Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study

Klaus Bonaventura, Markus Schwefer, Ahmad Khairuddin Mohamed Yusof, Matthias Waliszewski, Florian Krackhardt, Philip Steen, Raymundo Ocaranza, Ahmad Syadi Zuhdi, Liew Houng Bang, Kristof Graf, Ulrich Böck, Kenneth Chin, Klaus Bonaventura, Markus Schwefer, Ahmad Khairuddin Mohamed Yusof, Matthias Waliszewski, Florian Krackhardt, Philip Steen, Raymundo Ocaranza, Ahmad Syadi Zuhdi, Liew Houng Bang, Kristof Graf, Ulrich Böck, Kenneth Chin

Abstract

Introduction: Scoring balloon angioplasty (SBA) for lumen gain prior to stent implantations or drug-coated balloon angioplasty (DCB) is considered an essential interventional tool for lesion preparation. Recent evidence indicates that SBA may play a pivotal role in enhancing the angiographic and clinical outcomes of DCB angioplasty.

Methods: We studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292).

Results: A total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901).

Conclusions: The routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.

Keywords: De novo lesion; Drug-coated balloon; Lesion preparation; Scoring balloon; Stent-less intervention; Target lesion failure.

Figures

Fig. 1
Fig. 1
Scoring balloon catheter with three nylon elements having a triangular cross section of height 0.39 mm, bonded distally and proximally of the balloon (left panel, courtesy Nipro Corporation, Japan). When the balloon is inflated, the three non-slip elements are positioned on the cylindrical surface of the balloon spaced with 120° from each other (right panel)
Fig. 2
Fig. 2
Kaplan–Meier analysis for freedom from target lesion failure (TLF) with significant differences between lesion groups (log rank p < 0.001)

