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The aim of this study is to compare the safety and efficacy of Sirolimus (SES), Paclitaxel (PES), Everolimus–eluting stent (EES) and SeQuent™ Please, a drug–eluting balloon (DEB) on the outcome of patients with diffuse in–stent restenosis (D–ISR) after bare metal stent (BMS) implantation.
A prospective analysis of 1078 patients with 1251 D–ISR lesions (427 SES, 363 PES, 232 EES and 229 DEB) in six high volume Asian centers after successful stent implantation (SES: LAD 45.7%, LCX 27.9%, RCA 26.4%) (PES: LAD 46.0%, LCX 22.9%, RCA 31.1%) (EES: LAD 50.0%, LCX 21.0%, RCA 29.0%) (DEB: LAD 54.0%, LCX 23.0%, RCA 23.0%) was performed. The study endpoints were major adverse cardiac events (MACE) and target lesion revascularization (TLR) at 12 and 24 months.
See table for clinical Results.
(1) The use of SES, PES, EES and DEB in patients with D–ISR seems to be favorable in terms of in–hospital clinical outcome. (2) Patients treated with DEB showed higher restenosis rate and TLR compared with DES.
|Number of patients/lesions||365/427||313/363||200/232||200/229|
|Procedural success (%)||100||100||100||98.0|
|MACE at 30 days (%)||0.9||1.0||0||2.0|
|Proximal RD (mm)||2.86±0.74||2.80±0.80||2.79±0.71||2.81±0.79|
|MLD post procedure (mm)||2.60±0.77||2.61±0.74||2.66±0.76||2.28±0.78|
|MLD at 12 months (mm)||2.33±0.79||2.19±0.75||2.44±0.71||1.89±0.89|
|MLD at 24 months (mm)||2.19±0.84||2.06±0.80||2.31±0.75||1.66±0.90|
|TLR at 12 months (%)||6.9||11.5||5.0||27.5*|
|MACE at 12 months (%)||7.8||12.5||5.0||29.0*|
|TLR at 24 months (%)||8.2||13.1||7.5||32.0*|
|MACE at 24 months (%)||10.4||16.3||9.0||34.0*|
RD: reference diameter, MLD: minimum lumen diameter
↵* p<0.05 vs SES, PES and EES.
Poster Sessions, Expo North
Saturday, March 09, 2013, 10:00 a.m.–10:45 a.m.
Session Title: Coronary Stents
Abstract Category: 47. TCT@ACC–i2: Coronary Intervention, Devices
Presentation Number: 2101–222
- 2013 American College of Cardiology Foundation