title: Can the optimal type of stent be predicted based on clinical risk factors? A subgroup analysis of the randomized BASKET-PROVE trial.
abstract: BACKGROUND
  The randomized BASKET-PROVE study showed no significant differences between sirolimus-eluting stents (SES), everolimus-eluting stents (EES), and bare-metal stents (BMS) with respect to the primary end point, rates of death from cardiac causes, or myocardial infarction (MI) at 2 years of follow-up, in patients requiring stenting of a large coronary artery. Clinical risk factors may affect clinical outcomes after percutaneous coronary interventions. We present a retrospective analysis of the BASKET-PROVE data addressing the question as to whether the optimal type of stent can be predicted based on a cumulative clinical risk score.
  
  
  METHODS
  A total of 2,314 patients (mean age 66 years) who underwent coronary angioplasty and implantation of ≥1 stents that were ≥3.0 mm in diameter were randomly assigned to receive SES, EES, or BMS. A cumulative clinical risk score was derived using a Cox model that included age, gender, cardiovascular risk factors (hypercholesterolemia, hypertension, family history of cardiovascular disease, diabetes, smoking), presence of ≥2 comorbidities (stroke, peripheral artery disease, chronic kidney disease, chronic rheumatic disease), a history of MI or coronary revascularization, and clinical presentation (stable angina, unstable angina, ST-segment elevation MI).
  
  
  RESULTS
  An aggregate drug-eluting stent (DES) group (n = 1,549) comprising 775 patients receiving SES and 774 patients receiving EES was compared to 765 patients receiving BMS. Rates of death from cardiac causes or nonfatal MI at 2 years of follow-up were significantly increased in patients who were in the high tertile of risk stratification for the clinical risk score compared to those who were in the aggregate low-mid tertiles. In patients with a high clinical risk score, rates of death from cardiac causes or nonfatal MI were lower in patients receiving DES (2.4 per 100 person-years, 95% CI 1.6-3.6) compared with BMS (5.5 per 100 person-years, 95% CI 3.7-8.2, hazard ratio 0.45, 95% CI 0.26-0.80, P = .007). However, they were not significantly different between receivers of DES and BMS in patients in the low-mid risk tertiles.
  
  
  CONCLUSIONS
  This exploratory analysis suggests that, in patients who require stenting of a large coronary artery, use of a clinical risk score may identify those patients for whom DES use may confer a clinical advantage over BMS, beyond lower restenosis rates.
authors.affiliation: Fondazione Cardiocentro Ticino, Lugano, Switzerland; Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Vassalli
authors.affiliation: IRCCS Policlinico San Matteo, Servizio di Biometria e Statistica, Pavia, Italy.
authors.forename: Catherine
authors.initials: C
authors.lastname: Klersy
authors.affiliation: Ospedale Civile di Legnano, Milan, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: De Servi
authors.affiliation: Gentofte University Hospital, Hellerup, Denmark.
authors.forename: Soeren
authors.initials: S
authors.lastname: Galatius
authors.affiliation: State Hospital, Lucerne, Switzerland.
authors.forename: Paul
authors.initials: P
authors.lastname: Erne
authors.affiliation: Triemli Hospital, Zurich, Switzerland.
authors.forename: Franz
authors.initials: F
authors.lastname: Eberli
authors.affiliation: State Hospital, St Gallen, Switzerland.
authors.forename: Hans
authors.initials: H
authors.lastname: Rickli
authors.affiliation: Clara Hospital, Basel, Switzerland.
authors.forename: Burkhard
authors.initials: B
authors.lastname: Hornig
authors.affiliation: Cardiovascular Center Zurich, Zurich, Switzerland.
authors.forename: Osmund
authors.initials: O
authors.lastname: Bertel
authors.affiliation: State Hospital, Chur, Switzerland.
authors.forename: Piero
authors.initials: P
authors.lastname: Bonetti
authors.affiliation: Fondazione Cardiocentro Ticino, Lugano, Switzerland.
authors.forename: Tiziano
authors.initials: T
authors.lastname: Moccetti
authors.affiliation: University Hospital Basel, Basel, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Kaiser
authors.affiliation: University Hospital Basel, Basel, Switzerland.
authors.forename: Matthias
authors.initials: M
authors.lastname: Pfisterer
authors.affiliation: Fondazione Cardiocentro Ticino, Lugano, Switzerland. Electronic address: giovanni.pedrazzini@cardiocentro.org.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Pedrazzini
mesh_terms: D000367:Age Factors; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D001317:Austria / Q000453:epidemiology; D002423:Cause of Death / Q000639:trends; D003324:Coronary Artery Disease / Q000401:mortality / Q000601:surgery*; D003718:Denmark / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology*; D011379:Prognosis; D011474:Prosthesis Design; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D015607:Stents / Q000592:standards*; D015996:Survival Rate / Q000639:trends; D013557:Switzerland / Q000453:epidemiology; D013997:Time Factors