Abstract

Patients with peripheral arterial disease (PAD) undergoing PCI are at high risk for adverse cardiovascular events in follow up. Trends over time in outcomes with advances in PCI and medical therapy are unknown. We evaluated 866 patients with PAD in the NHLBI Dynamic Registry undergoing PCI according to treatment eras: the early bare metal stent (BMS) era (Wave 1: ‘97–’98, n=180), the BMS era (Waves 2 and 3; ’99 and ’01–’02; n=339), and the drug-eluting stent (DES) era (Waves 4 and 5:’04 and ‘06; n=347). We compared in-hospital and 1-year outcomes by recruitment era. In-hospital CABG rates were significantly lower in the later eras (3.9%, 0.9%, 0.6%, early BMS, BMS, and DES eras respectively, p=0.005), and an increasing percentage of patients were discharged on asprin, beta blockers, statins, and ticlopidine or clopidogrel (all p<0.001). The cumulative 1-year adverse event rates are seen in the table . Comparison cumulative 1-year event rates in patients without PAD in the early BMS era (n=2323), BMS era (n=3803) and DES era (n=3915) of death were 4.2%, 4.4%, and 4.0% (p=0.76); of MI were 5.3%, 5.0%, and 4.4% (p=0.19), and repeat revasculatization were 21.5%, 15.9%, and 11.4% (p<0.001). The 1-year adjusted hazard ratios (HR) of adverse events in patients with PAD using the early BMS era as the reference are as follows: Death: BMS era HR=0.84 (95% CI 0.46–1.55, p=0.58) and DES era HR=1.35 (95% CI 0.71–2.56, p=0.36); MI: BMS era HR=0.89 (95% CI 0.48–1.66, p=0.72) and DES era HR=1.02 (95% CI 0.55–1.87, p=0.95); and Repeat Revascularization: BMS era HR=0.63 (95% CI 0.41– 0.97, p=0.04) and DES era HR=0.46 (95% CI 0.29–0.73, p=001).

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