Uporedna analiza efektivnosti, sigurnosti i isplativosti stentova obloženih lekovima u odnosu na klasične metalne stentove u lečenju ishemijske bolesti srca

Abstract

Korišćenje stentova obloženih lekovima (DES) neosporno je smanjilo incidencu ponovne revaskularizacije nakon perkutane koronarne intervencije (PCI) sa implantacijom stenta u lečenju ishemijske bolesti srca (IHD). Međutim, pojedinačne studije koje su ispitivale efektivnost upotrebe DES-a nisu imale dovoljnu snagu za utvrđivanje dugoročne sigurnosti njihove primene, zbog pojave događaja sa malom frekvencijom pojavljivanja, kao što je veoma kasna tromboza stenta. Integrativne studije sa zbirnim analizama ostale su bez pouzdanih zaključaka, zbog neuniformnog korišćenja različitih definicija tromboze stenta i ograničenog trajanja perioda praćenja u kliničkim studijama koje su poredile DES sa klasičnim metalnim stentovima (BMS). Takođe, nedostaju informacije o kost-efektivnosti DES-a u poređenju sa BMS-om za vremenski period nakon prve godine od implantacije, i ne postoje zaključci bazirani na podacima studija koje su završile ukupan protokolom preporučen petogodišnji period praćenja. Kombinujući podatke iz objavljene literature, sumirane meta-analizom praćenih kliničkih ishoda u publikacijama koje porede efektivnost DES-a sa BMS-om, sa tržišno dobijenim troškovima, procenjena je kost-efektivnost DES-a u lečenju IHD u petogodišnjem periodu evaluacije. U uporednoj analizi efektivnosti i sigurnosti DES vs BMS izračunati su odnosi šansi (OR) i prikazani zajedno sa 95% intervalima poverenja. Tromboza stenta je definisana prema standardizovanoj klasifikaciji predloženoj od strane Konzorcijuma za akademska istraživanja (ARC). Efektivnost je procenjivana stopom revaskularizacije ciljne lezije (TLR). Analiza isplativosti je rađena iz perspektive Fonda za zdravstveno osiguranje Republike Srbije. Ishod analize troškova i efekata prikazan je u vidu koeficijenta rastuće isplativosti (ICER) – kao rastući troškovi po izbegnutoj ponovnoj revaskularizaciji i rastući troškovi po dobijenoj kvalitetom prilagođenoj godini života (QALY)...

Drug-eluting stents (DES) dramatically reduced the incidence of repeat revascularization after percutaneous coronary intervention (PCI) with stent implantation in ischemic heart disease (IHD). However, individual trials of these stents have not had sufficient power to ascertain their long-term safety, in particular the low-frequency events like very late stent thrombosis. Performed pooled analyses were inconclusive because of the nonuniform stent thrombosis definitions used and limited duration of follow-up data in clinical trials comparing drug-eluting vs bare-metal stents (BMS). There is also limited information about cost-effectiveness of DES compared with BMS over a time horizon of more than 1 year, and no information based on data from studies with accomplished 5 year follow-up recommended by regulatory agencies. Combining the data from published evidence, by conducting meta-analysis on clinical outcome data from publications discussing the use of DES and BMS, with field evaluation costs, the cost effectiveness of DES were estimated, relative to BMS over a time horizon of 5 years. For efficacy and safety outcomes odds ratios (OR) and number needed to treat were calculated and presented with 95% confidence intervals. Stent thrombosis was defined according to hierarchical classification set by Academic Research Consortium (ARC). Effectiveness was assessed by target lesion revascularization (TLR) incidence. Costs were obtained as reimbursement rates for diagnosis related groups from the Serbian Health Care Third Party payer perspective. Cost effectiveness outcomes were expressed as incremental cost-effectiveness ratios (ICER’s) – the incremental cost per revascularization avoided and the incremental cost per QALY gained. Ten double blinded randomized controlled trials with median follow up of 5 years were identified. Of 6454 patients involved, 3230 patients were randomized to receive DES (Sirolimus, Paclitaxel or Zotarolimus) and 3224 were enrolled to BMS group. In five years follow-up period DES resulted in a 57% lower risk of repeat target lesion revascularization (TLR) (OR=0,43; 95% CI 0,37-0,50)...