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10-Year Clinical Follow-Up Result of Intracoronary Radiation Therapy with Rhenium -188-Diethylene Triamine Penta-Acetic Acid-Filled Balloon
서울대학교병원 순환기내과¹ , 분당서울대학교병원 순환기내과 ²
서명기¹, 양한모¹,윤창환²,서정원²,박경우¹,이해영¹,조영석²,김광일²,강현재¹,연태진¹,구본권¹,채인호²,김효수¹,오병희¹,박영배¹
Background and objectives: Considerable rate of restensosis occurs after brachytheraphy. Up to now, there was no long term outcome for brachytheraphy. So we investigated the 10-year clinical follow-up results of intracoronary radiation therapy using a rhenium-188-diethylene triamine penta-acetic acid (188Re-DTPA)-filled balloon system. Methods and Results: After successful catheter-based treatment of either a de novo or restenotic lesion, 185 patients were randomly assigned to either the radiation (N=103) or the control (N=82) group. Irradiation to deliver 17.6 Gy at a depth of 1.0mmin to the vessel wall was carried out after successful intervention. Patients were followed up by telephone or hospital visit at each year and will continue to be followed annually for 10 years. Angiographic follow-up was achieved at total 178 patients. At 10-year follow-up, cumulative target lesion revascularization (TVR) rate was not significantly different between radiation group (n = 101) and control group (n = 77; 26.7% vs. 16.9%; P = 0.148). But the rate of major adverse cardiac events (MACE) including death, myocardial infarction (MI), and TLR were significantly higher in radiation group than control group (30.1 % vs. 17.0%; P = 0.012). And there was no manifestation of hematologic or oncologic illness suspected associated with brachytherapy. Conclusion: Intracoronary radiation therapy mostly in patients with de-novo or in-stent restenosis lesion did not show significant clinical benefit in 10-year follow-up results
Table. Clinical outcome at 10 year follow-up

 

Control

(N=82)

Radiation

(N=103)

Hazard ratio

(95% CI)

P-value

Median follow up duration (Months)

102.6

100.8

 

 

Death

  8(9.8%)

19(18.4%)

1.91(0.84-4.37)

0.141

Cardiac death

  2(2.4%)

6(5.8%)

2.40(0.48-11.90)

  0.469

MI

  5(6.1%)

10(9.7%)

1.64(0.56-4.81)

0.429

TLR

 13/77(16.9%)

27/101(26.7%)

1.66(0.85-3.21)

  0.148

TVR

3/77(3.9%)

10/101(9.9%)

2.75(0.76-9.96)

  0.154

MACE

  14(17.0%)

31(30.1%)

 2.26(1.14-4.50)

  0.012

 


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