Skip to main content
Erschienen in: Herz 4/2023

09.04.2022 | Original articles

Outcome of a polymer-free drug-coated coronary stent in bifurcation lesions—Pilot registry with serial OCT imaging

verfasst von: Hendrik Wienemann, MD, Felix Meincke, MD, Marius Vach, MD, Christian-Hendrik Heeger, MD, Annika Meyer, Tobias Spangenberg, MD, Karl Heinz Kuck, MD, PhD, Alexander Ghanem, MD, PhD

Erschienen in: Herz | Ausgabe 4/2023

Einloggen, um Zugang zu erhalten

Abstract

Background

Polymer-free and carrier-free drug-coated stents (DCS) represent a novel therapeutic option for the treatment of coronary artery disease. The objective of this pilot registry is to evaluate the safety and efficacy of DCS implantation in bifurcation lesions.

Methods

Overall, 23 consecutive patients with 24 lesions received a Biolimus A9-coated DCS for coronary bifurcation lesions. Patients were examined with quantitative coronary angiography (QCA) and optical coherence tomography (OCT) at 3–6 months of follow-up.

Results

A total of 23 patients with 24 bifurcation lesions were included in this study. Nine (33.3%) lesions of eight patients revealed angiographical target lesion failure due to in-stent restenosis (ISR). In total, 19 patients with 20 bifurcation lesions were suitable for OCT analysis. A total of 2936 struts were analyzed and 14 struts (0.47%) were classified as malapposed. The mean luminal area (mm2) was not different in lesions with ISR vs. lesions with no ISR (5.07 ± 2.0 vs. 5.73 ± 1.34, p = 0.39) at follow-up. Lesions with ISR showed higher mean neointimal burden (27.11 ± 10.59 vs. 13.93 ± 9.16%, respectively; p = 0.009). All of the patients who presented with significant ISR required percutaneous re-intervention.

