Unprotected left main coronary artery stenting with everolimus (Xience V) drug-eluting stents: A single center retrospective experience

Juan C. Fernandez-Guerrero, Juan A. Herrador, Manuel Guzman, Victor Aragon, Carmen Adamuz

Unidad de Hemodinámica, Servicio de Cardiología, Complejo Hospitalario de Jaén, Jaén, Spain.

DOI: 10.4236/wjcd.2013.32026                

Abstract

Objectives: We sought to evaluate the efficacy and safety of unrestricted implantation of everolimus eluting stent Xience V (EES-XV) in a cohort of real- world patients with unprotected left main coronary disease (ULMCD). Background: The second-generation EES-XV stent is currently one of the most commonly used drug-eluting stents in clinical practice. It has been shown to be superior to paclitaxel-eluting stents, but its relative merits on unprotected left main coronary disease have been less extensively assessed. Methods: Between 2007 and 2010, in this single-center registry, we evaluated the clinical outcomes of 98 patients with ULMCD who underwent percutaneous coronary intervention (PCI) with EES-XV. Results: There were no in-hospital deaths. At 25.63 ± 14.41 months of follow-up, 17 patients (17.3%) experienced major adverse coronary event (MACE), death from cardiovascular disease (n = 6; 6.1%) and target lesion revascularization (TLR; n = 7; 7.1%). The predictors of death from cardiovascular disease were: previous PCI and left ventricular dysfunction. The only predictor of TLR was the placement of 2 stents in the left main coronary artery. Conclusions: In this single- center real-world registry, we found that elective ULMCD stenting with EES-XV provided good short-, medium- and long-term outcomes, with an estimated cumulative need for TLR of 7.1%, a cardiac mortality rate of 6.1%, and a MACE rate of 17.3% at 2 years.

