Abstract
Drug-eluting stents (DES) reduce subsequent revascularization procedures. Although randomized trials have compared DES to brachytherapy and balloon angioplasty (PTCA) for in-stent restenosis, few long-term comparisons have been made to bare metal stents (BMS) or bypass surgery (CABG), particularly following second procedures. We sought to assess the association between revascularization modality and long-term clinical outcomes of patients receiving a second procedure for coronary artery disease. Between January 2000 and July 2005, 4,666 consecutive patients underwent initial coronary stent implantation (DES or BMS). From this population we identified 569 patients undergoing a second target vessel revascularization (DES, BMS, PTCA or CABG). Outcomes were assessed at 6, 12, and 24 months after the second procedure, with follow-up through September 2006. Adjusted cumulative incidence rates were calculated using inverse probability weighted estimators. We found that at 24 months, there were no significant differences in death or myocardial infarction for PTCA, BMS, DES, and CABG (17.7%, 14.9%, 7.5%, and 10.2%, p = 0.26[3df]). DES patients had lower rates of death or myocardial infarction or third target vessel procedures than patients receiving PTCA (14.6% vs. 30.0%, p = 0.01) and BMS (14.6% vs. 42.2%, p < 0.01), but rates similar to CABG patients (14.6% vs. 14.6%, p = 0.99). For patients undergoing a second revascularization procedure, PTCA, BMS, DES, and CABG are associated with a similar risk of death or non-fatal myocardial infarction. DES and CABG are associated with lower rates of third revascularization procedures compared to PTCA and BMS. Further studies are needed to determine the optimum application for CABG vs. DES as a second or third revascularization procedure.
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Abbreviations
- BMS:
-
Bare metal stent
- CABG:
-
Coronary artery bypass grafting
- DES:
-
Drug-eluting stent
- DF:
-
Degrees of freedom
- MI:
-
Myocardial infarction
- PTCA:
-
Balloon angioplasty
- TVR:
-
Target vessel revascularization
- TVR3:
-
Third target vessel revascularization
Reference
Gruntzig, A. R., Senning, A., and Siegenthaler, W. E., Nonoperative dilatation of coronary-artery stenosis: Percutaneous transluminal coronary angioplasty. N. Engl. J. Med. 301:61–68, 1979.
Thom, T., Haase, N., Rosamond, W., Howard, V. J., Rumsfeld, J., Manolio, T., Zheng, Z. J., Flegal, K., O’Donnell, C., Kittner, S., Lloyd-Jones, D., Goff, D. C., Jr., Hong, Y., Adams, R., Friday, G., Furie, K., Gorelick, P., Kissela, B., Marler, J., Meigs, J., Roger, V., Sidney, S., Sorlie, P., Steinberger, J., Wasserthiel-Smoller, S., Wilson, M., and Wolf, P., Heart disease and stroke statistics—2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 113:e85–e151, 2006.
Hodgson, J. M., Bottner, R. K., Klein, L. W., Walpole, H. T., Jr., Cohen, D. J., Cutlip, D. E., Fenninger, R. B., Firth, B. G., Greenberg, D., Kalisky, I., Meskan, T., Powell, W., Stone, G. W., Zito, J. P., and Clark, M. A., Drug-eluting stent task force: final report and recommendations of the working committees on cost-effectiveness/economics, access to care, and medicolegal issues. Catheter. Cardiovasc. Interv. 62:1–17, 2004.
Serruys, P. W., Ong, A. T., van Herwerden, L. A., Sousa, J. E., Jatene, A., Bonnier, J. J., Schonberger, J. P., Buller, N., Bonser, R., Disco, C., Backx, B., Hugenholtz, P. G., Firth, B. G., and Unger, F., Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial. J. Am. Coll. Cardiol. 46:575–581, 2005.
Serruys, P. W., Kutryk, M. J., and Ong, A. T., Coronary-artery stents. N. Engl. J. Med. 354:483–495, 2006.
