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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bifurcation stent technique | Experimental | crush technique |
|
| bifurcation stent techniqe | Active Comparator | provisional T stenting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crush technique | Procedure | Crush technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic binary restenosis rate (diameter stenosis >= 50%) at 8 months in either main or side branch | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and ischemia-driven target vessel revascularization | 2 years | |
| Reocclusion rate at the side branch at 8 month angiographic follow-up | 8 months |
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Inclusion Criteria:
Clinical
Angiographic
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:
Renal dysfunction, creatinine >= 2.0mg/dL
Contraindication to aspirin, clopidogrel or cilostazol
LV ejection fraction =< 35%
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Bucheon Hospital | Bucheon-si | South Korea | ||||
| Busan Saint Mary's Hospital |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D017239 | Paclitaxel |
| C489443 | zotarolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 |
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| provisional T stenting | Procedure | Provisional T stenting |
|
|
| Late loss at the main vessel and the side branch | 8 months |
| Restenosis rate at the main vessel and/or side branch | 8 months |
| Influence of bifurcation angle | 8 months |
| Influence of new three segment bifurcation QCA software | 8 months |
| Fluoroscopic time | baseline |
| Procedure time | baseline |
| Amount of contrast agent | baseline |
| Number of used stents | baseline |
| FFR assessment in the side branch | baseline and 8 months |
| Busan |
| South Korea |
| Cheongju Saint Mary's Hospital | Cheongju-si | South Korea |
| Kangwon University Hospital | Chuncheon | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Kyungsang University Hospital | Jinju | South Korea |
| Hallym University Sacred Heart Hospital | Pyeongchon | South Korea |
| Catholic University, Kangnam St. Mary's Hospital | Seoul | South Korea |
| Hallym University Sacred Heart Hospital | Seoul | South Korea |
| Korea Veterans Hospital | Seoul | South Korea |
| Aju University Hospital | Suwon | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |