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Publications (10 of 137) Show all publications
Hörer, T. M., Abu-Zidan, F. M., McGreevy, D., Nilsson, K. F. & Gidlund, K. D. (2026). Abdominal Compartment Syndrome After Endovascular Repair of Ruptured Abdominal Aortic Aneurysms: A Single-Center Experience of Total Endovascular Care for Ruptured Abdominal Aneurysms. Journal of Endovascular Therapy, 33(4), 2021-2028
Open this publication in new window or tab >>Abdominal Compartment Syndrome After Endovascular Repair of Ruptured Abdominal Aortic Aneurysms: A Single-Center Experience of Total Endovascular Care for Ruptured Abdominal Aneurysms
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2026 (English)In: Journal of Endovascular Therapy, ISSN 1526-6028, E-ISSN 1545-1550, Vol. 33, no 4, p. 2021-2028Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: Open repair of ruptured abdominal aortic aneurysms (rAAA) has been increasingly replaced by endovascular aortic repair (EVAR) in many centers. Despite being a minimally invasive procedure, EVAR is associated with a risk of abdominal compartment syndrome (ACS), which can lead to significant morbidity and mortality. This study examines the incidence and clinical manifestation of ACS in a consecutive cohort of rAAA patients treated exclusively with EVAR at Örebro University Hospital over a 12-year period.

METHODS: This is a retrospective analysis of prospectively collected data. We identified 139 patients who had presented to Örebro University Hospital with rAAA between October 2009 and September 2021. Patients with isolated iliac artery, thoracic and thoracoabdominal aortic ruptures, previous aortic interventions (open or endovascular), and patients receiving palliative treatment were excluded. Patients developing ACS after rAAA were compared with those who did not develop ACS.

RESULTS: A total of 100 patients treated using EVAR were included in this study. ACS was identified in 17 patients, and these were compared with 83 patients who did not develop ACS. Mortality at 30 days was 53% in the ACS group (9/17) and 22% in the No-ACS group (18/83, p = 0.015). Regression analysis showed that advanced age and ACS were independent risk factors for death, with ACS increasing the hazard 4-fold (HR 4.26, CI 1.99-9.10, p < 0.001) and age increasing the hazard by 6% for every year (HR 1.06, CI 1.06-1.1, p = 0.004). The use of aortic balloon occlusion was not independently associated with the development of ACS.

CONCLUSIONS: ACS is a life-threatening complication of rAAA treated using EVAR and a significant number of patients developed ACS with high mortality and complication rates. All rAAA patients treated using EVAR should be monitored closely for ACS and treatment with decompressive laparotomy should be initiated without delay.Clinical ImpactOpen repair of ruptured abdominal aortic aneurysms (rAAA) has been increasingly replaced by endovascular aortic repair (EVAR). Despite being a minimally invasive procedure, EVAR is associated with a risk of abdominal compartment syndrome (ACS), which can lead to significant morbidity and mortality This article investigates abdominal compartment syndrome (ACS) in a cohort of total endovascular treated rAAA in a single centre and the treatment as well as the results, and gives insight on ACS in this patient group and might contribute to better understanding how to treat them and avoid this life-threatening complication.

