EVOLVE Short DAPT Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02605447
• Collaborator: (none)
• Enrollment: 2,009
• Locations: 110
• Arm: 1
• Actual Duration (Months): 41
• Patients Per Site: 18.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: 3 months of dual antiplatelet therapy (DAPT); Device: SYNERGY Stent System	Phase 4

Detailed Description

The primary objective of the EVOLVE Short DAPT Study is to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Stent System.

The study will be conducted up to 120 sites worldwide in the United States, Europe, Japan, and Brazil with planned enrollment of up to 2,250 subjects. Clinical follow-up will be required at the following time points: 3 months, 6 months, 12 months and 15 months post index procedure.

Subjects must be treated with one of the following P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor) for 3 months following the index procedure. Subjects must be treated with aspirin for the duration of the trial. The minimum daily maintenance dose of aspirin should be 75-100 mg.

Subjects are eligible for discontinuation of P2Y12 inhibitor at 3 months if they meet both of the following criteria: subject was treated with 3 months of study required antiplatelet therapy post index procedure; and subject was free from events (stroke, MI, PCI, coronary artery bypass graft [CABG], and stent thrombosis) between the index procedure and the 3 month visit.

Subjects are not eligible for discontinuation of P2Y12 inhibitor at 3 months if any of the following criteria are met: subject who experiences a stroke, MI, PCI, CABG and/or stent thrombosis, during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject who is non-compliant with study required antiplatelet therapy during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months due to another condition requiring chronic P2Y12 inhibitor use.

All enrolled subjects who receive a SYNERGY stent must be followed at all milestones through 15-months, regardless of eligibility to discontinue P2Y12 inhibitor. Following the 3-month milestone, subjects who experience MI or stent thrombosis events should be treated per the investigator's discretion and should be followed through the 15-month visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2009 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter, Single-arm Study Designed to Assess the Safety of 3-month Dual Antiplatelet Therapy (DAPT) in Subjects at High Risk for Bleeding Undergoing Percutaneous Coronary Intervention (PCI) With the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
• Actual Study Start Date: Feb 16, 2016
• Actual Primary Completion Date: Jul 17, 2019
• Actual Study Completion Date: Jul 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYNERGY stent + 3 month DAPT Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)	Drug: 3 months of dual antiplatelet therapy (DAPT); 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin; Device: SYNERGY Stent System; SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experienced Death or Myocardial Infarction (MI) [3 to 15 months]

   Rate of death or myocardial infarction

2. Number of Participants Who Experienced Stent Thrombosis (ST) [3 to 15 months]

   Rate of stent thrombosis: definite + probable, using the Academic Research Consortium (ARC) definition Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed) Probable Clinical definition of probable stent thrombosis is considered to have occurred in the following cases: Any unexplained death within the first 30 days Irrespective of the time after the index procedure and MI in the absence of any obvious cause which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis Possible Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained death beyond 30 days.

Secondary Outcome Measures

1. Number of Participants Who Experienced Major Bleeding [3 to 15 months]

   Rate of Bleeding, per Bleeding Academic Consortium definition (BARC2, 3a, 3b, 3c, 4, 5a and 5b) Type 0: No Bleeding Type 1: Bleeding that is not actionable and does not cause the patient to seek treatment Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional Type 3a: Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents Type 3c: Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision Type 4: CABG-related bleeding within 48 hours Type 5a: Probable fatal bleeding Type 5b: Definite fatal bleeding

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:

• ≥ 75 years of age and, in the opinion of the investigator, the risk of major bleeding associated with >3 months of DAPT outweighs the benefit,

• need for chronic or lifelong anticoagulation,

• history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,

• history of stroke (ischemic or hemorrhagic),

• renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),

• platelet count ≤100,000/μL

1. Subject must be at least 18 years of age

2. Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days

3. Subject must be able to take study required antiplatelet therapy (as required per protocol)

4. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol

5. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed

6. For subjects less than 20 years of age enrolled at a Japanese site, the subject/ the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed

Exclusion Criteria:

1. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)

2. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition

3. Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure

4. Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).

5. Subject has a known allergy to contrast (that cannot be adequately pre-medicated), the SYNERGY stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)

6. Subject with implantation of a drug-eluting stent within 9 months prior to index procedure

7. Subject previously treated at any time with intravascular brachytherapy

8. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding

9. Subject is participating in an investigational drug or device clinical trial that has not reached its primary endpoint (Note: registry, observational, data collection studies are not exclusionary)

10. Subject intends to participate in an investigational drug or device clinical trial within 15 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)

11. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use

12. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure

13. Subject is a woman who is pregnant or nursing

14. Subject with a current medical condition with a life expectancy of less than 15 months

15. Target lesion(s) is located in the left main

16. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate

17. Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)

18. Planned treatment of more than 3 lesion

19. Planned treatment of lesions in more than 2 major epicardial vessels

20. Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)

