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Research Article| Volume 250, P80-85, January 01, 2018

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Provisional versus elective two-stent strategy for unprotected true left main bifurcation lesions: Insights from a FAILS-2 sub-study

Published:October 05, 2017DOI:https://doi.org/10.1016/j.ijcard.2017.09.207

      Abstract

      Background

      This study sought to investigate the optimal percutaneous coronary intervention (PCI) strategy for true unprotected left main coronary artery (ULMCA) bifurcations.

      Methods

      The FAILS-2 was a retrospective multi-center study including patients with ULMCA disease treated with second-generation drug-eluting stents. Of these, we compared clinical outcomes of a provisional strategy (PS; n = 216) versus an elective two-stent strategy (E2S; n = 161) for true ULMCA bifurcations. The primary endpoint was the incidence of major adverse cardiac events (MACEs) at 3-years. We further performed propensity-score adjustment for clinical outcomes.

      Results

      There were no significant differences between the groups in terms of patient and lesion characteristics. 9.7% of patients in the PS group crossed over to a provisional two-stent strategy. MACEs were not significantly different between groups (MACE at 3-year; PS 28.1% vs. E2S 28.9%, adjusted p = 0.99). The rates of target lesion revascularization (TLR) on the circumflex artery (LCX) were numerically high in the E2S group (LCX-TLR at 3-years; PS 11.8% vs. E2S 16.6%, adjusted p = 0.51).

      Conclusions

      E2S was associated with a comparable MACE rate to PS for true ULMCA bifurcations. The rates of LCX-TLR tended to be higher in the E2S group although there was no statistical significance.

      Condensed abstract

      This study sought to compare the clinical outcomes of a provisional strategy (PS) with an elective two-stent strategy (E2S) for the treatment of true unprotected left main coronary artery bifurcations. 377 Patients (PS 216 vs. E2S 161 patients) were evaluated, and 9.7% in the PS group crossed over to a two-stent strategy. E2S was associated with a similar major adverse cardiac event rate at 3-years when compared to the PS strategy (PS 28.1% vs. E2S 28.9%, p = 0.99). However, the left circumflex artery TLR rate at 3-year tended to be higher in the E2S group (PS 11.8% vs. E2S 16.6%, p = 0.51).

      Abbreviations:

      ULMCA (unprotected left main coronary artery), PS (provisional stenting strategy), E2S (elective two-stent strategy), MACEs (major adverse cardiac events), TLR (target lesion revascularization)