Babapulle, M. N., Joseph, L., Belisle, P., Brophy, J. M., and Eisenberg, M. J., A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet 364:583–591, 2004.
Liistro, F., Stankovic, G., Di Mario, C., Takagi, T., Chieffo, A., Moshiri, S., Montorfano, M., Carlino, M., Briguori, C., Pagnotta, P., Albiero, R., Corvaja, N., and Colombo, A., First clinical experience with a paclitaxel derivate-eluting polymer stent system implantation for in-stent restenosis: immediate and long-term clinical and angiographic outcome. Circulation 105:1883–1886, 2002.
Tung, R., Kaul, S., Diamond, G. A., and Shah, P. K., Narrative review: Drug-eluting stents for the management of restenosis: a critical appraisal of the evidence. Ann. Intern. Med. 144:913–919, 2006.
Chen, M. S., John, J. M., Chew, D. P., Lee, D. S., Ellis, S. G., and Bhatt, D. L., Bare metal stent restenosis is not a benign clinical entity. Am. Heart. J. 151:1260–1264, 2006.
Morice, M. C., Serruys, P. W., Sousa, J. E., Fajadet, J., Ban, H. E., Perin, M., Colombo, A., Schuler, G., Barragan, P., Guagliumi, G., Molnar, F., and Falotico, R., A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N. Engl. J. Med. 346:1773–1780, 2002.
Moses, J. W., Leon, M. B., Popma, J. J., Fitzgerald, P. J., Holmes, D. R., O’Shaughnessy, C., Caputo, R. P., Kereiakes, D. J., Williams, D. O., Teirstein, P. S., Jaeger, J. L., and Kuntz, R. E., Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N. Engl. J. Med. 349:1315–1323, 2003.
Stone, G. W., Ellis, S. G., Cox, D. A., Hermiller, J., O’Shaughnessy, C., Mann, J. T., Turco, M., Caputo, R., Bergin, P., Greenberg, J., Popma, J. J., and Russell, M. E., One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation 109:1942–1947, 2004.
Rao, S. V., Shaw, R. E., Brindis, R. G., Klein, L. W., Weintraub, W. S., and Peterson, E. D., On- versus off-label use of drug-eluting coronary stents in clinical practice (report from the American College of Cardiology National Cardiovascular Data Registry [NCDR]). Am. J. Cardiol. 97:1478–1481, 2006.
Holmes, D. R., Jr., Teirstein, P., Satler, L., Sketch, M., O’Malley, J., Popma, J. J., Kuntz, R. E., Fitzgerald, P. J., Wang, H., Caramanica, E., and Cohen, S. A., Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA 295:1264–1273, 2006.
Stone, G. W., Ellis, S. G., O’Shaughnessy, C. D., Martin, S. L., Satler, L., McGarry, T., Turco, M. A., Kereiakes, D. J., Kelley, L., Popma, J. J., and Russell, M. E., Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA 295:1253–1263, 2006.
Kastrati, A., Mehilli, J., von Beckerath, N., Dibra, A., Hausleiter, J., Pache, J., Schuhlen, H., Schmitt, C., Dirschinger, J., and Schomig, A., Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA 293:165–171, 2005.
Dibra, A., Kastrati, A., Alfonso, F., Seyfarth, M., Perez-Vizcayno, M. J., Mehilli, J., and Schomig, A., Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials. J. Am. Coll. Cardiol. 49:616–623, 2007.
Neumann, F. J., Desmet, W., Grube, E., Brachmann, J., Presbitero, P., Rubartelli, P., Mugge, A., Di Pede, F., Fullgraf, D., Aengevaeren, W., Spedicato, L., and Popma, J. J., Effectiveness and safety of sirolimus-eluting stents in the treatment of restenosis after coronary stent placement. Circulation 111:2107–2111, 2005.
Pate, G. E., Lee, M., Humphries, K., Cohen, E., Lowe, R., Fox, R. S., Teskey, R., and Buller, C. E., Characterizing the spectrum of in-stent restenosis: implications for contemporary treatment. Can. J. Cardiol. 22:1223–1229, 2006.