21. Target lesion(s) is restenotic from a previous stent implantation

22. Target lesion(s) is located within a saphenous vein graft or an arterial graft

23. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing

24. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner Good Samaritan Regional Medical Center	Phoenix	Arizona	United States	85006
2	St. Joseph's Hospital & Medical Center	Phoenix	Arizona	United States	85013
3	Baptist Health Medical Center (Little Rock)	Little Rock	Arkansas	United States	72205
4	Arkansas Heart Hospital	Little Rock	Arkansas	United States	72211
5	Bakersfield Memorial Hospital	Bakersfield	California	United States	93301
6	USC Medical Center	Los Angeles	California	United States	90033
7	Cedars - Sinai Medical Center	Los Angeles	California	United States	90048
8	El Camino Hospital	Mountain View	California	United States	94040
9	HCA Riverside Community Hospital	Riverside	California	United States	92506
10	Sutter Medical Center, Sacramento	Sacramento	California	United States	95816
11	University of California, Davis Medical Center	Sacramento	California	United States	95817
12	Kaiser Foundation Hospital - San Francisco	San Francisco	California	United States	94115
13	John Muir Medical Center	Walnut Creek	California	United States	94598
14	South Denver Cardiology Associates, PC	Littleton	Colorado	United States	80120
15	Yale-New Haven Hospital	New Haven	Connecticut	United States	06510
16	Washington Hospital Center	Washington	District of Columbia	United States	20010
17	JFK Medical Center	Atlantis	Florida	United States	33462
18	Morton Plant Mease Healthcare System	Clearwater	Florida	United States	33756
19	North Florida Regional Medical Center	Gainesville	Florida	United States	32605
20	Memorial Regional Hospital	Hollywood	Florida	United States	33021
21	Mediquest Research at Munroe Regional Medical Center	Ocala	Florida	United States	34471
22	Florida Hospital	Orlando	Florida	United States	32803
23	Florida Hospital Heartland Medical Center	Sebring	Florida	United States	33870
24	Tallahassee Memorial Hospital	Tallahassee	Florida	United States	32308
25	University Hospital	Augusta	Georgia	United States	30901
26	Medical Center of Central Georgia	Macon	Georgia	United States	31201
27	Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
28	Kootenai Medical Center	Coeur d'Alene	Idaho	United States	83814
29	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
30	Edward Hospital	Naperville	Illinois	United States	60566
31	St. John's Hospital	Springfield	Illinois	United States	62701
32	Carle Foundation Hospital	Urbana	Illinois	United States	61801
33	Franciscan St. Francis Hospital	Beech Grove	Indiana	United States	46237
34	Northern Indiana Research Alliance - Lutheran Hospital	Fort Wayne	Indiana	United States	46804
35	Community Heart and Vascular Hospital	Indianapolis	Indiana	United States	46250
36	Mercy Hospital Medical Center	Des Moines	Iowa	United States	50314
37	Jewish Hospital and St. Mary's Healthcare	Louisville	Kentucky	United States	40202
38	Cardiovascular Research, LLC	Shreveport	Louisiana	United States	71103
39	Maine Medical Center	Portland	Maine	United States	04102
40	Union Memorial Hospital	Baltimore	Maryland	United States	21218
41	Tufts Medical Center	Boston	Massachusetts	United States	02111
42	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
43	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
44	Henry Ford Hospital	Detroit	Michigan	United States	48202
45	St. Mary's Duluth Clinic Regional Heart Center	Duluth	Minnesota	United States	55805
46	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
47	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota	United States	55102
48	St. Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
49	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
50	Cox Medical Centers	Springfield	Missouri	United States	65802
51	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-1000
52	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
53	Morristown Memorial Hospital	Morristown	New Jersey	United States	07960
54	Presbyterian Hospital	Albuquerque	New Mexico	United States	87106
55	North Shore University Hospital	Manhasset	New York	United States	11030
56	New York University Medical Center	New York	New York	United States	10016
57	Columbia University Medical Center/ NewYork Presbyterian Hospital	New York	New York	United States	10032
58	St. Joseph's Hospital Health Center	Syracuse	New York	United States	13202
59	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
60	Wake Medical Center	Raleigh	North Carolina	United States	27610
61	Lindner Center for Research and Education at Christ Hospital	Cincinnati	Ohio	United States	45219
62	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
63	Ohio State University Medical Center	Columbus	Ohio	United States	03210
64	OhioHealth Research and Innovation Institute - Riverside Methodist Hospital	Columbus	Ohio	United States	43214
65	Mercy St. Vincent Medical Center	Toledo	Ohio	United States	43608
66	Integris Baptist Medical Center	Oklahoma City	Oklahoma	United States	73112
67	Oklahoma Heart Hospital	Oklahoma City	Oklahoma	United States	73120
68	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
69	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
70	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
71	Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
72	Sisters of Charity Providence Hospital	Columbia	South Carolina	United States	29204
73	University Medical Center-Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
74	Grand Strand Regional Medical Center	Myrtle Beach	South Carolina	United States	29572
75	Jackson-Madison County General Hospital	Jackson	Tennessee	United States	38301
76	Baptist Memorial Hospital	Memphis	Tennessee	United States	38120
77	Centennial Medical Center	Nashville	Tennessee	United States	37203
78	Baylor Heart & Vascular Hospital	Dallas	Texas	United States	75226
79	St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
80	The Heart Hospital Baylor Plano	Plano	Texas	United States	75093
81	St. David's Round Rock Medical Center	Round Rock	Texas	United States	78681
82	The University of Vermont Medical Center	Burlington	Vermont	United States	05401
83	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
84	Winchester Medical Center	Winchester	Virginia	United States	26015
85	Swedish Medical Center	Seattle	Washington	United States	98122
86	University of Washington Medical Center	Seattle	Washington	United States	98195
87	Charleston Area Medical Center	Charleston	West Virginia	United States	25304
88	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
89	Aspirus Heart and Vascular Institute - Research and Education	Wausau	Wisconsin	United States	54401
90	Instituto do Coração (InCor)	Sao Paulo		Brazil	05403-000
91	Instituto de Cardiologia Dante Pazzanese	São Paulo		Brazil	04012-909
92	Herzzentrum Bad Krozingen	Bad Krozingen		Germany	79189
93	Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH	Bad Segeberg		Germany	23795
94	Universitaetsklinikum Heidelberg	Heidelberg		Germany	69120
95	Uni Jena	Jena		Germany	07740
96	Fukuoka Sanno Hospital	Fukuoka-shi	Fukuoka	Japan	814-0001
97	Iwate Medical University Hospital	Morioka-shi	Iwate-ken	Japan	020-8505
98	Tokai University Hospital	Isehara-shi	Kanagawa	Japan	259-1193
99	Shonan Kamakura General Hospital	Kamakura-shi	Kanagawa	Japan	247-0072
100	Saiseikai Yokohama-City Eastern Hospital	Yokohama-shi	Kanagawa	Japan	230-8765
101	Mitsui Memorial Hospital	Chiyoda-ku	Tokyo	Japan	101-8643
102	Teikyo University Hospital	Itabashi-ku	Tokyo	Japan	173-8606
103	Toho University Ohashi Medical Center	Meguro-ku	Tokyo	Japan	153-8515
104	Kurume University Hospital	Kurume-shi		Japan	830-0011
105	Osaka Saiseikai Nakatsu Hospital	Osaka		Japan
106	P. Stradins University Hospital	Riga		Latvia	LV-1002
107	Falu Lasarett	Falun		Sweden	79182
108	Karlstadt Central Hospital	Karlstad		Sweden	65185
109	Skane University Hospital	Malmo		Sweden	SE-214 28
110	Hospital Cantonal Fribourg	Fribourg		Switzerland	1708

