Three-month evaluation of strut healing using a novel optical coherence tomography analytical method following bioresorbable polymer everolimus-eluting stent implantation in humans: The TIMELESS study

Boris Vesga, Hector Hernandez, Miguel Moncada, Pawel Gasior, Sergio Higuera, Antonio Dager, Camilo Arana, Juan A. Delgado, Philippe Genereux, Akiko Maehara, Juan F. Granada

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Aims Bioresorbable polymer drug-eluting stent technologies have been considered to have the potential to enhance vascular healing by reducing polymer exposure to the vessel wall, potentially allowing the earlier discontinuation of dual antiplatelet therapy. At present, the early vascular healing response to this type of technologies is still unclear. Patients and methods The TIMELESS study is a multicenter, prospective, single-arm study that enrolled real-world patients undergoing percutaneous coronary intervention. All patients underwent Synergy stent implantation, which consists of a platinum-chromium platform coated with an ultra-thin abluminal bioabsorbable poly-d,l-lactide-co-glycolide polymer-eluting everolimus. Results A total of 37 patients were included in the study. The majority of the patients underwent percutaneous coronary intervention because of acute coronary syndromes. At 3 months, angiographic follow-up showed a percentage diameter of stenosis of 8.1±7.5% and an angiographic late loss of 0.03±0.24 mm. In all analyzed struts, less than 1% of struts were definitely uncovered or covered with fibrin, 12.5% (5.0-18.5%) showed evidence of partial coverage, and the remaining (∼85%) were fully covered. No stent thrombosis was observed up to 12 months of clinical follow-up. Conclusion In a real-world population, the implantation of a bioresorbable polymer drug-eluting stent resulted in almost complete strut coverage throughout the entire stent length at 3 months. The clinical implications for antiplatelet therapy and outcomes should be investigated further.

Original languageEnglish (US)
Pages (from-to)126-134
Number of pages9
JournalCoronary Artery Disease
Volume28
Issue number2
DOIs
StatePublished - Jan 1 2017
Externally publishedYes

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Optical Coherence Tomography
Stents
Polymers
Drug-Eluting Stents
Percutaneous Coronary Intervention
Blood Vessels
Technology
Chromium
Acute Coronary Syndrome
Platinum
Fibrin
Pathologic Constriction
Thrombosis
Everolimus
Therapeutics
Population

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Vesga, Boris ; Hernandez, Hector ; Moncada, Miguel ; Gasior, Pawel ; Higuera, Sergio ; Dager, Antonio ; Arana, Camilo ; Delgado, Juan A. ; Genereux, Philippe ; Maehara, Akiko ; Granada, Juan F. / Three-month evaluation of strut healing using a novel optical coherence tomography analytical method following bioresorbable polymer everolimus-eluting stent implantation in humans : The TIMELESS study. In: Coronary Artery Disease. 2017 ; Vol. 28, No. 2. pp. 126-134.
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abstract = "Aims Bioresorbable polymer drug-eluting stent technologies have been considered to have the potential to enhance vascular healing by reducing polymer exposure to the vessel wall, potentially allowing the earlier discontinuation of dual antiplatelet therapy. At present, the early vascular healing response to this type of technologies is still unclear. Patients and methods The TIMELESS study is a multicenter, prospective, single-arm study that enrolled real-world patients undergoing percutaneous coronary intervention. All patients underwent Synergy stent implantation, which consists of a platinum-chromium platform coated with an ultra-thin abluminal bioabsorbable poly-d,l-lactide-co-glycolide polymer-eluting everolimus. Results A total of 37 patients were included in the study. The majority of the patients underwent percutaneous coronary intervention because of acute coronary syndromes. At 3 months, angiographic follow-up showed a percentage diameter of stenosis of 8.1±7.5{\%} and an angiographic late loss of 0.03±0.24 mm. In all analyzed struts, less than 1{\%} of struts were definitely uncovered or covered with fibrin, 12.5{\%} (5.0-18.5{\%}) showed evidence of partial coverage, and the remaining (∼85{\%}) were fully covered. No stent thrombosis was observed up to 12 months of clinical follow-up. Conclusion In a real-world population, the implantation of a bioresorbable polymer drug-eluting stent resulted in almost complete strut coverage throughout the entire stent length at 3 months. The clinical implications for antiplatelet therapy and outcomes should be investigated further.",
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Three-month evaluation of strut healing using a novel optical coherence tomography analytical method following bioresorbable polymer everolimus-eluting stent implantation in humans : The TIMELESS study. / Vesga, Boris; Hernandez, Hector; Moncada, Miguel; Gasior, Pawel; Higuera, Sergio; Dager, Antonio; Arana, Camilo; Delgado, Juan A.; Genereux, Philippe; Maehara, Akiko; Granada, Juan F.

