To assess procedural outcome, complications, and clinical follow up in 218 patients who underwent treatment with 297 Multi-link (Guidant)
stents implanted without the use of intravascular ultrasound (IVUS) or quantitative coronary angiography (QCA), and using
aspirin alone as antiplatelet
therapy.
METHODS: The case records and angiograms were reviewed and the patients were contacted by telephone to determine their symptoms and any adverse events at follow up. Data were analysed using Fisher's exact test.
RESULTS: Of the 218 patients included in the study, 45 had multivessel intracoronary intervention, and 55 had
unstable angina. The mean (SD) length of
hospital stay following the procedure was 2.0 (2.1) days. There were two early deaths at less than 30 days, and two deaths during follow up at more than 100 days. Ten patients suffered complications during the first 30 days: four had subacute
stent thrombosis, of whom two died and two were treated successfully with
coronary artery bypass grafting; five had a non-Q wave
myocardial infarction; and one had a femoral
false aneurysm. Patient outcome was analysed according to
stent diameter (3.0 mm or less, or 3.5 mm or more) and by angina status (stable or unstable). In patients in whom at least one
stent was 3.0 mm diameter, four of 86 patients suffered acute
stent occlusion, whereas in the 132 patients in whom all
stents were at least 3.5 mm diameter there were no cases of
stent occlusion (p = 0.02). In the
unstable angina group two of 55 patients suffered acute
stent occlusion compared to two of 163 patients in the
stable angina group (NS). In patients with
unstable angina and at least one
stent of 3.0 mm diameter, the acute occlusion rate was 7.1% (two of 28 patients). Three of the four patients with
stent occlusion had undergone complex procedures. Twenty eight patients were restudied for recurrent symptoms during the follow up period. Of these, eight patients had restenosis within their
stent. In seven of these patients the
stent size was 3.0 mm diameter, and in the remaining patient the
stent size was 4.0 mm diameter. Three of the 28 patients restudied had developed new disease remote from the stented site, and 17 had patent
stents and no significant other coronary lesion.
CONCLUSIONS: This study suggests that coronary intervention using the Multi-link
stent is safe and effective using
aspirin alone, without IVUS or QCA, when
stent diameter is greater than 3.0 mm. All cases of
stent occlusion in this series occurred in patients in whom at least one
stent was 3.0 mm diameter, with
stent occlusion being higher in patients with
unstable angina compared to those with
stable angina. Additional antiplatelet
therapy may be beneficial in those patients in whom Multi-link
stent diameter is less than 3.5 mm, particularly in those with
unstable angina, but is not necessary for patients receiving Multi-link
stents of 3.5 mm diameter or greater.