Coronary Restenosis
Conditions
Keywords
Prevention of Instent Restenosis
Brief summary
The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis.
Detailed description
This study consisted of a Phase I non-randomized dose escalation phase to determine the maximum tolerated dose and a randomized Phase II component to assess preliminary efficacy. Nanoparticle paclitaxel was administered by intracoronary catheter following either successful and uncomplicated stenting of de novo lesions in native coronary arteries or following successful and uncomplicated balloon angioplasty of instent restenosis (ISR) lesions.
Interventions
Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
Sponsors
Celgene Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant and non-lactating female, and ≥ 18 years of age. * Diagnosis of angina pectoris or unstable angina pectoris or patients with documented silent ischemia. * Left ventricular ejection fraction ≥30% * Patient has undergone successful and uncomplicated stenting of up to 2 de novo lesions in native coronary arteries OR patient has undergone successful and uncomplicated balloon angioplasty of up to 2 in-stent restenosis (ISR) lesions in native coronary arteries, but not both. * Thrombolysis In Myocardial Infarction (TIMI) 3 coronary flow post-stenting for de novo lesions or post balloon angioplasty for ISR lesions. * No angiographic evidence of thrombus post-procedure. * Target vessel ≥2.5 mm diameter (by angiography). * Each de novo lesion is such that it is stented with ≤ 25 mm of single continuous stent. * Each in-stent restenosis (ISR) lesion is ≤ 25 mm in length. * There is at least 5 mm of non-diseased vessel on either side of target lesion(s). * By intravascular ultrasound (IVUS), stent is fully opposed and has a minimum diameter of 2.5 mm or an in-stent luminal area ≥ 5.0 mm\^2 * Patient or guardian has provided a signed written informed consent to participate in the study and in all follow-up assessments using a form that is approved by the local Institutional Review Board (IRB)/Ethics Committee of the investigative site.
Exclusion criteria
* Target de novo lesion was treated with a drug-eluting stent * Target ISR lesion requires any treatment other than balloon angioplasty * Patient has both a de novo lesion and an ISR lesion. * If more than 2 lesions are treated with percutaneous coronary intervention (PCI), or it is anticipated that additional lesions will require treatment within 2 months. * Previous PCI within preceding two months. * Intended surgical intervention within 6 months of enrollment in the study. * Unprotected left main disease with \>50% stenosis * Malapposition, dissection, or unmasking of a significant narrowing in the inflow or outflow area of the implanted stent. * Women who are pregnant and women of child bearing potential who do not use adequate contraception * Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational drug or device trial. * Patient has a life expectancy of less than 12 months or there are factors making clinical and/or angiographic follow-up difficult * Any significant medical condition which, in the investigator's opinion, may interfere with the patient's optimal participation in the study * Heart transplant candidate or recipient * Patient is immunosuppressed or is HIV positive. * Patient has experienced a Q wave or a non Q wave myocardial infarction (MI) with documented total creatine kinase (CK) ≥2 times normal within the preceding 24 hours and the CK and creatine kinase-MB fraction (CK-MB) enzymes remain above normal at the time of the procedure. * Cardiogenic shock: sustained systolic blood pressure (SBP) less than 80 mmHg, with no response to fluids or SBP less than 100 mmHg with vasopressors (in absence of bradycardia) * Any individual who may refuse a blood transfusion * Documented major gastro-intestinal bleeding within 3 months * The following lab values at baseline are exclusionary: * Serum creatinine \> 2.5 mg/dl; * Platelet count \< 150,000 cells/mm\^3; * Absolute neutrophil count (ANC) \< 2000 cells/mm\^3; * Hemoglobin (HGB) \<9 g/dl; * Total bilirubin \>1.5 mg/dl; * Alanine Aminotransferase (SGPT) \> 2.5 x upper limit of normal range (ULN); * Aspartate Aminotransferase (SGOT) \> 2.5 x ULN; * Alkaline phosphatase \> 2.5 x ULN. * Known allergy/hypersensitivity/contraindication to the study drug; to any taxanes; or to any required study treatment: aspirin, clopidogrel bisulfate, stent materials * Pre-existing peripheral neuropathy of National Cancer Institute (NCI) Toxicity Grade \> 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months | From the day of Percutaneous Coronary Intervention to Month 6. | Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion. |
| Number of Participants With Procedural Complications | From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure). | Procedural complications include the following: 1. Haemodynamic monitoring: changes in heart rate, arterial blood pressure or electrocardiogram changes; 2. Arrhythmia: premature ventricular complexes, brady or tachyarrhythmia; 3. Allergic reactions: rash, flushing, pyrexia, urticaria, angio-oedema; 4. Angiographic complications: coronary artery spasm, dissection, thrombosis, TIMI (Thrombolysis In Myocardial Infarction) flow, no reflow; 5. Clinical changes: chest pain. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Up to 6 months. | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that: * is fatal or life threatening * results in persistent or significant disability or or incapacity; * requires or prolongs existing hospitalization; * is a congenital anomaly/birth defect in the offspring of a patient who received medication; * conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above. |
| Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month | From the day of Percutaneous Coronary Intervention to 1 Month. | Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion. |
| Phase I: Number of Participants With Dose-limiting Toxicities | Up to 1 week following percutaneous coronary intervention. | Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting. The maximum tolerated dose was defined as the lesser of 45 mg/m\^2 or the dose at which any drug related toxicities were observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Lumen Loss | Day 0 (post-procedure baseline) and 6 months. | Late lumen loss represents the extent of neointimal hyperplasia within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) and was measured by quantitative coronary angiography. Late Loss = Minimum Lumen Diameter (MLD) Post Procedure minus the MLD at Follow-up. |
| Percentage of In-Stent Volume Obstruction at 6 Months | 6 months | In-stent volume obstruction at 6 months was measured by intra-vascular ultrasound (IVUS) and centrally assessed by the IVUS Core Laboratory. Percent in-stent volume obstruction was calculated as neointimal volume / stent volume \* 100. |
| Percentage of Participants With Binary Restenosis | 6 months | Binary restenosis was assessed by quantitative coronary angiography and defined as \>50% diameter stenosis within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) at follow-up. Angiograms were centrally assessed by the Angiographic Core Laboratory. |
Participant flow
Pre-assignment details
122 patients were randomized into the study and 112 received study medication.
Participants by arm
| Arm | Count |
|---|---|
| 10 mg/m^2 Nanoparticle Paclitaxel Participants received a single dose of 10 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions). | 3 |
| 22 mg/m^2 Nanoparticle Paclitaxel Participants received a single dose of 22 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions). | 51 |
| 35 mg/m^2 Nanoparticle Paclitaxel Participants received a single dose of 35 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions). | 3 |
| 45 mg/m^2 Nanoparticle Paclitaxel Participants received a single dose of 45 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions). | 55 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Phase II | Adverse Event | 0 | 2 | 0 | 1 |
| Phase II | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Phase II | Protocol Violation | 0 | 0 | 0 | 1 |
| Phase II | Withdrawal by Subject | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | 10 mg/m^2 Nanoparticle Paclitaxel | 22 mg/m^2 Nanoparticle Paclitaxel | 35 mg/m^2 Nanoparticle Paclitaxel | 45 mg/m^2 Nanoparticle Paclitaxel | Total |
|---|---|---|---|---|---|
| Age Continuous | 63.7 years STANDARD_DEVIATION 6.51 | 59.0 years STANDARD_DEVIATION 9.26 | 63.3 years STANDARD_DEVIATION 6.81 | 60.3 years STANDARD_DEVIATION 8.89 | 59.9 years STANDARD_DEVIATION 8.94 |
| Diabetes mellitis Insulin Dependent | 0 participants | 5 participants | 0 participants | 1 participants | 6 participants |
