Stenting improved clinical outcomes in patients with isolated stenosis
ACP J Club. 1997 Sep-Oct;127:32. doi:10.7326/ACPJC-1997-127-2-032
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. N Engl J Med. 1997 Mar 20; 336:817-22.
To compare the effectiveness of primary stent implantation (SI) with percutaneous transluminal coronary angioplasty (PTCA) for selected patients with symptomatic isolated stenosis of the proximal left anterior descending (LAD) coronary artery.
Randomized controlled trial with 12-month follow-up.
120 patients (mean age 57 y, 88% men) with typical angina pectoris (AP), myocardial ischemia, or both; isolated stenosis of the proximal LAD coronary artery; and a left ventricular ejection fraction ≥ 40%. Exclusion criteria were recent myocardial infarction (MI) (1 mo), contraindication to oral anticoagulation or antiplatelet therapy, or anatomical contraindications. Follow-up was 97%.
Patients were allocated to either SI (n = 60) or PTCA (n = 60). All patients were given heparin at the beginning of the procedure. Warfarin was given within 24 hours and continued after discharge (3 mo).
Main outcome measures
The primary outcome was the rate of angiographic restenosis. Clinical outcomes were rates of procedural success, event-free survival (freedom from death, MI, and recurrent AP), in-hospital complications, and length of hospital stay.
Procedural success rates did not differ between groups (95% for SI and 93% for PTCA). At 12 months, restenosis rates were lower for SI than for PTCA (19% vs 40%, P = 0.02). More patients in the SI group than those in the PTCA group had event-free survival (P = 0.04) and were free of AP (P = 0.05) (Table). Hospital stay was longer in the SI group compared with the PTCA group (median 6.5 d vs 5.0 d, P = 0.04). No differences existed for death, nonfatal MI, or in-hospital complications.
Stent implantation reduced the rate of restenosis and increased favorable clinical outcomes in patients with isolated proximal left anterior descending coronary stenosis.
Source of funding: Not stated.
For article reprint: Professor Gioffrè, Divisione di Cardiochirurgia, Università di Roma Tor Vergata, via Portuense 700, 00149 Rome, Italy. FAX 39-6-659-75724.
Table. Stent implantation (SI) vs PTCA*
|Outcomes at 12 months||SI EER||PTCA CER||RBI (95% CI)||ABI |EER - CER|||NNT (CI)|
|Event-free survival||87%||70%||24% (26 to 53)||17%||6 (3 to 50)|
|No AP||90%||75%||20% (2 to 45)||15%||7 (3 to 68)|
*AP = angina pectoris; PTCA = percutaneous transluminal coronary angioplasty. Other abbreviations defined in Glossary; RBI, ABI, NNT, and CI calculated from data in article.
This important study by Versaci and colleagues confirms previous reports that intracoronary stent insertion is the only method that reduces the risk for restenosis, which has been the bane of PTCA. In this selected group of patients, the risk for restenosis was reduced by 53%. Although event-free survival at 12 months was improved with SI compared with PTCA, the difference resulted from the reduced recurrence of AP. Cardiac death and nonfatal MI were very infrequent, which shows that patients with single-vessel disease, even those with involvement of the proximal LAD coronary artery, have an excellent short-term prognosis.
Limiting the redevelopment of AP had a price, however, because there was a trend toward more vascular complications and length of hospital stay was increased. Both were related to the aggressive anticoagulation regimen in vogue at the time the study was done. Recent studies show that vascular complications are far less problematic and lengths of stay are shorter in the era of aspirin and ticlopidine, rather than warfarin, after SI (1).
In this study, 6 stents needed to be inserted to prevent 1 subsequent revascularization procedure at 1 year. Is this a cost-effective strategy? Ultimately, it will depend on the balance of the initial costs of SI compared with the downstream benefits of fewer episodes of AP, possibly an improved quality of life, fewer revascularization procedures, and possibly an earlier return to work. Cost-effectiveness and utility analyses will help to determine whether this benefit is worth the additional cost, particularly when considered in light of contemporary antithrombotic protocols.
David Massel, MD
Victoria General HospitalLondon, Ontario, Canada
David Massel, MD
Victoria General Hospital
London, Ontario, Canada