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DCB superior to DES for treatment of coronary in stent restenosis
In patients with coronary bare-metal in-stent restenosis, use of a paclitaxel-coated balloon catheter appears to yield superior long-term angiographic and clinical outcomes compared with a paclitaxel-eluting stent, according to 3-year follow-up data from the PEPCAD II ISR study.
In the randomized, nonblinded trial conducted at 10 German cardiology departments, researchers evaluated 131 patients who were enrolled in 2006. Eligible patients showed signs of stable/unstable angina or ischemia and exhibited a single, bare-metal in-stent restenosis (> 70%; length < 22 mm; vessel diameter 2.5-3.5 mm) of any type. The mean age of the patients was 65 ± 9.2 years (75% men). Sixty-six patients were randomly assigned a drug-coated balloon (DCB, 3 μg/mm²; SeQuent Please, B. Braun Melsungen AG), and 65 patients were randomly assigned a drug-eluting stent (Taxus Liberté, Boston Scientific). The two groups had similar baseline characteristics.
The primary endpoint was defined as late lumen loss, which was evaluated at a scheduled 6-month follow-up, or any clinically necessary follow-up before that time point. Secondary endpoints included the 3-year combined event rate, stent thrombosis, target lesion revascularization, MI and death.
At 6.1 ± 1.1 months, follow-up angiography revealed a superior outcome with DCB vs. DES in mean in-segment lumen loss (0.17 ± 0.42 mm vs. 0.38 ± 0.61 mm; P = .032), with a borderline difference in restenosis (7% in the DCB group vs. 20.3% in the DES group; P = .06). An as-treated analysis revealed that all DCB crossed the lesion, whereas four DES failed to cross the lesion.
At 12 months, an intention-to-treat analysis revealed lesion-related rates of MACE of 7.6% in the DCB group vs. 16.9% in the DES group (P = .11); at 36 months, these rates were 9.1% in the DCB group vs. 18.5% in the DES group (P = .14). These disparities were largely attributed to decreased TLR in DCB compared with DES (6.2% vs. 15.4%; P = .1). From month 12 to 36, MI occurred in 1.5% of patients with DCB; no patient in either group experienced TLR or death during this time.
According to the researchers, these findings are not suggestive of the late catch-up phenomenon in association with DCB.
“The [DCB] based on the PACCOCATH technology establishes its critical advantage over a stent coated with the same drug, primarily during the first 6 months,” the researchers wrote. “This benefit is maintained over the 3-year follow-up period. In patients with bare-metal in-stent restenosis, this device may be used universally, based on its superior angiographic and clinical success and easy handling.” – by Jennifer Byrne
Disclosure: The study was supported by B. Braun Melsungen AG. Please see the full study for a list of all of the researchers’ relevant financial disclosures.