(Circulation. 1995;91:1676-1688.)
© 1995 American Heart Association, Inc.
Articles |
Intracoronary Stenting Without Anticoagulation Accomplished With Intravascular Ultrasound Guidance
Presented in part at the 66th Scientific Sessions of the American Heart Association, Atlanta, Ga, November 8-11, 1993, and the American College of Cardiology Meeting, March 1994.
From the Centro Cuore Columbus, Milan, Italy (A.C., P.H., S.N., Y.A., L.M., G.M., S.L.G.); the Villa Bianca, Bari, Italy (A.G.); and the University of California at Irvine, Orange, Calif (J.M.T.).
Correspondence to Antonio Colombo, MD, Centro Coure Columbus, Via M. Buonarotti 48, 20145 Milan, Italy.
Background The placement of stents in coronary arteries has been shown to reduce restenosis in comparison to balloon angioplasty. However, clinical use of intracoronary stents is impeded by the risk of subacute stent thrombosis and complications associated with the anticoagulant regimen. To reduce these complications, the hypothesis that systemic anticoagulation is not necessary when adequate stent expansion is achieved was prospectively evaluated on a consecutive series of patients who received intracoronary stents.
Methods and Results From March 1993 to January 1994, 359 patients underwent Palmaz-Schatz coronary stent insertion. After an initial successful angiographic result with <20% stenosis by visual estimation had been achieved, intravascular ultrasound imaging was performed. Further balloon dilatation of the stent was guided by observation of the intravascular ultrasound images. All patients with adequate stent expansion confirmed by ultrasound were treated only with antiplatelet therapy (either ticlopidine for 1 month with short-term aspirin for 5 days or only aspirin) after the procedure. Clinical success (procedure success without early postprocedural events) at 2 months was achieved in 338 patients (94%). With an inflation pressure of 14.9±3.0 atm and a balloon-to-vessel ratio of 1.17±0.19, optimal stent expansion was achieved in 321 of the 334 patients (96%) who underwent intravascular ultrasound evaluation, with these patients receiving only antiplatelet therapy after the procedure. Despite the absence of anticoagulation, there were only two acute stent thromboses (0.6%) and one subacute stent thrombosis (0.3%) at 2-month clinical follow-up. Follow-up angiography at 3 to 6 months documented two additional occlusions (0.6%) at the stent site. At 6-month clinical follow-up, angiographically documented stent occlusion had occurred in 5 patients (1.6%). At 6-month clinical follow-up, there was a 5.7% incidence of myocardial infarction, a 6.4% rate of coronary bypass surgery, and a 1.9% incidence of death. Emergency intervention (emergency angioplasty or bailout stent) for a stent thrombosis event was performed in 3 patients (0.8%). The overall event rate was relatively high because of intraprocedural complications that occurred in 16 patients (4.5%). Intraprocedural complications, however, decreased to 1% when angiographically appropriately sized balloons were used for final stent dilations. There was one ischemic vascular complication that occurred at the time of the procedure and one ischemic vascular complication that occurred at the time of angiographic follow-up. By 6 months, repeat angioplasty for symptomatic restenosis was performed in 47 patients (13.1%).
Conclusions The Palmaz-Schatz stent can be safely inserted in coronary arteries without subsequent anticoagulation provided that stent expansion is adequate and there are no other flow-limiting lesions present. The use of high-pressure final balloon dilatations and confirmation of adequate stent expansion by intravascular ultrasound provide assurance that anticoagulation therapy can be safely omitted. This technique significantly reduces hospital time and vascular complications and has a low stent thrombosis rate.
