Clinical trial NCT00693251: Optimal Stenting Strategy For True Bifurcation Lesions
Official title: Phase IV Study of Optimal Stenting Strategy For True Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: stent
bifurcation
coronary artery stenosis
balloon angioplasty
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2008-06-09
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.

Detailed description: The outcome of percutaneous coronary intervention of bifurcation lesions with bare-metal stents is hindered by increased rates of procedural complications and long-term major adverse cardiac events compared with non-bifurcated lesions.1 Randomized studies have demonstrated that drug-eluting stents reduce restenosis when used in relatively simple lesions; and recent data have demonstrated efficacy of the sirolimus-eluting stent for bifurcation lesions compared with historical data of BMS. In one study of bifurcation lesions, the overall restenosis rate was 23%, with the majority of side branch restenoses occurring at the ostium after use of a T-stenting technique. Indeed, side branch restenosis occurred in 16.7% after T-stenting, compared with 7.1% after other stenting techniques.

The "crush" technique of bifurcation stenting with DESs was introduced by Colombo et al. in 2003 as a relatively simple technique that ensures complete coverage of the side branch ostium, thereby facilitating drug delivery at this site. Initial data of 20 patients treated with this technique with SES suggest that it is a safe method, with an acceptable rate of procedural complications and no further adverse events up to 30 days follow-up. Recently, angiographic data have shown the importance of simultaneous kissing balloon post-dilation in reducing restenosis and need for target lesion revascularization. They also reported that compared to T-stenting, crushing with final kissing balloon dilatation was associated with lower rate of restenosis and target lesion revascularization. Consequently, the crushing is currently most promising technique in treating bifurcation lesions using two stents. However, despite the advance of bifurcation stenting technique, the superiority of bifurcation stenting with crushing technique over simple stenting in bifurcation lesion has not been demonstrated.

Therefore, we conducted the prospective randomized study comparing crushing technique with final kissing balloon dilatation and a simple technique (main vessel stenting and provisional T-stenting) for treatment of true bifurcation lesions.

Eligibility criteria: Inclusion Criteria:

* Clinical

  * Patients with angina and documented ischemia or patients with documented silent ischemia
  * Patients who are eligible for intracoronary stenting
  * Age \>18 years, \<75 ages
* Angiographic

  * De novo lesion located in a major bifurcation point with the MEDINA classification type 1.1.0, 1.0.0, or 0.1.0
  * Main vessel : \>= 2.5 mm in vessel size, \>= 50% in diameter stenosis and =\< 50 mm in lesion length by visual estimation, in which the lesion seems to be covered with =\< 2 stents
  * Side branch : \>= 2.0 mm in vessel size, \>= 50% in diameter stenosis, and \< 20 mm in lesion length by visual estimation, in which the lesion seems to be covered with single stent

Exclusion Criteria:

* History of bleeding diathesis or coagulopathy
* Pregnant
* Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus and paclitaxel
* Limited life-expectancy (less than 1 year) due to combined serious disease
* ST-elevation acute myocardial infarction \< 2 weeks
* Characteristics of lesion:

  * Left main disease
  * In-stent restenosis
  * Graft vessels
  * Chronic total occlusion
  * TIMI flow =\< grade 2 in the side branch
* Renal dysfunction, creatinine \>= 2.0mg/dL
* Contraindication to aspirin, clopidogrel or cilostazol
* LV ejection fraction =\< 35%

Primary outcomes:
measure: Angiographic binary restenosis rate (diameter stenosis >= 50%) at 8 months in either main or side branch
timeFrame: 8 months
Secondary outcomes:
measure: Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and ischemia-driven target vessel revascularization
timeFrame: 2 years
measure: Reocclusion rate at the side branch at 8 month angiographic follow-up
timeFrame: 8 months
measure: Late loss at the main vessel and the side branch
timeFrame: 8 months
measure: Restenosis rate at the main vessel and/or side branch
timeFrame: 8 months
measure: Influence of bifurcation angle
timeFrame: 8 months
measure: Influence of new three segment bifurcation QCA software
timeFrame: 8 months
measure: Fluoroscopic time
timeFrame: baseline
measure: Procedure time
timeFrame: baseline
measure: Amount of contrast agent
timeFrame: baseline
measure: Number of used stents
timeFrame: baseline
measure: FFR assessment in the side branch
timeFrame: baseline and 8 months
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Busan Saint Mary's Hospital
city: Cheongju
country: Korea, Republic of
facility: Cheongju Saint Mary's Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Jinju
country: Korea, Republic of
facility: Kyungsang University Hospital
city: PyeongChon
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Catholic University, Kangnam St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Veterans Hospital
city: Suwon
country: Korea, Republic of
facility: Aju University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: