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Long-term clinical outcomes after everolimus- and sirolimus-eluting coronary stent implantation: final 3-year follow-up of the Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Shiomi, Hiroki Kozuma, Ken Morimoto, Takeshi Igarashi, Keiichi Kadota, Kazushige Tanabe, Kengo Morino, Yoshihiro Akasaka, Takashi Abe, Mitsuru Suwa, Satoru Muramatsu, Toshiya Kobayashi, Masakazu Dai, Kazuoki Nakao, Koichi Uematsu, Masaaki Tarutani, Yasuhiro Fujii, Kenshi Simonton, Charles A. Kimura, Takeshi |
| Copyright Year | 2014 |
| Abstract | BACKGROUND Long-term clinical outcomes of everolimus-eluting stent (EES) compared with sirolimus-eluting stent (SES) have not been evaluated fully yet, especially whether EES implantation could positively affect late adverse events reported after SES implantation occurring >1 year. METHODS AND RESULTS In this all-comer prospective multicenter randomized open-label trial, 3196 patients were assigned randomly to implant either EES (n=1596) or SES (n=1600). At 3 years, EES was noninferior to SES on the primary safety end point (all-cause death or myocardial infarction; 10.1% versus 11.5%; noninferiority P <0.001; and superiority P=0.19). Cumulative incidence of definite stent thrombosis was low and was not significantly different between the 2 groups (0.5% versus 0.6%; P=0.81). There was no significant difference in the efficacy end point of target-lesion revascularization between the EES and SES groups (6.6% versus 7.9%; P=0.16). However, the cumulative incidence of target-lesion failure (cardiac death/target-vessel myocardial infarction/ischemia-driven target-lesion revascularization) was significantly lower in the EES group than in the SES group (8.8% versus 11.4%; P=0.01). By a landmark analysis at 1 year, the cumulative incidence of very late stent thrombosis and late target-lesion revascularization was not significantly different between the 2 groups (0.2% versus 0.2%; P=0.99 and 2.2% versus 2.9%; P=0.21, respectively). CONCLUSIONS The efficacy and safety outcomes for this trial after EES implantation remained comparable with those after SES implantation through 3-year follow-up. However, improvement of clinical outcome after EES implantation compared with SES implantation was suggested by the significantly lower cumulative incidences of target-lesion failure, which has been the most widely used primary end point in the stent-versus-stent trials. CLINICAL TRIAL REGISTRATION URL http://www.clinicaltrials.gov. Unique identifier: NCT01035450. |
| File Format | PDF HTM / HTML |
| PubMed reference number | 24803436 |
| Journal | Medline |
| Volume Number | 7 |
| Issue Number | 3 |
| Alternate Webpage(s) | http://circinterventions.ahajournals.org/content/circcvint/7/3/343.full.pdf?download=true |
| Alternate Webpage(s) | https://doi.org/10.1161/CIRCINTERVENTIONS.113.001322 |
| Journal | Circulation. Cardiovascular interventions |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
