Einleitung
Methoden
Einschlusskriterien
Patient, Intervention, Comparison, Outcome (PICO)-Schema
Types of participants
Types of interventions
Types of outcome measures
Suchstrategie
Studienselektion
Ergebnisse
Beschreibung der Studienpopulationen
Geschlechterunterschiede
Diskussion
Autor und Jahr | Anzahl Patienten, % Frauen | Datenbasis | Zeitraum | Statistische Analysen | Behandlung | IC vs. CLTI | Endpunkte und Ergebnisse | Bewertung |
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Lee et al. 2020 [33] | 765 Patienten (22,1 % Frauen) | Single-center | 2004–2012 | PS matching Univariate Multivariate Cox regression | Endovaskulär | IC, CLTI | All-cause Mortality up to 5 years (matched cohorts): 13.2 % vs. 10.5 % (p = 0.54), female vs. male MACE up to 5 years (matched cohorts): 15.8 % vs 14.9 % (p = 0.838), female vs. male MALE up to 5 years (matched cohorts): 28.2 % vs. 34.8 % (p = 0.264), female vs. male | Nicht eindeutig |
Pawlik et al. 2020 [43] | 939 Patienten (37,4 % Frauen) | Multi-center | 2006–2016 | No matching Univariate Multivariate Cox regression | Endovaskulär | IC, CLTI | Follow-up (mean 1.144,9 ± 664,3 days): – Stroke/TIA: 3.14 % vs. 2.44 %, (p = 0.52), female vs. male – Myocardial Infarction: 3.72 % vs. 3.31 % (p = 0.73), female vs. male – Amputation: 19.94 % vs. 15.26 % (p = 0.07), female vs. male – Mortality: 14 % vs. 13.07 % (p = 0.68), female vs. male – 60-month Re-PVI-Rate: 35.8 % vs 41.2 %, (p = 0.047), female vs. male – Re-PVI-free Survival Probability: better in women (p = 0.047) – Male gender independent predictor of re-PVI (HR 1.276, p = 0.03) | Nicht eindeutig |
Miller et al. 2019 [41] | 139.435 (42,6 % Frauen) | Multi-center (Nationwide Inpatient Sample) | 2003–2012 | No matching Univariate Multivariate Logistic regression | Endovaskulär Offen-chirurgisch | IC, CLTI | In-hospital Mortality: 1.0 % vs. 0.8 % (p < 0.05), female vs. male Sex independent predictor of Mortality in IC: OR 1.74 (1.30–2.32), p < 0.001 for female | Schlechteres Outcome bei Frauen |
Ramkumar et al. 2019 [46] | 58.247 Patienten (41 % Frauen) 66.045 Prozeduren | Multi-center (Vascular Quality Initiative, VQI) | 01/2010–10/2016 | No matching Univariate Multivariate Logistic regression, Cox regression | Endovaskulär | IC, CLTI | Follow-up (median 376, IQR 310-460 days): – 2-year Reintervention-free Survival: 65 % vs. 73 % (p < 0.001), female vs. male – 2-year Occlusion-free Survival: 81 % vs. 84 % (p < 0.001), female vs. male (both results for femoropopliteal segment) | Schlechteres Outcome bei Frauen |
Behrendt et al. 2019 [4] | 23.715 Prozeduren (39.7 % Frauen) | Multi-center (EQS Registry) | 2004–2015 | No matching Univariate Multivariate Logistic regression | Endovaskulär | IC, CLTI | In-hospital Mortality: 3.2 % vs. 2.6 % (p = 0.062), female vs. male | Nicht eindeutig |
Liang et al. 2019 [34] | 14.125 Patienten (36,6 % Frauen) | Multi-center (ACS-NSQIP Database) | 2011–2015 | No matching Univariate Multivariate Logistic regression | Endovaskulär (37 %), Offen-chirurgisch | IC, CLTI | In-hospital MACE: OR 1.1 (0.8–1.3), p = 0.69 for female In-hospital Mortality: OR 1.4 (0.9–2.1), p = 0.9 for female 30-day MACE: OR 1.1 (0.9–1.3), p = 0.56 for female 30-day Mortality: OR 1.1 (0.8–1.5), p = 0.52 for female | Nicht eindeutig |
