Trial Outcomes & Findings for The Dual Antiplatelet Therapy Study (DAPT Study) (NCT NCT00977938)

Last Updated: 2017-06-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25682 participants

Primary outcome timeframe

18 months (12-30 months post-index procedure)

Results posted on

2017-06-09

Participant Flow

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).

Participant milestones

Participant milestones
Measure	DES 30-month DAPT Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).	DES 12-month DAPT Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).	BMS 30-month DAPT Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).	BMS 12-month DAPT Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
Treatment (12-30 mo. Post Procedure) STARTED	5020	4941	842	845
Treatment (12-30 mo. Post Procedure) COMPLETED	4783	4716	796	784
Treatment (12-30 mo. Post Procedure) NOT COMPLETED	237	225	46	61
Observation (30-33 mo. Post Procedure) STARTED	4783	4716	796	784
Observation (30-33 mo. Post Procedure) COMPLETED	4732	4658	784	781
Observation (30-33 mo. Post Procedure) NOT COMPLETED	51	58	12	3

Reasons for withdrawal

Reasons for withdrawal
Measure	DES 30-month DAPT Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).	DES 12-month DAPT Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).	BMS 30-month DAPT Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).	BMS 12-month DAPT Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
Treatment (12-30 mo. Post Procedure) Withdrawal by Subject	132	116	13	20
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
Observation (30-33 mo. Post Procedure) Withdrawal by Subject	9	12	2	0
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