Place, publisher, year, edition, pages
Sage Publications, 2026
Keywords
Abdominal aortic aneurysm, abdominal compartment syndrome, aortic aneurysm, aortic rupture, complications after aortic surgery, endovascular aortic repair, endovascular procedures
National Category
Surgery Cardiology and Cardiovascular Disease
Identifiers
urn:nbn:se:oru:diva-120356 (URN)10.1177/15266028251328494 (DOI)001457435100001 ()40165640 (PubMedID)2-s2.0-105002630728 (Scopus ID)
Available from: 2025-04-02 Created: 2025-04-02 Last updated: 2026-08-25Bibliographically approved
McGreevy, D. T., Zanzot, M., Hörer, T. M., D'Oria, M., Pirouzram, A. & Petri, M. H. (2026). Chimney in Ruptured Abdominal Aortic Aneurysms: A Retrospective Analysis of 14 Years in a cohort treated only by endovascular repair. Annals of Vascular Surgery, 128, 173-180
Open this publication in new window or tab >>Chimney in Ruptured Abdominal Aortic Aneurysms: A Retrospective Analysis of 14 Years in a cohort treated only by endovascular repair
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2026 (English)In: Annals of Vascular Surgery, ISSN 0890-5096, E-ISSN 1615-5947, Vol. 128, p. 173-180Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: Ruptured abdominal aortic aneurysm (rAAA) carries an extremely high mortality rate. Chimneys are used to gain proximal landing zone for sealing when the aortic neck is hostile due to conicity or distance to the renal arteries are not optimal. This study aimed to retrospectively evaluate the outcomes of patients with rAAA treated in an endovascular only center over a 14 year period, comparing those who underwent Chimney Endovascular Aortic Repair (Ch-EVAR) with those who received standard Endovascular Aortic Repair (EVAR).

METHODS: This single-center, retrospective observational study included all patients with a CT-confirmed rAAA between October 2009 and October 2023. All the patients were treated endovascular. Patient demographics, risk factors, anatomical characteristics, perioperative variables, and postoperative outcomes were analyzed and compared between the Ch-EVAR and EVAR groups.

RESULTS: A total of 121 (mean age 75) patients underwent endovascular repair for rAAA, with 19 patients receiving at least one chimney (Ch-EVAR) and 93 undergoing standard EVAR. A total of 28 chimney grafts were deployed in the Ch-EVAR group. The incidence of type Ia endoleaks was significantly higher in the Ch-EVAR group compared to the EVAR group (p<0.05). Whereas there were no significant differences in 30 days or 1 year mortality, complication rates, or postoperative renal function between the groups.

CONCLUSION: Ch-EVAR is a viable option for rAAA patients with unfavorable aortic neck anatomy when performed in specialized centers, offering comparable perioperative outcomes and mortality rates to standard EVAR. However, the increased risk of type Ia endoleaks warrants careful patient selection and long-term surveillance.

Place, publisher, year, edition, pages
Elsevier, 2026
Keywords
Aortic rupture, Ch-EVAR, Chimney, EVAR, Endovascular aortic repair, Hostile neck and endoleak, abdominal aneurysm, mortality, rAAA
National Category
Surgery Cardiology and Cardiovascular Disease
Identifiers
urn:nbn:se:oru:diva-127801 (URN)10.1016/j.avsg.2026.02.034 (DOI)001731425300001 ()41794125 (PubMedID)
Available from: 2026-03-09 Created: 2026-03-09 Last updated: 2026-06-09Bibliographically approved
Sellgren, F., Falkenberg, M., Andersson, M., Andersson, M., Le Corvec, T., Delle, M., . . . Nordanstig, J. (2026). Paclitaxel-Coated Devices in Patients With Chronic Limb-Threatening Ischemia and Tissue Loss Undergoing Infrainguinal Endovascular Revascularization: Insights From the SWEDEPAD-1 Trial. Circulation. Cardiovascular Interventions, Article ID e016977.
Open this publication in new window or tab >>Paclitaxel-Coated Devices in Patients With Chronic Limb-Threatening Ischemia and Tissue Loss Undergoing Infrainguinal Endovascular Revascularization: Insights From the SWEDEPAD-1 Trial
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2026 (English)In: Circulation. Cardiovascular Interventions, ISSN 1941-7640, E-ISSN 1941-7632, article id e016977Article in journal (Refereed) Epub ahead of print
Abstract [en]

BACKGROUND: Patients with chronic limb-threatening ischemia and tissue loss (Rutherford 5-6) are at high risk of major amputation. Drug-coated technologies are effective in coronary interventions, but their impact on limb outcomes in advanced ischemia remains uncertain. We evaluated whether drug-coated devices improve limb salvage in this high-risk population.

