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Published in: Heart and Vessels 6/2024

27-02-2024 | Intravascular Ultrasound | Original Article

Procedural characteristics and cardiovascular outcomes in patients undergoing drug-coated balloon angioplasty for de novo lesions in large coronary arteries: an observational study

Authors: Hiroshi Ueda, Yoshihiro Fujiwara, Yusuke Nishida, Motoyoshi Maenaka, Kojiro Yoshimura, Yuki Oshida, Seiji Matsuhisa, Naohiro Yoshida, Hidetoshi Yoshitani, Yukiko Kuga, Kazuya Ueda, Yasunori Nishida

Published in: Heart and Vessels | Issue 6/2024

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Abstract

Limited data exist regarding drug-coated balloon (DCB) treatment in de novo large coronary arteries. We sought to demonstrate procedural characteristics, residual stenosis, and clinical outcomes following DCB angioplasty for de novo lesions in large versus small coronary arteries. The study included 184 consecutive patients with 223 de novo coronary lesions undergoing paclitaxel DCB angioplasty between January 2019 and August 2020, who were divided according to whether the DCB diameter was ≥ 3.0 mm (large group, n = 58) or < 3.0 mm (small group, n = 125). The large group had a higher proportion of acute coronary syndrome more commonly with ostial, bifurcation, and calcified lesions in large vessels and received lesion preparation with more frequent use of scoring or cutting balloons and atherectomy devices compared to the small group. Postprocedural angiographic diameter stenosis was smaller in the large group compared to the small group (31% [22–37] vs. 35% [26–42], p = 0.032), and intravascular ultrasound revealed no significant difference in postprocedural area stenosis between the groups (66.2 ± 7.7% vs. 67.9 ± 7.8%; p = 0.26). The median follow-up duration was 995 days. The incidence of a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization was similar between the groups (log-rank p = 0.41) and was influenced by the presence of acute coronary syndrome and anemia but not by DCB diameter. The rate of cardiovascular outcomes after DCB treatment was comparable in de novo large and small coronary arteries. Notably, well-planned lesion preparation with intravascular imaging guidance was prevalent in large vessels.
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Literature
1.
go back to reference Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R (2020) Drug-coated balloon for de novo coronary artery disease: JACC state-of-the-art review. J Am Coll Cardiol 75:1061–1073CrossRefPubMed Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R (2020) Drug-coated balloon for de novo coronary artery disease: JACC state-of-the-art review. J Am Coll Cardiol 75:1061–1073CrossRefPubMed
2.
go back to reference Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U (2006) Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 355:2113–2124CrossRefPubMed Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U (2006) Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 355:2113–2124CrossRefPubMed
3.
go back to reference Jeger RV, Farah A, Ohlow MA, Mangner N, Möbius-Winkler S, Leibundgut G, Weilenmann D, Wöhrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B, BASKET-SMALL 2 Investigators (2018) Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet 392:849–856CrossRefPubMed Jeger RV, Farah A, Ohlow MA, Mangner N, Möbius-Winkler S, Leibundgut G, Weilenmann D, Wöhrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B, BASKET-SMALL 2 Investigators (2018) Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet 392:849–856CrossRefPubMed
4.
