Clinical InvestigationBleeding risk following percutaneous coronary intervention in patients with diabetes prescribed dual anti-platelet therapy
Section snippets
Study design and participants
Details regarding the OPS (Outcomes of PCI Study) and PRISM (Patient Risk Information Services Manager) prospective observational registries have been previously described.12., 13. From April 2009 to October 2011, consecutive PCI patients from 10 U.S. hospitals were prospectively approached for enrollment in OPS/PRISM (6 hospitals in PRISM, 3 hospitals in OPS, and 1 hospital with concurrent data collection [Saint Luke's Mid America Heart Institute]). The 2 registries had identical enrollment
Study participants
Of 3299 patients from 10 US sites enrolled in the OPS-PRISM registry, we excluded 135 (4.1%) patients who were not discharged on a thienopyridine or aspirin. We also excluded 218 patients (6.9%) who did not have available bleeding data during any follow-up assessment. Patients who were missing outcomes data were more likely to be younger, non-white race, smokers, and lower socioeconomic status compared with those in the analytic cohort (Supplemental Table II). In addition, patients with missing
Discussion
In this multicenter, contemporary PCI registry, we found that patients with DM experienced lower risk of BARC ≥1 bleeding over the year following PCI compared with patients who did not have DM. Importantly, these results persisted after adjustment for multiple potential confounders and in multiple sensitivity analyses. Collectively, these data reinforce the preferential use of DES over BMS in patients with DM by supplementing the well-known greater absolute risk reduction in restenosis in
Disclosures
Dr. Deepak L. Bhatt discloses the following relationships - Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: American Heart Association Get With The Guidelines Steering Committee; Data Monitoring Committees: Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Population Health Research Institute; Honoraria: American
References (25)
- et al.
The effect of drug-eluting stents on intermediate angiographic and clinical outcomes in diabetic patients: insights from randomized clinical trials
Am Heart J
(2008) - et al.
Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial
J Am Coll Cardiol
(2005) - et al.
Patients with poor responsiveness to thienopyridine treatment or with diabetes have lower levels of circulating active metabolite, but their platelets respond normally to active metabolite added ex vivo
J Am Coll Cardiol
(2008) - et al.
Safety and efficacy of protease-activated receptor-1 antagonists in patients with coronary artery disease: a meta-analysis of randomized clinical trials
J Thromb Haemost
(2012) What makes platelets angry: diabetes, fibrinogen, obesity, and impaired response to antiplatelet therapy?
J Am Coll Cardiol
(2008)- et al.
Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease
J Am Coll Cardiol
(1995) - et al.
Correlates of bleeding events among moderate-to high-risk patients undergoing percutaneous coronary intervention and treated with eptifibatide: observations from the PROTECT–TIMI-30 trial
J Am Coll Cardiol
(2006) - et al.
Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial
Lancet
(2009) - et al.
Nuisance bleeding with prolonged dual antiplatelet therapy after acute myocardial infarction and its impact on health status
J Am Coll Cardiol
(2013) - et al.
Impact of Bleeding on Quality of Life in Patients on DAPT: Insights From TRANSLATE-ACS
J Am Coll Cardiol
(2016)
Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents
JAMA
Clinical and angiographic predictors of restenosis after stent deployment in diabetic patients
Circulation
Cited by (17)
Questions and answers on the use of aspirin for primary prevention of cardiovascular disease in diabetes
2022, Diabetes Research and Clinical PracticeCitation Excerpt :Conversely, several data from secondary prevention cohorts have been published. The study by Grodzinsky et al. including 2,946 patients undergoing percutaneous coronary intervention, 33% of whom affected by diabetes, reported that hemorrhagic events at 12 months of follow-up classified as BARC (Bleeding Academic Research Consortium) 1 (i.e. bleedings that do not require medical intervention and/or hospitalization) were even lower in diabetic subjects than in non-diabetics (78.0% vs. 87.7%, p < 0.001) [9]. Instead, for bleeding events classified as BARC ≥ 2 (i.e. bleedings that require medical intervention or hospitalization) no significant differences among the two groups were noticed (respectively, 4.3% in patients with diabetes vs. 5.3% in patients without diabetes, p = 0.33) [9].
Adherence and persistence analysis in patients treated with double antiplatelet therapy (DAPT) at two years in real life
2021, Patient Education and CounselingCitation Excerpt :Unplanned interruption due to non-adherence to therapy can be more harmful than the interruption planned by the clinician according to treatment regulations and guidelines [38]. Causes of non-persistence can also be due to bleeding, in this case the interruption of the therapy is correct and in line with current guidelines [39]. As such it becomes essential to investigate the causes of non-persistence.
Association of diabetes with outcomes in patients undergoing contemporary percutaneous coronary intervention: Pre-specified subgroup analysis from the randomized GLOBAL LEADERS study
2020, AtherosclerosisCitation Excerpt :A large individual patient data meta-analysis of 11,473 patients studying the outcomes between short- or long-term DAPT after DES implantation according to the diabetic status showed similar bleeding risk between diabetic and non-diabetic patients [29]. Diabetic patients even experienced lower bleeding risk than non-diabetic patients after PCI in a multicenter US registry of consecutive PCI patients [34]. Nonetheless, most of the patients in these studies received clopidogrel as the P2Y12 inhibitor.
Use of prasugrel vs clopidogrel and outcomes in patients with and without diabetes mellitus presenting with acute coronary syndrome undergoing percutaneous coronary intervention
2019, International Journal of CardiologyCitation Excerpt :Importantly, we also described a higher rate of major bleeding events in diabetics. This finding is in contrast with prior reports which showed comparable 1-year rates of bleeding events in patients with and without diabetes [16]. The increased risk of bleeding in our study population became evident at 1 year follow up.
Funding source: The Outcomes of PCI Study (OPS) was supported by an American Heart Association Outcomes Research Center grant (0875149N) and the Personalized Risk Information Services Manager™ (PRISM) study was supported by a grant from the National Heart Lung and Blood Institute (R01-HL096624). Dr. Grodzinsky is supported by a T32 training grant from the NHLBI (HL110837). The funding agencies had no role in data collection, analysis, interpretation or the decision to submit the results. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding agencies.
Warren J. Cantor, MD served as guest editor for this article.