title: Impact of Patient and Lesion Complexity on Long-Term Outcomes Following Coronary Revascularization With New-Generation Drug-Eluting Stents.
abstract: Long-term clinical outcomes of new-generation drug-eluting stents in complex anatomic and clinical settings are not well defined. This study assessed the impact of patient and lesion complexity on 2-year outcomes after coronary revascularization with ultrathin strut biodegradable-polymer (BP) sirolimus-eluting stents (SES) versus durable-polymer (DP) everolimus-eluting stents (EES). In a prespecified analysis of the BIOSCIENCE randomized trial (NCT01443104), complex patients (911 of 2,119; 43%) were defined by the presence of acute ST-elevation myocardial infarction (MI); left ventricular ejection fraction ≤30%; renal dysfunction; insulin-treated diabetes; treatment of ostial lesion, bypass graft, unprotected left main lesion; or 3-vessel intervention. The primary end point was target lesion failure (TLF), a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization. At 2 years, complex compared with simple patients had a greater risk of TLF (14.5% vs 7.4%, risk ratio 2.05, 95% confidence interval 1.56 to 2.69; p <0.001). The difference was sustained beyond 1 year on landmark analysis. Complex patients had higher rates of the patient-oriented composite end point of death, any MI, or any revascularization (23% vs 14.4%; p <0.001) as well as definite stent thrombosis (1.6% vs 0.4%, p = 0.006). There were no differences in TLF and patient-oriented composite end point between the BP-SES versus DP-EES, consistently among simple and complex patients. In conclusion, patient and lesion complexity had a durable adverse impact on clinical outcomes throughout 2 years of follow-up in this all-comers randomized trial. Safety and efficacy of new-generation BP-SES and DP-EES were comparable, irrespective of complexity status.
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
authors.forename: Konstantinos C
authors.initials: KC
authors.lastname: Koskinas
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
authors.forename: Masanori
authors.initials: M
authors.lastname: Taniwaki
authors.affiliation: Department of Cardiology, University Hospital, Geneva, Switzerland.
authors.forename: Fabio
authors.initials: F
authors.lastname: Rigamonti
authors.affiliation: Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital, Bern, Switzerland.
authors.forename: Dik
authors.initials: D
authors.lastname: Heg
authors.affiliation: Department of Cardiology, University Hospital, Geneva, Switzerland.
authors.forename: Marco
authors.initials: M
authors.lastname: Roffi
authors.affiliation: Department of Cardiology, Triemlispital, Zurich, Switzerland.
authors.forename: David
authors.initials: D
authors.lastname: Tüller
authors.affiliation: Department of Cardiology, University Hospital, Lausanne, Switzerland.
authors.forename: Olivier
authors.initials: O
authors.lastname: Muller
authors.affiliation: Department of Cardiology, Kantonsspital, Aarau, Switzerland.
authors.forename: Andre
authors.initials: A
authors.lastname: Vuillomenet
authors.affiliation: Department of Cardiology, University Hospital, Fribourg, Switzerland.
authors.forename: Stephane
authors.initials: S
authors.lastname: Cook
authors.affiliation: Department of Cardiology, Kantonsspital, St. Gallen, Switzerland.
authors.forename: Daniel
authors.initials: D
authors.lastname: Weilenmann
authors.affiliation: Department of Cardiology, University Hospital, Basel, Switzerland.
authors.forename: Christopher
authors.initials: C
authors.lastname: Kaiser
authors.affiliation: Department of Cardiology, Kantonsspital, Luzern, Switzerland.
authors.forename: Peiman
authors.initials: P
authors.lastname: Jamshidi
authors.affiliation: Applied Health Research Centre (AHRC), St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D015897:Comorbidity; D003324:Coronary Artery Disease / Q000453:epidemiology / Q000503:physiopathology / Q000601:surgery*; D003920:Diabetes Mellitus / Q000188:drug therapy / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D011108:Polymers; D011379:Prognosis; D011446:Prospective Studies; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology; D000072657:ST Elevation Myocardial Infarction / Q000453:epidemiology / Q000503:physiopathology / Q000601:surgery*; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage; D013318:Stroke Volume; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000453:epidemiology / Q000503:physiopathology
chemical_list: D000903:Antibiotics, Antineoplastic; D007004:Hypoglycemic Agents; D007328:Insulin; D011108:Polymers; D020123:Sirolimus