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Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis.
JACC Cardiovasc Interv 2013; 6(9):905-13JC

Abstract

OBJECTIVES

This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials.

BACKGROUND

ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR.

METHODS

A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST).

RESULTS

Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p = 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively.

CONCLUSIONS

Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [RINT]; NCT00752128).

Authors+Show Affiliations

Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg, Germany. Electronic address: gert.richardt@segebergerkliniken.de.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23954063

Citation

Richardt, Gert, et al. "Clinical Outcomes of the Resolute Zotarolimus-eluting Stent in Patients With In-stent Restenosis: 2-year Results From a Pooled Analysis." JACC. Cardiovascular Interventions, vol. 6, no. 9, 2013, pp. 905-13.
Richardt G, Leschke M, Abdel-Wahab M, et al. Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis. JACC Cardiovasc Interv. 2013;6(9):905-13.
Richardt, G., Leschke, M., Abdel-Wahab, M., Toelg, R., El-Mawardy, M., Serruys, P. W., ... Widimsky, P. (2013). Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis. JACC. Cardiovascular Interventions, 6(9), pp. 905-13. doi:10.1016/j.jcin.2013.04.017.
Richardt G, et al. Clinical Outcomes of the Resolute Zotarolimus-eluting Stent in Patients With In-stent Restenosis: 2-year Results From a Pooled Analysis. JACC Cardiovasc Interv. 2013;6(9):905-13. PubMed PMID: 23954063.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis. AU - Richardt,Gert, AU - Leschke,Matthias, AU - Abdel-Wahab,Mohamed, AU - Toelg,Ralph, AU - El-Mawardy,Mohamed, AU - Serruys,Patrick W, AU - Silber,Sigmund, AU - Windecker,Stephan, AU - Belardi,Jorge A, AU - Neumann,Franz-Josef, AU - Widimsky,Petr, AU - ,, AU - ,, Y1 - 2013/08/14/ PY - 2012/09/10/received PY - 2013/04/12/revised PY - 2013/04/19/accepted PY - 2013/8/20/entrez PY - 2013/8/21/pubmed PY - 2014/5/20/medline KW - BMS KW - CD KW - DES KW - ISR KW - MI KW - PCI KW - R-ZES KW - Resolute zotarolimus-eluting stent(s) KW - ST KW - TLF KW - TLR KW - TVMI KW - TVR KW - bare-metal stent(s) KW - cardiac death KW - clinical outcome KW - drug-eluting stent(s) KW - in-stent restenosis KW - myocardial infarction KW - percutaneous coronary intervention KW - stent thrombosis KW - target lesion failure KW - target lesion revascularization KW - target vessel myocardial infarction KW - target vessel revascularization KW - zotarolimus-eluting stent SP - 905 EP - 13 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 6 IS - 9 N2 - OBJECTIVES: This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials. BACKGROUND: ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR. METHODS: A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST). RESULTS: Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p = 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively. CONCLUSIONS: Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [RINT]; NCT00752128). SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/23954063/Clinical_outcomes_of_the_Resolute_zotarolimus_eluting_stent_in_patients_with_in_stent_restenosis:_2_year_results_from_a_pooled_analysis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(13)01105-9 DB - PRIME DP - Unbound Medicine ER -