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Ajay Kirtane, MD, Columbia University Medical Center/ NewYork Presbyterian Hospital
• Principal Investigator: Stephan Windecker, Prof, MD, INSELSPITAL - Universitätsspital Bern

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 12, 2017

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02605447
• Other Study ID Numbers: S2073
• First Posted: Nov 16, 2015
• Last Update Posted: Sep 25, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	There were 2009 subjects enrolled at 110 centers in USA, Japan, Germany, Sweden, Brazil, Latvia and Switzerland between 16 February 2016 and 30 March 2018.
Pre-assignment Detail	2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints.

Arm/Group Title	SYNERGY Stent + 3 Month DAPT
Arm/Group Description	Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System 2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints.
Period Title: Overall Study
STARTED	1487
COMPLETED	1385
NOT COMPLETED	102

Baseline Characteristics

Arm/Group Title	SYNERGY Stent + 3 Month DAPT
Arm/Group Description	Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Overall Participants	1487
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.7 (8.5)
Sex: Female, Male (Count of Participants)
Female	506 34%
Male	981 66%
Race/Ethnicity, Customized (Count of Participants)
American Indian/Alaska Native	7 0.5%
Asian	130 8.7%
Black, African Heritage	70 4.7%
Caucasian	1159 77.9%
Hispanic or Latino	45 3%
Native Hawaian or other Pacific Islander	1 0.1%
Other	14 0.9%
Not Disclosed	66 4.4%
Region of Enrollment (participants) [Number]
Latvia	25 1.7%
Sweden	21 1.4%
United States	1177 79.2%
Japan	117 7.9%
Brazil	29 2%
Switzerland	13 0.9%
Germany	105 7.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experienced Death or Myocardial Infarction (MI)
Description	Rate of death or myocardial infarction
Time Frame	3 to 15 months

Outcome Measure Data

Analysis Population Description

2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. Among these, 30 patients who didn't have sufficient follow-up nor an event were not eligible for analysis of the CEC confirmed major adverse events from 3-month visit to 365 days post 3-month visit.

Arm/Group Title	SYNERGY Stent + 3 Month DAPT
Arm/Group Description	Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Measure Participants	1457
Count of Participants [Participants]	84 5.6%

2. Primary Outcome

Title	Number of Participants Who Experienced Stent Thrombosis (ST)
Description	Rate of stent thrombosis: definite + probable, using the Academic Research Consortium (ARC) definition Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed) Probable Clinical definition of probable stent thrombosis is considered to have occurred in the following cases: Any unexplained death within the first 30 days Irrespective of the time after the index procedure and MI in the absence of any obvious cause which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis Possible Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained death beyond 30 days.
Time Frame	3 to 15 months

Outcome Measure Data

Analysis Population Description

2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. Among these, 30 patients who didn't have sufficient follow-up nor an event were not eligible for analysis of the CEC confirmed major adverse events from 3-month visit to 365 days post 3-month visit.

Arm/Group Title	SYNERGY Stent + 3 Month DAPT
Arm/Group Description	Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Measure Participants	1457
Count of Participants [Participants]	3 0.2%

3. Secondary Outcome

Title	Number of Participants Who Experienced Major Bleeding
Description	Rate of Bleeding, per Bleeding Academic Consortium definition (BARC2, 3a, 3b, 3c, 4, 5a and 5b) Type 0: No Bleeding Type 1: Bleeding that is not actionable and does not cause the patient to seek treatment Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional Type 3a: Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents Type 3c: Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision Type 4: CABG-related bleeding within 48 hours Type 5a: Probable fatal bleeding Type 5b: Definite fatal bleeding
Time Frame	3 to 15 months

Outcome Measure Data

Analysis Population Description

2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. Among these, 30 patients who didn't have sufficient follow-up nor an event were not eligible for analysis of the CEC confirmed major adverse events from 3-month visit to 365 days post 3-month visit.

