PMID- 16750678
OWN - NLM
STAT- MEDLINE
DCOM- 20060627
LR  - 20131121
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 47
IP  - 11
DP  - 2006 Jun 6
TI  - A randomized comparison of sirolimus-eluting stent with balloon angioplasty in 
      patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon 
      Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial.
PG  - 2152-60
AB  - OBJECTIVES: We sought to assess the effectiveness of sirolimus-eluting stents 
      (SES) in patients with in-stent restenosis (ISR). BACKGROUND: Treatment of 
      patients with ISR remains a challenge. METHODS: The Restenosis Intrastent: 
      Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) study is 
      a multicenter randomized trial conducted in 150 patients with ISR (76 allocated 
      to SES and 74 to balloon angioplasty [BA]). The primary end point was recurrent 
      restenosis rate at nine months. Secondary end points included prespecified 
      subgroup analysis, lumen volume on intravascular ultrasound (IVUS), and a 
      composite of major clinical events at one year. RESULTS: Angiographic success was 
      obtained in all patients. At 9-month angiographic follow-up (96% of eligible 
      patients) minimal lumen diameter was larger (2.52 mm [interquartile range (IQR) 
      2.09 to 2.81] vs. 1.54 mm [IQR 0.91 to 2.05]; p < 0.001) and recurrent restenosis 
      rate was lower (11% vs. 39%; p < 0.001) in the SES group. Prespecified subgroup 
      analyses were consistent with the main outcome measure. Lumen volume on IVUS at 9 
      months was also larger (279 mm3 [IQR 227 to 300] vs. 197 mm3 [IQR 177 to 230]; p 
      < 0.001) in the SES group. At one-year clinical follow-up (100% of patients), the 
      event-free survival (freedom from death, myocardial infarction, and target vessel 
      revascularization) was significantly improved in the SES group (88% vs. 69%; p < 
      0.004) as the result of a lower requirement for target vessel revascularization 
      (11% vs. 30%; p < 0.003). CONCLUSIONS: In patients with ISR, the use of SES 
      provides superior long-term clinical, angiographic, and IVUS outcome than BA 
      treatment.
FAU - Alfonso, Fernando
AU  - Alfonso F
AD  - Clinico San Carlos University Hospital, Madrid, Spain. falf@hotmail.com
FAU - Perez-Vizcayno, Maria-Jose
AU  - Perez-Vizcayno MJ
FAU - Hernandez, Rosana
AU  - Hernandez R
FAU - Bethencourt, Armando
AU  - Bethencourt A
FAU - Marti, Vicens
AU  - Marti V
FAU - Lopez-Minguez, Jose R
AU  - Lopez-Minguez JR
FAU - Angel, Juan
AU  - Angel J
FAU - Mantilla, Ramon
AU  - Mantilla R
FAU - Moris, Cesar
AU  - Moris C
FAU - Cequier, Angel
AU  - Cequier A
FAU - Sabate, Manel
AU  - Sabate M
FAU - Escaned, Javier
AU  - Escaned J
FAU - Moreno, Raul
AU  - Moreno R
FAU - Banuelos, Camino
AU  - Banuelos C
FAU - Suarez, Alfonso
AU  - Suarez A
FAU - Macaya, Carlos
AU  - Macaya C
CN  - RIBS-II Investigators
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
RN  - W36ZG6FT64 (Sirolimus)
SB  - IM
CIN - J Am Coll Cardiol. 2006 Jun 6;47(11):2161-3. PMID: 16750679
MH  - Aged
MH  - Coronary Angiography
MH  - Coronary Restenosis/diagnosis/etiology/*therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Sirolimus/*administration & dosage/therapeutic use
MH  - *Stents/adverse effects
MH  - Treatment Outcome
MH  - Ultrasonography, Interventional
EDAT- 2006/06/06 09:00
MHDA- 2006/06/28 09:00
CRDT- 2006/06/06 09:00
PHST- 2005/08/21 00:00 [received]
PHST- 2005/10/14 00:00 [revised]
PHST- 2005/10/25 00:00 [accepted]
PHST- 2006/06/06 09:00 [pubmed]
PHST- 2006/06/28 09:00 [medline]
PHST- 2006/06/06 09:00 [entrez]
AID - S0735-1097(06)00621-8 [pii]
AID - 10.1016/j.jacc.2005.10.078 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2006 Jun 6;47(11):2152-60. doi: 10.1016/j.jacc.2005.10.078.