Bioresorbable scaffolds: Current evidence and ongoing clinical trials

Current Cardiology Reports

Volumn 14, Issue 5, 2012, Pages 626-634

  Bourantas, Christos V ^a   Zhang, Yaojun ^a   Farooq, Vasim ^a   Garcia Garcia, Hector M ^a   Onuma, Yoshinobu ^a   Serruys, Patrick W ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

Bioresorbable scaffolds; Coronary artery disease; Stents; Vascular restoration therapy

Indexed keywords

BIOMATERIAL; BIORESORBABLE SCAFFOLD; MAGNESIUM; PACLITAXEL; UNCLASSIFIED DRUG;

ANGIOCARDIOGRAPHY; ARTICLE; CAUSE OF DEATH; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; CORONARY STENT; DEVICE SAFETY; DRUG ELUTING STENT; HEART INFARCTION; HUMAN; INTRAVASCULAR ULTRASOUND; METAL STENT; NONHUMAN; STENT THROMBOSIS; TREATMENT OUTCOME;

ABSORBABLE IMPLANTS; BIOPROSTHESIS; CLINICAL TRIALS AS TOPIC; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; HUMANS; PERCUTANEOUS CORONARY INTERVENTION; STENTS; TISSUE SCAFFOLDS;

EID: 84870581791     PISSN: 15233782     EISSN: 15343170     Source Type: Journal    
DOI: 10.1007/s11886-012-0295-5     Document Type: Article

References (34)

1. Serruys PW, Garcia-Garcia HM, Onuma Y. From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? European Heart Journal. 2012;33:16-25b.
2. Waksman R. Biodegradable stents: they do their job and disappear. The Journal of Invasive Cardiology. 2006;18:70-4.
3. Colombo A, Karvouni E. Biodegradable stents: "fulfilling the mission and stepping away. Circulation. 2000;102:371-3. (Pubitemid 30490672)
4. Nakazawa G, Otsuka F, Nakano M, et al. The pathology of neoatherosclerosis in human coronary implants bare-metal and drugeluting stents. Journal of the American College of Cardiology. 2011;57:1314-22.
5. Virmani R, Guagliumi G, Farb A, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109:701-5. (Pubitemid 38222887)
6. 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;102:399-404. (Pubitemid 30490677)
7. Nishio S, Kosuga K, Igaki K, et al. Long-term (10 years) clinical outcomes of first-in-man biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai Stents. Circulation. 2012.
8. Post MJ, de Graaf-Bos AN, van Zanten HG, et al. Thrombogenicity of the human arterial wall after interventional thermal injury. Journal of Vascular Research. 1996;33:156-63. (Pubitemid 26089633)
9. Heublein B, Rohde R, Kaese V, Niemeyer M, Hartung W, Haverich A. Biocorrosion of magnesium alloys: a new principle in cardiovascular implant technology? Heart. 2003;89:651-6. (Pubitemid 36606211)
10. Waksman R, Pakala R, Kuchulakanti PK, et al. Safety and efficacy of bioabsorbable magnesium alloy stents in porcine coronary arteries. Catheterization and Cardiovascular Interventions. 2006;68:607-17. (Pubitemid 44546055)
11. Ghimire G, Spiro J, Kharbanda R, et al. Initial evidence for the return of coronary vasoreactivity following the absorption of bioabsorbable magnesium alloy coronary stents. EuroIntervention. 2009;4:481-4.
12. Waksman R. Current state of the absorbable metallic (magnesium) stent. EuroIntervention. 2009;5(Suppl F):F94-7.
13. Haude M. From PROGRESS to DREAMS. PCR focus group on bioresorbable vascular scaffolds. Rotterdam NL, March 2012.
14. Waksman R. Lessons learned from preclinical studies of magnesium scaffolds (Biotronik's DREAMS program). PCR focus group on bioresorbable vascular scaffolds. Rotterdam NL, March 2012.
15. 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 openlabel trial. Lancet. 2008;371:899-907. (Pubitemid 351384734)
16. Serruys PW, Ormiston JA, Onuma Y, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009;373:897-910.
17. Tanimoto S, Bruining N, van Domburg RT, et al. Late stent recoil of the bioabsorbable everolimus-eluting coronary stent and its relationship with plaque morphology. Journal of the American College of Cardiology. 2008;52:1616-20.
18. Garg S, Serruys P. Biodegradable stents and nonbiodegradable stents. Minerva Cardioangiologica. 2009;57:537-65.
19. Serruys PW, Onuma Y, Ormiston JA, et al. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010;122:2301-12.
20. Serruys PW, Onuma Y, on behalf of the ABSORB A & B investigators. ABSORB Cohort B: 6 m, 12 m, 18 m and 24 m follow-up. PCR focus group on bioresorbable vascular scaffolds. Rotterdam NL, March 2012.
21. 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. Journal of the American College of Cardiology. 2011;58:1578-88.
22. Strandberg E, Zeltinger J, Schulz DG, Kaluza GL. Late positive remodeling and late lumen gain contribute to vascular restoration by a nondrug eluting bioresorbable scaffold: a 4-year intravascular ultrasound study in normal porcine coronary arteries. Circulation Cardiovascular Interventions. 2012;5:39-46.
23. Schulze R. REVA Medical Inc. Bioresorbable stent Cardiovasc revascularisation therapies. 2007.
24. Grube E. Bioabsorbable stent. The Boston Scientific and REVA technology. Barcelona, Spain: EuroPCR; 2009.
25. Abizaid A. REVA: clinical update and case presentation. PCR focus group on bioresorbable vascular scaffolds. Rotterdam NL, March 2012.
26. Jabara R, Chronos N, Robinson K. Novel bioabsorbable salicylatebased polymer as a drug-eluting stent coating. Catheterization and Cardiovascular Interventions. 2008;72:186-94.
27. Jabara R. Poly-anhydride based on salicylic acid and adipic acid anhydride. Barcelona, Spain: EuroPCR; 2009.
28. Jabara R. Bio-mechanical properties and ABC of bioresorption of adipic acid. PCR focus group on bioresorbable vascular scaffolds. Rotterdam NL, March. 2012.
29. Verheye S. Desolve first in-man study preliminary results. PCR focus group on bioresorbable vascular scaffolds. Rotterdam NL, March 2012.
30. Lafont A. ART bioresorbable stent. Arterial remodeling in preclinical models. PCR focus group on bioresorbable vascular scaffolds. Rotterdam NL, March 2012.
31. Shen L, Wang Q, Wu Y, Xie J, Ge J. Short-term effects of sirolimus eluting fully bioabsorbable polymeric coronary stents in a porcine model. Proceedings of te 23rd Annual Scientific Symposium of Transcatheter Cardiovascular Therapeutics. San Francisco, CA, November 7-11, 2011.
32. Cottone RJ, Thatcher GL, Parker SP, et al. OrbusNeich fully absorbable coronary stent platform incorporating dual partitioned coatings. EuroIntervention. 2009;5(Suppl F):F65-71.
33. Cottone R. Structural lessons learned: blended plla scaffold partitioned coating with abluminal sirolimus drug elution matrix and luminal + CD34 antibody for epc capture. Barcelona, Spain: EuroPCR; 2009.
34. Onuma Y, Serruys PW. SerruBioresorbable Scaffold: the advent of a new era in percutaneous coronary and peripheral revascularization? Circulation. 2011;123:779-97.