Baseline Characteristics

The Dual Antiplatelet Therapy Study (DAPT Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DES 30-month DAPT n=5020 Participants 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	DES 12-month DAPT n=4941 Participants 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	BMS 30-month DAPT n=842 Participants 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	BMS 12-month DAPT n=845 Participants 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	Total n=11648 Participants Total of all reporting groups
Age, Continuous	61.84 years STANDARD_DEVIATION 10.18 • n=5 Participants	61.60 years STANDARD_DEVIATION 10.12 • n=7 Participants	58.86 years STANDARD_DEVIATION 10.54 • n=5 Participants	59.18 years STANDARD_DEVIATION 11.07 • n=4 Participants	61.33 years STANDARD_DEVIATION 10.29 • n=21 Participants
Sex: Female, Male Female	1242 Participants n=5 Participants	1284 Participants n=7 Participants	215 Participants n=5 Participants	184 Participants n=4 Participants	2925 Participants n=21 Participants
Sex: Female, Male Male	3778 Participants n=5 Participants	3657 Participants n=7 Participants	627 Participants n=5 Participants	661 Participants n=4 Participants	8723 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	17 participants n=5 Participants	41 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	60 participants n=21 Participants
Race/Ethnicity, Customized Asian	48 participants n=5 Participants	35 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	88 participants n=21 Participants
Race/Ethnicity, Customized Black or African American	252 participants n=5 Participants	253 participants n=7 Participants	38 participants n=5 Participants	33 participants n=4 Participants	576 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	13 participants n=5 Participants	9 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	24 participants n=21 Participants
Race/Ethnicity, Customized White	4480 participants n=5 Participants	4428 participants n=7 Participants	768 participants n=5 Participants	774 participants n=4 Participants	10450 participants n=21 Participants
Race/Ethnicity, Customized Other	108 participants n=5 Participants	106 participants n=7 Participants	20 participants n=5 Participants	23 participants n=4 Participants	257 participants n=21 Participants
Region of Enrollment North America	4502 participants n=5 Participants	4416 participants n=7 Participants	509 participants n=5 Participants	519 participants n=4 Participants	9946 participants n=21 Participants
Region of Enrollment Europe	402 participants n=5 Participants	405 participants n=7 Participants	304 participants n=5 Participants	300 participants n=4 Participants	1411 participants n=21 Participants
Region of Enrollment Australia	47 participants n=5 Participants	55 participants n=7 Participants	14 participants n=5 Participants	12 participants n=4 Participants	128 participants n=21 Participants
Region of Enrollment New Zealand	69 participants n=5 Participants	65 participants n=7 Participants	15 participants n=5 Participants	14 participants n=4 Participants	163 participants n=21 Participants
weight	91.49 kg STANDARD_DEVIATION 19.74 • n=5 Participants	91.52 kg STANDARD_DEVIATION 19.43 • n=7 Participants	87.99 kg STANDARD_DEVIATION 18.40 • n=5 Participants	88.54 kg STANDARD_DEVIATION 18.77 • n=4 Participants	91.04 kg STANDARD_DEVIATION 19.48 • n=21 Participants
Body Mass Index (BMI)	30.54 kg/m2 STANDARD_DEVIATION 5.79 • n=5 Participants	30.55 kg/m2 STANDARD_DEVIATION 5.77 • n=7 Participants	29.49 kg/m2 STANDARD_DEVIATION 5.18 • n=5 Participants	29.61 kg/m2 STANDARD_DEVIATION 5.55 • n=4 Participants	30.40 kg/m2 STANDARD_DEVIATION 5.73 • n=21 Participants
Diabetes Mellitus	1556 participants n=5 Participants	1481 participants n=7 Participants	181 participants n=5 Participants	173 participants n=4 Participants	3391 participants n=21 Participants
Hypertension	3796 participants n=5 Participants	3649 participants n=7 Participants	534 participants n=5 Participants	543 participants n=4 Participants	8522 participants n=21 Participants
Current cigarette smoker or within past year	1222 participants n=5 Participants	1210 participants n=7 Participants	360 participants n=5 Participants	350 participants n=4 Participants	3142 participants n=21 Participants
Stroke/Transient Ischemic Attack (TIA)	155 participants n=5 Participants	169 participants n=7 Participants	43 participants n=5 Participants	34 participants n=4 Participants	401 participants n=21 Participants
Congestive heart failure	238 participants n=5 Participants	223 participants n=7 Participants	35 participants n=5 Participants	28 participants n=4 Participants	524 participants n=21 Participants
Peripheral arterial disease	284 participants n=5 Participants	284 participants n=7 Participants	35 participants n=5 Participants	46 participants n=4 Participants	649 participants n=21 Participants
Prior percutaneous coronary intervention (PCI)	1518 participants n=5 Participants	1529 participants n=7 Participants	150 participants n=5 Participants	171 participants n=4 Participants	3368 participants n=21 Participants
