Randomized comparative trial of a thin-strut bare metal cobalt-chromium stent versus a sirolimus-eluting stent for coronary revascularization

2007 ◽  
Vol 69 (6) ◽  
pp. 790-798 ◽  
Author(s):  
Paolo Ortolani ◽  
Antonio Marzocchi ◽  
Cinzia Marrozzini ◽  
Tullio Palmerini ◽  
Francesco Saia ◽  
...  
2016 ◽  
Vol 29 (3) ◽  
pp. 300-310 ◽  
Author(s):  
Simona Silenzi ◽  
Pierfrancesco Grossi ◽  
Luca Mariani ◽  
Chiara Fraccaro ◽  
Fabio Vagnarelli ◽  
...  

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Kim W Hansen ◽  
Rikke Sørensen ◽  
Raban Jeger ◽  
Christoph Kaiser ◽  
Matthias Pfisterer ◽  
...  

Introduction: The new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS) are designed to accelerate rapid endothelialisation and reduce thrombogenicity when implanted in coronary arteries. However, smaller studies suggest reduced efficacy with higher rates of symptomatic restenosis in patients receiving the newer generation BMS. Objective: We investigated the efficacy and safety of a new generation thinner-strut SiC coated CoCr BMS (SCC-BMS) as compared to an older thin-strut uncoated CoCr BMS (UC-BMS) in patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0mm) and thus at low risk of restenosis. Methods: We included all patients randomized to SCC- (n=761) or UC-BMS (n=765) in the BASKET-PROVE II and I trials, respectively. Design, patients, interventions and follow-up were similar between trials except differing regimens of dual antiplatelet therapy. The primary endpoint was clinically driven target-vessel revascularization within 24 months. Safety endpoints of cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis were also assessed. We used Cox proportional hazards regressions to estimate relative hazards adjusting for known confounders. Results: Demographics, clinical presentation, and risk factors were comparable between the groups, but patients receiving SCC-BMS underwent less complex procedures. Rates of the primary endpoint were 10.4% in the SCC-BMS group and 8.4% among patients receiving UC-BMS yielding an adjusted relative hazard (HR) of 1.46 ([1.03-2.07], p=0.032). Estimates for the safety endpoints were: cardiac death (1.8% vs. 2.4% ; HR 0.77 [0.36-1.59], p=0.46), non-fatal MI (3.2% vs. 2.5% ; HR 1.68 [0.88-3.21], p=0.11), and definite/probable stent thrombosis (0.8% vs. 1.0% ; HR 0.97 [0.32-3.00], p=0.96). We detected no particular subgroups driving the increased risk of target-vessel revascularization in the SCC-BMS group. Conclusions: In patients requiring stenting of large coronary arteries, use of the newer generation SCC-BMS was associated with a higher risk of symptomatic restenosis despite less complex procedures compared to the UC-BMS with no signs of an offsetting safety benefit.


2007 ◽  
Vol 118 (1) ◽  
pp. e8-e10 ◽  
Author(s):  
Masamichi Takano ◽  
Daisuke Murakami ◽  
Kyoichi Mizuno

2006 ◽  
Vol 47 (5) ◽  
pp. 651-661 ◽  
Author(s):  
Hiroshi Sakamoto ◽  
Tetsuya Ishikawa ◽  
Makoto Mutoh ◽  
Hisayuki Okada ◽  
Tetsushi Tsurusaki ◽  
...  

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Takashi Kubo ◽  
Toshio Imanishi ◽  
Hiroki Matsumoto ◽  
Manabu Kashiwagi ◽  
Hiroto Tsujioka ◽  
...  

OBJECTIVE: An optical coherence tomography (OCT) study was performed to compre the vascular response to sirolimus-eluting stent (SES) with bare-metal stent (BMS) in patients with diabetic mellitus (DM). BACKGROUND: Despite advances in the medical treatment and revascularization procedures, coronary artery disease remains a leading cause of morbidity and mortality in patients with DM. Few retrospective subgroup analyses of pivotal clinical trials have suggested that SES may be effective for reduction of restenosis in diabetic patients. OCT is a new intravascular imaging method with a high resolution of approximately 10 micrometer and allows us to evaluate instent neointimal hyperplasia (NIH) in vivo. METHODS and RESULTS: Serial OCT analyses were performed in 60 lesions (SES in DM patients=19; SES in non-DM patients=14; BMS in DM patients=10; BMS in non-DM patients=17) at 9-month follow-up. A total of 6920 stent struts were visualized by OCT and NIH thickness inside each strut and incidence of exposed stnet struts were evaluated in cross-sectional image. The NIH thickness was significantly different among 4 groups (97 +/− 100 vs. 43 +/− 61 vs. 425 +/− 206 vs. 209 +/− 138 micrometer, respectively). The NIH thickness of SES in DM was significantly thicker than that of SES in non-DM (p<0.001), although it was significantly thinner than that of BMS in DM (p<0.001) or BMS in non-DM (p<0.001). All struts of BMS were covered by neointima, but 14% of struts of SES were exposed. The incidence of exposed struts and exposed struts with inadequate apposition in DES were significantly lower in DM compared with those in non-DM (5% vs. 34%, p<0.0001; 2% vs. 5%, p <0.001, respectively). Moreover, the frequency of DES with partially exposed strut was significantly lower in DM than non-DM (32% vs. 71%, p<0.027). CONCLUSION: The present OCT study revealed that DES inhibited the NIH effectively with low incidence of exposed stent strut in DM patients at 9-month after implantation.


Sign in / Sign up

Export Citation Format

Share Document