Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study
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Identificadores
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Fecha de publicación
2020Título de revista
ADVANCES IN THERAPY
Tipo de contenido
Journal Article
DeCS
resultado del tratamiento | anciano | factores de riesgo | estudios prospectivos | stents liberadores de fármacos | mediana edad | humanos | enfermedad arterial coronaria | angioplastiaMeSH
Risk Factors | Middle Aged | Humans | Treatment Outcome | Angioplasty | Coronary Artery Disease | Prospective Studies | Aged | Drug-Eluting StentsResumen
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.
Excepto si se señala otra cosa, la licencia del ítem se describe como Atribución-NoComercial 4.0 Internacional
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