Safety and efficacy of everolimus-eluting bioresorbable vascular scaffolds versus durable polymer everolimus-eluting metallic stents assessed at 1-year follow-up: A systematic review and meta-analysis of studies

International Journal of Cardiology

Volumn 221, Issue , 2016, Pages 1087-1094

  Mukete, Bertrand N ^a   van der Heijden, Liefke C ^b   Tandjung, Kenneth ^b   Baydoun, Hassan ^a   Yadav, Kapil ^a   Saleh, Qusai A ^a   Doggen, Carine J M ^c   Rafeh, Nidal Abi ^a   Le Jemtel, Thierry H ^a   von Birgelen, Clemens ^b,c  

^a TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b MEDISCH SPECTRUM TWENTE   (Netherlands)

^c UNIVERSITY OF TWENTE   (Netherlands)

Author keywords

Biodegradable device; Bioresorbable vascular scaffold; Everolimus eluting stent; Percutaneous coronary intervention; Scaffold thrombosis; Stent thrombosis

Indexed keywords

CHROMIUM; COBALT; EVEROLIMUS;

BARE METAL STENT; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CLINICAL EFFECTIVENESS; CORONARY ARTERY OBSTRUCTION; DEVICE SAFETY; EVEROLIMUS ELUTING CORONARY STENT; EVEROLIMUS ELUTING METALLIC STENT; FOLLOW UP; HEART DEATH; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HUMAN; META ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; STENT THROMBOSIS; SYSTEMATIC REVIEW; TARGET LESION REVASCULARIZATION; TREATMENT OUTCOME; ADVERSE EFFECTS; BIODEGRADABLE IMPLANT; BLOOD VESSEL PROSTHESIS; CLASSIFICATION; CORONARY ARTERY DISEASE; CORONARY RESTENOSIS; DEVICES; DRUG ELUTING STENT; PERCUTANEOUS CORONARY INTERVENTION; PROCEDURES; PROSTHESIS DESIGN; TISSUE SCAFFOLD;

ABSORBABLE IMPLANTS; BLOOD VESSEL PROSTHESIS; CORONARY ARTERY DISEASE; CORONARY RESTENOSIS; DRUG-ELUTING STENTS; EVEROLIMUS; HUMANS; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); PERCUTANEOUS CORONARY INTERVENTION; PROSTHESIS DESIGN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TISSUE SCAFFOLDS;

EID: 84978715218     PISSN: 01675273     EISSN: 18741754     Source Type: Journal    
DOI: 10.1016/j.ijcard.2016.07.101     Document Type: Review

References (37)

