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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.
The EBC DCB study is an investigator-initiated, prospective, multi-centre, open-label, randomized (1:1) non-inferiority trial.
Patients with non-left main bifurcations requiring revascularisation and both the main vessel and side branch significantly diseased ( ≥2.5mm and Medina 1/1/1, 1/0/1 or 0/1/1), constitute the source population. Patients with no more than two additional coronary disease may be considered for the study, with only one bifurcation lesion included.
Patients, pre-selected by their referring physicians, will be screened for eligibility by the study team. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. 20 sites will be involved, in 7 European countries and South Korea, for a total of 750 patients. After a 2-years recruitment period, the trial will include a Follow-Up period at 6-months, 1-year, 3-years, 5-years and 8-years. The 1-year check point will constitute the primary endpoint where the Bifurcation Orientated Composite Endpoint (BOCE) will be analyzed for non-inferiority (further analysis for superiority, if non-inferiority met).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepwise Provisional Stent Strategy | Active Comparator | Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). Stenting of the MV is undertaken with a wire jailed in the SB to preserve SB flow and access. Stent diameter is chosen according to the diameter of the distal MV. Following stent deployment, the stent portion in the proximal MV is dilated with a short non-compliant balloon (POT technique) to achieve full expansion and apposition. Finally, after POT technique, SB is rewired and a kissing balloon inflation (KBI) is undertaken to address any plaque or carina shift and to open stent struts. Thus, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure. Further SB treatment is required only if <TIMI 3 flow, significant stenosis >70% or significant dissection. Thus, a side vessel stent implantation followed with KBI are mandatory. |
|
| Drug Coated Balloon Strategy | Experimental | Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). If residual stenosis remains >30%, or TIMI flow<3, or dissection propagation, the stenting of the MV is mandatory. Otherwise, a paclitaxel-drug coated balloon (DCB) is inflated in the prepared SB for 60 seconds at nominal pressure. If residual stenosis remains >50%, or TIMI flow<3, or dissection propagation, the operator will decide between prolonged balloon dilatation (1-2 minutes) or stent implantation, in the SB. After SB treatment, MV is treated with a DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds. If result is unacceptable, MV stenting followed with kissing balloon inflation and DCB or stent implantation into SB, are mandatory. The procedure is complete when the MV has residual stenosis <30%, has TIMI 3 flow and has no dissection propagation ; when the SB has residual stenosis <50%, has TIMI 3 flow and has no dissection propagation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Angioplasty | Procedure | A Percutaneous Coronary Intervention is used in both arms, with the drug Zotarolimus for stenting strategy and Paclitaxel for balloon strategy. Coronary guide wires are passed into both the distal main vessel (distal MV) and side branch (SB) and predilation of MV on a 1:1 basis is required. The device component dilates the vessel lumen by Percutaneous Transluminal Coronary Angioplasty (PTCA), while the drug is intended to reduce the proliferative response associated with restenosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Bifurcation Orientated Composite Endpoint (BOCE) | The BOCE is defined by:
| At 1-year, after the day of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Bifurcation Orientated Composite Endpoint (BOCE) | BOCE non-inferiority and superiority | At 3, 5 and 8-years |
| Individual components of the Primary Endpoint |
|
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Inclusion Criteria:
True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1/1/1, 1/0/1, 0/1/1)
Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following:
Significant SB as described by diameter stenosis ≥50% and all of the following:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Basile GRAVEZ, PhD | Contact | +33 (0)789452048 | bgravez@cerc-europe.org | |
| Laure MORSIANI, PhD | Contact | +33 (0)176739236 | lmorsiani@cerc-europe.org |
| Name | Affiliation | Role |
|---|---|---|
| David HILDICK-SMITH, Prof., MD | Brighton & Sussex University NHS Hospitals Trust - Royal Sussex County Hospital - Eastern Road - Brighton, East Sussex - BN25BE, United Kingdom | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30170854 | Background | Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28. | |
| 26457558 |
| Label | URL |
|---|---|
| U.S. Food and Drug Administration. Medtronic Resolute Onyx Stent - Premarket Approval (PMA) | View source |
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Post-market study to compare Drug Coated Balloon versus Drug Eluted Stent.
