Complex CAD Treated With PCI With DES Implantation.

Complex Coronary Artery Disease Treated With Percutaneous Coronary Intervention - COMPLEX Registry.

COMPLEX Registry is an investigator-initiated, retrospective, high-volume Polish single-center clinical registry enrolling 980 consecutive patients with complex coronary artery lesions treated percutaneously between September 2015 and December 2021. All data were collected prospectively as regards the clinical and technical endpoints. The study aimed to assess the safety and efficacy of new-generation, thin-struts DES in patients with complex CAD at long-term clinical follow-up. The primary endpoint of the study was the occurrence of TLR during follow-up. Secondary endpoints were a procedural success and the occurrence of MACE, including all-cause death, MI, or TLR.

Study Overview

• Status: Completed
• Conditions: Complex Coronary Artery Disease
• Intervention / Treatment: Procedure: Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation

• Study Type: Observational
• Enrollment (Actual): 980

Contacts and Locations

Study Locations

• Poland
  • Wielkopolska
    • Poznań, Wielkopolska, Poland, 61-701
      • Poznan University of Medical Sciences, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All patients with symptomatic CAD, including chronic coronary syndromes (CCS) and acute coronary syndromes (ACS), qualified for PCI and meeting the criteria for complex CAD were included in the analysis.

Description

Inclusion Criteria:

• For the inclusion of patients in this study, the complexity of CAD was defined as having at least one of the following characteristics: chronic total occlusion (CTO), lesion length >40 mm, severe calcification assessed by angiography or intravascular imaging examination, multivessel PCI during the same intervention, or true bifurcation defined as any lesion involving both the main vessel (MV), proximal or distal and the ostium of the side branch (SB) (Medina 1,1,1; 1,0,1; or 0,1,1).

Exclusion Criteria:

• left main stem
• PCI treated during index procedure;
• cardiogenic shock,
• thrombolysis before PCI;
• 12-month follow-up not available

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Complex PCI; All consecutive patients with complex coronary artery disease (CAD) were treated with percutaneous coronary intervention (PCI). The complexity of CAD was defined as having at least one of the following characteristics: chronic total occlusion (CTO), lesion length >40 mm, severe calcification assessed by angiography or intravascular imaging examination, multivessel PCI during the same intervention, or true bifurcation defined as any lesion involving both the main vessel (MV), proximal or distal and the ostium of the side branch (SB) (Medina 1,1,1; 1,0,1; or 0,1,1).

Procedure: Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation; PCI was performed according to the general and local recommendations. The choice of DES among the new generation DES and the decision on procedure optimization belonged to the operator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion revascularization (TLR)	During the 12-month follow-up, the incidence of TLR in patients included in the study will be reported. TLR was defined as revascularization post-stenting within the stent or within the 5-mm borders adjacent to the stent.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events (MACE)	During the 12-month follow-up, the incidence of MACE in patients included in the study will be assessed. Major adverse cardiac event composed of all-cause death, myocardial infarction (MI), or TLR.	12 month
Procedural success	Procedural success was defined as angiographic success in the absence of in-hospital major events including death, MI, need for TLR, stroke, vascular access site complications, and contrast agent nephropathy.	Peri-procedural

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Estimated): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 821/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No