title: Two-year outcomes after first- or second-generation drug-eluting or bare-metal stent implantation in all-comer patients undergoing percutaneous coronary intervention: a pre-specified analysis from the PRODIGY study (PROlonging Dual Antiplatelet Treatment After Grading stent-induced Intimal hyperplasia studY).
abstract: OBJECTIVE
  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).
authors: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: m.valgimigli@erasmusmc.nl.
authors: Marco
authors: M
authors: Valgimigli
authors: Cardiology Department, University of Ferrara, Ferrara, Italy.
authors: Matteo
authors: M
authors: Tebaldi
authors: Cardiology Department, University of Ferrara, Ferrara, Italy.
authors: Marco
authors: M
authors: Borghesi
authors: Virga Jesse Ziekenhuis, Hasselt, Belgium.
authors: Pascal
authors: P
authors: Vranckx
authors: Cardiology Department, University of Ferrara, Ferrara, Italy.
authors: Gianluca
authors: G
authors: Campo
authors: Cardiology Department, University of Ferrara, Ferrara, Italy.
authors: Carlo
authors: C
authors: Tumscitz
authors: Cardiology Department, University of Ferrara, Ferrara, Italy.
authors: Elisa
authors: E
authors: Cangiano
authors: Cardiology Department, University of Ferrara, Ferrara, Italy.
authors: Monica
authors: M
authors: Minarelli
authors: Cardiology Department, University of Ferrara, Ferrara, Italy.
authors: Antonella
authors: A
authors: Scalone
authors: Cardiology Department, University of Ferrara, Ferrara, Italy.
authors: Caterina
authors: C
authors: Cavazza
authors: Cardiology Department, University of Ferrara, Ferrara, Italy.
authors: Jlenia
authors: J
authors: Marchesini
authors: Medical Statistics Unit, University of Brescia, Brescia, Italy.
authors: Giovanni
authors: G
authors: Parrinello
mesh_terms: D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D000077144:Clopidogrel; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D003328:Coronary Thrombosis / Q000209:etiology / Q000517:prevention & control; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D006965:Hyperplasia; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D058426:Neointima; D017239:Paclitaxel / Q000008:administration & dosage; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D015607:Stents; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008670:Metals; D010975:Platelet Aggregation Inhibitors; D000068338:Everolimus; D000077144:Clopidogrel; C489443:zotarolimus; D013988:Ticlopidine; D017239:Paclitaxel; D020123:Sirolimus
keywords: BMS; CI; CK-MB; DES; EES; MACE; MI; PES; ST; TLR; TVR; ZES-S; all-comer randomized clinical trial; bare-metal stent(s); confidence interval; creatine kinase myocardial band; drug-eluting stent(s); everolimus-eluting stent(s); major adverse cardiac event(s); myocardial infarction; paclitaxel-eluting stent(s); stent thrombosis; target lesion revascularization; target vessel revascularization; zotarolimus-eluting Endeavor Sprint stent(s); zotarolimus-eluting stent(s)