METHODS: This post hoc subgroup analysis used data from SWEDEPAD-1 (Swedish Drug-Elution Trial in Peripheral Arterial Disease), a multicenter registry-based randomized controlled trial of endovascular treatment for infrainguinal arterial disease. Adults with chronic limb-threatening ischemia were randomized 1:1 to treatment with paclitaxel-coated or uncoated endovascular devices. Only patients with tissue loss (Rutherford 5 or 6) were included. The primary end point was time to ipsilateral major amputation. Secondary end points were target vessel reintervention and a composite of major amputation or target vessel reintervention. Outcomes were assessed at 3 months, 1 year, and 5 years using intention-to-treat analyses and adjusted Cox proportional hazards models.

RESULTS: Among 1761 patients (median age, 77 years; 60.1% male; 58.4% diabetes), ipsilateral major amputation within 3 months was more frequent in the paclitaxel-coated group than in the uncoated group (10.4% versus 7.5%; adjusted hazard ratio, 1.43 [95% CI, 1.04-1.96]). Amputation rates were similar at 1 year (16.3% versus 14.6%) and remained comparable through 5 years. Target vessel reintervention at 1 year was lower with paclitaxel-coated devices (13.6% versus 18.0%; adjusted hazard ratio, 0.77 [95% CI, 0.61-0.97]), but this difference was attenuated when early limb loss was included in a composite end point. No significant between-group differences were observed at 5 years.

CONCLUSIONS: In patients with chronic limb-threatening ischemia and tissue loss, paclitaxel-coated devices did not improve limb salvage and were associated with a higher early risk of major amputation. Although target vessel reintervention was reduced at 1 year, this apparent benefit was not maintained when accounting for the competing risk of limb loss in a composite end point.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02051088.

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2026
Keywords
atherosclerosis, chronic limb-threatening ischemia, mortality, peripheral arterial disease, quality of life
National Category
Cardiology and Cardiovascular Disease
Identifiers
urn:nbn:se:oru:diva-131549 (URN)10.1161/CIRCINTERVENTIONS.126.016977 (DOI)42779544 (PubMedID)
Available from: 2026-09-25 Created: 2026-09-25 Last updated: 2026-09-25Bibliographically approved
Martínez-Hernández, A. & Hörer, T. M. (2026). REBOA in penetrating abdominal trauma: promise and precision [Letter to the editor]. Trauma surgery & acute care open, 11(1), Article ID e002228.
Open this publication in new window or tab >>REBOA in penetrating abdominal trauma: promise and precision
2026 (English)In: Trauma surgery & acute care open, E-ISSN 2397-5776, Vol. 11, no 1, article id e002228Article in journal, Letter (Other academic) Published
Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2026
Keywords
Shock, Hemorrhagic, Wounds, Penetrating, abdominal injuries, resuscitation
National Category
Surgery
Identifiers
urn:nbn:se:oru:diva-127031 (URN)10.1136/tsaco-2025-002228 (DOI)001673100500001 ()41624401 (PubMedID)
Available from: 2026-02-03 Created: 2026-02-03 Last updated: 2026-02-11Bibliographically approved
Coccolini, F., Cicuttin, E., Chirica, M., Reva, V., Coimbra, R., Sartelli, M., . . . Bass, G. (2026). The extended postoperative complication score: A dual-axis reporting plan for general surgery. Journal of Trauma and Acute Care Surgery, 101(2), 324-330
Open this publication in new window or tab >>The extended postoperative complication score: A dual-axis reporting plan for general surgery
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2026 (English)In: Journal of Trauma and Acute Care Surgery, ISSN 2163-0755, E-ISSN 2163-0763, Vol. 101, no 2, p. 324-330Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Grading surgical complications and sequelae is of paramount importance for analyzing results and improving patient care and system performance and in optimizing resource allocation and use. Existing systems for surgical complication classification do not consistently account for baseline physiologic vulnerability and often conflate treatment intensity with clinical severity. This limitation reduces interpretability across diverse patient populations, particularly in emergency and elective general surgery.

