Primjena balona s otpuštanjem lijeka u postraničnu granu bifurkacije koronarnih arterija

doctoral thesis

• Title (english): Use of drug-eluting balloons in side branch of bifurcation lesions on coronary arteries
• Author: Dario Gulin
• Mentor: Jozica Šikić (mentor)
• Mentor: Roman Urek (komentor)
• Committee member: nije dostupno (član povjerenstva)
• Granter: University of Zagreb; School of Medicine; Zagreb
• Defense date and country: 2019-05-14, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Clinical Medical Sciences
• Universal decimal classification (UDC): 61 - Medical sciences

Abstract

Unatoč razvoju intervencijske kardiologije s uspješnijim liječenjem koronarnih stenoza
i dalje se često susrećemo s poteškoćama u liječenju bifurkacijskih lezija s obzirom da se radi
o području najzahtjevnijih intervencija s većim udjelom komplikacija i neželjenih kratkoročnih
i dugoročnih događaja nakon zahvata.
Cilj ovog istraživanja je utvrditi angiografski rezultat balona s otpuštanjem lijeka (DEBa)
u postranični segment bifurkacije koronarnih arterija u odnosu na angiografski rezultat
primjenom stenta s otpuštanjem lijeka (DES-a) i provisonal stentiranja, prvenstveno
uspoređujući stupanj in-stent restenoze i kasnog gubitka lumena najmanje šest mjeseci nakon
intervencije. Istraživanje je definirano kao prospektivno jednocentrično istraživanje u koje su
uključeni bolesnici s koronarografski prikazanim bifurkacijskim lezijama koje zahvaćaju glavni
i postranični segment. Uključeno je 60 bolesnika i podijeljeno u tri jednake skupine: DES-DEB,
DES-DES te DES s provisional stentiranjem.
Medijan dobi u svim skupinama je bio 67 godina (47-84), dok je 76,6% bolesnika bilo
muškog spola. Indikacija za koronarografiju je bila stabilna angina pektoris u 77% te nestabilna
angina u 23% bolesnika. Nije bilo statistički značajne razlike u kliničkim i demografskim
značajkama, kao niti u kardiovaskularnim čimbenicima rizika između skupina. Niti jedan
bolesnik nije doživio veliki neželjeni događaj po tipu smrti od kardiovaskularnog događaja ili
infarkta miokarda. Ponovljena revaskularizacija s intervencijom na ciljnom segmentu je
zabilježena u dva bolesnika u drugoj i u dva u trećoj skupini zbog nestabilne angine pektoris,
dok nije zabilježena u prvoj skupini. Statistički je značajno povećanje lumena postraničnog
segmenta u prvoj skupini u periodu od zahvata do kontrolne koronarografije (0,90 mm), dok se
u drugoj i trećoj skupini bilježi gubitak lumena (0,10 mm i 0,20 mm). Razlike u inicijalnim
vrijednostima najužeg lumena postraničnog segmenta između skupina nije bilo, dok je nakon
zahvata najuži lumen bio veći u drugoj i trećoj skupini u odnosu na prvu skupinu s gubitkom
razlike na kontrolnoj koronarografiji između prve i druge skupine (2,25 vs. 2,22 mm; p=0,607).
Najuži dijametar postraničnog segmenta u prvoj skupini na kontrolnoj koronarografiji je bio
statistički značajno veći u odnosu na treću skupinu (2,25 vs. 1,74 mm; p=0,0003).
Dobiveni podaci ukazuju na superiorni šestomjesečni angiografski rezultat postraničnog
segmenta primjenom DEB-a u odnosu na provisional tehniku te neinferiorni rezultat u odnosu
na primjenu DES-a.

Abstract (english)

Despite the progress and development of interventional cardiology, treatment of
bifurcation lesions is still nonoptimal and presents one of the most demanded interventions with
a higher proportion of complications, short-term and long-term unwanted events.
The aim of this study was to compare the angiographic results of drug-eluting balloon
(DEB) in the side branch of coronary artery bifurcations to the angiographic results using the
drug-eluting stent (DES) or provisional stenting, primarily by comparing the degree of in-stent
restenosis and late luminal loss, at least six months after the intervention. The study was defined
as a prospective single-center study involving patients with true bifurcation lesions that affect
both the main and side branch. 60 patients were divided into three groups: DES-DEB, DESDES,
and DES with provisional stenting.
Overall, the median age was 67 years (47-84), with 76.6% male patients. The coronary
angiography indication was stable angina pectoris in 77% of patients and unstable angina in
23% of patients. There were no statistically significant differences in clinical and demographic
characteristics, nor cardiovascular risk factors among groups. No patient has experienced a
major adverse event, counted by the death of a cardiovascular cause or a myocardial infarction.
Target lesion revascularization with the repeated intervention was recorded in two patients in
the second, and two in the third group due to unstable angina while not observed in the first
group. A statistically significant increase in diameter of the side branch was recorded in the first
group from the period of the procedure to the control coronary angiography (0.90 mm), while
in the second and third group there was a lumen loss (0.10 mm and 0.20 mm). Differences in
initial values of the narrowest lumen diameter of the side branch stenosis between the groups
did not exist. After the intervention, the narrowest lumen diameter was higher in the second and
third group compared to the first group, with the loss of difference observed on follow-up
between the first and the second group (2.25 vs. 2.22 mm; p = 0.607). Also, the narrowest lumen
diameter in the first group on follow-up was significantly higher concerning the third group
(2.25 vs. 1.74 mm; p = 0.0003).
The data obtained show the superior six-month angiographic results of using DEB in
the side branch segment to the provisional technique and the non-inferiority to DES use.

• Keywords: medicina
• Keywords (english): medicine
• Language: croatian
• URN:NBN: urn:nbn:hr:105:944403
• Study programme: Title: Biomedicine and Health Sciences; Study programme type: university; Study level: postgraduate; Academic / professional title: doktor/doktorica znanosti, područje biomedicine i zdravstva (doktor/doktorica znanosti, područje biomedicine i zdravstva)
• Type of resource: Text
• Extent: 80 str.
• File origin: Born digital
• Access conditions: Open access
• Created on: 2023-05-05 08:27:19