Prior coronary artery bypass graf (CABG)	568 participants n=5 Participants	581 participants n=7 Participants	50 participants n=5 Participants	50 participants n=4 Participants	1249 participants n=21 Participants
Prior myocardial infarction (MI)	1092 participants n=5 Participants	1026 participants n=7 Participants	160 participants n=5 Participants	178 participants n=4 Participants	2456 participants n=21 Participants
Indication for PCI ST elevation MI (STEMI)	534 participants n=5 Participants	511 participants n=7 Participants	311 participants n=5 Participants	324 participants n=4 Participants	1680 participants n=21 Participants
Indication for PCI Non-ST elevation MI (NSTEMI)	776 participants n=5 Participants	767 participants n=7 Participants	184 participants n=5 Participants	169 participants n=4 Participants	1896 participants n=21 Participants
Indication for PCI Unstable angina	838 participants n=5 Participants	825 participants n=7 Participants	77 participants n=5 Participants	81 participants n=4 Participants	1821 participants n=21 Participants
Indication for PCI Stable angina	1882 participants n=5 Participants	1870 participants n=7 Participants	199 participants n=5 Participants	198 participants n=4 Participants	4149 participants n=21 Participants
Indication for PCI Other	990 participants n=5 Participants	968 participants n=7 Participants	71 participants n=5 Participants	73 participants n=4 Participants	2102 participants n=21 Participants
Any risk factor for stent thrombosis	2410 participants n=5 Participants	2389 participants n=7 Participants	568 participants n=5 Participants	569 participants n=4 Participants	5936 participants n=21 Participants
Number of treated lesions (per-patient)	1.30 lesions STANDARD_DEVIATION 0.55 • n=5 Participants	1.29 lesions STANDARD_DEVIATION 0.54 • n=7 Participants	1.16 lesions STANDARD_DEVIATION 0.40 • n=5 Participants	1.17 lesions STANDARD_DEVIATION 0.42 • n=4 Participants	1.28 lesions STANDARD_DEVIATION 0.53 • n=21 Participants
Number of treated vessels (per-patient)	1.11 vessels STANDARD_DEVIATION 0.33 • n=5 Participants	1.12 vessels STANDARD_DEVIATION 0.34 • n=7 Participants	1.03 vessels STANDARD_DEVIATION 0.18 • n=5 Participants	1.05 vessels STANDARD_DEVIATION 0.23 • n=4 Participants	1.11 vessels STANDARD_DEVIATION 0.32 • n=21 Participants
Number of stents (per-patient)	1.47 stents STANDARD_DEVIATION 0.75 • n=5 Participants	1.45 stents STANDARD_DEVIATION 0.75 • n=7 Participants	1.32 stents STANDARD_DEVIATION 0.60 • n=5 Participants	1.32 stents STANDARD_DEVIATION 0.60 • n=4 Participants	1.44 stents STANDARD_DEVIATION 0.73 • n=21 Participants
Minimum stent diameter (per-patient) <3 mm	2341 participants n=5 Participants	2293 participants n=7 Participants	201 participants n=5 Participants	206 participants n=4 Participants	5041 participants n=21 Participants
Minimum stent diameter (per-patient) ≥3 mm	2679 participants n=5 Participants	2648 participants n=7 Participants	641 participants n=5 Participants	639 participants n=4 Participants	6607 participants n=21 Participants
Total stent length (per-patient)	27.70 mm STANDARD_DEVIATION 16.77 • n=5 Participants	27.43 mm STANDARD_DEVIATION 17.02 • n=7 Participants	23.96 mm STANDARD_DEVIATION 13.01 • n=5 Participants	23.85 mm STANDARD_DEVIATION 13.12 • n=4 Participants	27.04 mm STANDARD_DEVIATION 16.44 • n=21 Participants
Treated Vessel Left main	55 lesions n=5 Participants	55 lesions n=7 Participants	0 lesions n=5 Participants	1 lesions n=4 Participants	111 lesions n=21 Participants
Treated Vessel Left anterior descending (LAD)	2715 lesions n=5 Participants	2586 lesions n=7 Participants	308 lesions n=5 Participants	306 lesions n=4 Participants	5915 lesions n=21 Participants
Treated Vessel Right coronary artery (RCA)	2153 lesions n=5 Participants	2057 lesions n=7 Participants	437 lesions n=5 Participants	452 lesions n=4 Participants	5099 lesions n=21 Participants
Treated Vessel Circumflex	1473 lesions n=5 Participants	1506 lesions n=7 Participants	206 lesions n=5 Participants	207 lesions n=4 Participants	3392 lesions n=21 Participants
Treated Vessel Venous graft	154 lesions n=5 Participants	173 lesions n=7 Participants	24 lesions n=5 Participants	25 lesions n=4 Participants	376 lesions n=21 Participants
Treated Vessel Arterial graft	36 lesions n=5 Participants	30 lesions n=7 Participants	0 lesions n=5 Participants	0 lesions n=4 Participants	66 lesions n=21 Participants
Modified ACC-AHA lesion class B2 or C	2754 lesions n=5 Participants	2643 lesions n=7 Participants	440 lesions n=5 Participants	450 lesions n=4 Participants	6287 lesions n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=5020 Participants 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	DES 12-month DAPT n=4941 Participants 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
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT	4.34 percentage of patients (KM estimate)	5.92 percentage of patients (KM estimate)

