Abstract

Introduction: article presents the first experience and long-term results of using domestic coronary balloon-expandable stents with a bioinert carbon coating, «Nanomed».

Aim: was to evaluate long-term results of using domestic coronary balloon-expandable stents with bioinert linear chain carbon coating (BLCCC), «Nanomed».

Materials and methods: the study included 387 patients, suffering from coronary heart disease, who underwent endovascular myocardial revascularization from 2016 to 2018, with implantation of coronary balloon-expandable stents with BLCCC by the Nanomed company, Penza. The control group included 320 patients who underwent endovascular myocardial revascularization with implantation of coronary balloon-expandable cobalt-chromium stents «MSure Cr» of the company «Multimedics», during the same period. A comparative estimation of long-term results was carried out on the basis of a study of the overall frequency of repeated myocardial revascularization; repeated interventions on the target vessel; the frequency of interventions on other coronary arteries with the progression of atherosclerosis; long-term survival rates.

Results: in the long-term period, the overall probability of absence of repeated revascularization in 47 months after PCI was 78,3 ± 2.1% and 72,1 ± 2.4% in the «Nanomed» BLCCC and «MSure Cr» groups, respectively. There was no statistically significant difference between groups (Log. Rank=0,77). However, the incidence of restenosis in the stent was statistically significantly higher in the «MSureCr» group. (p = 0,027). The overall probability of survival in 47 months after surgery was 98,2±2,4% and 98,1±2.6% in groups 1 and 2, respectively. No statistically significant difference between groups was found (Log. Rank=0,4).

Conclusions: 1. The use of a coronary balloon-expandable stent with a BLCCC, Nanomed for endovascular myocardial revascularization is an effective treatment in patients with coronary heart disease.

2. Long-term results of using bioinert carbon-coated stents, Nanomed and MSureCr stents were comparable in terms of absence of myocardial re-revascularization procedures due to relapse of the angina pectoris and survival time of up to 47 months. However, the incidence of restenosis in a stent with a bioinert carbon coating, Nanomed was statistically significantly lower.

References

1.     Allender S, Scarborough P, O’Flaherty M, Capewell S. Patterns of coronary heart disease mortality over the 20th century in England and Wales: Possible plateaus in the rate of decline. BMC Public Health 2008, 8, 148.

2.     De Scheerder I, Wang K, Wilczek K et al. Experimental study of thrombogenicity and foreign body reaction induced by heparin-coated coronary stents. Circulation. 1997; 95: 1549-1553.

3.     Morice M, Urban P, Greene S, Schuler G, Chevalier B. Why are we still using Coronary Bare-Metal Stents? JACC 2013;61;1122-3.

4.     De Mel A, Cousins BG, Seifalian AM. Surface modification of biomaterials: A quest for blood compatibility. Int. J. Biomater. 2012;  707863:1-707863:8.

5.     Kochkina K, Protopopov A. Comparative results of the use of stents with drug and carbon coatings in treatment of patients with all forms of acute coronary syndrome in the long-term follow-up. Kompleksnye problemy serdechno-sosudistyh zabolevanij. 2014; 1:52-58 [In Russ].

6.     Carrie D, Lefevre T, Cherradi R, et al. Does Carbofilm coating affect in-stent intimal proliferation? A randomized trial comparing Rx multi-link penta and TecnicCarbostent Stents: SIROCCO Trial. J Interv Cardiol. 2007; 20(5):3818.

7.     De Mel A, Jell G, Stevens MM, Seifalian AM. Biofunctionalization of biomaterials for accelerated in situ endothelialization: A review. Biomacromolecules. 2008; 9: 2969-2979.

8.     Hofma SH, Whelan DM, van Beusekom HM, Verdouw PD, van der Giessen WJ. Increasing arterial wall injury after long-term implantation of two types of stent in a porcine coronary model. Eur. Heart J. 1998; 19: 601-609.

9.     Wu KK, Thiagarajan, P. Role of endothelium in thrombosis and hemostasis. Annu. Rev. Med. 1996, 47, 315-331.

10.   Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: Delayed healing and late thrombotic risk. J. Am. Coll. Cardiol. 2006; 193-202.

