Angioplasty: intracoronary gamma radiation therapy reduced cardiac events following opening of a stenosed coronary stent

Clinical bottom line (level 1b)

  1. Patients undergoing PTCA for restenosis of a coronary stent who received intracoronary gamma radiation therapy compared with placebo were less likely to die, have a myocardial infarction or requiring revascularisation (NNT = 6 at 9 months) .
Leon et al: New Engl J Med 2001; 344 : 250-256
Expires March 2004

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 12 acute hospitals, USA

252 patients (aged mean 59, mean 75% male) with documented cardiac ischaemia due to in-stent restenosis scheduled to undergo PTCA to correct this

Excluded if
  • left ventricular function < 40%
  • myocardial infarction within previous 72 hours
  • total occlusion of vessel at sight of restenosis
  • operator intended to use abciximab
  • restenosis not in a native vessel
  • stenosis > 60% luminal diameter or > 45 mm long

Control Group: (n = 121, 121 analysed): placebo
Experimental Group: (n = 131, 131 analysed): indwelling intracoronary ribbon containing a sealed source of iridium-92

85% followed for 9 months
Outcome notes:
  • cardiac event : death, myocardial infarction, emergency revascularisation

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
cardiac event 9 months 53
(43.8%)		 37
(28.2%)		 36%
(9% to 54%)		 15.6%
(3.83% to 27.3%)		 6
(4 to 26)

Comments

  1. Patients were randomised in blocks.

Citation

  1. Leon MB, Teirstein PS, Moses JW, et al: localized intercoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. New Engl J Med 2001; 344 : 250-256
Search Terms: from ACP Journal Club other articles noted
Contributor: Chris Ball, March 2002
Reviewer:

Clinical Question.
Patient restenosis of coronary artery stent
Intervention or Exposure gamm radiation therapy
Comparison placebo
Outcome cardiac event: death, myocardial infarction, revascularisation