Keywords

Percutaneous Coronary Interventions; “Off Label” Lesions; Prognosis

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	Eagle, K.A., Guyton, R.A., Davidoff, R., Edwards, F.H., Ewy, G.A., Gardner, T.J., Hart, J.C., Herrmann, H.C., Hillis, L.D., Hutter Jr., A.M., Lytle, B.W., Marlow, R.A, Nugent, W.C., Orszulak, T.A., Antman, E.M., Smith Jr., S.C., Alpert, J.S., Anderson, J.L., Faxon, D.P., Fuster, V., Gibbons, R.J., Gregoratos, G., Halperin, J.L., Hiratzka, L.F. and Hunt, S.A. (2004) ACC/AHA 2004 guideline update for coronary artery bypass graft surgery: Summary article: A report of the American college of cardiology/American heart association task force on practice guidelines (committee to update the 1999 guidelines for coronary artery bypass graft surgery). Circulation, 110, 1168-1176. doi:10.1161/01.CIR.0000138790.14877.7D
[2]	Morice, M.C., Serruys, P.W., Kappetein, A.P., Feldman, T.E., Stahle, E., Colombo, A., Mack, M.J., Holmes, D.R., Torracca, L., van Es, G.A., Leadley, K., Dawkins, K.D. and Mohr, F. (2010) Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the synergy between percutaneous coronary intervention with TAXUS and cardiac surgery (SYNTAX) trial. Circulation, 121, 2645- 2653. doi:10.1161/CIRCULATIONAHA.109.899211
[3]	Kim, U., Park, J.S., Seol, S.H., Yang, T.H., Kim, S.M., Kim, D.K., Kim, D.I., Kim, D.S., Lee, W.J., Lee, S.H., Hong, G.R., Shin, D.G., Kim, Y.J., Shim, B.S., Cho, Y.K., Kim, H.S., Nam, C.W., Hur, S.H., Kim, K.B. and Kim, Y.N. (2009) Two-year outcomes of the sirolimus-eluting stent according to unprotected left main lesion. Clinical Cardiology, 32, 332-336. doi:10.1002/clc.20563
[4]	Mehilli, J., Kastrati, A., Byrne, R.A., Bruskina, O., Iijima, R., Schulz, S., Pache, J., Seyfarth, M., Massberg, S., Laugwitz, K.L., Dirschinger, J. and Schomig, A. (2009) Paclitaxel-versus sirolimus-eluting stents for unprotected left main coronary artery disease. Journal of the American College of Cardiology, 53, 1760-1768. doi:10.1016/j.jacc.2009.01.035
[5]	Meliga, E., Garcia-Garcia, H.M., Valgimigli, M., Chieffo, A., Biondi-Zoccai, G., Maree, A.O., Gonzalo, N., Cook, S., Marra, S., Moretti, C., De, S.S., Palacios, I.F., Windecker, S., van, D.R., Colombo, A., Sheiban, I. and Serruys, P.W. (2009) Impact of drug-eluting stent selection on long-term clinical outcomes in patients treated for unprotected left main coronary artery disease: The sirolimus vs paclitaxel drug-eluting stent for left main registry (SPDELFT). International Journal of Cardiology, 137, 16-21. doi:10.1016/j.ijcard.2008.06.006
[6]	Palmerini, T., Sangiorgi, D., Marzocchi, A., Tamburino, C., Sheiban, I., Margheri, M., Vecchi, G., Sangiorgi, G., Ruffini, M., Bartorelli, A.L., Briguori, C., Vignali, L., di, P.F., Ramondo, A., Inglese, L., de, C.M., Bolognese, L., Benassi, A., Palmieri, C., Filippone, V., Barlocco, F., Lauria, G. and De Servi, S. (2009) Ostial and midshaft lesions vs. bifurcation lesions in 1111 patients with unprotected left main coronary artery stenosis treated with drug-eluting stents: results of the survey from the Italian society of invasive cardiology. European Heart Journal, 30, 2087-2094. doi:10.1093/eurheartj/ehp223
[7]	Khattab, A.A., Hamm, C.W., Senges, J., Toelg, R., Geist, V., Bonzel, T., Kelm, M., Levenson, B., Neumann, F.J., Nienaber, C.A., Pfannebecker, T., Sabin, G., Schneider, S., Tebbe, U. and Richardt, G. (2007) Sirolimus-eluting stent treatment for unprotected versus protected left main coronary artery disease in widespread clinical routine: 6-month and 3-year clinical follow-up results from the prospective multicentre German cypher registry. Heart, 93, 1251-1255. doi:10.1136/hrt.2007.104703
[8]	Kedhi, E., Joesoef, K.S., McFadden, E., Wassing, J., van Mieghem, C., Goedhart, D. and Smits, P.C. (2010) Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): A randomised trial. Lancet, 375, 201-209. doi:10.1016/S0140-6736(09)62127-9
[9]	Serruys, P.W., Ruygrok, P., Neuzner, J., Piek, J.J., Seth, A., Schofer, J.J., Richardt, G., Wiemer, M., Carrie, D., Thuesen, L., Boone, E., Miquel-Herbert, K. and Daemen, J. (2006) A randomised comparison of an everolimus- eluting coronary stent with a paclitaxel-eluting coronary stent: The SPIRIT II trial. Euro-Intervention, 2, 286-294.
[10]	Stone, G.W., Midei, M., Newman, W., Sanz, M., Hermiller, J.B., Williams, J., Farhat, N., Mahaffey, K.W., Cutlip, D.E., Fitzgerald, P.J., Sood, P., Su, X. and Lansky, A.J. (2008) Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: A randomized trial. The Journal of the American Medical Association, 299, 1903-1913. doi:10.1001/jama.299.16.1903
[11]	Stone, G.W., Rizvi, A., Newman, W., Mastali, K., Wang, J.C., Caputo, R., Doostzadeh, J., Cao, S., Simonton, C.A., Sudhir, K., Lansky, A.J., Cutlip, D.E. and Kereiakes, D.J. (2010) Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. The New England Journal of Medicine, 362, 1663-1674. doi:10.1056/NEJMoa0910496
[12]	De Waha, A., Dibra, A., Byrne, R.A., Ndrepepa, G., Mehilli, J., Fusaro, M., Laugwitz, K.-L., Massberg, S., Schömig, A. and Kastrati, A. (2011) Everolimus-eluting versus sirolimus-eluting stents a meta-analysis of randomized trials. Circulation: Cardiovascular Interventions, 4, 371-377. doi:10.1161/CIRCINTERVENTIONS.111.963256
