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Intermediate term outcomes with bifurcation coronary stenting using the paclitaxel drug-eluting stent: a single
Nicolas W Shammas1, Eric J Dippel, Gail A Shammas
1Midwest Cardiovascular Research Foundation, Davenport, Iowa, USA.
Insights
Paclitaxel drug-eluting stents (PES) show acceptable intermediate-term outcomes for bifurcation coronary artery disease (BCD) treatment, with low rates of target lesion revascularization (TLR) and acute stent thrombosis (AST). Main branch stenting alone appears safe and trends toward fewer adverse events.
Area of Science:
- Interventional Cardiology
- Cardiovascular Research
- Medical Device Technology
Background:
- Percutaneous treatment of bifurcation coronary artery disease (BCD) presents significant challenges, historically associated with high target lesion revascularization (TLR) rates using bare metal stents (BMS).
- Paclitaxel drug-eluting stents (PES) offer improved outcomes over BMS for BCD, but concerns regarding acute stent thrombosis (AST) persist.
- This study evaluates intermediate-term outcomes of TAXUS Express PES for BCD stenting.
Purpose of the Study:
- To assess the intermediate-term safety and efficacy of TAXUS Express paclitaxel drug-eluting stents (PES) in treating de novo bifurcation coronary artery disease (BCD).
- To compare outcomes of bifurcation stenting versus main branch stenting alone in BCD.
- To report key adverse event rates including target lesion revascularization (TLR) and acute stent thrombosis (AST).
Main Methods:
- A retrospective analysis of 518 consecutive de novo bifurcation stenting procedures using TAXUS Express PES.
- Follow-up data was obtained for 312 patients (60.2%) at a mean of 6.7 months via telephone interviews and medical record reviews.
- Primary endpoint: composite of cardiac death, nonfatal myocardial infarction (MI), and TLR. Secondary endpoints included individual adverse events like AST and target vessel revascularization (TVR).
Main Results:
- Acute procedural success was high at 95%.
- Intermediate-term outcomes included: TLR 6.7%, TVR 12.2%, definite/probable AST 1.6%, cardiac death 2.9%, and a combined primary endpoint of 9.9%.
- Main branch stenting alone showed a trend toward fewer adverse events (5.8%) compared to bifurcation stenting (10.8%), though not statistically significant.
Conclusions:
- TAXUS Express PES demonstrate acceptable intermediate-term outcomes for BCD treatment, comparable to historical BMS data, with low rates of TLR and TVR.
- The incidence of AST was 1.6%, which is within the reported range and considered a manageable concern.
- Main branch stenting alone is a safe alternative, potentially reducing adverse events compared to complex bifurcation stenting techniques.
Background:
Percutaneous treatment of bifurcation coronary artery disease (BCD) is complex and, in the era of bare metal stents (BMS), was reported to have a high rate of repeat target lesion revascularization (TLR). Paclitaxel drug-eluting stents (PES) have been used in the treatment of BCD, with better overall outcomes than BMS. Also, acute stent thrombosis (AST), with an incidence ranging from 2.7% to 4.3%, has been reported with the use of bifurcation PES, and remains a concern in treating these patients. In the present report, intermediate term outcomes with BCD stenting using TAXUS Express (Boston Scientific, USA) PES are presented from the Genesis Medical Center.
Methods:
In the present retrospective study, 518 consecutive de novo bifurcation stenting procedures are reported. They were performed in 2005 at the present institution using the TAXUS Express PES. Follow-up data on 312 patients (60.2%) was achieved through telephone interviews and reviews of medical records after a mean of 6.7 months. The primary end point of the present study was the combined end points of cardiac death, nonfatal myocardial infarction (MI) and TLR. Secondary outcomes included the individual end points of death, cardiac death, AST, target vessel revascularization (TVR), TLR, ST elevation MI and non-ST elevation MI on intermediate term follow-up.
Results:
The mean (± SD) age of the patients was 66±12 years. Acute procedural success was 95% (main branch, 99%; side branch, 95.9%). The following intermediate term outcomes with bifurcation drug-eluting stents were: TLR, 6.7%; TVR, 12.2%; definite and probable AST, 1.6%; death, 6.7%; cardiac death, 2.9%; non-ST elevation MI, 0.7%; ST elevation MI, 2.0%; and the combined primary end point, 9.9%. The outcomes for patients who underwent main branch stenting were not statistically different from those with bifurcation stenting, with an overall combined end point favouring main branch stenting alone (5.8% versus 10.8%, P not significant).
Conclusion:
The TAXUS Express PES carry acceptable intermediate term outcomes in the treatment of BCD compared with historic controls with BMS, with low TLR, TVR and overall primary combined end point. Main branch stenting alone is safe, with a trend toward fewer adverse events than bifurcation stenting.