Conclusions

We observed a high rate of DCS ISR in bifurcation lesions, possibly related to increased inflammation and neoatherosclerosis. The small size of the study warrants careful interpretation of our results. Larger trials are necessary to expand knowledge of these findings.
Literatur
4.
Zurück zum Zitat Costa RA, Abizaid A, Mehran R et al (2016) Polymer-free biolimus A9-coated stents in the treatment of de novo coronary lesions: 4‑ and 12-month angiographic follow-up and final 5‑year clinical outcomes of the prospective, multicenter biofreedom FIM clinical trial. JACC Cardiovasc Interv 9:51–64. https://doi.org/10.1016/j.jcin.2015.09.008CrossRefPubMed Costa RA, Abizaid A, Mehran R et al (2016) Polymer-free biolimus A9-coated stents in the treatment of de novo coronary lesions: 4‑ and 12-month angiographic follow-up and final 5‑year clinical outcomes of the prospective, multicenter biofreedom FIM clinical trial. JACC Cardiovasc Interv 9:51–64. https://​doi.​org/​10.​1016/​j.​jcin.​2015.​09.​008CrossRefPubMed
9.
Zurück zum Zitat Jensen LO, Maeng M, Raungaard B et al (2020) Randomized comparison of the polymer-free biolimus-coated biofreedom stent with the ultrathin strut biodegradable polymer sirolimus-eluting orsiro stent in an all-comers population treated with percutaneous coronary intervention: the SORT OUT IX trial. Circulation 141:2052–2063. https://doi.org/10.1161/CIRCULATIONAHA.119.040241CrossRefPubMed Jensen LO, Maeng M, Raungaard B et al (2020) Randomized comparison of the polymer-free biolimus-coated biofreedom stent with the ultrathin strut biodegradable polymer sirolimus-eluting orsiro stent in an all-comers population treated with percutaneous coronary intervention: the SORT OUT IX trial. Circulation 141:2052–2063. https://​doi.​org/​10.​1161/​CIRCULATIONAHA.​119.​040241CrossRefPubMed
11.
Zurück zum Zitat Lee SWL, Tam FCC, Chan KKW et al (2018) Establishment of healing profile and neointimal transformation in the new polymer-free biolimus A9-coated coronary stent by longitudinal sequential optical coherence tomography assessments: the EGO-BIOFREEDOM study. EuroIntervention 14:780–788. https://doi.org/10.4244/EIJ-D-18-00061CrossRefPubMed Lee SWL, Tam FCC, Chan KKW et al (2018) Establishment of healing profile and neointimal transformation in the new polymer-free biolimus A9-coated coronary stent by longitudinal sequential optical coherence tomography assessments: the EGO-BIOFREEDOM study. EuroIntervention 14:780–788. https://​doi.​org/​10.​4244/​EIJ-D-18-00061CrossRefPubMed
16.
Zurück zum Zitat Prati F, Regar E, Mintz GS et al (2010) Expert review document on methodology, terminology, and clinical applications of optical coherence tomography: physical principles, methodology of image acquisition, and clinical application for assessment of coronary arteries and atherosclerosis. Eur Heart J 31:401–415. https://doi.org/10.1093/eurheartj/ehp433CrossRefPubMed Prati F, Regar E, Mintz GS et al (2010) Expert review document on methodology, terminology, and clinical applications of optical coherence tomography: physical principles, methodology of image acquisition, and clinical application for assessment of coronary arteries and atherosclerosis. Eur Heart J 31:401–415. https://​doi.​org/​10.​1093/​eurheartj/​ehp433CrossRefPubMed
18.
Zurück zum Zitat Tearney GJ, Regar E, Akasaka T et al (2012) Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol 59:1058–1072. https://doi.org/10.1016/j.jacc.2011.09.079CrossRefPubMed Tearney GJ, Regar E, Akasaka T et al (2012) Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol 59:1058–1072. https://​doi.​org/​10.​1016/​j.​jacc.​2011.​09.​079CrossRefPubMed
19.
Zurück zum Zitat Heeger C‑H, Busjahn A, Hildebrand L et al (2016) Delayed coverage of drug-eluting stents after interventional revascularisation of chronic total occlusions assessed by optical coherence tomography: the ALSTER-OCT-CTO registry. EuroIntervention 11:1004–1012. https://doi.org/10.4244/EIJY14M10_01CrossRefPubMed Heeger C‑H, Busjahn A, Hildebrand L et al (2016) Delayed coverage of drug-eluting stents after interventional revascularisation of chronic total occlusions assessed by optical coherence tomography: the ALSTER-OCT-CTO registry. EuroIntervention 11:1004–1012. https://​doi.​org/​10.​4244/​EIJY14M10_​01CrossRefPubMed
20.
Zurück zum Zitat Nakatani S, Sotomi Y, Ishibashi Y et al (2016) Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomography at baseline and follow-up. EuroIntervention 12:1498–1509. https://doi.org/10.4244/EIJY15M10_03CrossRefPubMed Nakatani S, Sotomi Y, Ishibashi Y et al (2016) Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomography at baseline and follow-up. EuroIntervention 12:1498–1509. https://​doi.​org/​10.​4244/​EIJY15M10_​03CrossRefPubMed
21.
Zurück zum Zitat Ryan TJ, Faxon DP, Gunnar RM et al. Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty). Circulation. 1988;78:486–502. https://doi.org/10.1161/01.cir.78.2.486CrossRefPubMed Ryan TJ, Faxon DP, Gunnar RM et al. Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty). Circulation. 1988;78:486–502. https://​doi.​org/​10.​1161/​01.​cir.​78.​2.​486CrossRefPubMed
24.
Zurück zum Zitat Waksman R, Pakala R, Baffour R et al (2012) In vivo comparison of a polymer-free Biolimus A9-eluting stent with a biodegradable polymer-based Biolimus A9 eluting stent and a bare metal stent in balloon denuded and radiated hypercholesterolemic rabbit iliac arteries. Catheter Cardiovasc Interv 80:429–436. https://doi.org/10.1002/ccd.23407CrossRefPubMed Waksman R, Pakala R, Baffour R et al (2012) In vivo comparison of a polymer-free Biolimus A9-eluting stent with a biodegradable polymer-based Biolimus A9 eluting stent and a bare metal stent in balloon denuded and radiated hypercholesterolemic rabbit iliac arteries. Catheter Cardiovasc Interv 80:429–436. https://​doi.​org/​10.​1002/​ccd.​23407CrossRefPubMed
32.
Zurück zum Zitat Chen S‑L, Sheiban I, Xu B et al (2014) Impact of the complexity of bifurcation lesions treated with drug-eluting stents: the DEFINITION study (Definitions and impact of complEx biFurcation lesIons on clinical outcomes after percutaNeous coronary IntervenTIOn using drug-eluting steNts). JACC Cardiovasc Interv 7:1266–1276. https://doi.org/10.1016/j.jcin.2014.04.026CrossRefPubMed Chen S‑L, Sheiban I, Xu B et al (2014) Impact of the complexity of bifurcation lesions treated with drug-eluting stents: the DEFINITION study (Definitions and impact of complEx biFurcation lesIons on clinical outcomes after percutaNeous coronary IntervenTIOn using drug-eluting steNts). JACC Cardiovasc Interv 7:1266–1276. https://​doi.​org/​10.​1016/​j.​jcin.​2014.​04.​026CrossRefPubMed
Metadaten
Titel
Outcome of a polymer-free drug-coated coronary stent in bifurcation lesions—Pilot registry with serial OCT imaging
verfasst von
Hendrik Wienemann, MD
Felix Meincke, MD
Marius Vach, MD
Christian-Hendrik Heeger, MD
Annika Meyer
Tobias Spangenberg, MD
Karl Heinz Kuck, MD, PhD
Alexander Ghanem, MD, PhD
Publikationsdatum
09.04.2022
Verlag
Springer Medizin
Erschienen in
Herz / Ausgabe 4/2023
Print ISSN: 0340-9937
Elektronische ISSN: 1615-6692
DOI
https://doi.org/10.1007/s00059-022-05109-7