go back to reference Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO, ESC Scientific Document Group (2019) 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 40:87–165CrossRefPubMed Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO, ESC Scientific Document Group (2019) 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 40:87–165CrossRefPubMed
5.
go back to reference Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX, International DCB Consensus Group (2020) Drug-coated balloons for coronary artery disease: third report of the international DCB consensus group. JACC Cardiovasc Interv 13:1391–1402CrossRefPubMed Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX, International DCB Consensus Group (2020) Drug-coated balloons for coronary artery disease: third report of the international DCB consensus group. JACC Cardiovasc Interv 13:1391–1402CrossRefPubMed
6.
go back to reference Mintz GS, Nissen SE, Anderson WD, Bailey SR, Erbel R, Fitzgerald PJ, Pinto FJ, Rosenfield K, Siegel RJ, Tuzcu EM, Yock PG (2001) American College of Cardiology clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound studies (IVUS). A report of the American College of Cardiology task force on clinical expert consensus documents. J Am Coll Cardiol 37:1478–1492CrossRefPubMed Mintz GS, Nissen SE, Anderson WD, Bailey SR, Erbel R, Fitzgerald PJ, Pinto FJ, Rosenfield K, Siegel RJ, Tuzcu EM, Yock PG (2001) American College of Cardiology clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound studies (IVUS). A report of the American College of Cardiology task force on clinical expert consensus documents. J Am Coll Cardiol 37:1478–1492CrossRefPubMed
7.
go back to reference Suwannasom P, Sotomi Y, Ishibashi Y, Cavalcante R, Albuquerque FN, Macaya C, Ormiston JA, Hill J, Lang IM, Egred M, Fajadet J, Lesiak M, Tijssen JG, Wykrzykowska JJ, de Winter RJ, Chevalier B, Serruys PW, Onuma Y (2016) The impact of post-procedural asymmetry, expansion, and eccentricity of bioresorbable everolimus-eluting scaffold and metallic everolimus-eluting stent on clinical outcomes in the ABSORB II trial. JACC Cardiovasc Interv 9:1231–1242CrossRefPubMed Suwannasom P, Sotomi Y, Ishibashi Y, Cavalcante R, Albuquerque FN, Macaya C, Ormiston JA, Hill J, Lang IM, Egred M, Fajadet J, Lesiak M, Tijssen JG, Wykrzykowska JJ, de Winter RJ, Chevalier B, Serruys PW, Onuma Y (2016) The impact of post-procedural asymmetry, expansion, and eccentricity of bioresorbable everolimus-eluting scaffold and metallic everolimus-eluting stent on clinical outcomes in the ABSORB II trial. JACC Cardiovasc Interv 9:1231–1242CrossRefPubMed
8.
go back to reference Mintz GS, Garcia-Garcia HM, Nicholls SJ, Weissman NJ, Bruining N, Crowe T, Tardif JC, Serruys PW (2011) Clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound regression/progression studies. EuroIntervention 6:1123–1130CrossRefPubMed Mintz GS, Garcia-Garcia HM, Nicholls SJ, Weissman NJ, Bruining N, Crowe T, Tardif JC, Serruys PW (2011) Clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound regression/progression studies. EuroIntervention 6:1123–1130CrossRefPubMed
9.
go back to reference Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD, Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction (2018) Fourth universal definition of myocardial infarction (2018). J Am Coll Cardiol 72:2231–2264CrossRefPubMed Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD, Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction (2018) Fourth universal definition of myocardial infarction (2018). J Am Coll Cardiol 72:2231–2264CrossRefPubMed
10.
go back to reference Scheller B, Ohlow MA, Ewen S, Kische S, Rudolph TK, Clever YP, Wagner A, Richter S, El-Garhy M, Böhm M, Degenhardt R, Mahfoud F, Lauer B (2020) Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. EuroIntervention 15:1527–1533CrossRefPubMed Scheller B, Ohlow MA, Ewen S, Kische S, Rudolph TK, Clever YP, Wagner A, Richter S, El-Garhy M, Böhm M, Degenhardt R, Mahfoud F, Lauer B (2020) Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. EuroIntervention 15:1527–1533CrossRefPubMed