Arm/Group Title	SYNERGY Stent + 3 Month DAPT
Arm/Group Description	Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System 2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints.
Measure Participants	1457
Count of Participants [Participants]	103 6.9%

Adverse Events

Time Frame	Study start to end of study (15 month)
Adverse Event Reporting Description	2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Arm/Group Title	SYNERGY Stent + 3 Month DAPT
Arm/Group Description	Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
All Cause Mortality
	SYNERGY Stent + 3 Month DAPT
	Affected / at Risk (%)	# Events
Total	66/1487 (4.4%)
Serious Adverse Events
	SYNERGY Stent + 3 Month DAPT
	Affected / at Risk (%)	# Events
Total	607/1487 (40.8%)
Blood and lymphatic system disorders
Anaemia	20/1487 (1.3%)	22
Anaemia of chronic disease	1/1487 (0.1%)	1
Anaemia of malignant disease	1/1487 (0.1%)	1
Haemorrhagic anaemia	8/1487 (0.5%)	9
Iron deficiency anaemia	4/1487 (0.3%)	4
Leukaemoid reaction	1/1487 (0.1%)	1
Nephrogenic anaemia	2/1487 (0.1%)	2
Neutropenia	1/1487 (0.1%)	1
Splenic infarction	1/1487 (0.1%)	1
Thrombocytopenia	1/1487 (0.1%)	1
Cardiac disorders
Acute coronary syndrome	2/1487 (0.1%)	2
Acute myocardial infarction	21/1487 (1.4%)	24
Acute right ventricular failure	1/1487 (0.1%)	1
Angina pectoris	33/1487 (2.2%)	36
Angina unstable	17/1487 (1.1%)	17
Aortic valve disease	1/1487 (0.1%)	1
Aortic valve stenosis	16/1487 (1.1%)	17
Arrhythmia	1/1487 (0.1%)	1
Atrial fibrillation	60/1487 (4%)	73
Atrial flutter	5/1487 (0.3%)	5
Atrial tachycardia	1/1487 (0.1%)	1
Atrioventricular block complete	5/1487 (0.3%)	5
Bradycardia	8/1487 (0.5%)	8
Cardiac arrest	9/1487 (0.6%)	9
Cardiac failure	15/1487 (1%)	15
Cardiac failure acute	6/1487 (0.4%)	6
Cardiac failure chronic	10/1487 (0.7%)	15
Cardiac failure congestive	47/1487 (3.2%)	61
Cardiac perforation	1/1487 (0.1%)	1
Cardio-respiratory arrest	5/1487 (0.3%)	5
Cardiogenic shock	3/1487 (0.2%)	3
Cardiomyopathy	4/1487 (0.3%)	4
Cardiopulmonary failure	2/1487 (0.1%)	2
Cardiorenal syndrome	1/1487 (0.1%)	1
Conduction disorder	1/1487 (0.1%)	1
Coronary artery disease	18/1487 (1.2%)	20
Coronary artery dissection	1/1487 (0.1%)	1
Coronary artery occlusion	2/1487 (0.1%)	2
Coronary artery stenosis	10/1487 (0.7%)	10
Extrasystoles	1/1487 (0.1%)	1
Intracardiac thrombus	1/1487 (0.1%)	1
Ischaemic cardiomyopathy	2/1487 (0.1%)	2
Mitral valve incompetence	4/1487 (0.3%)	5
Mitral valve stenosis	1/1487 (0.1%)	1
Myocardial infarction	2/1487 (0.1%)	2
Myocardial ischaemia	4/1487 (0.3%)	4
Palpitations	1/1487 (0.1%)	1
Pericardial effusion	1/1487 (0.1%)	1
Pulseless electrical activity	1/1487 (0.1%)	1
Sick sinus syndrome	3/1487 (0.2%)	3
Sinus arrest	3/1487 (0.2%)	3
Sinus arrhythmia	1/1487 (0.1%)	1
Sinus bradycardia	1/1487 (0.1%)	1
Ventricular fibrillation	1/1487 (0.1%)	1
Ventricular tachycardia	3/1487 (0.2%)	3
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy	1/1487 (0.1%)	1
Ear and labyrinth disorders
Sudden hearing loss	1/1487 (0.1%)	1
Vertigo	3/1487 (0.2%)	3
Endocrine disorders
Steroid withdrawal syndrome	1/1487 (0.1%)	1
Eye disorders
Retinal artery occlusion	1/1487 (0.1%)	1
Gastrointestinal disorders
Abdominal adhesions	1/1487 (0.1%)	1
Abdominal hernia	2/1487 (0.1%)	2
Abdominal pain	3/1487 (0.2%)	3
Abdominal pain lower	1/1487 (0.1%)	1
Abdominal pain upper	2/1487 (0.1%)	2
Abdominal wall haematoma	1/1487 (0.1%)	1
Abdominal wall haemorrhage	1/1487 (0.1%)	1
Ascites	1/1487 (0.1%)	2
Constipation	2/1487 (0.1%)	2
Diarrhoea	2/1487 (0.1%)	2
