Restenosis after placement of Palmaz-Schatz stents in native coronary arteries. Initial results of a multicenter experience

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Circulation. 1992;86:1836-1844

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ARTICLES

Restenosis after placement of Palmaz-Schatz stents in native coronary arteries. Initial results of a multicenter experience

SG Ellis, M Savage, D Fischman, DS Baim, M Leon, S Goldberg, JW Hirshfeld, MW Cleman, PS Teirstein and C Walker
University of Michigan Medical Center, Ann Arbor.

BACKGROUND. Several metallic intracoronary stents are currently undergoing preliminary evaluation to ascertain potential benefit as means to reduce the 30-40% incidence of restenosis after balloon angioplasty. METHODS AND RESULTS. To determine the incidence and correlates of restenosis after placement of Palmaz-Schatz stents in native coronary arteries in the first group of patients selected for this procedure, clinical and quantitative angiographic data from 206 consecutive patients (221 stenoses) with successful stent placement (diameter stenosis < 50%) were analyzed. Six patients (2.9%) had thrombosis-mediated stent closure within 1 month after stent placement and were excluded from long-term angiographic follow-up. One hundred eighty-one (91%) of the remaining 200 patients had angiography at 5.8 +/- 2.1 months. Patients with and without follow-up did not differ in any baseline characteristic; in particular, history of restenosis at the site stented (73% versus 65%), placement of multiple overlapping stents (17% versus 20%), and mean poststent diameter stenosis (16 +/- 12% versus 14 +/- 12%). The overall incidence of restenosis (diameter stenosis > or = 50% at follow-up) in this group at high risk for restenosis was 36% (95% confidence interval, 29-43%) on a per-stenosis basis. The incidence of restenosis when a single stent was placed was 30% (95% confidence interval, 23-37%). Risk was dependent upon a history of restenosis (present versus absent 36% versus 16%, p = 0.02) and upon whether or not a poststent stenosis < or = 0% was achieved (6% versus 33%, p = 0.02). When multiple overlapping stents were placed, restenosis occurred at 64% of sites, and placement of multiple stents was discouraged during the later phases of this study as these results became apparent. CONCLUSIONS. Although multiple stents appear to yield a poor long-term result, placement of single stents may offer a benefit compared with standard coronary angioplasty, particularly if an excellent angiographic result can be obtained in patients without prior restenosis. Further randomized trials in such patients are needed.

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				M. Gyongyosi, P. Yang, A. Khorsand, D. Glogar, on behalf of the Austrian Wiktor Stent Study Group, and European Paragon Stent Investigators Longitudinal straightening effect of stents is an additional predictor for major adverse cardiac events J. Am. Coll. Cardiol., May 1, 2000; 35(6): 1580 - 1589. [Abstract] [Full Text] [PDF]

				R. Kornowski, B. Bhargava, D. M. S. Fuchs, A. J. Lansky, L. F. Satler, A. D. Pichard, M. K. Hong, K. M. Kent, R. Mehran, G. W. Stone, et al. Procedural results and late clinical outcomes after percutaneous interventions using long (>=25 mm) versus short (<20 mm) stents J. Am. Coll. Cardiol., March 1, 2000; 35(3): 612 - 618. [Abstract] [Full Text] [PDF]

				L. Gruberg, R. Mehran, G. Dangas, M. K. Hong, G. S. Mintz, R. Kornowski, A. J. Lansky, K. M. Kent, A. D. Pichard, L. F. Satler, et al. Effect of plaque debulking and stenting on short- and long-term outcomes after revascularization of chronic total occlusions J. Am. Coll. Cardiol., January 1, 2000; 35(1): 151 - 156. [Abstract] [Full Text] [PDF]

				P. R. Moreno, J. T. Fallon, A. M. Murcia, M. N. Leon, H. Simosa, V. Fuster, and I. F. Palacios Tissue characteristics of restenosis after percutaneous transluminal coronary angioplasty in diabetic patients J. Am. Coll. Cardiol., October 1, 1999; 34(4): 1045 - 1049. [Abstract] [Full Text] [PDF]

				P. W. Serruys, I. P. Kay, C. Disco, N. V. Deshpande, P. J. de Feyter, and on behalf of the BENESTENT I BENESTENT II Pilot BE Periprocedural quantitative coronary angiography after Palmaz-Schatz stent implantation predicts the restenosis rate at six months: Results of a meta-analysis of the belgian netherlands stent study (BENESTENT) I, BENESTENT II pilot, BENESTENT II and MUSIC trials J. Am. Coll. Cardiol., October 1, 1999; 34(4): 1067 - 1074. [Abstract] [Full Text] [PDF]

				Y. Kobayashi, J. De Gregorio, N. Kobayashi, T. Akiyama, B. Reimers, L. Finci, C. Di Mario, and A. Colombo Stented segment length as an independent predictor of restenosis J. Am. Coll. Cardiol., September 1, 1999; 34(3): 651 - 659. [Abstract] [Full Text] [PDF]

				J. Schofer, T. Rau, M. Schluter, and D.G. Mathey Restenosis after stenting of matched occluded and non-occluded coronary arteries. Should there be a difference? Eur. Heart J., August 2, 1999; 20(16): 1175 - 1181. [Abstract] [PDF]

