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The Spanish Multicenter Registry

Date: 2009/12/01

The Spanish Multicenter Registry - DIOR® in ISR and Small Vessel Disease - Excellent Intermediate Results presented on AHA congress 2009

Percutaneous Coronary Intervention with a New Placlitaxel Eluting Balloon for the Treatment of in-Stent Restenosis and Small Vessel Disease: Mid-term Outcomes of the Spanish Multicenter Registry

The Spanish DIOR Registry is a prospective and multicenter registry of percutaneous coronary intervention set up to assess the efficacy and safety of a new placlitaxel--eluting balloon (Dior) in these settings.

Background: In some situations the use of BMS or DES may be considered inappropriate or harmful. We sought to assess the efficacy and safety of a new placlitaxel-coated, drug-eluting balloon (DEB) in these situations.

Methods: 115 lesions in 110 patients were included in this prospective multicenter registry using a new paclitaxel-eluting balloon (3.0µg/m2 balloon surface area) in the following situations: in-stent restenosis: 52%; de novo lesions in small vessels (2.5mm): 43% (which include bifurcation lesions type 1,1,1: 12% and type 0,0,1: 11%); and in patients with a contraindication to dual anti-platelet therapy (DAT): 5%. In each case, after optimal dilatation using conventional balloon angioplasty, a DEB was inflated for a minimum of 60 seconds. Clinical follow-up was planned at 1, 6 and 12 months with repeat angiography at 6 – 8 months. DAT was recommended at standard doses for at least 1month.

Results: Patients were 66±10 years old, 29% diabetic, 16% renal impairment, 63.5% had previous angioplasty, 36% had bifurcation lesions and 17% had 3-vessel disease. The baseline vessel diameter, lesion length and percentage diameter stenosis were as follows: 2.4±0.5mm, 12±6.5mm and 71±18%. The mean DEB diameter length used was 20±5mm, diameter 2.7±0.5mm. Maximum inflation pressure and time were: 13±4mmHg and 105±37 sec. In 6% of lesions a BMS was subsequently implanted because of significant recoil and/or more than type B dissection. At a mean of 3.5±2.2 month there was only 3.4% MACE (1 peri-procedural non-Q-wave MI revealed by asymptomatic CPK elevation, 0 cardiac death, 1 TLR). There was no subacute thrombosis or occlusion.

Conclusion: In this population at high risk of restenosis and/or stent thrombosis the use of this new paclitaxel-eluting balloon, according to the technique described, provides excellent acute angiographic results and short-term outcomes with 3.4% MACE at 3 months.

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P-C-I Flyer

AHA Presentation