Outcomes after drug‐coated balloon treatment for patients with calcified coronary lesions

Ito, Ryuta; Ueno, Katsumi; Yoshida, Tamao; Tatsumi, Tomohiko; Hashimoto, Yasumasa; Kojima, Yoshinobu; Kitamura, Tomoya; Morita, N.

doi:10.1111/joic.12484

Cited by 19 publications

(16 citation statements)

References 17 publications

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“…Ito et al reported a restenosis incidence of 13.9% at 6.5 months, late lumen loss of 0.03 mm, and late lumen enlargement of 47.2% after DCB for patients with de novo calcified coronary lesions using QCA (RA was used in 82% of cases), in accord with the present study. However, it should be noted that the present study enrolled restenosis cases including ISR as well as de novo lesion cases [18]. Intracoronary imaging modalities such as OFDI, OCT, and IVUS have facilitated PCI development by expanding our understanding of coronary calcium placing and wire bias.…”

Section: Discussionmentioning

confidence: 99%

Acute and mid-term outcomes of drug-coated balloon following rotational atherectomy

Nagai

Mizobuchi

Funatsu

et al. 2019

Cardiovasc Interv and Ther

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Rotational atherectomy (RA) is effective for reducing calcified plaque volume as part of percutaneous coronary intervention (PCI). Most lesions are then treated by stenting, but we often observe in-stent restenosis (ISR) due to an under-expanded stent associated with severe calcification, a condition that is particularly challenging to treat. It is unknown if drug-coated balloon (DCB) application following RA can be used as a "stentless" treatment strategy for calcified lesions. The aim of this study is to assess the acute and mid-term efficacy of DCB following RA (RA + DCB) at our institute and to evaluate the overall clinical utility of this stentless strategy for complex calcified lesions. From October 2014 to June 2018, 3644 lesions in 2424 consecutive cases were treated with PCI at our institute. Rotational atherectomy was used for 12.3% of all lesions and 42.3% of these RA-treated lesions were then treated using DCBs (n = 190 RA + DCB-treated lesions, of which 72% were in males). In-hospital major adverse cardiac events included only one case of non-Q-wave myocardial infarction. Average duration of follow-up coronary angiography after initial PCI was 199 ± 61 days. Angiographic restenosis was observed in 17.8% of RA + DCB-treated lesions, with mean late lumen loss of 0.23 ± 0.69 mm, while late lumen enlargement was observed in 39.1% of RA + DCB-treated lesions. At mid-term clinical follow-up, there were no cardiac deaths and target lesion revascularization rate was only 16.4%. Rotational atherectomy followed by DCB demonstrated acceptable acute and mid-term efficacy, suggesting that this stentless strategy may be an effective option for complex calcified lesions with high risk of ISR.

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Section: Discussionmentioning

confidence: 99%

Acute and mid-term outcomes of drug-coated balloon following rotational atherectomy

Nagai

Mizobuchi

Funatsu

et al. 2019

Cardiovasc Interv and Ther

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“…A recent study that compared outcomes of the treatment of de novo coronary artery lesions with DCB and nDES showed similar safety and long-term efficacy [5, 6]. In addition, we recently reported that the clinical outcomes after DCB treatment of moderate or severe calcified lesions and noncalcified lesions were similar [7].…”

Section: Introductionmentioning

confidence: 92%

Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy for Severely Calcified Coronary Lesions Compared with New Generation Drug-Eluting Stents

Ueno

Morita

Kojima

et al. 2019

Journal of Interventional Cardiology

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Objectives. This study sought to assess the safety and long-term efficacy of drug-coated balloons (DCB) following aggressive intracoronary image-guided rotational atherectomy (iRA) for severe coronary artery calcification (CAC), and to compare this strategy with new generation drug-eluting stents (nDES) following iRA. Background. Ischemic events following the treatment of CAC is still relatively high. Thus, more innovative strategies are required. Methods. We evaluated 123 consecutive patients (166 lesions) with de novo CAC undergoing an iRA (burr size; 0.7 of the mean reference diameter by intracoronary imaging) followed by DCB (DCB-iRA; 54 patients, 68 lesions) or nDES (nDES-iRA; 69 patients, 98 lesions). Follow-up angiography was obtained at > 6 months. Results. The target vessels (right coronary and circumflex), bifurcation (67.6% versus 47.9%), reference diameter (2.28mm versus 2.49mm), and lesion length (11.89mm versus 18.78mm) were significantly different between the two groups. The median follow-up was 732 days. TLR and TVR in DCB-iRA and nDES-iRA at 3 years were similar: 15.6% versus 16.3% (P=0.99) and 15.6% versus 23.3% (P=0.38). In 41 well-matched lesion pairs after propensity score analysis, the cumulative incidence of TLR and TVR in DCB-iRA and nDES-iRA at 3 years was 12.9% versus 16.3% (P=0.70) and 12.9% versus 26.1% (P=0.17), respectively. On QCA analysis, although the acute gain was smaller in DCB-iRA (0.85 mm versus 1.53 mm, P<0.001), the minimum lumen diameter at follow-up was similar (1.69 mm versus 1.87 mm, P=0.29). The late lumen loss was lower (0.09 mm versus 0.52 mm, P=0.009) in DCB-iRA. Conclusions. DCB-iRA is feasible for CAC.