      Keywords

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      References

        • Windecker S.
        • Kolh P.
        • Alfonso F.
        • Collet J.P.
        • Cremer J.
        • Falk V.
        • et al.
        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: 2541-2619
        • Naganuma T.
        • Chieffo A.
        • Meliga E.
        • Capodanno D.
        • Park S.J.
        • Onuma Y.
        • et al.
        Long-term clinical outcomes after percutaneous coronary intervention versus coronary artery bypass grafting for ostial/midshaft lesions in unprotected left main coronary artery from the DELTA registry: a multicenter registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment.
        J. Am. Coll. Cardiol. Intv. 2014; 7: 354-361
        • Park D.W.
        • Seung K.B.
        • Kim Y.H.
        • Lee J.Y.
        • Kim W.J.
        • Kang S.J.
        • et al.
        Long-term safety and efficacy of stenting versus coronary artery bypass grafting for unprotected left main coronary artery disease: 5-year results from the MAIN-COMPARE (revascularization for unprotected left main coronary artery stenosis: comparison of percutaneous coronary angioplasty versus surgical revascularization) registry.
        J. Am. Coll. Cardiol. 2010; 56: 117-124
        • Chieffo A.
        • Park S.J.
        • Valgimigli M.
        • Kim Y.H.
        • Daemen J.
        • Sheiban I.
        • et al.
        Favorable long-term outcome after drug-eluting stent implantation in nonbifurcation lesions that involve unprotected left main coronary artery: a multicenter registry.
        Circulation. 2007; 116: 158-162
        • Palmerini T.
        • Sangiorgi D.
        • Marzocchi A.
        • Tamburino C.
        • Sheiban I.
        • Margheri M.
        • et al.
        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.
        Eur. Heart J. 2009; 30: 2087-2094
        • Tiroch K.
        • Mehilli J.
        • Byrne R.A.
        • Schulz S.
        • Massberg S.
        • Laugwitz K.L.
        • et al.
        Impact of coronary anatomy and stenting technique on long-term outcome after drug-eluting stent implantation for unprotected left main coronary artery disease.
        J. Am. Coll. Cardiol. Intv. 2014; 7: 29-36
        • Chieffo A.
        • Meliga E.
        • Latib A.
        • Park S.J.
        • Onuma Y.
        • Capranzano P.
        • et al.
        Drug-eluting stent for left main coronary artery disease. The DELTA registry: a multicenter registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment.
        J. Am. Coll. Cardiol. Intv. 2012; 5: 718-727
        • Colombo A.
        • Moses J.W.
        • Morice M.C.
        • Ludwig J.
        • Holmes Jr., D.R.
        • Spanos V.
        • et al.
        Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions.
        Circulation. 2004; 109: 1244-1249
        • Kimura T.
        • Morimoto T.
        • Nakagawa Y.
        • Kawai K.
        • Miyazaki S.
        • Muramatsu T.
        • et al.
        Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry.
        Circulation. 2012; 125: 584-591
        • Song Y.B.
        • Hahn J.Y.
        • Yang J.H.
        • Choi S.H.
        • Choi J.H.
        • Lee S.H.
        • et al.
        Differential prognostic impact of treatment strategy among patients with left main versus non-left main bifurcation lesions undergoing percutaneous coronary intervention: results from the COBIS (Coronary Bifurcation Stenting) Registry II.
        J. Am. Coll. Cardiol. Intv. 2014; 7: 255-263
        • Toyofuku M.
        • Kimura T.
        • Morimoto T.
        • Hayashi Y.
        • Ueda H.
        • Kawai K.
        • et al.
        Three-year outcomes after sirolimus-eluting stent implantation for unprotected left main coronary artery disease: insights from the j-Cypher registry.
        Circulation. 2009; 120: 1866-1874
        • Hildick-Smith D.
        • Behan M.W.
        • Lassen J.F.
        • Chieffo A.
        • Lefevre T.
        • Stankovic G.
        • et al.
        The EBC TWO Study (European Bifurcation Coronary TWO): a randomized comparison of provisional T-stenting versus a systematic 2 stent culotte strategy in large caliber true bifurcations.
        Circ. Cardiovasc. Interv. 2016; 9https://doi.org/10.1161/CIRCINTERVENTIONS.115.003643
        • D'Ascenzo F.
        • Iannaccone M.
