Long-term safety and efficacy of drug-eluting stents: two-year results of the REAL (REgistro AngiopLastiche dell'Emilia Romagna) multicenter registry.
BACKGROUND
The long-term safety and efficacy of drug-eluting stents (DES) have been questioned recently.


RESULTS
Between July 2002 and June 2005, 10,629 patients undergoing elective percutaneous coronary intervention with either DES (n=3064) or bare-metal stents (BMS, n=7565) were enrolled in a prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and angiographic stent thrombosis during 2-year follow-up. A propensity score analysis to adjust for different baseline clinical, angiographic, and procedural characteristics was performed. The 2-year unadjusted cumulative incidence of major adverse cardiac events was 17.8% in the DES group and 21.0% in the BMS group (P=0.003 by log-rank test). Angiographic stent thrombosis was 1.0% in the DES group and 0.6% in the BMS group (P=0.09). After adjustment, the 2-year cumulative incidence of death was 6.8% in the DES group and 7.4% in the BMS group (P=0.35), whereas the rates were 5.3% in DES and 5.8% in BMS for acute myocardial infarction (P=0.46), 9.1% in DES and 12.9% in BMS for target-vessel revascularization (P<0.00001), and 16.9% in DES and 21.8% in BMS for major adverse cardiac events (P<0.0001). Independent predictors of target-vessel revascularization in the DES group were diabetes mellitus (hazard ratio 1.36, 95% confidence interval 1.06 to 1.76), renal failure (hazard ratio 1.69, 95% confidence interval 1.06 to 2.69), and reference vessel diameter (hazard ratio 0.64, 95% confidence interval 0.45 to 0.93).


CONCLUSIONS
In this large real-world population, the beneficial effect of DES in reducing the need for new revascularization compared with BMS extends to 2 years without evidence of a worse safety profile.
Marzocchi
Antonio
A
Istituto di Cardiologia, Università di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
Saia
Francesco
F
Piovaccari
Giancarlo
G
Manari
Antonio
A
Aurier
Enrico
E
Benassi
Alberto
A
Cremonesi
Alberto
A
Percoco
Gianfranco
G
Varani
Elisabetta
E
Magnavacchi
Paolo
P
Guastaroba
Paolo
P
Grilli
Roberto
R
Maresta
Aleardo
A
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000188:drug therapy / Q000628:therapy*; D003328:Coronary Thrombosis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D003331:Coronary Vessels / Q000648:ultrastructure; D003920:Diabetes Mellitus / Q000453:epidemiology; D004343:Drug Implants; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control / Q000628:therapy; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data; D051437:Renal Insufficiency / Q000453:epidemiology; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D015607:Stents / Q000009:adverse effects; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome
D004343:Drug Implants; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D017239:Paclitaxel; D001241:Aspirin; D020123:Sirolimus