METHODS: A multidisciplinary expert panel conducted a modified Delphi process to develop a dual-axis classification system, the Extended Postoperative Complication Score (EPCS). This system stratifies patients preoperatively into three baseline classes (A, B, C) reflecting physiologic reserve and immunocompetence. Postoperative events are then graded by physiologic impact from Grade 0 (minor, no impact) to Grade IV (death). Sequelae, defined as anticipated events related to underlying pathology or chronic disease, are separately categorized. Representatives of the most relevant international emergency and trauma surgical associations were involved (World Society of Emergency Surgery, European Society for Trauma and Emergency Surgery, American Association for the Surgery of Trauma, Panamerican Trauma Society, EndoVascular and Trauma Management Society, Global Alliance for Infections in Surgery).

RESULTS: The EPCS yields 18 mutually exclusive strata, combining five complication grades and three baseline classes, plus three sequelae codes. The matrix enables interpretable outcome reporting across settings, accounting for both event severity and host vulnerability. Expert consensus confirmed conceptual clarity and operational feasibility. The system allows applications to elective, urgent, and emergent operations, and is compatible with clinical audit, observational research, and pragmatic trials.

CONCLUSIONS: The EPCS provides a structured, physiologically anchored method for postoperative complication stratification. Its dual-axis design may improve the validity of outcome comparisons and support real-world evaluation of surgical quality. Further validation is warranted through prospective multicenter implementation and time-bound observational methodologies. ( J Trauma Acute Care Surg . 2026;100:700-706. 

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2026
Keywords
Surgery, outcomes, postoperative complications, registry
National Category
Surgery
Identifiers
urn:nbn:se:oru:diva-128837 (URN)10.1097/TA.0000000000005014 (DOI)001833125600014 ()42130329 (PubMedID)
Available from: 2026-05-15 Created: 2026-05-15 Last updated: 2026-08-11Bibliographically approved
D'Oria, M., Lembo, R., Hörer, T. M., Rasmussen, T., Mani, K., Parlani, G., . . . Bertoglio, L. (2025). An International Expert-Based CONsensus on Indications and Techniques for aoRtic balloOn occLusion in the Management of Ruptured Abdominal Aortic Aneurysms (CONTROL-RAAA). Journal of Endovascular Therapy, 32(5), 1623-1633
Open this publication in new window or tab >>An International Expert-Based CONsensus on Indications and Techniques for aoRtic balloOn occLusion in the Management of Ruptured Abdominal Aortic Aneurysms (CONTROL-RAAA)
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2025 (English)In: Journal of Endovascular Therapy, ISSN 1526-6028, E-ISSN 1545-1550, Vol. 32, no 5, p. 1623-1633Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: To report on the recommendations of an expert-based consensus on the indications, timing, and techniques of aortic balloon occlusion (ABO) in the management of ruptured abdominal aortic aneurysms (rAAA).

METHODS: Eleven facilitators created appropriate statements regarding the study issues that were voted on using a 4-point Likert scale with open-comment fields, by a selected panel of international experts (vascular surgeons and interventional radiologists) using a 3-round modified Delphi consensus procedure (study period: January-April 2023). Based on the experts' responses, only the statements reaching grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final study report. The consistency of each round's answers was also graded using Cohen's kappa, the intraclass correlation coefficient, and, in case of double resubmission, Fleiss kappa.

RESULTS: Sixty-three experts were included in the final analysis and voted on 25 statements related to indication and timing (n=6), and techniques (n=19) of ABO in the setting of rAAA. Femoral sheath or ABO should be preferably placed in the operating room, via a percutaneous transfemoral access, on a stiff wire (grade B, consistency I), ABO placement should be suprarenal and last less than 30 minutes (grade B, consistency II), postoperative peripheral vascular status (grade A, consistency II) and laboratory testing every 6 to 12 hours (grade B, consistency) should be assessed to detect complications. Formal training for ABO should be implemented (grade B, consistency I). Most of the statements in this international expert-based Delphi consensus study might guide current choices for indications, timing, and techniques of ABO in the management of rAAA. Clinical practice guidelines should incorporate dedicated statements that can guide clinicians in decision-making.

CONCLUSIONS: At arrival and during both open or endovascular procedures for rAAA, selective use of intra-aortic balloon occlusion is recommended, and it should be performed preferably by the treating physician in aortic pathology.

CLINICAL IMPACT: This is the first consensus study of international vascular experts aimed at defining the indications, timing, and techniques of optimal use of ABO in the clinical setting of rAAA. Aortic occlusion by endovascular means (or ABO) is a quick procedure in properly trained hands that may play an important role as a temporizing measure until the definitive aortic repair is achieved, whether by endovascular or open means. Since data on its use in hemodynamically unstable patients are limited in the literature, owing to practical challenges in the performance of well-conducted prospective studies, understanding real-world use by experts is of importance in addressing critical issues and identifying main gaps in knowledge.

Place, publisher, year, edition, pages
Sage Publications, 2025
Keywords
Delphi consensus, aortic aneurysm, balloon occlusion, ruptured aneurysm
National Category
Surgery
Identifiers
urn:nbn:se:oru:diva-110373 (URN)10.1177/15266028231217233 (DOI)001117776400001 ()38062565 (PubMedID)2-s2.0-85179301934 (Scopus ID)
Available from: 2023-12-18 Created: 2023-12-18 Last updated: 2025-09-22Bibliographically approved
Larsen, J., Stene Hurtsén, A., McGreevy, D. T., Chwich, J., Hörer, T. M. & Gidlund, K. D. (2025). Endovascular management of iatrogenic femoral access site vascular injuries: A case series and literature review. JVS-Vascular Insights (JVS-VI), 3, Article ID 100274.
Open this publication in new window or tab >>Endovascular management of iatrogenic femoral access site vascular injuries: A case series and literature review
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2025 (English)In: JVS-Vascular Insights (JVS-VI), E-ISSN 2949-9127, Vol. 3, article id 100274Article in journal (Refereed) Published
Abstract [en]

Objective: Iatrogenic major vascular injuries at femoral artery access sites are potentially life-threatening complications of endovascular procedures. Although open surgical repair remains the standard treatment, it carries significant morbidity. Endovascular management using covered stent grafts, deployed via a contralateral or ipsilateral approach, presents a minimally invasive alternative in selected cases. This study reports a single-center experience with an endovascular-first strategy and review of relevant published data.

Methods: A retrospective single-center observational study was conducted between 2016 and 2024. Patients treated with covered stent grafts for iatrogenic vascular access site injuries, defined as access site-related hemorrhage or pseudoaneurysm involving the external iliac artery, common femoral artery or superficial femoral artery, were included. The most common mechanism of injury requiring stenting was closure device failure. A literature review of published data on PubMed was performed. The primary outcomes assessed were technical success and stent graft patency during follow-up.

Results: A total of 20 access site-related vascular injuries were treated using covered stent grafts. Technical success was achieved in 95% (19/20). Stent graft patency was maintained in 100% of cases at 30 days (n = 15) and 1 year (n = 11). The literature review identified 15 studies and a total of 585 patients treated with covered stent grafts with technical success in nearly 100% and preserved stent graft patency throughout a follow-up period ranging from 3 months to a maximum of 3 years in all but a handful of cases.

Conclusions: Endovascular repair using covered stent grafts is a viable treatment option for iatrogenic access site vascular injuries of the external iliac, common femoral, and superficial femoral arteries. This approach may be particularly beneficial for frail patients or those with hemodynamic instability. Further studies are needed to confirm long-term outcomes and optimal patient selection. 