Choi et al. 2019 [8] | 3.073 Patienten (17,9 % Frauen) | Multi-center (K-VIS ELLA Registry) | 01/2006–07/2015 | No matching Univariate Multivariate Cox regression | Endovaskulär | IC, CLTI | In-hospital Mortality: p = 0.50, female vs. male Follow-up (median 701 days, IQR 299–995): – 2-year Composite Outcome of Death, Myocardial Infarction or Major Amputation: 14.8 % vs. 9.8 %, female vs. male Unadjusted: HR 1.706 (1.345–2.163), p < 0.001 Adjusted: HR 1.350 (1.017–1.792), p = 0.038 – 2-year All-cause Death: 9.8 % vs. 6.9 %, female vs. male Unadjusted: HR 1.474 (1.086–2.000), p = 0.013 Adjusted: HR 1.203 (0.874–1.656), p = 0.256 – 2-year MI: 1.8 % vs. 1.0 %, female vs. male Unadjusted: HR 2.140 (0.931–4.923), p = 0.073 Adjusted: HR 1.925 (0.790–4.687), p = 0.149 – 2-year MALE: 19.9 % vs. 14.5 %, female vs. male Unadjusted: HR 1.506 (1.191–1.905), p < 0.001 Adjusted: HR 1.301 (1.014–1.670), p = 0.039 | Schlechteres Outcome bei Frauen |
Schaumeier et al. 2018 [51] | 125.934 Patienten (48.3 % Frauen) 113.631 Aufnahmen (47,8 % Frauen) | Multi-center (Nationwide Inpatient Sample) | 2007–2010 | No matching Univariate Multivariate Logistic regression | Amputation, Endovaskulär (15,7 % der Aufnahmen), Offen-chirurgisch | CLTI | – In-hospital Mortality: 1.7 % vs. 1.6 % (p = 0.63), female vs. male – In-hospital Amputation (after revascularization): OR 1.33 (1.22–1.45, p < 0.001) for male | Nicht eindeutig |
Freisinger et al. 2018 [17] | 41.873 Patienten (44,4 % Frauen) 66.045 Prozeduren | Multi-center (BARMER health insurance claims) | 2009–2011 | PS matching Univariate Multivariate Logistic regression | Angiography, Endovaskulär (44 %), Offen-chirurgisch | IC, CLTI | In-hospital Mortality Unadjusted: 3.4 % vs. 2.5 % (p < 0.001), female vs. male PS matched: 3.1 % vs. 2.7 % (p = 0.059), female vs. male In-hospital Amputation Unadjusted: 9.3 % vs. 11.4 %, (p < 0.001), female vs. male PS matched: 9.1 % vs. 11.1 %, (p < 0.001), female vs. male Follow-up up to 4 years: Mortality Risk: HR 1.155 (1.105–1.207), p < 0.001 for male Amputation Risk: HR 1.284 (1.218–1.353), p < 0.001 for male | Schlechteres Outcome bei Männern |
Hess et al. 2018 [23] | 381.415 Patienten (41,7 % Frauen) | Multi-center (Premier Healthcare Database US) | 01/2009–09/2014 | No matching Univariate Multivariate Logistic regression | Endovaskulär (77.3 %), Offen-chirurgisch | IC, CLTI, ALI | 1‑year MALE Hospitalization: OR 0.91 (0.89–0.93), p < 0.0001 for female | Schlechteres Outcome bei Männern |
Doshi et al. 2017 [13] | 62.444 Patienten (43 % Frauen) | Multi-center (Nationwide Inpatient Sample) | 2012–2014 | PS matching Univariate Multivariate Logistic regression | Endovaskulär | IC, CLTI | In-hospital Mortality: 2.4 % vs. 2.3 % (p = 0.25), female vs. male In-hospital Stroke: 1 % vs. 1 % (p = 0.62), female vs. male In-hospital Major Amputation: 4 % vs. 4.1 % (p = 0.69), female vs. male | Nicht eindeutig |
