Six-Month Clinical and Angiographic Results of Paclitaxel Eluting Simpax Stent

Öz

Introduction: We aimed to evaluate the safety and efficacy of the simpax stent in the treatment of different patient groups. Patients and Methods: Forty-five patients were treated with the simpax stent. Of these patients, 23 patients gave consent for six months of follow-up by quantitative coronary angiography (QSA) and six patients were evaluated by exercise electrocardiographic test. Only the patients having lesions with stenosis > 50% of diameter and lengths > 16 mm with reference diameters < 2.75 mm were included. Results: The device success rate was 100% and procedure success rate was 97.7%. The mean stent length was 24.6 ± 7.3 mm and stent size was 2.54 ± 0.24 mm. The overall six months incidence of major adverse cardiac events (MACE) was 8.8%. MACE was consisted of two cases of non-Q wave myocardial infarction and two cases of repeated revascularization of the target lesion. MACE rate was higher in chronic total occlusion (CTO) group than non-CTO group (respectively 33.3% and 5.1). Also when compared to stent size, MACE rate was 25% in < 2.5 mm, 0% ? 2.5 mm. The QSA results at six months showed in-stent late lumen loss witha diameter of 0.25 ± 0.15 mm in 17 patients. Conclusion: The six month results in this study demonsrated excellent procedural and device success. Simpax stent was associated with a low in-stent late lumen loss. Also this study showed simpax stent was a safe and effective device in non-CTO group with stent size ? 2.5 mm.

Anahtar Kelimeler

• Drug eluting stents; paclitaxel; coronary restenosis

Paklitaksel Kaplı Simpax Stentin Altı Aylık Klinik ve Anjiyografik Sonuçları

Öz

Giriş: Bu çalışmadaki amacımız farklı hasta gruplarında simpax stentin etkinliği ve güvenilirliğini değerlendirmektir. Hastalar ve Yöntem: Kırk beş hasta simpax stent ile tedavi edildi. Altı aylık takipte 23 hasta kantitatif koroner anjiyografi (QSA) ve altı hasta egzersiz elektrokardiyografi testiyle değerlendirildi. Çalışmaya > %50 çap daralması olan ve uzunluğu > 16 mm ile referans damar çapı < 2.75 mm olan hastalar dahil edildi.Bulgular: Cihaz başarı oranı %100, prosedür başarı oranı %97.7 idi. Ortalama stent uzunluğu 24.6 ± 7.3 mm ve stent çapı 2.54 ± 0.24 mm idi. Altı aylık majör istenmeyen kardiyak olayların (MACE) genel insidansı %8.8 olarak bulundu. MACE oranı kronik total oklüzyon (KTO) grubunda KTO olamayan gruba göre daha fazlaydı (sırasıyla %33.3 ve %5.1). Ayrıca, stent çaplarına göre karşılaştırıldığında, MACE oranı çapı < 2.5 mm olan stentlerde %25; > 2.5 mm olan stentlerde %0 olarak bulundu. On yedi hastadaki altıncı ay QSA sonuçları stent içi geç lümen kaybını 0.25 ± 0.15 mm olarak gösterdi. Sonuç: Çalışmanın altı aylık sonuçlarına göre prosedür ve cihaz başarı oranı mükemmeldi. Simpax stent düşük stent içi geç lümen kaybı ile ilişkili bulunmuştur. Ayrıca bu çalışma simpax stentin, kronik total oklüzyonu olmayan ve stent çapı > 2.5 mm olan grupta güvenli ve etkili olduğunu gösterdi

Anahtar Kelimeler

• İlaç kaplı stent; paklitaksel; koroner restenoz.

Kaynakça

1. Katritsis DG, Karvouni E, Ioannidis JP. Meta-analysis compa- ring drug-eluting stents with bare metal stents. Am J Cardiol 2005;95:640-3.
2. Kastrati A, Mehilli J, Pache J, Kaiser C, Valgimigli M, Kelbaek H, et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007; 356:1030-9.
3. Meredith IT, Worthley S, Whitbourn R, Walters D, Pompa J, Cutlip D, et al. The new-generation Endeavor Resolute stent: 4 month clinical and angiographic results from the resolute first-in-man tri- al. Euro Intervention 2007;3:50-3.
4. Bavry AA, Kumbhani DJ, Helton TJ, Bhatt DL. Risk of thrombosis with the use of sirolimus-eluting stents for percutaneous coronary intervention (from registry and clinical trial data). Am J Cardiol 2005;95:1469-72.
5. Menichelli M, Parma A, Pucci E, Fiorilli R, De Felice F, Nazzaro M, et al. Randomized trial of sirolimus-eluting stent versus bare-metal stent in acute myocardial infarction (SESAMI). J Am Coll Cardiol 2007;49:1924-30.
6. Valgimigli M, Campo G, Arcozzi C, Malagutti P, Carletti R, Ferrari F, et al. Two-year clinical follow-up after sirolimus-eluting versus bare-metal stent implantation assisted by systematic glycoprotein IIb/IIIa inhibitor infusion in patients with myocardial infarction: re- sults from the STRATEGY study. J Am Coll Cardiol 2007;50:138- 45.
7. Chamié D, Abizaid A, Costa JR Jr, Feres F, Almiro da Silva JF, Mattos LA. Serial angiographic and intravascular ultrasound eva- luation to interrogate the presence of late “catch-up” phenomenon after cypher® sirolimus-eluting stent implantation. Int J Cardiovasc Imaging 2010; Epub ahead of print.
8. Kastrati A, Mehilli J, Dirschinger J, Dotzer F, Schunhlen H, Neu- mann FJ, et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR STEREO) trial. Circulation 2001;103: 2816-21.

9. Binary restenosis was defined as > 50% diameter stenosis. 11 (2/18)
10. Rittersma SZ, de Winter RJ, Koch KT, Bax M, Schotborgh CE, Mulder KJ, et al. Impact of strut thickness on late luminal loss after coronary artery stent placement. Am J Cardiol 2004;93:477-80.
11. Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, et al. Safety an defficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 2007;356:998-1008.
12. Han YL, Zhang J, Li Y, Wang SL, Jing QM, Yi XH et al. Long-term outcomes of drug-eluting versus bare-metal stent implantation in patients with chronic total coronary artery occlusions. Chin Med J (Engl) 2009;122:643-7.
13. Chen SL, Ye F, Zhang JJ, Lin S, Zhu ZS, Tian NL, et al. Clinica- loutcomes of percutaneous coronary intervention for chronic total occlusion lesions in remote hospitals without on-site surgical sup- port. Chin Med J (Engl) 2009;122:2278-85.