Clinical trial NCT04885816: Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty
Official title: Drug-Eluting Balloon Versus Drug-eluting Stent On de Novo coRonary Artery Disease in Patients With High Bleeding Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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)
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Drug Eluting Stents (DES) are the devices of choice for coronary angioplasty, including in patients with high-bleeding risk.

Different studies have been done to determine which strategy improves bleeding outcomes without risking the benefit of stenting. Different Double Anti-Platelet Therapy (DAPT) durations in different devices have shown that it is safe to reduce DAPT, with an increase in ischemic events but a better net clinical outcome.

Safety and efficacy of Drug Eluting Balloons (DEB) were proved when it was compared with Bare Metal Stents (BMS) in de-novo coronary lesions by presenting no events of target vessel closure after treatment.

Our hypothesis is that treating this group of high-bleeding risk patients with DEB will be no-inferior in terms of target vessel failure at 12 months when compared with DES for treatment of de-novo coronary lesions in high bleeding risk population, reducing incidence of significant bleeding events with DAPT reduction.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. Anticipated use of long-term oral anticoagulation
  2. Severe or end-stage CKD (eGFR \<30 mL/min)
  3. Hemoglobin \< 11 g/dL
  4. Spontaneous bleeding requiring hospitalization or transfusion in the last 6 months, or any time, if recurrent.
  5. Moderate or severe baseline thrombocytopenia (\<100,000/uL)
  6. Chronic bleeding diathesis
  7. Liver cirrhosis with portal hypertension
  8. Active malignancy (excluding nonmelanoma skin cancer) within the past 12 months
  9. Previous spontaneous intracranial hemorrhage
  10. Previous traumatic intracranial hemorrhage within the past 12 months
  11. Presence of Brain arteriovenous malformation (AVM)
  12. Moderate or severe ischemic stroke (NIHSS score equal or more than 5) within the past 6 months
  13. Non deferrable major surgery while on DAPT
  14. Recent major surgery or major trauma within 30 days before PCI
* Minor Criteria:

  1. Age 75 years old and older
  2. Moderate Chronic Kidney Disease (CKD) (eGFR 30-59 mL/min)
  3. Hemoglobin 11 - 12.9 g/dL in men and 11 - 11.9 g/dL in women
  4. Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months, not meeting major criterion
  5. Long term use of NSAIDs or steroids
  6. Any ischemic stroke at any time not meeting major criterion

Exclusion Criteria:

* 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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 12 months
measure: Myocardial Infarction related to the treated vessel
timeFrame: 12 months
measure: Target Lesion Revascularization
timeFrame: 12 months
measure: Target Vessel Failure (TVF)
timeFrame: 12 months
measure: Target Vessel Revascularization
timeFrame: 12 months
measure: Non-cardiovascular death
timeFrame: 12 months
measure: Major Bleeding
timeFrame: 12 months
measure: Technical success
timeFrame: Periprocedural
measure: Subgroup analysis of target lesion failure
timeFrame: 12 months
measure: Subgroup analysis of major bleeding events
timeFrame: 12 months
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Cardiologia "Ignacio Chávez"
Study officials:
affiliation: Instituto Nacional de Cardiología "Ignacio Chávez"
name: Guering Eid-Lidt, MD
role: STUDY_DIRECTOR
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