Jeon-Slaughter et al. 2017 [27] | 1.084 Patienten (40 % Frauen) 1702 Prozeduren | Multi-center (XLPAD Registry) | 01/2005–10/2015 | PS matching Univariate Multivariate Cox regression | Endovaskulär | IC, CLTI | 1‑year Mortality: Unmatched: HR 0.19 (0.04–0.85), p = 0.0295 for female PS matched: HR 0.22 (0.05–1.02), p = 0.0528 for female 1‑year re-PVI: Unmatched: HR 1.62 (1.13–2.31), p = 0.0083 for female PS matched: HR 1.51 (1.02–2.22), p = 0.0378 for female | Schlechteres Outcome bei Frauen |
Rieß et al. 2017 [47] | 2798 Prozeduren (38 % Frauen) | Multi-center (PSI Registry) | 09/2015–11/2015 | No matching Univariate Multivariate Logistic regression | Endovaskulär | IC, CLTI | In-hospital Mortality: 0.6 % vs. 0.9 % (p = 0.496), female vs. male In-hospital Major Amputation: 0.3 % vs. 1.4 % (p = 0.056), female vs. male | Nicht eindeutig |
Brothers et al. 2016 [7] | 4355 Prozeduren (31,3 % Frauen) | Multi-center (Vascular Quality Initiative, VQI) | 01/2003–08/2014 | No matching Univariate Multivariate Logistic regression | Endovaskulär (30.3 %), Offen-chirurgisch | CLTI | Follow-up (9-22 months) MALE: OR 1.57 (1.32–1.86), p < 0.001 for female | Schlechteres Outcome bei Frauen |
Broich et al. 2016 [6] | 582 Patienten (29,4 % Frauen) | Single-center | 2005–2009 | No matching Univariate Multivariate Cox regression | Angiographie, Endovaskulär (68,7 %) | Asymptomatic, IC, CLTI | Follow-up (median 3,3 years; CI 3.2–3.4) Long-term mortality: OR 0.57 (0.36–0.93), p = 0.02 for female gender | Schlechteres Outcome bei Männern |
Hedayati et al. 2015 [21] | 25.635 Patienten (44,4 % Frauen) | Multi-center (PPD from California’s OSHPD Database) | 2005–2009 | No matching Univariate Multivariate Logistic regression Cox regression | Endovaskulär | IC, CLTI | 30-day Myocardial Infarction: 0.8 % vs. 0.7 % (p = 0.648), female vs. male 30-day Major Amputation: 2.5 % vs. 3.0 % (p = 0.004), female vs. male 30-day All-cause Mortality: 1.9 % vs. 1.5 % (p = 0.024), female vs. male – 1-year Re-PVI: 32.8 % vs. 34.1 % (p = 0.149), female vs male – 1-year Major Amputation: 6.1 % vs. 7.2 % (p = 0.0008), female vs. male – 1-year All-cause Mortality: 10.7 % vs. 10.6 % (p = 0.188), female vs. male – 1-year Amputation-free Survival: HR 0.84 (0.76–0.93), p = 0.0006 for female | Schlechteres Outcome bei Männern |
Ferranti et al. 2015 [15] | 3.338 Patienten (39 % Frauen) | Multi-center (VSGNE PVI Registry) | 01/2010–06/2012 | No matching Univariate | Endovaskulär | IC, CLTI | 30-day Mortality: 2.1 % vs. 1.5 % (p = 0.20), female vs. male 30-day Major Amputation: 0.6 % vs. 0.6 % (p = 0.81), female vs. male 1‑year Survival for IC: 95 % vs. 96 % (p = 0.19), female vs. male 1‑year Survival for CLTI: 77 % vs. 79 % (p = 0.35), female vs. male 1‑year Major Amputation for IC: p < 0.55, female vs. male 1‑year Major Amputation for CLTI: p < 0.23, female vs. male | Nicht eindeutig |
Vierthaler et al. 2015 [59] | 1.244 Patienten (42 % Frauen) 1.414 Prozeduren | Multi-center (VSGNE PVI Registry) | 2010–2011 | No matching Univariate Multivariate Cox regression | Endovaskulär | CLTI | 1‑year Amputation-free Survival: HR 1.5 (CI 1.1–2.0), p = 0.02 for male 1‑year Major Amputation: HR 1.6 (CI 1.1–2.6), p = 0.03 for male | Schlechteres Outcome bei Männern |
