Published Online
on October 14, 2002

A more recent version of this article appeared on October 29, 2002

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Submitted on May 3, 2002
Revised on July 29, 2002
Accepted on August 21, 2002

Long-Term Outcome of Patients Treated With Repeat Percutaneous Coronary Intervention After Failure of -Brachytherapy for the Treatment of In-Stent Restenosis

Ross Prpic MBBS^*, Paul S. Teirstein MD, John P. Reilly MD, Jeffrey W. Moses MD, Prabhakar Tripuraneni MD, Alexandra J. Lansky MD, Joseph-Anthony Giorgianni BA, Shirish Jani PhD, S. Chiu Wong MD, R. David Fish MD, Stephen Ellis MD, David R. Holmes MD, Dean Kereiakas MD, Richard E. Kuntz MD, and Martin B. Leon MD

From the Harvard Clinical Research Institute, Boston, Mass (R.P., R.E.K.); Scripps Clinic, La Jolla, Calif (P.S.T., J.P.R., P.T., S.J.); Cardiovascular Research Foundation, Lenox Hill Hospital, New York, NY (J.W.M., A.J.L., M.B.L.); Cordis, a Johnson and Johnson Company, Warren, NJ (J.-A.G.); Cornell-New York Hospital, New York, NY (S.C.W.); Texas Heart Institute/St. Luke's Episcopal Hospital and Baylor College of Medicine, Houston, Tex (R.D.F.); Cleveland Clinic, Cleveland, Ohio (S.E.); Mayo Clinic, Rochester, Minn (D.R.H.); and Christ Hospital, Cincinnati, Ohio (D.K.).

^* To whom correspondence should be addressed. E-mail: rprpic{at}hcri.harvard.edu.

Background—Although ¹⁹²Ir intracoronary brachytherapy has been demonstrated to dramatically reduce the recurrence of in-stent restenosis, up to 24% of these patients will still require repeat target-vessel revascularization. The short- and long-term outcomes of repeat percutaneous intervention in this population have not been characterized.

Methods and Results—Analysis was performed of all patients enrolled in the GAMMA-I and GAMMA-II brachytherapy trials who underwent repeat percutaneous target lesion revascularization (TLR) because of restenosis. Subjects were divided into 2 cohorts: those who had received ¹⁹²Ir brachytherapy and those randomized to placebo. Forty-five (17.6%) of a total of 256 patients whose index treatment was intracoronary radiation therapy and 36 (29.8%) of 121 patients whose index treatment was placebo required repeat percutaneous TLR. The mean time to this first TLR was 295±206 days in the irradiated group and 202±167 days in the placebo group (P=0.03). Acute procedural success occurred in 100% of irradiated patients and 94% of placebo controls (P=0.19). After the first TLR, a subsequent TLR was required in 15 (33.3%) of 45 brachytherapy patients versus 17 (47.2%) of 36 placebo failure patients (P=0.26). There was no significant difference in time to second TLR between the 2 groups. Other long-term major adverse event rates in both groups were comparable to those of other contemporary angioplasty/stenting series.

Conclusions—In those patients who "fail" ¹⁹²Ir intracoronary brachytherapy for in-stent restenosis, treatment with ¹⁹²Ir delays the time to first TLR. Additionally, repeat percutaneous intervention in these patients is safe and efficacious in the short term, with acceptable long-term results.

Key words: angioplasty • stents • restenosis • brachytherapy

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