Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials.
BACKGROUND
In the first year after coronary stent implantation, clinical failures are driven mainly by procedural complications and restenosis, but the subsequent relative contributions of restenosis and disease progression to late failures are less clear.


RESULTS
We observed 1228 patients for 5 years after the implantation of stents as part of pivotal second-generation coronary stent trials. Clinical events of death, myocardial infarction, repeat revascularization, and repeat hospitalization for acute coronary syndrome or congestive heart failure were attributed to the index stented (target) lesion or other distinct sites (either in the target or other coronary vessels) and further classified as procedural, restenosis, or nonrestenosis. During the first year the hazard rate was 18.3% for target-lesion events and 12.4% for events unrelated to the target lesion. After the first year the average annual hazard rate was 1.7% for target-lesion events and 6.3% for nontarget-lesion events. By the fifth year, restenosis events occurred in 20.3% of patients, whereas 30-day procedural complications or later nonrestenosis events occurred in 37.9%, including 11.4% who also experienced a restenosis event, for a combined cumulative event rate of 46.4%. Diabetes mellitus and multivessel disease were independently associated with increased risk for both restenosis and nonrestenosis events.


CONCLUSIONS
In a low-risk clinical trial population, the clinical outcome beyond 1 year after stenting is determined by a high rate of events related to disease progression in segments other than the stented lesion, which itself remains relatively stable.
Cutlip
Donald E
DE
Harvard Clinical Research Institute, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA. dcutlip@hcri.harvard.edu
Chhabra
Amit G
AG
Baim
Donald S
DS
Chauhan
Manish S
MS
Marulkar
Sachin
S
Massaro
Joseph
J
Bakhai
Ameet
A
Cohen
David J
DJ
Kuntz
Richard E
RE
Ho
Kalon K L
KK
D000368:Aged; D015897:Comorbidity; D023903:Coronary Restenosis / Q000453:epidemiology*; D023921:Coronary Stenosis / Q000601:surgery*; D003920:Diabetes Mellitus / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000453:epidemiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D006949:Hyperlipidemias / Q000453:epidemiology; D006973:Hypertension / Q000453:epidemiology; D015994:Incidence; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D009203:Myocardial Infarction / Q000453:epidemiology / Q000601:surgery; D017202:Myocardial Ischemia / Q000453:epidemiology; D011183:Postoperative Complications / Q000453:epidemiology*; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012042:Registries / Q000706:statistics & numerical data; D012086:Reoperation / Q000706:statistics & numerical data; D012307:Risk Factors; D012494:Sampling Studies; D012907:Smoking / Q000453:epidemiology; D015607:Stents; D013318:Stroke Volume; D016896:Treatment Outcome