In the present multicenter randomized trial, percutaneous coronary intervention of true distal LM bifurcation lesions using a planned DK crush 2-stent strategy resulted in a lower rate of TLF at 1 year than a PS strategy. (Double Kissing and Double Crush Versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-Center Clinical Trial [DKCRUSH-V]; ChiCTR-TRC-11001213).
Aim
The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions.
Methods and results
In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-stent technique (two-stent group) or provisional stenting (provisional group). The primary endpoint was the composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR). The safety endpoint was definite or probable stent thrombosis. At the 1-year follow-up, TLF occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and two-stent groups, respectively [77.8%: double-kissing crush; hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30–0.90; P = 0.019], largely driven by increased TVMI (7.1%, HR 0.43, 95% CI 0.20–0.90; P = 0.025) and clinically driven TLR (5.5%, HR 0.43, 95% CI 0.19–1.00; P = 0.049) in the provisional group. At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31–2.37; P = 0.772).
Conclusion
For DEFINITION criteria-defined complex coronary bifurcation lesions, the systematic two-stent approach was associated with a significant improvement in clinical outcomes compared with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting.
Study registration
http://www.clinicaltrials.com; Identifier: NCT02284750.
Aims: A novel method for computation of fractional flow reserve (FFR) from optical coherence tomography (OCT) was developed recently. This study aimed to evaluate the diagnostic accuracy of a new OCTbased FFR (OFR) computational approach, using wire-based FFR as the reference standard.Methods and results: Patients who underwent both OCT and FFR prior to intervention were analysed.The lumen of the interrogated vessel and the ostia of the side branches were automatically delineated and used to compute OFR. Bifurcation fractal laws were applied to correct the change in reference lumen size due to the step-down phenomenon. OFR was compared with FFR, both using a cut-off value of 0.80 to define ischaemia. Computational analysis was performed in 125 vessels from 118 patients. Average FFR was 0.80±0.09. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value for OFR to identify FFR ≤0.80 was 90% (95% CI: 84-95), 87% (95% CI: 77-94), 92% (95% CI: 82-97), 92% (95% CI: 82-97), and 88% (95% CI: 77-95), respectively. The AUC was higher for OFR than minimal lumen area (0.93 [95% CI: 0.87-0.97] versus 0.80 [95% CI: 0.72-0.86], p=0.002). Average OFR analysis time was 55±23 seconds for each OCT pullback. Intra-and inter-observer variability in OFR analysis was 0.00±0.02 and 0.00±0.03, respectively. FFR fractional flow reserve IVUS intravascular ultrasound MLA minimal lumen area OCT optical coherence tomography OFR optical coherence tomography-based fractional flow reserve QFR quantitative flow ratio
DK crush was associated with a significant reduction of TLR and TVR in this unselected patient population. However, there was no significant difference in MACE between DK and the PS groups. (Randomized Study on DK Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions; ChicTR-TRC-00000015).
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