Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery (RegistStents)

Evaluation and Monitoring of Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery

The purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery.

Objectives:

• To describe the incidence and severity of adverse cardiovascular events in patients with coronary stents undergoing noncardiac surgery with admission.
• To assess the following-up of the guidelines about the perioperative management of antiplatelet therapy in these patients.
• To assess the relationship between the incidence of cardiac or neurovascular events, as well as bleeding complications with the perioperative management of antiplatelet therapy.
• Number of Participants with Adverse Events as a Measure of Safety

Study Overview

• Status: Completed
• Conditions: Surgery; Acute Coronary Syndrome; Coronary Stent Occlusion

Detailed Description

(Not desired)

• Study Type: Observational
• Enrollment (Actual): 483

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Clínic
  • Barcelona, Spain
    • Parc de Salut Mar
  • Barcelona, Spain
    • Fundació Puigvert - IUNA
  • Barcelona, Spain
    • Parc de Salut Mar-Esperança
  • Barcelona
    • Badalona, Barcelona, Spain
      • Hospital Germans Trias i Pujol
    • Badalona, Barcelona, Spain
      • Hospital Municipal de Badalona
    • Igualada, Barcelona, Spain
      • Hospital Igualada
    • Mataró, Barcelona, Spain
      • Hospital de Mataro
    • Sabadell, Barcelona, Spain, 08208
      • Hospital de Sabadell. Corporació Sanitària Parc Taulí
    • Sant Celoni, Barcelona, Spain
      • Hospital de Sant Celoni
    • Sant Cugat del Valles, Barcelona, Spain
      • Clínica ASEPEYO
    • Sant Joan Despi, Barcelona, Spain
      • Hospital Sant Joan Despi Moises Broggi
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Mutua De Terrassa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary stents undergoing noncardiac surgery with admission between May 2010 and April 2012

Description

Inclusion Criteria:

• > 18 years old, with coronary stents
• American Society of Anaesthesia physical status II-V
• noncardiac surgery wiht admission
• informed consent

Exclusion Criteria:

• < 18 years old
• American Society of Anaesthesia physical status I
• ambulatory surgery
• pregnancy
• obstetric anaesthesia
• endoscopic procedures
• cardiac surgery
• not informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Coronary Stent; Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Events (MACCEs)	Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest	up to 90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Haemorrhagic Events	Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage	up to 90 days after surgery
Number of Patients With Adverse Events Related With Antiplatelet Therapy Management	Perioperative withdrawal antiplatelet therapy is defined with > or = 5 days without therapy We create 3 categories: Not withdrawal; Complete withdrawal (5 or > days without antiplatelet drugs , mono or dual therapy); Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ > 5 days	90 days after surgery

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: Anna Rodriguez-Pont, MD, Corporació Sanitària Parc Taulí

Publications and helpful links

General Publications

• Rodriguez A, Guilera N, Mases A, Sierra P, Oliva JC, Colilles C; REGISTRESTENTS group. Management of antiplatelet therapy in patients with coronary stents undergoing noncardiac surgery: association with adverse events. Br J Anaesth. 2018 Jan;120(1):67-76. doi: 10.1016/j.bja.2017.11.012. Epub 2017 Nov 21. Erratum In: Br J Anaesth. 2018 May;120(5):1143-1144.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: July 23, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 2010

Study Record Updates

• Last Update Posted (Estimate): April 7, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Bleeding; transfusion; Coronary Stent; cardiac event; DES stent; BMS stent; Date of stent implantation; neurovascular event
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: CIR2009017