Intensive plaque modification with rotational atherectomy and cutting balloon before drug-eluting stent implantation for patients with severely calcified coronary lesions: a pilot clinical study

Qiyong Li, Yong He, Li Chen, Mao Chen, Qiyong Li, Yong He, Li Chen, Mao Chen

Abstract

Background: This study investigated whether, for patients with severely calcified coronary lesions, use of a cutting balloon (CB) during rotational atherectomy (RA) before placing a drug-eluting stent will improve periprocedural outcomes, compared to RA with a conventional plain balloon.

Methods: In a randomized controlled trial, patients with severely calcified lesions of calcium arc ≥180° were apportioned to receive intensive plaque modification with RA and CB (RA + CB; n = 35) or RA with conventional plain balloon (RA; n = 36). Intravascular ultrasound was applied for quantitative or qualitative analyses of percutaneous coronary intervention outcomes. The primary outcome was acute lumen gain after drug-eluting stent.

Results: The RA + CB and RA groups were similar in baseline mean arcs of superficial calcium, and minimum lumen cross-sectional areas (CSAs). The mean minimum stent CSA after percutaneous coronary intervention (PCI) of the RA + CB group (5.9 ± 1.7 mm(2)) was significantly larger than that of the RA group (5.0 ± 1.4 mm(2); P = 0.021). Patients in the RA + CB group achieved significantly larger acute CSA gain after PCI (4.5 ± 1.5 mm(2)) relative to the RA group (3.8 ± 1.5 mm(2); P = 0.035). The groups were similar in rates of periprocedural complications, but at the 1-year follow-up the RA + CB had a lower rate of revascularization for restenosis of the target vessel and MACE (5.7 %) than did the RA group (22.2 %, P = 0.046).

Conclusion: Aggressive plaque preparation with RA and CB seems to be safe and effective for patients with severely calcified coronary lesions.

Trial registration: Current Controlled Trials ChiCTR-INR-16008274 . Retrospectively registered 12 April 2016.

Keywords: Coronary calcification; Cutting balloon; Randomized controlled trial; Rotational atherectomy.

Figures

Fig. 1
Fig. 1
The angiography and intravascular ultrasound (IVUS) images of severe coronary calcification lesion before and after rotational atherectomy, cutting balloon, and stent deployment. A1 and A2, Severe calcific stenosis of the left anterior descending artery; B1 and B2, post-rotablator; C1 and C2, post-cutting balloon; D1 and D2, post-stent

