Effect of intravascular ultrasound-guided drug-eluting stent implantation: 5-year follow-up of the IVUS-XPL randomized trial

Selected in JACC: Cardiovascular Interventions by B. Ezhumalai , S. Brugaletta

In IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial the long-term outcomes of stent optimisation with IVUS were analysed.

Reviewers

Babu Ezhumalai

@Babu_Ezhumalai

Interventional cardiologist / Cardiologist

Fortis Malar Hospital - Tamil Nadu, India

Salvatore Brugaletta

@sbrugaletta

Interventional cardiologist / Cardiologist

Barcelona, Spain

Our Comment

This joint review is part of the PCRonline GLOBAL Journal Club Initiative by selected members of the EAPCI/PCR Journal Club and EAPCI young ambassadors, and is based on the underlying idea of “Bringing peers together, exchanging ideas, towards a common standard of care”.

Why this study – the rationale/objective?

Intravascular ultrasound (IVUS) guided PCI produces favourable 1-year clinical outcome but there is hardly any randomized trial which evaluated the long-term effect of IVUS guidance during DES implantation. In IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial the long-term outcomes of stent optimisation with IVUS were analysed.

How was it executed – the methodology?

The IVUS-XPL trial was an investigator-initiated, multicenter study that included 1,400 patients with long coronary lesions (implanted stent length ≥28 mm), randomised to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation (Xience Prime, Abbott Vascular, Santa Clara, California). Patients in IVUS-XPL were followed up to 5 years. The primary outcome was the composite of major adverse cardiac events, including cardiac death, target lesion–related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years.

What is the main result?

• 1,315 patients (94%) completed 1-year follow-up and 1,183 patients (85%) completed 5-year follow-up in this study.
• Major adverse cardiac events at 5 years occurred in 36 patients (5.6%) receiving IVUS guidance and in 70 patients (10.7%) receiving angiographic guidance (p = 0.001).
• This difference was driven mainly by a lower risk for target lesion revascularization (31 [4.8%] vs. 55 [8.4%]; p = 0.007).
• Major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (p = 0.031).

Critical reading and relevance for clinical practice

Several previous studies have shown that IVUS-guided DES implantation was superior to angiography-guided DES implantation but all these studies reported outcomes within 2 years. IVUS-XPL trial demonstrated that IVUS guided PCI was associated with a substantial reduction in the risk for major adverse cardiac events at 5 years compared with angiographic guided PCI; 1-year beneficial effect of IVUS guidance was not only sustained up to 5 years but increased between 1 and 5 years.

In the angiography-guided stent implantation group, stent size and length were chosen based on visual estimation and post dilatation was performed only if the optimal result was not achieved. In the IVUS-guided stent implantation group, IVUS was used at any step of PCI (before, during, or after PCI): stent size and length were selected by IVUS measurements, and high-pressure dilation was performed on the basis of the IVUS findings. IVUS criteria for stent optimization after PCI were defined as a minimal luminal cross-sectional area greater than the luminal cross-sectional area at the distal reference segments.

This study had the following limitations: only long lesions were included and only single type of DES was used for PCI; drop-out rate was high (15%) and the observed event rate was relatively low in this study. Further randomised studies involving more complex lesions are required to evaluate the real-world long-term outcomes of IVUS guided PCI.
IVUS guidance is of utmost utility in PCI of left main coronary artery. IVUS-guided optimisation of stent may reduce events like stent thrombosis by avoiding stent under-expansion and strut malapposition. This may enable to shorten the duration of dual-antiplatelet therapy.