New-DES vs BMS in SVG -1 Year Outcomes

Coronary Artery Disease Clinical Trial

— BALTIC  

Official title:

New-generation Drug Eluting Stent vs. Bare Metal Stent in Saphenous Vein Graft - 1 Year Outcomes by a Propensity Score Ascertainment (SVG Baltic Registry)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338308
• Other study ID #: 01
• Status: Completed
• Start date: February 1, 2008
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Data regarding the efficacy of the percutaneous coronary intervention (PCI) with new-designed drug-eluting stent (new-DES) vs. bare metal stent (BMS) of saphenous vein grafts (SVG) stenosis is scarce. The primary objective was to compare one-year clinical outcomes of PCI in stenosis of SVG using new-DES vs. BMS in a real-world population. We carried out a multi-center registry comparing new-DES with BMS in all consecutive patients undergoing PCI of SVG. The primary composite endpoint was major adverse cardiac and cerebrovascular events (MACCE) at 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 792
• Est. completion date: March 1, 2020
• Est. primary completion date: October 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients after CABG with significant SVG stenosis referred for PCI

Exclusion Criteria:

• patients who had both types of stents implanted in the same procedure

• patients with the old-DES

• patients who had PCI of other vascular territories during the same procedure

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• new-DES
with ot without embolic protection device
• BMS
with ot without embolic protection device

Locations

Country	Name	City	State
Poland	First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland	Gdansk
Poland	Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland	Katowice
Poland	Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland	Kraków

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Silesia	Wojciech Wojakowski

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Wanha W, Mielczarek M, Roleder T, Ladzinski S, Milewski M, Gilis-Malinowska N, Chmielecki M, Ciecwierz D, Bachorski W, Kunik P, Trznadel A, Mecka K, Genc A, Januszek R, Paczek P, Dziewierz A, Bartus S, Gruchala M, Smolka G, Dudek D, Navarese EP, Ochala A, Jaguszewski M, Wojakowski W. New-generation drug eluting stent vs. bare metal stent in saphenous vein graft - 1 year outcomes by a propensity score ascertainment (SVG Baltic Registry). Int J Cardiol. 2019 Oct 1;292:56-61. doi: 10.1016/j.ijcard.2019.04.022. Epub 2019 Apr 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardiac and cerebrovascular event		1 year
Secondary	death		1 year
Secondary	myocardial infarction		1 year
Secondary	target vessel revascularization		1 year
Secondary	target lesion revascularization		1 year
Secondary	stroke		1 year