CONNECT DES Registrty

NCT04715594 | Unknown

• 1 other identifier: 4-2019-0596
• Study Type: observational
• Target: 350,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stent Thrombosis; Coronary Artery Disease; Stent Stenosis; Myocardial Infarction; Ischemic Heart Disease

Keywords

coronary artery disease; drug-eluting stents; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Death from any cause

  5 years

Secondary Outcomes (12)

• Cardiovascular mortality

  5 years

• Myocardial infarction

  5 years

• Cardiovascular mortality or myocardial infarction

  5 years

• Ischemic Stroke

  5 years

• Hemorrhagic stroke

  5 years

Study Arms (1)

CONNECT DES Registrty

Device: 1st-generation drug-eluting stent; Device: 2nd-generation drug-eluting stents

Interventions

1st-generation drug-eluting stent DEVICE

Implantation of 1st-generation drug-eluting stent

CONNECT DES Registrty

2nd-generation drug-eluting stents DEVICE

Implantation of 2nd-generation drug-eluting stent

CONNECT DES Registrty

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 350,000 patients with DES implantation between 2005 and 2016 would be incorporated in the analyses from National Health Insurance Service (NHIS) database

You may qualify if:

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

You may not qualify if:

• Patients who died within 1 week after DES implantation

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Hong Myeong-Ki

Seoul, South Korea

Location

Related Publications (11)

• 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. doi: 10.1056/NEJM199408253310802.

  PMID: 8041414 BACKGROUND

• Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate 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, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.

  PMID: 17869634 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.106.666800. Epub 2007 Mar 7. No abstract available.

  PMID: 17344324 BACKGROUND

• 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.

  PMID: 29945934 BACKGROUND

• 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.

  PMID: 33022705 BACKGROUND

• Lee SJ, Joo JH, Park S, Kim C, Choi DW, Lee YJ, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Nam CM, Hong MK. Combination therapy with moderate-intensity atorvastatin and ezetimibe vs. high-intensity atorvastatin monotherapy in patients treated with percutaneous coronary intervention in practice: assessing RACING generalizability. Eur Heart J Cardiovasc Pharmacother. 2025 Jan 11;10(8):676-685. doi: 10.1093/ehjcvp/pvad083.

  PMID: 37951292 DERIVED

• Lee SJ, Joo JH, Park S, Kim C, Choi DW, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Nam CM, Hong MK. Combination Lipid-Lowering Therapy in Patients Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2023 Aug 1;82(5):401-410. doi: 10.1016/j.jacc.2023.05.042.

  PMID: 37495276 DERIVED

• Lee SJ, Choi DW, Kim C, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Prolonged dual antiplatelet therapy after drug-eluting stent implantation in patients with diabetes mellitus: A nationwide retrospective cohort study. Front Cardiovasc Med. 2022 Aug 11;9:954704. doi: 10.3389/fcvm.2022.954704. eCollection 2022.

  PMID: 36035946 DERIVED

• Kim C, Choi DW, Lee SJ, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Benefit and risk of prolonged dual antiplatelet therapy after drug-eluting stent implantation in patients with chronic kidney disease: A nationwide cohort study. Atherosclerosis. 2022 Jul;352:69-75. doi: 10.1016/j.atherosclerosis.2022.05.019. Epub 2022 Jun 8.

  PMID: 35714431 DERIVED

• Lee SJ, Choi DW, Kim C, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Long-Term Beta-Blocker Therapy in Patients With Stable Coronary Artery Disease After Percutaneous Coronary Intervention. Front Cardiovasc Med. 2022 May 17;9:878003. doi: 10.3389/fcvm.2022.878003. eCollection 2022.

  PMID: 35656394 DERIVED

• Lee SJ, Choi DW, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Long-Term Clinical Outcomes Between Biodegradable and Durable Polymer Drug-Eluting Stents: A Nationwide Cohort Study. Front Cardiovasc Med. 2022 Apr 29;9:873114. doi: 10.3389/fcvm.2022.873114. eCollection 2022.

  PMID: 35571196 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: August 11, 2019
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)