An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: A LEADERS trial sub-study

Peter Barlis, Evelyn Regar, Patrick W. Serruys, Konstantinos Dimopoulos, Willem J. Van Der Giessen, Robert Jan M Van Geuns, Giuseppe Ferrante, Simon Wandel, Stephan Windecker, Gerrit Anne Van Es, Pedro Eerdmans, Peter Jüni, Carlo Di Mario

Research output: Contribution to journalArticle

Abstract

AimsIncomplete endothelialization has been found to be associated with late stent thrombosis, a rare but devastating phenomenon, more frequent after drug-eluting stent implantation. Optical coherence tomography (OCT) has 10 times greater resolution than intravascular ultrasound and thus appears to be a valuable modality for the assessment of stent strut coverage. The LEADERS trial was a multi-centre, randomized comparison of a biolimus-eluting stent (BES) with biodegradable polymer with a sirolimus-eluting stent (SES) using a durable polymer. This study sought to evaluate tissue coverage and apposition of stents using OCT in a group of patients from the randomized LEADERS trial.Methods and resultsFifty-six consecutive patients underwent OCT during angiographic follow-up at 9 months. OCT images were acquired using a non-occlusive technique at a pullback speed of 3 mm/s. Data were analysed using a Bayesian hierarchical random-effects model, which accounted for the correlation of lesion characteristics within patients and implicitly assigned analytical weights to each lesion depending on the number of struts observed per lesion. Primary outcome was the difference in percentage of uncovered struts between BESs and SESs. Twenty patients were included in the analysis in the BES group (29 lesions with 4592 struts) and 26 patients in the SES group (35 lesions with 6476 struts). A total of 83 struts were uncovered in the BES group and 407 out of 6476 struts were uncovered in the SES group [weighted difference-1.4, 95 confidence interval (CI)-3.7 to 0.0, P = 0.04]. Results were similar after adjustment for pre-procedure lesion length, reference vessel diameter, number of implanted study stents, and presence of stent overlap. There were three lesions in the BES group and 15 lesions in the SES group that had ≥5 of all struts uncovered (difference-33.1, 95 CI-61.7 to-10.3, P <0.01).ConclusionStrut coverage at an average follow-up of 9 months appears to be more complete in patients allocated to BESs when compared with SESs. The impact of this difference on clinical outcome and, in particular, on the risk of late stent thrombosis is yet to be determined.

Original languageEnglish
Pages (from-to)165-176
Number of pages12
JournalEuropean Heart Journal
Volume31
Issue number2
DOIs
Publication statusPublished - Jan 2010

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Optical Coherence Tomography
Stents
Polymers
Sirolimus
Thrombosis
Confidence Intervals
Drug-Eluting Stents

Keywords

  • Biodegradable polymer
  • Drug-eluting stents
  • Optical coherence tomography
  • Stent thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Barlis, P., Regar, E., Serruys, P. W., Dimopoulos, K., Van Der Giessen, W. J., Van Geuns, R. J. M., ... Di Mario, C. (2010). An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: A LEADERS trial sub-study. European Heart Journal, 31(2), 165-176. https://doi.org/10.1093/eurheartj/ehp480

An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent : A LEADERS trial sub-study. / Barlis, Peter; Regar, Evelyn; Serruys, Patrick W.; Dimopoulos, Konstantinos; Van Der Giessen, Willem J.; Van Geuns, Robert Jan M; Ferrante, Giuseppe; Wandel, Simon; Windecker, Stephan; Van Es, Gerrit Anne; Eerdmans, Pedro; Jüni, Peter; Di Mario, Carlo.

In: European Heart Journal, Vol. 31, No. 2, 01.2010, p. 165-176.

