Trial Outcomes & Findings for Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery (NCT NCT01171612)

NCT ID: NCT01171612

Last Updated: 2016-04-07

Results Overview

Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest

• Recruitment status: COMPLETED
• Target enrollment: 483 participants
• Primary outcome timeframe: up to 90 days after surgery
• Results posted on: 2016-04-07

Participant Flow

Observational, multicenter and prospective study, approved by the Ethics Committee. All patients with coronary stents undergoing noncardiac surgery with admission from February 2010 to April 2012 were the basis of the study.

Patients scheduled for noncardiac surgery with admission

Participant milestones

Measure	Coronary Stent Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
Overall Study STARTED	483
Overall Study COMPLETED	432
Overall Study NOT COMPLETED	51

Reasons for withdrawal

Measure	Coronary Stent Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
Overall Study Lost to Follow-up	51

Baseline Characteristics

Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery

Baseline characteristics by cohort

Measure	Coronary Stent n=432 Participants Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
Age, Customized Between 18 and 70 years	219 participants n=93 Participants
Age, Customized >70 years	213 participants n=93 Participants
Sex: Female, Male Female	72 Participants n=93 Participants
Sex: Female, Male Male	360 Participants n=93 Participants
Region of Enrollment Spain	432 participants n=93 Participants
Body Mass Index	27.9 Kgm^2 n=93 Participants
Antiplatelet Therapy Antiplatelet therapy	412 participants n=93 Participants
Antiplatelet Therapy Not antiplatelet therapy	20 participants n=93 Participants

PRIMARY outcome

Timeframe: up to 90 days after surgery

Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest

Outcome measures

Measure	Coronary Stent n=432 Participants Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery	Incomplete Withdrawal (Mantaining ASA, Clopidogrel Withdrawn) Patients under dual antiplatelet therapy, wich maintain aspirin, and withdrawn clopidogrel 5 or more days	Complete Withdrawal patients with aspirin oand/or clopidogrel, which stopped therapy \> 5 days
Major Adverse Cardiac and Cerebrovascular Events (MACCEs)	63 participants	—	—

SECONDARY outcome

Timeframe: up to 90 days after surgery

Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage

Outcome measures

Measure	Coronary Stent n=432 Participants Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery	Incomplete Withdrawal (Mantaining ASA, Clopidogrel Withdrawn) Patients under dual antiplatelet therapy, wich maintain aspirin, and withdrawn clopidogrel 5 or more days	Complete Withdrawal patients with aspirin oand/or clopidogrel, which stopped therapy \> 5 days
Major Haemorrhagic Events	161 participants	—	—

SECONDARY outcome

Timeframe: 90 days after surgery

Population: MACCEs

Perioperative withdrawal antiplatelet therapy is defined with > or = 5 days without therapy

We create 3 categories:

1. Not withdrawal

2. Complete withdrawal (5 or > days without antiplatelet drugs , mono or dual therapy)

3. Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ > 5 days

Outcome measures

Measure	Coronary Stent n=294 Participants Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery	Incomplete Withdrawal (Mantaining ASA, Clopidogrel Withdrawn) n=72 Participants Patients under dual antiplatelet therapy, wich maintain aspirin, and withdrawn clopidogrel 5 or more days	Complete Withdrawal n=46 Participants patients with aspirin oand/or clopidogrel, which stopped therapy \> 5 days
Number of Patients With Adverse Events Related With Antiplatelet Therapy Management	38 participants Interval 0.733 to 3.662	10 participants Interval 0.513 to 2.299	9 participants

Adverse Events

Cardiac and Cerebrovascular Events

Serious events: 61 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cardiac and Cerebrovascular Events n=432 participants at risk Adverse events registered independently related with antiplatelet therapy management
Cardiac disorders Cardiac Arrest	0.23% 1/432 • Number of events 1 • Perioperative events from surgery to 90 days after We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions
Cardiac disorders Cardiac Death	0.23% 1/432 • Number of events 1 • Perioperative events from surgery to 90 days after We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions
Cardiac disorders Acute Myocardial Infarction	2.8% 12/432 • Number of events 13 • Perioperative events from surgery to 90 days after We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions
Cardiac disorders Unstable Angina	9.0% 39/432 • Number of events 39 • Perioperative events from surgery to 90 days after We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions
Cardiac disorders Significant Arrythmia	3.0% 13/432 • Number of events 15 • Perioperative events from surgery to 90 days after We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions
Cardiac disorders Cardiac Failure	1.9% 8/432 • Number of events 8 • Perioperative events from surgery to 90 days after We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions

Other adverse events

Measure	Cardiac and Cerebrovascular Events n=432 participants at risk Adverse events registered independently related with antiplatelet therapy management
Nervous system disorders Stroke, Transient Ischaemic Attack	0.93% 4/432 • Number of events 4 • Perioperative events from surgery to 90 days after We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions
Vascular disorders Deep Venous Thrombosis	0.23% 1/432 • Number of events 1 • Perioperative events from surgery to 90 days after We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions
Vascular disorders Arterial ischaemia	0.23% 1/432 • Number of events 1 • Perioperative events from surgery to 90 days after We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions

Additional Information

Anna Rodriguez-Pont

Corporacion Sanitaria y Universitaria Parc Tauli

Phone: 0034937231010

Email: anna.r.pont@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place