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master's thesis
Retrospective analysis of the Spur™-stent and drug-coated balloon intervention for infrapopliteal lesions: long-term patency, mortality and amputation-free survival
2024. urn:nbn:hr:171:539864
Fuß, Charlott
University of Split
School of Medicine

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Fuß, C. (2024). Retrospective analysis of the Spur™-stent and drug-coated balloon intervention for infrapopliteal lesions: long-term patency, mortality and amputation-free survival (Master's thesis). Split: University of Split, School of Medicine. Retrieved from https://urn.nsk.hr/urn:nbn:hr:171:539864

Fuß, Charlott. "Retrospective analysis of the Spur™-stent and drug-coated balloon intervention for infrapopliteal lesions: long-term patency, mortality and amputation-free survival." Master's thesis, University of Split, School of Medicine, 2024. https://urn.nsk.hr/urn:nbn:hr:171:539864

Fuß, Charlott. "Retrospective analysis of the Spur™-stent and drug-coated balloon intervention for infrapopliteal lesions: long-term patency, mortality and amputation-free survival." Master's thesis, University of Split, School of Medicine, 2024. https://urn.nsk.hr/urn:nbn:hr:171:539864

Fuß, C. (2024). 'Retrospective analysis of the Spur™-stent and drug-coated balloon intervention for infrapopliteal lesions: long-term patency, mortality and amputation-free survival', Master's thesis, University of Split, School of Medicine, accessed 06 September 2024, https://urn.nsk.hr/urn:nbn:hr:171:539864

Fuß C. Retrospective analysis of the Spur™-stent and drug-coated balloon intervention for infrapopliteal lesions: long-term patency, mortality and amputation-free survival [Master's thesis]. Split: University of Split, School of Medicine; 2024 [cited 2024 September 06] Available at: https://urn.nsk.hr/urn:nbn:hr:171:539864

C. Fuß, "Retrospective analysis of the Spur™-stent and drug-coated balloon intervention for infrapopliteal lesions: long-term patency, mortality and amputation-free survival", Master's thesis, University of Split, School of Medicine, Split, 2024. Available at: https://urn.nsk.hr/urn:nbn:hr:171:539864

