title: The paclitaxel-eluting PTCA-balloon in combination with a cobalt-chromium stent in two different sequences to treat de novo coronary artery lesions: an angiographic follow up study.
abstract: BACKGROUND
  The paclitaxel-coated balloon catheter (DCB) based on the PACCOCATH(®) technology has yielded angiographic and clinical results superior to drug-eluting stents (DES) in situations like in-stent restenosis (ISR) and a trend towards superior results in small coronary vessels and side branches of coronary bifurcations. Using the DCB followed by cobalt-chromium stent (CoCr) deployment or with a reverse sequence may yield different outcomes in terms of late loss.
  
  
  METHODS
  97 patients with de-novo coronary stenosis (55.6 ± 10.7 years, 79.4% male, ≥70%, length: ≤25 mm, vessel diameter: 2.5-4.0 mm) were randomly treated with the DCB (3 μg/mm²) followed by a CoCr-stent or stent first and DCB later. Six-month angiographic and one-year clinical follow-up intention-to-treat analyses were performed.
  
  
  RESULTS
  Angiographic and demographic baseline data was comparable between the two groups. When comparing balloon first versus stent first technique, the primary outcome variables were not statistically different for mean in-segment (0.51 ± 0.56 mm vs. 0.36 ± 0.55 mm, p = 0.23) and in-stent (0.52 ± 0.55 mm vs. 0.46 ± 0.52 mm, p = 0.65) late lumen loss. The lesion related 12-month MACE rates were 5/49 (10.2%) and 2/48 (4.2%) (p = 0.44). Lesion related thrombotic events occurred in three patients in balloon first and in one patient in stent first group, two of which were associated with early discontinuation of continuous dual anti-platelet therapy, two with suboptimal PCI, and one each were performed in a thrombotic lesion and a bifurcation type 1.1.0.
  
  
  CONCLUSIONS
  Drug-coated balloon first followed by cobalt chromium stent deployment versus a reverse sequence is not associated with statistically significantly different 6-month angiographic or 12-month clinical outcomes.
authors.affiliation: Fortis Escorts Heart Institute and Research Centre, New Delhi, India; Fortis Flt. Lt. Rajan Dhall Hospital, New Delhi, India. Electronic address: kaul.upendra@gmail.com.
authors.forename: Upendra
authors.initials: U
authors.lastname: Kaul
authors.forename: Martin
authors.initials: M
authors.lastname: Unverdorben
authors.forename: Ralf
authors.initials: R
authors.lastname: Degenhardt
authors.forename: Ashok
authors.initials: A
authors.lastname: Seth
authors.forename: Vinay K
authors.initials: VK
authors.lastname: Bahl
authors.forename: Shirish M S
authors.initials: SM
authors.lastname: Hiremath
authors.forename: Praveen
authors.initials: P
authors.lastname: Chandra
authors.forename: Ajit S
authors.initials: AS
authors.lastname: Mullesari
authors.forename: P S
authors.initials: PS
authors.lastname: Sandhu
authors.forename: Seshagiri
authors.initials: S
authors.lastname: Rao
authors.forename: Oommen
authors.initials: O
authors.lastname: George
authors.forename: Hanns
authors.initials: H
authors.lastname: Ackermann
authors.forename: Michael
authors.initials: M
authors.lastname: Boxberger
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D002857:Chromium / Q000494:pharmacology; D003035:Cobalt / Q000494:pharmacology; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000453:epidemiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007194:India; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000494:pharmacology*; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D002857:Chromium; D003035:Cobalt; D017239:Paclitaxel
keywords: Bail out stenting; Drug coated balloon; Paclitaxel