Research output: Contribution to journalArticle

Barlis, P, Regar, E, Serruys, PW, Dimopoulos, K, Van Der Giessen, WJ, Van Geuns, RJM, Ferrante, G, Wandel, S, Windecker, S, Van Es, GA, Eerdmans, P, Jüni, P & Di Mario, C 2010, 'An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: A LEADERS trial sub-study', European Heart Journal, vol. 31, no. 2, pp. 165-176. https://doi.org/10.1093/eurheartj/ehp480
Barlis, Peter ; Regar, Evelyn ; Serruys, Patrick W. ; Dimopoulos, Konstantinos ; Van Der Giessen, Willem J. ; Van Geuns, Robert Jan M ; Ferrante, Giuseppe ; Wandel, Simon ; Windecker, Stephan ; Van Es, Gerrit Anne ; Eerdmans, Pedro ; Jüni, Peter ; Di Mario, Carlo. / An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent : A LEADERS trial sub-study. In: European Heart Journal. 2010 ; Vol. 31, No. 2. pp. 165-176.
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abstract = "AimsIncomplete endothelialization has been found to be associated with late stent thrombosis, a rare but devastating phenomenon, more frequent after drug-eluting stent implantation. Optical coherence tomography (OCT) has 10 times greater resolution than intravascular ultrasound and thus appears to be a valuable modality for the assessment of stent strut coverage. The LEADERS trial was a multi-centre, randomized comparison of a biolimus-eluting stent (BES) with biodegradable polymer with a sirolimus-eluting stent (SES) using a durable polymer. This study sought to evaluate tissue coverage and apposition of stents using OCT in a group of patients from the randomized LEADERS trial.Methods and resultsFifty-six consecutive patients underwent OCT during angiographic follow-up at 9 months. OCT images were acquired using a non-occlusive technique at a pullback speed of 3 mm/s. Data were analysed using a Bayesian hierarchical random-effects model, which accounted for the correlation of lesion characteristics within patients and implicitly assigned analytical weights to each lesion depending on the number of struts observed per lesion. Primary outcome was the difference in percentage of uncovered struts between BESs and SESs. Twenty patients were included in the analysis in the BES group (29 lesions with 4592 struts) and 26 patients in the SES group (35 lesions with 6476 struts). A total of 83 struts were uncovered in the BES group and 407 out of 6476 struts were uncovered in the SES group [weighted difference-1.4, 95 confidence interval (CI)-3.7 to 0.0, P = 0.04]. Results were similar after adjustment for pre-procedure lesion length, reference vessel diameter, number of implanted study stents, and presence of stent overlap. There were three lesions in the BES group and 15 lesions in the SES group that had ≥5 of all struts uncovered (difference-33.1, 95 CI-61.7 to-10.3, P <0.01).ConclusionStrut coverage at an average follow-up of 9 months appears to be more complete in patients allocated to BESs when compared with SESs. The impact of this difference on clinical outcome and, in particular, on the risk of late stent thrombosis is yet to be determined.",
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AU - Dimopoulos, Konstantinos

AU - Van Der Giessen, Willem J.

AU - Van Geuns, Robert Jan M

AU - Ferrante, Giuseppe

AU - Wandel, Simon

AU - Windecker, Stephan

AU - Van Es, Gerrit Anne

AU - Eerdmans, Pedro

AU - Jüni, Peter

AU - Di Mario, Carlo

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N2 - AimsIncomplete endothelialization has been found to be associated with late stent thrombosis, a rare but devastating phenomenon, more frequent after drug-eluting stent implantation. Optical coherence tomography (OCT) has 10 times greater resolution than intravascular ultrasound and thus appears to be a valuable modality for the assessment of stent strut coverage. The LEADERS trial was a multi-centre, randomized comparison of a biolimus-eluting stent (BES) with biodegradable polymer with a sirolimus-eluting stent (SES) using a durable polymer. This study sought to evaluate tissue coverage and apposition of stents using OCT in a group of patients from the randomized LEADERS trial.Methods and resultsFifty-six consecutive patients underwent OCT during angiographic follow-up at 9 months. OCT images were acquired using a non-occlusive technique at a pullback speed of 3 mm/s. Data were analysed using a Bayesian hierarchical random-effects model, which accounted for the correlation of lesion characteristics within patients and implicitly assigned analytical weights to each lesion depending on the number of struts observed per lesion. Primary outcome was the difference in percentage of uncovered struts between BESs and SESs. Twenty patients were included in the analysis in the BES group (29 lesions with 4592 struts) and 26 patients in the SES group (35 lesions with 6476 struts). A total of 83 struts were uncovered in the BES group and 407 out of 6476 struts were uncovered in the SES group [weighted difference-1.4, 95 confidence interval (CI)-3.7 to 0.0, P = 0.04]. Results were similar after adjustment for pre-procedure lesion length, reference vessel diameter, number of implanted study stents, and presence of stent overlap. There were three lesions in the BES group and 15 lesions in the SES group that had ≥5 of all struts uncovered (difference-33.1, 95 CI-61.7 to-10.3, P <0.01).ConclusionStrut coverage at an average follow-up of 9 months appears to be more complete in patients allocated to BESs when compared with SESs. The impact of this difference on clinical outcome and, in particular, on the risk of late stent thrombosis is yet to be determined.

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KW - Biodegradable polymer

KW - Drug-eluting stents

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KW - Stent thrombosis

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