[13]	Onuma, Y., Kukreja, N., Piazza, N., Eindhoven, J., Girasis, C., Schenkeveld, L., van Domburg, R. and Serruys, P.W. (On Behalf of the Interventional Cardiologists of the Thoraxcenter (2000 to 2007)) (2009) The everolimus- eluting stent in real-world patients 6-month follow-up of the X-SEARCH (Xience V) stent evaluated at Rotterdam Cardiac Hospital registry. Journal of the American College of Cardiology, 54, 269-276.
[14]	Cutlip, D.E., Windecker, S., Mehran, R., Boam, A., Cohen, D.J., van Es, G.A., Steg, P.G., Morel, M.A., Mauri, L., Vranckx, P., McFadden, E., Lansky, A., Hamon, M., Krucoff, M.W. and Serruys, P.W. (On Behalf of the Academic Research Consortium) (2007) Clinical end points in coronary stent trials: A case for standardized definitions. Circulation, 115, 2344-2351. doi:10.1161/CIRCULATIONAHA.106.685313
[15]	Sianos, G., Morel, M.A., Kappetein, A.P., Morice, M.C., Colombo, A., Dawkins, K., van den Brand, M., Van Dyck, N., Russell, M.E., Mohr, F.W. and Serruys, P.W. (2005) The SYNTAX score: An angiographic tool grading the complexity of coronary artery disease. EuroIntervention, 1, 219-227.
[16]	Park, S.J., Kim, Y.H., Park, D.W., Lee, S.W., Kim, W.J., Suh, J., Yun, S.C., Lee, C.W., Hong, M.K., Lee, J.H. and Park, S.W. (MAIN-COMPARE Investigators) (2009) Impact of intravascular ultrasound guidance on long-term mortality in stenting for unprotected left main coronary artery stenosis. Circulation: Cardiovascular Interventions, 2, 167-177. doi:10.1161/CIRCINTERVENTIONS.108.799494
[17]	Vaquerizo, B., Lefèvre, T., Darremont, O., Silvestri, M., Louvard, Y., Leymarie, J.L., Garot, P., Routledge, H., de Marco, F., Unterseeh, T., Zwahlen, M. and Morice, M.C. (2009) Unprotected left main stenting in the real world: Two-year outcomes of the French left main taxus registry. Circulation, 119, 2349-2356. doi:10.1161/CIRCULATIONAHA.108.804930
[18]	Meliga, E., Garcia-Garcia, H.M., Valgimigli, M., Chieffo, A., Biondi-Zoccai, G., Maree, A.O., Cook, S., Reardon, L., Moretti, C., De Servi, S., Palacios, I.F., Windecker, S., Colombo, A., van Domburg, R., Sheiban, I., Serruys, P.W. (2008) Longest available clinical outcomes after drug- eluting stent implantation for unprotected left main coronary artery disease: The DELFT (drug eluting stent for LeFT main) registry. Journal of the American College of Cardiology, 51, 2212-2219. doi:10.1016/j.jacc.2008.03.020
[19]	Wood, F.O., Saylors, E.K., Schneider, J.E., Jobe, R.L. and Mann, J.T. 3rd. (2008) Unprotected left main disease managed with drug-eluting stents: Long-term outcome of 100 patients with increased surgical risk. Catheterization and Cardiovascular Interventions, 71, 533-538. doi:10.1002/ccd.21447
[20]	Toyofuku, M., Kimura, T., Morimoto, T., Hayashi, Y., Ueda, H., Kawai, K., Nozaki, Y., Hiramatsu, S., Miura, A., Yokoi, Y., Toyoshima, S., Nakashima, H., Haze, K., Tanaka, M., Take, S., Saito, S., Isshiki, T. and Mitsudo, K. (On Behalf of the j-Cypher Registry Investigators) (2009) Three-year outcomes after sirolimus-eluting stent implantation for unprotected left main coronary artery disease. Insights from the j-Cypher Registry Circulation, 120, 1866-1874.
[21]	Wu, X.-F., Chen, Y.-D., Kubo, T., Ge, C.-J., Ren, F., Wu, X., Chen, W.-J., Zhou, Y., Liu, H. and Lv, S. (2010) Long-term (4-year) outcomes and predictors of adverse cardiac events after sirolimus-eluting stent implantation in unprotected left main coronary artery. International Heart Journal, 51, 377-382. doi:10.1536/ihj.51.377
[22]	Lee, J.-Y., Park, D.-W., Yun, S.-C., Lee, S.-W., Kim, Y.-K., Lee, C.W., Hong, M.-K., Park, S.-W. and Park, S.-J. (2009) Long-term clinical outcomes of sirolimus- versus paclitaxel-eluting stents for patients with unprotected left main coronary artery disease. Analysis of the MAIN-COMPARE (Revascularization for unprotected left main coronary artery stenosis: Comparison of percutaneous coronary angioplasty versus surgical revascularization) registry. Journal of the American College of Cardiology, 54, 853-859. doi:10.1016/j.jacc.2009.04.071
[23]	Latib, A., Ferri, L., Ielasi, A., Godino, C., Chieffo, A., Magni, V., Bassanelli, G., Sharp, A.S.P., Gerber, R., Michev, I., Carlino, M., Airoldi, F., Sangiorgi, G.M., Montorfano, M. and Colombo, A. (2009) Clinical outcomes after unrestricted implantation of everolimus-eluting stents. Journal of the American College of Cardiology, 2, 1219- 1226.
[24]	Stone, G.W., Midei, M., Newman, W., Sanz, M., Hermiller, J.B., Williams, J., Farhat, N., Caputo, R., Xenopoulos, N., Applegate, R., Gordon, P., White, R.M., Sudhir, K., Cutlip, D.E. and Petersen, J.L. (SPIRIT III Investigators) (2009) Randomized comparison of everolimus- eluting and paclitaxel-eluting stents. Two-year clinical follow-up from the clinical evaluation of the Xience V everolimus-eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions (SPIRIT) III trial. Circulation, 119, 680-686. doi:10.1161/CIRCULATIONAHA.108.803528
[25]	Joner, M., Nakazawa, G., Finn, A.V., Quee, S.C., Coleman, L., Acampado, E., Wilson, P.S., Skorija, K., Cheng, Q., Xu, X., Gold, H.K., Kolodgie, F.D. and Virmani, R. (2008) Endothelial cell recovery between comparator polymer-based drug-eluting stents. Journal of the American College of Cardiology, 52, 333-342. doi:10.1016/j.jacc.2008.04.030