TY - JOUR
T1 - Risk of bleeding after percutaneous coronary intervention and its impact on further adverse events in clinical trial participants with comorbid peripheral arterial disease
AU - Pinxterhuis, Tineke H.
AU - Ploumen, Eline H.
AU - Zocca, Paolo
AU - Doggen, Carine J.M.
AU - Schotborgh, Carl E.
AU - Anthonio, Rutger L.
AU - Roguin, Ariel
AU - Danse, Peter W.
AU - Benit, Edouard
AU - Aminian, Adel
AU - Stoel, Martin G.
AU - Linssen, Gerard C.M.
AU - Geelkerken, Robert H.
AU - von Birgelen, Clemens
N1 - Funding Information:
CvB reports that the Research Department of Thoraxcentrum Twente has received research grants provided by Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. RLA reports a teaching grant from Biotronic, a lincense from Sanofi, a speaking fee from Abiomed and support from Amgen for attending a meeting, all outside the submitted work. All other authors declared that they have no conflict of interest.
Publisher Copyright:
© 2022 The Author(s)
PY - 2023/3/1
Y1 - 2023/3/1
N2 - Background: Both patients with obstructive coronary artery disease (CAD) and patients with peripheral arterial disease (PADs) have an increased bleeding risk. Information is scarce on bleeding in CAD patients, treated with percutaneous coronary intervention (PCI), who have comorbid PADs. We assessed whether PCI patients with PADs have a higher bleeding risk than PCI patients without PADs. Furthermore, in PCI patients with PADs we evaluated the extent by which bleeding increased the risk of further adverse events.Methods: Three-year pooled patient-level data of two randomized PCI trials (BIO-RESORT, BIONYX) with drug-eluting stents were analyzed to assess mortality and the composite endpoint major adverse cardiac events (MACE: all-cause mortality, any myocardial infarction, emergent coronary artery bypass surgery, or target lesion revascularization).Results: Among 5989 all-comer patients, followed for 3 years, bleeding occurred in 7.7% (34/440) with comorbid PADs and 5.0% (279/5549) without PADs (HR: 1.59, 95%CI: 1.11–2.23, p = 0.010). Of all PADs patients, those with a bleeding had significantly higher rates of all-cause mortality (HR: 4.70, 95%CI: 2.37–9.33, p < 0.001) and MACE (HR: 2.39, 95%CI: 1.23–4.31, p = 0.003). Furthermore, PADs patients with a bleeding were older (74.4 ± 6.9 vs. 67.4 ± 9.5, p < 0.001). After correction for age and other potential confounders, bleeding remained independently associated with all-cause mortality (adj.HR: 2.97, 95%CI: 1.37–6.43, p = 0.006) while the relation of bleeding with MACE became borderline non-significant (adj.HR: 1.85, 95%CI: 0.97–3.55, p = 0.06).Conclusion: PCI patients with PADs had a higher bleeding risk than PCI patients without PADs. In PADs patients, bleeding was associated with all-cause mortality, even after adjustment for potential confounders.
AB - Background: Both patients with obstructive coronary artery disease (CAD) and patients with peripheral arterial disease (PADs) have an increased bleeding risk. Information is scarce on bleeding in CAD patients, treated with percutaneous coronary intervention (PCI), who have comorbid PADs. We assessed whether PCI patients with PADs have a higher bleeding risk than PCI patients without PADs. Furthermore, in PCI patients with PADs we evaluated the extent by which bleeding increased the risk of further adverse events.Methods: Three-year pooled patient-level data of two randomized PCI trials (BIO-RESORT, BIONYX) with drug-eluting stents were analyzed to assess mortality and the composite endpoint major adverse cardiac events (MACE: all-cause mortality, any myocardial infarction, emergent coronary artery bypass surgery, or target lesion revascularization).Results: Among 5989 all-comer patients, followed for 3 years, bleeding occurred in 7.7% (34/440) with comorbid PADs and 5.0% (279/5549) without PADs (HR: 1.59, 95%CI: 1.11–2.23, p = 0.010). Of all PADs patients, those with a bleeding had significantly higher rates of all-cause mortality (HR: 4.70, 95%CI: 2.37–9.33, p < 0.001) and MACE (HR: 2.39, 95%CI: 1.23–4.31, p = 0.003). Furthermore, PADs patients with a bleeding were older (74.4 ± 6.9 vs. 67.4 ± 9.5, p < 0.001). After correction for age and other potential confounders, bleeding remained independently associated with all-cause mortality (adj.HR: 2.97, 95%CI: 1.37–6.43, p = 0.006) while the relation of bleeding with MACE became borderline non-significant (adj.HR: 1.85, 95%CI: 0.97–3.55, p = 0.06).Conclusion: PCI patients with PADs had a higher bleeding risk than PCI patients without PADs. In PADs patients, bleeding was associated with all-cause mortality, even after adjustment for potential confounders.
KW - Bleeding
KW - Coronary artery disease
KW - Drug-eluting stents
KW - Percutaneous coronary intervention
KW - Peripheral arterial disease
KW - UT-Hybrid-D
UR - http://www.scopus.com/inward/record.url?scp=85144772502&partnerID=8YFLogxK
U2 - 10.1016/j.ijcard.2022.12.009
DO - 10.1016/j.ijcard.2022.12.009
M3 - Article
C2 - 36496036
AN - SCOPUS:85144772502
SN - 0167-5273
VL - 374
SP - 27
EP - 32
JO - International journal of cardiology
JF - International journal of cardiology
ER -
