What outcomes have been reported for the use of bare-metal stents (BMS) in percutaneous coronary intervention (PCI)?

Updated: Nov 27, 2019
  • Author: George A Stouffer, III, MD; Chief Editor: Karlheinz Peter, MD, PhD  more...
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Answer

The major limitations of balloon angioplasty were acute vessel closure and restenosis. Early studies with intracoronary stents showed that these devices were highly effective for treating or preventing acute or threatened vessel closure and thereby avoiding emergency bypass surgery.

Two randomized trials, BENESTENT (Belgian Netherlands Stent) [27] and STRESS (Stent Restenosis Study), [28] demonstrated that coronary stenting of de novo lesions in native vessels reduced angiographic restenosis by approximately 30% as compared with conventional balloon angioplasty. Stenting produces a larger lumen diameter than conventional balloon angioplasty both immediately after the procedure (acute gain) and at follow-up (net gain), resulting in less restenosis.

The use of BMSs was compared to bypass surgery for the treatment of multivessel CAD in the ARTS (Arterial Revascularization Therapies Study) trial. [29] After 1 year of follow-up, no difference was noted between the groups in the rate of death, stroke, or MI. Event-free survival was better in the surgery group than in the stent group (87.8% vs 73.8%), and only 3.5% in the surgery group required a second revascularization procedure, compared with 16.8% in the stent group.

The SoS (Stent or Surgery) trial compared BMSs with CABG and reported a 2-year target vessel revascularization rate of 21% in stent patients, compared with 6% in CABG patients. [30] Death and MI rates were similar in the two groups. However, the SoS trial had a higher noncardiac death rate in the PCI arm, thought to be attributed to a type II error that may have affected the study results.

The SoS trial and the ARTS study demonstrate the safety of PCI treatment in multivessel disease. Cardiac mortality risk is low, and the rates of repeat target vessel revascularization are less than half of those seen with balloon angioplasty. [31]

According to the New York Cardiac Registry, as with the prior trials, patients who received PCI as the initial therapy had a higher incidence of target vessel revascularization (35.1%) than those who received CABG (4.9%). [32] The registry identified 59,314 patients with multivessel disease who either underwent CABG (n = 37,212) or had PCI with bare-metal stents (n = 22,102), with reported endpoints of repeat revascularization and survival rates within 3 years.

Using unadjusted survival curves, the registry demonstrated that for patients who had two-vessel disease without LAD artery involvement, PCI offered a small survival benefit. [32] For patients who had two-vessel disease with proximal LAD artery involvement, the two procedures had similar mortalities (91.4% for CABG and 91.2% for PCI). The registry reported a statistically significant survival benefit of CABG over PCI in patients who had three-vessel disease with proximal LAD artery involvement.


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