| Diabetes mellitis No Diabetes | 3 participants | 40 participants | 2 participants | 46 participants | 91 participants |
| Diabetes mellitis Non-Insulin Dependent | 0 participants | 6 participants | 1 participants | 8 participants | 15 participants |
| Diameter Stenosis | 80.92 % diameter stenosis STANDARD_DEVIATION 9.521 | 68.94 % diameter stenosis STANDARD_DEVIATION 15.083 | 70.50 % diameter stenosis STANDARD_DEVIATION 8.789 | 66.28 % diameter stenosis STANDARD_DEVIATION 14.253 | 68.01 % diameter stenosis STANDARD_DEVIATION 14.523 |
| Lesion Length | 6.342 mm STANDARD_DEVIATION 0.9086 | 10.720 mm STANDARD_DEVIATION 5.9338 | 7.900 mm STANDARD_DEVIATION 1.263 | 10.067 mm STANDARD_DEVIATION 5.7097 | 10.203 mm STANDARD_DEVIATION 5.6932 |
| Lesion type Patients with de novo Lesions | 3 participants | 49 participants | 3 participants | 50 participants | 105 participants |
| Lesion type Patients with In-Stent Restenosis Lesions | 0 participants | 2 participants | 0 participants | 5 participants | 7 participants |
| Minimum Lumen Diameter | 0.790 mm STANDARD_DEVIATION 0.3941 | 0.842 mm STANDARD_DEVIATION 0.3628 | 0.762 mm STANDARD_DEVIATION 0.1804 | 0.986 mm STANDARD_DEVIATION 0.374 | 0.908 mm STANDARD_DEVIATION 0.3691 |
| Race/Ethnicity, Customized Black, of African Heritage | 0 participants | 1 participants | 0 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized White, Hispanic or Latino | 0 participants | 6 participants | 0 participants | 6 participants | 12 participants |
| Race/Ethnicity, Customized White, Non-Hispanic and Non-Latino | 3 participants | 44 participants | 3 participants | 46 participants | 96 participants |
| Reference Diameter | 2.668 mm STANDARD_DEVIATION 0.0753 | 2.577 mm STANDARD_DEVIATION 0.3899 | 2.650 mm STANDARD_DEVIATION 0.429 | 2.703 mm STANDARD_DEVIATION 0.4664 | 2.643 mm STANDARD_DEVIATION 0.4259 |
| Sex: Female, Male Female | 1 Participants | 20 Participants | 1 Participants | 15 Participants | 37 Participants |
| Sex: Female, Male Male | 2 Participants | 31 Participants | 2 Participants | 40 Participants | 75 Participants |
| Weight | 82.80 kg STANDARD_DEVIATION 10.318 | 83.56 kg STANDARD_DEVIATION 13.659 | 91.33 kg STANDARD_DEVIATION 21.333 | 85.01 kg STANDARD_DEVIATION 17.915 | 84.46 kg STANDARD_DEVIATION 15.88 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 34 / 51 | 3 / 3 | 31 / 55 |
| serious Total, serious adverse events | 0 / 3 | 14 / 51 | 0 / 3 | 18 / 55 |
Outcome results
Primary
Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month
Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.
Time frame: From the day of Percutaneous Coronary Intervention to 1 Month.
Population: Treated population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month | 0 participants |
| 22 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month | 1 participants |
| 35 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month | 0 participants |
| 45 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month | 1 participants |
Comparison: The statistical testing of treatment difference is for exploratory purposes.p-value: >0.999Fisher Exact
Primary
Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months
Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.
Time frame: From the day of Percutaneous Coronary Intervention to Month 6.
Population: Treated population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months | 0 participants |
| 22 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months | 7 participants |
| 35 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months | 0 participants |
| 45 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months | 16 participants |
Comparison: The statistical testing of treatment difference is for exploratory purposes.p-value: 0.061Fisher Exact
Primary
Number of Participants With Procedural Complications
Procedural complications include the following: 1. Haemodynamic monitoring: changes in heart rate, arterial blood pressure or electrocardiogram changes; 2. Arrhythmia: premature ventricular complexes, brady or tachyarrhythmia; 3. Allergic reactions: rash, flushing, pyrexia, urticaria, angio-oedema; 4. Angiographic complications: coronary artery spasm, dissection, thrombosis, TIMI (Thrombolysis In Myocardial Infarction) flow, no reflow; 5. Clinical changes: chest pain.
