CONNECT DES Registrty

Coronary Artery Disease Clinical Trial

Official title:

A Whole Population-based Study on COreaN NationwidE Claims daTa on Drug-Eluting Stent (CONNECT DES) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04715594
• Other study ID #: 4-2019-0596
• Status: Active, not recruiting
• Start date: August 11, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To date, drug-eluting stents (DES) have become the standard of care in daily practice for the treatment of ischemic heart disease, by overcoming the risk of in-stent restenosis, a major issue raised in the bare-mare stents era. The application of potent anti-proliferative drugs and polymer structures that ensures sustained released of the drugs markedly reduced the neointimal hyperplasia, leading to much improved clinical outcomes compared with bare-metal stents. However, although first-generation sirolimus-eluting stents and paclitaxel-eluting stents significantly reduced the risk of in-stent restenosis and target-vessel revascularization, an augmented risk for very late stent thrombosis and fatal clinical events emerged as a new issue to be solved. Second- and newer- generation DESs adopted innovative stent platforms, novel stent materials, anti-proliferative drugs, and biocompatible polymers (including both durable and bioresorbable). Nowadays, numerous types of DESs (over 20 types) are available in clinical practice as well as bare-metal stents. However, little is known about the clinical outcome according to type of DESs in real-word practice. Given that many of recent randomized clinical trials (RCTs) demonstrate the 'non-inferiority' of brand-new DESs over older DESs in limited period time (usually for 1-year) in a selected patients eligible for RCTs, the real-world clinical outcomes according to type of DES implanted are still unveiled. Although, the question about the differential impact of generation of DES, type of biocompatible polymers (bioresorbable versus durable), thickness of stent struts and type of eluted anti-proliferative drugs are very important in clinical aspect of view, but there is little study conducted on all patients who are actually confronted in daily clinical practice.

Korea operates national insurance system that covers most of the Koreans (97.1%) that are strictly monitored by National Health Insurance Service (NHIS). Of note, the claims database of NHIS of Korea contains all information including the demographic characters of patietns, diagnosis codes (ICD-9 and ICD-10), type of procedures or surgeries and the medical devices utilized, death certificates that contains type of death, and the drugs prescribe in outpatient clinic and hospitals in a individual pill level, that enables monitoring for the drug compliance. This unique feature of NHIS database allows the investigators to gain access to the dose and duration of cardio-protective medications including anti-platelet agents, lipid-lowering agents, anti-hypertensive agents, glucose-lowering agents, nitrate donors, vasodilators, and others. Given the benefits of NHIS database of Korea, we would like to establish a whole-population registry, named as COreaN NationwidE Claims daTa on Drug-Eluting Stent Registry (CONNECT DES Registry). A comprehensive analysis of this data is expected to shed new light on the impact of type of DESs and drug use in real-world practice that could be fully revealed through RCTs.

Description:

According to stringent policy of NHIS database to protect personal information, information regarding type of DES including the thickness of strut, eluted drugs, type of polymer, generation of the DES will be provided after sufficient encryption. Likewise, all information regarding drug prescription, including the total number of pills prescribed during the period, patients' compliance and dosage of drugs will be provided after sufficient encryption. After decrypting the information provided to establish a database suitable for analysis, all eligible patients will be divided into two or more groups according to the type of DES or drug use pattern after DES implantation, which include:

1. 1st-generation vs. 2nd-generation DES

2. Durable polymer vs. bioresorbable polymer 2nd-generaion DES

3. Ultra-thin strut vs. Conventional strut vs. Thick-strut DES

4. According to the type of eluted drugs

5. DAPT duration after DES implantation

6. Type of anti-platelet therapy after cessation of DAPT

7. Intensity of statin therapy after DES implantation

8. According to use of nitrate donor or vasodilator after DES implantation

9. Use of anti-hypertensive agents after DES implantation

10. Use of glucose-lowering agents in diabetic subset of patients

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350000
• Est. completion date: December 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who were over 20 years old at the implantation of DES and treated with DES between 1-January-2005 and 31-December-2016

Exclusion Criteria:

• Patients who died within 1 week after DES implantation

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• Stent Stenosis
• Stent Thrombosis
• Thrombosis

Intervention

Device:
• 1st-generation drug-eluting stent
Implantation of 1st-generation drug-eluting stent
• 2nd-generation drug-eluting stents
Implantation of 2nd-generation drug-eluting stent

Locations

Country	Name	City	State
Korea, Republic of	Hong Myeong-Ki	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Bangalore S, Toklu B, Patel N, Feit F, Stone GW. Newer-Generation Ultrathin Strut Drug-Eluting Stents Versus Older Second-Generation Thicker Strut Drug-Eluting Stents for Coronary Artery Disease. Circulation. 2018 Nov 13;138(20):2216-2226. doi: 10.1161/CIRCULATIONAHA.118.034456. — View Citation

Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation. 2007 Mar 20;115(11):1440-55; discussion 1455. Epub 2007 Mar 7. Review. — View Citation

Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. — View Citation

Kim D, Yang PS, Sung JH, Jang E, Yu HT, Kim TH, Uhm JS, Kim JY, Pak HN, Lee MH, Lip GYH, Joung B. Less dementia after catheter ablation for atrial fibrillation: a nationwide cohort study. Eur Heart J. 2020 Dec 14;41(47):4483-4493. doi: 10.1093/eurheartj/ehaa726. — View Citation

Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Jüni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Death from any cause	5 years
Secondary	Cardiovascular mortality	Confirmed by death certificate with cardiovascular related diagnosis	5 years
Secondary	Myocardial infarction		5 years
Secondary	Cardiovascular mortality or myocardial infarction	A composite of cardiovascular mortality and myocardial infarction	5 years
Secondary	Ischemic Stroke		5 years
Secondary	Hemorrhagic stroke		5 years
Secondary	Any Stroke	A composite of ischemic stroke and hemorrhagic stroke	5 years
Secondary	Gastrointestinal bleeding		5 years
Secondary	Any bleeding	Any bleeding	5 years
Secondary	Major bleeding	Any bleeding that requires transfusion =2 units of red-blood cells, hospitalizaiton, procedure, surgery, or leading to disability or death	5 years
Secondary	Net adverse clinical events (NACE)	A composite of all-cause mortality, recurrent MI, revascularization, ischemic stroke, and major bleeding	5 years
Secondary	Major adverse cardiac events (MACE)	A composite of all-cause mortality, recurrent MI, and revascularization	5 years
Secondary	Major adverse cardiac and cerebrovascular events (MACCE)	A composite of all-cause mortality, recurrent MI, revascularization, and ischemic stroke	5 years