Diverticulum intestinal haemorrhagic	2/1487 (0.1%)	2
Duodenal ulcer	1/1487 (0.1%)	1
Duodenal ulcer haemorrhage	2/1487 (0.1%)	2
Dysphagia	3/1487 (0.2%)	3
Enteritis	2/1487 (0.1%)	2
Enterocolitis	1/1487 (0.1%)	2
Faecaloma	2/1487 (0.1%)	2
Gastritis	2/1487 (0.1%)	2
Gastrointestinal haemorrhage	20/1487 (1.3%)	21
Gastrooesophageal reflux disease	2/1487 (0.1%)	2
Haematemesis	2/1487 (0.1%)	2
Haematochezia	1/1487 (0.1%)	1
Ileus	2/1487 (0.1%)	2
Incarcerated umbilical hernia	1/1487 (0.1%)	1
Inguinal hernia	3/1487 (0.2%)	3
Intestinal ischaemia	1/1487 (0.1%)	1
Intestinal mass	1/1487 (0.1%)	1
Intestinal obstruction	3/1487 (0.2%)	3
Large intestine polyp	1/1487 (0.1%)	1
Lower gastrointestinal haemorrhage	8/1487 (0.5%)	8
Mallory-Weiss syndrome	1/1487 (0.1%)	1
Melaena	5/1487 (0.3%)	5
Nausea	1/1487 (0.1%)	1
Oesophagitis	1/1487 (0.1%)	1
Pancreatitis	2/1487 (0.1%)	3
Pancreatitis acute	2/1487 (0.1%)	2
Rectal haemorrhage	2/1487 (0.1%)	2
Retroperitoneal haematoma	1/1487 (0.1%)	1
Small intestinal obstruction	2/1487 (0.1%)	2
Upper gastrointestinal haemorrhage	5/1487 (0.3%)	6
Vomiting	1/1487 (0.1%)	1
General disorders
Adverse drug reaction	1/1487 (0.1%)	1
Asthenia	1/1487 (0.1%)	1
Cardiac death	1/1487 (0.1%)	1
Catheter site haematoma	7/1487 (0.5%)	7
Chest discomfort	3/1487 (0.2%)	3
Chest pain	13/1487 (0.9%)	13
Coronary artery restenosis	1/1487 (0.1%)	1
Death	6/1487 (0.4%)	6
Device lead damage	1/1487 (0.1%)	1
General physical health deterioration	1/1487 (0.1%)	1
Hypothermia	1/1487 (0.1%)	1
Impaired healing	1/1487 (0.1%)	1
Implant site haematoma	1/1487 (0.1%)	1
Mucosal inflammation	1/1487 (0.1%)	1
Non-cardiac chest pain	41/1487 (2.8%)	47
Peripheral swelling	2/1487 (0.1%)	3
Pyrexia	4/1487 (0.3%)	4
Strangulated hernia	1/1487 (0.1%)	1
Systemic inflammatory response syndrome	1/1487 (0.1%)	1
Thrombosis in device	1/1487 (0.1%)	1
Hepatobiliary disorders
Bile duct obstruction	1/1487 (0.1%)	1
Bile duct stone	1/1487 (0.1%)	1
Biliary colic	1/1487 (0.1%)	1
Cholangitis	3/1487 (0.2%)	3
Cholecystitis	4/1487 (0.3%)	4
Cholecystitis acute	1/1487 (0.1%)	1
Cholecystitis chronic	1/1487 (0.1%)	1
Cholelithiasis	2/1487 (0.1%)	3
Hepatic cirrhosis	1/1487 (0.1%)	1
Portal vein thrombosis	1/1487 (0.1%)	1
Immune system disorders
Anaphylactic reaction	1/1487 (0.1%)	1
Anti-neutrophil cytoplasmic antibody positive vasculitis	1/1487 (0.1%)	1
Drug hypersensitivity	2/1487 (0.1%)	2
Kidney transplant rejection	1/1487 (0.1%)	1
Seasonal allergy	1/1487 (0.1%)	1
Infections and infestations
Abdominal abscess	2/1487 (0.1%)	2
Abscess limb	1/1487 (0.1%)	1
Appendicitis	1/1487 (0.1%)	1
Bacteraemia	1/1487 (0.1%)	1
Bronchitis	2/1487 (0.1%)	2
Bronchitis viral	1/1487 (0.1%)	1
Catheter site cellulitis	1/1487 (0.1%)	1
Cellulitis	5/1487 (0.3%)	5
Clostridium difficile colitis	1/1487 (0.1%)	1
Cytomegalovirus infection	1/1487 (0.1%)	2
Cytomegalovirus viraemia	1/1487 (0.1%)	1
Device related infection	1/1487 (0.1%)	1
Diabetic gangrene	1/1487 (0.1%)	1
Diverticulitis	3/1487 (0.2%)	3
Endocarditis	1/1487 (0.1%)	1
Endophthalmitis	1/1487 (0.1%)	1
Enterococcal bacteraemia	1/1487 (0.1%)	1
Gastroenteritis	4/1487 (0.3%)	4
Herpes zoster	1/1487 (0.1%)	1
Herpes zoster disseminated	1/1487 (0.1%)	1
Influenza	10/1487 (0.7%)	10
Intervertebral discitis	1/1487 (0.1%)	1
Lobar pneumonia	2/1487 (0.1%)	2
Localised infection	1/1487 (0.1%)	1
Lower respiratory tract infection	1/1487 (0.1%)	1
Osteomyelitis	1/1487 (0.1%)	1
Parainfluenzae virus infection	2/1487 (0.1%)	2
Perirectal abscess	1/1487 (0.1%)	1
Peritonitis	1/1487 (0.1%)	2
Peritonitis bacterial	1/1487 (0.1%)	1
