12-month intravascular ultrasound observations from BiOSS® first-in-man studies.
The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM® stents than in BiOSS Expert® stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process.
Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, 137 Woloska Street, 02-507, Warsaw, Poland. scorpirg@gmail.com.|Institute of Experimental and Clinical Medicine, Polish Academy of Science, Warsaw, Poland. scorpirg@gmail.com.
Robert J
RJ
Gil
Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, 137 Woloska Street, 02-507, Warsaw, Poland.
Jacek
J
Bil
Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil.
Ricardo A
RA
Costa
Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, 137 Woloska Street, 02-507, Warsaw, Poland.
Katarzyna E
KE
Gil
Alexandrovska University Hospital, Sofia, Bulgaria.
Dobrin
D
Vassiliev
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D049109:Cell Proliferation; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima; D000072658:Non-ST Elevated Myocardial Infarction / Q000000981:diagnostic imaging / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D002317:Cardiovascular Agents; D017239:Paclitaxel; D020123:Sirolimus
BiOSS Expert®; BiOSS LIM®; Dedicated bifurcation stent; IVUS; Paclitaxel-eluting stent; QCA; Sirolimus-eluting stent