Comparison of Double-kissing Crush and Double-kissing Culotte Stenting

Comparison of Double-kissing Crush and Double-kissing Culotte Stenting in Patients With True Bifurcation Lesion

True bifurcation lesions (TBLs) are not rare clinical conditions and may be associated with adverse cardiovascular outcomes due to their complex anatomy and the variety of interventional therapy. Although the provisional stenting is still effective in suitable lesions, double stent techniques can be required in selected patients. In previous studies, double kissing crush (DK-crush) stenting was revealed as superior to provisional stenting in TBL of left main coronary artery. Additionally, in recent studies, double kissing approach facilitates and highlights double kissing culotte (DK-culotte) stenting with lower stent malapposition compared to DK-crush stenting. However, to the best of our knowledge, there is no study about comparing DK-crush and DK-culotte stenting in TBLs. Our aim in this study is to compare DK-crush and DK-culotte stenting in patients with TBL.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: double kissing crush stenting; Procedure: double kissing culotte stenting

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34303
    • Istanbul Mehmet Akif Ersoy Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with stable or unstable angina pectoris or patients with non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention and performing double stent techniques (DK-crush or DK-culotte) are included in this study.

Description

Inclusion Criteria:

• Patients with de novo true bifurcation lesion (Medina classification 1,1,1 or 0,1,1 or 1,0,1)
• The main vessel diameter is least 2.5 mm and the side branch diameter is at least 2.25 mm

Exclusion Criteria:

• Patients presenting with ST segment elevation myocardial infarction, cardiogenic shock and Killip class III-IV heart failure
• Patients with a history of coronary artery bypass grafting surgery
• Patients with a chronic total occlusion in the bifurcation area
• Lesions with severe calcification that needs additional intervention such as atherectomy
• Patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up
• Patients with hematological disorders, malignancy, end stage renal (GFR<30 ml/min) and hepatic failure
• Patients with active bleeding
• Pregnant women
• Patients with life-expectancy < 1 year

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
double kissing crush stenting; patients with true bifurcation lesion undergoing double kissing crush stenting	Procedure: double kissing crush stenting; Patients with true bifurcation lesion treating with double kissing crsuh stenting technique
double kissing culotte stenting; patients with true bifurcation lesion undergoing double kissing culotte stenting	Procedure: double kissing culotte stenting; Patients with true bifurcation lesion treating with double kissing culotte stenting technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE (major adverse cardiovascular events)	target vessel revascularization, myocardial infarction and cardiac death	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCEs (major adverse cerebral and cardiovascular events)	all cause death, myocardial infarction, target lesion revascularization, target lesion revascularization, in-stent thrombosis and/or restenosis, stroke	12, 24, 36 months
target lesion failure	myocardial infarction, cardiac death	24, 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
contrast induced nephropathy	25 percent (%) increase in serum creatinine level from baseline or a 0.5 mg/dL increase in absolute serum creatinine value within 72 hours after percutaneous coronary intervention	12 months

Collaborators and Investigators

• Sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Publications and helpful links

General Publications

• Colombo A, Bramucci E, Sacca S, Violini R, Lettieri C, Zanini R, Sheiban I, Paloscia L, Grube E, Schofer J, Bolognese L, Orlandi M, Niccoli G, Latib A, Airoldi F. 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 Jan 6;119(1):71-8. doi: 10.1161/CIRCULATIONAHA.108.808402. Epub 2008 Dec 22.
• 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.
• Hildick-Smith D, de Belder AJ, Cooter N, Curzen NP, Clayton TC, Oldroyd KG, Bennett L, Holmberg S, Cotton JM, Glennon PE, Thomas MR, Maccarthy PA, Baumbach A, Mulvihill NT, Henderson RA, Redwood SR, Starkey IR, Stables RH. Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies. Circulation. 2010 Mar 16;121(10):1235-43. doi: 10.1161/CIRCULATIONAHA.109.888297. Epub 2010 Mar 1.
• Chen SL, Zhang JJ, Han Y, Kan J, Chen L, Qiu C, Jiang T, Tao L, Zeng H, Li L, Xia Y, Gao C, Santoso T, Paiboon C, Wang Y, Kwan TW, Ye F, Tian N, Liu Z, Lin S, Lu C, Wen S, Hong L, Zhang Q, Sheiban I, Xu Y, Wang L, Rab TS, Li Z, Cheng G, Cui L, Leon MB, Stone GW. Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial. J Am Coll Cardiol. 2017 Nov 28;70(21):2605-2617. doi: 10.1016/j.jacc.2017.09.1066. Epub 2017 Oct 30.
• Toth GG, Sasi V, Franco D, Prassl AJ, Di Serafino L, Ng JCK, Szanto G, Schneller L, Ang HY, Plank G, Wijns W, Barbato E. Double-kissing culotte technique for coronary bifurcation stenting. EuroIntervention. 2020 Oct 9;16(9):e724-e733. doi: 10.4244/EIJ-D-20-00130.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): May 4, 2024

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 7, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: IMAEETH-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No