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“… 14 , 15 , 16 A recent report from Japanese investigators has indicated that among de novo coronary lesions with a mean reference diameter of 2.22 mm, angiographic and clinical outcomes of DCB-based stentless PCI in the noncalcified lesions were comparable with those in the calcified lesions. 17 As for large vessel de novo lesions, a single report has shown that DCB-based stentless PCI is safe and effective even among coronary arteries (> 2.75 mm) with average reference diameter of 3.16 mm and calcification frequency of approximately 20%. 18 The noncalcified lesions tended to have a larger reference diameter and a shorter lesion length than the calcified lesions, which might account for the difference in the distribution of the guiding catheter size between the noncalcified and calcified lesions in the present study.…”

Section: Discussionmentioning

confidence: 99%

Stentless Interventional Procedure Using Rotational Atherectomy and Drug-Coated Balloon for Noncalcified De Novo Lesions

et al. 2021

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Background: Several recent reports have shown that a stentless interventional procedure using rotational atherectomy followed by drug-coated balloon (DCB) treatment (RA/DCB) is a potent revascularization therapy for calcified de novo lesions even in the newgeneration drug-eluting stent era; however, the role of the RA/DCB procedure for noncalcified de novo lesions remains unclear. Methods: A total of 47 consecutive patients (53 lesions) who underwent RA/DCB for coronary de novo lesions were enrolled. According to the presence or absence of severe calcification at target lesions on fluoroscopy, the 47 patients were divided into the noncalcified cases (n ¼ 12) and the calcified cases (n ¼ 35), and the 53 lesions were R ESUM E Contexte : Plusieurs rapports r ecents ont montr e qu'une revascularisation sans endoprothèse effectu ee par ath erectomie rotationnelle (AR) suivie d'un traitement par ballonnet m edicament e (BM) constitue une m ethode efficace pour traiter les nouvelles l esions calcifi ees, même à l'ère des endoprothèses m edicament ees de nouvelle g en eration; on ne connaît toutefois pas bien l'utilit e de l'intervention par AR et BM en cas de nouvelles l esions non calcifi ees. M ethodologie : Au total, 47 patients cons ecutifs (53 l esions) ayant subi une intervention par AR et BM pour traiter de nouvelles l esions coronariennes ont et e admis dans l' etude. Ces 47 patients ont et e r epartis en deux groupes, en fonction de l'absence (n ¼ 12) ou de laDrug-eluting stent (DES) implantation has been a standard interventional treatment of coronary artery disease (CAD); however, there still remain several DES-unfavourable clinical or lesion backgrounds, such as bleeding tendency, intolerance to antiplatelet agents, metal allergy, severe or diffuse calcified lesions, calcified nodules, and ostial or bifurcation lesions. For CAD patients complicated with these specific conditions, percutaneous coronary intervention (PCI) without stent implantation "stentless PCI" is theoretically a promising revascularization therapy. Recently drug-coated balloon (DCB)-only angioplasty for de novo lesions has attracted greater attention, and pretreatment with rotational atherectomy (RA) followed by DCB treatment (RA/DCB) has been reported to be an option of stentless PCI particularly for calcified de novo lesions. [1][2][3][4] However, even small-sized data regarding the RA/ DCB procedure for noncalcified de novo lesions are still lacking. The purpose of the present retrospective study was therefore to compare angiographic results and clinical outcomes in patients with noncalcified de novo lesions who underwent RA/ DCB with patients with calcified de novo lesions in a real-world clinical practice. Methods Patient population and procedureFrom December 2014 to September 2019, 47 consecutive patients (53 lesions) who eventually underwent stentless PCI using RA/DCB for coronary de novo lesions or restenotic lesions after balloon angioplasty in our hospital were retrospectively enrolled. Lesions requiring bailout stenting and in-s...

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Outcomes after drug‐coated balloon treatment for patients with calcified coronary lesions

Abstract: Calcified coronary lesions might dilute the effect of DCB. However, clinical outcomes in the calcified group were similar to those in the non-calcified group.

Cited by 19 publications

References 17 publications

Acute and mid-term outcomes of drug-coated balloon following rotational atherectomy

Acute and mid-term outcomes of drug-coated balloon following rotational atherectomy

Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy for Severely Calcified Coronary Lesions Compared with New Generation Drug-Eluting Stents

Stentless Interventional Procedure Using Rotational Atherectomy and Drug-Coated Balloon for Noncalcified De Novo Lesions

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