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

Not Applicable

Terminated

• Conditions: Percutaneous Coronary Intervention (PCI); Coronary Artery Disease (CAD); High Bleeding Risk
• Interventions: Device: Drug Eluting Stents (DES); Device: Drug Eluting Balloon (DEB)

• Registration Number: NCT04885816
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

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.

Study Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2021-05-08
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-13
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Eluting Stents (DES)	Drug Eluting Stents (DES)	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.
Drug Eluting Balloon (DEB)	Drug Eluting Balloon (DEB)	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).

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 months	Composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Major Bleeding	12 months	Incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater
Target Lesion Revascularization	12 months	Rate of repeated percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion
Cardiovascular death	12 months	Rate of death resulting from cardiovascular causes in each group: Death caused by acute MI Death caused by sudden cardiac, including unwitnessed, death Death resulting from heart failure Death caused by stroke Death caused by cardiovascular procedures Death resulting from cardiovascular hemorrhage Death resulting from other cardiovascular cause Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI.; Percutaneous coronary intervention (PCI) related MI is termed type 4a MI.
Target Vessel Revascularization	12 months	Rate of repeated percutaneous intervention or surgical bypass of any segment of the target vessel in each group.
Non-cardiovascular death	12 months	Rate of any death that is not thought to be the result of a cardiovascular cause in each group: 1. Death resulting from malignancy; 2. Death resulting from pulmonary causes; 3. Death caused by infection (includes sepsis); 4. Death resulting from gastrointestinal causes; 5. Death resulting from accident/trauma; 6. Death caused by other noncardiovascular organ failure; 7. Death resulting from other noncardiovascular cause
Subgroup analysis of target lesion failure	12 months	Rate of TLF in treatment of bifurcations vs no bifurcation, by vessel size, in diabetes, by clinical Presentation (acute or chronic).
Myocardial Infarction related to the treated vessel	12 months	Rate of myocardial infarction related to the treated vessel (according to the 4th international definition of myocardial infarction) in each group: detection of an increase or decrease in cardiac troponin values with at least 1 of the values above the upper reference limit of the 99th percentile and at least 1 of the following conditions : Symptoms of acute myocardial ischemia. New ischemic changes in the electrocardiogram. Appearance of pathological Q waves. Imaging evidence of loss of viable myocardium or new regional abnormalities in myocardial wall mobility following a pattern compatible with ischemic etiology.; Identification of a coronary thrombus by angiography with intracoronary imaging or by autopsy Any MI that cannot be clearly attributed to a vessel other than the revascularized one will be considered as MI related to the treated vessel.
Target Vessel Failure (TVF)	12 months	Rate of TVF in each group (composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target vessel revascularization)
Technical success	Periprocedural	Rate of restoration of antegrade Thrombolysis In Myocardial Infarction (TIMI) flow 2 or 3 and a \<30% residual stenosis.
Subgroup analysis of major bleeding events	12 months	Rate of BARC 3-5 bleeding events in patients with anticoagulation vs no anticoagulation, by DAPT duration, by inclusion criteria

Trial Locations

Locations (1)

Instituto Nacional de Cardiologia "Ignacio Chávez"; 🇲🇽 Ciudad de México, Mexico