A randomised comparison of Conventional versus Intentional straTegy in patients with high Risk prEdiction of Side branch OccLusion in coronary bifurcation interVEntion: rationale and design of the CIT-RESOLVE trial

Dong Zhang, Dong Yin, Chenxi Song, Chengang Zhu, Ajay J Kirtane, Bo Xu, Kefei Dou, Dong Zhang, Dong Yin, Chenxi Song, Chengang Zhu, Ajay J Kirtane, Bo Xu, Kefei Dou

Abstract

Introduction: The intentional strategy (aggressive side branch (SB) protection strategy: elective two-stent strategy or jailed balloon technique) is thought to be associated with lower SB occlusion rate than conventional strategy (provisional two-stent strategy or jailed wire technique). However, most previous studies showed comparable outcomes between the two strategies, probably due to no risk classification of SB occlusion when enrolling patients. There is still no randomised trial compared the intentional and conventional strategy when treating bifurcation lesions with high risk of SB occlusion. We aim to investigate if intentional strategy is associated with significant reduction of SB occlusion rate compared with conventional strategy in high-risk patients.

Methods and analysis: The Conventional versus Intentional straTegy in patients with high Risk prEdiction of Side branch OccLusion in coronary bifurcation interVEntion (CIT-RESOLVE) is a prospective, randomised, single-blind, multicentre clinical trial comparing the rate of SB occlusion between the intentional strategy group and the conventional strategy group (positive control group) in a consecutive cohort of patients with high risk of side branch occlusion defined by V-RESOLVE score, which is a validated angiographic scoring system to evaluate the risk of SB occlusion in bifurcation intervention and used as one of the inclusion criteria to select patients with high SB occlusion risk (V-RESOLVE score ≥12). A total of 21 hospitals from 10 provinces in China participated in the present study. 566 patients meeting all inclusion/exclusion criteria are randomised to either intentional strategy group or conventional strategy group. The primary endpoint is SB occlusion (defined as any decrease in thrombolysis in myocardial infarction flow grade or absence of flow in SB after main vessel stenting). All patients are followed up for 12-month postdischarge.

Ethics and dissemination: The protocol has been approved by all local ethics committee. The ethics committee have approved the study protocol, evaluated the risk to benefit ratio, allowed operators with a minimum annual volume of 200 cases to participate in the percutaneous coronary intervention procedure and permitted them to perform both conventional and intentional strategies. Written informed consent would be acquired from all participants. The findings of the trial will be shared by the participant hospitals and disseminated through peer-reviewed journals.

Trial registration number: NCT02644434; Pre-results.

Keywords: conventional strategy; coronary bifurcation intervention; intentional strategy; randomized comparison; side branch occlusion.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Study flowchart screening, randomisation, intervention, procedure, study endpoint and follow-up of CIT-RESOLVE trial. CIT-RESOLVE, Conventional versus Intentional straTegy in patients with high Risk prEdiction of Side branch OccLusion in coronary bifurcation interVEntion.

