Acute Coronary Syndrome
Conditions
Keywords
Unstable angina, Non ST elevation myocardial infarction, PCI, unfractionated heparin, fondaparinux, acute coronary syndrome
Brief summary
The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.
Detailed description
Subjects presenting at hospital with suspected UA or NSTEMI and who are likely to undergo angiography (ideally within 72 hours) will be assessed for eligibility and consented. Suitable subjects will be enrolled and commence treatment with open-label fondaparinux, 2.5 milligram (mg), subcutaneous (s.c.), once daily. Following angiography subjects indicated for PCI and meeting the additional requirements for randomization will be randomised to receive one of two dose regimens of UFH either standard dose or low dose immediately prior to the PCI procedure. Post-PCI, therapy with fondaparinux (2.5 mg, s.c.) may be resumed at the investigator's discretion for up to a maximum of 8 days or hospital discharge, whichever is earlier. Subjects not indicated for PCI, will continue treatment with fondaparinux, 2.5mg, s.c, once daily for up to 8 days or hospital discharge, whichever is earlier. All subjects will be followed up for 30 days after randomization/angiography.
Interventions
DRUGfondaparinux background and standard dose UFH
Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned glycoprotein \[GP\] IIb/IIIa inhibitor use: 60 units/kilogram (U/kg); no planned use: 85 U/kg and adjusted based on activated clotting time (ACT) \[maximum two additional bolus doses\]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
DRUGFondaparinux background and low dose heparin
Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose UFH (50 U/kg), which was not adjusted for planned GPIIb/IIIa inhibitor use or ACT). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
DRUGOpen label fondaparinux
Open-label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for PCI and not randomized
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The following are inclusion and
Exclusion criteria
for enrollment in the study: Inclusion Criteria: * Presenting or admitted to hospital with symptoms suspected to represent UA or NSTEMI, i.e., clinical history consistent with new onset, or a worsening pattern of, characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than 5 minutes or requiring sublingual nitro-glycerine for relief of the pain). * Available to be enrolled within 48 hours of the onset of the most recent episode of symptoms. * Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible. * At least two of the three following additional criteria: * Age greater than or equal to 60 years * Troponin T or I or CK-MB above the upper limit of normal for the local institution; * Electrocardiogram (ECG) changes compatible with ischemia, i.e., ST depression at least 1 mm in 2 contiguous leads or T wave inversion \> 3 mm or any dynamic ST shift or transient ST elevation. * Written informed consent dated and signed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Bleeding During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC. |
| Number of Participants With Minor Bleeding During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC. |
| Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site. |
| Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30 | Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR | The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC. |
| Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30 | Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30 | The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC. |
| Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30 | The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC. |
| Number of Participants With Major PCI-related Procedural Complications | During PCI procedure: immediately after randomization (approximately 10-75 minutes) | Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC. |
Countries
Argentina, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, India, Italy, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
All participants (par.) received open-label (OL) fondaparinux (fond.). Par. indicated for percutaneous coronary intervention (PCI) were randomized to low- or standard-dose unfractionated heparin during PCI. Post-PCI, par. could resume OL fond. Par. not indicated for PCI weren't randomized and continued OL fond.
Participants by arm
| Arm | Count |
|---|---|
| Open-label Fondaparinux 2.5 mg Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized | 1,209 |
| OL Fondaparinux Background + Low Dose UFH During PCI OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram \[U/kg\], which was not adjusted for planned glycoprotein \[GP\] IIb/IIIa use or activated clotting time \[ACT\]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization. | 1,024 |
| OL Fondaparinux Background + Standard Dose UFH During PCI OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT \[maximum two additional bolus doses\]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization. | 1,002 |
| Total | 3,235 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 7 | 6 |
| Overall Study | Bleeding Event | 11 | 16 | 21 |
| Overall Study | Did Not Receive Study Drug | 10 | 0 | 0 |
| Overall Study | Physician Decision | 304 | 271 | 255 |
| Overall Study | Qualifying Condition Not Present | 29 | 14 | 16 |
| Overall Study | Required Protocol-prohibited Therapy | 17 | 5 | 7 |
| Overall Study | Verbatim Reason on the Case Report Form | 74 | 20 | 29 |
| Overall Study | Withdrawal by Subject | 1 | 7 | 5 |
Baseline characteristics
| Characteristic | Open-label Fondaparinux 2.5 mg | OL Fondaparinux Background + Low Dose UFH During PCI | OL Fondaparinux Background + Standard Dose UFH During PCI | Total |
|---|---|---|---|---|
| Age, Continuous | 65.8 Years STANDARD_DEVIATION 11.07 | 65.3 Years STANDARD_DEVIATION 11.25 | 65.5 Years STANDARD_DEVIATION 11.1 | 65.5 Years STANDARD_DEVIATION 11.14 |
| Race/Ethnicity, Customized Arab | 3 participants | 5 participants | 3 participants | 11 participants |
| Race/Ethnicity, Customized Black African | 4 participants | 1 participants | 3 participants | 8 participants |
| Race/Ethnicity, Customized European | 830 participants | 768 participants | 749 participants | 2347 participants |
| Race/Ethnicity, Customized Missing | 1 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Native Latin | 57 participants | 37 participants | 33 participants | 127 participants |
| Race/Ethnicity, Customized Other Asian | 63 participants | 61 participants | 61 participants | 185 participants |
| Race/Ethnicity, Customized Other - verbatim reason collected on the CRF | 2 participants | 1 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized South Asian | 249 participants | 151 participants | 150 participants | 550 participants |
| Sex: Female, Male Female | 486 Participants | 335 Participants | 316 Participants | 1137 Participants |
| Sex: Female, Male Male | 723 Participants | 689 Participants | 686 Participants | 2098 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 117 / 1,209 | 100 / 1,024 | 113 / 1,002 |
| serious Total, serious adverse events | 48 / 1,209 | 28 / 1,024 | 20 / 1,002 |
Outcome results
Primary
Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period
The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.
Time frame: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Population: Intent-to-Treat (ITT) Population: all randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period | 48 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period | 58 participants |
p-value: 0.26795% CI: [0.54, 1.19]Regression, Logistic
Secondary
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC.
Time frame: Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Death during peri-PCI period | 1 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | MI during peri-PCI period | 20 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | TVR during peri-PCI period | 3 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Definite/Probable Stent Thrombosis during peri-PCI | 1 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Stroke during peri-PCI | 3 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Death at Day 30 | 8 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | MI at Day 30 | 31 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | TVR at Day 30 | 9 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Definite/Probable Stent Thrombosis at Day 30 | 12 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Stroke at Day 30 | 5 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | TVR at Day 30 | 3 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Death during peri-PCI period | 2 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Death at Day 30 | 6 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | MI during peri-PCI period | 16 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Stroke at Day 30 | 5 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | TVR during peri-PCI period | 2 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | MI at Day 30 | 25 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Definite/Probable Stent Thrombosis during peri-PCI | 2 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Definite/Probable Stent Thrombosis at Day 30 | 5 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Stroke during peri-PCI | 5 participants |
Secondary
Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC.
Time frame: Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30 | Composite of death, MI, and TVR Peri-PCI | 23 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30 | Composite of death, MI, and TVR at Day 30 | 46 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30 | Composite of death, MI, and TVR Peri-PCI | 19 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30 | Composite of death, MI, and TVR at Day 30 | 29 participants |
Secondary
Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.
Time frame: Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30 | 59 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30 | 39 participants |
Secondary
Number of Participants With Major Bleeding During the Peri-PCI Period
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.
Time frame: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Major Bleeding During the Peri-PCI Period | 14 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Major Bleeding During the Peri-PCI Period | 12 participants |
Secondary
Number of Participants With Major PCI-related Procedural Complications
Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC.
Time frame: During PCI procedure: immediately after randomization (approximately 10-75 minutes)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | Abrupt Vessel Closure | 10 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | New Angiographic Thrombus | 11 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | Suspected Catheter-related Thrombus | 4 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | Catheter-related Thrombus-Adjudicated | 4 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | No-reflow Phenomenon | 20 participants |
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | New Major Dissection with Reduced Flow | 10 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | No-reflow Phenomenon | 22 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | Abrupt Vessel Closure | 17 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | Catheter-related Thrombus-Adjudicated | 1 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | New Angiographic Thrombus | 8 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | New Major Dissection with Reduced Flow | 10 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Major PCI-related Procedural Complications | Suspected Catheter-related Thrombus | 3 participants |
Secondary
Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site.
Time frame: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period | 33 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period | 43 participants |
Secondary
Number of Participants With Minor Bleeding During the Peri-PCI Period
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC.
Time frame: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | Number of Participants With Minor Bleeding During the Peri-PCI Period | 7 participants |
| OL Fondaparinux Background + Standard Dose UFH During PCI | Number of Participants With Minor Bleeding During the Peri-PCI Period | 17 participants |