Drug-Coated Balloons Best Suited for In-Stent Restenosis in BMS, not DES

Drug-coated balloons (DCBs) may be better suited at treating restenosis when it arises in BMS versus DES, results of a new study show. Even after propensity matching, the 1-year risks of MI and TLR trended higher for patients with DES restenosis, and the difference was especially stark in nonostial lesions.

Predictors of TLR among DCB-treated patients were end-stage renal disease and previous DCB failure. The findings, from a single-center study conducted at Kaohsiung Chang Gung Memorial Hospital (Kaohsiung, Taiwan), were published online earlier this month in the Journal of Invasive Cardiology.

Commenting on the study for TCTMD, Robert Schwartz, MD (Minneapolis Heart Institute, Minneapolis, MN), described it as “positive” and said it confirms that DCBs are a viable option in treating some in-stent restenosis cases. As to why the DES group did worse, “it may be the same issue as always of inhibition of neointima: that maybe in some cases, the DES is too much and this leaves more bare metal hanging out there,” he suggested. Also, with DES, “the drug lasts for a long, long time [and therefore there] perhaps is an issue with overdosing.”

Today, rather than use a DCB, “I think most people will obviously put a second stent on top of [in-stent restenosis],” Schwartz reported. “The results are decent. They’re not the best, so there’s room for improvement, but overall it works pretty well.”

More Adverse Outcomes at 1 Year

For the study, Wei-Chieh Lee, MD, and colleagues examined outcomes of 426 coronary lesions with in-stent restenosis among 312 patients. All had received the SeQuent Please paclitaxel-coated balloon (B Braun Melsungen AG, Germany) between November 2011 and December 2014. Slightly more than half were being treated for BMS restenosis and the remainder for DES restenosis.

On multivariate Cox regression analysis, predictors of recurrent restenosis at 1 year were end-stage renal disease (P = 0.047) and previous DCB failure (P < 0.001).

Propensity-score matching was done in an attempt to overcome baseline differences in lesion characteristics and comorbidities between the two groups. After these adjustments, patients with DES restenosis trended toward higher 1-year risks of MI (8.3% vs 2.8%; P = 0.075) and TLR (15.4% vs 8.1%; P = 0.051). The disparity in TLR risk reached statistical significance when looking loosely at nonostial lesions (14.9% vs 5.7%; P = 0.030). While there were no differences in all-cause mortality risk, major adverse cardiac or cerebral events (MI, TLR, stroke, and cardiovascular mortality) were more common in the DES group than in the BMS group (22.1% vs 11.7%; P = 0.038).

Like Schwartz noted, the researchers state that DES are still considered the “best possible care” for treating in-stent restenosis, but there are limitations. The approach can further reduce the flexibility of the vessel and limit the repeatability of the procedure. Further, stents can’t always be implanted at all sites, especially at the site of in-stent restenosis, and repeated stent-in-stent therapy can cause lumen loss and repeat stenosis. DCBs are “reasonable” if additional stenting is not desirable, write Lee and colleagues.  

Related Stories:

• DCB Matches DES in Treating ‘Real-World’ Patients With In-Stent Restenosis
• Paclitaxel-Eluting Balloon Effective for DES Restenosis
• PEPCAD II: Paclitaxel Balloon Matches Taxus for Treating In-Stent Restenosis