Clinical InvestigationInterventional CardiologyTen-year clinical follow-up after sirolimus-eluting stent implantation
Section snippets
Methods
Prospective follow-up was undertaken in the first 200 patients with unrestricted SES (Cypher; Cordis, Miami Lakes, FL) implantation between April 2002 and April 2003 in two Swiss hospitals. A number of patients were included in the e-Cypher Internet-based post-marketing surveillance registry, the database of which has previously been published.16 The “Ten’n’C” trial complied with the Declaration of Helsinki and was approved by the local ethics committee of Fribourg University and Hospital,
Population and percutaneous coronary intervention characteristics
A total of 200 consecutive patients were included in the registry. Complete follow-up was available in all patients. Full baseline and procedural characteristics are depicted in Table I, Table II. Mean age was 64 ± 10 years with a majority of men (77%), 18% were diabetic, 25% had a prior history of myocardial infarction and a third had already undergone percutaneous coronary intervention. The clinical presentation was an acute coronary syndrome (ACS) in 16% of the cases.
Overall, the
Discussion
The present prospective cohort of 200 patients with a complete 10-year follow-up after unrestricted SES implantation has the following important findings: (1) TLR is highest during the 3- to 6-year period after implantation, and thereafter declines; (2) ST is rare; (3) Non TVR rates increase out of proportion with TVR and TLR which remain stable; (4) patient-centered MACE rates increase along with total coronary revascularization and death while MI rates are low.
Table IV illustrates the 10-year
Conclusion
SES has a satisfactory safety profile on the very long term with ST rates that remain low. The maximal TLR rates are found between 3 and 6 years and then decrease. Coronary artery disease is dynamic and not just limited to target vessels. At 10-year follow-up, the continuous increase in MACE, death and revascularisation are primarily due to the progression of coronary artery disease with new coronary lesions beyond target vessels. Additional very long-term follow-ups from major registries are
Disclosures
Conflict of interest: Dr. Cook receives research grants from Boston Scientific and Biosensors International. The other authors have no conflict to declare. This work was presented in part at the 2013 Scientific Sessions of the American Heart Association in Dallas, TX, November 17-19, 2013.
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