Ben Gal, Y., Moshkovitz, Y., Nesher, N., Uretzky, G., Braunstein, R., Hendler, A., Zivi, E., Herz, I., and Mohr, R., Drug-eluting stents versus coronary artery bypass grafting in patients with diabetes mellitus. Ann. Thorac. Surg. 82:1692–1697, 2006.
Rosati, R. A., McNeer, J. F., Starmer, C. F., Mittler, B. S., Morris, J. J., Jr., and Wallace, A. G. A new information system for medical practice. Arch. Intern. Med. 135:1017–1024, 1975.
Califf, R. M., Harrell, F. E., Jr., Lee, K. L., Rankin, J. S., Hlatky, M. A., Mark, D. B., Jones, R. H., Muhlbaier, L. H., Oldham, H. N., Jr., and Pryor, D. B., The evolution of medical and surgical therapy for coronary artery disease. A 15-year perspective. JAMA 261:2077–2086, 1989.
Fortin, D. F., Califf, R. M., Pryor, D. B., and Mark, D. B., The way of the future redux. Am. J. Cardiol. 76:1177–1182, 1995.
Eisenstein, E. L., Anstrom, K. J., Kong, D. F., Shaw, L. K., Tuttle, R. H., Mark, D. B., Kramer, J. M., Harrington, R. A., Matchar, D. B., Kandzari, D. E., Peterson, E. D., Schulman, K. A., and Califf, R. M., Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA 297:159–168, 2007.
Bang, H., and Tsiatis, A. A., Estimating medical costs with censored data. Biometrika 87:329–343, 2000.
Anstrom, K. J., and Tsiatis, A. A., Utilizing propensity scores to estimate causal treatment effects with censored time-lagged data. Biometrics 57:1207–1218, 2001.
Cole, S. R., and Hernan, M. A., Adjusted survival curves with inverse probability weights. Comput. Methods Programs Biomed. 75:45–49, 2004.
Gooley, T. A., Leisenring, W., Crowley, J., and Storer, B. E., Estimation of cumulative incidence in the presence of competing risks. In: Crowley, D., Ankerst, D. P., (Eds.), Handbook of Statistics in Clinical Oncology. Chapman & Hall/CRC, 557–565; 2006.
Pfisterer, M., Brunner-La Rocca, H. P., Buser, P. T., Rickenbacher, P., Hunziker, P., Mueller, C., Jeger, R., Bader, F., Osswald, S., and Kaiser, C., For the BASKET-LATE Investigators. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 48:2584–2591, 2006.
Lagerqvist, B., James, S. K., Stenestrand, U., Lindback, J., Nilsson, T., and Wallentin, L., Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N. Engl. J. Med. 356:1009–1019, 2007.
Mehran, R., Dangas, G., Abizaid, A. S., Mintz, G. S., Lansky, A. J., Satler, L. F., Pichard, A. D., Kent, K. M., Stone, G. W., and Leon, M. B., Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation 100:1872–1878, 1999.
Reimers, B., Moussa, I., Akiyama, T., Tucci, G., Ferraro, M., Martini, G., Blengino, S., Di Mario, C., and Colombo, A., Long-term clinical follow-up after successful repeat percutaneous intervention for stent restenosis. J. Am. Coll. Cardiol. 30:186–192, 1997.
Thielmann, M., Leyh, R., Massoudy, P., Neuhauser, M., Aleksic, I., Kamler, M., Herold, U., Piotrowski, J., and Jakob, H., Prognostic significance of multiple previous percutaneous coronary interventions in patients undergoing elective coronary artery bypass surgery. Circulation 114:I441–I447, 2006.
Gaudino, M., Cellini, C., Pragliola, C., Trani, C., Burzotta, F., Schiavoni, G., Nasso, G., and Possati, G., Arterial versus venous bypass grafts in patients with in-stent restenosis. Circulation 112:I265–I269, 2005.
