August 09, 2016
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BVS yield acceptable TLF rates, higher stent thrombosis at midterm follow-up in GHOST-EU registry

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Treatment of coronary bifurcation lesions with bioresorbable vascular scaffolds in an all-comers population was associated with “acceptable” rates of target lesion failure at midterm follow-up, but an increased rate of stent thrombosis compared with contemporary metallic stents, researchers reported in Catheterization and Cardiovascular Interventions.

GHOST EU is a retrospective, nonrandomized, multicenter, all-comers registry that enrolled 1,189 patients who underwent multivessel PCI with the latest-generation everolimus-eluting bioresorbable vascular scaffolds (Absorb BVS, Abbott Vascular) from Nov. 11, 2011, to Jan. 29, 2014.

For the new substudy of the registry, researchers evaluated 289 patients (302 bifurcations) who underwent provisional single stenting (n = 260) or systematic double stenting (n = 42). The primary outcome measure was TLF, which the researchers defined as a device-oriented composite endpoint including cardiac death, target vessel MI or clinically-driven target lesion revascularization. Median follow-up was 356 days (interquartile range, 191-419).

Overall, 44.7% of true bifurcations were treated. Chronic total occlusions were seen in 8.3% of cases and in-stent restenosis in 4.6% of cases. In 5% of cases, distal left main bifurcation was treated.

Only 22% of procedures utilized intravascular ultrasound and 21% of procedures utilized optical coherence tomography. Nineteen percent of procedures were performed with kissing balloon inflation with no or minimal protusion of a side branch balloon into the main branch. Almost all cases (95.4%) utilized predilation, while 61% of cases utilized postdilation of the main branch, according to the findings.

In total, 141 patients (48.8%) completed 360 days’ follow-up. Eleven patients were lost during follow-up.

According to Kaplan-Meier estimates, the rate of TLF was 4.9% at 180 days and 6.4% at 360 days. The rate of stent thrombosis was 2.5% at 180 days and 2.5% at 360 days. No cases of probable stent thrombosis were observed. Most stent thrombosis events occurred within 90 days of the procedure.

“The stent thrombosis rate in this early experience with BVS in bifurcations is higher than seen with contemporary metallic stents, although the negative impact of suboptimal implantation technique may have contributed,” the researchers wrote.

ACS (HR = 4.67; 95% CI, 1.78-12.3) and diabetes (HR = 3.37; 95% CI, 1.38-8.26) were identified as independent predictors of TLF, according to multivariable Cox regression analysis.

About 6% of patients without ACS had periprocedural MI. Acute side branch occlusion occurred in 3.1% of patients who underwent the provisional single stenting strategy and in no patients who underwent double stenting, according to the findings.

“Currently, the use of BVS is expanding from the treatment of simple to more complex lesions, including coronary bifurcations,” the researchers wrote. These findings “further [support] the importance of meticulous implantation technique.” – by Jennifer Byrne

Disclosure: Several researchers report financial ties with Abbott Vascular. Please see the full study for a list of the researchers’ relevant financial disclosures.