References

    1. Iakovou I, Schmidt T, Bonizzoni E, et al. . Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005;293:2126–30. 10.1001/jama.293.17.2126
    1. Steigen TK, Maeng M, Wiseth R, et al. . Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation 2006;114:1955–61. 10.1161/CIRCULATIONAHA.106.664920
    1. Latib A, Colombo A. Bifurcation disease: what do we know, what should we do? JACC Cardiovasc Interv 2008;1:218–26. 10.1016/j.jcin.2007.12.008
    1. Singh J, Patel Y, Depta JP, et al. . A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the "jailed-balloon technique". J Interv Cardiol 2012;25:289–96. 10.1111/j.1540-8183.2011.00716.x
    1. Burzotta F, Trani C, Sianos G. Jailed balloon protection: a new technique to avoid acute side-branch occlusion during provisional stenting of bifurcated lesions. Bench test report and first clinical experience. EuroIntervention 2010;5:809–13. 10.4244/EIJV5I7A135
    1. Chen SL, Santoso T, Zhang JJ, et al. . A randomized clinical study comparing double kissing crush with provisional stenting for treatment of coronary bifurcation lesions: results from the DKCRUSH-II (Double Kissing Crush versus Provisional Stenting Technique for treatment of coronary bifurcation lesions) trial. J Am Coll Cardiol 2011;57:914–20. 10.1016/j.jacc.2010.10.023
    1. Généreux P, Kumsars I, Lesiak M, et al. . A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions. J Am Coll Cardiol 2015;65:533–43. 10.1016/j.jacc.2014.11.031
    1. Abdel-Latif A, Moliterno DJ. Bifurcation stenting techniques and outcomes in patients with stable coronary artery disease: more evidence suggesting simpler is safer. JACC Cardiovasc Interv 2015;8:561–3. 10.1016/j.jcin.2015.02.004
    1. Dou K, Zhang D, Xu B, et al. . An angiographic tool for risk prediction of side branch occlusion in coronary bifurcation intervention: the RESOLVE score system (Risk prEdiction of Side branch OccLusion in coronary bifurcation interVEntion). JACC Cardiovasc Interv 2015;8:39–46. 10.1016/j.jcin.2014.08.011
    1. Kralev S, Poerner TC, Basorth D, et al. . Side branch occlusion after coronary stent implantation in patients presenting with ST-elevation myocardial infarction: clinical impact and angiographic predictors. Am Heart J 2006;151:153–7. 10.1016/j.ahj.2005.01.034
    1. Aliabadi D, Tilli FV, Bowers TR, et al. . Incidence and angiographic predictors of side branch occlusion following high-pressure intracoronary stenting. Am J Cardiol 1997;80:994–7. 10.1016/S0002-9149(97)00591-2
    1. Hahn JY, Chun WJ, Kim JH, et al. . Predictors and outcomes of side branch occlusion after main vessel stenting in coronary bifurcation lesions: results from the COBIS II Registry (COronary BIfurcation stenting). J Am Coll Cardiol 2013;62:1654–9. 10.1016/j.jacc.2013.07.041
    1. Muramatsu T, Onuma Y, García-García HM, et al. . Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv 2013;6:247–57. 10.1016/j.jcin.2012.10.013
    1. Dou K, Zhang D, Xu B, et al. . An angiographic tool based on visual estimation for risk prEdiction of Side branch OccLusion in coronary bifurcation interVEntion: the V-RESOLVE score system. EuroIntervention 2016;11:e1604–e1611. 10.4244/EIJV11I14A311
    1. Colombo A, Ruparelia N. When you ask yourself the question "should I protect the side branch?": the answer is "yes". JACC Cardiovasc Interv 2015;8:47–8. 10.1016/j.jcin.2014.11.007
    1. Chen SL, Ye F, Zhang JJ, et al. . [DK crush technique: modified treatment of bifurcation lesions in coronary artery]. Chinese Med J 2005;118:1746–50.
    1. Lim PO, Dzavík V. Balloon crush: treatment of bifurcation lesions using the crush stenting technique as adapted for transradial approach of percutaneous coronary intervention. Catheter Cardiovasc Interv 2004;63:412–6. 10.1002/ccd.20179
    1. Colombo A, Moses JW, Morice MC, et al. . Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation 2004;109:1244–9. 10.1161/01.CIR.0000118474.71662.E3
    1. Adriaenssens T, Byrne RA, Dibra A, et al. . Culotte stenting technique in coronary bifurcation disease: angiographic follow-up using dedicated quantitative coronary angiographic analysis and 12-month clinical outcomes. Eur Heart J 2008;29:2868–76. 10.1093/eurheartj/ehn512
    1. Sheiban I, Albiero R, Marsico F, et al. . Immediate and long-term results of "T" stenting for bifurcation coronary lesions. Am J Cardiol 2000;85:1141–4. 10.1016/S0002-9149(00)00712-8
    1. Moussa ID, Klein LW, Shah B, et al. . Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol 2013;62:1563–70. 10.1016/j.jacc.2013.08.720
    1. Thygesen K, Alpert JS, Jaffe AS, et al. . Third universal definition of myocardial infarction. J Am Coll Cardiol 2012;60:1581–98. 10.1016/j.jacc.2012.08.001
    1. Cutlip DE, Windecker S, Mehran R, et al. . Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344–51. 10.1161/CIRCULATIONAHA.106.685313
