to our study. The results should be viewed s hypothesis generting rther thn implying custion. We only hd intermedite-term follow-up dt on QOH following PVI. Longer follow-up dt will provide better understnding of sustinbility of improvement in QOH in men nd women. CONCLUSIONS In ptients receiving PVI, women nd men hd similr QOH scores t bseline. There ws lso significnt nd similr improvement in QOH scores following PVI in both genders. These findings showed tht PVI hd similr effectiveness for improving QOH significntly nd eqully in both men nd women with symptomtic PAD. n Disclosure: The uthors hve completed nd returned the ICMJE Form for Disclosure of Potentil Conflicts of Interest. The uthors report no conflicts of interest regrding the content herein. Mnuscript submitted June 12, 2017; provisionl cceptnce given July 26, 2017; finl version ccepted September 28, 2017. Address for correspondence: Sudrshn Pudel, MD; St John Hospitl nd Medicl Center, Detroit, Michign. Emil: mkikhol@gmil.com. Vsculr Disese Mngement Volume 14, No. 10, October 2017 E222
REFERENCES 1. Selvin E, Erlinger TP. Prevlence of nd risk fctors for peripherl rteril disese in the United Sttes: results from the Ntionl Helth nd Nutrition Exmintion Survey, 1999-2000. Circultion. 2004;110(6):738-743. 2. Higgins JP, Higgins JA. Epidemiology of peripherl rteril disese in women. J Epidemiol. 2003;13(1):1-14. 3. Vvr AK, Kibbe MR. Women nd peripherl rteril disese. Womens Helth. 2009;5(6):669-683. 4. McDermott MM, Ferrucci L, Liu K, et l. Women with peripherl rteril disese experience fster functionl decline thn men with peripherl rteril disese. J Am Coll Crdiol. 2011;57(6):707-714. 5. Jckson EA, Munir K, Schreiber T, et l. Impct of sex on morbidity nd mortlity rtes fter lower extremity interventions for peripherl rteril disese: observtions from the Blue Cross Blue Shield of Michign Crdiovsculr Consortium. J Am Coll Crdiol. 2014;63(23):2525-2530. 6. Hoel AW, Kyssi A, Brhmnndm S, Belkin M, Conte MS, Nguyen LL. Under-representtion of women nd ethnic minorities in vsculr surgery rndomized controlled trils. J Vsc Surg. 2009;50(2):349-354. 7. Hirsch AT, Allison MA, Gomes AS, et l. A cll to ction: women nd peripherl rtery disese: scientific sttement from the Americn Hert Assocition. Circultion. 2012;125(11):1449-1472. 8. Mukherjee D, Munir K, Hirsch AT, et l. Development of multicenter peripherl rteril interventionl dtbse: the PVD-QI2. Am Hert J. 2005;149(6):1003-1008. 9. Diehm N, Bumgrtner I, Jff M, et l. A cll for uniform reporting stndrds in studies ssessing endovsculr tretment for chronic ischemi of lower limb rteries. Eur Hert J. 2007;28(7):798-805. 10. Rutherford RB, Bker JD, Ernst C, et l. Recommended stndrds for reports deling with lower extremity ischemi: revised version. J Vsc Surg. 1997;26(3):517-538. 11. Spertus J, Jones P, Poler S, Roch-Singh K. The peripherl rtery questionnire: new disese-specific helth sttus mesure for ptients with peripherl rteril disese. Am Hert J. 2004;147(2):301-308. Appendix 1. Thirty-Dy Outcomes nd Complictions 12. Sfley DM, House JA, Lster SB, Dniel WC, Spertus JA, Mrso SP. Quntifying improvement in symptoms, functioning, nd qulity of life fter peripherl endovsculr revsculriztion. Circultion. 