Angina: angioplasty: Stenting reduced restenosis and prevented MI and death in single-vessel disease.

Clinical bottom line (level 1b)

  1. Patients with angina and single-vessel lesions who received a stent during angioplasty were less likely to have a cardiac endpoint (death, recurrent angina or an MI) than those who did not (NNT = 6 at 12 months) .
  2. Restenosis occured less often (NNT = 5 at 12 months) .
  3. Patients were more likely to have a complication following angioplasty requiring a major intervention (NNH = 15 at 6 days) or an increase in the length of hospital stay.
Versaci et al: New England Journal of Medicine 1997; 336 (12): 817-822
Expires June 2003

The study

Unblinded concealed randomised trial with intention-to-treat
Setting: university hospital, Italy

120 patients (aged range 34 to 84 years; mean 57, 88% male)
  • typical angina pectoris, documented myocardial ischaemia or both
  • newly-diagnosed, isolated stenosis of the proximal portion of the left anterior descending coronary artery (>50% stenosis on angiography, extending <15 mm in a vessel >3 mm diammeter)
  • left ejection fraction >40%


Excluded if
  • MI within one month
  • contraindication to oral anticoagulation, antiplatelet therapy or both
  • anatomical contraindications (ostial lesions, major branching of the vessel within in lesion, total occlusion and severe tortuosity of the proximal portion of the left anterior descending artery)
  • unable to have either procedure


Control Group: (n = 60, 60 analysed): angioplasty alone
Experimental Group: (n = 60, 60 analysed): angioplasty and stent insertion. Patients started heparin and warfarin 2 to 4 hours after removal of cannula. Heparin was continued until the INR was 2.5 to 3.5. Warfarin was continued for three months.
All patients received aspirin 300 mg and diltiazem before procedure and continued indefinitely.
97% followed for 12 months
Outcome notes:

  • complication : at puncture sites, requiring major interventions and increasing length of hospital stay

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
death, MI or recurrence of angina 12 months 18
(30.0%)		 8
(13.3%)		 56%
(6% to 79%)		 16.7%
(2.23% to 31.1%)		 6
(3 to 45)
restenosis on angioplasty (>50%) 12 months 24
(40.0%)		 11
(18.3%)		 54%
(15% to 75%)		 21.7%
(5.87% to 37.5%)		 5
(3 to 17)
complication 6 days 0
(0.00%)		 4
(6.67%)		 %
(% to %)		 -6.67%
(-13.0% to -0.35%)		 -15
(-280 to -8)

Hospital stay was longer in the stenting group compared with the PTCA group (median 6.5 days vs 5.0 days, p=0.04).

Comments

  1. Cardiac death and nonfatal MI were very infrequent, which shows that patients with single-vessel disease, even those with involvement of the proximal left anterior descending coronary artery, have an excellent short-term prognosis.
  2. Cost-effectiveness and utility analyses will help to determine whether this benefit is worth the additional cost.
  3. Other studies have shown little benefit from using warfarin over aspirin alone in patients with stents.

Citation

  1. Versaci F, Gaspardone A, Tomai F, et al: A comparison of coronary-artery stenting with angioplasty for isolated stenosis of the proximal left anterior descending coronary artery.. New England Journal of Medicine 1997; 336 (12): 817-822
Search Terms: unstable angina in Best Evidence
Contributor: Chris Ball and Clare Wotton, June 2000
Reviewer: Edward Havranek

Clinical Question.
Patient angina and single-vessel lesions
Intervention or Exposure angioplasty and stent insertion
Comparison angioplasty alone
Outcome death, MI or recurrence of angina