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 Abstract:

Aim: was to compare endothelialization of stents with permanent and biodegradable coatings at an early stage with help of optical coherence tomography (OCT).

Materials and methods: this study is a prospective, randomized trial that includes a comparative analysis of OCT data in patients after implantation of coronary stents with biodegradable (study group) and permanent coatings (control group). 98 patients were randomized 1:1 into 2 groups. After 3 months, 10 patients from each group - were randomized to conduct OCT.

Results: we analyzed OCT data of 10 studies in the biodegradable group (1,776 struts and 247 sections) and 10 studies in the permanent coating group (1562 struts and 226 sections). There were no differences in proportion of uncovered (8,9% vs. 8,5%, p=0,49) and non-exposed struts (1,6% vs. 1,3%, p=0,2). Thus, 98,4% of struts in study group and 98.7% in control group were endothelialized.

Conclusions: according to OCT data, similar results were obtained in both groups. After 3 months of observation in two groups, the overwhelming number of struts were endothelialized. At the early stage of observation, none of groups, achievement of endpoints was detected. 

 

References

1.     Mauri L., Kereiakes D., Yeh R. et al. Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents. N Engl J Med. 2014; 371:2155-2166.

2.     Authors/Task Force members , Windecker S., Kolh P., et al. ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35:2541-619.

3.     Kim S., Kim J.S., Shin D.H., et al. Comparison of early strut coverage between zotarolimus- and everolimus-eluting stents using optical coherence tomography. Am J Cardiol. 2013;111:1-5.

4.     Izumi D., Miyahara M., Sakai M., Fukuoka S. OCT- based comparison of early strut coverage between zotarolimus- and everolimus-eluting stents with second stent designs. Eurointervention. 2014;5;20.

5.     Ormiston J., Webster M., Stewart J. et al. First-inHuman Evaluation of a Bioabsorbable Polymer-Coated Sirolimus-Eluting Stent. JACC: Cardiovasc int 2013; 6(10): 1026-1034.

6.     Karjalainen P, Varho V., Nammas W. et al. Early Neointimal Coverage and Vasodilator Response Following Biodegradable Polymer Sirolimus-Eluting vs. Durable Polymer Zotarolimus-Eluting Stents in Patients With Acute Coronary Syndrome. Circulation Journal .2015;79(2): 360-367. 

Abstract:

Aim: was to provide design and direct clinical outcomes of ORENBURG (Optimal dRug Eluting steNts implantation guided By combination of intravascular Ultrasound and optical coheRence tomoGraphy) - single-center randomized clinical trial.

Materials and methods: 1032 patients were included in this study These patients were treatec with 6 types of drug eluting stents. Patients were randomized not only to the type of implanted stent, but also to the type of guidance of the procedure: intravascular ultrasound (IVUS) - 676 patients, quantitative coronary arteriography (QCA) - 356 patients. Before the procedure was finished, all patients underwent optical coherence tomography (OCT) analysis. Regardless of its results no more adjacent procedures were performed.

Results: we provide characteristics of patients included in this study These characteristics showed an absence of significant differences between two groups of patients (IVUS and QCA groups) and between subgroups of patients, received different types of DES. While analyzing parameters of index procedure, it was emphasized that IVUS group involved a bigger number of patients with left main disease and bifurcation disease, and also a bigger number of stents per lesion, diameter of first stent, total length of used stents, maximal diameter of the postdilatation balloon. Characteristics of Nobori stent (range of sizes) can explain that significantly smaller diameter and length of the first and the second stent implanted, total length of stents per lesion, and maximal diameter of postdilatation balloon were recorded in the Nobori stent subgroup of patients. Besides that, in that subgroup were no patients with left main disease, smaller number of patients with angiographically evident calcifications, but was a bigger number of patients with circumflex artery disease. Immediate effect of the implantation was obtained in 100% of patients. According to the short-term follow-up, 1 patient died due to the myocardial infarction in the region of the untreated artery

Conclusion: angiographic data, and IVUS and OCT results of analyzed patients are going to be published in the next article.  

 

References 

1.    Mintz G.S. Intracoronary Ultrasound. London and New York: Taylor & Francis. 2005, 408.

2.    Colombo A., Tobis J. Techniques in Coronary Artery Stenting. London: Martin Dunitz. 2000, 422.

3.    Demin V.V. Klinicheskoe rukovodstvo po vnutrisosudistomu ultrazvukovomu skanirovaniyu [Clinical guide to intravascular ultrasound]. Orenburg: Yuzhnyj Ural [South Ural]. 2005; 400.[In Russ].

4.    Demin V.V., Zelenin V.V., Zheludkov A.N. et al. Vnutrisosudistoe ultrazvukovoe skanirovanie pri intervencionnyh vmeshatelstvah na koronarnyh arteriyah: optimalnoe primenenie i kriterii ocenki [Intravascular ultrasound scanning during coronary interventions: optimum application and assessment criteria]. International Journal of Interventional Cardioangiology.2003; 1: 66-72 [In Russ].

5.    Demin V.V., Demin D.V., Dolgov S.A. et al. Sravnenie informativnosti vnutrisosudistogo ultrazvukovogo issledovania I opticheskoj kogerentnoj tomografii vo vremj operacii stentirovanij koronarnyh arterij. [Comparison of intravascular ultrasound and optical coherence tomography informativeness in coronary stenting]. Ultrazvukovye i luchevye diagnostiki v klinicheskoj praktike [Ultrasound and radiology technic in clinical practice]. Ad by Sandrilov V.A., Fisenko E.P., Kulagina T.Yu. Moscow: «Firma STROM». 2012; 12-18 [In Russ].

6.    Demin V.V., Demin D.V., Dolgov S.A. et al. Primemenie vnutrisosudistogo ultrazvukovogo issledovania i opticheskoj kogerentnoj tomografii pri implantacii koronarnyh stentov s lekarstvennym pokrytiem. [Using of intravascular ultrasound and optical coherence tomography in coronary drug-eluting stents implantation]. Oblastnaj bolnitza v sisteme regionalnogo zdravoohranenij. [Regional clinic in regional health care system]. Orenburg: Gazprompechat. 2012; 73-77 [In Russ].

7.    Oemrawsingh P.V., Mintz G.S., Scalij M.J. et al. Intravascular ultrasound guidance improves angiographic and clinical outcome of stent implantation for long coronary artery stenosis: Final results of randomized comparison with angiographic guidance (TULIP Study). Circulation. 2003; 107: 62-67.

8.    Gaster A.L., Slothuus Skjoldborg U., Larsen J. et al. Continued improvement of clinical outcome and cost effectiveness following intravascular ultrasound guided PCI: Insights from a prospective, randomized study. Heart. 2003; 89 (9): 1043-1049.

9.    Gil R.J., Pawlowski T., Dudek D. et al. Comparison of angiographically guided direct stenting technique with direct stenting and optimal balloon angioplasty guided with intravascular ultrasound. The multicenter, randomized trial results. Am. HeartJournal. 2007; 154 (4): 669-675.

10.  Frey A.W., Hodgson J.M., Muller C. et al. Ultrasound-guided strategy for provisional stenting with focal balloon combination catheter. Results from the randomized Strategy for Intracoronary ultrasound-guided PTCA and Stenting (SIPS) trial. Circulation. 2000; 102 (20): 2497-2502.

11.  Fitzgerald P.J., Oshima A., Hayase M. et al. Final results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) study. Circulation. 2000; 102 (5): 523-530.

12.  Sousa A., Abizaid A., Mintz G.S. et al. The influence of intravascular ultrasound guidance on the in-hospital outcomes after stent implantation: results from the Brazilian Society of Interventional Cardiology Registry - CENIC. J. Am. Coll. Cardiol. 2002; 39: 54A.

13.  Russo R.J., Attubato M.J., Davidson C.J. et al. Angiography versus intravascular ultrasound-directed stent placement: final results from AVID. Circulation. 1999; 100: I-234.

14.  Russo R.J., Silva P.D., Teirstein P.S. et al. A Randomized Controlled Trial of Angiography versus Intravascular Ultrasound-Directed Bare-Metal Coronary Stent Placement (The AVID Trial). Cathet Cardiovasc Intervent. 2009; 2: 113-123.

15.  Schiele F., Meneveau N., Vuillemenot A. et al. Impact of intravascular ultrasound guidance in stent deployment on 6-month restenosis rate: a multicenter, randomized study comparing two strategies - with and without intravascular ultrasound guidance. RESIST Study Group. REStenosis after IVUS guided Stenting. J. Am. Coll. Cardiol.1998; 32: 320-328.

 

 

Abstract:

Aim: was to analyze long-term results of coronary artery stenting with drug-eluting stents «Zotarolimus» and bare metal stents in patients with a concomitant diabetes mellitus type II.

Materials and methods: 37 patients with ischemic heart disease and concomitant diabetes mellitus type II were selected for analysis; they underwent implantation of stents without drug coverage («Intergrity» «Medtronic») or stents with drug-eluting «Zotarolimus» («Resolute Integrity» «Medtronic»). All patients were divided into 2 groups: first group consisted of 11 patients, who underwent implantation of bare metal stents, second group - 26 patients who underwent implantation of drug-eluting stents, «Zotarolimus». Follow-up period was 26±4 months. Criteria of stenting efficiency were: angiographic assessment of coronary arteries anatomy in control angiography after stent implantation, reccurence of angina or functional class increase, the survival rate in the nearest postoperative period, before discharge, but not more than 30 days, and in the early post-operative period up to 6 months. In the medium-distant post-operative period - 12 months, and in the late postoperative period - 24 months.

Results: all patients underwent successfully performed endovascular revascularization. The optimal angiographic result was achieved in all patients. Regression of ischemic changes on ECG data and increase myocardial contractility by echocardiography data also were marked in all patients. In long-term follow-up period, in 5 (45%) patients with bare metal stents we noted the appearence of hemodynamically significant restenosis, that needed performance of secondary angioplasty with stenting.

Conclusion: the use of antiproliferative drug-eluting stents «Zotarolimus» is possible in treatment of patients with coronary artery disease and comorbid diagnosis of diabetes mellitus type II. Bare metal stents in coronary stenting in patients with concomitant diagnosis of diabetes mellitus type II is impractical due to developing in-stent restenosis (45% of patients). 

 

References

1.     Kereiakes D.J., Cutlip D.E., Applegate R.J., Wang J., Yaqub M., Sood P., Su X., Su G., Farhat N., Rizvi A., Simonton C.A., Sudhir K., Stone G.W. Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Limus Eluting Coronary Stent System). J. Am. Coll. Cardiol. 2010 Dec 14; 56(25):2084-2089.

2.     Petrova K.N., Kozlov S.G., Ljakishev A.A., Savchenko A.P. Vlijanie saharnogo diabeta 2 tipa na rezul'taty jendovaskuljarnogo lechenija IBS s pomoshhju stentov s lekarstvennym pokrytiem (dannye godichnogo nabljudenija) [Influence of diabetes mellitus type 2 on results of endovascular treatment of IHD with help of drug-eluting stents (data monitoring for one year)]. Kardiohgija. 2006; 12: 22-6 [In Russ].

3.     Abizaid A., Costa M.A., Blanchard D. et al. Sirolimus-Eluting Stents Inhibit Neointimal Hyperplasia in Diabetic Patients. Insights from the RAVEL Trial. Eur. Heart J. 2004; 25: 107-12.

4.     Moussa I., Leon M.B., Baim D.S. et al. Impact of Sirolimus-Eluting Stents on Outcome in Diabetic Patients. Circulation .2004; 109: 2273-8.

5.     Hermiller J.B., Raizner A., Cannon L. et al. TAXUS-IV Investigators. Outcomes With the Polymer-Based Paclitaxel-Eluting TAXUS Stent in Patients With Diabetes Mellitus: the TAXUS-IV trial. JACC. 2005; 45: 1172-9.

6.     Sabate M., Jim Onez-Quevedo P., Angiolillo D.J. et al. Randomized Comparison of Limus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients. Circulation. 2005; 112: 2175-83.

7.     Jensen J., Lagerqvist B., Aasa M., Sarev T., Nilsson T., Tornvall P. Clinical and angiographic follow-up after coronary drug-eluting and bare metal stent implantation. Do drug-eluting stents hold the promise? J. Intern. Med. 2006 Aug; 260(2):118-24.

8.     Jain A.K., Lotan C., Meredith I.T., Feres F., Zambahari R., Sinha N., Rothman M.T. E-Five Registry Investigators. Twelve-month outcomes in patients with diabetes implanted with a zotarolimus-eluting stent: results from the E-Five Registry. Heart. 2010 Jun; 96(11):848-53. doi: 10.1136/hrt.2009.184150.

9.     Stettler C., Allemann S., Egger M. et al. Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials. Heart. 2006; 92: 650-7.

10.   Scheen A.J., Warzee F. Diabetes Is Still a Risk Factor for Restenosis After Drug-Eluting Stent in Coronary Arteries. Diabetes Care. 2004; 27: 1840-1.

11.   Park K.W., Lee J.M., Kang S.H., Ahn H.S., Kang H.J., Koo B.K., Rhew J.Y, Hwang S.H., Lee S.Y, Kang T.S., Kwak C.H., Hong B.K., Yu C.W., Seong I.W., Ahn T., Lee H.C., Lim S.W., Kim H.S. Everolimus-eluting xience v/promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus. JACC. Cardiovasc. Interv. 2014 May;7(5):471-81. doi: 10.1016/j.jcin.2013.12.201. 

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