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
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