Coronary heart disease: chronic coronary occlusions: stent implantation decreased restenosis.

Clinical bottom line (level 1b)

  1. Patients who had chronic coronary occlusions and were given stent implantation after percutaneous transluminal coronary angioplasty were less likely to have restenosis, than those given balloon angioplasty alone (NNT = 3 at 9 months) .
  2. Patients who were given stent implantation were less likely to have recurrent ischaemia, than those given balloon angioplasty alone (NNT = 3 at 9 months) .
  3. Patients who were given stent implantation were more likely to have bleeding or vascular complications (NNH = 14 at 9 months) .
Rubartelli et al: Journal of the American College of Cardiology 1998; 32 (1): 90-96
Expires March 2003

The study

Unblinded ?concealed randomised trial ?with intention-to-treat
Setting: eight interventional cardiology centres with experience in Palmaz-Schatz coronary stenting, Italy

110 patients (aged mean 58 years, 85% male) scheduled to undergo percutaneous transluminal coronary angioplasty of a chronic total occlusion (TIMI I and II), with symptomatic chest pain or demonstrating inducible ischaemia in the territory supplied by the occluded artery

Excluded if
  • acute myocardial infarction within 30 days or chest pain at rest within 7 days
  • contraindications to aspirin or warfarin sodium
  • total occlusions at a site of a previous percutaneous transluminal coronary angioplasty and occlusions <30 days in duration
  • significant left main disease
  • vessels <3 mm in diameter or presenting severe tortuosity and lesions >13 mm or involving a major side branch
  • evidence after recanalisation of diffuse disease, additional stenosis >50% of the lumen diameter in the distal segment and complex dissection



Control Group: (n = 54, 47 analysed): percutaneous transluminal coronary angioplasty alone. No heparin or warfarin were given after the procedure, but aspirin was.
Experimental Group: (n = 56, 50 analysed): stent implantation- a standard Palmaz-Schatz stent was used. Heparin, warfarin and aspirin were given after the procedure. (Warfarin was continued for one month.)
All patients received aspirin (150 to 325 mg daily) and a calcium blocking agent starting at least 24 hours before percutaneous transluminal coronary angioplasty. There was no use of glycoprotein IIa/IIIb inhibitors. During the procedure, heparin was given to maintain the activated clotting time >250 seconds.
88% followed for 9 months (mean 9.1 months)

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
restenosis 9 months 37
(68.5%)		 18
(32.1%)		 53.0%
(29.0% to 69.0%)		 36.4%
(19.0% to 53.8%)		 3
(2 to 5)
recurrent ischaemia 9 months 25
(46.3%)		 8
(14.3%)		 69.0%
(38.0% to 85.0%)		 32.0%
(15.9% to 48.2%)		 3
(2 to 6)
bleeding and vascular complications 9 months 0
(0.00%)		 4
(7.14%)		 %
(% to %)		 -7.14%
(-13.9% to -0.40%)		 -14
(-252 to -7)

Outcome Control Group
(SD)		 Experimental Group
(SD)		 Mean Difference
(95% CI)
minimal lumen diameter (mm) 0.85
(0.75) 		1.74
(0.88) 		-0.89
(-1.20 to -0.58)

Citation

  1. Rubartelli P, Niccoli L, Verna E, et al: Stent implantation versus balloon angioplasty in chronic coronary occlusions: Results from the GISSOC trial. Journal of the American College of Cardiology 1998; 32 (1): 90-96
Contributor: Clare Wotton and Bob Phillips, January 2000
Reviewer: William Rhoton

Clinical Question.
Patient undergone chronic coronary occlusions
Intervention or Exposure stent implantation
Comparison balloon angioplasty
Outcome incidence of restenosis