Two-year clinical follow-up of 90Sr/90 Y β-radiation versus placebo control for the treatment of in-stent restenosis

Sigmund Silber, Jeffrey J. Popma, Mohan Suntharalingam, Alexandra J. Lansky, Richard R. Heuser, Burton Speiser, Paul S. Teirstein, Theodore Bass, William O'Neill, John Lasala, Mark Reisman, Samin K. Sharma, Richard E. Kuntz, Raoul Bonan

Research output: Contribution to journalArticlepeer-review

23 Scopus citations


Background: It is an ongoing concern that intracoronary brachytherapy may possibly just delay the problem of in-stent restenosis ("late catch up"). For γ-radiation, 3 placebo-controlled studies have shown the maintenance of the initially positive effect after 2 years, but similar data do not exist for β-radiation. STents And Restenosis Trial (START) was the first placebo-controlled randomized trial for in-stent restenosis with β-radiation; herein, we report the 2-year clinical follow-up. Methods and Results: Two hundred and forty-four patients were randomized to active treatment, 232 patients to placebo (nonactive source train) treatment. The primary end point of efficacy was target vessel revascularization (TVR); primary safety end point was any major adverse cardiac event (MACE) at 8 months and 2 years. Two-year clinical outcome in patients receiving brachytherapy was based on 195 of 244 original patients (79.9%) and in the placebo arm on 183 of 232 original patients (78.9%). TVR was significantly reduced by 25%; from 36.6% (placebo) to 27.5% (brachytherapy) remained significant after 2 years (RR. 7 [.57-.98], 95% CI -9.2 [-17.5-0.8]). The Kaplan-Meier analysis for TVR and MACE showed improvement beginning approximately 90 days after radiation and remained almost constant for the 2 following years. Freedom from TVR was significantly increased from 62.4% ± 3.8% to 71.6% ± 3.3% (P = .027) and freedom from MACE from 58.9% ± 3.7% to 68.0% ± 3.4% (P = .035). Conclusions: The START trial shows for the first time that the initial beneficial effects of intracoronary brachytherapy with β-radiation using 90Sr/90Y are maintained at 2-year clinical follow-up period.

Original languageEnglish
Pages (from-to)689-694
Number of pages6
JournalAmerican Heart Journal
Issue number4
StatePublished - Apr 2005


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