Time frame: From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).
Population: Treated population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Procedural Complications | 1 participants |
| 22 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Procedural Complications | 5 participants |
| 35 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Procedural Complications | 1 participants |
| 45 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Procedural Complications | 9 participants |
Comparison: The statistical testing of treatment difference is for exploratory purposes.p-value: 0.396Fisher Exact
Primary
Number of Participants With Treatment Emergent Adverse Events (AEs)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that: * is fatal or life threatening * results in persistent or significant disability or or incapacity; * requires or prolongs existing hospitalization; * is a congenital anomaly/birth defect in the offspring of a patient who received medication; * conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.
Time frame: Up to 6 months.
Population: Treated population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Treatment Emergent Adverse Events (AEs) | Patients with at Least 1 AE | 3 participants |
| 10 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Treatment Emergent Adverse Events (AEs) | Patients with at Least 1 Serious AE | 0 participants |
| 22 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Treatment Emergent Adverse Events (AEs) | Patients with at Least 1 Serious AE | 14 participants |
| 22 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Treatment Emergent Adverse Events (AEs) | Patients with at Least 1 AE | 43 participants |
| 35 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Treatment Emergent Adverse Events (AEs) | Patients with at Least 1 AE | 3 participants |
| 35 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Treatment Emergent Adverse Events (AEs) | Patients with at Least 1 Serious AE | 0 participants |
| 45 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Treatment Emergent Adverse Events (AEs) | Patients with at Least 1 AE | 48 participants |
| 45 mg/m^2 Nanoparticle Paclitaxel | Number of Participants With Treatment Emergent Adverse Events (AEs) | Patients with at Least 1 Serious AE | 18 participants |
Comparison: Comparison of the number of patients with any treatment emergent adverse event. The statistical testing of treatment difference is for exploratory purposes.p-value: 0.783Fisher Exact
Primary
Phase I: Number of Participants With Dose-limiting Toxicities
Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting. The maximum tolerated dose was defined as the lesser of 45 mg/m\^2 or the dose at which any drug related toxicities were observed.
Time frame: Up to 1 week following percutaneous coronary intervention.
Population: Phase I treated population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 mg/m^2 Nanoparticle Paclitaxel | Phase I: Number of Participants With Dose-limiting Toxicities | 0 participants |
| 22 mg/m^2 Nanoparticle Paclitaxel | Phase I: Number of Participants With Dose-limiting Toxicities | 0 participants |
| 35 mg/m^2 Nanoparticle Paclitaxel | Phase I: Number of Participants With Dose-limiting Toxicities | 0 participants |
| 45 mg/m^2 Nanoparticle Paclitaxel | Phase I: Number of Participants With Dose-limiting Toxicities | 0 participants |
Secondary
Late Lumen Loss
Late lumen loss represents the extent of neointimal hyperplasia within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) and was measured by quantitative coronary angiography. Late Loss = Minimum Lumen Diameter (MLD) Post Procedure minus the MLD at Follow-up.
Time frame: Day 0 (post-procedure baseline) and 6 months.
Population: Treated population for whom data was available (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg/m^2 Nanoparticle Paclitaxel | Late Lumen Loss | In-stent [n=3, 46, 3, 50] | 0.403 mm | Standard Deviation 0.2267 |
| 10 mg/m^2 Nanoparticle Paclitaxel | Late Lumen Loss | In-segment [n=3, 47, 3, 50] | 0.281 mm | Standard Deviation 0.2116 |
| 22 mg/m^2 Nanoparticle Paclitaxel | Late Lumen Loss | In-stent [n=3, 46, 3, 50] | 0.871 mm | Standard Deviation 0.4188 |
| 22 mg/m^2 Nanoparticle Paclitaxel | Late Lumen Loss | In-segment [n=3, 47, 3, 50] | 0.631 mm | Standard Deviation 0.407 |
| 35 mg/m^2 Nanoparticle Paclitaxel | Late Lumen Loss | In-segment [n=3, 47, 3, 50] | 0.355 mm | Standard Deviation 0.3101 |
| 35 mg/m^2 Nanoparticle Paclitaxel | Late Lumen Loss | In-stent [n=3, 46, 3, 50] | 0.747 mm | Standard Deviation 0.1626 |
| 45 mg/m^2 Nanoparticle Paclitaxel | Late Lumen Loss | In-segment [n=3, 47, 3, 50] | 0.697 mm | Standard Deviation 0.5323 |
| 45 mg/m^2 Nanoparticle Paclitaxel | Late Lumen Loss | In-stent [n=3, 46, 3, 50] | 0.835 mm | Standard Deviation 0.5328 |
Comparison: Comparison of in-stent late lumen loss. The statistical testing of treatment difference is for exploratory purposes.p-value: 0.709Fisher Exact
Comparison: Comparison of in-segment late lumen loss. The statistical testing of treatment difference is for exploratory purposes.p-value: 0.495Fisher Exact
Secondary
Percentage of In-Stent Volume Obstruction at 6 Months
In-stent volume obstruction at 6 months was measured by intra-vascular ultrasound (IVUS) and centrally assessed by the IVUS Core Laboratory. Percent in-stent volume obstruction was calculated as neointimal volume / stent volume \* 100.
Time frame: 6 months
Population: Treated population for whom data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 mg/m^2 Nanoparticle Paclitaxel | Percentage of In-Stent Volume Obstruction at 6 Months | 14.080 Percentage of obstruction | Standard Deviation 11.5163 |
| 22 mg/m^2 Nanoparticle Paclitaxel | Percentage of In-Stent Volume Obstruction at 6 Months | 24.908 Percentage of obstruction | Standard Deviation 15.322 |
| 35 mg/m^2 Nanoparticle Paclitaxel | Percentage of In-Stent Volume Obstruction at 6 Months | 31.016 Percentage of obstruction | Standard Deviation 8.9722 |
| 45 mg/m^2 Nanoparticle Paclitaxel | Percentage of In-Stent Volume Obstruction at 6 Months | 21.663 Percentage of obstruction | Standard Deviation 14.0249 |
p-value: 0.317ANOVA
Secondary
Percentage of Participants With Binary Restenosis
Binary restenosis was assessed by quantitative coronary angiography and defined as \>50% diameter stenosis within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) at follow-up. Angiograms were centrally assessed by the Angiographic Core Laboratory.
Time frame: 6 months
Population: Treated Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10 mg/m^2 Nanoparticle Paclitaxel | Percentage of Participants With Binary Restenosis | In-stent | 0.0 percentage of participants |
| 10 mg/m^2 Nanoparticle Paclitaxel | Percentage of Participants With Binary Restenosis | In-segment | 0.0 percentage of participants |
| 22 mg/m^2 Nanoparticle Paclitaxel | Percentage of Participants With Binary Restenosis | In-segment | 27.5 percentage of participants |
| 22 mg/m^2 Nanoparticle Paclitaxel | Percentage of Participants With Binary Restenosis | In-stent | 25.5 percentage of participants |
| 35 mg/m^2 Nanoparticle Paclitaxel | Percentage of Participants With Binary Restenosis | In-stent | 0.0 percentage of participants |
| 35 mg/m^2 Nanoparticle Paclitaxel | Percentage of Participants With Binary Restenosis | In-segment | 0.0 percentage of participants |
| 45 mg/m^2 Nanoparticle Paclitaxel | Percentage of Participants With Binary Restenosis | In-stent | 34.5 percentage of participants |
| 45 mg/m^2 Nanoparticle Paclitaxel | Percentage of Participants With Binary Restenosis | In-segment | 34.5 percentage of participants |
Comparison: Comparison of in-stent binary restenosis. The statistical testing of treatment difference is for exploratory purposes.p-value: 0.293Fisher Exact
Comparison: Comparison of in-segment binary restenosis. The statistical testing of treatment difference is for exploratory purposesp-value: 0.4Fisher Exact