Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID

NCT04403048 | Unknown

• 1 other identifier: PRO-DAVID
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bifurcation lesions (BL) on coronary arteries account for 15-20 % of all performed percutaneous coronary interventions (PCI). Preferred approach for treatment of most bifurcation lesions is the stepwise provisional stent strategy with main branch-only stenting followed by provisional balloon angioplasty with or without stenting of the side branch (SB). Stenting of the side branch is indicated when the angiographic result in SB is clearly suboptimal and when flow remains reduced. Upfront use of two stent techniques may be indicated in very complex lesions with large calcified side branches ( most likely to supply at least 10% of fractional myocardial mass), with a long ostial side branch lesion (\>5mm) or anticipated difficulty in accessing an important side branch after main branch stenting, and true distal LM bifurcations. From a technical point of view, we propose a "Provisional DCB approach" that differs from the standard provisional approach with obligatory SB predilation and good lesion preparation. In case of an adequate result of predilation, the procedure on the SB ends with the DCB deployment. This is followed by main branch stenting with DES, finished with POT. Final 'kissing' balloon dilation is generally not recommended because there is no advantage from final kissing with the one-stent technique. With this approach, there is no need for re-wiring, re-ballooning, side branching and wire jailing and final kissing. This technique is close to a contemporary approach to bifurcation lesions based on the fundamental philosophy of the European Bifurcation Club (EBC): keep it simple, systematic, and safe, with a limited number of stents that should be well apposed and expanded with limited overlap, with respect of the original bifurcation anatomy.

Conditions

Stable Angina; Ischemic Heart Disease; Coronary Artery Disease; Unstable Angina; NSTEMI - Non-ST Segment Elevation MI

Keywords

Drug Coated Ballon; Bifurcation coronary disease; SYNTAX score; Medina classification; Coronary angiography

Outcome Measures

Primary Outcomes (1)

• Number of participants who develop major adverse cardiac events

  Defined as cardiac death, myocardial infarction unrelated to the procedure which demanded hospitalization, revascularization of the target lesion

  12 months after the procedure

Secondary Outcomes (11)

• Number of patients who develop an individual component of the primary endpoint

  12 months and 36 months after the procedure

• Rate of angiographic success

  immediately after the procedure

• Rate of procedural success

  immediately after the procedure

• Rate of possible, probable or definitive stent thrombosis

  12 months after the procedure

• Rate of in segment late lumen loss in any of the treated branches

  9 months after the procedure

Study Arms (2)

Patients in which standard provisional approach is preformed

ACTIVE COMPARATOR

Detailed technique is described in the Detailed study description paragraph

Procedure: Standard provisional approach PCI procedure

Patients in which provisional DCB approach is preformed

EXPERIMENTAL

Detailed technique is described in the Detailed study description paragraph

Procedure: Provisional DCB approach PCI procedure

Interventions

Provisional DCB approach PCI procedure PROCEDURE

Intervention is explained in detail in group description

Patients in which provisional DCB approach is preformed

Standard provisional approach PCI procedure PROCEDURE

Intervention is explained in detail in group description

Also known as: any 2-stent technique for bail-out patients

Patients in which standard provisional approach is preformed

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical:
• stable angina Canadian Cardiovascular Society (CCS) 2 to 4, unstable angina, NSTEMI
• clinical and anatomic eligibility for PCI as agreed to by the local Heart Team
• in stable angina: a. ischaemic symptoms, or b. proof of ischemia on nonvasive testing, or c. positive FFR or iFR or d. ( for LMS ) IVUS minimal lumen area \<6 mm²
• patients with mental and logistical conditions for further monitoring
• patients need to accept clinical monitoring during 3 years and sign a written consent form
• patients need to be older than 18 years
• Angiographical:
• de novo bifurcational lesion with affected side branch (Medina 1,1,1; 1,0,1; 0,1,1)
• side branch diameter ≥ 2,5 mm
• LM SB-DS ≥70% and SB lesion length \> 5 mm
• non LM: SB-DS ≥ 90% and SB lesion length \> 5 mm
• side branch length ≥ 73mm
• for patients with LAD/diagonal BL - Scoring system for diagonal branches (Modified SNuHscore) ≥ 2

You may not qualify if:

• Clinical:
• STEMI \<72 hours preceding
• Chronic total occlusion of either vessel
• SYNTAX score for planned lesions to be treated \>32
• cerebrovascular accident within 6 months, surgical procedure within one week
• pregnant/nursing women
• ejection fraction LV\< 30%, congestive heart failure, cardiogenic shock or sever valvular disease
• unfavourable long-term prognosis - patient life expectancy less than 12 months
• creatinine \> 2,0 mg/dl ( 177 mmol/L)
• hypersensibility, allergies or contraindication to: aspirin, heparin, clopidogrel, prasugel, steel, sirolimus, everolimus, zotarolimus, biolimus or contrast agents
• treatment of hyperthyroidism, administration of immunosuppressives or anticoagulant therapy, addiction to alcohol or drugs
• patients included in other clinical trials
• Angiographical:
• thrombotic lesions
• severe calcification

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Related Publications (12)

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  PMID: 19463303 BACKGROUND

• Meier B, Gruentzig AR, King SB 3rd, Douglas JS Jr, Hollman J, Ischinger T, Aueron F, Galan K. Risk of side branch occlusion during coronary angioplasty. Am J Cardiol. 1984 Jan 1;53(1):10-4. doi: 10.1016/0002-9149(84)90675-1.

  PMID: 6229173 BACKGROUND

• Myler RK, Shaw RE, Stertzer SH, Hecht HS, Ryan C, Rosenblum J, Cumberland DC, Murphy MC, Hansell HN, Hidalgo B. Lesion morphology and coronary angioplasty: current experience and analysis. J Am Coll Cardiol. 1992 Jun;19(7):1641-52. doi: 10.1016/0735-1097(92)90631-v.

  PMID: 1593061 BACKGROUND

• Lefevre T, Louvard Y, Morice MC, Dumas P, Loubeyre C, Benslimane A, Premchand RK, Guillard N, Piechaud JF. Stenting of bifurcation lesions: classification, treatments, and results. Catheter Cardiovasc Interv. 2000 Mar;49(3):274-83. doi: 10.1002/(sici)1522-726x(200003)49:33.0.co;2-n.

  PMID: 10700058 BACKGROUND

• Banning AP, Lassen JF, Burzotta F, Lefevre T, Darremont O, Hildick-Smith D, Louvard Y, Stankovic G. Percutaneous coronary intervention for obstructive bifurcation lesions: the 14th consensus document from the European Bifurcation Club. EuroIntervention. 2019 May 20;15(1):90-98. doi: 10.4244/EIJ-D-19-00144.

  PMID: 31105066 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.

  PMID: 30165437 BACKGROUND

• 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.

  PMID: 29096915 BACKGROUND

• 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 May 17;12(1):47-52. doi: 10.4244/EIJV12I1A8.

  PMID: 27173861 BACKGROUND

• Ann SH, Balbir Singh G, Lim KH, Koo BK, Shin ES. Anatomical and Physiological Changes after Paclitaxel-Coated Balloon for Atherosclerotic De Novo Coronary Lesions: Serial IVUS-VH and FFR Study. PLoS One. 2016 Jan 29;11(1):e0147057. doi: 10.1371/journal.pone.0147057. eCollection 2016.

  PMID: 26824602 BACKGROUND

• Her AY, Ann SH, Singh GB, Kim YH, Yoo SY, Garg S, Koo BK, Shin ES. Comparison of Paclitaxel-Coated Balloon Treatment and Plain Old Balloon Angioplasty for De Novo Coronary Lesions. Yonsei Med J. 2016 Mar;57(2):337-41. doi: 10.3349/ymj.2016.57.2.337.

  PMID: 26847284 BACKGROUND

• Niemela M, Kervinen K, Erglis A, Holm NR, Maeng M, Christiansen EH, Kumsars I, Jegere S, Dombrovskis A, Gunnes P, Stavnes S, Steigen TK, Trovik T, Eskola M, Vikman S, Romppanen H, Makikallio T, Hansen KN, Thayssen P, Aberge L, Jensen LO, Hervold A, Airaksinen J, Pietila M, Frobert O, Kellerth T, Ravkilde J, Aaroe J, Jensen JS, Helqvist S, Sjogren I, James S, Miettinen H, Lassen JF, Thuesen L; Nordic-Baltic PCI Study Group. Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic Bifurcation Study III. Circulation. 2011 Jan 4;123(1):79-86. doi: 10.1161/CIRCULATIONAHA.110.966879. Epub 2010 Dec 20.

  PMID: 21173348 BACKGROUND

• Gwon HC, Hahn JY, Koo BK, Song YB, Choi SH, Choi JH, Lee SH, Jeong MH, Kim HS, Seong IW, Yang JY, Rha SW, Jang Y, Yoon JH, Tahk SJ, Seung KB, Park SJ. Final kissing ballooning and long-term clinical outcomes in coronary bifurcation lesions treated with 1-stent technique: results from the COBIS registry. Heart. 2012 Feb;98(3):225-31. doi: 10.1136/heartjnl-2011-300322. Epub 2011 Sep 20.

  PMID: 21933939 BACKGROUND

MeSH Terms

Conditions

Angina, Stable; Myocardial Ischemia; Coronary Artery Disease; Angina, Unstable; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Deiti Prvulovic, MD, PhD

  Clinical Hospital Center Rijeka

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deiti Prvulovic, MD, PhD

CONTACT

+385 91 5547 188; deiti.prvulovic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 27, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2024
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share