Extended 5-year Amputation and Survival Outcomes from SINGAPACLI: a Randomised Clinical Trial Comparing Drug-coated Balloon to Conventional Balloon Angioplasty for Below-the-Knee Arteries in Critical Limb Ischemia

Monday, March 6, 2023

3:00 PM – 3:09 PM

Location: Phoenix Convention Center, 221C

Abstract Speaker(s)

KZ

Kun Da Zhuang, MBBS, FRCR, MMed (Diag. Radiology), MCI

Consultant
Department of Vascular and Interventional Radiology, Singapore General Hospital

Disclosure(s): BD: Honorarium for giving a lecture (); Boston Scientific: Honorarium for giving a lecture. (), Research Grant or Support ()

Author/Co-author(s)

AP

Ankur Patel, MBChB FRCR FAMS

Senior Consultant
Department of Vascular and Interventional Radiology, Singapore General Hospital
EC

En Fui Raelene Chong, n/a

Medical Student
Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore
SC

Shih Yen Edwin Chan, BSc, BVMS(Hons), PhD

Chief Scientific Officer
Singapore Clinical Research Institute
HW

Hlaing Hlaing Win, MBBS, MS (Biomedical/Medical Engineering)

Clinical Research Coordinator
Department of Vascular and Interventional Radiology, Singapore General Hospital
ZT

Zehao Tan, MD, FRCR, MMed (Diagnostic Radiology)

Associate Consultant
Department of Vascular and Interventional Radiology, Singapore General Hospital
TH

Ta Yi Hon, n/a

Medical Student
Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore
FI

Farah Gillan Irani, MD FRCR FAMS

Senior Consultant
Department of Vascular and Interventional Radiology, Singapore General Hospital
AG

Apoorva Gogna, MBBS FRCR FAMS

Senior Consultant
Department of Vascular and Interventional Radiology, Singapore General Hospital
MC

Ming Er Jasmine Chua, MBBS FRCR

Consultant
Department of Vascular and Interventional Radiology, Singapore General Hospital
SL

Sum Leong, MBBChBAO FFR RCSI

Senior Consultant
Department of Vascular and Interventional Radiology, Singapore General Hospital
CS

Chandramohan Sivanathan, MBBS FRCR

Senior Consultant
Department of Vascular and Interventional Radiology, Singapore General Hospital
Kiang Hiong Tay, MBBS, FSIR

Professor and Head of Department of Vascular & Interventional Radiology
Singapore General Hospital
TC

Tze Tec Chong, MBBS (Sydney, Honours 1st Class), FACS (General & Vascular Surgery), RPVI

Head and Senior Consultant
Department of Vascular Surgery, Singapore General Hospital
BT

Bien Soo Tan, MBBS, FRCR, FAMS

Senior Consultant
Department of Vascular and Interventional Radiology, Singapore General Hospital

Disclosure(s):

Kun Da Zhuang, MBBS, FRCR, MMed (Diag. Radiology), MCI: BD: Honorarium for giving a lecture (); Boston Scientific: Honorarium for giving a lecture. (), Research Grant or Support ()

Kiang Hiong Tay, MBBS, FSIR: Becton Dickenson: Speaking and Teaching (Ongoing); Biotronik: Speaking and Teaching (Ongoing); Boston Scientific: Advisory Committee or Review Panel Member (Ongoing), Research Grant Recipient (Ongoing), Speaking and Teaching (Ongoing); Canon: Consultant (Ongoing), Research Grant Recipient (Ongoing), Speaking and Teaching (Ongoing); Medtronic: Speaking and Teaching (Ongoing); Sirtex: Speaking and Teaching (Ongoing)

Purpose:

The Singapore Infra-Genicular Angioplasty with Paclitaxel-eluting Balloon for Critical Limb Ischemia (SINGA-PACLI) trial {1} is a randomised clinical trial comparing drug-coated balloon angioplasty (DCBA) to conventional (uncoated) percutaneous transluminal angioplasty (PTA) for below-the-knee (BTK) lesions in patients with chronic limb-threatening ischemia. We sought to assess the long-term safety outcomes of the SINGA-PACLI trial by analysing the 5-year freedom from major amputation, survival and amputation-free survival (no amputation or death) in trial participants.

Materials and Methods:

The SINGA-PACLI trial recruited and randomised 138 participants across two centres in a 1:1 ratio to either DCBA or PTA treatment. After obtaining additional consent for study period extension to 5 years (beyond the original 1-year follow-up), 112 participants were analysed with Kaplan-Meier analysis.

Results:
There was no significant difference between both groups for freedom from major amputation (DBCA vs PTA: 70.8% vs 79.7%, logrank p = 0.43; HR 1.39, 95% CI 0.61 – 3.16), survival (DBCA vs PTA: 37.5% vs 42.3%, log-rank p = 0.69; HR 1.11, 95% CI 0.65 – 1.91) and amputation-free survival (DBCA vs PTA: 32.9% vs 40.0%, log-rank p = 0.29; HR 1.31, 95% CI 0.79 – 2.17) at 5-year follow-up.

Conclusion: There was no significant difference in the risk of death and major amputation between the DCBA and PTA arms in the SINGA-PACLI trial at 5 years follow-up.