Coronary Artery DiseaseBalancing Long-Term Risks of Ischemic and Bleeding Complications After Percutaneous Coronary Intervention With Drug-Eluting Stents
Section snippets
Methods
The study population consisted of 9,727 subjects enrolled in the Patient Related Outcomes With Endeavor vs Cypher Stenting Trial (PROTECT) or in the PROTECT US study.11, 12 The PROTECT trial was a large, broadly inclusive, multicenter randomized controlled trial comparing the long-term safety of 2 different DES, the Endeavor zotarolimus-eluting stent (Medtronic Inc, Santa Rosa, CA), and the Cypher sirolimus-eluting stent (Cordis J&J, Fremont, CA); 8,709 subjects were randomized from May 2007 to
Results
Complete follow-up was available for 9,410 patients (96.7% of 9,727 patients). Baseline/procedural characteristics of patients according to the occurrence of each primary end point are listed in Table 1. Median follow-up duration was 4.1 years (interquartile range 4.0 to 5.0). Use of DAPT was assessed at 1, 6, 12, 24, 36, and 48 months and was 96%, 94%, 87%, 39%, 32%, and 27%, respectively. Median DAPT use was 507.0 days (interquartile range 366.0 to 1,119.0).
The long-term event rate was 6.3%
Discussion
The current analysis performed on the data derived from 2 large prospective cohorts with broad inclusion criteria reflecting contemporary interventional cardiology practice, and with clinical event adjudication, showed that the predicted long-term risk of ischemic events (cardiovascular death/non-periprocedural MI/definite or probable stent thrombosis) was greater than the risk of bleeding events (moderate/severe bleeding) in the large majority of patients. In the small subset of patients that
Disclosures
Relation with industry: Dr. Mattenone; Dr. Yeh: salary (Harvard Clinical Research Institute [HCRI]) and grant (HCRI); Dr. Camenzind: none; Dr. Steg: research support (NYU School of Medicine, Sanofi-Aventis, and Servier), consulting fees (Ablynx, Amarin, Astellas, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo-Lilly, GlaxoSmithKline, Medtronic, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, Servier, and The Medicines Company), and stockholding (Aterovax); Dr. Wijns: grant (to
References (27)
- et al.
Duration of dual antiplatelet therapy following drug-eluting stent implantation: a systematic review and meta-analysis of randomized controlled trials
J Am Coll Cardiol
(2015) - et al.
Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial
Lancet
(2014) - et al.
Balancing the risks of bleeding and stent thrombosis: a decision analytic model to compare durations of dual antiplatelet therapy after drug-eluting stents
Am Heart J
(2015) - et al.
Rationale and design of the Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation
Am Heart J
(2009) - et al.
Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial
Lancet
(2012) - et al.
Internal validation of predictive models: efficiency of some procedures for logistic regression analysis
J Clin Epidemiol
(2001) - et al.
Comparison between the NERS (New Risk Stratification) score and the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score in outcome prediction for unprotected left main stenting
JACC Cardiovas Interv
(2010) - et al.
Predicting 3-year mortality after percutaneous coronary intervention: updated logistic clinical SYNTAX score based on patient-level data from 7 contemporary stent trials
JACC Cardiovasc Interv
(2014) - et al.
Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial
J Am Coll Cardiol
(2007) - et al.
Development and validation of a stent thrombosis risk score in patients with acute coronary syndromes
JACC Cardiovasc Interv
(2012)
Impact of bleeding on mortality after percutaneous coronary intervention results from a patient-level pooled analysis of the REPLACE-2 (randomized evaluation of PCI linking angiomax to reduced clinical events), ACUITY (acute catheterization and urgent intervention triage strategy), and HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trials
JACC Cardiovasc Interv
Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation
JAMA
Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents
N Engl J Med
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