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|
| Stepwise Provisional Stent Strategy | Device | In the stepwise provisional stent strategy, stenting of the MV is undertaken with a wire jailed in the SB. Then, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure (kissing balloon inflation ; KBI). |
|
| Drug Coated Balloon Strategy | Device | In the drug coated balloon (DCB) strategy, SB is prepared with a balloon at a 1:1 diameter, followed with a 1:1 sized DCB inflation for 60 seconds at nominal pressure. Then, MV is re-evaluated and treated with DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds. |
|
| Cross-Over Stepwise Provisional Stent Strategy | Device | Following Drug Coated Balloon treatment in the Main vessel (MV) in the Drug Coated Balloon Arm, if the result is unacceptable in the MV, with either TIMI>3 flow and/or dissection propagation, MV stenting is mandatory followed with Kissing Balloon Inflation (KBI), where non-compliant balloons sized to the diameter of the distal main and side branch are sequentially inflated at high pressure, and then simultaneously at low pressure. If the cross-over stent implantation in the MV is used, a further SB treatment with either DCB or stent implantation is used, according to operator preference. |
|
| At 1, 3, 5 and 8-years |
| Safety Composite Endpoint | - Safety Composite Endpoint defined as:
| At 1, 3, 5 and 8-years |
| Individual components of the Safety Composite Endpoint |
| At 1, 3, 5 and 8-years |
| BARC 3 or 5 bleeding rate | BARC 3 or 5 bleeding rate | At 1, 3, 5 and 8-years |
| Angina status | Questionnaire: Seattle Angina Questionnaire - 7 (SAQ-7) Scale Range (Minimum and Maximum Values): 0 to 100 Higher scores indicate a better outcome (better health status, less angina, and better quality of life). | At 1, 3, 5 and 8-years |
| Angina index | No. of antianginals | At 1, 3, 5 and 8-years |
| Background |
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| 16003787 | Background | Ormiston JA, Webster MW, El Jack S, Ruygrok PN, Stewart JT, Scott D, Currie E, Panther MJ, Shaw B, O'Shaughnessy B. Drug-eluting stents for coronary bifurcations: bench testing of provisional side-branch strategies. Catheter Cardiovasc Interv. 2006 Jan;67(1):49-55. doi: 10.1002/ccd.20453. |
| 35595676 | Background | Ninomiya K, Serruys PW, Garg S, Gao C, Masuda S, Lunardi M, Lassen JF, Banning AP, Colombo A, Burzotta F, Morice MC, Mack MJ, Holmes DR, Davierwala PM, Thuijs DJFM, van Klaveren D, Onuma Y; SYNTAX Extended Survival Investigators. Predicted and Observed Mortality at 10 Years in Patients With Bifurcation Lesions in the SYNTAX Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1231-1242. doi: 10.1016/j.jcin.2022.04.025. Epub 2022 May 17. |
| 35570753 | Background | Lassen JF, Albiero R, Johnson TW, Burzotta F, Lefevre T, Iles TL, Pan M, Banning AP, Chatzizisis YS, Ferenc M, Dzavik V, Milasinovic D, Darremont O, Hildick-Smith D, Louvard Y, Stankovic G. Treatment of coronary bifurcation lesions, part II: implanting two stents. The 16th expert consensus document of the European Bifurcation Club. EuroIntervention. 2022 Aug 19;18(6):457-470. doi: 10.4244/EIJ-D-22-00166. |
| 35866256 | Background | Hildick-Smith D, Arunothayaraj S, Stankovic G, Chen SL. Percutaneous coronary intervention of bifurcation lesions. EuroIntervention. 2022 Jul 22;18(4):e273-e291. doi: 10.4244/EIJ-D-21-01065. |
| 35570748 | Background | Albiero R, Burzotta F, Lassen JF, Lefevre T, Banning AP, Chatzizisis YS, Johnson TW, Ferenc M, Pan M, Daremont O, Hildick-Smith D, Chieffo A, Louvard Y, Stankovic G. Treatment of coronary bifurcation lesions, part I: implanting the first stent in the provisional pathway. The 16th expert consensus document of the European Bifurcation Club. EuroIntervention. 2022 Aug 5;18(5):e362-e376. doi: 10.4244/EIJ-D-22-00165. |
