The Cone Flare Crush Modified-T (CFCT) stenting technique for coronary artery bifurcation lesions

Int J Cardiol Heart Vasc. 2020 Sep 25:30:100643. doi: 10.1016/j.ijcha.2020.100643. eCollection 2020 Oct.

Abstract

Background: The present study is a prospective observational single arm clinical investigation, with parallel bench test interrogation, aimed at investigating the technical feasibility, safety and clinical outcomes with the cone flare crush modified-T (CFCT) bifurcation stenting technique. Bifurcation percutaneous coronary intervention (PCI) remains an area of ongoing procedural evolution. More widely applicable and reproducible techniques are required.

Methods: From April 2018 until March 2019, 20 consecutive patients underwent bifurcation PCI using the CFCT technique with a Pt-Cr everolimus drug-eluting stent with a bioresorbable polymer. Exercise stress echocardiography was performed at 12-month follow-up. The primary outcome was a composite of cardiac related mortality, myocardial infarction, target lesion/vessel revascularization and stroke. Safety secondary endpoints included bleeding, all-cause mortality and stent thrombosis.

Results: All patients underwent a successful CFCT bifurcation procedure with no complications to 30-day follow-up. One patient met the primary endpoint requiring target lesion revascularization at 9 months for stable angina. There were no other primary or secondary outcome events in the cohort. There were no strokes, deaths, stent thrombosis or myocardial infarction during the follow-up period. The mean CCS score improved from 2.25 to 0.25 (p < 0.0001). Optical coherence tomography (OCT) and bench test findings indicated optimal side branch ostial coverage and minimal redundant strut material crowding the neo-carina.

Conclusions: The CFCT technique appears to be a safe, efficacious and feasible strategy for managing coronary artery bifurcation disease. Expanded and randomized datasets with longer term follow-up are required to further explore confirm this feasibility data. (ANZCTR ID: ACTRN12618001145291).

Keywords: ACS, Acute coronary syndrome; ACT, Activated clotting time; AHA, American Heart Association; ARC, Academic Research Consortium; BARC, British Academic Research Consortium; CABG, Coronary artery bypass grafting; CCS, Canadian Cardiovascular Society; CFCT, Cone Flare Crush Modified-T; CFI, Cone Flare Inflation; DAPT, Dual antiplatelet therapy; DES, Drug Eluting Stent; DMV, Distal main vessel; DSE, Dobutamine stress echocardiography; Drug Eluting Stent (DES); ESE, Exercise stress echocardiography; ISKB, Intermediary simultaneous kissing balloon; ISR, In stent restenosis; LAD, Left anterior descending artery; LCx, Left circumflex artery; LMCA, Left main coronary artery; MACCE, Major adverse cardiac and cerebrovascular event; MI, Myocardial infarct; MRA, Mechanical rotational atherectomy; MV, Main Vessel; NSTEMI, Non-ST elevation Myocardial Infarction; NYHA, New York heart association; OCT, Optical coherence tomography; PCI, Percutaneous Coronary Intervention; PMV, Proximal main vessel; POT, Proximal Optimisation Technique; PUKBI, Penultimate kissing balloon inflation; Percutaneous Coronary Intervention (PCI); QCA, Quantitative Coronary Angiography; RBP, Rated Burst Pressure; SB, Side Branch; SEM, Standard Error of the mean; ST, Stent thrombosis; STEMI, ST elevation Myocardial Infarction; SYNTAX, Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery; Stenting technique (STEC); TLR, Target Lesion Revascularisation; TVR, Target Vessel Revascularisation; UAP, Unstable angina pectoris.