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TitleRetrospective analysis of the Spur™-stent and drug-coated balloon intervention for infrapopliteal lesions: long-term patency, mortality and amputation-free survival
Title (croatian)Retrospektivna analiza Spur™-stenta i balonske intervencije obložene lijekom za infrapoplitealne lezije: dugoročna prohodnost, smrtnost i preživljenje bez amputacije
AuthorCharlott Fuß
MentorHans Krankenberg https://orcid.org/0000-0002-1025-1749 (mentor)
Committee memberJohannes Brachmann (predsjednik povjerenstva)
Committee memberGeorg Gerhard Grabenbauer (član povjerenstva)
Committee memberMarino Vilović (član povjerenstva)
GranterUniversity of Split
School of Medicine
Split
Defense date and country2024-09-05, Croatia
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Clinical Medical Sciences
Internal Medicine
Abstract
Objectives: This study aims to determine the therapeutic efficacy and potential risks of the Spur-stent as an additional vessel preparation technique before standard DCB-use in endovascular therapy for infrapopliteal chronic PAD. The primary outcomes of minor and major amputation-free survival, reintervention-free survival, MALE-free survival, MACE-free survival, overall mortality, and assessments of postinterventional vessel patency were collected for a maximum follow-up-period of 5 years. Patient characteristics were analyzed to detect possible confounders. Material and methods: This retrospective thesis included 24 patients with chronic PAD treated between August 2017 and March 2022 at Medinos Vascular Centre in Sonneberg, Germany. Interventions of the P3-segment of the popliteal artery and further distal arteries were included. Follow-up data was collected prior to and after the procedure and at 3, 6, 12, 24, 36, 48 and 60 months after the procedure. Data was sourced from the clinic’s Orbis database system and surgical implant records. Propensity-score matching of consecutive patients treated with the Spur-stent followed by conventional DCB was conducted and matched to patients of similar lesion length and gender that received Luminor-DCB alone. Event-free survival was analyzed using Kaplan-Meier methodology. Results: The rate of death during the follow-up period was significantly (P = 0.001) higher in the Luminor-group than in the Spur-group. Postoperative MALE-free survival was significantly better in the Spur-group (P = 0.031) than in the Luminor-group with an average of 511±0 days from intervention to MALE-events in the Spur-group and an average of 349.3±384.7 days from intervention to MALE-events in the Luminor-group. There were no significant differences in MACE-free survival (P= 0.334), reintervention-free survival (P = 0.325) and minor amputation-free survival (P = 0.768) between both groups. No major amputations were observed in the Spur-group, but 2 major amputations on average 186±241.8 days after the intervention were observed in the Luminor-group. Major amputation-free survival of the Luminor-group was 4.0±0.7 years. Conclusion: Differences in reintervention-free survival could not be proven clearly, which might have been due to limitations in study design. However, major amputation-free survival and mortality was significantly better for patients treated with the adjunctive Spur-stent. There was an overall tendency of improved vessel patency parameters in the Spur-group, suggesting the effectiveness of this device. Further large, prospective, randomized, and multi-group studies comparing the Spur-stent to other endovascular treatment options are required.
Abstract (croatian)
Ciljevi: Ova studija ima za cilj utvrditi terapijsku učinkovitost i potencijalne rizike Spur-stenta kao dodatne tehnike pripreme žila prije standardne uporabe balona obloženog lijekom u endovaskularnoj terapiji infrapoplitealne kronične periferne arterijske bolesti. Primarni ishodi preživljenja bez manje i veće amputacije, preživljenja bez ponovne intervencije, preživljenja bez većih nepovoljnih događaja na udovima, preživljenja bez većih nepovoljnih kardiovaskularnih događaja, ukupnog mortaliteta i procjene postintervencijske prohodnosti krvnih žila prikupljeni su za maksimalno praćenje od 5 godina. Analizirane su karakteristike pacijenata kako bi se otkrili mogući zbunjujući faktori. Materijal i metode: Ovaj retrospektivni rad uključio je 24 bolesnika s kroničnom perifernom arterijskom bolešću liječenih između kolovoza 2017. i ožujka 2022. u Medinos Vascular Ventre u Sonnebergu, Njemačka. Uključene su intervencije P3-segmenta poplitealne arterije i daljnjih distalnih arterija. Podaci o praćenju prikupljeni su prije i nakon zahvata te 3, 6, 12, 24, 36, 48 i 60 mjeseci nakon zahvata. Podaci su dobiveni iz kliničkog sustava baze podataka Orbis i zapisa o kirurškim implantatima. Provedeno je usklađivanje rezultata sklonosti uzastopnih pacijenata liječenih Spur stentom nakon čega je slijedio konvencionalni balon obložen lijekom i uparen s pacijentima slične duljine lezije i spola koji su primili samo balon obložen lijekom Luminor. Preživljenje bez događaja analizirano je pomoću Kaplan-Meierove metodologije. Rezultati: Stopa smrtnosti tijekom razdoblja praćenja bila je značajno (P = 0,001) viša u Luminor grupi nego u Spur grupi. Postoperativno preživljenje bez većih štetnih događaja na udovima bilo je značajno bolje u Spur skupini (P = 0,031) nego u Luminor skupini s prosjekom od 511±0 dana od intervencije do velikih štetnih događaja na udovima u Spur skupini i prosječno 349,3±384,7 dana od intervencije do velikih neželjenih događaja udova u Luminor grupi. Nije bilo značajnih razlika u preživljenju bez većih nepovoljnih kardiovaskularnih događaja (P= 0,334), preživljenju bez ponovne intervencije (P = 0,325) i preživljenju bez manje amputacije (P = 0,768) između obje skupine. Nisu uočene veće amputacije u Spur-skupini, ali 2 velike amputacije u prosjeku 186±241,8 dana nakon intervencije uočene su u Luminor-skupini. Glavno preživljenje bez amputacije Luminor grupe bilo je 4,0±0,7 godina. Zaključak: Razlike u preživljenju bez reintervencije nisu se mogle jasno dokazati, što je moglo biti posljedica ograničenja u dizajnu studije. Međutim, veće preživljenje i smrtnost bez amputacije bili su značajno bolji za pacijente liječene dodatnim Spur-stentom. Postojala je opća tendencija poboljšanja parametara prohodnosti krvnih žila u Spur grupi, što ukazuje na učinkovitost ovog uređaja. Potrebne su daljnje velike, prospektivne, randomizirane studije s više skupina koje uspoređuju Spur-stent s drugim opcijama endovaskularnog liječenja.
Keywords
Keywords (croatian)
Languageenglish
URN:NBNurn:nbn:hr:171:539864
Study programmeTitle: Medical Studies in English
Study programme type: university
Study level: integrated undergraduate and graduate
Academic / professional title: doktor/doktorica medicine (doktor/doktorica medicine)
Type of resourceText
File originBorn digital
Access conditionsOpen access
Embargo expiration date: 2024-09-05
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Created on2024-08-28 07:24:28