Primjena balona s otpuštanjem lijeka u postraničnu granu bifurkacije koronarnih arterija [Use of drug-eluting balloons in side branch of bifurcation lesions on coronary arteries]

Gulin, Dario (2019) Primjena balona s otpuštanjem lijeka u postraničnu granu bifurkacije koronarnih arterija [Use of drug-eluting balloons in side branch of bifurcation lesions on coronary arteries]. PhD thesis, Sveučilište u Zagrebu.

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Abstract

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.

Abstract in Croatian

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.

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