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Original article
Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions
  1. U Zeymer1,
  2. M Waliszewski2,
  3. M Spiecker3,
  4. O Gastmann4,
  5. B Faurie5,
  6. M Ferrari6,
  7. M Alidoosti7,
  8. C Palmieri8,
  9. T N Heang9,
  10. P JL Ong10,
  11. U Dietz11
  1. 1Klinikum Ludwigshafen, Ludwigshafen, Germany
  2. 2Medical Scientific Affairs, B.Braun Melsungen AG, Melsungen, Germany
  3. 3Klinik für Kardiologie, Marien-Hospital Marl, Marl, Germany
  4. 4Klinik für Innere Medizin, Ilm-Kreis-Kliniken Arnstadt, Arnstadt, Germany
  5. 5Service de Cardiologie, Clinique Mutualiste des Eaux Claires, Grenobles, France
  6. 6Klinik für Innere Medizin I, Universitäts Klinikum Jena, Jena, Germany
  7. 7Cardiology Department, Tehran Heart Center, Tehran, Iran
  8. 8Dipartimento Cardiotoracico, Ospediale Pediatrico Massa, Massa, Italy
  9. 9Cardiology Department, Pantai Hospital Ayer Keroh, Ayer Keroh, Malaysia
  10. 10Cardiology Clinic, Tan Tock Seng Hospital, Singapore, Singapore
  11. 11Fachbereich Kardiologie, Stiftung Deutsche Klinik für Diagnostik, Wiesbaden, Germany
  1. Correspondence to Prof. Uwe Zeymer, Klinikum der Stadt Ludwigshafen am Rhein, Bremserstrasse 79 D-67063 Ludwigshafen, Germany; zeymeru{at}klilu.de

Abstract

Background This prospective registry assessed the safety and efficacy of paclitaxel coated balloon (PCB) angioplasty for small vessel coronary artery disease in Europe and Asia with the intention to treat lesions without additional stenting. The use of PCBs in small vessels seems to be associated with favourable outcomes; however, prospective data for the use of PCBs without stenting are limited.

Methods The SeQuent Please Small Vessel ‘PCB only’ Registry was an international, prospective, multicentre registry enrolling patients with de novo lesions of small reference diameters (≥2.0 mm, ≤2.75 mm). The primary end point was clinically driven target lesion revascularisation (TLR) at 9 months. Secondary end points were acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) (death, myocardial infarction, or TLR), and the occurrence of definite lesion and vessel thrombosis.

Results A total of 479 patients (66.1±10.9 years, 36.7% diabetics) were enrolled, 105 (23.5%) with an acute coronary syndrome, 41 (9.2%) with ST elevation myocardial infarction (STEMI), and 60 (14.8%) with non-STEMI. The initial procedural success rate was 99.0%; 27 patients (6%) needed additional bare metal stent implantation. TLR at 9.4±1.7 months occurred in 14 patients (3.6%), while three patients (0.6%) had vessel thrombosis in non-target lesions. There was no cardiac death or coronary artery bypass graft surgery.

Conclusions To date, this is the largest prospective study with PCBs in small vessel de novo lesions in unselected patients. Rates of TLR and MACE were low, suggesting the use of PCBs may be an attractive alternative treatment option to drug eluting stents in small vessels.

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