References

    1. Mauri L, Bonan R, Weiner BH, et al. Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial. Am J Cardiol. 2002;90(10):1079–1083. doi: 10.1016/S0002-9149(02)02773-X.
    1. Danek BA, Karatasakis A, Karacsonyi J, et al. A meta-analysis of contemporary lesion modification strategies during percutaneous coronary intervention in 244,795 patients from 22 studies. J Invasive Cardiol. 2017;29(12):E167–E176.
    1. Barbato E, Shlofmitz E, Milkas A, et al. State of the art: evolving concepts in the treatment of heavily calcified and undilatable coronary stenoses—from debulking to plaque modification, a 40-year-long journey. EuroIntervention. 2017;13(6):696–705. doi: 10.4244/EIJ-D-17-00473.
    1. Giacoppo D, Alfonso F, Xu B, et al. Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study) Eur Heart J. 2019 doi: 10.1093/eurheartj/ehz594.
    1. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40(2):87–165. doi: 10.1093/eurheartj/ehy394.
    1. Latib A, Colombo A, Castriota F, et al. 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. 2012;60(24):2473–2480. doi: 10.1016/j.jacc.2012.09.020.
    1. Jeger RV, Farah A, Ohlow MA, et al. BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018;392(10150):849–856. doi: 10.1016/S0140-6736(18)31719-7.
    1. Merat B, Waliszewski M, Dillinger G, et al. Can you score with balloons to enhance outcomes after drug coated balloon angioplasty? Insights from the Paris DCB Registry for in-stent restenosis. J Interv Cardiol. 2018;31(3):353–359. doi: 10.1111/joic.12506.
    1. Yu X, Ji F, Xu F, et al. Treatment of large de novo coronary lesions with paclitaxel-coated balloon only: results from a Chinese institute. Clin Res Cardiol. 2019;108(3):234–243. doi: 10.1007/s00392-018-1346-8.
    1. Ashida K, Hayase T, Shinmura T. Efficacy of lacrosse NSE using the "leopard-crawl" technique on severely calcified lesions. J Invasive Cardiol. 2013;25(10):555–564.
    1. Rosenberg M, Waliszewski M, Chin K, et al. Prospective, large-scale multicenter trial for the use of drug coated balloons (DCB) in coronary lesions: the DCB-only all-comers registry. Catheter Cardiovasc Interv. 2018 doi: 10.1002/ccd.27724.
    1. Rosenberg R, Waliszewski W, Krackhardt F, et al. Drug coated balloon-only strategy in de novo lesions of large coronary vessels. J Interv Cardiol. 2019;2019:6548696. doi: 10.1155/2019/6548696.
    1. Wöhrle J, Zadura M, Möbius-Winkler S, et al. SeQuent Please World Wide Registry clinical results of SeQuent Please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol. 2012;60(18):1733–1738. doi: 10.1016/j.jacc.2012.07.040.
    1. Zeymer U, Waliszewski M, Spiecker M, et al. Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions. Heart. 2014;100(4):311–316. doi: 10.1136/heartjnl-2013-304881.
    1. Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012;60:1581–1598. doi: 10.1016/j.jacc.2012.08.001.
    1. Kleber FX, Rittger H, Bonaventura K, et al. Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol. 2013;102(11):785–797. doi: 10.1007/s00392-013-0609-7.
    1. Xu B, Gao R, Wang J, et al. A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial. JACC Cardiovasc Interv. 2014;7(2):204–211. doi: 10.1016/j.jcin.2013.08.011.
    1. Sugawara Y, Ueda T, Soeda T, et al. Plaque modification of severely calcified coronary lesions by scoring balloon angioplasty using Lacrosse non-slip element: insights from an optical coherence tomography evaluation. Cardiovasc Interv Ther. 2019;34(3):242–248. doi: 10.1007/s12928-018-0553-6.
    1. Yamagishi M, Terashima M, Awano K, et al. Morphology of vulnerable coronary plaque: insights from follow-up of patients examined by intravascular ultrasound before an acute coronary syndrome. J Am Coll Cardiol. 2000;35(1):106–111. doi: 10.1016/S0735-1097(99)00533-1.
    1. Schoenhagen P, Nissen SE. Assessing coronary plaque burden and plaque vulnerability: atherosclerosis imaging with IVUS and emerging noninvasive modalities. Am Heart Hosp J. 2003;1(2):164–169. doi: 10.1111/j.1541-9215.2003.02108.x.
    1. Tzafriri AR, Garcia-Polite F, Zani B, et al. Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis. J Control Release. 2017;28(264):203–210. doi: 10.1016/j.jconrel.2017.08.037.
    1. Kleber FX, Schulz A, Waliszewski M, et al. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015;104(3):217–225. doi: 10.1007/s00392-014-0775-2.
    1. Buiten RA, Ploumen EH, Zocca P, et al. Thin, very thin, or ultrathin strut biodegradable or durable polymer-coated drug-eluting stents: 3-year outcomes of BIO-RESORT. JACC Cardiovasc Interv. 2019;12(17):1650–1660. doi: 10.1016/j.jcin.2019.04.054.
    1. Nichols AB, Smith R, Berke AD, et al. Importance of balloon size in coronary angioplasty. J Am Coll Cardiol. 1989;13(5):1094–1100. doi: 10.1016/0735-1097(89)90267-2.
    1. Her AY, Shin ES, Bang LH, et al. Drug-coated balloon treatment in coronary artery disease: recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2019 doi: 10.5603/CJ.a2019.0093.
    1. Hwang DS, Shin ES, Kim SJ, et al. Early differential changes in coronary plaque composition according to plaque stability following statin initiation in acute coronary syndrome: classification and analysis by intravascular ultrasound-virtual histology. Yonsei Med J. 2013;54(2):336–344. doi: 10.3349/ymj.2013.54.2.336.
    1. Garcia-Garcia HM, McFadden EP, Farb A, et al. Academic Research Consortium standardized end point definitions for coronary intervention trials: the Academic Research Consortium-2 consensus document. Eur Heart J. 2018;39(23):2192–2207. doi: 10.1093/eurheartj/ehy223.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner