Impact of Dissection after Drug-Coated Balloon Treatment of De Novo Coronary Lesions: Angiographic and Clinical Outcomes

Lin Hui, Eun Seok Shin, Eun Jung Jun, Youngjune Bhak, Scot Garg, Tae Hyun Kim, Chang Bae Sohn, Byung Joo Choi, Liu Kun, Song Lin Yuan, Wang Zhi, Jiang Hao, Shi Zhentao, Tang Qiang, Lin Hui, Eun Seok Shin, Eun Jung Jun, Youngjune Bhak, Scot Garg, Tae Hyun Kim, Chang Bae Sohn, Byung Joo Choi, Liu Kun, Song Lin Yuan, Wang Zhi, Jiang Hao, Shi Zhentao, Tang Qiang

Abstract

Purpose: Dissection after plain balloon angioplasty is required to achieve adequate luminal area; however, it is associated with a high risk of vascular events. This study aimed to examine the relationship between non-flow limiting coronary dissections and subsequent lumen loss and long-term clinical outcomes following successful drug-coated balloon (DCB) treatment of de novo coronary lesions.

Materials and methods: A total of 227 patients with good distal flow (Thrombolysis in Myocardial Infarction flow grade 3) following DCB treatment were retrospectively enrolled and stratified according to the presence or absence of a non-flow limiting dissection. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction, target vessel revascularization, and target vessel thrombosis).

Results: The cohort consisted of 95 patients with and 132 patients without a dissection. There were no between-group differences in LLL (90.8%) returning for angiography at 6 months (0.05±0.19 mm in non-dissection and 0.05±0.30 mm in dissection group, p=0.886) or in TVF (6.8% in non-dissection and 8.4% in dissection group, p=0.799) at a median follow-up of 3.4 years. In a multivariate analysis, the presence of dissection and its severity were not associated with LLL or TVF. Almost dissections (93.9%) were completely healed, and there was no newly developed dissection at 6-month angiography.

Conclusion: The presence of a dissection following successful DCB treatment of a de novo coronary lesion may not be associated with an increased risk of LLL or TVF (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277).

Keywords: Balloon angioplasty; coronary heart disease; dissection; outcome research.

Conflict of interest statement

The authors have no potential conflicts of interest to disclose.

© Copyright: Yonsei University College of Medicine 2020.

Figures

Fig. 1. The fate of dissections after…
Fig. 1. The fate of dissections after drug-coated balloon treatment.
Fig. 2. Comparison of late lumen loss…
Fig. 2. Comparison of late lumen loss according to the presence of dissection (A) and the severity of dissection (B).
Fig. 3. Cumulative frequency distribution curves of…
Fig. 3. Cumulative frequency distribution curves of minimal lumen diameter (A) and percent diameter stenosis (B) before procedure, after procedure, and at follow-up.
Fig. 4. Cumulative frequency distribution curves of…
Fig. 4. Cumulative frequency distribution curves of late lumen loss according to dissection.

References

    1. Roubin GS, King SB, 3rd, Douglas JS., Jr Restenosis after percutaneous transluminal coronary angioplasty: the Emory University Hospital experience. Am J Cardiol. 1987;60:39B–43B.
    1. Douglas JS, Jr, King SB, 3rd, Roubin GS. Influence of the methodology of percutaneous transluminal coronary angioplasty on restenosis. Am J Cardiol. 1987;60:29B–33B.
    1. Leimgruber PP, Roubin GS, Hollman J, Cotsonis GA, Meier B, Douglas JS, et al. Restenosis after successful coronary angioplasty in patients with single-vessel disease. Circulation. 1986;73:710–717.
    1. Roubin GS, Douglas JS, Jr, King SB, 3rd, Lin SF, Hutchison N, Thomas RG, et al. Influence of balloon size on initial success, acute complications, and restenosis after percutaneous transluminal coronary angioplasty. A prospective randomized study. Circulation. 1988;78:557–565.
    1. Cripps TR, Morgan JM, Rickards AF. Outcome of extensive coronary artery dissection during coronary angioplasty. Br Heart J. 1991;66:3–6.
    1. Hermans WR, Rensing BJ, Foley DP, Deckers JW, Rutsch W, Emanuelsson H, et al. Therapeutic dissection after successful coronary balloon angioplasty: no influence on restenosis or on clinical outcome in 693 patients. The MERCATOR Study Group (Multicenter European Research Trial with Cilazapril after Angioplasty to prevent Transluminal Coronary Obstruction and Restenosis) J Am Coll Cardiol. 1992;20:767–780.
    1. Cappelletti A, Margonato A, Rosano G, Mailhac A, Veglia F, Colombo A, et al. Short- and long-term evolution of unstented nonocclusive coronary dissection after coronary angioplasty. J Am Coll Cardiol. 1999;34:1484–1488.
    1. Leimgruber PP, Roubin GS, Anderson HV, Bredlau CE, Whitworth HB, Douglas JS, Jr, et al. Influence of intimal dissection on restenosis after successful coronary angioplasty. Circulation. 1985;72:530–535.
    1. Serruys PW, Luijten HE, Beatt KJ, Geuskens R, de Feyter PJ, van den Brand M, et al. Incidence of restenosis after successful coronary angioplasty: a time-related phenomenon. A quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months. Circulation. 1988;77:361–371.
    1. Ernst SM, van der Feltz TA, Bal ET, van Bogerijen L, van den Berg E, Ascoop CA, et al. Long-term angiographic follow up, cardiac events, and survival in patients undergoing percutaneous transluminal coronary angioplasty. Br Heart J. 1987;57:220–225.
    1. Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, et al. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009;119:3198–3206.
    1. Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, et al. Drug-coated balloon for de novo coronary artery disease: JACC state-of-the-art review. J Am Coll Cardiol. 2020;75:1061–1073.
    1. Jeger RV, Farah A, Ohlow MA, Mangner N, Möbius-Winkler S, Leibundgut G, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018;392:849–856.
    1. Her AY, Shin ES, Bang LH, Nuruddin AA, Tang Q, Hsieh IC, et al. Drug-coated balloon treatment in coronary artery disease: recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2019 (Forthcoming)
    1. Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, et al. Drug-coated balloons for coronary artery disease: third report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020;13:1391–1402.
    1. Ishikawa S, Yoshinaga Y, Kantake D, Nakamura D, Yoshida N, Hisatomi T, et al. Development of a novel noninvasive system for measurement and imaging of the arterial phase oxygen density ratio in the retinal microcirculation. Graefes Arch Clin Exp Ophthalmol. 2019;257:557–565.
    1. Her AY, Shin ES, Lee JM, Garg S, Doh JH, Nam CW, et al. Paclitaxel-coated balloon treatment for functionally nonsignificant residual coronary lesions after balloon angioplasty. Int J Cardiovasc Imaging. 2018;34:1339–1347.
    1. Shin ES, Ann SH, Balbir Singh G, Lim KH, Kleber FX, Koo BK. Fractional flow reserve-guided paclitaxel-coated balloon treatment for de novo coronary lesions. Catheter Cardiovasc Interv. 2016;88:193–200.
    1. Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, et al. Paclitaxel-coated balloon angioplasty versus drug-eluting stent in acute myocardial infarction: the REVELATION randomized trial. JACC Cardiovasc Interv. 2019;12:1691–1699.
    1. Albertal M, Van Langenhove G, Regar E, Kay IP, Foley D, Sianos G, et al. Uncomplicated moderate coronary artery dissections after balloon angioplasty: good outcome without stenting. Heart. 2001;86:193–198.
    1. Her AY, Ann SH, Singh GB, Kim YH, Yoo SY, Garg S, et al. Comparison of paclitaxel-coated balloon treatment and plain old balloon angioplasty for de novo coronary lesions. Yonsei Med J. 2016;57:337–341.
    1. Cortese B, Silva Orrego P, Agostoni P, Buccheri D, Piraino D, Andolina G, et al. Effect of drug-coated balloons in native coronary artery disease left with a dissection. JACC Cardiovasc Interv. 2015;8:2003–2009.
    1. Funatsu A, Kobayashi T, Mizobuchi M, Nakamura S. Clinical and angiographic outcomes of coronary dissection after paclitaxelcoated balloon angioplasty for small vessel coronary artery disease. Cardiovasc Interv Ther. 2019;34:317–324.

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