Intracoronary Brachytherapy Reduces DES ISR but Restenosis not Eliminated

Intracoronary brachytherapy demonstrated safety and efficacy in the treatment of recurrent in-stent restenosis (ISR) within multiple DES in the single-center, observational SCRIPPS V study, according to a report presented at TCT 2015.

“TVR rates following brachytherapy for multidrug-resistant ISR are favorable at 8 months and acceptable at 2 years in this challenging patient group,” said Paul Teirstein, MD, of Scripps Clinic, San Diego, Calif.

For SCRIPPS V, 65 adults eligible for PCI with a target lesion with recurrent restenosis (> 50%) were enrolled between May 2006 and September 2013. All were previously treated with two or more layers of different DES. Sixty-six percent of patients had two layers of stents, 14% had three layers, 5% had four layers and some were unknown. The majority of DES were Cypher (Cordis Corporation) and Taxus (Boston Scientific) stents; very few patients had second-generation stents, Teirstein noted.

At baseline, all patients had hyperlipidemia, 92% had hypertension, 54% were smokers, 50% had diabetes and 45% had previous CABG. Most were taking aspirin, clopidogrel, statins and beta-blockers. Follow-up by phone was 100% at 8 months and 98.5% at 2 years. The primary location of restenosis was the left anterior descending artery (39%).

Intracoronary brachytherapy was performed with the FDA-approved Novoste Beta-Cath System (Novoste Corporation). The median dose was 23 Gy, the median time 4 minutes 26 seconds and the treatment length 40 to 60 mm.

Overall, treatment results at 30 days and 8 months were favorable for primary and secondary endpoints (Table). At 2 years, the rate of all-cause death was 5%, MI was 8% and TVR was 14%.

In other results, non-TVR was 3% at 30 days, 11% at 8 months and 14% at 2 years; any revascularization was 3%, 34% and 50%, respectively; TVR using CABG was 0%, 5% and 6%, respectively; and stent thrombosis was 0% at all time points.

“While brachytherapy reduces and slows the time frame of ISR following DES, restenosis is not eliminated,” Teirstein said.

“Multidrug-resistant ISR is infrequent, but the absolute number of patients with DES ISR is growing,” he concluded. “DES reduces ISR, and brachytherapy is an effective and FDA-approved treatment for bare-metal stent ISR. Brachytherapy is not a bad option in this patient population.”