Drug therapy during percutaneous coronary interventions in stable and unstable coronary artery disease: the Italian Drug Evaluation in Angioplasty (IDEA) study

BACKGROUND: Although periprocedural drug therapy has been shown to improve the outcome of percutaneous coronary intervention (PCI), information regarding its use in daily clinical practice is limited. METHODS: We conducted a national survey on periprocedural drug therapy across the spectrum of PCI practice in Italy. Seventy-nine centers (41% of the Italian interventional cath labs) with a fair distribution across the country volunteered to enroll consecutive patients undergoing PCI for any indication from September 15 to 29, 2003. RESULTS: Of the 1517 patients enrolled, 745 (49 %) had stable coronary disease and 772 (51%) acute coronary syndromes (ACS): 457 without and 315 with ST-segment elevation. Stenting was used in 89% of cases. N-acetylcysteine was used in 23% of the patients with preexisting renal dysfunction. Thienopyridine (63% clopidogrel) pretreatment was given in 49 % of the cases and, at logistic regression analysis, was independently associated with prior myocardial infarction (p 90% of cases, 50% of the patients were discharged on symptomatic anti-ischemic therapy. CONCLUSIONS: A wide gap exists between guideline recommendations and periprocedural drug therapy in PCI, the only exception being full prescription of aspirin and a thienopyridine at discharge after stenting. In patients with ACS, thienopyridine pretreatment is often used as a surrogate for GP IIb/IIIa blockade, whose use rather is associated with emergency procedures. Off-label use of drugs is not uncommon

Sicilian DES Registry: Prospective in-hospital and 9-month clinical and angiographic follow-up in selected high restenosis risk patients

OBJECTIVE: This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world. METHODS: From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure. RESULTS: Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 ± 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%). CONCLUSIONS: Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity. © 2008 Italian Federation of Cardiology

Early Aggressive Versus Initially Conservative Treatment in Elderly Patients With Non-ST-Segment Elevation Acute Coronary Syndrome: A Randomized Controlled Trial.

OBJECTIVES: This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). BACKGROUND: Elderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS. METHODS: A total of 313 patients ≥75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year. RESULTS: During admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03). CONCLUSIONS: The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185)