Place, publisher, year, edition, pages
Elsevier, 2025
Keywords
Covered stent graft, Endovascular repair, Femoral artery, Hybrid operating rooms, Iatrogenic vascular injuries, Vascular access complication
National Category
Surgery
Identifiers
urn:nbn:se:oru:diva-126284 (URN)10.1016/j.jvsvi.2025.100274 (DOI)001813437400016 ()2-s2.0-105013677641 (Scopus ID)
Available from: 2026-01-14 Created: 2026-01-14 Last updated: 2026-07-29Bibliographically approved
Hörer, T. M. & McGreevy, D. T. (2025). EVTM Today: Building Knowledge, Structure, and Evidence. Journal of Endovascular Resuscitation and Trauma Management (JEVTM), 9(2), 31-32
Open this publication in new window or tab >>EVTM Today: Building Knowledge, Structure, and Evidence
2025 (English)In: Journal of Endovascular Resuscitation and Trauma Management (JEVTM), ISSN 2002-7567, Vol. 9, no 2, p. 31-32Article in journal, Editorial material (Other academic) Published
Place, publisher, year, edition, pages
Örebro: Örebro University Hospital, 2025
National Category
Cardiology and Cardiovascular Disease Surgery
Identifiers
urn:nbn:se:oru:diva-127973 (URN)10.26676/jevtm.63479 (DOI)001705892400001 ()
Available from: 2026-03-16 Created: 2026-03-16 Last updated: 2026-03-16Bibliographically approved
McGreevy, D., Hörer, T. M. & Petri, M. (2025). In-Vivo Optical Spectroscopy (INVOS) as a Prognostic Tool for Peripheral Artery Disease During Endovascular Intervention: A Pilot Study [Letter to the editor]. Journal of Endovascular Therapy, Article ID 15266028251380182.
Open this publication in new window or tab >>In-Vivo Optical Spectroscopy (INVOS) as a Prognostic Tool for Peripheral Artery Disease During Endovascular Intervention: A Pilot Study
2025 (English)In: Journal of Endovascular Therapy, ISSN 1526-6028, E-ISSN 1545-1550, article id 15266028251380182Article in journal, Letter (Other academic) Epub ahead of print
Abstract [en]

INTRODUCTION: Peripheral arterial disease (PAD), including intermittent claudication (IC) or critical limb ischemia (CLI), can be treated with endovascular revascularization; however, tools for intraoperative prognostication are limited. The In-Vivo Optical Spectroscopy (INVOS) system, a non-invasive near-infrared spectroscopy device, measures tissue oxygenation. This pilot study aims to investigate the use of INVOS during endovascular surgery for PAD as a prognostic tool for endovascular PAD treatment. This study is intended as a feasibility and hypothesis-generating pilot, rather than one designed to draw definitive conclusions.

METHODS: Thirty patients with PAD undergoing endovascular treatment were prospectively enrolled. In-Vivo Optical Spectroscopy sensors were applied to the treated foot preoperatively. Measurements were recorded preoperatively, postoperatively, and at 1, 2, and 3 hours post-surgery. Raw INVOS values and INVOS/systolic blood pressure (SBP) ratios were calculated and normalized to baseline values to determine fold changes. Clinical outcomes were assessed at 30 days.

RESULTS: No significant changes in raw INVOS or SBP values were observed before or after the procedure in both IC and CLI groups. However, the normalized INVOS/SBP ratio was significantly higher in IC patients at 1 and 2 hours postoperatively (p<0.05). A fold change greater than 1.25 was associated with better clinical outcomes, including fewer complications and higher rates of patient- and physician-reported improvement.

CONCLUSION: An INVOS/SBP ratio fold change greater than 1.25-fold is associated with improved outcomes following endovascular intervention for PAD. In-Vivo Optical Spectroscopy may serve as a valuable intraoperative prognostic tool, particularly in IC patients. Further studies are needed to validate these findings.Clinical ImpactThe clinical impact of the current work is to improve the knowledge in the application of INVOS measurements peri operative in clinical practices and improve patients care. Post operative surveillance with INVOS could be used to confirm surgical success. INVOS ratio lower than 1.25-fold after first revascularization should be reassessed and improve blood flow towards the limb. Although limited, this pilot study shows that the use of INVOS can be an adjuvanted tool in monitoring surgical outcomes in patients with PAD.

