Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PA
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ORIGINAL RESEARCH
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 . ¨ ck . Kenneth Chin Kristof Graf . Ulrich Bo Received: February 24, 2020 Ó The Author(s) 2020
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-
Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12018669. K. Bonaventura (&) P. Steen Klinikum Ernst Von Bergmann, Potsdam, Germany e-mail: [email protected] M. Schwefer Elblandklinikum Riesa, Riesa, Germany A. K. M. Yusof The National Heart Institute of Malaysia, Kuala Lumpur, Malaysia M. Waliszewski P. Steen Medical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany M. Waliszewski F. Krackhardt Department of Cardiology and Internal Medicine, Charite´ – Universita¨tsmedizin Berlin, Campus Virchow, Berlin, Germany
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 R. Ocaranza Hospital Universitario Lucus Augusti, Lugo, Spain A. S. Zuhdi Pusat Perubatan Universiti Malaya, Kuala Lumpur, Malaysia L. H. Bang Hospital Queen Elizabeth II, Kota Kinabalu, Sabah, Malaysia K. Graf ¨ disches Krankenhaus Berlin, Berlin, Germany Ju ¨ ck U. Bo Marien-Hospital Marl, Marl, Germany K. Chin Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
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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 (BMSISR), 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 gro
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