Safety, efficacy and long-term durability of endovascular therapy for carotid artery disease: the tailored-Carotid Artery Stenting Experience of a single high-volume centre (tailored-CASE Registry).

AIMS: We aimed to determine the success, safety and long-term durability of carotid artery stenting (CAS) in stroke prevention for all-comers managed with mandatory neuroprotection and a tailored-approach to intervention. METHODS AND RESULTS: From our CAS registry (beginning July 1997) all procedures up to September 2007 with intention-to-treat by stenting under distal filter or proximal occlusion neuroprotection devices were analysed (N=1523; mean age 72 years [237 >or=80 years, 15.5%]). Indications included symptomatic stenoses >or=50% (366, 24.1%) and asymptomatic stenoses >or=80% (1157, 75.9%). CAS success was 99.6% and the 30-day all-stroke/death rate was 1.5% (minor stroke 11 [0.7%], major stroke 8 [0.5%], death 5 [0.3%]). The risk was 1.2% for asymptomatic patients and 2.7% for symptomatic patients (p=0.042). Regarding octogenarians this risk was 2.1% versus 1.5% for patients or=80 1.2%, symptomatic or=80 4.5%. The event free survival rates from all strokes or stroke-related deaths at eight years were 96% for asymptomatic and 92% for symptomatic patients. CONCLUSIONS: Results from this large cohort show that carotid stenting in a real-world setting is safe and efficacious, and durable in the long-term prevention of stroke.

[Coronary angioplasty in the real world: the RESTEM registry. Outcome of patients treated with sirolimus-eluting stents]. / L'angioplastica coronarica nel mondo reale: il registro RESTEM. Impatto degli stent a base di sirolimus sull'outcome dei pazienti.

BACKGROUND: RESTEM, a prospective multicenter registry collecting all percutaneous coronary interventions made over 20 months and monitored up to 2 years, had been performed to assess, in the real world, the impact of sirolimus-eluting stents (SES) versus bare metal stents (BMS) on patients' outcomes. METHODS: The registry includes 5524 consecutive patients treated with BMS (72%), SES (15%), BMS+SES (4%) or other techniques (9%). The combination of death, acute myocardial infarction, unstable angina and revascularization had been chosen as primary endpoint. RESULTS: The 2-year adjusted results confirm a significant advantage of SES in target vessel revascularization (8.3 vs 13.7%, odds ratio [OR] 0.66), a benefit for overall revascularizations (18.3 vs 25.6%, OR 0.76) without reducing mortality, other clinical events and primary endpoint, therefore denying the benefit on primary endpoint observed at 12 months (18.5 vs 25.0%, OR 0.68 at 1 year and 25.8 vs 32.4%, OR 0.84 at 2 years). CONCLUSIONS: RESTEM results confirm the SES capacity to reduce target vessel revascularization without decreasing other clinical events, suggest that this advantage is limited to the first 6 months after percutaneous coronary intervention, and show no evidence of excess of deaths, acute myocardial infarction and late thrombosis following SES implantation described in recent meta-analyses.

RESTEM: a percutaneous coronary intervention 'real world' registry in the drug-eluting stent era.

Sirolimus-eluting stents (SESs) reduce the rate of in-stent restenosis in selected cases. Their performance in more complex patients and their impact on the final clinical outcome of these patients, however, remains uncertain. RESTEM Registry (REgistro delle PCI in era di STEnt Medicati), a prospective multicenter registry collecting all percutaneous coronary interventions (PCIs) performed over 20 months and monitored up to 2 years, includes 5524 consecutive patients treated with bare metal stent (BMS) (72%), sirolimus-eluting stent (SES) (15%), combined BMS+SES (4%), or other techniques (9%). The combination of death, acute myocardial infarction (AMI), unstable angina and revascularizations had been chosen as primary endpoint. One-year multivariate analysis shows no significant advantage of SES in combined clinical events, a slight benefit in primary endpoint [18.5 vs. 25.0% BMS=odds ratio (OR) 0.78) and revascularizations (13.6 vs. 20.4% BMS=OR 0.74], a consistent advantage when only target vessel revascularizations (TVRs) are considered (5.5 vs. 10.5% BMS=OR 0.52). The two-year adjusted results confirm a significant advantage of SES in TVR (8.3 vs. 13.7% BMS=OR 0.65), a slight benefit for revascularizations (18.3 vs. 25.6% BMS=OR 0.76), without reducing mortality and other clinical events; these data refute the benefit on primary endpoint observed at 12 months (25.8 vs. 32.4% BMS=OR 0.84). After analyzing events recorded during the first and second year follow-up periods separately, the incidence of many of them favors SES in the first year, yet appear independent of the technique utilized in the second. RESTEM results confirming SES's capacity to reduce TVR without reduction of other clinical events, suggest that this advantage is limited to the first year after PCI, and show no evidence of excess of deaths, AMIs and late thrombosis following SES implantation described in recent meta-analyses.