1. [1] Wiebe, J., Nef, H.M., Hamm, C.W., Current status of bioresorbable scaffolds in the treatment of coronary artery disease. J. Am. Coll. Cardiol. 64 (2014), 2541–2551.
2. [2] Waksman, R., Biodegradable stents: they do their job and disappear. J. Invasive Cardiol. 18 (2006), 70–74.
3. [3] Iqbal, J., Onuma, Y., Ormiston, J., Abizaid, A., Waksman, R., Serruys, P., Bioresorbable scaffolds: rationale, current status, challenges, and future. Eur. Heart J. 35 (2014), 765–776.
4. [4] Gomez-Lara, J., Garcia-Garcia, H.M., Onuma, Y., et al. A comparison of the conformability of everolimus-eluting bioresorbable vascular scaffolds to metal platform coronary stents. JACC Cardiovasc. Interv. 3 (2010), 1190–1198.
5. [5] Serruys, P.W., Garcia-Garcia, H.M., Onuma, Y., From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade?. Eur. Heart J. 33 (2012), 16–25b.
6. [6] Tandjung, K., Sen, H., Lam, M.K., et al. Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial. J. Am. Coll. Cardiol. 61 (2013), 2406–2416.
7. [7] Ormiston, J.A., Serruys, P.W., Onuma, Y., et al. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ. Cardiovasc. Interv. 5 (2012), 620–632.
8. [8] Serruys, P.W., 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. 58 (2011), 1578–1588.
9. [9] Capodanno, D., Gori, T., Nef, H., et al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention 10 (2015), 1144–1153.
10. [10] Jaguszewski, M., Ghadri, J.R., Zipponi, M., et al. Feasibility of second-generation bioresorbable vascular scaffold implantation in complex anatomical and clinical scenarios. Clin. Res. Cardiol. 104 (2015), 124–135.
11. [11] Kraak, R.P., Hassell, M.E., Grundeken, M.J., et al. Initial experience and clinical evaluation of the absorb bioresorbable vascular scaffold (BVS) in real-world practice: the AMC Single Centre Real World PCI Registry. EuroIntervention 10 (2015), 1160–1168.
12. [12] Raber, L., Brugaletta, S., Yamaji, K., et al. Very late scaffold thrombosis: intracoronary imaging and histopathological and spectroscopic findings. J. Am. Coll. Cardiol. 66 (2015), 1901–1914.
13. [13] Moher, D., Liberati, A., Tetzlaff, J., Altman, D.G., Group, P., Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann. Intern. Med. 151 (2009), 264–269 (W64).
14. [14] Food and Drug Administration, Circulatory System Devices Panel Meeting. 2006.
15. [15] Serruys, P.W., Chevalier, B., Dudek, D., et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet 385 (2015), 43–54.
16. [16] Kimura, T., Kozuma, K., Tanabe, K., et al. A randomized trial evaluating everolimus-eluting absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur. Heart J. 36 (2015), 3332–3342.
17. [17] Ellis, S.G., Kereiakes, D.J., Metzger, D.C., et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N. Engl. J. Med. 373 (2015), 1905–1915.
18. [18] Gao, R., Yang, Y., Han, Y., et al. Bioresorbable vascular scaffolds versus metallic stents in patients with coronary artery disease: ABSORB China trial. J. Am. Coll. Cardiol. 66 (2015), 2298–2309.
19. [19] Abizaid, A., ABSORB EXTEND: One-Year Results in Moderately Complex Lesions (Abstr.). Presented at: EuroPCR. Paris, France. 2015.
20. [20] Brugaletta, S., Gori, T., Low, A.F., et al. Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc. Interv. 8 (2015), 189–197.
21. [21] Higgins, J.P., Altman, D.G., Gotzsche, P.C., et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ, 343, 2011, d5928.
22. [22] Begg, C.B., Mazumdar, M., Operating characteristics of a rank correlation test for publication bias. Biometrics 50 (1994), 1088–1101.
23. [23] Higgins, J.P., Thompson, S.G., Quantifying heterogeneity in a meta-analysis. Stat. Med. 21 (2002), 1539–1558.
24. [24] Mantel, N., Haenszel, W., Statistical aspects of the analysis of data from retrospective studies of disease. J. Natl. Cancer Inst. 22 (1959), 719–748.
25. [25] DerSimonian, R., Laird, N., Meta-analysis in clinical trials. Control. Clin. Trials 7 (1986), 177–188.
26. [26] Borenstein, M., Introduction to Meta-Analysis. 2009, Wiley, Chichester.
27. [27] Cassese, S., Byrne, R.A., Ndrepepa, G., et al. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials. Lancet 387 (2015), 537–544.
28. [28] Lipinski, M.J., Escarcega, R.O., Baker, N.C., et al. Scaffold thrombosis after percutaneous coronary intervention with ABSORB bioresorbable vascular scaffold: a systematic review and meta-analysis. JACC Cardiovasc. Interv. 9 (2016), 12–24.
29. [29] Onuma, Y., Serruys, P.W., Perkins, L.E., 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 122 (2010), 2288–2300.
30. [30] Onuma, Y., Serruys, P.W., Ormiston, J.A., et al. Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention 6 (2010), 447–453.
31. [31] Bourantas, C.V., Papafaklis, M.I., Garcia-Garcia, H.M., et al. Short- and long-term implications of a bioresorbable vascular scaffold implantation on the local endothelial shear stress patterns. JACC Cardiovasc. Interv. 7 (2014), 100–101.
32. [32] Karanasos, A., Van Mieghem, N., van Ditzhuijzen, N., et al. Angiographic and optical coherence tomography insights into bioresorbable scaffold thrombosis: single-center experience. Circ. Cardiovasc. Interv., 8, 2015, 10.1161/CIRCINTERVENTIONS.114.002369.
33. [33] Puricel, S., Cuculi, F., Weissner, M., et al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J. Am. Coll. Cardiol. 67 (2016), 921–931.
34. [34] von Birgelen, C., Basalus, M.W.Z., Oversized post-dilatation of current bioresorbable vascular scaffolds: kill or cure?. EuroIntervention 11 (2016), 1330–1333.
35. [35] Cortese, B., Piraino, D., Ielasi, A., Steffenino, G., Orrego, P.S., Very late bioresorbable vascular scaffold thrombosis due to late device recoil. Int. J. Cardiol. 189 (2015), 132–133.
36. [36] Timmers, L., Stella, P.R., Agostoni, P., Very late bioresorbable vascular scaffold thrombosis following discontinuation of antiplatelet therapy. Eur. Heart J., 36, 2015, 393.
37. [37] Karanasos, A., van Geuns, R.J., Zijlstra, F., Regar, E., Very late bioresorbable scaffold thrombosis after discontinuation of dual antiplatelet therapy. Eur. Heart J., 35, 2014, 1781.