Continued benefit of coronary stenting versus balloon angioplasty: one-year clinical follow-up of Benestent trial. Benestent Study Group

Catheterization Laboratory, Thorax Center, Erasmus University, Rotterdam, The Netherlands.

OBJECTIVES. This study sought to determine the 1-year clinical follow-up of patients included in the Benestent trial. BACKGROUND. The Benestent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defers restenosis and its subsequent clinical manifestations. METHODS. To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle and included death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previously treated lesion. RESULTS. After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stent and balloon angioplasty groups, respectively. However, the requirement for a repeat angioplasty procedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = 0.001), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differences were found between groups with respect to functional class angina and prescribed medication at the time of follow-up. CONCLUSIONS. These clinical follow-up data show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.

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				M. B. Leon, D. S. Baim, J. J. Popma, P. C. Gordon, D. E. Cutlip, K. K.L. Ho, A. Giambartolomei, D. J. Diver, D. M. Lasorda, D. O. Williams, et al. A Clinical Trial Comparing Three Antithrombotic-Drug Regimens after Coronary-Artery Stenting N. Engl. J. Med., December 3, 1998; 339(23): 1665 - 1671. [Abstract] [Full Text] [PDF]

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				D. R. Holmes Jr., J. Hirshfeld Jr., D. Faxon, R. Vlietstra, A. Jacobs, S. B. King III, T. M. Bashore, N. D. Bridges, C. B. Higgins, L. F. Hiratzka, et al. ACC expert consensus document on coronary artery stents: Document of the American College of Cardiology J. Am. Coll. Cardiol., November 1, 1998; 32(5): 1471 - 1482. [Full Text] [PDF]

				E. J. Topol and P. W. Serruys Frontiers in Interventional Cardiology Circulation, October 27, 1998; 98(17): 1802 - 1820. [Full Text] [PDF]

				D. R. Holmes Jr., K. E. Kip, W. Yeh, S. F. Kelsey, K. M. Detre, D. O. Williams, and for the Investigators of the NHLBI PTCA Registry Long-term analysis of conventional coronary balloon angioplasty and an initial "stent-like" result: The NHLBI PTCA registry J. Am. Coll. Cardiol., September 1, 1998; 32(3): 590 - 595. [Abstract] [Full Text] [PDF]

				P. A. Sirnes, S. Golf, Y. Myreng, P. Molstad, P. Albertsson, A. Mangschau, K. Endresen, and J. Kjekshus Sustained benefit of stenting chronic coronary occlusion: long-term clinical follow-up of the Stenting in Chronic Coronary Occlusion (SICCO) study J. Am. Coll. Cardiol., August 1, 1998; 32(2): 305 - 310. [Abstract] [Full Text] [PDF]

				F. Schiele, N. Meneveau, A. Vuillemenot, D. D. Zhang, S. Gupta, M. Mercier, N. Danchin, B. Bertrand, J.-P. Bassand, and on behalf of the RESIST Study Group Impact of intravascular ultrasound guidance in stent deployment on 6-month restenosis rate: a multicenter, randomized study comparing two strategies--with and without intravascular ultrasound guidance J. Am. Coll. Cardiol., August 1, 1998; 32(2): 320 - 328. [Abstract] [Full Text] [PDF]

				M. S. Gotsman and D. Admon Paradigm Shifts in Coronary Artery Disease: The Old New Initiatives Arch Intern Med, May 11, 1998; 158(9): 949 - 953. [Full Text] [PDF]

				F. Versaci, A. Gaspardone, F. Tomai, F. Crea, L. Chiariello, and P. A. Gioffre A Comparison of Coronary-Artery Stenting with Angioplasty for Isolated Stenosis of the Proximal Left Anterior Descending Coronary Artery N. Engl. J. Med., March 20, 1997; 336(12): 817 - 822. [Abstract] [Full Text] [PDF]

				J. A. Bittl Advances in Coronary Angioplasty N. Engl. J. Med., October 24, 1996; 335(17): 1290 - 1302. [Full Text] [PDF]

				P. N. Ruygrok and P. W. Serruys Intracoronary Stenting: From Concept to Custom Circulation, September 1, 1996; 94(5): 882 - 890. [Full Text]