				R. Erbel, M. Haude, H. W. Hopp, D. Franzen, H. J. Rupprecht, B. Heublein, K. Fischer, P. de Jaegere, P. Serruys, W. Rutsch, et al. Coronary-Artery Stenting Compared with Balloon Angioplasty for Restenosis after Initial Balloon Angioplasty N. Engl. J. Med., December 3, 1998; 339(23): 1672 - 1678. [Abstract] [Full Text] [PDF]

				S. Elezi, A. Kastrati, J.u. Pache, A. Wehinger, M. Hadamitzky, J. Dirschinger, F.-J. Neumann, and A. Schomig Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement J. Am. Coll. Cardiol., December 1, 1998; 32(7): 1866 - 1873. [Abstract] [Full Text] [PDF]

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				S. Kasaoka, J. M. Tobis, T. Akiyama, B. Reimers, C. Di Mario, N. D. Wong, and A. Colombo Angiographic and intravascular ultrasound predictors of in-stent restenosis J. Am. Coll. Cardiol., November 15, 1998; 32(6): 1630 - 1635. [Abstract] [Full Text] [PDF]

				S. Elezi, A. Kastrati, F.-J. Neumann, M. Hadamitzky, J. Dirschinger, and A. Schomig Vessel Size and Long-Term Outcome After Coronary Stent Placement Circulation, November 3, 1998; 98(18): 1875 - 1880. [Abstract] [Full Text] [PDF]

				J. S. Munn, K. M. Jain, and E. J. Simoni Reoperation for Recurrent Carotid Stenosis: A Ten-Year Experience Vascular and Endovascular Surgery, September 1, 1998; 32(5): 425 - 432. [Abstract] [PDF]

				R. Kornowski, R. Mehran, M. K. Hong, L. F. Satler, A. D. Pichard, K. M. Kent, G. S. Mintz, R. Waksman, J. R. Laird, A. J. Lansky, et al. Procedural Results and Late Clinical Outcomes After Placement of Three or More Stents in Single Coronary Lesions Circulation, April 14, 1998; 97(14): 1355 - 1361. [Abstract] [Full Text] [PDF]

				C di Mario, B Reimers, Y Almagor, I Moussa, L Di Francesco, M Ferraro, M B Leon, K Richter, and A Colombo Procedural and follow up results with a new balloon expandable stent in unselected lesions Heart, March 1, 1998; 79(3): 234 - 241. [Abstract] [Full Text]

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				A. Schomig, A. Kastrati, S. Elezi, H. Schuhlen, J. Dirschinger, F. Dannegger, M. Wilhelm, and K. Ulm Bimodal Distribution of Angiographic Measures of Restenosis Six Months After Coronary Stent Placement Circulation, December 2, 1997; 96(11): 3880 - 3887. [Abstract] [Full Text]

				M. P. Savage, J. S. Douglas, D. L. Fischman, C. J. Pepine, S. B. King, J. A. Werner, S. R. Bailey, P. A. Overlie, S. H. Fenton, J. A. Brinker, et al. Stent Placement Compared with Balloon Angioplasty for Obstructed Coronary Bypass Grafts N. Engl. J. Med., September 11, 1997; 337(11): 740 - 747. [Abstract] [Full Text] [PDF]

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				I. Moussa, C. Di Mario, J. Moses, B. Reimers, L. Di Francesco, G. Martini, J. Tobis, and A. Colombo Coronary Stenting After Rotational Atherectomy in Calcified and Complex Lesions : Angiographic and Clinical Follow-Up Results Circulation, July 1, 1997; 96(1): 128 - 136. [Abstract] [Full Text]

				E. A. Tovar and A. Borsari Effects of Surgical Manipulation on Coronary Stents: Should Surgical Strategy Be Altered? Ann. Thorac. Surg., January 1, 1997; 63(1): 37 - 40. [Abstract] [Full Text]

				T. Kimura, H. Yokoi, Y. Nakagawa, T. Tamura, S. Kaburagi, Y. Sawada, Y. Sato, H. Yokoi, N. Hamasaki, H. Nosaka, et al. Three-Year Follow-Up after Implantation of Metallic Coronary-Artery Stents N. Engl. J. Med., February 29, 1996; 334(9): 561 - 567. [Abstract] [Full Text] [PDF]

				C. Rogers and E. R. Edelman Endovascular Stent Design Dictates Experimental Restenosis and Thrombosis Circulation, June 15, 1995; 91(12): 2995 - 3001. [Abstract] [Full Text]

				G. L. Nunes, D. S. Sgoutas, R. A. Redden, S. R. Sigman, M. B. Gravanis, S. B. King III, and B. C. Berk Combination of Vitamins C and E Alters the Response to Coronary Balloon Injury in the Pig Arterioscler Thromb Vasc Biol, January 1, 1995; 15(1): 156 - 165. [Abstract] [Full Text]

				D. L. Fischman, M. B. Leon, D. S. Baim, R. A. Schatz, M. P. Savage, I. Penn, K. Detre, L. Veltri, D. Ricci, M. Nobuyoshi, et al. A Randomized Comparison of Coronary-Stent Placement and Balloon Angioplasty in the Treatment of Coronary Artery Disease N. Engl. J. Med., August 25, 1994; 331(8): 496 - 501. [Abstract] [Full Text]