Abstract
While rotational atherectomy (RA) is used for complex lesions in percutaneous coronary intervention, there are several contraindications such as unprotected left main stenosis or left ventricular dysfunction. We previously reported that the incidence of in-hospital complications was significantly greater in off-label as compared to on-label use RA. However, the mid-term clinical outcomes between off-label and on-label RA have not been investigated. The purpose of this study was to compare the mid-term clinical outcomes between off-label (n = 156) and on-label RA (n = 94). The primary endpoint was the incidence of major adverse cardiovascular events (MACE) defined as the composite of ischemia-driven target vessel revascularization (TVR), non-fatal MI, and all-cause death. We also identified 154 patients who underwent RA and follow-up angiography within 1 year, and compared quantitative coronary analysis between the off-label group (n = 96) and on-label group (n = 58). There was no significant difference in late luminal loss between the groups (0.03 ± 0.53 mm in the off-label and −0.05 ± 0.44 mm in the on-label groups, P = 0.57). However, the incidence of MACE was less in the on-label group (3.2 %) as compared to the off-label group (9.0 %) without reaching statistical significance (P = 0.08). In conclusion, mid-term clinical outcomes tended to be worse in the off-label group than in the on-label group. We may have to follow-up the patient who underwent off-label RA more carefully than the patient who underwent on-label RA.
Similar content being viewed by others
References
Cavusoglu E, Kini AS, Marmur JD, Sharma SK (2004) Current status of rotational atherectomy. Catheter Cardiovasc Interv 62:485–498
Lee SW, Hong MK, Lee CW, Kim YH, Song JM, Han KH, Kang DH, Song JK, Kim JJ, Park SW, Park SJ (2004) Early and late clinical outcomes after rotational atherectomy with stenting versus rotational atherectomy with balloon angioplasty for complex coronary lesions. J Invasive Cardiol 16:406–409
Boston_Scientific_Corporation (2009) Rotablator, product document
Garcia-Lara J, Pinar E, Valdesuso R, Lacunza J, Gimeno JR, Hurtado JA, Valdes-Chavarri M (2012) Percutaneous coronary intervention with rotational atherectomy for severely calcified unprotected left main: Immediate and two years follow-up results. Catheter Cardiovasc Interv 80:215–220
Sakakura K, Ako J, Wada H, Naito R, Funayama H, Arao K, Kubo N, Momomura SI (2012) Comparison of frequency of complications with on-label versus off-label use of rotational atherectomy. Am J Cardiol 110:498–501
Barbato E, Carrie D, Dardas P, Fajadet J, Gaul G, Haude M, Khashaba A, Koch K, Meyer-Gessner M, Palazuelos J, Reczuch K, Ribichini FL, Sharma S, Sipotz J, Sjogren I, Suetsch G, Szabo G, Valdes-Chavarri M, Vaquerizo B, Wijns W, Windecker S, de Belder A, Valgimigli M, Byrne RA, Colombo A, Di Mario C, Latib A, Hamm C (2015) European expert consensus on rotational atherectomy. EuroIntervention 11:30–36
Tamekiyo H, Hayashi Y, Toyofuku M, Ueda H, Sakuma T, Okimoto T, Otsuka M, Imazu M, Kihara Y (2009) Clinical outcomes of sirolimus-eluting stenting after rotational atherectomy. Circ J 73:2042–2049
Rathore S, Matsuo H, Terashima M, Kinoshita Y, Kimura M, Tsuchikane E, Nasu K, Ehara M, Asakura Y, Katoh O, Suzuki T (2010) Rotational atherectomy for fibro-calcific coronary artery disease in drug eluting stent era: procedural outcomes and angiographic follow-up results. Catheter Cardiovasc Interv 75:919–927
Sakakura K, Ako J, Wada H, Naito R, Arao K, Funayama H, Kubo N, Momomura S (2012) Beta-blocker use is not associated with slow flow during rotational atherectomy. J Invasive Cardiol 24:379–384
Shiono Y, Kubo T, Tanaka A, Ino Y, Yamaguchi T, Tanimoto T, Yamano T, Matsuo Y, Nishiguchi T, Teraguchi I, Ota S, Ozaki Y, Orii M, Shimamura K, Kitabata H, Hirata K, Imanishi T, Akasaka T (2015) Long-term outcome after deferral of revascularization in patients with intermediate coronary stenosis and gray-zone fractional flow reserve. Circ J 79:91–95
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW (2007) Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115:2344–2351