Weitere Artikel der Ausgabe 4/2023

Herz 4/2023 Zur Ausgabe

Schadet Ärger den Gefäßen?

14.05.2024 Arteriosklerose Nachrichten

In einer Studie aus New York wirkte sich Ärger kurzfristig deutlich negativ auf die Endothelfunktion gesunder Probanden aus. Möglicherweise hat dies Einfluss auf die kardiovaskuläre Gesundheit.

Intervallfasten zur Regeneration des Herzmuskels?

14.05.2024 Herzinfarkt Nachrichten

Die Nahrungsaufnahme auf wenige Stunden am Tag zu beschränken, hat möglicherweise einen günstigen Einfluss auf die Prognose nach akutem ST-Hebungsinfarkt. Darauf deutet eine Studie an der Uniklinik in Halle an der Saale hin.

Shunt-Therapie bei Herzinsuffizienz: Kein Anzug, der allen passt

13.05.2024 Chronische Herzinsuffizienz Nachrichten

Die Anlage eines interatrialen Shunts zur Reduktion des linksatrialen Drucks ist ein neuer Therapieansatz bei Herzinsuffizienz. Viele Patienten sprechen darauf an, andere jedoch nicht. 

Vorsicht, erhöhte Blutungsgefahr nach PCI!

10.05.2024 Koronare Herzerkrankung Nachrichten

Nach PCI besteht ein erhöhtes Blutungsrisiko, wenn die Behandelten eine verminderte linksventrikuläre Ejektionsfraktion aufweisen. Das Risiko ist umso höher, je stärker die Pumpfunktion eingeschränkt ist.

Update Kardiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.