Original title: A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis. Referencia: Seiji Habara et al. Am Heart J 2013;166:527-533.e2.
Paclitaxel – eluting balloons have recently emerged as an option for treating in-stent restenosis, both conventional stents ( BMS ) and with drugs (DES ). This study randomized patients 2:1 with in-stent restenosis of BMS or DES ( sirolimus , zotarolimus or everolimus) to angioplasty with paclitaxel eluting balloon ( SeQuent Please balloon catheter , B. Braun Melsungen AG , Vascular Systems, Berlin , Germany) versus conventional balloon . The primary objective of the study was a composite of cardiac death , myocardial infarction and target vessel revascularization at 6 months, point when it was scheduled for angiographic protocol follow-up.
The study included 208 patients ( 137 received eluting balloon and 71 conventional balloons) . Of the total, 123 injuries were due to restenosis of BMS and 90 by DES restenosis . The type of stent restenosis was similar in both treatment branches. The incidence of the combined end point was 6.6 % for drug balloon versus 31% for conventional balloon group ( p < 0.001 ) . This difference was due to target vessel revascularization since no infarctions or deaths were observed in either group.
In the group of drug balloons restenosis in angiographic follow-up was 1.1% for patients who previously had a BMS versus 9.1% for those with a DES ( p = 0.04 ) . This happens despite the fact that BMS had more extensive and diffuse restenosis at baseline than DES. Drug balloon late lumen loss was lower in the BMS than DES ( 0.05 ± 0.28 mm versus 0.18 ± 0.38mm respectively; P = .03) .
Conclusion:
The paclitaxel – eluting balloons provide better angiographic and clinical outcomes than conventional balloons in patients with in-stent restenosis both conventional and drug eluting stents .
Editorial Comment:
Striking that standard balloon is still used as a control group to treat in-stent restenosis . After ISAR- DESIRE trials became clear that one DES was best for restenosis of BMS , leaving some unknowns still for DES restenosis ( e.g. same or different drugs tested in the ISAR- DESIRE 2). Despite this, the ISAR- DESIRE 3 also included a conventional balloon branch like this study.
Beyond the expected pharmacological superiority of the balloon , it is important to note the different response to the same when it comes to treating a BMS or DES with restenosis.
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