High Bleeding Risk, Coronary Artery Disease, Percutaneous Coronary Intervention
Conditions
Keywords
Short DAPT
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 who underwent elective coronary percutaneous intervention with a zotarolimus eluting stent versus a sirolimus eluting stent and short Dual Antiplatelet Therapy (DAPT).
Interventions
Size (diameter and length) will be chosen at operator's discretion aided by simple angiography, 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. Device will be used by CE mark instructions. All patients will receive DAPT as follows: After a loading dose (if necessary) of aspirin and a P2Y12 inhibitor, aspirin 100 mg and a P2Y12 inhibitor daily will be indicated for 1 month in both ACS and Chronic Coronary Syndrome (CCS). Patients with high ischemic risk could be extended to 3 months. After DAPT, SAPT will be continued with the drug of choice, preferably P2Y12 inhibitor. Patients requiring chronic anticoagulation will receive triple therapy only during hospitalization. At release, an oral anticoagulant (NOAC preferred over VKA) will be indicated along with 6 months of SAPT with a P2Y12 inhibitor.
DEVICESirolimus eluting stent
Size (diameter and length) will be chosen at operator's discretion aided by simple angiography, 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. Device will be used in accordance with the CE mark instructions. All patients will receive DAPT as follows: After a loading dose (if necessary) of aspirin and a P2Y12 inhibitor, aspirin 100 mg and a P2Y12 inhibitor daily will be indicated for 1 month in both ACS and CCS. Patients with high ischemic risk could be extended to 3 months. After DAPT, SAPT will be continued with the drug of choice, preferably P2Y12 inhibitor. Patients requiring chronic anticoagulation will receive triple therapy only during hospitalization. At release, an oral anticoagulant (NOAC preferred over VKA) will be indicated along with 6 months of SAPT with a P2Y12 inhibitor.
Sponsors
Instituto Nacional de Cardiologia Ignacio Chavez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Randomized treatment will not be revealed to patient or data analyst at any time during procedure or afterwards until follow-up and analysis has been done.
Intervention model description
Randomized, double-blind, non-inferiority clinical trial enrolling eligible subjects with high bleeding risk 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients 18 years old or older with an ischemic de-novo lesion(s) in coronary artery or coronary bypass graft suitable for 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 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 Chronic Kidney Disease (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 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 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 * Cardiogenic shock or resuscitation with uncertain neurological status at arrival to PCI * Unprotected left main lesion * Reference diameter larger or shorter than available stents * Life expectancy \< 12 months * In-stent restenosis o thrombosis of previous stent * Inability to give written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 12 months | Rate of composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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): 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 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. |
| Target Vessel Failure (TVF) | 12 months | Rate of TVF (composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target vessel revascularization) |
| Cardiovascular death | 12 months | Rate of death resulting from cardiovascular causes: 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. |
| Non-cardiovascular death | 12 months | Rate of any death that is not thought to be the result of a cardiovascular cause: 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 |
| Major Bleeding | 12 months | Incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater |
| Technical success | Periprocedural | Rate of restoration of antegrade Thrombolysis In Myocardial Infarction (TIMI) flow 2 or 3 and a \<30% residual stenosis. |
| Target Vessel Revascularization | 12 months | Rate of repeat percutaneous intervention or surgical bypass of any segment of the target vessel |
Countries
Mexico
Contacts
Primary ContactDaniel F Zazueta, MD
Backup ContactGuering Eid-Lidt, MD
Outcome results
None listed