Healthy Skepticism Library item: 13166

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Publication type: Journal Article

Roy P, Buch AN, Javaid A, Okabe T, Raya V, Pinto Slottow TL, Steinberg DH, Smith K, Xue Z, Gevorkian N, Satler LF, Kent KM, Suddath WO, Pichard AD, Lindsay J, Waksman R.
Impact of 'off-label' utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention.
Am J Cardiol 2008 Feb 1; 101:(3):293-9
http://linkinghub.elsevier.com/retrieve/pii/S0002-9149(07)01903-0

Abstract:

The utilization of drug-eluting stents (DES) in “real world” practice has deviated from Food and Drug Administration-approved indications. Safety concerns have arisen from recent reports that suggested increased mortality and nonfatal myocardial infarction (MI) with DES usage. Little is known about the clinical outcomes of patients undergoing intracoronary DES implantation for unapproved indications as a group compared with outcomes after bare metal stent (BMS) placement. The clinical outcomes of 546 patients undergoing DES implantation for >or=1 non-Food and Drug Administration-approved (“off label”) indication since the approval of the device were assessed. The group was then matched by propensity score with 546 patients receiving BMSs prior to DES approval for the same indications. The primary endpoint was major adverse cardiac events (cardiac death, nonfatal Q-wave myocardial infarction [MI], and target vessel revascularization) at 12 months. Baseline clinical and angiographic characteristics were well matched between BMS and DES groups. The use of debulking devices was higher in the BMS group. Patients in the BMS group were more likely to be treated with larger diameter and shorter stents. There was no significant difference in the rate of in-hospital and 30-day adverse cardiac events. At 12 months, the primary endpoint of major adverse cardiac events was significantly reduced in the DES group (23.6% vs 16.7%, p=0.004), driven by reductions in the need for repeat revascularization (target lesion revascularization: 16.4% vs 7.8%, p<0.001; target vessel revascularization: 20.2% vs 13.1%, p=0.003). There was no significant difference in freedom from cardiac death or nonfatal Q-wave MI between groups (p=0.27). In conclusion, the utilization of DES for non-Food and Drug Administration-approved indications proved to be efficacious and safe when compared with a BMS cohort matched by propensity score. The advantage for DES was driven by reductions in repeat revascularization. “Off-label” DES use was not associated with increased rates of cardiac death and nonfatal MI at 12 months.

Keywords:
Publication Types: Research Support, Non-U.S. Gov't MeSH Terms: Aged Angioplasty, Transluminal, Percutaneous Coronary* Coronary Restenosis/epidemiology Coronary Restenosis/prevention & control Drug Labeling Drug-Eluting Stents/standards Drug-Eluting Stents/utilization* Female Humans Male Middle Aged Myocardial Infarction/epidemiology Myocardial Infarction/prevention & control Prosthesis Design Retreatment Retrospective Studies Safety United States