| Abstract | Unatoč razvoju suvremenih metoda PCI-a i kvalitetnijeg liječenja bolesnika s akutnim koronarnim sindromom, u svakodnevnoj praksi se i dalje susrećemo s problemom ISR i potrebom reintervencija u tih bolesnika.
Cilj ovog ispitivanja bio je utvrditi sigurnost i učinkovitost primjene DEB-a u kombinaciji s BMS-om u PCI-a kod bolesnika s akutnim koronarnim sindromom bez ST elevacije, prvenstveno u pogledu redukcije LLL-a, te smanjenja incidencije binarne ISR.
Ovo je bilo prospektivno randomiziran ispitivanje koje je uključilo bolesnike hospitalizirane zbog NSTEMI-ja ili nestabilne angine pektoris. Bolesnici su bili podvrgnuti koronarografiji unutar 24-48 sati od primitka, te su bili randomizirani u dvije skupine: BMS skupina – PCI ciljne lezije s BMS-om i BMS+DEB skupina – PCI ciljne lezije s BMS-om uz postdilataciju s paklitaksel DEB-om. Angiografska kontrola je bila nakon šest mjeseci zbog najveće incidencije restenoze u tom vremenskom periodu. Primarni ispitivani ishodi bili su binarna ISR i LLL, a sekundarni ispitivani ishodi bili su TLR, ST i novi akutni koronarni sindrom nakon šest mjeseci.
U ispitivanje je bilo uključeno ukupno 85 ispitanika, 44 u BMS skupini i 41 u BMS+DEB skupini. Medijan životne dobi iznosio je 68 (36-84) godina a 68 (80%) ispitanika je bilo muškog spola. Pedeset i dva (61,2%) bolesnika su imala NSTEMI, a 33 (38,8%) bolesnika nestabilnu anginu pektoris. Nije bilo statistički značajne razlike u demografskim karakteristikama, rizičnim čimbenicima i kliničkim karakteristikama između ispitivanih skupina (dob, spol, BMI, NSTEMI ili nestabilna angina pektoris, GRACE zbroj bodova, EF, šećerna bolest, hipertenzija, hiperlipidemija, kronično bubrežno zatajenje) osim većeg broja aktualnih pušača u BMS+DEB skupini 18/41 (43,9%) naspram 9/44 (20,5%); p=0,033. U većine bolesnika učinjena je kontrolna koronarografija nakon šest mjeseci, osim u 3/44 (6,8%) bolesnika iz BMS skupine i 2/41 (4,8%) bolesnika iz BMS+DEB skupine koji su ranije podvrgnuti koronarografiji zbog novog akutnog koronarnog sindroma.
Nije bilo statistički značajne razlike u binarnoj ISR nakon šest mjeseci između ispitivanih skupina, p=0,593, međutim LLL je bio statistički značajno niži u BMS+DEB skupini 0,22 (0,00-2,35) mm naspram 0,68 (0,00-2,25) mm; p=0,002. Također nije bilo razlike u velikim neželjenim kardijalnim događajima koji obuhvaćaju TLR, ST i novi akutni koronarni sindrom između ispitivanih skupina, 29,5% (BMS) naspram 24,4% (BMS+DEB); p=0,835. Jedan je bolesnik iz BMS+DEB skupine imao subakutnu ST zbog rezistencije na klopidogrel koja je dokazana agregometrijom.
U zaključku, upotreba kombinacije BMS-a i DEB-a u bolesnika sa akutnim koronarnim sindromom bez ST elevacije je sigurna u smislu akutne ili subakutne ST. U bolesnika s BMS+DEB zabilježena je statistički značajna redukcija LLL-a u odnosu na bolesnike s izoliranom primjenom BMS-a, no bez utjecaja na klinički ishod bolesnika. BMS +DEB nije bio superiorniji u odnosu na izoliranu primjenu BMS-a u redukciji binarne ISR i MACE (TLR, ST, novi akutni koronarni sindrom). Potrebna su ispitivanja s većim brojem ispitanika kako bi se utvrdila potencijalna dobrobit od kombinacije BMS+DEB u tih bolesnika. S obzirom na dobre rezultate „DEB only“ u bolesnika sa stabilnom koronarnom bolešću, taj koncept može predstavljati alternativu u bolesnika s akutnim koronarnim sindromom. |
| Abstract (english) | Despite the development of PCI techniques and better quality in treating patients with acute coronary syndromes, we have to deal with the problem of restenosis and reinterventions in those patients in our daily practice.
The purpose of this study was to determine the safety and efficacy of DEB in combination with BMS in PCI of patients with non-ST elevation acute coronary syndrome primarily in reducing the incidence of LLL and binary ISR.
This was a prospective randomized study which included patients who were hospitalized because of NSTEMI or UA. Coronary angiography was performed in the first 24-48 hours and the patients were randomized into two groups: BMS only group - PCI of the target lesion with BMS and BMS+DEB group - PCI of the target lesion with BMS followed by postdilatation with paclitaxel DEB. Angiographic follow- up was performed after 6 months because of the highest incidence of restenosis in this time period. The primary endpoints were binary ISR and LLL and the secondary endpoints were TLR, ST and new ACS at 6 months.
A total of 85 patients were enrolled in the study, 44 in the BMS group and 41 in the BMS+DEB group. The median age was 67 (36-84) years and there were 68 males (80%). Fifty two patients (61.2%) had NSTEMI and 33 patients (38.8%) UA. There was no statistically significant difference in patient demographics, risk factors and clinical characteristics between the two groups except for the fact that there were more smokers in the BMS+DEB group 18/41 (43.9%) vs. 9/44 (20.5%), p=0.033. Follow-up angiography was performed in all patients after 6 months, except in 3/44 (6.8%) patients in the BMS group and in 2/41 (4.8%) in the BMS+DEB group, in which angiography was performed earlier because of a new ASC. There was no statistical significant difference in binary ISR after 6 months between the two groups; p=0.593, but LLL was significant lower in the BMS+DEB group 0.22 (0.00-2.35) mm vs. 0.68 (0.00-2.25) mm; p= 0.002. The difference in MACE rate combining TLR, ST and ACS, between the groups was also nonsignificant, 29.5% (BMS) vs 24.4% (BMS+DEB); p= 0.835. One patient had subacute ST (BMS+DEB) due to clopidogrel resistance proofed by aggregometry.
In conclusion, the use of BMS+DEB in patients with non-ST elevation acute coronary syndromes seems to be safe in terms of acute or subacute stent thrombosis. There was significant less LLL in BMS+DEB in comparison to BMS alone but without an impact in patient clinical outcomes. BMS+DEB was not superior to BMS in reduction of binary ISR and MACE (TLR, ST, ACS). More studies with larger sample sizes are needed to evaluate the potential benefit of BMS+DEB in those patients. The “DEB only” concept can also be an alternative considering the good results in patients with stable coronary artery disease. |