| 32579300 | Background | Burzotta F, Lassen JF, Louvard Y, Lefevre T, Banning AP, Daremont O, Pan M, Hildick-Smith D, Chieffo A, Chatzizisis YS, Dzavik V, Gwon HC, Hikichi Y, Murasato Y, Koo BK, Chen SL, Serruys P, Stankovic G. European Bifurcation Club white paper on stenting techniques for patients with bifurcated coronary artery lesions. Catheter Cardiovasc Interv. 2020 Nov;96(5):1067-1079. doi: 10.1002/ccd.29071. Epub 2020 Jun 24. |
| 29061550 | Background | Lassen JF, Burzotta F, Banning AP, Lefevre T, Darremont O, Hildick-Smith D, Chieffo A, Pan M, Holm NR, Louvard Y, Stankovic G. Percutaneous coronary intervention for the left main stem and other bifurcation lesions: 12th consensus document from the European Bifurcation Club. EuroIntervention. 2018 Jan 20;13(13):1540-1553. doi: 10.4244/EIJ-D-17-00622. |
| 21930492 | Background | Hildick-Smith D, Lassen JF, Koo BK. One or two stents for coronary bifurcation lesions? EuroIntervention. 2010 Dec;6 Suppl J:J61-4. No abstract available. |
| 30165437 | Background | Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. |
| 26649651 | Background | Grundeken MJ, Wykrzykowska JJ, Ishibashi Y, Garg S, de Vries T, Garcia-Garcia HM, Onuma Y, de Winter RJ, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Meier B, Juni P, Yazdani A, Copt S, Windecker S, Serruys PW. First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial. Catheter Cardiovasc Interv. 2016 Jun;87(7):E248-60. doi: 10.1002/ccd.26344. Epub 2015 Dec 9. |
| 11356386 | Background | Al Suwaidi J, Yeh W, Cohen HA, Detre KM, Williams DO, Holmes DR Jr. Immediate and one-year outcome in patients with coronary bifurcation lesions in the modern era (NHLBI dynamic registry). Am J Cardiol. 2001 May 15;87(10):1139-44. doi: 10.1016/s0002-9149(01)01482-5. |
| 17060387 | Background | Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemela M, Kervinen K, Jensen JS, Galloe A, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Lassen JF, Thuesen L; Nordic PCI Study Group. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation. 2006 Oct 31;114(18):1955-61. doi: 10.1161/CIRCULATIONAHA.106.664920. Epub 2006 Oct 23. |
| 16540043 | Background | Medina A, Suarez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006 Feb;59(2):183. No abstract available. Spanish. |
| 27173860 | Background | Lassen JF, Holm NR, Banning A, Burzotta F, Lefevre T, Chieffo A, Hildick-Smith D, Louvard Y, Stankovic G. Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club. EuroIntervention. 2016 May 17;12(1):38-46. doi: 10.4244/EIJV12I1A7. |
| 17985377 | Background | Louvard Y, Thomas M, Dzavik V, Hildick-Smith D, Galassi AR, Pan M, Burzotta F, Zelizko M, Dudek D, Ludman P, Sheiban I, Lassen JF, Darremont O, Kastrati A, Ludwig J, Iakovou I, Brunel P, Lansky A, Meerkin D, Legrand V, Medina A, Lefevre T. Classification of coronary artery bifurcation lesions and treatments: time for a consensus! Catheter Cardiovasc Interv. 2008 Feb 1;71(2):175-83. doi: 10.1002/ccd.21314. |
| 42066936 | Derived | Broyd CJ, Arunothayaraj S, Scheller B, Eccleshall S, Lassen JF, Stankovic G, Hildick-Smith D. The European bifurcation club randomized trial of stepwise provisional stenting vs drug-coated balloon therapy for nonleft main true coronary bifurcations: The EBC DCB trial. Am Heart J. 2026 Apr 29;300:107463. doi: 10.1016/j.ahj.2026.107463. Online ahead of print. |
| Sealed Envelope \| Power calculator for binary outcome non-inferiority trial | View source |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015906 | Angioplasty, Balloon, Coronary |
| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D062645 | Percutaneous Coronary Intervention |
| D019060 | Minimally Invasive Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D008919 | Investigative Techniques |
Not provided
Not provided