| Abstract | Perkutana koronarna intervencija sa implantacijom stenta, postala je standardna procedura u bolesnika s koronarnom bolešću, a pogotovo u akutnom koronarnom sindromu. Dugoročni rezultati su dobri, no problem restenoze u stentu još nije riješen. U najnovije vrijeme, čini se, da bi stentovi koji izlučuju lijekove, mogli biti rješenje za ovaj problem, no još nema sigurnih dokaza o njihovom dugoročnom ishodu u situacijama akutnog koronarnog sindroma. Stent graft (stent presvučen PTFE-om) također bi mogao dovesti do redukcije akutnih komplikacija intervencije, kao i restenoze tijekom praćenja, i to smanjenjem protruzije aktivnog plaka kroz stent i distalne embolizacije, kao i smanjenjem interreakcije pojedinih oslobođenih faktora rasta iz stanica tkiva i krvi, u ranom postintervencijskom periodu, smanjujući na taj način incidenciju restenoze. Proveli smo randomiziranu studiju u svrhu evaluacije stent grafta u usporedbi sa sirolimus stentom i standardnim metalnim stentom u bolesnika koji su podvrgnuti perkutanoj koronarnoj intervenciji u akutnom koronarnom sindromu. Primarni cilj ispitivanja bila je angiografska restenoza nakon 6-mjesečnog praćenja, mjerena metodom kvantitativne koronarne angiografske analize. Sekundarni cilj bila je pojava velikih nepovoljnih kardioloških događaja (MACE) tijekom 6-mjesečnog praćenja. U našem Laboratoriju 119 bolesnika s akutnim koronarnim sindromom, nakon što su isključeni bolesnici nepovoljni za ispitivanje, randomizirano je ili za implantaciju stent grafta (skupina 1, n=40), ili sirolimus stenta (skupina 2, n=39), ili standardnog metalnog stenta (skupina 3, n=40). Skupine se nisu razlikovale prema demografskim, angiografskim i proceduralnim karakteristikama osim što je u skupini 1 implantirano više stentova većih dimenzija. Incidencija MACE bila je slična u sve tri skupine. Potreba za revaskularizacijom ciljne lezije bila je veća u skupini sa implantiranim standardnim metalnim stentom (p=0,044). Primarni cilj ispitivanja, pojava restenoze u 6-mjesečnom praćenju bila je veća u kontrolnoj skupini s implantiranim standardnim metalnim stentom (skupina 3) u usporedbi sa stent graft i sirolimus skupinom (skupina 1 i 2). Postotak stenoze u praćenju bio značajno veći u skupini 3 (p=0,005). Kasni gubitak lumena bio je značajno niži u sirolimus skupini u usporedbi sa standardnim metalnim stentom (p=0,034). Nađen je i trend nižem kasnom gubitku lumena i u grupi sa stent graftom u usporedbi sa standardnim metalnim stentom, ali nije dostignuta statistička značajnost. Restenoza je bila najniža u sirolimus grupi (kasni gubitak od 0,23 mm). Studija nije pokazala razliku u kumulativnim nepovoljnim kardiološkim događajima ( MACE) između bolesnika, nakon implantacije stent grafta, sirolimus stenta i standardnog metalnog stenta u akutnom koronarnom sindromu. Pokazala je značajnu razliku u incidenciji restenoze između sirolimus stenta i standardnog metalnog stenta, te trend nižoj incidenciji restenoze u stent graftu u usporedbi sa standardnim metalnim stentom. |
| Abstract (english) | Percutanous coronary intervention with stent implantation becomes a standard procedure in patients with coronary decease, and spatially in acute coronary syndrome. The long-term outcomes are good, but the problem of in-stent restenosis is not jet solved. Recently the drug eluting stents seems to be an answer to this challenge, but there is no evidence-based data about their long-term outcome in the state of acute coronary situations. The stent grafts (PTFE covered stent) could also reduce the incidence of acute complications and restenosis on follow up by reduction of protrusion of active plaque through stent struts, and distal embolisation, and in other hand by reduction of interaction of tissue and blood growth factors in the early postinterventional period, reducing in that way the incidence of in stent restenosis. We conduced a randomized trial to evaluate the usefulness of stent graft compared with a sirolimus eluting stent and standard metal stent in patients undergoing interventions in acute coronary syndrome. The primary end point was angiographic restenosis in 6-month follow up by quantitative coronary angiography analysis. Secondary endpoint was 6-month MACE rates. In our Laboratory 119 patients with ACS, after exclusion of unsuitable patients, were randomized to either stent graft (group1, n=40), or sirolimus stent (group 2, n=39) or standard metal stent (group 3, n=40). Demographic, angiographic and procedural characteristic was similar for all three groups, except there was a greater incidence of bigger stents implantation in-group 1. The incidence of 6-month MACE was similar in all three groups. The TLR was higher in the control group (group 3 with standard metal stent implantation) p=0,044. The primary end-point, the restenosis rate at six month follow up was higher in the control standard metal stent group (group 1), compared with the stent graft, and sirolimus stent group (group 1 and 2). The percent diameter stenosis on follow up was significantly higher in-group 3 (p=0,005). The late loss was significantly lower in the sirolimus group comparing with the standard metal stent group (p= 0,034). There was a trend of lower late loss in the stent graft group, comparing with the standard metal stent, but without statistical significance. The restenosis rate in the sirolimus group was the lowest (late loss was 0,23 mm). The study did not demonstrate a difference in cumulative MACE between patients after implantation of stent grafts, sirolimus stent and standard metal stents in acute coronary syndrome. There was a significant difference in restenosis rate between the sirolimus stent and standard metal stent and a trend of lower restenosis rate of stent graft in comparison with standard metal stent. |
