Five-Year Outcomes of Biodegradable Polymer Drug-Eluting Stents Versus Second-Generation Durable Polymer Drug-Eluting Stents: a Meta-Analysis of Randomized Controlled Trials
- 37 Downloads
We investigated the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) versus second-generation durable polymer drug-eluting stents (DP-DES) in a follow-up period of 5 years.
A meta-analysis was performed using data from the PubMed, EMBASE, and Cochrane Library databases. The primary endpoint was target lesion failure (TLF), a composite endpoint of safety and efficacy, which included cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR). Secondary endpoints were all-cause death, MI, TLR, definite or probable stent thrombosis (ST), and definite or probable very late ST. In addition, we performed subgroup analyses based on patient and stent characteristics.
Nine randomized controlled trials (RCTs) in 11,817 patients were included in the meta-analysis. Compared with second-generation DP-DES, BP-DES was not associated with increased risk of TLF (odds ratio (OR) 1.06, 95 % confidence interval [CI] 0.94–1.20; p = 0.33), all-cause death (OR 1.04, [0.92–1.18], p = 0.49), myocardial infarction (OR 0.97, [0.83–1.13], p = 0.67), target lesion revascularization (OR 1.08, [0.94–1.23], p = 0.27), definite or probable stent thrombosis (OR 0.85, [0.66–1.11], p = 0.24), or definite or probable very late stent thrombosis (OR 0.86, [0.58–1.26],p = 0.43). Furthermore, the subgroup analyses did not reveal any statistically significant differences between the stent groups.
At 5 years of follow-up, the safety and efficacy of BP-DES are clinically comparable to those of second-generation DP-DES.
KeywordsDrug-eluting stents Biodegradable polymer Durable polymer Meta-analysis Everolimus Zotarolimus
We thank Clare Cox, PhD, from Liwen Bianji, Edanz Editing China (www.liwenbianji.cn/ac), for editing the English text of a draft of this manuscript.
This work was supported by the National Natural Science Foundation of China (NO. 81470429) and Beijing Science and Technology Development Fund of Traditional Chinese Medicine (NO. JJ2016-31).
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest.
This article does not contain any studies with human participants performed by any of the authors.
- 9.Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vázquez N, Valdés M, et al. Biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: final 5-year report from the COMPARE II trial (abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent). JACC Cardiovasc Interv. 2017;10(12):1215–21.CrossRefGoogle Scholar
- 13.Li C, Xu B, Guan C, Gao R. Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions. Chin J Cardiol. 2017;45(11):940–7.Google Scholar
- 14.Kufner S, Byrne RA, Valeskini M, Schulz S, Ibrahim T, Hoppmann P, et al. Five-year outcomes from a trial of three limus-eluting stents with different polymer coatings in patients with coronary artery disease: final results from the ISAR-TEST 4 randomised trial. EuroIntervention. 2016;11(12):1372–9.CrossRefGoogle Scholar
- 16.Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, et al. Five-year outcome of a randomised trial comparing second-generation drug-eluting stents using either biodegradable polymer or durable polymer: the NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent trial (NEXT). EuroIntervention. 2018;14(7):815–8.CrossRefGoogle Scholar
- 17.Wijns W, Vrolix M, Verheye S, Schoors D, Slagboom T, Gosselink M, et al. Long-term clinical outcomes of a crystalline sirolimus-eluting coronary stent with a fully bioabsorbable polymer coating: five-year outcomes from the DESSOLVE I and II trials. EuroIntervention. 2018;13(18):e2147–51.CrossRefGoogle Scholar
- 18.Lefevre T, Haude M, Neumann FJ, Stangl K, Skurk C, Slagboom T, et al. Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: 5-year outcomes of the randomized BIOFLOW-II trial. J Am Coll Cardiol Intv. 2018;11(10):995–1002.CrossRefGoogle Scholar
- 19.Wijns W, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez-Romo A, Barbato E, et al. Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation: final five-year results of the CENTURY II randomised clinical trial. EuroIntervention. 2018;14(3):e343–51.CrossRefGoogle Scholar
- 20.Pilgrim T, Piccolo R, Heg D, Roffi M, Tuller D, Muller O, et al. Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial. Lancet. 2018;392(10149):737–46.CrossRefGoogle Scholar
- 21.Kandzari DE, Mauri L, Koolen JJ, Massaro JM, Doros G, Garcia-Garcia HM, et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017;390(10105):1843–52.CrossRefGoogle Scholar
- 22.Pilgrim T, Heg D, Roffi M, Tüller D, Muller O, Vuilliomenet A, et al. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial. Lancet. 2014;384(9960):2111–22.CrossRefGoogle Scholar
- 23.Saito S, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez Romo A, Barbato E, et al. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial. Eur Heart J. 2014;35(30):2021–31.CrossRefGoogle Scholar
- 24.Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, et al. Final 3-year outcome of a randomized trial comparing second-generation drug-eluting stents using either biodegradable polymer or durable polymer: NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent trial. Circ Cardiovasc Interv. 2015;8(10).Google Scholar
- 25.de Winter RJ, Katagiri Y, Asano T, Milewski KP, Lurz P, Buszman P, et al. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial. Lancet. 2018;391(10119):431–40.CrossRefGoogle Scholar
- 28.Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, et al. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials. Eur Heart J. 2012;33(10):1214–22.CrossRefGoogle Scholar
- 30.Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Sabaté M, Smits PC, et al. Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2014;63(4):299–307.CrossRefGoogle Scholar
- 31.Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, et al. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013;6(8):777–89.CrossRefGoogle Scholar
- 36.Kolandaivelu K, Swaminathan R, Gibson WJ, Kolachalama VB, Nguyen-Ehrenreich KL, Giddings VL, et al. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011;123(13):1400–9.CrossRefGoogle Scholar
- 38.Buiten RA, Ploumen EH, Zocca P, Doggen CJM, van der Heijden LC, Kok MM, et al. Outcomes in patients treated with thin-strut, very thin-strut, or ultrathin-strut drug-eluting stents in small coronary vessels: a prespecified analysis of the randomized BIO-RESORT trial. JAMA Cardiol. 2019;4(7):659–69.CrossRefGoogle Scholar
- 40.Franzone A, Pilgrim T, Heg D, Roffi M, Tuller D, Vuilliomenet A, et al. Clinical outcomes according to diabetic status in patients treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: prespecified subgroup analysis of the BIOSCIENCE trial. Circ Cardiovasc Interv. 2015;8(6).Google Scholar
- 41.Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, et al. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015;11(3):272–9.CrossRefGoogle Scholar