Key result
Flexible DES yields similar 2-year target vessel failure rates in bifurcation versus non-bifurcation PCI.
Why the study?
PCI in bifurcated lesions with second-generation DES was associated with increased MI rates. Flexible stent designs that accommodate vessel tapering may benefit bifurcated target lesions, but data were scarce.
RCT (n=1,811)
Single-blind
1:1 randomization to Resolute Integrity zotarolimus-eluting stent or Promus Element everolimus-eluting stent (post-hoc analysis stratified by bifurcated vs non-bifurcated target lesions)
Yes
Answers are grounded in this paper and cite their sources.
Reassures on provisional stenting with flexible DES in bifurcations; extends all-comer trial data but leaves open dedicated randomized evaluation.
BACKGROUND: Percutaneous coronary intervention (PCI) in bifurcated lesions with second-generation drug-eluting stents (DES) was associated with increased myocardial infarction (MI) rates. Flexible stent designs that accommodate well to vessel tapering may be of benefit in challenging anatomies such as bifurcated target lesions, but so far data are scarce. METHODS: We analyzed the 2-year follow-up data of the DUTCH PEERS (TWENTE II) trial, which randomized 1811 all-comer patients to PCI with newer generation resolute integrity zotarolimus-eluting (Medtronic) or promus element everolimus-eluting stents (Boston Scientific). In bifurcated lesions, provisional stenting was generally performed. Target vessel failure is a composite endpoint, consisting of cardiac death, target vessel MI, or target vessel revascularization. RESULTS: Patients with at least one bifurcated lesion (n = 465, 25.7 %) versus patients with non-bifurcated target lesions only (n = 1346, 74.3 %) showed similar rates of clinical endpoints including target vessel failure (9.2 versus 7.9 %, p = 0.36) and definite stent thrombosis (0.4 versus 1.0 %, p = 0.38). Target vessel MI was more common in patients with bifurcated lesions (3.4 versus 1.6 %, p = 0.02); but after multivariate analysis with propensity score adjustment, bifurcation treatment was found not to be an independent predictor of target vessel MI (HR 1.40, 95 % CI 0.71-2.76; p = 0.34). Among patients with bifurcated lesions, DES type and side-branch size did not affect outcome, but periprocedural MI occurred more often after two-stent approaches (9.0 versus 2.1 %; p = 0.002). CONCLUSION: All-comer patients treated for bifurcated and non-bifurcated target lesions showed similar and low rates of clinical endpoints, suggesting that the DES used are efficacious and safe for treating bifurcated target lesions.
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Heijden et al. (2015) conducted an RCT in Coronary artery disease undergoing percutaneous coronary intervention (bifurcated vs non-bifurcated target lesions) (n=1,811). PCI for bifurcated coronary target lesions with novel flexible drug-eluting stents (Resolute Integrity ZES or Promus Element EES) vs. PCI for non-bifurcated target lesions only was evaluated on Target vessel failure (composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization) at 2 years (p=0.36). PCI with flexible drug-eluting stents in bifurcated versus non-bifurcated lesions yielded similar 2-year target vessel failure rates (9.2% vs 7.9%, p=0.36) and no independent increase in target vessel MI (HR 1.40, p=0.34).
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