Pneumonia	34/1487 (2.3%)	38
Postoperative wound infection	1/1487 (0.1%)	1
Proteus infection	1/1487 (0.1%)	1
Pyelonephritis	2/1487 (0.1%)	2
Respiratory syncytial virus infection	1/1487 (0.1%)	1
Sepsis	19/1487 (1.3%)	22
Septic shock	3/1487 (0.2%)	3
Subcutaneous abscess	1/1487 (0.1%)	1
Upper respiratory tract infection	1/1487 (0.1%)	1
Urinary tract infection	14/1487 (0.9%)	17
Urosepsis	4/1487 (0.3%)	4
Viral infection	1/1487 (0.1%)	1
Viral pericarditis	1/1487 (0.1%)	1
Injury, poisoning and procedural complications
Anaemia postoperative	1/1487 (0.1%)	1
Animal scratch	1/1487 (0.1%)	1
Ankle fracture	2/1487 (0.1%)	2
Bone contusion	1/1487 (0.1%)	1
Cervical vertebral fracture	1/1487 (0.1%)	1
Cystitis radiation	2/1487 (0.1%)	3
Fall	3/1487 (0.2%)	3
Femoral neck fracture	1/1487 (0.1%)	1
Femur fracture	2/1487 (0.1%)	2
Head injury	1/1487 (0.1%)	1
Hip fracture	4/1487 (0.3%)	4
Humerus fracture	3/1487 (0.2%)	3
Incisional hernia	1/1487 (0.1%)	1
Laceration	1/1487 (0.1%)	1
Limb injury	1/1487 (0.1%)	1
Lumbar vertebral fracture	2/1487 (0.1%)	2
Muscle strain	1/1487 (0.1%)	1
Near drowning	1/1487 (0.1%)	1
Post procedural discomfort	1/1487 (0.1%)	1
Post procedural haematoma	2/1487 (0.1%)	2
Post procedural haemorrhage	4/1487 (0.3%)	4
Post procedural swelling	1/1487 (0.1%)	1
Procedural complication	1/1487 (0.1%)	1
Procedural haemorrhage	1/1487 (0.1%)	1
Procedural hypotension	1/1487 (0.1%)	1
Procedural pain	1/1487 (0.1%)	1
Radius fracture	2/1487 (0.1%)	2
Rib fracture	2/1487 (0.1%)	2
Road traffic accident	1/1487 (0.1%)	1
Spinal compression fracture	3/1487 (0.2%)	3
Spinal cord injury cervical	1/1487 (0.1%)	1
Subdural haematoma	1/1487 (0.1%)	1
Tendon rupture	1/1487 (0.1%)	1
Thoracic vertebral fracture	1/1487 (0.1%)	1
Tibia fracture	1/1487 (0.1%)	1
Traumatic fracture	1/1487 (0.1%)	1
Upper limb fracture	1/1487 (0.1%)	1
Vascular procedure complication	10/1487 (0.7%)	11
Vascular pseudoaneurysm	12/1487 (0.8%)	12
Venous injury	1/1487 (0.1%)	1
Wound dehiscence	3/1487 (0.2%)	3
Investigations
Blood pressure decreased	1/1487 (0.1%)	1
Computerised tomogram abdomen abnormal	1/1487 (0.1%)	1
Hepatic enzyme increased	1/1487 (0.1%)	1
International normalised ratio increased	1/1487 (0.1%)	1
Troponin increased	2/1487 (0.1%)	2
Metabolism and nutrition disorders
Dehydration	3/1487 (0.2%)	3
Diabetes mellitus	1/1487 (0.1%)	1
Diabetic ketoacidosis	1/1487 (0.1%)	1
Fluid overload	3/1487 (0.2%)	3
Gout	2/1487 (0.1%)	2
Hyperglycaemia	1/1487 (0.1%)	1
Hyperkalaemia	4/1487 (0.3%)	5
Hypokalaemia	2/1487 (0.1%)	2
Malnutrition	1/1487 (0.1%)	1
Metabolic acidosis	1/1487 (0.1%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	3/1487 (0.2%)	3
Arthritis	2/1487 (0.1%)	2
Back pain	4/1487 (0.3%)	4
Bone lesion	1/1487 (0.1%)	1
Costochondritis	1/1487 (0.1%)	1
Foot deformity	1/1487 (0.1%)	1
Hungry bone syndrome	1/1487 (0.1%)	1
Intervertebral disc degeneration	1/1487 (0.1%)	1
Lumbar spinal stenosis	3/1487 (0.2%)	3
Musculoskeletal chest pain	1/1487 (0.1%)	1
Myalgia	1/1487 (0.1%)	1
Osteoarthritis	8/1487 (0.5%)	8
Pain in extremity	1/1487 (0.1%)	1
Polymyalgia rheumatica	1/1487 (0.1%)	1
Rhabdomyolysis	2/1487 (0.1%)	2
Rheumatoid arthritis	1/1487 (0.1%)	2
Rotator cuff syndrome	1/1487 (0.1%)	1
Scoliosis	1/1487 (0.1%)	1
Spinal column stenosis	1/1487 (0.1%)	1
Spondylolisthesis	1/1487 (0.1%)	1
Tendon disorder	1/1487 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia	1/1487 (0.1%)	1
Adenocarcinoma of colon	2/1487 (0.1%)	2
Basal cell carcinoma	2/1487 (0.1%)	2
Benign hepatic neoplasm	1/1487 (0.1%)	1
Benign neoplasm of skin	1/1487 (0.1%)	1
Bladder cancer	2/1487 (0.1%)	3
Breast cancer	3/1487 (0.2%)	3
Cholesteatoma	1/1487 (0.1%)	1
Colon cancer	4/1487 (0.3%)	4
Gastric cancer stage III	1/1487 (0.1%)	1
Hepatic cancer	1/1487 (0.1%)	1
Hepatocellular carcinoma	1/1487 (0.1%)	1
Lip and/or oral cavity cancer	1/1487 (0.1%)	1
Lip squamous cell carcinoma	1/1487 (0.1%)	1
Lung adenocarcinoma	1/1487 (0.1%)	1
Lung neoplasm malignant	5/1487 (0.3%)	5
Malignant ascites	1/1487 (0.1%)	1
Malignant neoplasm of renal pelvis	1/1487 (0.1%)	1
Metastatic malignant melanoma	2/1487 (0.1%)	2
Metastatic neoplasm	1/1487 (0.1%)	1
Myelodysplastic syndrome	2/1487 (0.1%)	2
Ovarian cancer metastatic	1/1487 (0.1%)	1
Pancreatic carcinoma	1/1487 (0.1%)	1
Plasma cell myeloma	1/1487 (0.1%)	1
Prostate cancer	2/1487 (0.1%)	2
Prostate cancer metastatic	1/1487 (0.1%)	1
Rectal adenocarcinoma	1/1487 (0.1%)	1
Renal cancer	1/1487 (0.1%)	1
Skin cancer	1/1487 (0.1%)	1
Squamous cell carcinoma	3/1487 (0.2%)	3
Squamous cell carcinoma of head and neck	1/1487 (0.1%)	1
Squamous cell carcinoma of lung	1/1487 (0.1%)	1
Squamous cell carcinoma of the hypopharynx	1/1487 (0.1%)	1
Throat cancer	1/1487 (0.1%)	1
Tonsil cancer	1/1487 (0.1%)	1
Transitional cell carcinoma	1/1487 (0.1%)	1
Nervous system disorders
Aphasia	2/1487 (0.1%)	2
Ataxia	1/1487 (0.1%)	1
Brain oedema	1/1487 (0.1%)	1
Carotid artery stenosis	8/1487 (0.5%)	9
Cerebellar haemorrhage	1/1487 (0.1%)	1
Cerebral haemorrhage	2/1487 (0.1%)	2
Cerebral infarction	4/1487 (0.3%)	4
Cerebrovascular accident	13/1487 (0.9%)	14
Cerebrovascular disorder	1/1487 (0.1%)	1
Coma	1/1487 (0.1%)	1
Convulsion	2/1487 (0.1%)	2
Dementia	1/1487 (0.1%)	1
Dementia Alzheimer's type	2/1487 (0.1%)	2
Dementia with Lewy bodies	1/1487 (0.1%)	1
Dizziness	4/1487 (0.3%)	4
Dysarthria	1/1487 (0.1%)	1
Embolic stroke	1/1487 (0.1%)	1
Encephalopathy	5/1487 (0.3%)	5
Haemorrhage intracranial	1/1487 (0.1%)	1
Headache	1/1487 (0.1%)	1
Hepatic encephalopathy	1/1487 (0.1%)	2
Intracranial aneurysm	1/1487 (0.1%)	1
Ischaemic stroke	2/1487 (0.1%)	2
Metabolic encephalopathy	2/1487 (0.1%)	2
Migraine	1/1487 (0.1%)	1
Monoparesis	1/1487 (0.1%)	1
Myasthenic syndrome	1/1487 (0.1%)	1
Orthostatic intolerance	1/1487 (0.1%)	1
Parkinson's disease	1/1487 (0.1%)	1
Presyncope	6/1487 (0.4%)	6
Sciatica	1/1487 (0.1%)	1
Subarachnoid haemorrhage	2/1487 (0.1%)	2
Syncope	10/1487 (0.7%)	11
Tension headache	1/1487 (0.1%)	1
Transient ischaemic attack	7/1487 (0.5%)	7
Psychiatric disorders
Mental status changes	3/1487 (0.2%)	3
Neurosis	1/1487 (0.1%)	1
Renal and urinary disorders
Bladder neck obstruction	1/1487 (0.1%)	1
Calculus ureteric	1/1487 (0.1%)	1
Diabetic end stage renal disease	1/1487 (0.1%)	1
Haematuria	8/1487 (0.5%)	9
Nephrolithiasis	6/1487 (0.4%)	6
Obstructive uropathy	1/1487 (0.1%)	1
Renal artery stenosis	1/1487 (0.1%)	1
Renal failure	5/1487 (0.3%)	5
Renal failure acute	35/1487 (2.4%)	39
Renal failure chronic	11/1487 (0.7%)	11
Renal haemorrhage	1/1487 (0.1%)	1
Renal impairment	1/1487 (0.1%)	1
Urethral stenosis	1/1487 (0.1%)	1
Urinary retention	6/1487 (0.4%)	6
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/1487 (0.1%)	1
Pelvic haemorrhage	1/1487 (0.1%)	1
Priapism	1/1487 (0.1%)	1
Prostatomegaly	1/1487 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	6/1487 (0.4%)	6
Aspiration	1/1487 (0.1%)	1
Asthma	1/1487 (0.1%)	1
Chronic obstructive pulmonary disease	16/1487 (1.1%)	18
Diaphragmatic paralysis	1/1487 (0.1%)	1
Diaphragmatic spasm	1/1487 (0.1%)	1
Dyspnoea	10/1487 (0.7%)	12
Epistaxis	4/1487 (0.3%)	4
Haemoptysis	1/1487 (0.1%)	1
Hypoxia	1/1487 (0.1%)	1