    1. Maeng M, Holm NR, Erglis A, et al. . Long-term results after simple versus complex stenting of coronary artery bifurcation lesions: nordic Bifurcation Study 5-year follow-up results. J Am Coll Cardiol 2013;62:30–4. 10.1016/j.jacc.2013.04.015
    1. Sirker A, Sohal M, Oldroyd K, et al. . The impact of coronary bifurcation stenting strategy on health-related functional status: a quality-of-life analysis from the BBC one (British Bifurcation Coronary; Old, New, and Evolving strategies) study. JACC Cardiovasc Interv 2013;6:139–45. 10.1016/j.jcin.2012.10.010
    1. Song YB, Hahn JY, Song PS, et al. . Randomized comparison of conservative versus aggressive strategy for provisional side branch intervention in coronary bifurcation lesions: results from the SMART-STRATEGY (Smart Angioplasty Research Team-Optimal Strategy for Side Branch intervention in coronary bifurcation lesions) randomized trial. JACC Cardiovasc Interv 2012;5:1133–40. 10.1016/j.jcin.2012.07.010
    1. Behan MW, Holm NR, Curzen NP, et al. . Simple or complex stenting for bifurcation coronary lesions: a patient-level pooled-analysis of the nordic bifurcation study and the British bifurcation coronary study. Circ Cardiovasc Interv 2011;4:57–64. 10.1161/CIRCINTERVENTIONS.110.958512
    1. Lin QF, Luo YK, Lin CG, et al. . Choice of stenting strategy in true coronary artery bifurcation lesions. Coron Artery Dis 2010;21:345–51. 10.1097/MCA.0b013e32833ce04c
    1. Hildick-Smith D, de Belder AJ, Cooter N, et al. . Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the british bifurcation coronary study: old, new, and evolving strategies. Circulation 2010;121:1235–43. 10.1161/CIRCULATIONAHA.109.888297
    1. Jensen JS, Galløe A, Lassen JF, et al. . Safety in simple versus complex stenting of coronary artery bifurcation lesions. the nordic bifurcation study 14-month follow-up results. EuroIntervention 2008;4:229–33. 10.4244/EIJV4I2A41
    1. Colombo A, Bramucci E, Saccà S, et al. . Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations: the CACTUS (Coronary bifurcations: application of the Crushing Technique using Sirolimus-Eluting stents) Study. Circulation 2009;119:71–8. 10.1161/CIRCULATIONAHA.108.808402
    1. Ferenc M, Gick M, Kienzle RP, et al. . Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions. Eur Heart J 2008;29:2859–67. 10.1093/eurheartj/ehn455
    1. Pan M, de Lezo JS, Medina A, et al. . Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy. Am Heart J 2004;148:857–64. 10.1016/j.ahj.2004.05.029
    1. Park TK, Park YH, Song YB, et al. . Long-Term clinical outcomes of true and Non-True bifurcation lesions according to Medina classification- Results from the COBIS (COronary BIfurcation stent) II registry. Circ J 2015;79:1954–62. 10.1253/circj.CJ-15-0264
    1. Chen X, Zhang D, Yin D, et al. . Can "true bifurcation lesion" actually be regarded as an independent risk factor of acute side branch occlusion after main vessel stenting?: A retrospective analysis of 1,200 consecutive bifurcation lesions in a single center. Catheter Cardiovasc Interv 2016;87(Suppl 1):554–63. 10.1002/ccd.26403
    1. Medina A, Suárez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol 2006;59:183.
    1. Y-Hassan S, Lindroos MC, Sylvén C. A novel descriptive, intelligible and ordered (DINO) classification of coronary bifurcation lesions. review of current classifications. Circ J 2011;75:299–305.
    1. Movahed MR, Stinis CT. A new proposed simplified classification of coronary artery bifurcation lesions and bifurcation interventional techniques. J Invasive Cardiol 2006;18:99–204. 10.1016/j.carrev.2006.03.040
    1. Lefèvre T, Louvard Y, Morice MC, et al. . Stenting of bifurcation lesions: classification, treatments, and results. Catheter Cardiovasc Interv 2000;49:274–83. 10.1002/(SICI)1522-726X(200003)49:3<274::AID-CCD11>;2-N
    1. Popma J, Bashore T. Qualitative and quantitative angiography—Bifurcation lesions. Textbook of interventional cardiology. Philadelphia: WB Saunders, 1994:1055–8.
    1. George BS, Myler RK, Stertzer SH, et al. . Balloon angioplasty of coronary bifurcation lesions: the kissing balloon technique. Cathet Cardiovasc Diagn 1986;12:124–38. 10.1002/ccd.1810120212
    1. Tsuchida K, Colombo A, Lefèvre T, et al. . The clinical outcome of percutaneous treatment of bifurcation lesions in multivessel coronary artery disease with the sirolimus-eluting stent: insights from the arterial revascularization therapies Study part II (ARTS II). Eur Heart J 2007;28:433–42. 10.1093/eurheartj/ehl539
    1. RDS. Bifurcation lesions. the manual of interventional cardiology. 2001:233–43.
    1. Dauerman HL, Higgins PJ, Sparano AM, et al. . Mechanical debulking versus balloon angioplasty for the treatment of true bifurcation lesions. J Am Coll Cardiol 1998;32:1845–52. 10.1016/S0735-1097(98)00488-4
    1. Al Suwaidi J, Berger PB, Rihal CS, et al. . Immediate and long-term outcome of intracoronary stent implantation for true bifurcation lesions. J Am Coll Cardiol 2000;35:929–36. 10.1016/S0735-1097(99)00648-8

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