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Erschienen in: Clinical Research in Cardiology 9/2020

29.01.2020 | Original Paper

Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial

verfasst von: Gregor Fahrni, Bruno Scheller, Michael Coslovsky, Nicole Gilgen, Ahmed Farah, Marc-Alexander Ohlow, Norman Mangner, Daniel Weilenmann, Jochen Wöhrle, Florim Cuculi, Gregor Leibundgut, Sven Möbius-Winkler, Robert Zweiker, Raphael Twerenbold, Christoph Kaiser, Raban Jeger, For the BASKET-SMALL 2 Investigators

Erschienen in: Clinical Research in Cardiology | Ausgabe 9/2020

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Abstract

Background

The randomized BASKET-SMALL 2 trial showed non-inferiority for treatment with drug-coated balloon (DCB) compared with drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) for de novo lesions in small coronary arteries regarding clinical endpoints at 1 year. In this predefined substudy, we investigated the angiographic findings in patients undergoing a clinically indicated follow-up angiography during the study phase.

Methods

Eight-hundred and eighty-three patients underwent PCI with either DES or DCB in a culprit vessel < 3 mm in diameter for stable coronary artery disease or acute coronary syndrome. Event-driven re-angiographies and the corresponding images at baseline were analyzed for angiographic endpoints.

Results

One-hundred and eleven patients (117 lesions, 66 DES versus 51 DCB) presented for an unscheduled re-angiography at median 5.7 months after the index procedure. At baseline, mean reference vessel diameter was 2.05 mm and the residual in-segment stenosis after the index procedure was less in DES compared to DCB (23.7% vs 33.8%, p = 0.001). At follow-up angiography, diameter stenosis in the DES group (29.0%) was still somewhat smaller than after DCB angioplasty (35.8%) when adjusting for time since PCI (p = 0.047), whereas lumen loss (LL) did not differ between the two treatment arms (LL-DES 0.06 mm vs LL-DCB 0.10 mm, p = 0.20). Eight patients following DES implantation presented with a complete occlusion of the target lesion compared to no occlusion in the DCB group (p = 0.009).

Conclusions

The clinically indicated follow-up angiography within 1 year showed no difference in LL. Complete thrombotic vessel occlusions were found only in the DES group.

