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Long-term angiographic and clinical outcome after implantation of a balloon-expandable stent in the native coronary circulation. Palmaz-Schatz Stent Study Group.

Abstract：

OBJECTIVES:The purpose of this study was to examine the long-term clinical and angiographic outcome after coronary stent implantation. BACKGROUND:Previous reports have shown a discordance between the excellent initial angiographic results and subsequent adverse clinical events after coronary artery stenting. METHODS:Single Palmaz-Schatz stents were electively implanted in the native coronary arteries of 300 consecutive patients. Angiograms were obtained at baseline, after balloon angioplasty, after stent implantation and at 6 months after implantation. Films were analyzed by a panel of angiographers utilizing an automated edge detection program. Clinical events, including death, myocardial infarction, coronary bypass surgery and repeat angioplasty, were recorded for 1 year. RESULTS:Although there were no acute in laboratory vessel closures, stent thrombosis occurred in 14 patients (4.7%) at a mean +/- SD of 5 +/- 3 days after implantation. Two hundred fifty-eight (90%) of 286 eligible patients had follow-up angiography at 6.1 +/- 2.2 months after stent implantation. Minimal lumen diameter increased from 0.80 +/- 0.39 mm at baseline to 1.65 +/- 0.51 mm after angioplasty and further increased to 2.55 +/- 0.49 mm after stent placement (p = 0.0001). At follow-up there was a 0.85-mm late loss in lumen diameter, with a final minimal lumen diameter at 6 months of 1.70 +/- 0.71 mm. Restenosis, defined as > or = 50% diameter stenosis at follow-up, occurred in 14% of patients with previously untreated lesions and in 39% of patients with previous angioplasty (p < 0.001). Clinical events after 1 year for the entire group of 300 patients included death in 0.7%, myocardial infarction in 3.7%, bypass grafting in 8% and repeat angioplasty in 13%. Freedom from any adverse clinical event was 80% for all treated patients and 87% for those with previously untreated lesions. CONCLUSIONS:Elective use of this balloon-expandable stent in the native coronary circulation is associated with a low restenosis rate by quantitative angiography in previously untreated lesions and a favorable clinical outcome with an excellent event-free survival rate at 1 year.

journal_name

J Am Coll Cardiol

journal_title

Journal of the American College of Cardiology

authors

Savage MP,Fischman DL,Schatz RA,Teirstein PS,Leon MB,Baim D,Ellis SG,Topol EJ,Hirshfeld JW,Cleman MW

doi

10.1016/0735-1097(94)90099-x

subject

Has Abstract,Author List Incomplete

pub_date

1994-11-01 00:00:00

pages

1207-12

issue

eissn

0735-1097

issn

1558-3597

pii

0735-1097(94)90099-X

journal_volume

pub_type

临床试验,杂志文章,多中心研究

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Long-term angiographic and clinical outcome after implantation of a balloon-expandable stent in the native coronary circulation. Palmaz-Schatz Stent Study Group.