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Previous Volume 331:496-501 August 25, 1994 Number 8 Next

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ABSTRACT

Background Coronary-stent placement is a new technique in which a balloon-expandable, stainless-steel, slotted tube is implanted at the site of a coronary stenosis. The purpose of this study was to compare the effects of stent placement and standard balloon angioplasty on angiographically detected restenosis and clinical outcomes.

Methods We randomly assigned 410 patients with symptomatic coronary disease to elective placement of a Palmaz-Schatz stent or to standard balloon angioplasty. Coronary angiography was performed at base line, immediately after the procedure, and six months later.

Results The patients who underwent stenting had a higher rate of procedural success than those who underwent standard balloon angioplasty (96.1 percent vs. 89.6 percent, P = 0.011), a larger immediate increase in the diameter of the lumen (1.72 ±0.46 vs. 1.23 ±0.48 mm, P<0.001), and a larger luminal diameter immediately after the procedure (2.49 ±0.43 vs. 1.99 ±0.47 mm, P<0.001). At six months, the patients with stented lesions continued to have a larger luminal diameter (1.74 ±0.60 vs. 1.56 ±0.65 mm, P = 0.007) and a lower rate of restenosis (31.6 percent vs. 42.1 percent, P = 0.046) than those treated with balloon angioplasty. There were no coronary events (death; myocardial infarction; coronary-artery bypass surgery; vessel closure, including stent thrombosis; or repeated angioplasty) in 80.5 percent of the patients in the stent group and 76.2 percent of those in the angioplasty group (P = 0.16). Revascularization of the original target lesion because of recurrent myocardial ischemia was performed less frequently in the stent group than in the angioplasty group (10.2 percent vs. 15.4 percent, P = 0.06).

Conclusions In selected patients, placement of an intracoronary stent, as compared with balloon angioplasty, results in an improved rate of procedural success, a lower rate of angiographically detected restenosis, a similar rate of clinical events after six months, and a less frequent need for revascularization of the original coronary lesion.

Source Information

From Jefferson Medical College, Philadelphia (D.L.F., M.P.S., R.R., S.G.); Washington Cardiology Center, Washington, D.C. (M.B.L.); Beth Israel Hospital, Boston (D.S.B.); Scripps Clinic and Research Center, La Jolla, Calif. (R.A.S., P.S.T.); Victoria General Hospital, Halifax, N.S. (I.P.); the University of Pittsburgh, Pittsburgh (K.D., L.V.); Vancouver General Hospital, Vancouver, B.C. (D.R.); Kokura Memorial Hospital, Kyushu, Japan (M.N.); Yale University, New Haven, Conn. (M.C.); Arizona Heart Institute, Phoenix (R.H.); Toronto General Hospital, Toronto (D.A.); St. Luke's Hospital, Houston (R.D.F.); Centro Cuore Columbus, Milan, Italy (A.C.); Johns Hopkins Hospital, Baltimore (J.B.); Lenox Hill Hospital, New York (J.M., A.S.); Hospital of the University of Pennsylvania, Philadelphia (J.H.); the University of Texas at San Antonio, San Antonio (S.B.); and the Cleveland Clinic Foundation, Cleveland (S.E.). Additional participants in the Stent Restenosis Study (STRESS) trial are listed in the Appendix.

Address reprint requests to Dr. Goldberg at Jefferson Medical College, Division of Cardiology, Suite 403, 1025 Walnut St., Philadelphia, PA 19107.

Full Text of this Article

Related Letters:

Coronary-Stent Placement Compared with Balloon Angioplasty
Bittl J. A., Schwartz L., Serruys P. W., The Benestent Investigators , Fischman D. L., Savage M. P., Goldberg S., Topol E. J.
Extract | Full Text  
N Engl J Med 1995; 332:536-538, Feb 23, 1995. Correspondence

Antithrombotic Therapy after Coronary-Artery Stenting
Ferrer F., Moraleda J. M., Vicente V., LoGerfo F. W., Wohl V. R., Hecht E., Shaughnessy K., Leon M. B., Dangas G., Erbel R., Haude M., The Restenosis Stent Study Group , Topol E. J.
Extract | Full Text  
N Engl J Med 1999; 340:1365-1368, Apr 29, 1999. Correspondence

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