Two-year clinical follow-up of 90Sr/90 Y beta-radiation versus placebo control for the treatment of in-stent restenosis.
BACKGROUND
It is an ongoing concern that intracoronary brachytherapy may possibly just delay the problem of in-stent restenosis ("late catch up"). For gamma-radiation, 3 placebo-controlled studies have shown the maintenance of the initially positive effect after 2 years, but similar data do not exist for beta-radiation. STents And Restenosis Trial (START) was the first placebo-controlled randomized trial for in-stent restenosis with beta-radiation; herein, we report the 2-year clinical follow-up.


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 beta-radiation using 90 Sr/ 90 Y are maintained at 2-year clinical follow-up period.
Dr. Mueller Hospital, Munich, Germany.
Sigmund
S
Silber
Jeffrey J
JJ
Popma
Mohan
M
Suntharalingam
Alexandra J
AJ
Lansky
Richard R
RR
Heuser
Burton
B
Speiser
Paul S
PS
Teirstein
Theodore
T
Bass
William
W
O'Neill
John
J
Lasala
Mark
M
Reisman
Samin K
SK
Sharma
Richard E
RE
Kuntz
Raoul
R
Bonan
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000627:therapeutic use; D001610:Beta Particles / Q000627:therapeutic use*; D001918:Brachytherapy; D017023:Coronary Angiography; D003327:Coronary Disease / Q000150:complications / Q000473:pathology / Q000628:therapy; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000532:radiotherapy*; D048909:Diabetes Complications / Q000532:radiotherapy / Q000628:therapy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D015607:Stents; D013326:Strontium Radioisotopes / Q000008:administration & dosage / Q000627:therapeutic use*; D019851:Thrombophilia / Q000188:drug therapy / Q000209:etiology; D016896:Treatment Outcome; D015021:Yttrium Radioisotopes / Q000008:administration & dosage / Q000627:therapeutic use*
D000925:Anticoagulants; D013326:Strontium Radioisotopes; D015021:Yttrium Radioisotopes