Clinical Investigation
Interventional Cardiology
Ten-year clinical follow-up after sirolimus-eluting stent implantation

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Background

Little is known on the “very” long-term incidence of major adverse cardiac events (MACE), target-lesion revascularization (TLR), target-vessel revascularization and stent thrombosis after sirolimus-eluting stent (SES) implantation. We present the first study to provide a 10-year clinical follow-up in an unselected patient population who underwent SES implantation.

Methods and Results

We ran a systematic 10-year clinical follow-up in a series of 200 consecutive patients treated with unrestricted SES implantation between April 2002 and April 2003 in two Swiss hospitals. Outcomes and follow-up were obtained in all 200 patients. The cumulative 10-year MACE rate was 47% with all-cause death of 20%, cardiac death of 9%, myocardial infarction of 7%, TLR and target-vessel revascularization of 8% and 11% respectively. Academic Research Consortium–defined “definite and probable” stent thrombosis-rate was 2.5%. TLR risk was maximal between 3 to 6 years. New lesion revascularization increased throughout the study period.

Conclusion

Incidence of TLR was maximal 3 to 6 years after SES implantation and decreased thereafter. MACE and non-TLR revascularization rates steadily increased during the complete follow-up underlining the progression of coronary artery disease.

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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