BACKGROUND: Whether final kissing ballooning (FKB) is mandatory in the 1-stent technique is uncertain. OBJECTIVE: To evaluate the effect of FKB on long-term clinical outcomes in coronary bifurcation lesions treated with the 1-stent technique. METHODS:Consecutive patients undergoingpercutaneous coronary intervention using drug-eluting stentsfor non-left main bifurcation lesions were enrolled from 16 centres in Korea between January 2004 and June 2006. In patients treated with the 1-stent technique major adverse cardiac events (MACE; cardiac death, myocardial infarction (MI), or target lesion revascularisation (TLR)) were compared between those undergoing main vessel stenting only (non-FKB group, n=736) or those undergoing FKB after main vessel stenting (FKB group, n=329). Propensity score-matching analysis was also performed in 222 patient pairs (444 from the non-FKB group and 222 from the FKB group). RESULTS: During follow-up (median 22 months), the FKB group had a higher incidence of MACE (HR 2.58; 95% CI 1.52 to 4.37; p<0.001) and TLR (HR 3.63; 95% CI 2.00 to 6.56; p<0.001), but not of cardiac death or MI. Most TLR occurred in the main vessel (HR 3.39 for the FKB group; 95% CI 1.86 to 6.19; p<0.001). The rate of stent thrombosis was similar in both groups (0.5% in the non-FKB group vs 0.6% in the FKB group, p=0.99). After propensity score matching, the FKB group still had higher rates of MACE and TLR than the non-FKB group (HR 2.13; 95% CI 1.15 to 3.95; p=0.02 and HR 2.84; 95% CI 1.45 to 5.55; p=0.002, respectively). CONCLUSIONS: In patients treated with the 1-stent technique for bifurcation lesions, FKB after main vessel stenting may be harmful mainly due to increased TLR. TRIAL REGISTRATION NUMBER: clinicaltrials.gov number: NCT00851526.
RCT Entities:
BACKGROUND: Whether final kissing ballooning (FKB) is mandatory in the 1-stent technique is uncertain. OBJECTIVE: To evaluate the effect of FKB on long-term clinical outcomes in coronary bifurcation lesions treated with the 1-stent technique. METHODS: Consecutive patients undergoing percutaneous coronary intervention using drug-eluting stents for non-left main bifurcation lesions were enrolled from 16 centres in Korea between January 2004 and June 2006. In patients treated with the 1-stent technique major adverse cardiac events (MACE; cardiac death, myocardial infarction (MI), or target lesion revascularisation (TLR)) were compared between those undergoing main vessel stenting only (non-FKB group, n=736) or those undergoing FKB after main vessel stenting (FKB group, n=329). Propensity score-matching analysis was also performed in 222 patient pairs (444 from the non-FKB group and 222 from the FKB group). RESULTS: During follow-up (median 22 months), the FKB group had a higher incidence of MACE (HR 2.58; 95% CI 1.52 to 4.37; p<0.001) and TLR (HR 3.63; 95% CI 2.00 to 6.56; p<0.001), but not of cardiac death or MI. Most TLR occurred in the main vessel (HR 3.39 for the FKB group; 95% CI 1.86 to 6.19; p<0.001). The rate of stent thrombosis was similar in both groups (0.5% in the non-FKB group vs 0.6% in the FKB group, p=0.99). After propensity score matching, the FKB group still had higher rates of MACE and TLR than the non-FKB group (HR 2.13; 95% CI 1.15 to 3.95; p=0.02 and HR 2.84; 95% CI 1.45 to 5.55; p=0.002, respectively). CONCLUSIONS: In patients treated with the 1-stent technique for bifurcation lesions, FKB after main vessel stenting may be harmful mainly due to increased TLR. TRIAL REGISTRATION NUMBER: clinicaltrials.gov number: NCT00851526.