Fujimoto S, Kondo T, Yamamoto H, Yokoyama N, Tarutani Y, Takamura K, Urabe Y, Konno K, Nishizaki Y, Shinozaki T, Kihara Y, Daida H, Isshiki T, Takase S (2015) Development of new risk score for pre-test probability of obstructive coronary artery disease based on coronary CT angiography. Heart Vessels 30:563–571
Norioka N, Iwata S, Yanagi S, Ishii H, Sugioka K, Kamimori K, Ota T, Di Tullio MR, Homma S, Yoshiyama M (2016) Higher visit-to-visit intra-dialytic blood pressure is associated with the progression of aortic valve stenosis in chronic hemodialysis patients. Heart Vessels 31:1491–1496
Ellis SG, Popma JJ, Lasala JM, Koglin JJ, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Stone GW (2005) Relationship between angiographic late loss and target lesion revascularization after coronary stent implantation: analysis from the TAXUS-IV trial. J Am Coll Cardiol 45:1193–1200
Naito R, Sakakura K, Wada H, Funayama H, Sugawara Y, Kubo N, Ako J, Momomura S (2012) Mid-term clinical outcomes of ACS and non-ACS patients treated with everolimus-eluting stents. Int Heart J 53:215–220
Yabushita H, Takagi K, Tahara S, Fujino Y, Warisawa T, Kawamoto H, Watanabe Y, Mitomo S, Karube K, Matsumoto T, Sato T, Naganuma T, Kobayashi T, Ishiguro H, Fukino K, Kurita N, Nakamura S, Hozawa K, Nakamura S (2014) Impact of rotational atherectomy on heavily calcified, unprotected left main disease. Circ J 78:1867–1872
Sulimov DS, Abdel-Wahab M, Toelg R, Kassner G, Geist V, Richardt G (2015) High-speed rotational atherectomy of the left main coronary artery: a single-center experience in 50 high-risk patients. Cardiovasc Revasc Med 16:284–289
Basavarajaiah S, Naganuma T, Latib A, Hasegawa T, Sharp A, Rezq A, Sticchi A, Figini F, Amato A, Colombo A (2014) Extended follow-up following “full-metal jacket” percutaneous coronary interventions with drug-eluting stents. Catheter Cardiovasc Interv 84:1042–1050
O’Neill WW (1992) Mechanical rotational atherectomy. Am J Cardiol 69:12F–18F
Yamamoto S, Sakakura K, Funayama H, Wada H, Fujita H, Momomura S (2015) Percutaneous coronary artery bypass for type 3 coronary perforation. JACC Cardiovasc Interv 8:1396–1398
Sakakura K, Ako J, Momomura S (2011) Successful removal of an entrapped rotablation burr by extracting drive shaft sheath followed by balloon dilatation. Catheter Cardiovasc Interv 78:567–570
Totsugawa T, Kuinose M, Yoshitaka H, Katayama K, Tsushima Y, Ishida A, Chikazawa G, Hiraoka A (2012) Surgical treatment for Ellis type 3 coronary perforation during percutaneous catheter intervention. Circ J 76:377–381
Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW (2009) Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 360:961–972
Choi IJ, Koh YS, Lim S, Choo EH, Kim JJ, Hwang BH, Kim TH, Seo SM, Kim CJ, Park MW, Shin DI, Choi YS, Park HJ, Her SH, Kim DB, Park CS, Lee JM, Moon KW, Chang K, Kim HY, Yoo KD, Jeon DS, Chung WS, Ahn Y, Jeong MH, Seung KB, Kim PJ (2016) Impact of percutaneous coronary intervention for chronic total occlusion in non-infarct-related arteries in patients with acute myocardial infarction (from the COREA-AMI Registry). Am J Cardiol 117:1039–1046
Wallace TW, Berger JS, Wang A, Velazquez EJ, Brown DL (2009) Impact of left ventricular dysfunction on hospital mortality among patients undergoing elective percutaneous coronary intervention. Am J Cardiol 103:355–360
Acknowledgments
The authors acknowledge all staff in the catheter laboratory in Jichi Medical University, Saitama Medical Center for their technical support in this study.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
This research received no Grant from any funding agency in the public, commercial, or not-for-profit sectors. Dr. Sakakura received speaking honorarium from Abbott Vascular, Boston Scientific, Medtronic Cardiovascular, and Terumo; and served as a consultant for Abbott Vascular and Boston Scientific.
Rights and permissions
About this article
Cite this article
Mori, T., Sakakura, K., Wada, H. et al. Comparison of mid-term clinical outcomes between on-label and off-label use of rotational atherectomy. Heart Vessels 32, 514–519 (2017). https://doi.org/10.1007/s00380-016-0899-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00380-016-0899-6