Clinical Trial Registration

www.​clinicaltrials.​gov; number, NCT01574534
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Literatur
1.
Zurück zum Zitat Akiyama T, Moussa I, Reimers B et al (1998) Angiographic and clinical outcome following coronary stenting of small vessels: a comparison with coronary stenting of large vessels. J Am Coll Cardiol 20:20 Akiyama T, Moussa I, Reimers B et al (1998) Angiographic and clinical outcome following coronary stenting of small vessels: a comparison with coronary stenting of large vessels. J Am Coll Cardiol 20:20
2.
Zurück zum Zitat Alfonso F, Scheller B (2017) State of the art: balloon catheter technologies—drug-coated balloon. EuroIntervention 13:680–695CrossRef Alfonso F, Scheller B (2017) State of the art: balloon catheter technologies—drug-coated balloon. EuroIntervention 13:680–695CrossRef
3.
Zurück zum Zitat Colleran R, Kastrati A (2018) Percutaneous coronary intervention: balloons, stents and scaffolds. Clin Res Cardiol 107:55–63CrossRef Colleran R, Kastrati A (2018) Percutaneous coronary intervention: balloons, stents and scaffolds. Clin Res Cardiol 107:55–63CrossRef
4.
Zurück zum Zitat Jeger RV, Farah A, Ohlow M-A et al (2018) Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet 392:849–856CrossRef Jeger RV, Farah A, Ohlow M-A et al (2018) Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet 392:849–856CrossRef
5.
Zurück zum Zitat Cortese B, Micheli A, Picchi A et al (2010) Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart 96:1291–1296CrossRef Cortese B, Micheli A, Picchi A et al (2010) Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart 96:1291–1296CrossRef
6.
Zurück zum Zitat Latib A, Colombo A, Castriota F et al (2012) A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol 60:2473–2480CrossRef Latib A, Colombo A, Castriota F et al (2012) A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol 60:2473–2480CrossRef
7.
Zurück zum Zitat Tang Y, Qiao S, Su X et al (2018) Drug-Coated balloon versus drug-eluting stent for small-vessel disease: the RESTORE SVD China randomized trial. JACC Cardiovasc Interv 11:2381–2392CrossRef Tang Y, Qiao S, Su X et al (2018) Drug-Coated balloon versus drug-eluting stent for small-vessel disease: the RESTORE SVD China randomized trial. JACC Cardiovasc Interv 11:2381–2392CrossRef
8.
Zurück zum Zitat Kleber FX, Rittger H, Bonaventura K et al (2013) Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol 102:785–797CrossRef Kleber FX, Rittger H, Bonaventura K et al (2013) Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol 102:785–797CrossRef
9.
Zurück zum Zitat Sianos G, Papafaklis MI, Serruys PW (2010) Angiographic thrombus burden classification in patients with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention. J Invasive Cardiol 22:6B–14BPubMed Sianos G, Papafaklis MI, Serruys PW (2010) Angiographic thrombus burden classification in patients with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention. J Invasive Cardiol 22:6B–14BPubMed
10.
Zurück zum Zitat Maechler M, Rousseeuw P, Croux C, et al. 2019 robustbase: basic robust statistics. R package version 0.93-4 Maechler M, Rousseeuw P, Croux C, et al. 2019 robustbase: basic robust statistics. R package version 0.93-4
11.
Zurück zum Zitat R Core Team (2018) R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna R Core Team (2018) R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna
12.
Zurück zum Zitat Serruys PW, Garcia-Garcia HM, Onuma Y (2012) From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? Eur Heart J 33:16–25bCrossRef Serruys PW, Garcia-Garcia HM, Onuma Y (2012) From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? Eur Heart J 33:16–25bCrossRef
13.
Zurück zum Zitat Varenhorst C, Lindholm M, Sarno G et al (2018) Stent thrombosis rates the first year and beyond with new- and old-generation drug-eluting stents compared to bare metal stents. Clin Res Cardiol 107:816–823CrossRef Varenhorst C, Lindholm M, Sarno G et al (2018) Stent thrombosis rates the first year and beyond with new- and old-generation drug-eluting stents compared to bare metal stents. Clin Res Cardiol 107:816–823CrossRef
14.
Zurück zum Zitat Glagov S, Weisenberg E, Zarins CK, Stankunavicius R, Kolettis GJ (1987) Compensatory enlargement of human atherosclerotic coronary arteries. N Engl J Med 316:1371–1375CrossRef Glagov S, Weisenberg E, Zarins CK, Stankunavicius R, Kolettis GJ (1987) Compensatory enlargement of human atherosclerotic coronary arteries. N Engl J Med 316:1371–1375CrossRef
15.
Zurück zum Zitat Unverdorben M, Kleber FX, Heuer H et al (2010) Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol 99:165–174CrossRef Unverdorben M, Kleber FX, Heuer H et al (2010) Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol 99:165–174CrossRef
16.
Zurück zum Zitat Post MJ, Borst C, Kuntz RE (1994) The relative importance of arterial remodeling compared with intimal hyperplasia in lumen renarrowing after balloon angioplasty. A study in the normal rabbit and the hypercholesterolemic Yucatan micropig. Circulation 89:2816–2821CrossRef Post MJ, Borst C, Kuntz RE (1994) The relative importance of arterial remodeling compared with intimal hyperplasia in lumen renarrowing after balloon angioplasty. A study in the normal rabbit and the hypercholesterolemic Yucatan micropig. Circulation 89:2816–2821CrossRef
17.
Zurück zum Zitat Diletti R, Farooq V, Girasis C et al (2013) Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial. Heart 99:98–105CrossRef Diletti R, Farooq V, Girasis C et al (2013) Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial. Heart 99:98–105CrossRef
18.
Zurück zum Zitat Latib A, Ruparelia N, Menozzi A et al (2015) 3-year follow-up of the balloon elution and late loss optimization study (BELLO). JACC Cardiovasc Interv 8:1132–1134CrossRef Latib A, Ruparelia N, Menozzi A et al (2015) 3-year follow-up of the balloon elution and late loss optimization study (BELLO). JACC Cardiovasc Interv 8:1132–1134CrossRef
19.
Zurück zum Zitat Venetsanos D, Lawesson SS, Panayi G et al (2018) Long-term efficacy of drug coated balloons compared with new generation drug-eluting stents for the treatment of de novo coronary artery lesions. Catheter Cardiovasc Interv 92:E317–E326CrossRef Venetsanos D, Lawesson SS, Panayi G et al (2018) Long-term efficacy of drug coated balloons compared with new generation drug-eluting stents for the treatment of de novo coronary artery lesions. Catheter Cardiovasc Interv 92:E317–E326CrossRef
20.
Zurück zum Zitat Sarno G, Lagerqvist B, Fröbert O et al (2012) Lower risk of stent thrombosis and restenosis with unrestricted use of “new-generation” drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J 33:606–613CrossRef Sarno G, Lagerqvist B, Fröbert O et al (2012) Lower risk of stent thrombosis and restenosis with unrestricted use of “new-generation” drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J 33:606–613CrossRef
21.
Zurück zum Zitat Cortese B, Silva Orrego P, Agostoni P et al (2015) Effect of drug-coated balloons in native coronary artery disease left with a dissection. JACC Cardiovasc Interv 8:2003–2009CrossRef Cortese B, Silva Orrego P, Agostoni P et al (2015) Effect of drug-coated balloons in native coronary artery disease left with a dissection. JACC Cardiovasc Interv 8:2003–2009CrossRef
Metadaten
Titel
Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial
verfasst von
Gregor Fahrni
Bruno Scheller
Michael Coslovsky
Nicole Gilgen
Ahmed Farah
Marc-Alexander Ohlow
Norman Mangner
Daniel Weilenmann
Jochen Wöhrle
Florim Cuculi
Gregor Leibundgut
Sven Möbius-Winkler
Robert Zweiker
Raphael Twerenbold
Christoph Kaiser
Raban Jeger
For the BASKET-SMALL 2 Investigators
Publikationsdatum
29.01.2020
Verlag
Springer Berlin Heidelberg
Erschienen in
Clinical Research in Cardiology / Ausgabe 9/2020
Print ISSN: 1861-0684
Elektronische ISSN: 1861-0692
DOI
https://doi.org/10.1007/s00392-020-01603-2

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