Interstitial lung disease	1/1487 (0.1%)	1
Pleural effusion	7/1487 (0.5%)	9
Pleurisy	1/1487 (0.1%)	1
Pleuritic pain	1/1487 (0.1%)	1
Pneumonia aspiration	5/1487 (0.3%)	7
Pneumothorax	1/1487 (0.1%)	1
Pulmonary embolism	6/1487 (0.4%)	6
Pulmonary fibrosis	1/1487 (0.1%)	1
Pulmonary hypertension	1/1487 (0.1%)	1
Pulmonary oedema	1/1487 (0.1%)	1
Respiratory distress	1/1487 (0.1%)	1
Respiratory failure	9/1487 (0.6%)	9
Upper airway obstruction	1/1487 (0.1%)	1
Skin and subcutaneous tissue disorders
Angioedema	1/1487 (0.1%)	1
Blister	1/1487 (0.1%)	1
Skin lesion	1/1487 (0.1%)	1
Vascular disorders
Aortic aneurysm	5/1487 (0.3%)	5
Aortic dissection	1/1487 (0.1%)	1
Aortic stenosis	5/1487 (0.3%)	5
Arterial occlusive disease	1/1487 (0.1%)	1
Arteriosclerosis	1/1487 (0.1%)	1
Deep vein thrombosis	3/1487 (0.2%)	3
Femoral artery aneurysm	1/1487 (0.1%)	1
Haematoma	3/1487 (0.2%)	3
Hypertension	3/1487 (0.2%)	3
Hypertensive crisis	6/1487 (0.4%)	8
Hypertensive emergency	1/1487 (0.1%)	1
Hypotension	10/1487 (0.7%)	11
Intermittent claudication	2/1487 (0.1%)	2
Orthostatic hypotension	4/1487 (0.3%)	4
Peripheral arterial occlusive disease	5/1487 (0.3%)	6
Peripheral artery stenosis	3/1487 (0.2%)	4
Peripheral ischaemia	2/1487 (0.1%)	2
Peripheral vascular disorder	4/1487 (0.3%)	4
Shock	1/1487 (0.1%)	1
Thrombophlebitis	1/1487 (0.1%)	1
Venous thrombosis	1/1487 (0.1%)	1
Other (Not Including Serious) Adverse Events
	SYNERGY Stent + 3 Month DAPT
	Affected / at Risk (%)	# Events
Total	100/1487 (6.7%)
Blood and lymphatic system disorders
Anaemia	1/1487 (0.1%)	1
Cardiac disorders
Acute myocardial infarction	1/1487 (0.1%)	1
Myocardial infarction	2/1487 (0.1%)	2
Eye disorders
Eye haemorrhage	1/1487 (0.1%)	1
Gastrointestinal disorders
Diarrhoea haemorrhagic	1/1487 (0.1%)	1
Gastritis	1/1487 (0.1%)	1
Gastrointestinal haemorrhage	3/1487 (0.2%)	3
Gingival bleeding	4/1487 (0.3%)	5
Haematochezia	3/1487 (0.2%)	3
Haemorrhoids	1/1487 (0.1%)	1
Melaena	2/1487 (0.1%)	2
Rectal haemorrhage	9/1487 (0.6%)	9
General disorders
Catheter site haematoma	7/1487 (0.5%)	7
Catheter site haemorrhage	3/1487 (0.2%)	3
Implant site haematoma	1/1487 (0.1%)	1
Infections and infestations
Urinary tract infection	1/1487 (0.1%)	1
Injury, poisoning and procedural complications
Anaemia postoperative	1/1487 (0.1%)	1
Contusion	5/1487 (0.3%)	6
Incision site haemorrhage	1/1487 (0.1%)	1
Laceration	3/1487 (0.2%)	3
Post procedural haematuria	1/1487 (0.1%)	1
Post procedural haemorrhage	3/1487 (0.2%)	3
Procedural haemorrhage	2/1487 (0.1%)	2
Skin abrasion	1/1487 (0.1%)	1
Skin injury	1/1487 (0.1%)	1
Subcutaneous haematoma	1/1487 (0.1%)	1
Traumatic haematoma	1/1487 (0.1%)	1
Traumatic haemorrhage	1/1487 (0.1%)	1
Vascular procedure complication	1/1487 (0.1%)	1
Vascular pseudoaneurysm	1/1487 (0.1%)	1
Wound	1/1487 (0.1%)	1
Wound haemorrhage	1/1487 (0.1%)	1
Investigations
Occult blood	1/1487 (0.1%)	1
Musculoskeletal and connective tissue disorders
Joint swelling	1/1487 (0.1%)	1
Nervous system disorders
Cerebral infarction	1/1487 (0.1%)	1
Renal and urinary disorders
Haematuria	15/1487 (1%)	18
Reproductive system and breast disorders
Vaginal haemorrhage	1/1487 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Bronchiectasis	1/1487 (0.1%)	1
Epistaxis	26/1487 (1.7%)	28
Haemoptysis	1/1487 (0.1%)	1
Skin and subcutaneous tissue disorders
Ecchymosis	1/1487 (0.1%)	1
Haemorrhage subcutaneous	3/1487 (0.2%)	3
Vascular disorders
Bleeding varicose vein	2/1487 (0.1%)	2
Haematoma	2/1487 (0.1%)	3
Haemorrhage	1/1487 (0.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor