Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty

NCT04885816 | Terminated DMC

• 2 other identifiers: INCAR-DG-DACEP-020-202121-1223
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients undergoing elective coronary percutaneous intervention comparing limus-eluting balloon vs. limus-eluting stents.

Conditions

High Bleeding Risk; Coronary Artery Disease (CAD); Percutaneous Coronary Intervention (PCI)

Keywords

Drug Eluting Balloon (DEB); Drug Eluting Stent (DES); High bleeding risk (HBR); High hemorrhagic risk; Dual anti-platelet therapy (DAPT)

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF)

  Composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target lesion revascularization

  12 months

Secondary Outcomes (10)

• Cardiovascular death

  12 months

• Myocardial Infarction related to the treated vessel

  12 months

• Target Lesion Revascularization

  12 months

• Target Vessel Failure (TVF)

  12 months

• Target Vessel Revascularization

  12 months

Study Arms (2)

Drug Eluting Balloon (DEB)

EXPERIMENTAL

High Bleeding Risk patients treated with 2.5 - 4.0 mm drug-eluting balloons (DEB). Bailout stenting is permitted in case of a flow-limiting dissection or significant recoil (\>30% in main branch and \>50% side-branch), includes both stable coronary artery disease (SCAD) and acute coronary syndromes (ACS) patients undergoing elective Percutaneous Coronary Intervention (PCI).

Device: Drug Eluting Balloon (DEB)

Drug Eluting Stents (DES)

ACTIVE COMPARATOR

High Bleeding Risk patients treated with 2.5 - 4.0 mm drug-eluting stents (DES). Includes both stable CAD and ACS patients undergoing elective PCI.

Device: Drug Eluting Stents (DES)

Interventions

Drug Eluting Balloon (DEB) DEVICE

Size (diameter and length) will be chosen at operator's discretion aid by simple angiography, quantitative coronary analysis (QCA), or intravascular image; so that the lesion previously prepared and 2 mm at each end are covered by DEB, and the diameter and pressure used aims a balloon to artery ratio of 1. In case of significant recoil (more than 30% for main vessels and 50% for side vessels), coronary perforation or flow limiting dissection, provisional stent will be implanted with a stent to artery ratio of 1.1 with stent post-dilatation when indicated. Device will be used in accordance with the CE mark instructions. DAPT will be given for a month with aspirin and a P2Y12 inhibitor (clopidogrel will be favored). Single anti-platelet therapy (SAPT) with aspirin will be continued thereafter.

Also known as: MagicTouch, Sirolimus coated balloon catheter, diameters 2.5 - 4.0 mm (Concept Medicals, Surat, India)

Drug Eluting Balloon (DEB)

Drug Eluting Stents (DES) DEVICE

Size (diameter and length) will be chosen at operator's discretion aid by simple angiography, quantitative coronary analysis (QCA), or intravascular image; so that the lesion previously prepared and 2 mm at each end are covered by DES with an stent to artery ratio of 1.1. Post-dilatation will be performed when indicated. Devices will be used in accordance with the CE mark instructions. DAPT will be indicated according to actual international guidelines.

Also known as: Orsiro, Sirolimus eluting stent, diameters 2.5 - 4.0 mm (Biotronik AG, Bülach, Switzerland), Resolute Onyx, Zotarolimus eluting stent, diameters 2.5 - 4.0 mm (Medtronic, Santa Rosa, CA, USA), Xiencie Sierra, Everolimus eluting stent, diameters 2.5 - 4.0 mm (Abbott Vascular, Santa Clara, CA, USA), Synergy, Everolimus eluting stent, diameters 2.5 - 4.0 mm (Boston Scientific, Natick, MA, USA)

Drug Eluting Stents (DES)

Eligibility Criteria

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

You may qualify if:

• Patients 18 years old or older with an ischemic de-novo lesion(s) in a 2.5 - 4.0 mm reference diameter coronary artery suitable for elective percutaneous coronary intervention, in context of acute coronary syndrome or chronic coronary syndrome with evidence of ischemia by non-invasive study or pressure guidewire that can be treated by DEB or DES, and has at least 1 major or 2 minor Academic Research Consortium High Bleeding Risk criteria:
• Major criteria:
• Anticipated use of long-term oral anticoagulation
• Severe or end-stage CKD (eGFR \<30 mL/min)
• Hemoglobin \< 11 g/dL
• Spontaneous bleeding requiring hospitalization or transfusion in the last 6 months, or any time, if recurrent.
• Moderate or severe baseline thrombocytopenia (\<100,000/uL)
• Chronic bleeding diathesis
• Liver cirrhosis with portal hypertension
• Active malignancy (excluding nonmelanoma skin cancer) within the past 12 months
• Previous spontaneous intracranial hemorrhage
• Previous traumatic intracranial hemorrhage within the past 12 months
• Presence of Brain arteriovenous malformation (AVM)
• Moderate or severe ischemic stroke (NIHSS score equal or more than 5) within the past 6 months
• Non deferrable major surgery while on DAPT

You may not qualify if:

• STEMI undergoing primary PCI
• Any ACS undergoing urgent PCI
• Cardiogenic shock or resuscitation with uncertain neurological status at arrival to PCI
• Unprotected left main lesion
• Life expectancy \< 12 months
• Reference vessel diameter \< 2.5 mm or \> 4.0 mm
• Bifurcation lesion requiring 2-stent technique
• Chronic total occlusion
• In-stent restenosis
• Dissection affecting the flow (TIMI\<3) or significant recoil (\>30% in main branch, \>50% in side branch) after predilatation
• Inability to give written consent

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiologia "Ignacio Chávez"

Mexico City, 14080, Mexico

Location

Related Publications (10)

• Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13.

  PMID: 31204115 RESULT

• Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, Stone GW; Onyx ONE US/Japan Investigators. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. 2020 Nov;13(11):e009565. doi: 10.1161/CIRCINTERVENTIONS.120.009565. Epub 2020 Nov 10.

  PMID: 33167705 RESULT

• Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.

  PMID: 26466021 RESULT

• Alfonso F, Scheller B. State of the art: balloon catheter technologies - drug-coated balloon. EuroIntervention. 2017 Aug 25;13(6):680-695. doi: 10.4244/EIJ-D-17-00494.

  PMID: 28844030 RESULT

• Varenne O, Cook S, Sideris G, Kedev S, Cuisset T, Carrie D, Hovasse T, Garot P, El Mahmoud R, Spaulding C, Helft G, Diaz Fernandez JF, Brugaletta S, Pinar-Bermudez E, Mauri Ferre J, Commeau P, Teiger E, Bogaerts K, Sabate M, Morice MC, Sinnaeve PR; SENIOR investigators. Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. Lancet. 2018 Jan 6;391(10115):41-50. doi: 10.1016/S0140-6736(17)32713-7. Epub 2017 Nov 1.

  PMID: 29102362 RESULT

• Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC. Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2019 Jul 16;140(3):240-261. doi: 10.1161/CIRCULATIONAHA.119.040167. Epub 2019 May 22.

  PMID: 31116032 RESULT

• Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.

  PMID: 31504439 RESULT

• Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

  PMID: 28886621 RESULT

• Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.

  PMID: 32860058 RESULT

• Zocca P, Kok MM, van der Heijden LC, Danse PW, Schotborgh CE, Scholte M, Hartmann M, Linssen GCM, Doggen CJM, von Birgelen C. High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial. Cardiovasc Drugs Ther. 2018 Dec;32(6):567-576. doi: 10.1007/s10557-018-6823-9.

  PMID: 30143879 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Guering Eid-Lidt, MD

  Instituto Nacional de Cardiología "Ignacio Chávez"

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomized treatment will not be revealed to patient at any time during procedure or afterwards until follow-up is done.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, single-blind, non-inferiority clinical trial enrolling high bleeding risk patients and coronary artery disease to be treated by percutaneous coronary intervention at the National Institute of Cardiology "Ignacio Chávez" in México. Included patients will have follow-up at the outpatient clinic through 1 year, until death or study exit, whichever comes first.

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: May 13, 2021
• Study Start: April 20, 2021
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)