2007;115(5):569-575. 13. Norgren L, Hitt WR, Dormndy JA, et l. Inter-Society consensus for the mngement of peripherl rteril disese (TASC II). J Vsc Surg. 2007;45 Suppl S:S5-S67. 14. Hirsch AT, Hskl ZJ, Hertzer NR, et l. ACC/AHA 2005 guidelines for the mngement of ptients with peripherl rteril disese (lower extremity, renl, mesenteric, nd bdominl ortic): executive summry collbortive report from the Americn Assocition for Vsculr Surgery/Society for Vsculr Surgery, Society for Crdiovsculr Angiogrphy nd Interventions, Society for Vsculr Medicine nd Biology, Society of Interventionl Rdiology, nd the ACC/AHA Tsk Force on Prctice Guidelines (Writing Committee to Develop Guidelines for the Mngement of Ptients With Peripherl Arteril Disese) endorsed by the Americn Assocition of Crdiovsculr nd Pulmonry Rehbilittion; Ntionl Hert, Lung, nd Blood Institute; Society for Vsculr Nursing; TrnsAtlntic Inter-Society Consensus; nd Vsculr Disese Foundtion. J Am Coll Crdiol. 2006;47(6):1239-1312. 15. Ahimstos AA, Ppps EP, Buttner PG, Wlker PJ, Kingwell BA, Golledge J. A met-nlysis of the outcome of endovsculr nd noninvsive therpies in the tretment of intermittent cludiction. J Vsc Surg. 2011;54(5):1511-1521. 16. Vouyouk AG, Egorov NN, Slloum A, et l. Lessons lerned from the nlysis of gender effect on risk fctors nd procedurl outcomes of lower extremity rteril disese. J Vsc Surg. 2010;52(5):1196-1202. 17. Ok RK, Szub A, Gicomini JC, Cooke JP. Gender differences in perception of PAD: pilot study. Vsc Med. 2003;8(2):89-94. 18. McDermott MM, Greenlnd P, Liu K, et l. Sex differences in peripherl rteril disese: leg symptoms nd physicl functioning. J Am Geritr Soc. 2003;51(2):222-228. 19. Roumi M, Aronow HD, Souks P, et l. Sex differences in disesespecific helth sttus mesures in ptients with symptomtic peripherl rtery disese: dt from the PORTRAIT study. Vsc Med. 2017;22(2):103-109. Outcomes/Gender Men Women P Vlue Deth 2(1.3) 1(0.6) 0.55 MACE 2(1.3) 3(1.9) 0.68 Repet procedure 8(5.2) 5(3.1) 0.35 New vsculr procedure 37(23.4) 25(15.4) 0.07 Infection 12(7.8) 8(5.1) 0.33 Access site compliction 3(1.9) 2(1.2) 0.63 Amputtion 8(5.1) 9(5.6) 0.86 Myocrdil infrction 1(0.6) 1(0.6) 0.98 TIA/Stroke 0(0) 1(0.6) -- Trnsfusion 6(3.8) 7(4.3) 0.82 CV = crdiovsculr; MACE = mjor dverse crdiovsculr event; TIA = trnsient ischemic ttck. Vsculr Disese Mngement Volume 14, No. 10, October 2017 E223
Appendix 2. One- to 6-Month Outcomes nd Complictions Outcomes/Gender Men Women P Vlue Deth 8(4.7) 9(5.1) 0.86 MACE 1(0.6) 3(1.6) 0.33 Repet procedure 12(6.7) 14(7.8) 0.71 New vsculr procedure 13(7.3) 14(7.8) 0.87 Infection 7(4.0) 4(2.2) 0.34 Access site compliction 1(0.6) 1(0.6) 0.99 Amputtion 11(6.2) 7(3.9) 0.32 Myocrdil infrction 0(0) 0(0) -- TIA/Stroke 1(0.6) 1(0.6) 0.99 Trnsfusion 4(2.3) 5(2.8) 0.77 CV = crdiovsculr; MACE = mjor dverse crdiovsculr event; TIA = trnsient ischemic ttck. Vsculr Disese Mngement Volume 14, No. 10, October 2017 E224