Place, publisher, year, edition, pages
Sage Publications, 2025
Keywords
acute limb ischemia, endovascular treatment/therapy, intermittent claudication, ischemia, peripheral artery disease, revascularization
National Category
Cardiology and Cardiovascular Disease
Identifiers
urn:nbn:se:oru:diva-124190 (URN)10.1177/15266028251380182 (DOI)001587022900001 ()41035344 (PubMedID)
Available from: 2025-10-06 Created: 2025-10-06 Last updated: 2026-07-02Bibliographically approved
Falkenberg, M., James, S., Andersson, M., Andersson, M., Delle, M., Engström, J., . . . Nordanstig, J. (2025). Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial. The Lancet, 406(10508), 1103-1114
Open this publication in new window or tab >>Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial
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2025 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 406, no 10508, p. 1103-1114Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Drug-coated devices are frequently used in coronary and peripheral interventions, but their effect on amputation risk in peripheral artery disease is unclear. We assessed whether drug-coated devices affect the rate of above-ankle amputation in patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation.

METHODS: The Swedish Drug-Elution Trial in Peripheral Arterial Disease 1 (SWEDEPAD 1) was a pragmatic, nationwide, multicentre, participant-masked, registry-based, randomised controlled trial at 22 Swedish centres. Adult patients with Rutherford category 4-6 peripheral artery disease scheduled for infrainguinal endovascular treatment were eligible for inclusion. Participants were randomly allocated in a 1:1 ratio after successful guidewire crossing to receive either paclitaxel-coated or uncoated balloons or stents. Randomisation was stratified by centre and performed using a computer-generated sequence with allocation concealment via a secure, registry-embedded web system. The primary efficacy endpoint was ipsilateral major amputation (above the ankle) during follow-up. All analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02051088) and the primary analysis is complete; further analyses are ongoing.

FINDINGS: From Nov 5, 2014, to Sept 29, 2023, 2400 patients were randomly assigned to treatment with paclitaxel-coated devices (n=1206) or with uncoated devices (n=1194). 2355 patients were included in the intention-to-treat analysis (1180 in the paclitaxel-coated group and 1175 in the uncoated group). The median age was 77 years (IQR 71-83), 1317 (55·9%) of 2355 patients were male and 1038 (44·1%) were female, and 1237 (52·6%) patients had preoperative diabetes. Median follow-up was 2·67 years (IQR 1·08-4·78). Most patients (1761 [74·9%] of 2351) had wounds or tissue loss (Rutherford stage 5 or 6). Treated lesions were located in the femoropopliteal vascular segment in 1241 (52·7%) of 2355 patients, in the infrapopliteal segment in 537 (22·8%) patients, and in both segments in 561 (23·8%) patients. Nearly all paclitaxel-coated devices (>99%) used paclitaxel as the coating agent (>99%). There was no significant difference in the rate of ipsilateral major amputation between using paclitaxel-coated or uncoated devices (hazard ratio [HR] 1·05 [95% CI 0·87-1·27]; p=0·61) with maximum of 5 years of follow-up. There was no difference in all-cause mortality (HR 1·04 [95% CI 0·92-1·17]; p=0·54).

INTERPRETATION: In patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not reduce major ipsilateral amputations.

Place, publisher, year, edition, pages
Elsevier, 2025
National Category
Cardiology and Cardiovascular Disease Public Health, Global Health and Social Medicine
Identifiers
urn:nbn:se:oru:diva-123358 (URN)10.1016/S0140-6736(25)01585-5 (DOI)001575231200006 ()40902617 (PubMedID)
Funder
Swedish Research CouncilSwedish Heart Lung Foundation
Note

Funding Agencies:

Swedish Research Council, Swedish Heart Lung Foundation, and the Swedish state under the agreement between the Swedish Government and county councils.

Available from: 2025-09-04 Created: 2025-09-04 Last updated: 2025-10-07Bibliographically approved
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ORCID iD: ORCID iD iconorcid.org/0000-0003-3912-4732

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