        • Giordana F.
        • Chieffo A.
        • Connor S.O.
        • Napp L.C.
        • et al.
        Provisional vs. two-stent technique for unprotected left main coronary artery disease after ten years follow up: a propensity matched analysis.
        Int. J. Cardiol. 2016; 211: 37-42
        • Chieffo A.
        • Hildick-Smith D.
        The European Bifurcation Club Left Main Study (EBC MAIN): rationale and design of an international, multicentre, randomised comparison of two stent strategies for the treatment of left main coronary bifurcation disease.
        EuroIntervention. 2016; 12: 47-52
        • D'Ascenzo F.
        • Chieffo A.
        • Cerrato E.
        • Ugo F.
        • Pavani M.
        • Kawamoto H.
        • et al.
        Incidence and management of restenosis after treatment of unprotected left main disease with second-generation drug-eluting stents (from failure in left main study with 2nd generation stents-cardiogroup III study).
        Am. J. Cardiol. 2017; 119: 978-982
        • Medina A.
        • Suarez de Lezo J.
        • Pan M.
        A new classification of coronary bifurcation lesions.
        Rev. Esp. Cardiol. 2006; 59: 183
        • Thygesen K.
        • Alpert J.S.
        • Jaffe A.S.
        • Simoons M.L.
        • Chaitman B.R.
        • White H.D.
        • et al.
        Third universal definition of myocardial infarction.
        Eur. Heart J. 2012; 33: 2551-2567
        • Laskey W.K.
        • Yancy C.W.
        • Maisel W.H.
        Thrombosis in coronary drug-eluting stents: report from the meeting of the Circulatory System Medical Devices Advisory Panel of the Food and Drug Administration Center for Devices and Radiologic Health, December 7–8, 2006.
        Circulation. 2007; 115: 2352-2357
        • D'Agostino Jr., R.B.
        Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group.
        Stat. Med. 1998; 17: 2265-2281
        • Rubin D.B.
        Estimating causal effects from large data sets using propensity scores.
        Ann. Intern. Med. 1997; 127: 757-763
        • Lassen J.F.
        • Holm N.R.
        • Banning A.
        • Burzotta F.
        • Lefevre T.
        • Chieffo A.
        • et al.
        Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club.
        EuroIntervention. 2016; 12: 38-46
        • Takagi K.
        • Naganuma T.
        • Chieffo A.
        • Fujino Y.
        • Latib A.
        • Tahara S.
        • et al.
        Comparison between 1- and 2-stent strategies in unprotected distal left main disease: the Milan and New-Tokyo registry.
        Circ. Cardiovasc. Interv. 2016; 9https://doi.org/10.1161/CIRCINTERVENTIONS.116.003359
        • Amemiya K.
        • Domei T.
        • Iwabuchi M.
        • Shirai S.
        • Ando K.
        • Goya M.
        • et al.
        Impact of the bifurcation angle on major cardiac events after cross-over single stent strategy in unprotected left main bifurcation lesions: 3-dimensional quantitative coronary angiographic analysis.
        Am. J. Cardiovasc. Dis. 2014; 4: 168-176
        • Girasis C.
        • Farooq V.
        • Diletti R.
        • Muramatsu T.
        • Bourantas C.V.
        • Onuma Y.
        • et al.
        Impact of 3-dimensional bifurcation angle on 5-year outcome of patients after percutaneous coronary intervention for left main coronary artery disease: a substudy of the SYNTAX trial (synergy between percutaneous coronary intervention with taxus and cardiac surgery).
        J. Am. Coll. Cardiol. Intv. 2013; 6: 1250-1260
        • Kim Y.H.
        • Park D.W.
        • Lee S.W.
        • Yun S.C.
        • Lee C.W.
        • Hong M.K.
        • et al.
        Long-term safety and effectiveness of unprotected left main coronary stenting with drug-eluting stents compared with bare-metal stents.
        Circulation. 2009; 120: 400-407
        • Palmerini T.
        • Marzocchi A.
        • Tamburino C.
        • Sheiban I.
        • Margheri M.
        • Vecchi G.
        • et al.
        Impact of bifurcation technique on 2-year clinical outcomes in 773 patients with distal unprotected left main coronary artery stenosis treated with drug-eluting stents.
        Circ. Cardiovasc. Interv. 2008; 1: 185-192
        • Kang S.J.
        • Ahn J.M.
        • Song H.
        • Kim W.J.
        • Lee J.Y.
        • Park D.W.
        • et al.