Key Words: stents • ultrasonics • balloon • platelets
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R. Waksman, B. Bhargava, G. S. Mintz, R. Mehran, A. J. Lansky, L. F. Satler, A. D. Pichard, K. M. Kent, and M. B. Leon Late total occlusion after intracoronary brachytherapy for patients with in-stent restenosis J. Am. Coll. Cardiol., July 1, 2000; 36(1): 65 - 68. [Abstract] [Full Text] [PDF]
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 H. W. ROBERTS and S. W. REDDING CORONARY ARTERY STENTS: REVIEW AND PATIENT-MANAGEMENT RECOMMENDATIONS J Am Dent Assoc, June 1, 2000; 131(6): 797 - 801. [Abstract] [Full Text] [PDF]
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 J. H. Baron, A. H. Gershlick, K. Hogrefe, J. Armstrong, C. M. Holt, R. K. Aggarwal, M. Azrin, M. Ezekowitz, and D. P. de Bono In vitro evaluation of c7E3-Fab (ReoProTM) eluting polymer-coated coronary stents Cardiovasc Res, June 1, 2000; 46(3): 585 - 594. [Abstract] [Full Text] [PDF]
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R. Albiero, T. Nishida, M. Adamian, A. Amato, M. Vaghetti, N. Corvaja, C. Di Mario, and A. Colombo Edge Restenosis After Implantation of High Activity 32P Radioactive {beta}-Emitting Stents Circulation, May 30, 2000; 101(21): 2454 - 2457. [Abstract] [Full Text] [PDF]
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 B. Moy, J. C. Wang, G. D. Raffel, and J. P. Marcoux II Hemolytic Uremic Syndrome Associated With Clopidogrel: A Case Report Arch Intern Med, May 8, 2000; 160(9): 1370 - 1372. [Abstract] [Full Text] [PDF]
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W. W. O'Neill, P. Serruys, M. Knudtson, G.-A. van Es, G. C. Timmis, C. van der Zwaan, J. Kleiman, J. Gong, E. B. Roecker, R. Dreiling, et al. Long-Term Treatment with a Platelet Glycoprotein-Receptor Antagonist after Percutaneous Coronary Revascularization N. Engl. J. Med., May 4, 2000; 342(18): 1316 - 1324. [Abstract] [Full Text] [PDF]
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M. Silvestri, P. Barragan, J. Sainsous, G. Bayet, J.-B. Simeoni, P.-O. Roquebert, G. Macaluso, J.-L. Bouvier, and B. Comet Unprotected left main coronary artery stenting: immediate and medium- term outcomes of 140 elective procedures J. Am. Coll. Cardiol., May 1, 2000; 35(6): 1543 - 1550. [Abstract] [Full Text] [PDF]
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I. Bossi, C. Klersy, A. J. Black, R. Cortina, R. Choussat, B. Cassagneau, C. Jordan, J.-C. Laborde, J.-P. Laurent, M. Bernies, et al. In-stent restenosis: long-term outcome and predictors of subsequent target lesion revascularization after repeat balloon angioplasty J. Am. Coll. Cardiol., May 1, 2000; 35(6): 1569 - 1576. [Abstract] [Full Text] [PDF]
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J. P. Carrozza Jr. In-stent restenosis: should an old device treat a new problem? J. Am. Coll. Cardiol., May 1, 2000; 35(6): 1577 - 1579. [Full Text] [PDF]
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G. L. Kaluza, J. Joseph, J. R. Lee, M. E. Raizner, and A. E. Raizner Catastrophic outcomes of noncardiac surgery soon after coronary stenting J. Am. Coll. Cardiol., April 1, 2000; 35(5): 1288 - 1294. [Abstract] [Full Text] [PDF]
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D. Alexopoulos, C. Stefanadis, C. Olympios, V. Voudris, S. Hatzimiltiadis, D. Sionis, E. Vavouranakis, A. Vrahatis, C. Fakiolas, E. Pissimisis, et al. Antiplatelet Is Superior to Anticoagulant Treatment After Coronary Stenting: Fewer Coronary and Other Events Within 30 Days After Stenting Angiology, April 1, 2000; 51(4): 289 - 294. [Abstract] [PDF]
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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]
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P. Henry, F. Beverelli, P. B. Berger, M. R. Bell, D. Hasdai, D. R. Holmes Jr, S. Melby, and D. Grill Safety and Efficacy of Ticlopidine After Stent Placement • Response Circulation, January 25, 2000; 101 (3): e46 - e47. [Full Text] [PDF]
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R. Albiero, M. Adamian, N. Kobayashi, A. Amato, M. Vaghetti, C. Di Mario, and A. Colombo Short- and Intermediate-Term Results of 32P Radioactive {beta}-Emitting Stent Implantation in Patients With Coronary Artery Disease : The Milan Dose-Response Study Circulation, January 4, 2000; 101(1): 18 - 26. [Abstract] [Full Text] [PDF]
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J.-P. Bassand Intravascular ultrasound guided PTCA: a way to escape stent mania? Eur. Heart J., January 2, 2000; 21(2): 92 - 94. [PDF]
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P. H. Grewe, T. Deneke, A. Machraoui, J.u. Barmeyer, and K.-M. Muller Acute and chronic tissue response to coronary stent implantation: pathologic findings in human specimen J. Am. Coll. Cardiol., January 1, 2000; 35(1): 157 - 163. [Abstract] [Full Text] [PDF]
