Author + information
- Received September 18, 2013
- Accepted September 28, 2013
- Published online January 1, 2014.
- Marco Valgimigli, MD, PhD∗∗ (, )
- Matteo Tebaldi, MD†,
- Marco Borghesi, MD†,
- Pascal Vranckx, MD‡,
- Gianluca Campo, MD†,
- Carlo Tumscitz, MD†,
- Elisa Cangiano, MD†,
- Monica Minarelli, MD†,
- Antonella Scalone, MD†,
- Caterina Cavazza, MD†,
- Jlenia Marchesini, MD†,
- Giovanni Parrinello, PhD§,
- PRODIGY Investigators
- ∗Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- †Cardiology Department, University of Ferrara, Ferrara, Italy
- ‡Virga Jesse Ziekenhuis, Hasselt, Belgium
- §Medical Statistics Unit, University of Brescia, Brescia, Italy
- ↵∗Reprint requests and correspondence:
Dr. Marco Valgimigli, Thoraxcenter, Ba 587, Erasmus MC, Rotterdam, the Netherlands.
Objectives This study sought to assess device-specific outcomes after implantation of bare-metal stents (BMS), zotarolimus-eluting Endeavor Sprint stents (ZES-S), paclitaxel-eluting stents (PES), or everolimus-eluting stents (EES) (Medtronic Cardiovascular, Santa Rosa, California) in all-comer patients undergoing percutaneous coronary intervention.
Background Few studies have directly compared second-generation drug-eluting stents with each other or with BMS.
Methods We randomized 2,013 patients to BMS, ZES-S, PES, or EES implantation. At 30 days, each stent group received up to 6 or 24 months of clopidogrel therapy. The key efficacy endpoint was the 2-year major adverse cardiac event (MACE) including any death, myocardial infarction, or target vessel revascularization, whereas the cumulative rate of definite or probable stent thrombosis (ST) was the key safety endpoint.
Results Clinical follow-up at 2 years was complete for 99.7% of patients. The MACE rate was lowest in EES (19.2%; 95% confidence interval [CI]: 16.0 to 22.8), highest in BMS (32.1%; 95% CI: 28.1 to 36.3), and intermediate in PES (26.2%; 95% CI: 22.5 to 30.2) and ZES-S (27.8%; 95% CI: 24.1 to 31.9) groups (chi-square test = 18.9, p = 0.00029). The 2-year incidence of ST in the EES group (1%; 95% CI: 0.4 to 2.2) was similar to that in the ZES-S group (1.4%; 95% CI: 0.7 to 2.8), whereas it was lower compared with the PES (4.6%, 95% CI: 3.1 to 6.8) and BMS (3.6%; 95% CI: 2.4 to 5.6) groups (chi-square = 16.9; p = 0.0001).
Conclusions Our study shows that cumulative MACE rate, encompassing both safety and efficacy endpoints, was lowest for EES, highest for BMS, and intermediate for PES and ZES-S groups. EES outperformed BMS also with respect to the safety endpoints with regard to definite or probable and definite, probable, or possible ST. (PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY [PRODIGY]; NCT00611286)
- all-comer randomized clinical trial
- bare-metal stent(s)
- everolimus-eluting stent(s)
- paclitaxel-eluting stent(s)
- zotarolimus-eluting stent(s)
Dr. Valgimigli has received honoraria for lectures, advisory board membership, and research grants from Merck, Iroko, Eli Lilly, and Medtronic; honoraria for advisory board membership and lectures from The Medicines Company, Daiichi Sankyo, St. Jude, and Abbott Vascular; and honoraria for lectures from Cordis, CID, and Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Online Appendix)
- Received September 18, 2013.
- Accepted September 28, 2013.
- American College of Cardiology Foundation