Drug Coated Balloon (DCB) angioplasty; DCB Norwich Registry (2009-2015) and a Propensity Score Matched Comparison between DCB and Second Generation Drug Eluting Stents.

Wickramarachchi, Upul (2020) Drug Coated Balloon (DCB) angioplasty; DCB Norwich Registry (2009-2015) and a Propensity Score Matched Comparison between DCB and Second Generation Drug Eluting Stents. Doctoral thesis, University of East Anglia.

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Abstract

Background
Drug coated balloons are semi compliant balloons coated with a chemotherapeutic drug to reduce neo intimal hyperplasia thus reducing the risk of re-stenosis. The lack of any permanent metal/polymer in the coronary artery may reduce future risk of adverse clinical events.

Objectives
The main objective of the DCB NORWICH observational registry was to assess the efficacy and safety of drug coated balloon angioplasty in a real world setting. The propensity matched analysis compared clinical outcomes between DCB-only angioplasty and second generation drug eluting stents (DES).

Methods
All patients who received DCB angioplasty in the Norfolk and Norwich University Hospitals NHS Foundation Trust from 01/01/2009 to 31/12/2015 were included retrospectively in the DCB NORWICH registry study. In the propensity score matched study, DCB-only PCI in de novo vessels were compared to second generation DES. Clinical outcomes were obtained from the National Institute for Cardiovascular Outcomes Research and NHS Digital.

Results
A total of 1394 lesions in 1122 patients were treated with DCBs. There were 1026 lesions in 812 patients in the de novo group. The mean age was 65.8. 60.1% presented with MI or acute coronary syndrome. 12 month all cause death was 3.6%, MI 3.1% and target lesion revascularisation (TLR) 2.1%. MACE (death, MI, TLR) was 8.1%. No definite treated segment thrombosis was noted up to 12 months.
The propensity score matched study had 904 DCB and 1424 DES treated de novo lesions. Results showed no difference in clinical outcomes between PCI with DCB-only strategy vs. 2nd generation DES. The MACE rate for the DCB arm met the pre specified non-inferiority margin of 4.5%.

Conclusions
DCB-only PCI is safe and feasible in a wide range of patients and showed no difference in clinical outcomes compared to second generation DES up to 12 months

Item Type: Thesis (Doctoral)
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Depositing User: Chris White
Date Deposited: 12 Nov 2020 12:16
Last Modified: 12 Nov 2020 12:16
URI: https://ueaeprints.uea.ac.uk/id/eprint/77670
DOI:

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