11.   Farb A, et al., Pathology of acute and chronic coronary stenting in humans. Circulation. 1999; 99(1): 44-52.

12.   Sarno G, et al., Lower risk of stent thrombosis and restenosis with unrestricted use of 'newgeneration' drug-eluting stents: a report from the nation wide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J. 2012;  33(5): 606-13.

13.   Palmerini T, et al., Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;  379(9824): 1393-402.

14.   Antoniucci D, Bartorelli A, Vaenti R, et al. Clinical and angiographic outcome after coronary artery stenting with the Carbostent. Am J Cardiol. 2000; 85: 821-825.

15.   Antoniucci D, Valenti R, Migliorini A, et al. Clinical and angiographic outcomes following elective implantation of the Carbostent in patients at high risk of restenosis and target vessel failure. CathetCardiovasc Interv. 2001; 54: 420-426.

16.   Gian B Danzi, Cinzia Capuano, Marco Sesana et al. Six-Month Clinical and Angiographic Outcomes of the Technic Carbostent(TM) Coronary System: The Phantom IV Study. J Invasive Cardiol. 2004; 16(11): 641-4.

17.   Wiemer M, Butz T, Schmidt W, Schmitz KP, Horstkotte D, Langer C. Scanning electron microscopic analysis of different drug eluting stents after failed implantation: From nearly undamaged to major damaged polymers. Catheter. Cardiovasc. Interv. Off. J. Soc. Cardiac. Angiogr. Interv. 2010; 75: 905-911.

18.   Pendyala L, Jabara R, Robinson K, Chronos N. Passive and active polymer coatings for intracoronary stents: Novel devices to promote arterial healing. J. Interv. Cardiol. 2009; 22: 37-48.

19.   Kesavan S, Strange J, Johnson T et al. First-in-man evaluation of the MOMO cobalt-chromium carbon-coated stent. EuroIntervention 2013; 8:1012-1018.

20.   Jung JH, Min PK, Kin JY, Park S, Choi EY, Ko YG, Choi D, Jang Y, Shim WH and Cho SY: Does a carbon ion-implanted surface reduce the restenosis rate of coronary stents? Cardiology. 2005; 104 (2): 72-75,

21.   Kim Y, Whan Lee C, Hong M et al. Randomized comparison of carbon ion-implanted stent versus bare metal stent in coronary artery disease: The Asian Pacific Multicenter Arthos Stent Study (PASS) trial. American Heart Journal. 2005; 149 (2).

22.   George Cesar Ximenes Meireles, Luciano Mauricio de Abreu, Antonio Artur da Cruz Forte et al . Randomized comparative study of diamond-like carbon coated stainless steel stent versus uncoated stent implantation in patients with coronary artery disease. Cardiol. Sro Paulo Apr. 2007; 88 (4).

23.   Ben-Dor I, Waksman R, Pichard A.et al. The Current Role of Bare-Metal Stents. Cardiac interv. 2011; 1:40-45.

24.   Snoep JD, Hovens MM, Eikenboom JC, van der Bom JG, Jukema JW, Huisman MV. Clopidogrel nonresponsiveness in patients undergoing percutaneous coronary intervention with stenting: a systematic review and metaanalysis. Am Heart J. 2007; 154:221-31.

25.   Bartorelli A, Trabattoni D, Montorsi P Aspirin alone antiplatelet regimen after intracoronary placement of the Carbostent: the ANTARES study. Catheter Cardiovasc Interv. 2002 Feb; 55(2):150-6.

26.   Goods C, Al-Shaibi, Liu M et al. Comparison of aspirin alone versus aspirin plus ticlopidin after coronary artery stenting. Am J Cardiol. 1996; 78:1042-1044.

27.   Leon M, Baim D,Popma J et al. A clinical trial comparing three anthitrombotic drug regimens after coronary artery stentings. Stent Anticoagulation Restenosis Study Investigators. N Engl J Med. 1998; 339:1665-1671.

28.   Braun P et al. Prospective randomized study of the restenotic process in small coronary arteries using a Carbofilm coated stent in comparison with plain old balloon angioplasty: a multicenter study. Catheter Cardiovasc Interv. 2007 Dec 1; 70(7):920-7.

29.   Taema K, Moharram A. Long Term Clinical Follow-up of Carbon Coated Stents: Comparative Study with Bare-Metal Stents Med. J. Cairo Univ. 1-8, March: 18, 2014; 82 (2).