Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): Rationale and study design of the randomized TWENTE III multicenter trial

Ming Kai Lam, Hanim Sen, Kenneth Tandjung, K. Gert van Houwelingen, Arie G. de Vries, Peter W. Danse, Carl E. Schotborgh, Martijn Scholte, Marije M. Löwik, Gerard C.M. Linssen, Maarten J. IJzerman, Jacobus Adrianus Maria van der Palen, Carine J.M. Doggen, Clemens von Birgelen

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Abstract

Aim: To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES.

Methods and Results: BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non‐inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012.

Conclusions: BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome
Original languageEnglish
Pages (from-to)445-451
JournalAmerican heart journal
Volume167
Issue number4
DOIs
Publication statusPublished - 2014

Fingerprint

Drug-Eluting Stents
Multicenter Studies
Polymers
Percutaneous Coronary Intervention
Stents
Diabetes Mellitus
Sirolimus
Random Allocation
Myocardial Infarction
Research Personnel
Safety
Incidence

Keywords

  • METIS-303307
  • IR-90443

Cite this

Lam, Ming Kai ; Sen, Hanim ; Tandjung, Kenneth ; van Houwelingen, K. Gert ; de Vries, Arie G. ; Danse, Peter W. ; Schotborgh, Carl E. ; Scholte, Martijn ; Löwik, Marije M. ; Linssen, Gerard C.M. ; IJzerman, Maarten J. ; van der Palen, Jacobus Adrianus Maria ; Doggen, Carine J.M. ; von Birgelen, Clemens. / Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT) : Rationale and study design of the randomized TWENTE III multicenter trial. In: American heart journal. 2014 ; Vol. 167, No. 4. pp. 445-451.
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title = "Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): Rationale and study design of the randomized TWENTE III multicenter trial",
abstract = "Aim: To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES.Methods and Results: BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5{\%} with a 3.5{\%} non‐inferiority margin, giving the study a power of 85{\%} (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012.Conclusions: BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome",
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author = "Lam, {Ming Kai} and Hanim Sen and Kenneth Tandjung and {van Houwelingen}, {K. Gert} and {de Vries}, {Arie G.} and Danse, {Peter W.} and Schotborgh, {Carl E.} and Martijn Scholte and L{\"o}wik, {Marije M.} and Linssen, {Gerard C.M.} and IJzerman, {Maarten J.} and {van der Palen}, {Jacobus Adrianus Maria} and Doggen, {Carine J.M.} and {von Birgelen}, Clemens",
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Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT) : Rationale and study design of the randomized TWENTE III multicenter trial. / Lam, Ming Kai; Sen, Hanim; Tandjung, Kenneth; van Houwelingen, K. Gert; de Vries, Arie G.; Danse, Peter W.; Schotborgh, Carl E.; Scholte, Martijn; Löwik, Marije M.; Linssen, Gerard C.M.; IJzerman, Maarten J.; van der Palen, Jacobus Adrianus Maria; Doggen, Carine J.M.; von Birgelen, Clemens.

In: American heart journal, Vol. 167, No. 4, 2014, p. 445-451.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT)

T2 - Rationale and study design of the randomized TWENTE III multicenter trial

AU - Lam, Ming Kai

AU - Sen, Hanim

AU - Tandjung, Kenneth

AU - van Houwelingen, K. Gert

AU - de Vries, Arie G.

AU - Danse, Peter W.

AU - Schotborgh, Carl E.

AU - Scholte, Martijn

AU - Löwik, Marije M.

AU - Linssen, Gerard C.M.

AU - IJzerman, Maarten J.

AU - van der Palen, Jacobus Adrianus Maria

AU - Doggen, Carine J.M.

AU - von Birgelen, Clemens

N1 - Open access

PY - 2014

Y1 - 2014

N2 - Aim: To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES.Methods and Results: BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non‐inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012.Conclusions: BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome

AB - Aim: To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES.Methods and Results: BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non‐inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012.Conclusions: BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome

KW - METIS-303307

KW - IR-90443

U2 - 10.1016/j.ahj.2013.11.014

DO - 10.1016/j.ahj.2013.11.014

M3 - Article

VL - 167

SP - 445

EP - 451

JO - American heart journal

JF - American heart journal

SN - 0002-8703

IS - 4

ER -