Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Abstract Body (Do not enter title and authors here): Background: Despite the effectiveness of drug-eluting stents (DES) in preventing restenosis, many patients still experience DES restenosis. Neointimal hyperplasia and neoatherosclerosis can develop within these stents, leading to recurrent coronary syndromes.
Hypothesis: Repeated stenting with DES is limited by additional metal layers, the need for prolonged dual antiplatelet therapy, and heightened risks of stent thrombosis. Locally acting drugs with sustained efficacy may prevent this progression. Paclitaxel delivery via contrast medium or drug-coated balloon catheters could exert antiproliferative effects, reducing neointimal proliferation.
Aims: To synthesize existing evidence on the efficacy and safety of Paclitaxel-Coated Balloons versus Uncoated Balloons in coronary in-stent restenosis.
Methods: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched five electronic databases (PubMed, EMBASE, Cochrane Library, Scopus, and Web of Science) to identify eligible studies reported up to March 23, 2024. Using R version 4.4.0, we reported outcomes as risk ratios (RRs) or mean differences (MD) and confidence intervals (CIs). This review has been registered and published in PROSPERO (CRD42024527412).
Results: The meta-analysis included a total of six trials with 1,541 patients. PCB significantly reduced the incidence of myocardial infarction (RR 0.65, 95% CI [0.42, 1.00], p = 0.052), stent thrombosis (RR 0.26, 95% CI 0.08, to 0.83], p = 0.023), major adverse cardiac events (RR 0.32, 95% CI 0.25, to 0.42], P < 0.001), target lesion revascularization (RR 0.34, 95% CI [0.14, 0.84], p < 0.001). No significant differences were observed between PCB and UCB regarding cardiac-related mortality, target vessel revascularization, percutaneous coronary intervention, all-cause death, Q wave and non-Q wave myocardial infarction, coronary artery bypass grafting, and target vessel failure.
Conclusion: PCB for ISR significantly reduced the incidence of myocardial infarction, MACE, and stent thrombosis compared to UCB.
Tanashat, Mohammad
( Yarmouk University
, Irbid
, Jordan
)
Abuelazm, Mohamed
( Tanta University
, Tanta
, Egypt
)
Manasrah, Almothana
( UHS-WIlson Medical Center
, Binghamton
, New York
, United States
)
Abouzid, Mohamed
( Poznan University of Medical Sciences
, Poznan
, Poland
)
Abu El Haija, Mohanned
( King Hussein Cancer Center
, Amman
, Jordan
)
El Khatib, Suhaib
( UCHealth Parkview Medical Center
, Pueblo
, Colorado
, United States
)
Abu-laila, Mutaz
( Yarmouk University
, Irbid
, Jordan
)
Ayyad, Mohammed
( Rutgers New Jersey Medical School
, New Jersey
, New Jersey
, United States
)
Author Disclosures:
Mohammad Tanashat:DO NOT have relevant financial relationships
| Mahmoud Shaaban Abdelgalil:DO NOT have relevant financial relationships
| Mohamed Abuelazm:DO NOT have relevant financial relationships
| AlMothana Manasrah:DO NOT have relevant financial relationships
| Mohamed Abouzid:DO NOT have relevant financial relationships
| Mohanned Abu El Haija:DO NOT have relevant financial relationships
| Suhaib El Khatib:No Answer
| Mutaz Abu-Laila:DO NOT have relevant financial relationships
| Mohammed Ayyad:DO NOT have relevant financial relationships
