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

Launched by INSTITUTO NACIONAL DE CARDIOLOGIA IGNACIO CHAVEZ · May 12, 2021

Keywords

ClinConnect Summary

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 presen...

Gender

ALL

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