The relative safety and efficacy of bare-metal and drug-eluting stents in low and high-risk patient subsets. An epidemiological analysis of three sequential cohorts of consecutive all comers (n = 6129).
OBJECTIVE
Sirolimus- and paclitaxel- eluting stents (SES and PES respectively) have been shown to produce a sustained reduction in restenosis and repeat revascularisations as compared to bare-metal stents (BMS) up to four years. There is still limited data about the long-term safety and efficacy of DES in high-risk subgroups.


RESULTS
A total of 6,129 consecutive patients were treated during three sequential periods with BMS (n = 2,428; January, 2000 to April, 2002), SES (n = 866; April 2002 to February 2003) or PES (n = 2,835; February 2003 to December 2005). A stratified analysis (including age, gender, diabetes, clinical presentation, treated vessel, multivessel disease, AHA lesion class, bifurcation, in-stent restenosis, average stent diameter < or = 2.5 mm and total stented length < or = 30 mm) was performed to evaluate possible heterogeneities in treatment effect. At four years, all-cause mortality was identical between the drug-eluting stent (DES) and BMS cohorts (13.5% vs. 13.4%, respectively; Adjusted HR 1.10, 95% CI 0.90 - 1.34) without evidence of heterogeneity in the high-risk patient subsets. Both DES significantly reduced the risk for target vessel revascularisation (TVR) as compared to BMS (TVR: 11.9% vs. 15.7% respectively; Adjusted HR 0.69, 95% CI 0.58 - 0.82) along with a reduced risk for post-operative MI (adjusted HR 0.75, 95% CI 0.57 - 0.98), but counterbalanced by a non-significantly higher risk for stent thrombosis (3.1% vs. 1.6%; adjusted HR 1.26, 95% CI 0.82 - 1.95). DES failed to show superiority to BMS in patients with acute myocardial infarction (TVR 10.5% vs. 9.2% respectively; Adjusted HR 1.26, 95% CI 0.82 - 1.93).


CONCLUSIONS
In a real world patient population, after four years, the overall use of DES was associated with similar all-cause mortality rates and a significantly reduced risk for post-operative MI and TVR as compared to BMS.
Daemen
Joost
J
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
van Twisk
Piet-Hein
PH
Kukreja
Neville
N
van Domburg
Ron T
RT
Boersma
Eric
E
de Jaegere
Peter
P
Serruys
Patrick W
PW
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D048909:Diabetes Complications / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D017239:Paclitaxel / Q000008:administration & dosage*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D016016:Proportional Hazards Models; D012042:Registries; D018570:Risk Assessment; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D008670:Metals; D010975:Platelet Aggregation Inhibitors; D017239:Paclitaxel; D020123:Sirolimus