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J. M. Rankin, J. J. Spinelli, R. G. Carere, D. R. Ricci, I. M. Penn, J. D. Hilton, M. A. Henderson, R. I. Hayden, and C. E. Buller Improved Clinical Outcome after Widespread Use of Coronary-Artery Stenting in Canada N. Engl. J. Med., December 23, 1999; 341(26): 1957 - 1965. [Abstract] [Full Text] [PDF]
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R. A. M. van Liebergen, J. J. Piek, K. T. Koch, R. J. G. Peters, R. J. de Winter, C. E. Schotborgh, and K. I. Lie Hyperemic coronary flow after optimized intravascular ultrasound-guided balloon angioplasty and stent implantation J. Am. Coll. Cardiol., December 1, 1999; 34(7): 1899 - 1906. [Abstract] [Full Text] [PDF]
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C. Briguori, I. Sheiban, J. De Gregorio, A. Anzuini, M. Montorfano, P. Pagnotta, F. Marsico, F. Leonardo, C. Di Mario, and A. Colombo Direct coronary stenting without predilation J. Am. Coll. Cardiol., December 1, 1999; 34(7): 1910 - 1915. [Abstract] [Full Text] [PDF]
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A. Cappelletti, A. Margonato, G. Rosano, A. Mailhac, F. Veglia, A. Colombo, and S. L. Chierchia Short- and long-term evolution of unstented nonocclusive coronary dissection after coronary angioplasty J. Am. Coll. Cardiol., November 1, 1999; 34(5): 1484 - 1488. [Abstract] [Full Text] [PDF]
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P. J. de Feyter, P. Kay, C. Disco, and P. W. Serruys Reference Chart Derived From Post-Stent-Implantation Intravascular Ultrasound Predictors of 6-Month Expected Restenosis on Quantitative Coronary Angiography Circulation, October 26, 1999; 100(17): 1777 - 1783. [Abstract] [Full Text] [PDF]
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E. Tsuchikane, S. Sumitsuji, N. Awata, T. Nakamura, T. Kobayashi, M. Izumi, S. Otsuji, H. Tateyama, M. Sakurai, and T. Kobayashi Final results of the STent versus directional coronary Atherectomy Randomized Trial (START) J. Am. Coll. Cardiol., October 1, 1999; 34(4): 1050 - 1057. [Abstract] [Full Text] [PDF]
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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]
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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]
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D. E. Cutlip, M. B. Leon, K. K. L. Ho, P. C. Gordon, A. Giambartolomei, D. J. Diver, D. M. Lasorda, D. O. Williams, M. M. Fitzpatrick, A. Desjardin, et al. Acute and nine-month clinical outcomes after "suboptimal" coronary stenting: Results from the STent anti-thrombotic regimen study (STARS) registry J. Am. Coll. Cardiol., September 1, 1999; 34(3): 698 - 706. [Abstract] [Full Text] [PDF]
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J. Dirschinger, A. Kastrati, F.-J. Neumann, P. Boekstegers, S. Elezi, J. Mehilli, H. Schuhlen, J. Pache, E. Alt, R. Blasini, et al. Influence of Balloon Pressure During Stent Placement in Native Coronary Arteries on Early and Late Angiographic and Clinical Outcome : A Randomized Evaluation of High-Pressure Inflation Circulation, August 31, 1999; 100(9): 918 - 923. [Abstract] [Full Text] [PDF]
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R. Waksman Late Thrombosis After Radiation : Sitting on a Time Bomb Circulation, August 24, 1999; 100(8): 780 - 782. [Full Text] [PDF]
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M. A. Costa, M. Sabate, W. J. van der Giessen, I. P. Kay, P. Cervinka, J. M. R. Ligthart, P. Serrano, V. L. M. A. Coen, P. C. Levendag, and P. W. Serruys Late Coronary Occlusion After Intracoronary Brachytherapy Circulation, August 24, 1999; 100(8): 789 - 792. [Abstract] [Full Text] [PDF]
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J. P. Carrozza Jr, S. E. Hosley, D. J. C. MD, and D. S. Baim In Vivo Assessment of Stent Expansion and Recoil in Normal Porcine Coronary Arteries : Differential Outcome by Stent Design Circulation, August 17, 1999; 100(7): 756 - 760. [Abstract] [Full Text] [PDF]
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I. Moussa, M. Oetgen, G. Roubin, A. Colombo, X. Wang, S. Iyer, R. Maida, M. Collins, E. Kreps, and J. W. Moses Effectiveness of Clopidogrel and Aspirin Versus Ticlopidine and Aspirin in Preventing Stent Thrombosis After Coronary Stent Implantation Circulation, May 11, 1999; 99(18): 2364 - 2366. [Abstract] [Full Text] [PDF]
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E. D. Peterson, P. A. Cowper, E. R. DeLong, J. P. Zidar, R. S. Stack, and D. B. Mark Acute and long-term cost implications of coronary stenting J. Am. Coll. Cardiol., May 1, 1999; 33(6): 1610 - 1618. [Abstract] [Full Text] [PDF]
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