BACKGROUND: This study investigated p aclitaxel-induced luminal changes following drug-coated balloon (DCB) angioplasty to treat coronary de novo lesions without additional stenting. DCB-mediated local drug delivery reduces late lumen loss in de novo coronary artery lesions. We performed a retrospective clinical assessment based on a pre-specified quantitative coronary angiography (QCA) protocol. METHODS: QCA was performed for each centre to assess the primary endpoint late lumen changes, i.e. the difference between in-lesion minimal lumen diameter (MLD) at the routine angiographic follow-up as compared to post-procedural in-lesion MLDs. These MLD changes were compared to corresponding reference vessel diameter changes as an intra-patient control. RESULTS: We evaluated 58 consecutive native coronary artery lesions directly after DCB angioplasty and at a routine target follow-up angiography of 4 months by QCA. Target lesion MLD increased significantly within the 4.1 ± 2.1 month observation period (1.75 ± 0.55 vs. 1.91 ± 0.55 mm, p < 0.001, diameter stenosis 33.8 ± 12.3 vs. 26.9 ± 13.8 %, p < 0.001), while there were no changes in non-target reference vessel diameters (2.33 ± 0.60 vs. 2.34 ± 0.61 mm, p = ns). A total of 69 % of patients showed luminal enlargement whereas 29 % had minor luminal loss. CONCLUSION: Local application of paclitaxel by DCB angioplasty to native coronary arteries after pre-dilatation without major dissection and recoil leads to late lumen increase.
BACKGROUND: This study investigated p aclitaxel-induced luminal changes following drug-coated balloon (DCB) angioplasty to treat coronary de novo lesions without additional stenting. DCB-mediated local drug delivery reduces late lumen loss in de novo coronary artery lesions. We performed a retrospective clinical assessment based on a pre-specified quantitative coronary angiography (QCA) protocol. METHODS: QCA was performed for each centre to assess the primary endpoint late lumen changes, i.e. the difference between in-lesion minimal lumen diameter (MLD) at the routine angiographic follow-up as compared to post-procedural in-lesion MLDs. These MLD changes were compared to corresponding reference vessel diameter changes as an intra-patient control. RESULTS: We evaluated 58 consecutive native coronary artery lesions directly after DCB angioplasty and at a routine target follow-up angiography of 4 months by QCA. Target lesion MLD increased significantly within the 4.1 ± 2.1 month observation period (1.75 ± 0.55 vs. 1.91 ± 0.55 mm, p < 0.001, diameter stenosis 33.8 ± 12.3 vs. 26.9 ± 13.8 %, p < 0.001), while there were no changes in non-target reference vessel diameters (2.33 ± 0.60 vs. 2.34 ± 0.61 mm, p = ns). A total of 69 % of patients showed luminal enlargement whereas 29 % had minor luminal loss. CONCLUSION: Local application of paclitaxel by DCB angioplasty to native coronary arteries after pre-dilatation without major dissection and recoil leads to late lumen increase.
Authors: Bruno Scheller; Christoph Hehrlein; Wolfgang Bocksch; Wolfgang Rutsch; Dariush Haghi; Ulrich Dietz; Michael Böhm; Ulrich Speck Journal: N Engl J Med Date: 2006-11-13 Impact factor: 91.245
Authors: A W Heldman; L Cheng; G M Jenkins; P F Heller; D W Kim; M Ware; C Nater; R H Hruban; B Rezai; B S Abella; K E Bunge; J L Kinsella; S J Sollott; E G Lakatta; J A Brinker; W L Hunter; J P Froehlich Journal: Circulation Date: 2001-05-08 Impact factor: 29.690
Authors: U Zeymer; M Waliszewski; M Spiecker; O Gastmann; B Faurie; M Ferrari; M Alidoosti; C Palmieri; T N Heang; P Jl Ong; U Dietz Journal: Heart Date: 2013-11-26 Impact factor: 5.994
Authors: P P Leimgruber; G S Roubin; H V Anderson; C E Bredlau; H B Whitworth; J S Douglas; S B King; A R Greuntzig Journal: Circulation Date: 1985-09 Impact factor: 29.690
Authors: Franz X Kleber; Harald Rittger; Josef Ludwig; Antonia Schulz; Detlef G Mathey; Michael Boxberger; Ralf Degenhardt; Bruno Scheller; Ruth H Strasser Journal: Clin Res Cardiol Date: 2016-01-14 Impact factor: 5.460