Comparative Efficacy of Limus-, and Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis: A Pairwise and Network Meta-Analysis of Randomized Controlled Trials
Abstract Body (Do not enter title and authors here): Background: Drug-coated balloon angioplasty is an established treatment strategy for coronary in-stent restenosis (ISR). While paclitaxel-coated balloons (PCB) have been studied most extensively, limus-coated balloons—including sirolimus- (SCB) and biolimus-coated balloons (BCB)—offer potential advantages due to their antiproliferative effects and pharmacokinetic profiles. However, direct comparisons remain limited. Objectives: To compare the efficacy of SCB, BCB, and PCB for the treatment of coronary ISR using a pairwise and network meta-analysis of randomized controlled trials (RCTs). Methods: A systematic search of PubMed, Scopus, and Cochrane was performed to identify RCTs comparing any combination of SCB, BCB and PCB angioplasty for ISR lesions. Outcomes of interest include target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR), as well as these individual outcomes. A pairwise and frequentist network meta-analysis with random-effects models was used to estimate risk ratios (RR) and 95% confidence intervals (CIs) for each comparison. Treatments were ranked with P-scores. Results: Five RCTs with 977 patients with ISR were included in the analysis (SCB 25.8%; BCB 27.6%; PCB 46.6%). In pairwise comparisons, limus-coated balloons demonstrated similar efficacy to PCB across all endpoints. Network meta-analysis revealed no significant differences among SCB, BCB, and PCB in the risk of TLF, TV-MI, cardiac death, or TLR (Figure 1). P-score rankings indicated that PCB was most favorable for reducing TLF and TLR, while SCB and BCB ranked highest for reducing cardiac death and TV-MI, respectively. Conclusions: In this network meta-analysis of RCTs, limus-coated balloons and PCB demonstrated comparable efficacy profiles for the treatment of coronary ISR. P-score rankings suggest potential outcome-specific differences that warrant further investigation in adequately powered head-to-head trials.
Ezenna, Chidubem
( UMass- Baystate Medical Center
, Springfield
, Massachusetts
, United States
)
Ibrahim, Sammudeen
( Piedmont Athens Regional
, Athens
, Georgia
, United States
)
Nanna, Michael
( Yale University
, New Haven
, Connecticut
, United States
)
Goldsweig, Andrew
( Baystate Medical Center
, West Hartford
, Connecticut
, United States
)
Krishna, Mrinal
( Medical College Thiruvananthapuram
, Mavelikara
, India
)
Joseph, Meghna
( Medical College Thiruvananthapuram
, Thodupuzha
, India
)
Chi, Kuan Yu
( Jacobi Medical Center
, Bronx
, New York
, United States
)
Lee, Pei-lun
( Jacobi Medical Center
, Bronx
, New York
, United States
)
Chinnatambi, Christopher
( Piedmont Athens Regional
, Athens
, Georgia
, United States
)
Rossi, Raiza
( Yale University
, New Haven
, Connecticut
, United States
)
Khan, Muhammad Ahmed
( U Mass Chan-Baystate Medical Center
, Springfield
, Massachusetts
, United States
)
Nouri, Armin
( Yale School of Medicine
, New Haven
, Connecticut
, United States
)
Author Disclosures:
Chidubem Ezenna:DO NOT have relevant financial relationships
| Sammudeen Ibrahim:No Answer
| Michael Nanna:DO have relevant financial relationships
;
Consultant:HeartFlow, Inc.:Active (exists now)
; Consultant:Merck:Active (exists now)
; Consultant:Novo Nordisk:Active (exists now)
| Andrew Goldsweig:DO have relevant financial relationships
;
Consultant:Philips:Past (completed)
; Consultant:Occlutech:Active (exists now)
; Consultant:Conformal Medical:Active (exists now)
; Speaker:Boston Scientific:Past (completed)
; Consultant:Abbott:Past (completed)
| Mrinal Krishna:DO NOT have relevant financial relationships
| Meghna Joseph:DO NOT have relevant financial relationships
| Kuan Yu Chi:DO NOT have relevant financial relationships
| Pei-Lun Lee:DO NOT have relevant financial relationships
| Christopher Chinnatambi:DO NOT have relevant financial relationships
| Raiza Rossi:DO NOT have relevant financial relationships
| Muhammad Ahmed Khan:DO NOT have relevant financial relationships
| Armin Nouri:DO NOT have relevant financial relationships
Bakht Danyal, Bokhari Dr. Syed Faqeer Hussain, Hassan Ahmad, Zahid Muhammad, Cheema Umaima, Ali Eshah, Nisar Muhammad Soban, Abdullah Abdullah, Zaman Shah E, Haroon Ahmad, Mustafa Ahmad, Sattar Osama Abdul