Coronary Artery Disease
Conditions
Keywords
Acute Coronary Syndrome, Adverse event, Antiplatelet therapy, Sirolimus, Everolimus, Paclitaxel, Zotarolimus, Bare Metal Stent, Drug Eluting Stent, Clinical Events Committee, Dual antiplatelet therapy, Harvard Clinical Research Institute, Major Adverse Cardiac and Cerebral Event, Major Bleeding, Myocardial infarction, Myocardial ischemia, Percutaneous coronary intervention, Stent placement, Stent Thrombosis, Thienopyridine, Clopidogrel, Prasugrel
Brief summary
The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.
Detailed description
Subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention (PCI) with stent placement and no contraindications to prolonged dual antiplatelet therapy are eligible to be enrolled in the study. All enrolled subjects will undergo PCI with stent placement. All enrolled subjects will be treated with either an FDA-approved drug eluting stent(s) (DES) or an FDA-approved bare metal stent(s) (BMS) (per their respective Instructions for Use) and assigned to 12 months of open label FDA-approved thienopyridine treatment in addition to aspirin. Operators will select the thienopyridine according to the package insert. Thienopyridine treatment dose will be according to the standard of practice and prescribing information for the selected medication. Aspirin treatment will be 75-325 mg for the first 6 months after the procedure and 75-162 mg subsequently, to be continued indefinitely. All DES or BMS subjects who are treated with 12 months of dual antiplatelet therapy post index procedure and who are event free per protocol will be eligible for randomization to either placebo (12 m DAPT Study arm) or an additional 18 months of thienopyridine treatment (30 m DAPT Study arm). Both arms will continue aspirin therapy. Up to four (4) separate post-market approval studies will be allowed to incorporate the randomized design of the DAPT Study for a subset of subjects who may then be contributed for the DAPT Study analyses.
Interventions
Sponsors
Abbott
Boston Scientific Corporation
Bristol-Myers Squibb
Sanofi-Synthelabo
Cordis US Corp.
Eli Lilly and Company
Daiichi Sankyo
Medtronic
Baim Institute for Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Enrollment): 1. Subject is \> 18 years of age. 2. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours). 3. Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation. 4. The subject has consented to participate and has authorized the collection and release of his medical information by signing the Patient Informed Consent Form. The informed consent will be valid for the duration of the trial or until the subject withdraws. Inclusion Criterion (Randomization at 12 months): 1\. Subject, at 12 months, is free from death, MI, stroke, repeat coronary revascularization, major bleeding, and stent thrombosis and has been compliant with dual antiplatelet therapy following stent implantation.
Exclusion criteria
(Enrollment): 1. Index procedure stent placement with stent diameter \<2.25 mm or \>4.0 mm. 2. Pregnant women. 3. Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment. 4. Current medical condition with a life expectancy of less than 3 years. 5. Concurrent enrollment in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a DES or BMS other than those included as DAPT Study devices. The subject may only be enrolled in the DAPT Study once. 6. Subjects on warfarin or similar anticoagulant therapy. 7. Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted. 8. Subjects unable to give informed consent. 9. Subject treated with both DES and BMS during the index procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | 18 months (12-30 months post-index procedure) | The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure. |
| Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | 18 months (12-30 months post-index procedure) | The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions. |
| GUSTO Severe or Moderate Bleeding - Randomized DES ITT | 18 months (12-30 months post-index procedure) | The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | 21 months (12-33 months post-index procedure) | ST was assessed according to the Academic Research Consortium (ARC) definitions. |
| GUSTO Severe or Moderate Bleeding - Randomized DES ITT | 21 months (12-33 months post-index procedure) | Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. |
| MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS | 33 months (0-33 months post-index procedure) | Secondary powered endpoint |
| Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT | 18 months (12-30 months post-index procedure) | ST was assessed according to the Academic Research Consortium (ARC) definitions. |
| GUSTO Severe or Moderate Bleeding - Randomized BMS ITT | 18 months (12-30 months post-index procedure) | Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. |
| MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT | 18 months (12-30 months post-index procedure) | — |
| Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS | 33 months (0-33 months post-index procedure) | Secondary powered endpoint |
| MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | 21 months (12-33 months post-index procedure) | — |
Countries
Australia, Czechia, France, Germany, Hungary, New Zealand, Poland, Romania, United Kingdom, United States
Participant flow
Recruitment details
Between 08/13/2009 and 07/01/2011, a total of 25682 patients were enrolled into the DAPT Study either by HCRI (NCT00977938; 14491 pts) or from 1 of 4 PMS studies: Abbott Xience V US (NCT01106534; 2998 pts), Boston Scientific Liberté PAS (NCT00997503; 3904 pts), Cordis CYPRESS (NCT00954707; 2029 pts) and Medtronic EDUCATE (NCT01069003; 2260 pts).
Participants by arm
| Arm | Count |
|---|---|
| DES 30-month DAPT Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT | 5,020 |
| DES 12-month DAPT Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT | 4,941 |
| BMS 30-month DAPT Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT | 842 |
| BMS 12-month DAPT Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT | 845 |
| Total | 11,648 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Observation (30-33 mo. Post Procedure) | Lost to Follow-up | 34 | 42 | 10 | 3 |
| Observation (30-33 mo. Post Procedure) | Other | 8 | 4 | 0 | 0 |
| Observation (30-33 mo. Post Procedure) | Withdrawal by Subject | 9 | 12 | 2 | 0 |
| Treatment (12-30 mo. Post Procedure) | Lost to Follow-up | 88 | 91 | 30 | 37 |
| Treatment (12-30 mo. Post Procedure) | Other | 17 | 18 | 3 | 4 |
| Treatment (12-30 mo. Post Procedure) | Withdrawal by Subject | 132 | 116 | 13 | 20 |
Baseline characteristics
| Characteristic | DES 30-month DAPT | BMS 12-month DAPT | BMS 30-month DAPT | DES 12-month DAPT | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.84 years STANDARD_DEVIATION 10.18 | 59.18 years STANDARD_DEVIATION 11.07 | 58.86 years STANDARD_DEVIATION 10.54 | 61.60 years STANDARD_DEVIATION 10.12 | 61.33 years STANDARD_DEVIATION 10.29 |
| Any risk factor for stent thrombosis | 2410 participants | 569 participants | 568 participants | 2389 participants | 5936 participants |
| Body Mass Index (BMI) | 30.54 kg/m2 STANDARD_DEVIATION 5.79 | 29.61 kg/m2 STANDARD_DEVIATION 5.55 | 29.49 kg/m2 STANDARD_DEVIATION 5.18 | 30.55 kg/m2 STANDARD_DEVIATION 5.77 | 30.40 kg/m2 STANDARD_DEVIATION 5.73 |
| Congestive heart failure | 238 participants | 28 participants | 35 participants | 223 participants | 524 participants |
| Current cigarette smoker or within past year | 1222 participants | 350 participants | 360 participants | 1210 participants | 3142 participants |
| Diabetes Mellitus | 1556 participants | 173 participants | 181 participants | 1481 participants | 3391 participants |
| Hypertension | 3796 participants | 543 participants | 534 participants | 3649 participants | 8522 participants |
| Indication for PCI Non-ST elevation MI (NSTEMI) | 776 participants | 169 participants | 184 participants | 767 participants | 1896 participants |
| Indication for PCI Other | 990 participants | 73 participants | 71 participants | 968 participants | 2102 participants |
| Indication for PCI Stable angina | 1882 participants | 198 participants | 199 participants | 1870 participants | 4149 participants |
| Indication for PCI ST elevation MI (STEMI) | 534 participants | 324 participants | 311 participants | 511 participants | 1680 participants |
| Indication for PCI Unstable angina | 838 participants | 81 participants | 77 participants | 825 participants | 1821 participants |
| Minimum stent diameter (per-patient) <3 mm | 2341 participants | 206 participants | 201 participants | 2293 participants | 5041 participants |
| Minimum stent diameter (per-patient) ≥3 mm | 2679 participants | 639 participants | 641 participants | 2648 participants | 6607 participants |
| Modified ACC-AHA lesion class B2 or C | 2754 lesions | 450 lesions | 440 lesions | 2643 lesions | 6287 lesions |
| Number of stents (per-patient) | 1.47 stents STANDARD_DEVIATION 0.75 | 1.32 stents STANDARD_DEVIATION 0.6 | 1.32 stents STANDARD_DEVIATION 0.6 | 1.45 stents STANDARD_DEVIATION 0.75 | 1.44 stents STANDARD_DEVIATION 0.73 |
| Number of treated lesions (per-patient) | 1.30 lesions STANDARD_DEVIATION 0.55 | 1.17 lesions STANDARD_DEVIATION 0.42 | 1.16 lesions STANDARD_DEVIATION 0.4 | 1.29 lesions STANDARD_DEVIATION 0.54 | 1.28 lesions STANDARD_DEVIATION 0.53 |
| Number of treated vessels (per-patient) | 1.11 vessels STANDARD_DEVIATION 0.33 | 1.05 vessels STANDARD_DEVIATION 0.23 | 1.03 vessels STANDARD_DEVIATION 0.18 | 1.12 vessels STANDARD_DEVIATION 0.34 | 1.11 vessels STANDARD_DEVIATION 0.32 |
| Peripheral arterial disease | 284 participants | 46 participants | 35 participants | 284 participants | 649 participants |
| Prior coronary artery bypass graf (CABG) | 568 participants | 50 participants | 50 participants | 581 participants | 1249 participants |