11.
go back to reference Rissanen TT, Uskela S, Eränen J, Mäntylä P, Olli A, Romppanen H, Siljander A, Pietilä M, Minkkinen MJ, Tervo J, Kärkkäinen JM, DEBUT trial investigators (2019) Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet 394:230–239CrossRefPubMed Rissanen TT, Uskela S, Eränen J, Mäntylä P, Olli A, Romppanen H, Siljander A, Pietilä M, Minkkinen MJ, Tervo J, Kärkkäinen JM, DEBUT trial investigators (2019) Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet 394:230–239CrossRefPubMed
12.
go back to reference Uskela S, Kärkkäinen JM, Eränen J, Siljander A, Mäntylä P, Mustonen J, Rissanen TT (2019) Percutaneous coronary intervention with drug-coated balloon-only strategy in stable coronary artery disease and in acute coronary syndromes: an all-comers registry study. Catheter Cardiovasc Interv 93:893–900CrossRefPubMed Uskela S, Kärkkäinen JM, Eränen J, Siljander A, Mäntylä P, Mustonen J, Rissanen TT (2019) Percutaneous coronary intervention with drug-coated balloon-only strategy in stable coronary artery disease and in acute coronary syndromes: an all-comers registry study. Catheter Cardiovasc Interv 93:893–900CrossRefPubMed
13.
go back to reference Funayama N, Muratsubaki S, Ito R, Tobisawa T, Konishi T (2023) Drug-coated balloons versus drug-eluting stents for coronary de novo lesions in dialysis patients. Heart Vessels 38:300–308CrossRefPubMed Funayama N, Muratsubaki S, Ito R, Tobisawa T, Konishi T (2023) Drug-coated balloons versus drug-eluting stents for coronary de novo lesions in dialysis patients. Heart Vessels 38:300–308CrossRefPubMed
14.
go back to reference Okutsu M, Mitomo S, Ouchi T, Yuki H, Ueno T, Onish H, Yabushita H, Matsuoka S, Kawamoto H, Watanabe Y, Tanaka K, Naganuma T, Sato T, Tahara S, Kurita N, Nakamura S, Nakamura S (2022) Impact of directional coronary atherectomy followed by drug-coated balloon strategy to avoid the complex stenting for bifurcation lesions. Heart Vessels 37:919–930CrossRefPubMed Okutsu M, Mitomo S, Ouchi T, Yuki H, Ueno T, Onish H, Yabushita H, Matsuoka S, Kawamoto H, Watanabe Y, Tanaka K, Naganuma T, Sato T, Tahara S, Kurita N, Nakamura S, Nakamura S (2022) Impact of directional coronary atherectomy followed by drug-coated balloon strategy to avoid the complex stenting for bifurcation lesions. Heart Vessels 37:919–930CrossRefPubMed
15.
go back to reference Muramatsu T, Kozuma K, Tanabe K, Morino Y, Ako J, Nakamura S, Yamaji K, Kohsaka S, Amano T, Kobayashi Y, Ikari Y, Kadota K, Nakamura M, Task Force of the Japanese Association of Cardiovascular Intervention, Therapeutics (CVIT) (2023) Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther 38:166–176CrossRefPubMedPubMedCentral Muramatsu T, Kozuma K, Tanabe K, Morino Y, Ako J, Nakamura S, Yamaji K, Kohsaka S, Amano T, Kobayashi Y, Ikari Y, Kadota K, Nakamura M, Task Force of the Japanese Association of Cardiovascular Intervention, Therapeutics (CVIT) (2023) Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther 38:166–176CrossRefPubMedPubMedCentral
Metadata
Title
Procedural characteristics and cardiovascular outcomes in patients undergoing drug-coated balloon angioplasty for de novo lesions in large coronary arteries: an observational study
Authors
Hiroshi Ueda
Yoshihiro Fujiwara
Yusuke Nishida
Motoyoshi Maenaka
Kojiro Yoshimura
Yuki Oshida
Seiji Matsuhisa
Naohiro Yoshida
Hidetoshi Yoshitani
Yukiko Kuga
Kazuya Ueda
Yasunori Nishida
Publication date
27-02-2024
Publisher
Springer Japan
Published in
Heart and Vessels / Issue 6/2024
Print ISSN: 0910-8327
Electronic ISSN: 1615-2573
DOI
https://doi.org/10.1007/s00380-024-02368-8

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