        Comprehensive intravascular ultrasound assessment of stent area and its impact on restenosis and adverse cardiac events in 403 patients with unprotected left main disease.
        Circ. Cardiovasc. Interv. 2011; 4: 562-569
        • Carrie D.
        • Eltchaninoff H.
        • Lefevre T.
        • Silvestri M.
        • Brunel P.
        • Fajadet J.
        • et al.
        Early and long-term results of unprotected left main coronary artery stenosis with paclitaxel-eluting stents: the FRIEND (French multicentre RegIstry for stenting of uNprotecteD LMCA stenosis) registry.
        EuroIntervention. 2011; 7: 680-688
        • Chen S.L.
        • Santoso T.
        • Zhang J.J.
        • Ye F.
        • YW Xu
        • Fu Q.
        • 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: 914-920
        • Colombo A.
        • Bramucci E.
        • Sacca S.
        • Violini R.
        • Lettieri C.
        • Zanini R.
        • 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: 71-78
        • Morice M.C.
        • Feldman T.E.
        • Mack M.J.
        • Stahle E.
        • Holmes D.R.
        • Colombo A.
        • et al.
        Angiographic outcomes following stenting or coronary artery bypass surgery of the left main coronary artery: fifteen-month outcomes from the synergy between PCI with TAXUS express and cardiac surgery left main angiographic substudy (SYNTAX-LE MANS).
        EuroIntervention. 2011; 7: 670-679
        • Salvatella N.
        • Morice M.C.
        • Darremont O.
        • Tafflet M.
        • Garot P.
        • Leymarie J.L.
        • et al.
        Unprotected left main stenting with a second-generation drug-eluting stent: one-year outcomes of the LEMAX pilot study.
        EuroIntervention. 2011; 7: 689-696
        • Koo B.K.
        • Park K.W.
        • Kang H.J.
        • Cho Y.S.
        • Chung W.Y.
        • Youn T.J.
        • et al.
        Physiological evaluation of the provisional side-branch intervention strategy for bifurcation lesions using fractional flow reserve.
        Eur. Heart J. 2008; 29: 726-732
        • Morice M.C.
        • Serruys P.W.
        • Kappetein A.P.
        • Feldman T.E.
        • Stahle E.
        • Colombo A.
        • et al.
        Five-year outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the synergy between percutaneous coronary intervention with taxus and cardiac surgery trial.
        Circulation. 2014; 129: 2388-2394
        • Kim Y.H.
        • Park D.W.
        • Ahn J.M.
        • Yun S.C.
        • Song H.G.
        • Lee J.Y.
        • et al.
        Everolimus-eluting stent implantation for unprotected left main coronary artery stenosis. The PRECOMBAT-2 (premier of randomized comparison of bypass surgery versus angioplasty using sirolimus-eluting stent in patients with left main coronary artery disease) study.
        J. Am. Coll. Cardiol. Intv. 2012; 5: 708-717
        • Takagi K.
        • Ielasi A.
        • Shannon J.
        • Latib A.
        • Godino C.
        • Davidavicius G.
        • et al.
        Clinical and procedural predictors of suboptimal outcome after the treatment of drug-eluting stent restenosis in the unprotected distal left main stem: the Milan and New-Tokyo (MITO) registry.
        Circ. Cardiovasc. Interv. 2012; 5: 491-498
        • Park S.J.
        • Kim Y.H.
        • Park D.W.
        • Lee S.W.
        • Kim W.J.
        • Suh J.
        • et al.
        Impact of intravascular ultrasound guidance on long-term mortality in stenting for unprotected left main coronary artery stenosis.
        Circ. Cardiovasc. Interv. 2009; 2: 167-177
        • Fujino Y.
        • Attizzani G.F.
        • Bezerra H.G.
        • Wang W.
        • Tahara S.
        • Yamamoto H.
        • et al.
        Serial assessment of vessel interactions after drug-eluting stent implantation in unprotected distal left main coronary artery disease using frequency-domain optical coherence tomography.
        J. Am. Coll. Cardiol. Intv. 2013; 6: 1035-1045
        • Fujino Y.
        • Bezerra H.G.
        • Attizzani G.F.
        • Wang W.
        • Yamamoto H.
        • Chamie D.
        • et al.
        Frequency-domain optical coherence tomography assessment of unprotected left main coronary artery disease-a comparison with intravascular ultrasound.
        Catheter. Cardiovasc. Interv. 2013; 82: E173-83

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