Lemos, P. A., van Mieghem, C. A., Arampatzis, C. A., Hoye, A., Ong, A. T., McFadden, E., Sianos, G., van der Giessen, W. J., de Feyter, P. J., van Domburg, R. T., and Serruys, P. W., Post-sirolimus-eluting stent restenosis treated with repeat percutaneous intervention: late angiographic and clinical outcomes. Circulation 109:2500–2502, 2004.
Mehran, R., Dangas, G., Abizaid, A., Lansky, A. J., Mintz, G. S., Pichard, A. D., Satler, L. F., Kent, K. M., Waksman, R., Stone, G. W., and Leon, M. B., Treatment of focal in-stent restenosis with balloon angioplasty alone versus stenting: Short- and long-term results. Am. Heart J. 141:610–614, 2001.
Alfonso, F., Cequier, A., Zueco, J., Moris, C., Suarez, C. P., Colman, T., Esplugas, E., Perez-Vizcayno, M. J., Fernandez, C., and Macaya, C., Stenting the stent: initial results and long-term clinical and angiographic outcome of coronary stenting for patients with in-stent restenosis. Am. J. Cardiol. 85:327–332, 2000.
Airoldi, F., Briguori, C., Iakovou, I., Stankovic, G., Biondi-Zoccai, G., Carlino, M., Chieffo, A., Montorfano, M., Cosgrave, J., Michev, I., Rogacka, R., Sangiorgi, G. M., and Colombo, A., Comparison of sirolimus versus paclitaxel eluting stents for treatment of coronary in-stent restenosis. Am. J. Cardiol. 97:1182–1187, 2006.
Acknowledgments
We thank Maqui Ortiz, Duke Clinical Research Institute, for her expert editing of these materials and Elise Berliner, PhD, Agency for Healthcare Research and Quality for her advocacy for the Treatment of In-Stent Restenosis project and for her feedback during its execution.
This project was funded under Contract No. 290-05-0032 from the Agency for Healthcare Research and Quality, US Department of Health and Human Services, Rockville, MD as part of the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) program. The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the US Department of Health and Human Services. Based on the AHRQ DEcIDE report titled “Treatment of In-Stent Restenosis” (AHRQ Publication, under review).
Conflict of Interest
Dr. Konstance, Dr. Kong, Ms. Shaw, and Dr. Matchar did not report any conflicts of interest. Dr. Eisenstein reported receiving research grants from Medtronic Vascular. Dr. Anstrom reported receiving research support from National Institutes of Health / National Heart, Lung, and Blood Institute, the Agency for Healthcare Research and Quality, Proctor and Gamble, Pfizer, Medtronic, Alexion Pharmaceuticals, Medicure, Medtronic Vascular, Bristol-Myers Squibb, and Novartis Pharmaceuticals. Dr. Califf reported receiving grants or contracts from Abbott Vascular Devices, Advanced Cardiovascular Systems, Advanced Stent Technologies, Boston Scientific, Bristol-Myers Squibb, Conor Medsystems Inc., Cordis Corporation, Guidant Corporation, Medtronic, Sanofi-Aventis, and Terumo Medical Corporation. Dr. Harrington reported receiving research grants from Boston Scientific, Cordis Corporation, Medtronic, Conor Medsystems Inc, Bristol-Myers Squibb, and Sanofi-Aventis; and performs consulting work for Bristol-Myers Squibb and Sanofi-Aventis. Dr. Schulman reported research support from Bristol-Myers Squibb Company and Johnson & Johnson; and he has served as a consultant for Sanofi-Aventis US LLC and Boston Scientific Corporation.
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Konstance, R.P., Eisenstein, E.L., Anstrom, K.J. et al. Outcomes of Second Revascularization Procedures after Stent Implantation. J Med Syst 32, 177–186 (2008). https://doi.org/10.1007/s10916-007-9120-x
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DOI: https://doi.org/10.1007/s10916-007-9120-x