| Prior myocardial infarction (MI) | 1092 participants | 178 participants | 160 participants | 1026 participants | 2456 participants |
| Prior percutaneous coronary intervention (PCI) | 1518 participants | 171 participants | 150 participants | 1529 participants | 3368 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 17 participants | 2 participants | 0 participants | 41 participants | 60 participants |
| Race/Ethnicity, Customized Asian | 48 participants | 2 participants | 3 participants | 35 participants | 88 participants |
| Race/Ethnicity, Customized Black or African American | 252 participants | 33 participants | 38 participants | 253 participants | 576 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 13 participants | 1 participants | 1 participants | 9 participants | 24 participants |
| Race/Ethnicity, Customized Other | 108 participants | 23 participants | 20 participants | 106 participants | 257 participants |
| Race/Ethnicity, Customized White | 4480 participants | 774 participants | 768 participants | 4428 participants | 10450 participants |
| Region of Enrollment Australia | 47 participants | 12 participants | 14 participants | 55 participants | 128 participants |
| Region of Enrollment Europe | 402 participants | 300 participants | 304 participants | 405 participants | 1411 participants |
| Region of Enrollment New Zealand | 69 participants | 14 participants | 15 participants | 65 participants | 163 participants |
| Region of Enrollment North America | 4502 participants | 519 participants | 509 participants | 4416 participants | 9946 participants |
| Sex: Female, Male Female | 1242 Participants | 184 Participants | 215 Participants | 1284 Participants | 2925 Participants |
| Sex: Female, Male Male | 3778 Participants | 661 Participants | 627 Participants | 3657 Participants | 8723 Participants |
| Stroke/Transient Ischemic Attack (TIA) | 155 participants | 34 participants | 43 participants | 169 participants | 401 participants |
| Total stent length (per-patient) | 27.70 mm STANDARD_DEVIATION 16.77 | 23.85 mm STANDARD_DEVIATION 13.12 | 23.96 mm STANDARD_DEVIATION 13.01 | 27.43 mm STANDARD_DEVIATION 17.02 | 27.04 mm STANDARD_DEVIATION 16.44 |
| Treated Vessel Arterial graft | 36 lesions | 0 lesions | 0 lesions | 30 lesions | 66 lesions |
| Treated Vessel Circumflex | 1473 lesions | 207 lesions | 206 lesions | 1506 lesions | 3392 lesions |
| Treated Vessel Left anterior descending (LAD) | 2715 lesions | 306 lesions | 308 lesions | 2586 lesions | 5915 lesions |
| Treated Vessel Left main | 55 lesions | 1 lesions | 0 lesions | 55 lesions | 111 lesions |
| Treated Vessel Right coronary artery (RCA) | 2153 lesions | 452 lesions | 437 lesions | 2057 lesions | 5099 lesions |
| Treated Vessel Venous graft | 154 lesions | 25 lesions | 24 lesions | 173 lesions | 376 lesions |
| weight | 91.49 kg STANDARD_DEVIATION 19.74 | 88.54 kg STANDARD_DEVIATION 18.77 | 87.99 kg STANDARD_DEVIATION 18.4 | 91.52 kg STANDARD_DEVIATION 19.43 | 91.04 kg STANDARD_DEVIATION 19.48 |
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 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 617 / 2,642 | 572 / 2,634 | 144 / 842 | 150 / 845 |
Outcome results
Primary
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions.
Time frame: 18 months (12-30 months post-index procedure)
Population: All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | 0.40 percentage of patients (KM estimate) |
| DES 12-month DAPT | Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | 1.35 percentage of patients (KM estimate) |
Comparison: The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.p-value: <0.00195% CI: [0.17, 0.48]Log Rank
Primary
GUSTO Severe or Moderate Bleeding - Randomized DES ITT
The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
Time frame: 18 months (12-30 months post-index procedure)
Population: Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | GUSTO Severe or Moderate Bleeding - Randomized DES ITT | 2.53 percentage of patients |
| DES 12-month DAPT | GUSTO Severe or Moderate Bleeding - Randomized DES ITT | 1.57 percentage of patients |
p-value: 0.70495% CI: [0.38, 1.53]Farrington-Manning
Primary
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure.
Time frame: 18 months (12-30 months post-index procedure)
Population: All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | 4.34 percentage of patients (KM estimate) |
| DES 12-month DAPT | MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | 5.92 percentage of patients (KM estimate) |
Comparison: The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.p-value: <0.00195% CI: [0.59, 0.85]Log Rank
Secondary
Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS
Secondary powered endpoint
Time frame: 33 months (0-33 months post-index procedure)
Population: A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS | 1.70 percentage of patients |
| DES 12-month DAPT | Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS | 2.61 percentage of patients |
Comparison: The null hypothesis was that DAPT patients treated with DES would have stent thrombosis rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.p-value: <0.001Nam and Kwon
Secondary
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
ST was assessed according to the Academic Research Consortium (ARC) definitions.
Time frame: 18 months (12-30 months post-index procedure)
Population: All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT | 0.50 percentage of patients (KM estimate) |
| DES 12-month DAPT | Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT | 1.11 percentage of patients (KM estimate) |
Comparison: This analysis was not powered.p-value: 0.47895% CI: [0.15, 1.64]Log Rank
Secondary
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
ST was assessed according to the Academic Research Consortium (ARC) definitions.
Time frame: 21 months (12-33 months post-index procedure)
Population: All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT | 0.50 percentage of patients (KM estimate) |
| DES 12-month DAPT | Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT | 1.11 percentage of patients (KM estimate) |
95% CI: [0.15, 1.64]
Secondary
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
ST was assessed according to the Academic Research Consortium (ARC) definitions.
Time frame: 21 months (12-33 months post-index procedure)
Population: All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | 0.69 percentage of patients (KM estimate) |
| DES 12-month DAPT | Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | 1.45 percentage of patients (KM estimate) |
95% CI: [0.29, 0.69]
Secondary
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
Time frame: 21 months (12-33 months post-index procedure)
Population: Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | GUSTO Severe or Moderate Bleeding - Randomized BMS ITT | 2.09 percentage of patients |
| DES 12-month DAPT | GUSTO Severe or Moderate Bleeding - Randomized BMS ITT | 1.05 percentage of patients |
95% CI: [-0.21, 2.28]
Secondary
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
Time frame: 18 months (12-30 months post-index procedure)
Population: Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | GUSTO Severe or Moderate Bleeding - Randomized BMS ITT | 2.03 percentage of patients |
| DES 12-month DAPT | GUSTO Severe or Moderate Bleeding - Randomized BMS ITT | 0.90 percentage of patients |
p-value: 0.70695% CI: [-0.06, 2.31]Farrington-Manning
Secondary
GUSTO Severe or Moderate Bleeding - Randomized DES ITT
Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
Time frame: 21 months (12-33 months post-index procedure)
Population: Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | GUSTO Severe or Moderate Bleeding - Randomized DES ITT | 2.74 percentage of patients |
| DES 12-month DAPT | GUSTO Severe or Moderate Bleeding - Randomized DES ITT | 1.88 percentage of patients |
95% CI: [0.24, 1.48]
Secondary
MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS
Secondary powered endpoint
Time frame: 33 months (0-33 months post-index procedure)
Population: A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS | 11.37 percentage of patients |
| DES 12-month DAPT | MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS | 13.24 percentage of patients |
Comparison: The null hypothesis was that DAPT patients treated with DES would have MACCE rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.p-value: <0.001Nam and Kwon
Secondary
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
Time frame: 21 months (12-33 months post-index procedure)
Population: All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT | 4.68 percentage of patients (KM estimate) |
| DES 12-month DAPT | MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT | 5.48 percentage of patients (KM estimate) |
95% CI: [0.58, 1.4]
Secondary
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
Time frame: 18 months (12-30 months post-index procedure)
Population: All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT | 4.04 percentage of patients (KM estimate) |
| DES 12-month DAPT | MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT | 4.69 percentage of patients (KM estimate) |
Comparison: This analysis was not powered.p-value: 0.72295% CI: [0.57, 1.47]Log Rank
Secondary
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
Time frame: 21 months (12-33 months post-index procedure)
Population: All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DES 30-month DAPT | MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | 5.62 percentage of patients (KM estimate) |
| DES 12-month DAPT | MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | 6.49 percentage of patients (KM estimate) |
95% CI: [0.7, 0.97]