Can the optimal type of stent be predicted based on clinical risk factors? A subgroup analysis of the randomized BASKET-PROVE trial

Publication

Can the optimal type of stent be predicted based on clinical risk factors? A subgroup analysis of the randomized BASKET-PROVE trial

Journal Paper/Review - Dec 1, 2015

Vassalli Giuseppe, Pedrazzini Giovanni, Pfisterer Matthias, Kaiser Christoph, Moccetti Tiziano, Bonetti Piero, Bertel Osmund, Hornig Burkhard, Rickli Hans, Eberli Franz, Erne Paul, Galatius Soeren, De Servi Stefano, Klersy Catherine, BASKET-PROVE Investigators

Citation

Vassalli G, Pedrazzini G, Pfisterer M, Kaiser C, Moccetti T, Bonetti P, Bertel O, Hornig B, Rickli H, Eberli F, Erne P, Galatius S, De Servi S, Klersy C, BASKET-PROVE Investigators. Can the optimal type of stent be predicted based on clinical risk factors? A subgroup analysis of the randomized BASKET-PROVE trial. Am Heart J 2015; 173:1-7.

Type

Journal Paper/Review (English)

Journal

Am Heart J 2015; 173

Publication Date

Dec 1, 2015

Issn Electronic

1097-6744

Pages

1-7

Brief description/objective

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.