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=5020 Participants 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	DES 12-month DAPT n=4941 Participants 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
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT	0.40 percentage of patients (KM estimate)	1.35 percentage of patients (KM estimate)

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=4710 Participants 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	DES 12-month DAPT n=4649 Participants 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
GUSTO Severe or Moderate Bleeding - Randomized DES ITT	2.53 percentage of patients	1.57 percentage of patients

SECONDARY outcome

Timeframe: 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.

Secondary powered endpoint

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=8308 Participants 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	DES 12-month DAPT n=1718 Participants 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
MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS	11.37 percentage of patients	13.24 percentage of patients

SECONDARY outcome

Timeframe: 33 months (0-33 months post-index procedure)

Secondary powered endpoint

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=8308 Participants 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	DES 12-month DAPT n=1718 Participants 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
Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS	1.70 percentage of patients	2.61 percentage of patients

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=5020 Participants 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	DES 12-month DAPT n=4941 Participants 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
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT	5.62 percentage of patients (KM estimate)	6.49 percentage of patients (KM estimate)

SECONDARY outcome

Timeframe: 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.

ST was assessed according to the Academic Research Consortium (ARC) definitions.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=5020 Participants 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	DES 12-month DAPT n=4941 Participants 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
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT	0.69 percentage of patients (KM estimate)	1.45 percentage of patients (KM estimate)

SECONDARY outcome

Timeframe: 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).

Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=4525 Participants 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	DES 12-month DAPT n=4476 Participants 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
GUSTO Severe or Moderate Bleeding - Randomized DES ITT	2.74 percentage of patients	1.88 percentage of patients

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=842 Participants 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	DES 12-month DAPT n=845 Participants 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
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT	4.04 percentage of patients (KM estimate)	4.69 percentage of patients (KM estimate)

SECONDARY outcome

Timeframe: 18 months (12-30 months post-index procedure)

ST was assessed according to the Academic Research Consortium (ARC) definitions.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=842 Participants 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	DES 12-month DAPT n=845 Participants 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
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT	0.50 percentage of patients (KM estimate)	1.11 percentage of patients (KM estimate)

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=790 Participants 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	DES 12-month DAPT n=776 Participants 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
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT	2.03 percentage of patients	0.90 percentage of patients

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=842 Participants 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	DES 12-month DAPT n=845 Participants 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
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT	4.68 percentage of patients (KM estimate)	5.48 percentage of patients (KM estimate)

SECONDARY outcome

Timeframe: 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.

ST was assessed according to the Academic Research Consortium (ARC) definitions.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=842 Participants 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	DES 12-month DAPT n=845 Participants 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
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT	0.50 percentage of patients (KM estimate)	1.11 percentage of patients (KM estimate)

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DES 30-month DAPT n=766 Participants 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	DES 12-month DAPT n=759 Participants 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
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT	2.09 percentage of patients	1.05 percentage of patients

Adverse Events

HCRI DAPT - DES 30-month DAPT

Serious events: 617 serious events

Other events: 0 other events

Deaths: 0 deaths

HCRI DAPT - DES 12-month DAPT

Serious events: 572 serious events

Other events: 0 other events

Deaths: 0 deaths

HCRI DAPT - BMS 30-month DAPT

Serious events: 144 serious events

Other events: 0 other events

Deaths: 0 deaths

HCRI DAPT - BMS 12-month DAPT

Serious events: 150 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	HCRI DAPT - DES 30-month DAPT n=2642 participants at risk Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT	HCRI DAPT - DES 12-month DAPT n=2634 participants at risk Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT	HCRI DAPT - BMS 30-month DAPT n=842 participants at risk Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT	HCRI DAPT - BMS 12-month DAPT n=845 participants at risk Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
Cardiac disorders AEs were not collected in the DAPT Trial	— 0/0 • 12-33 months post-index procedure (randomization to 33 months post-index procedure)	— 0/0 • 12-33 months post-index procedure (randomization to 33 months post-index procedure)	— 0/0 • 12-33 months post-index procedure (randomization to 33 months post-index procedure)	— 0/0 • 12-33 months post-index procedure (randomization to 33 months post-index procedure)

Additional Information

Priscilla Driscoll Shempp, Sr. Director Trial Design, Development and Strategy

Harvard Clinical Research Institute

Phone: 617.307.5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place