Background
The treatment of left main bifurcation stenoses remains challenging.
Aims
We compare the “Reverse T and Protrusion” (reverse-TAP) technique to Double-Kissing and crush (DK-crush).
Methods
The study was designed as non-inferiority trial, the primary endpoint was percentage stent expansion in the ostial side branch at optical coherence tomography.
Results
52 consecutive patients (13 females, 17 diabetics, Syntax score 25 [22–29]) with complex coronary bifurcation lesions of the left main were randomized in a 1:1 ratio to Reverse-TAP or DK-crush stenting. The intervention was performed according to protocol in all patients in both randomization groups. Side branch stent expansion was 75 [67–90]% in the DK-crush group and 86 [75–95]% in the reverse-TAP group (one-sided 97.5% lower parametric confidence interval: − 0.28%; P < 0.01 for non-inferiority; P = 0.037 for superiority). Side branch balloon pressure during final kissing was higher in the DK-crush group (14 [12–16] vs. reverse-TAP: 13 [12–14]; P = 0.043). Procedural time was shorter with reverse-TAP (DK-crush: 32 [24–44] min vs reverse–TAP: 25 [22–33] min; P = 0.044). Other procedural parameters were not different between groups. There was no difference in any of the safety endpoints up to 1 month.
Conclusions
A reverse-TAP strategy for the interventional treatment of complex coronary lesions was non-inferior and superior to DK-crush for the primary endpoint side branch expansion while requiring less time. A larger study testing long-term clinical outcomes is warranted.
Trail Registration
NCT: NCT03714750.
Graphical abstract
BackgroundApproximately 50% of the patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) have additional stenotic lesions in non-infarct-related coronary arteries. The decision whether these stenoses require further treatment is routinely based on angiography alone. The quantitative flow ratio (QFR) is a simple non-invasive method that may help quantify the functional significance of these intermediate coronary artery lesions. The aim of our single-center, randomized superiority trial is to test the impact and efficacy of QFR, as compared to angiography, in the treatment of patients with ACS with multivessel coronary artery disease. Primary goal of the study is to investigate 1. The impact of QFR on the proportion of patients receiving PCI vs. conservative therapy and 2. whether QFR improves angina pectoris and overall cardiovascular outcomes.Methods and AnalysisAfter treatment of the culprit lesion(s), a total of 200 consecutive ACS patients will be randomized 1:1 to angiography- vs. QFR-guided revascularization of non-culprit stenoses. Patients and clinicians responsible are blinded to the randomization group. The primary functional endpoint is defined as the proportion of patients assigned to medical treatment in the two groups. The primary clinical endpoint is a composite of death, non-fatal myocardial infarction, revascularization and significant angina at 12 months. Secondary endpoints include changes in the SAQ subgroups, and clinical events at 3- and 12-month follow-up.DiscussionThis study is designed to investigate whether QFR-based decision-making is associated with a decrease in angina and an improved prognosis in patients with multivessel disease.Trial Registration NumberClinicalTrials.gov Registry (NCT04808310).
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