DCB therapy confers improved efficacy in patients with in-stent restenosis
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Drug-coated balloons to treat patients with in-stent restenosis resulted in improved outcomes compared with plain balloon angioplasty, according to a meta-analysis published in EuroIntervention.
Salvatore Cassese, MD, senior physician at the German Heart Centre of the Technical University Munich, and colleagues performed a meta-analysis of 367 patients (median age, 68 years) from four studies that compared DCB angioplasty (n = 188) with plain balloon angioplasty (n = 179). Patients were followed up for a median of 12 months.
The primary outcome of this analysis was target lesion revascularization. The main secondary outcome was recurrent in-stent restenosis. Researchers also reviewed data for ankle-brachial index, Rutherford class improvement and death.
Patients treated with DCB had reduced risk for TLR (14.9%) compared with those treated with plain balloon angioplasty (44.3%; OR = 0.2; 95% CI, 0.07-0.55). The risk for recurrent in-stent restenosis was also reduced in the DCB group (32.5%) vs. the plain balloon group (66.9%; OR = 0.24; 95% CI, 0.09-0.61).
A sustained Rutherford class improvement was seen in patients treated with DCB (76.3%) vs. those with the plain balloon (55.6%; OR = 2.57; 95% CI, 1.4-4.72; I2 = 0%; P for heterogeneity = 0.8).
No significant differences were found for ankle-brachial index and the risk for death between the two groups.
“These findings should be interpreted with caution in view of the limited number and the different design of the included studies,” Cassese and colleagues wrote. “Future randomized trials should compare DCB with therapies other than plain balloon angioplasty in a larger number of patients with follow-up longer than 1 year in order to address definitively the role of DCB in this complex patient population.” – by Darlene Dobkowski
Disclosures: Cassese reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.