Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: the nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation XXXX ) trial.

@entity1 @entity1311 @entity299 @entity583 @entity715
OBJECTIVE: To evaluate a @entity1311 drug-eluting balloon (DEB) only strategy in primary percutaneous coronary intervention (PPCI), aiming at a comparison with bare metal stent (BMS) alone, DEB followed by BMS, and @entity1311 eluting stent (PES), as assessed in the randomized Drug Eluting Balloon in Acute ST-Segment Elevation @entity583 (DEB-AMI) trial. BACKGROUND: DEB-only seems an attractive strategy in PPCI, as it obviates the risk of stent @entity715 . METHODS: This study is a prospective registry with the same inclusion/exclusion criteria used in the DEB-AMI trial, as it constitutes the fourth, nonrandomized, treatment arm of this trial. @entity1 presenting with ST-elevation @entity583 were allocated to DEB-only (DIOR II, Eurocor GmbH, Bonn, Germany) after successful thrombus aspiration and predilatation. Primary endpoint was 6-month angiographic in-balloon/stent late-luminal loss (LLL). Secondary endpoints were in-balloon/stent binary restenosis and major adverse @entity299 (MACE: death, @entity583 , target-vessel revascularization). RESULTS: Forty @entity1 underwent PPCI by DEB-only. Procedural success was achieved in 97.5% with bail-out stenting required in 10.0% of procedures. In DEB-only, LLL was 0.51        0.59 mm as compared to 0.74        0.57 mm in BMS (P   =   0.44), 0.64        0.56 mm in DEB+BMS (P   =   0.88) and 0.21        0.32 mm in PES (P   <   0.01); in-balloon/stent binary restenosis rates were 22.2%, 23.8% (P   =   0.67), 28.6% (P   =   0.97), and 4.5% (P   =   0.07), respectively; and MACE rates were 17.5%, 23.5% (P   =   0.20), 20.0% (P   =   0.26), and 4.1% (P   =   0.90), respectively. No acute or late @entity715 events occurred in the DEB-only group. CONCLUSIONS: PPCI by DEB-only in selected @entity1 yielded an angiographic outcome comparable to BMS alone and DEB followed by BMS. PES proved angiographic superiority to DEB-only. DEB-only is therefore a potential treatment alternative during PPCI in @entity1 with contra-indications to drug-eluting stents.