In: Coronary Artery Disease, Vol. 28, No. 2, 01.01.2017, p. 126-134.

Research output: Contribution to journalArticle

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T1 - Three-month evaluation of strut healing using a novel optical coherence tomography analytical method following bioresorbable polymer everolimus-eluting stent implantation in humans

T2 - The TIMELESS study

AU - Vesga, Boris

AU - Hernandez, Hector

AU - Moncada, Miguel

AU - Gasior, Pawel

AU - Higuera, Sergio

AU - Dager, Antonio

AU - Arana, Camilo

AU - Delgado, Juan A.

AU - Genereux, Philippe

AU - Maehara, Akiko

AU - Granada, Juan F.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Aims Bioresorbable polymer drug-eluting stent technologies have been considered to have the potential to enhance vascular healing by reducing polymer exposure to the vessel wall, potentially allowing the earlier discontinuation of dual antiplatelet therapy. At present, the early vascular healing response to this type of technologies is still unclear. Patients and methods The TIMELESS study is a multicenter, prospective, single-arm study that enrolled real-world patients undergoing percutaneous coronary intervention. All patients underwent Synergy stent implantation, which consists of a platinum-chromium platform coated with an ultra-thin abluminal bioabsorbable poly-d,l-lactide-co-glycolide polymer-eluting everolimus. Results A total of 37 patients were included in the study. The majority of the patients underwent percutaneous coronary intervention because of acute coronary syndromes. At 3 months, angiographic follow-up showed a percentage diameter of stenosis of 8.1±7.5% and an angiographic late loss of 0.03±0.24 mm. In all analyzed struts, less than 1% of struts were definitely uncovered or covered with fibrin, 12.5% (5.0-18.5%) showed evidence of partial coverage, and the remaining (∼85%) were fully covered. No stent thrombosis was observed up to 12 months of clinical follow-up. Conclusion In a real-world population, the implantation of a bioresorbable polymer drug-eluting stent resulted in almost complete strut coverage throughout the entire stent length at 3 months. The clinical implications for antiplatelet therapy and outcomes should be investigated further.

AB - Aims Bioresorbable polymer drug-eluting stent technologies have been considered to have the potential to enhance vascular healing by reducing polymer exposure to the vessel wall, potentially allowing the earlier discontinuation of dual antiplatelet therapy. At present, the early vascular healing response to this type of technologies is still unclear. Patients and methods The TIMELESS study is a multicenter, prospective, single-arm study that enrolled real-world patients undergoing percutaneous coronary intervention. All patients underwent Synergy stent implantation, which consists of a platinum-chromium platform coated with an ultra-thin abluminal bioabsorbable poly-d,l-lactide-co-glycolide polymer-eluting everolimus. Results A total of 37 patients were included in the study. The majority of the patients underwent percutaneous coronary intervention because of acute coronary syndromes. At 3 months, angiographic follow-up showed a percentage diameter of stenosis of 8.1±7.5% and an angiographic late loss of 0.03±0.24 mm. In all analyzed struts, less than 1% of struts were definitely uncovered or covered with fibrin, 12.5% (5.0-18.5%) showed evidence of partial coverage, and the remaining (∼85%) were fully covered. No stent thrombosis was observed up to 12 months of clinical follow-up. Conclusion In a real-world population, the implantation of a bioresorbable polymer drug-eluting stent resulted in almost complete strut coverage throughout the entire stent length at 3 months. The clinical implications for antiplatelet therapy and outcomes should be investigated further.

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