Second-Generation DES, DCB Both Strategies for Treating In-Stent Restenosis

For the treatment of DES restenosis, drug-coated balloon (DCBs) and DES are each effective approaches. However, DES—particularly those that release everolimus—appear to result in the best clinical and angiographic outcomes, according to a presentation on Sunday at TCT 2015. 

During a didactic symposium on controversies related to metallic DES, Fernando Alfonso, MD, PhD, of Hospital Universitario de la Princesa, in Madrid, Spain, said that DES restenosis is a particularly difficult condition to treat. Several mechanical factors can influence the complication; these include stent fracture or gap, geographic miss and potential stent damage, which can result in uneven or interrupted drug delivery. Severe underexpansion is a particularly important factor for most patients with in-stent restenosis, Alfonso noted, adding that IVUS and OCT can prove useful in identifying mechanical concerns.

“IVUS is very good in this regard … any imaging technique is able to demonstrate where the underexpansion is located, and this should be corrected,” Alfonso said. “This is the first thing we need to do in the treatment of these patients.”

RIBS trials 

Of the many treatment methods available to address in-stent restenosis, including medical management and repeat PCI, Alfonso highlighted the use of DCB or DES as most effective, citing several studies. DCB have shown superiority to conventional balloon angioplasty at reducing restenosis, decreasing target lesion revascularization and maintaining minimal lumen diameter (MLD) among patients treated with DCB. In the RIBS I, RIBS II and RIBS V trials, improvements in MLD and late loss were observed both in patients whose narrowing had initially occurred within DES and those who had restenosis in BMS, Alfonso said.

Recent guidelines from the European Society of Cardiology recommend the use of either DES or DCB for the treatment of BMS or DES restenosis, Alfonso reported. But results from RIBS IV, in which he and colleagues randomized more than 300 patients with DES restenosis to receive either DES or DCB, indicated significantly better in-segment and in-lesion MLD with the use of DES as well as lower rates of restenosis and TLR at 6 to 9 months of follow-up. A “switch” strategy—treatment of in-stent restenosis with a different type of DES, as explored in the RIBS III study—also yields better results than repeat use of the same DES, Alfonso said, adding that second-generation devices did particularly well. Some comparisons between DCB- and DES-based approaches have shown similar results for the two methods.

PEPCAD, ISAR-DESIRE 3 

Additionally, Alfonso noted, the PEPCAD China ISR trial comparing a paclitaxel DCB (SeQuent, B. Braun) with a first-generation paclitaxel-eluting stent (Taxus, Boston Scientific) demonstrated that the 2 options yield similar MLD and restenosis rates, indicating noninferiority of the DCB. Comparison between a paclitaxel DCB, a paclitaxel-eluting stent and conventional balloon angioplasty in the ISAR-DESIRE 3 study indicated that both drug-eluting treatments surpassed conventional angioplasty but were similar to one another with regard to diameter stenosis on follow-up angiography, he reported.

Meta-analysis of research 

However, Alfonso also cited a meta-analysis published in August 2015 in The Lancet that incorporated 27 trials of 5,923 patients. That study, he said, indicated that everolimus-eluting stents are superior at increasing percent diameter stenosis compared with DCB, sirolimus-eluting stents, paclitaxel-eluting stents, brachytherapy, BMS, conventional balloon angioplasty and rotational atherectomy.

“When there is a mechanical problem – a gap, fracture or an edge – implantation of a second-generation DES is a better strategy,” Alfonso concluded. “In other cases, we should try to address underexpansion … and then we can choose between DES or DCB, but using a second-generation DES is the preferred strategy.”

Disclosures: 

• Alfonso reports no relevant conflicts of interest.