PMID- 24281754
OWN - NLM
STAT- MEDLINE
DCOM- 20140318
LR  - 20161125
IS  - 1468-201X (Electronic)
IS  - 1355-6037 (Linking)
VI  - 100
IP  - 4
DP  - 2014 Feb
TI  - Prospective 'real world' registry for the use of the 'PCB only' strategy in small 
      vessel de novo lesions.
PG  - 311-6
LID - 10.1136/heartjnl-2013-304881 [doi]
AB  - 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.
FAU - Zeymer, U
AU  - Zeymer U
AD  - Klinikum Ludwigshafen, , Ludwigshafen, Germany.
FAU - Waliszewski, M
AU  - Waliszewski M
FAU - Spiecker, M
AU  - Spiecker M
FAU - Gastmann, O
AU  - Gastmann O
FAU - Faurie, B
AU  - Faurie B
FAU - Ferrari, M
AU  - Ferrari M
FAU - Alidoosti, M
AU  - Alidoosti M
FAU - Palmieri, C
AU  - Palmieri C
FAU - Heang, T N
AU  - Heang TN
FAU - Ong, P Jl
AU  - Ong PJ
FAU - Dietz, U
AU  - Dietz U
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20131126
PL  - England
TA  - Heart
JT  - Heart (British Cardiac Society)
JID - 9602087
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 0 (Coated Materials, Biocompatible)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Aged
MH  - Angioplasty, Balloon, Coronary/*instrumentation
MH  - Antineoplastic Agents, Phytogenic/pharmacology
MH  - *Coated Materials, Biocompatible
MH  - Coronary Angiography
MH  - Coronary Artery Disease/diagnostic imaging/*therapy
MH  - Female
MH  - Follow-Up Studies
MH  - *Guideline Adherence
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Paclitaxel/*pharmacology
MH  - Prospective Studies
MH  - Treatment Outcome
EDAT- 2013/11/28 06:00
MHDA- 2014/03/19 06:00
CRDT- 2013/11/28 06:00
PHST- 2013/11/28 06:00 [entrez]
PHST- 2013/11/28 06:00 [pubmed]
PHST- 2014/03/19 06:00 [medline]
AID - heartjnl-2013-304881 [pii]
AID - 10.1136/heartjnl-2013-304881 [doi]
PST - ppublish
SO  - Heart. 2014 Feb;100(4):311-6. doi: 10.1136/heartjnl-2013-304881. Epub 2013 Nov 
      26.