title: Impact of routine angiographic follow-up after percutaneous coronary intervention with drug-eluting stents in the SPIRIT III randomized trial at three years.
abstract: Routine angiographic follow-up after bare-metal stent implantation has been associated with an increase in coronary revascularization. The impact of angiographic follow-up after drug-eluting stent placement remains poorly characterized. The prospective, randomized, single-blinded SPIRIT III trial assigned patients to the everolimus-eluting stent or the paclitaxel-eluting stent (PES). Major adverse cardiovascular events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization [ID-TLR]) at 3 years were assessed by angiographic versus clinical-only follow-up at 8 months ± 28 days and a landmark survival analysis from 9 months to 3 years. Of 1,002 patients, 564 patients were assigned to angiographic follow-up at 8 months ± 28 days and 438 patients underwent clinical follow-up alone. Three-year major adverse cardiovascular event rates were 10.6% in the angiographic group and 12.0% in the clinical follow-up group (p = 0.64). Ischemia-driven revascularization increased twofold at 9 months, but no difference was noted in ID-TLR for either device. Non-ID-TLR was significantly higher in patients in the angiographic group (4.5% vs 1.0%, p = 0.002), a difference resulting from PES (9.1% vs 0.7%, p = 0.0007) rather than everolimus-eluting stent (2.2% vs 1.1%, p = 0.36) treatment. The landmark analysis showed no significant differences between the angiographic and clinical follow-up groups from 9 months to 3 years of major clinical outcomes. In conclusion, routine angiographic follow-up in SPIRIT III did not increase rates of ID-TLR compared to clinical follow-up alone. Despite higher nonischemia-driven revascularization rates with angiographic follow-up of patients with PESs, none of the safety end points were adversely affected.
authors.affiliation: Yale University School of Medicine, New Haven, CT, USA. alexandra.lansky@yale.edu
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Somjot S
authors.initials: SS
authors.lastname: Brar
authors.forename: Manejeh
authors.initials: M
authors.lastname: Yaqub
authors.forename: Poornima
authors.initials: P
authors.lastname: Sood
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Applegate
authors.forename: Dana
authors.initials: D
authors.lastname: Lazar
authors.forename: Ivana
authors.initials: I
authors.lastname: Jankovic
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.forename: Kai
authors.initials: K
authors.lastname: Koo
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000601:surgery; D000068338:Everolimus; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D017239:Paclitaxel / Q000494:pharmacology; D011446:Prospective Studies; D011474:Prosthesis Design; D015203:Reproducibility of Results; D016037:Single-Blind Method; D020123:Sirolimus / Q000031:analogs & derivatives / Q000494:pharmacology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D007166:Immunosuppressive Agents; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus