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 < 0.001), prior PCI (p = 0.007), stable coronary disease (p = 0.005), and treatment in northern Italy (p < 0.05). Platelet glycoprotein (GP) IIb/IIIa receptor blockers (50% abciximab 50% tirofiban) were used in 22% of the stable patients and 40 % of those with ACS, a proportion increasing to 62 % when PCI was undertaken as an emergency procedure. Off-label use of these drugs was frequent (direct cath lab use of tirofiban in 55% of the cases; bailout use: 16% with abciximab and 26% with tirofiban). At logistic regression analysis, independent predictors of GP IIb/IIIa receptor blocker use were emergency procedure (odds ratio 3.6, 95 % confidence interval 2.6 to 5.0, p < 0.0001) and treatment for an ACS (odds ratio 1.6, 95% confidence interval 1.3 to 2.1, p = 0.0002). An emergency procedure was the only independent predictor for the use of abciximab instead of tirofiban (odds ratio 4.1, 95% confidence interval 2.6 to 6.5, p < 0.0001). Triple periprocedural antiplatelet therapy, including aspirin, a thienopyridine and a GP IIb/IIIa receptor blocker was administered in only 21% of cases. At discharge, all stented patients received aspirin and a thienopyridine. Despite complete procedural success in > 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.