Stavroulakis et al. 2015 [55] | 517 Patienten (35,6 % Frauen) | Multi-center (2 centers) | 09/2006–08-2010 | No matching Univariate Multivariate Cox regression | Endovaskulär | IC, CLTI | 5‑year Survival: 82.6 % vs. 83.3 % (p = 0.63), female vs. male 5‑year Major Amputation: 1.6 % vs. 1.5 % (p = 0.83), female vs. male | Nicht eindeutig |
Lo et al. 2014 [37] | 1.797.885 Patienten (44 % Frauen) 1.865.999 Prozeduren | Multi-center (Nationwide Inpatient Sample) | 1998–2009 | No matching Univariate Multivariate Logistic regression | Endovaskulär (20 %), Offen-chirurgisch, Majoramputation | IC, CLTI | Results for endovascular: – In-hospital Mortality for IC: 0.5 % vs. 0.2 % (p < 0.01), female vs. male – In-hospital Mortality for CLTI: 2.3 % vs. 1.6 % (p < 0.01), female vs. male – sex predictor of In-hospital Mortality – negative impact greatest for endovascular procedures | Schlechteres Outcome bei Frauen |
Jackson et al. 2014 [24] | 12.379 Patienten (41 % Frauen) | Multi-center (Blue Cross Blue Shield of Michigan Cardiovascular Consortium PVI Registry) | 2004–2009 | PS matching Univariate Multivariate Logistic regression | Endovaskulär | IC, CLTI | In-hospital Mortality: Unmatched: 0.6 % vs. 0.4 % (p = 0.08), female vs. male PS matched: 0.38 % vs. 0.21 % (p = 0.3), female vs. male In-hospital Amputation: Unmatched: 2.0 % vs. 1.8 % (p = 0.6), female vs. male PS matched: 2.0 % vs. 1.84 % (p = 0.4), female vs. male In-hospital MI: Unmatched: 0.6 % vs. 0.48 % (p = 0.3), female vs. male PS matched: 0.6 % vs. 0.3 % (p = 0.2), female vs. male In-hospital MACE: Unmatched: 1.2 % vs. 0.9 % (p = 0.06), female vs. male PS matched: 0.9 % vs. 0.6 % (p = 0.2), female vs. male In-hospital Stroke/TIA: Unmatched: 0.22 % vs. 0.2 % (p = 0.8), female vs. male PS matched: 0.2 % vs. 0.2 % (p = 1.0), female vs. male | Nicht eindeutig |
Mao et al. 2014 [39] | 7.568 Patienten (38 % Frauen) | Taiwan’s National Health Insurance Research Database | 1997–2010 | No matching Univariate Multivariate Cox regression | Endovaskulär, Amputation | IC, CLTI | Follow-up (mean 2.45 ± 2.54 years): Death after Major Amputation: HR 1.19 (1.00–1.42), p = 0.049 for male | Nicht eindeutig |
Krishnamurthy et al. 2014 [31] | 4.459 Patienten (46 % Frauen) | Multi-center | 2008–2011 | No matching Univariate Multivariate Cox regression | Endovaskulär | CLTI | Amputation or Death at 6 months: HR 0.7 (0.6–0.8), p < 0.0001 for female | Schlechteres Outcome bei Männern |
Tadros et al. 2014 [56] | 287 Patienten (33,8 % Frauen) | Multi-center | 10/2007–04/2010 | No matching Univariate | Endovaskulär | IC, CLTI | 30-day All-cause Mortality: 0 % vs. 0 % (p =NS), female vs. male 30-day Major Adverse Event: 0 % vs. 0 % (p =NS), female vs. male 1‑year All-cause Mortality: p = NS, female vs. male | Nicht eindeutig |
McCoach et al. 2013 [40] | 219 Patienten (44,3 % Frauen) | Single-center (PAD-UCD Registry) | 2006–2010 | No matching Univariate Multivariate Cox regression | Endovaskulär | CLTI | Follow-up (median 2.2 years) – All-cause Mortality: HR 1.24 (0.77–2.01), p = 0.3 for female – MACE: HR 1.63 (1.01–2.63), p = 0.04 for female – Freedom from Amputation: HR 0.94 (0.45–1.94), p = 0.9 for female | Schlechteres Outcome bei Frauen |
