Optimal Stenting Strategy For True Bifurcation Lesions (PERFECT)

Seung-Jung Park

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Procedure: provisional T stenting

Procedure: Crush technique

Study type

Interventional

Funder types

Other

Identifiers

NCT00693251

2007-0714

Details and patient eligibility

About

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

Full 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.

Enrollment

420 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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%