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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).
JACC Cardiovasc Interv 2014; 7(1):20-8JC

Abstract

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).

Authors+Show Affiliations

Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: m.valgimigli@erasmusmc.nl.Cardiology Department, University of Ferrara, Ferrara, Italy.Cardiology Department, University of Ferrara, Ferrara, Italy.Virga Jesse Ziekenhuis, Hasselt, Belgium.Cardiology Department, University of Ferrara, Ferrara, Italy.Cardiology Department, University of Ferrara, Ferrara, Italy.Cardiology Department, University of Ferrara, Ferrara, Italy.Cardiology Department, University of Ferrara, Ferrara, Italy.Cardiology Department, University of Ferrara, Ferrara, Italy.Cardiology Department, University of Ferrara, Ferrara, Italy.Cardiology Department, University of Ferrara, Ferrara, Italy.Medical Statistics Unit, University of Brescia, Brescia, Italy.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24332420

Citation

Valgimigli, Marco, et al. "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)." JACC. Cardiovascular Interventions, vol. 7, no. 1, 2014, pp. 20-8.
Valgimigli M, Tebaldi M, Borghesi M, et al. 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). JACC Cardiovasc Interv. 2014;7(1):20-8.
Valgimigli, M., Tebaldi, M., Borghesi, M., Vranckx, P., Campo, G., Tumscitz, C., ... Parrinello, G. (2014). 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). JACC. Cardiovascular Interventions, 7(1), pp. 20-8. doi:10.1016/j.jcin.2013.09.008.
Valgimigli M, et al. 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). JACC Cardiovasc Interv. 2014;7(1):20-8. PubMed PMID: 24332420.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). AU - Valgimigli,Marco, AU - Tebaldi,Matteo, AU - Borghesi,Marco, AU - Vranckx,Pascal, AU - Campo,Gianluca, AU - Tumscitz,Carlo, AU - Cangiano,Elisa, AU - Minarelli,Monica, AU - Scalone,Antonella, AU - Cavazza,Caterina, AU - Marchesini,Jlenia, AU - Parrinello,Giovanni, AU - ,, Y1 - 2013/12/11/ PY - 2013/09/18/received PY - 2013/09/28/accepted PY - 2013/12/17/entrez PY - 2013/12/18/pubmed PY - 2014/9/30/medline KW - BMS KW - CI KW - CK-MB KW - DES KW - EES KW - MACE KW - MI KW - PES KW - ST KW - TLR KW - TVR KW - ZES-S KW - all-comer randomized clinical trial KW - bare-metal stent(s) KW - confidence interval KW - creatine kinase myocardial band KW - drug-eluting stent(s) KW - everolimus-eluting stent(s) KW - major adverse cardiac event(s) KW - myocardial infarction KW - paclitaxel-eluting stent(s) KW - stent thrombosis KW - target lesion revascularization KW - target vessel revascularization KW - zotarolimus-eluting Endeavor Sprint stent(s) KW - zotarolimus-eluting stent(s) SP - 20 EP - 8 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 7 IS - 1 N2 - 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). SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/24332420/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__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(13)01545-8 DB - PRIME DP - Unbound Medicine ER -