The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Clinical Outcomes with Unselected Use of an Ultrathin-Strut Sirolimus-Eluting Stent: A Report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
Sergio Buccheri1; Giovanna Sarno1; David Erlinge2; Henrik Renlund3; Bo Lagerqvist1; Per Grimfjärd4; Nils Witt5; Troels Yndigegn2; Ole Fröbert6; Jonas Persson7; Felix Böhm8; Stefan James1;
1. Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden, Sweden 2. Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden 3. Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden 4. Department of Cardiology, Västerås Hospital, Västerås, Sweden 5. Department of Clinical Science and Education, Karolinska Institutet, Unit of Cardiology, Södersjukhuset, Stockholm, Sweden 6. Örebro University, Faculty of Health, Department of Cardiology, Örebro, Sweden 7. Department of Cardiology, Danderyd University Hospital, Stockholm, Sweden 8. Coronary Artery Disease Area, Heart and Vascular Theme, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
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Aims: To assess the real-world clinical performance of a sirolimus-eluting ultrathin-strut drug-eluting stent (DES) [Orsiro, Biotronik AG] in a large nationwide cohort of patients undergoing percutaneous coronary intervention (PCI).
Methods and results: From the Swedish Coronary Angiography and Angioplasty Registry, the 2-year outcomes of 4,561 patients implanted with Orsiro (Orsiro group) and 69,570 receiving other newer generation DES (n-DES group) were analyzed. The rate of definite stent thrombosis was low in both groups (0.67% and 0.83% for Orsiro and n-DES, respectively; adjusted hazard ratio [HR] 0.90, 95% confidence interval [CI] 0.55-1.46, p-value 0.66). Restenosis was also infrequent (1.5% versus 2.0% with Orsiro and n-DES, adjusted HR 0.81, 95% CI 0.63-1.03, p-value=0.09). The risk of target lesion revascularization by PCI was lower in the Orsiro group (1.6% versus 2.3%, adjusted HR 0.75, 95% CI 0.60-0.94, p-value=0.013). All-cause mortality and myocardial infarction did not show a statistically significant difference between the two groups (mortality of 7.5% in both groups, adjusted HR 0.99, 95% CI 0.72-1.35, p-value=0.94; 6.0% versus 5.2% for myocardial infarction, adjusted HR 1.19, 95% CI 1.00-1.43, p-value=0.06).
Conclusions: In a nationwide scenario, the use of a sirolimus-eluting ultrathin-strut DES portended favorable clinical outcomes.