Fully absorbable drug eluting coronary stent: where do we stand in 2014?

Česká verzia

Authors: Viktor Kočka; Petr Toušek; Libor Lisa; Tomáš Buděšínský
Authors place of work: III. interní – kardiologická klinika 3. LF UK a FN Královské Vinohrady Praha, přednosta prof. MUDr. Petr Widimský, DrSc., FESC, FACC
Published in the journal: Vnitř Lék 2014; 60(4): 322-326
Category: 60th Birthday - prof. MUDr. Petr Widimský, DrSc., FESC, FACC

Summary

Coronary stent is routinely used in majority percutaneous coronary interventions for a long time. They have an important role, especially, in the first months after intervention. We can consider as a breakthrough point the development of stent which has ability to absorb in intervened artery after a few years. The review presents current techniques of fully absorbable coronary stents and also provides clinical trials and experiences available in 2014. The article continues with discussion between supporters and opponents of this new technique, but definitive conclusion can´t be done yet. The authors conclude the review with their own opinion. There are many encouraging data in patients with good clinical outcome after implantation of absorbable stents in more than 10 years follow-up.

Keywords:
absorbable stent – acute myocardial infarction – coronary stent – percutaneous coronary intervention

Zdroje

1. Sigwart U, Puel J, Mirkovitch V et al. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 1987; 316(12): 701–706.

2. Serruys PW, de Jaegere P, Kiemeneij F et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med 1994; 331(8): 489–495.

3. Widimsky P, Groch L, Zelizko M et al. Multicentre randomized trial comparing transport to primary angioplasty vs immediate thrombolysis vs combined strategy for patients with acute myocardial infarction presenting to a community hospital without a catheterization laboratory. The PRAGUE study. Eur Heart J 2000; 21(10): 823–831.

4. Morice MC, Serruys PW, Sousa JE et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002; 346(23): 1773–1780.

5. Tamai H, Igaki K, Kyo E et al. Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans. Circulation 2000; 102(4): 399–404.

6. Ormiston JA, Webster MW, Armstrong G First-in-human implantation of a fully bioabsorbable drug-eluting stent: the BVS poly-L-lactic acid everolimus-eluting coronary stent. Catheter Cardiovasc Interv 2007; 69(1): 128–131.

7. Onuma Y, Serruys PW, Perkins LE et al. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial. Circulation 2010; 122(22): 2288–2300.

8. Haude M, Erbel R, Erne P et al. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. Lancet 2013; 381(9869): 836–844.

9. Ormiston JA, Serruys PW, Regar E et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet 2008; 371 (9616): 899–907.

10. Dudek D, Onuma Y, Ormiston JA et al. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention 2012; 7(9): 1060–1061.

11. Onuma Y, Serruys PW, Gomez J et al. Comparison of in vivo acute stent recoil between the bioresorbable everolimus-eluting coronary scaffolds (revision 1.0 and 1.1) and the metallic everolimus-eluting stent. Catheter Cardiovasc Interv 2011; 78(1): 3–12.

12. Gomez-Lara J, Garcia-Garcia HM, Onuma Y et al. A comparison of the conformability of everolimus-eluting bioresorbable vascular scaffolds to metal platform coronary stents. JACC Cardiovasc Interv 2010; 3(11): 1190–1198.

13. Garcia-Garcia HM, Gonzalo N, Pawar R et al. Assessment of the absorption process following bioabsorbable everolimus-eluting stent implantation: temporal changes in strain values and tissue composition using intravascular ultrasound radiofrequency data analysis. A substudy of the ABSORB clinical trial. EuroIntervention 2009; 4(4): 443–448.

14. Bruining N, de Winter S, Roelandt JR et al. Monitoring in vivo absorption of a drug-eluting bioabsorbable stent with intravascular ultrasound-derived parameters a feasibility study. JACC Cardiovasc Interv 2010; 3(4): 449–456.

15. Brugaletta S, Gomez-Lara J, Bruining N et al. Head to head comparison of optical coherence tomography, intravascular ultrasound echogenicity and virtual histology for the detection of changes in polymeric struts over time: insights from the ABSORB trial. EuroIntervention 2012; 8(3): 352–358.

16. Serruys PW, Onuma Y, Dudek D et al. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol 2011; 58(15): 1578–1588.

17. Gomez-Lara J, Radu M, Brugaletta S et al. Serial analysis of the malapposed and uncovered struts of the new generation of everolimus-eluting bioresorbable scaffold with optical coherence tomography. JACC Cardiovasc Interv 2011; 4(9): 992–1001.

18. Muramatsu T, Onuma Y, Garcia-Garcia HM et al. Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv 2013; 6(3): 247–257.

19. Wiebe J, Mollmann H, Most A et al. Short-term outcome of patients with ST-segment elevation myocardial infarction (STEMI) treated with an everolimus-eluting bioresorbable vascular scaffold. Clin Res Cardiol 2014; 103(2): 141–148.

20. Kocka V, Lisa L, Tousek P et al. ST elevation myocardial infarction treated with bioresorbable vascular scaffold: rationale and first cases. Eur Heart J 2013; 34(27): 2073.

21. Kajiya T, Liang M, Sharma RK et al. Everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). EuroIntervention 2013; 9(4): 501–504.

22. Kocka V, Maly M, Tousek P et al. Bioresorbable vascular scaffolds in acute ST-segment elevation myocardial infarction: a prospective multicentre study “Prague 19”. Eur Heart J 2014; 35(12): 787–794.

23. Diletti R, Karanasos A, Muramatsu T et al. Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study. Eur Heart J. 2014; 35(12): 777–786.

24. La Manna A, Ohno Y, Attizzani GF et al. Successful retrograde recanalization of chronic total coronary occlusion with multiple bioresorbable vascular scaffolds (“full polymer jacket”): initial experience and rationale. Eur Heart J 2013; 34(37): 2925.

25. Grundeken MJ, Kraak RP, de Bruin DM et al. Three-dimensional optical coherence tomography evaluation of a left main bifurcation lesion treated with ABSORB(R) bioresorbable vascular scaffold including fenestration and dilatation of the side branch. Int J Cardiol 2013; 168(3): e107-e108.

26. Ong PJ, Jafary FH, Ho HH “First-in-man” use of bioresorbable vascular scaffold in saphenous vein graft. EuroIntervention 2013; 9(1): 165.

27. Nieman K, Serruys PW, Onuma Y et al. Multislice computed tomography angiography for noninvasive assessment of the 18-month performance of a novel radiolucent bioresorbable vascular scaffolding device: the ABSORB trial (a clinical evaluation of the bioabsorbable everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions). J Am Coll Cardiol 2013; 62(19): 1813–1814.

28. Okamura T, Onuma Y, Garcia-Garcia HM et al. 3-Dimensional optical coherence tomography assessment of jailed side branches by bioresorbable vascular scaffolds: a proposal for classification. JACC Cardiovasc Interv 2010; 3(8): 836–844.

29. Okamura T, Serruys PW, Regar E Cardiovascular flashlight. The fate of bioresorbable struts located at a side branch ostium: serial three-dimensional optical coherence tomography assessment. Eur Heart J 2010; 31(17): 2179.

30. Farooq V, Onuma Y, Radu M et al. Optical coherence tomography (OCT) of overlapping bioresorbable scaffolds: from benchwork to clinical application. EuroIntervention 2011; 7(3): 386–399.

31. Nishio S, Kosuga K, Igaki K et al. Long-Term (>10 Years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents. Circulation 2012; 125(19): 2343–2353.