References

    1. Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Genereux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014;63(17):1703–1714. doi: 10.1016/j.jacc.2014.01.017.
    1. Ellis SG, Vandormael MG, Cowley MJ, DiSciascio G, Deligonul U, Topol EJ, Bulle TM. Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection. Multivessel Angioplasty Prognosis Study Group. Circulation. 1990;82(4):1193–1202. doi: 10.1161/01.CIR.82.4.1193.
    1. Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992;86(1):64–70. doi: 10.1161/01.CIR.86.1.64.
    1. Tanigawa J, Barlis P, Di Mario C. Heavily calcified coronary lesions preclude strut apposition despite high pressure balloon dilatation and rotational atherectomy: in-vivo demonstration with optical coherence tomography. Circ J. 2008;72(1):157–160. doi: 10.1253/circj.72.157.
    1. Fujimoto H, Nakamura M, Yokoi H. Impact of calcification on the long-term outcomes of sirolimus-eluting stent implantation: subanalysis of the Cypher Post-Marketing Surveillance Registry. Circ J. 2012;76(1):57–64. doi: 10.1253/circj.CJ-11-0738.
    1. Fujii K, Carlier SG, Mintz GS, Yang YM, Moussa I, Weisz G, Dangas G, Mehran R, Lansky AJ, Kreps EM, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol. 2005;45(7):995–998. doi: 10.1016/j.jacc.2004.12.066.
    1. Kawaguchi R, Tsurugaya H, Hoshizaki H, Toyama T, Oshima S, Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients. Cardiovasc Revasc Med. 2008;9(1):2–8. doi: 10.1016/j.carrev.2007.07.004.
    1. Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revasc Med. 2005;6(4):147–153. doi: 10.1016/j.carrev.2005.08.008.
    1. Mota P, de Belder A, Leitao-Marques A. Rotational atherectomy: Technical update. Rev Port Cardiol. 2015;34(4):271–278.
    1. Tomey MI, Kini AS, Sharma SK. Current status of rotational atherectomy. JACC Cardiovasc Interv. 2014;7(4):345–353. doi: 10.1016/j.jcin.2013.12.196.
    1. Tian W, Lhermusier T, Minha S, Waksman R. Rational use of rotational atherectomy in calcified lesions in the drug-eluting stent era: Review of the evidence and current practice. Cardiovasc Revasc Med. 2015;16(2):78–83. doi: 10.1016/j.carrev.2014.12.011.
    1. Zimarino M, Corcos T, Bramucci E, Tamburino C. Rotational atherectomy: a "survivor" in the drug-eluting stent era. Cardiovasc Revasc Med. 2012;13(3):185–192. doi: 10.1016/j.carrev.2012.03.002.
    1. Sun Y, Jiang J, Zhu G, Li C, Dong L, Liu X, Lyu L, Hu X, Xiang M, Wang J. Efficacy of intravascular ultrasound guided rotational atherectomy for heavily calcified coronary lesions. Zhonghua Xin Xue Guan Bing Za Zhi. 2014;42(7):545–550.
    1. Cui JG, Yang YJ, Wu YJ, Qiao SB, Xu B, Yuan JQ, Chen J, Liu HB, You SJ, Hu FH, et al. Clinical outcomes of rotational atherectomy followed by drug-eluting stenting via the transradial approach for the treatment of heavily calcified coronary lesions. Zhonghua Xin Xue Guan Bing Za Zhi. 2013;41(6):462–465.
    1. Abdel-Wahab M, Baev R, Dieker P, Kassner G, Khattab AA, Toelg R, Sulimov D, Geist V, Richardt G. Long-term clinical outcome of rotational atherectomy followed by drug-eluting stent implantation in complex calcified coronary lesions. Catheter Cardiovasc Interv. 2013;81(2):285–291. doi: 10.1002/ccd.24367.
    1. Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011;124(23):e574–651. doi: 10.1161/CIR.0b013e31823ba622.
    1. Barbato E, Carrie D, Dardas P, Fajadet J, Gaul G, Haude M, Khashaba A, Koch K, Meyer-Gessner M, Palazuelos J, et al. European expert consensus on rotational atherectomy. EuroIntervention. 2015;11(1):30–36. doi: 10.4244/EIJV11I1A6.
    1. Abdel-Wahab M, Richardt G, Joachim Buttner H, Toelg R, Geist V, Meinertz T, Schofer J, King L, Neumann FJ, Khattab AA. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013;6(1):10–19. doi: 10.1016/j.jcin.2012.07.017.
    1. Asakura Y, Furukawa Y, Ishikawa S, Asakura K, Sueyoshi K, Sakamoto M, Takagi S, Takatsuki S, Oyamada K, Okabe T, et al. Successful predilation of a resistant, heavily calcified lesion with cutting balloon for coronary stenting: a case report. Cathet Cardiovasc Diagn. 1998;44(4):420–422. doi: 10.1002/(SICI)1097-0304(199808)44:4<420::AID-CCD13>;2-M.
    1. Karvouni E, Stankovic G, Albiero R, Takagi T, Corvaja N, Vaghetti M, Di Mario C, Colombo A. Cutting balloon angioplasty for treatment of calcified coronary lesions. Catheter Cardiovasc Interv. 2001;54(4):473–481. doi: 10.1002/ccd.1314.
    1. Vaquerizo B, Serra A, Miranda F, Triano JL, Sierra G, Delgado G, Puentes A, Mojal S, Brugera J. Aggressive plaque modification with rotational atherectomy and/or cutting balloon before drug-eluting stent implantation for the treatment of calcified coronary lesions. J Interv Cardiol. 2010;23(3):240–248. doi: 10.1111/j.1540-8183.2010.00547.x.
    1. Agarwal SK, Nadkarni GN, Yacoub R, Patel AA, Jenkins JS, Collins TJ, Annapureddy N, Kumbala D, Bodana S, Benjo AM. Comparison of cutting balloon angioplasty and percutaneous balloon angioplasty of arteriovenous fistula stenosis: a meta-analysis and systematic review of randomized clinical trials. J Interv Cardiol. 2015;28(3):288–295. doi: 10.1111/joic.12202.
    1. Furuichi S, Tobaru T, Asano R, Watanabe Y, Takamisawa I, Seki A, Sumiyoshi T, Tomoike H. Rotational atherectomy followed by cutting-balloon plaque modification for drug-eluting stent implantation in calcified coronary lesions. J Invasive Cardiol. 2012;24(5):191–195.
    1. Hsu JT, Kyo E, Chu CM, Tsuji T, Watanabe S. Impact of calcification length ratio on the intervention for chronic total occlusions. Int J Cardiol. 2011;150(2):135–141. doi: 10.1016/j.ijcard.2010.03.002.
    1. Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Eur Heart J. 2014;35(37):2541–2619. doi: 10.1093/eurheartj/ehu278.
    1. Mintz GS, Nissen SE, Anderson WD, Bailey SR, Erbel R, Fitzgerald PJ, Pinto FJ, Rosenfield K, Siegel RJ, Tuzcu EM, et al. American College of Cardiology Clinical Expert Consensus Document on Standards for Acquisition, Measurement and Reporting of Intravascular Ultrasound Studies (IVUS). A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2001;37(5):1478–1492. doi: 10.1016/S0735-1097(01)01175-5.
    1. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Katus HA, Apple FS, Lindahl B, Morrow DA, et al. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012;60(16):1581–1598. doi: 10.1016/j.jacc.2012.08.001.
    1. Song HG, Kang SJ, Ahn JM, Kim WJ, Lee JY, Park DW, Lee SW, Kim YH, Lee CW, Park SW, et al. Intravascular ultrasound assessment of optimal stent area to prevent in-stent restenosis after zotarolimus-, everolimus-, and sirolimus-eluting stent implantation. Catheter Cardiovasc Interv. 2014;83(6):873–878. doi: 10.1002/ccd.24560.
    1. Palmer ND, Nair RK, Ramsdale DR. Treatment of calcified ostial disease by rotational atherectomy and adjunctive cutting balloon angioplasty prior to stent implantation. Int J Cardiovasc Intervent. 2004;6(3-4):134–136. doi: 10.1080/14628840410030487.

Source: PubMed

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