Percutaneous coronary intervention (PCI) to the left main coronary artery (LMCA) with drug-eluting stent implantation is currently a major challenge due to the size of the vessel, the compromise of a bifurcation lesion in important branches, and the potential risk of complications.
Available information on LMCA PCI comes from studies where DES stents were implanted without the scaffold corresponding to the vessel size and with limited expansion capacity. The new generation of Resolute-Onyx stents includes devices with diameters of 3.5-4.0 mm, expandable to 5.0 mm, and devices with diameters of 4.5-5.0 mm, expandable to 6.0 mm. These devices were designed to optimize the treatment of large bore arteries, such as the LMCA.
The aim of this prospective, multicenter study was to evaluate the results obtained using Resolute Onyx DES in LMCA PCI.
The primary endpoint (PEP) was treated lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction (TVMI), and ischemia-driven treated lesion revascularization (ID-TLR) at 1 year. The secondary endpoint (SEP) was all-cause mortality, TVMI, ID-TLR, periprocedural acute myocardial infarction, stroke, and stent thrombosis at 30 days and 1 year.
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The study enrolled 450 patients. Mean patient age was 71 years old, and most subjects were male. The most frequent clinical indication was acute coronary syndrome (53%), and 15% of patients were functional class III-IV. The mean SYNTAX score was 24.5, and 10% of patients had LMCA disease only.
Most patients with LMCA disease presented bifurcation lesions (78%), and a lower number had ostial disease (20%). Transradial access was the most common. In 77% of cases, the one-stent technique was the most common, while the two-stent technique was used in the remaining cases. Intravascular imaging was used in 45% of cases (42%, intravascular ultrasound [IVUS]; 3%, optical coherence tomography [OCT]).
In terms of the PEP at 1 year, the cardiac death rate was 2.7%; TVMI, 2.7%, and ID-TLR, 2.0%. The stent thrombosis rate was 1.1%. In an adjusted sub-analysis, patients who underwent IVUS/OCT-guided PCI had a lower incidence of the PEP (2.0 vs. 7.6%; hazard ratio: 0.28; 95% confidence interval: 0.13-0.58; p < 0,001).
Conclusion
In this prospective study of LMCA PCI using the Resolute Onyx stent, the 1-year incidence of TLF was low, suggesting these devices are safe and efficient for these procedures. When compared with angiographically-guided PCI, using IVUS/OCT was associated with clinical benefit. Randomized studies are needed to confirm these findings.
Dr. Andrés Rodríguez.
Member of the editorial board of SOLACI.org.
Original Title: A large, prospective, multicentre study of left main PCI using a latest-generation zotarolimus-eluting stent: the ROLEX study.
Reference: Giuseppe Tarantini MD et al. EuroIntervention 2022;18.
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