Impact of coronary artery tortuosity on outcomes following stenting with newer-generation drug-eluting stents. An analysis of the randomized BIOFLOW trials.
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BORIS DOI
Date of Publication
January 4, 2025
Publication Type
Article
Division/Institute
Contributor
Mankerious, Nader | |
Toelg, Ralph | |
Abdelghani, Mohammad | |
Farhan, Serdar | |
Allali, Abdelhakim | |
Lefèvre, Thierry | |
Saito, Shigeru | |
Kandzari, David E | |
Waksman, Ron | |
Richardt, Gert | |
Hemetsberger, Rayyan |
Subject(s)
Series
Revista Española de Cardiología (English ed.)
ISSN or ISBN (if monograph)
1885-5857
Publisher
Elsevier
Language
English
Spanish, Castilian
Publisher DOI
PubMed ID
39761745
Description
Introduction And Objectives
Patients undergoing percutaneous coronary intervention in vessels with moderate-to-severe tortuosity are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation stents. We compared outcomes following percutaneous coronary intervention in vessels with moderate-to-severe tortuosity using a bioresorbable-polymer sirolimus-eluting stent (BP-SES) vs a durable-polymer everolimus-eluting stent.
Methods
A total of 2350 patients from the BIOFLOW II, IV, and V randomized trials were stratified into 2 groups based on target-vessel tortuosity: none-to-mild and moderate-to-severe. The primary endpoints included target lesion failure (TLF)-a composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (TLR)-and probable/definite stent thrombosis at 3 years.
Results
Patients with moderate-to-severe tortuosity (n = 903) had more comorbidities than those with none-to-mild tortuosity (n = 1447). Rates of TLF (P = .354), cardiac death (P = .690), TLR (P = .447), and stent thrombosis (P = .084) were similar between the 2 groups, whereas TV-MI occurred more frequently in the moderate-to-severe tortuosity group (P = .031). However, on multivariate analysis, moderate-to-severe tortuosity was not an independent predictor of TV-MI (adjusted HR, 1.06; 95% CI, 0.72-1.55; P = .772). Among patients with moderate-to-severe tortuosity, the use of BP-SES was associated with significantly lower rates of TLF compared with the durable-polymer everolimus-eluting stent (7.8% vs 13.4%; HR, 0.57; 95% CI, 0.37-0.87; P = .009), driven by reductions in TV-MI (5.0% vs 9.2%; HR, 0.54; 95% CI, 0.32-0.90; P = .018) and TLR (2.7% vs 6.1%; HR, 0.45; 95% CI, 0.23-0.90; P = .021).
Conclusions
This pooled analysis of the randomized BIOFLOW trials demonstrates that patients with none-to-mild and moderate-to-severe tortuosity have comparable long-term adverse event rates. However, the use of BP-SES in patients with moderate-to-severe tortuosity may help mitigate potential ischemic risks.Clinical Trial Registration
Clinicaltrials.gov NCT01356888, NCT01939249, NCT02389946.
Patients undergoing percutaneous coronary intervention in vessels with moderate-to-severe tortuosity are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation stents. We compared outcomes following percutaneous coronary intervention in vessels with moderate-to-severe tortuosity using a bioresorbable-polymer sirolimus-eluting stent (BP-SES) vs a durable-polymer everolimus-eluting stent.
Methods
A total of 2350 patients from the BIOFLOW II, IV, and V randomized trials were stratified into 2 groups based on target-vessel tortuosity: none-to-mild and moderate-to-severe. The primary endpoints included target lesion failure (TLF)-a composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (TLR)-and probable/definite stent thrombosis at 3 years.
Results
Patients with moderate-to-severe tortuosity (n = 903) had more comorbidities than those with none-to-mild tortuosity (n = 1447). Rates of TLF (P = .354), cardiac death (P = .690), TLR (P = .447), and stent thrombosis (P = .084) were similar between the 2 groups, whereas TV-MI occurred more frequently in the moderate-to-severe tortuosity group (P = .031). However, on multivariate analysis, moderate-to-severe tortuosity was not an independent predictor of TV-MI (adjusted HR, 1.06; 95% CI, 0.72-1.55; P = .772). Among patients with moderate-to-severe tortuosity, the use of BP-SES was associated with significantly lower rates of TLF compared with the durable-polymer everolimus-eluting stent (7.8% vs 13.4%; HR, 0.57; 95% CI, 0.37-0.87; P = .009), driven by reductions in TV-MI (5.0% vs 9.2%; HR, 0.54; 95% CI, 0.32-0.90; P = .018) and TLR (2.7% vs 6.1%; HR, 0.45; 95% CI, 0.23-0.90; P = .021).
Conclusions
This pooled analysis of the randomized BIOFLOW trials demonstrates that patients with none-to-mild and moderate-to-severe tortuosity have comparable long-term adverse event rates. However, the use of BP-SES in patients with moderate-to-severe tortuosity may help mitigate potential ischemic risks.Clinical Trial Registration
Clinicaltrials.gov NCT01356888, NCT01939249, NCT02389946.
File(s)
File | File Type | Format | Size | License | Publisher/Copright statement | Content | |
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1-s2.0-S1885585724003700-main.pdf | text | Adobe PDF | 1.53 MB | Attribution (CC BY 4.0) | accepted |