Tye et al. 2013 [58] | 81 Patienten (53 % Frauen) | Single-center | 01/2005–02/2011 | No matching Univariate | Endovaskulär | CLTI | 30-day Mortality: 0 % vs. 2.4 % (p = 0.323), female vs. male 2‑year Survival: 59.8 %± 7.6 % vs. 68 % ± 8.1 (p = 0.351), female vs. male 2‑year Limb Salvage: 85.0 % ± 7.9 % vs. 83.4 % ± 7.7 % (p = 0.351), female vs. male | Nicht eindeutig |
Domenick et al. 2012 [12] | 201 Patienten (40 % Frauen) | Single-center | 2004–2010 | No matching Univariate Multivariate Logistic regression Cox regression | Endovaskulär | CLTI | 30-day Mortality: 1 % vs. 1 % (p = 0.84), female vs. male 1‑year Amputation: 8.1 % vs. 14.1 % (p = 0.18), female vs. male | Nicht eindeutig |
Lindgren et al. 2012 [36] | 112 Patienten (60 % Frauen) | Single-center | 2006–2008 | No matching Univariate Multivariate Logistic regression | Endovaskulär | IC, CLTI | 1‑year Mortality: 28 % vs. 18 % (p = 0.2), female vs. male 1‑year Amputation: 22 % vs. 4 % (p = 0.01), female vs. male 1‑year Amputation-free Survival: 58 % vs. 80 %, (p = 0.03), female vs. male Risk of Amputation: OR 9.0 (1.1–76.5), p = 0.045 for female | Schlechteres Outcome bei Frauen |
Pulli et al. 2012 [45] | 258 Patienten 258 Prozeduren (31 % Frauen) | Single-center | 2000–2010 | No matching Univariate Multivariate Cox regression | Endovaskulär | IC, CLTI | 30-day Mortality: 0 % vs. 1.6 % (p = 0.4), female vs. male 30-day Amputation: 2.5 % vs. 0.6 % (p = 0.4), female vs. male Follow-up (mean 17 months, range 1–85): Estimated 36-months Survival: 95 % vs. 84.5 % (p = 0.4), female vs. male | Nicht eindeutig |
Gallagher et al. 2011 [18] | 537 Patienten (42,6 % Frauen) 1.017 Prozeduren | Single-center | 2004–2009 | No matching Univariate | Endovaskulär | IC, CLTI | 30-day Mortality: 0 % vs. 0 %, female vs. male 30-months Amputation: 10 % vs. 14.3 %, female vs. male | Nicht eindeutig |
Egorova et al. 2010 [14] | 2,4 Mio. Entlassungen (ca. 500.000 mit PAVK) (46 % Frauen) | Multi-center (Inpatient Discharge Database of New York, New Jersey and Florida) | 1998–2007 | No matching Univariate Multivariate Logistic regression | Endovaskulär, Offen-chirurgisch, Majoramputation | IC, CLTI | Results for endovascular: – In-hospital Mortality: in 1998: 3.56 % vs. 2.86 % (p < 0.0001), female vs. male in 2007: 2.32 % vs. 1.69 % (p = 0.0001), female vs. male – Periprocedural Mortality: female gender strong predictor in patients aged 40–80 years – Amputation-related Mortality: female gender protective | Schlechteres Outcome bei Frauen |
Vouyouka et al. 2010 [60] | 372.692 Prozeduren (43.66 % Frauen) | Multi-center (Inpatient Discharge Database of New York, New Jersey and Florida) | 1998–2007 | No matching Univariate Multivariate Logistic regression | Endovaskulär, Offen-chirurgisch, Majoramputation | IC, CLTI | Results for endovascular: In-hospital Mortality: 1.97 % vs. 1.46 % (p = 0.002), female vs. male | Schlechteres Outcome bei Frauen |
DeRubertis et al. 2008 [11] | 730 Patienten (42,3 % Frauen) 1.000 Prozeduren | Single-center | 2001–2006 | No matching Univariate Multivariate Cox regression | Endovaskulär | IC, CLTI | 30-day Mortality: 0.7 % vs. 0.4 % (p > 0.05), female vs. male | Nicht eindeutig |
Kawamura et al. 2005 [28] | 268 Patienten (45,5 % Frauen) 405 Prozeduren | Single-center | 10/2001–01/2004 | No matching Univariate Multivariate | Endovaskulär | Lower extremity (66,2 %), Renal artery (27,9 %), Upper extremity (5,9 %) | In-hospital Mortality: 1.6 % vs. 0.7 % (p = 0.59), female vs. male In-hospital Stroke/TIA: 0.8 % vs. 0.7 % (p > 0.99), female vs. male | Nicht eindeutig |
Orr et al. 2002 [42] | 84 Patienten (52,4 % Frauen) 104 Prozeduren | Single-center | 1993–1999 | No matching Univariate | Endovaskulär | IC, CLTI | Median FU: 12,6 months Limb Salvage at 2 years: 88 ± 5 % vs. 94 ± 4 % (p = 0.26), female vs. male | Nicht eindeutig |
Timaran et al. 2002 [57] | 74 Patienten (41,9 % Frauen) 85 Prozeduren | Single-center | 7/1996–7/2001 | No matching Univariate Multivariate Cox regression | Endovaskulär | CLTI | Limb Salvage at 1 year: 97 % vs. 100 %, female vs. male Limb Salvage at 3 years: 92 % vs. 98 %, female vs. male Limb Salvage at 5 years: 92 % vs. 98 %, female vs. male Limb Salvage: trend towards decrease in women (p = 0.06) Gender no predictor for Limb Salvage and Long-term Survival | Nicht eindeutig |
Krikoarian et al. 1997 [30] | 206 Patienten (30,6 % Frauen) 293 Prozeduren | Single-center | 06/1988–06/1994 | No matching Univariate | Endovaskulär | IC, CLTI | In-hospital Death: 0 % vs. 0 % (p = NS), female vs. male In-hospital Stroke: 0 % vs. 0 % (p = NS), female vs. male In-hospital Amputation: 0 % vs. 0 % (p = NS), female vs. male In-hospital MI: 0 % vs. 0 % (p = NS), female vs. male Follow-up (mean 24.7 ± 20 months, range 9–70): – All-cause Mortality: 13 % vs. 14 %, female vs. male – Estimated 60-month Survival: 73 % vs. 77 % (p = NS), female vs. male | Nicht eindeutig |
Fazit für die Praxis
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Obwohl Frauen im Mittel etwa 40 % der behandelten Kohorten ausmachten, ist deren Anteil in prospektiven kontrollierten Studien weiterhin niedrig.
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Insgesamt ist die Evidenzbasis zu geschlechterspezifischen Unterschieden nach perkutaner endovaskulärer Behandlung der symptomatischen peripheren arteriellen Verschlusskrankheit (PAVK) weiterhin uneindeutig. Es gibt sowohl Studien, die über einen Nachteil für Frauen als auch für Männer bzw. keine eindeutigen Unterschiede berichtet haben.
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Die wenigsten der verfügbaren Studien haben eine adäquate Kontrolle wesentlicher Confounder, z. B. mittels Matching-Verfahren, vorgenommen.
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Das GenderReality-Projekt der Forschungsgruppe GermanVasc verfolgt das Ziel, geschlechterspezifische Unterschiede in der Diagnostik und Behandlung von zentralen Herz-Kreislauf-Erkrankungen in Deutschland zu untersuchen.
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Mit der IDOMENEO- und RABATT-Studie stehen multimethodale und mehrstufige Konsortialprojekte zur Verfügung, die sich mit der Qualitätsentwicklung in der invasiven Behandlung der peripheren arteriellen Verschlusskrankheit beschäftigen.