Two-Year Comparison of Drug-Eluting Versus Bare Metal Stents
Two-Year Comparison of Drug-Eluting Versus Bare Metal Stents
Objective: The aim was to compare 2-year outcomes with the routine use of drug-eluting stents (DES) (>75% “off-label”) with a comparable group treated with bare-metal stents (BMS).
Background: Safety concerns >1 year from implantation have been raised about DES used “off-label.” There are limited data comparing DES and BMS in “off-label” patients.
Methods: Clinical outcomes (nonfatal myocardial infarction [MI], all-cause mortality) were assessed in 1,164 consecutive patients who received BMS in the year before introduction of DES at Wake Forest University Baptist Medical Center and 1,285 consecutive patients who received DES after it became our routine choice. “On-label” stent use was defined as treatment for a single de novo lesion <30 mm, without recent MI or other major illnesses.
Results: At 2 years, the hazard ratio for DES compared with BMS for nonfatal MI or death was 0.77 (95% confidence interval [CI] 0.62 to 0.95), for all-cause mortality 0.71 (0.54 to 0.92), and stent thrombosis (ST) 0.97 (0.49 to 1.91). “On-label” stent procedures were associated with lower risk of MI, death, and ST than “off-label” stent procedures. For “off-label” stent procedures, the hazard ratio for DES compared with BMS for nonfatal MI or death was 0.78 (95% CI 0.62 to 0.98), all-cause mortality 0.72 (0.54 to 0.94), and ST 0.91 (0.46 to 1.80). The hazard of nonfatal MI or death was similar or lower for DES than BMS in high-risk subgroups, including renal failure and recent MI.
Conclusions: The routine clinical use of drug-eluting stents for “off-label” indications was associated with lower nonfatal MI and death at 2 years than in a comparable group of patients treated with BMS.
Drug-eluting stents (DES) have reduced the incidence of angiographic and clinical restenosis compared with bare-metal stents (BMS) in randomized clinical trials (RCT) of highly selected patients. This benefit appears to persist for up to 4 years after stent implantation. This has led to the widespread use of DES, including in patients who would not have met the eligibility criteria for inclusion in the RCT of DES versus BMS. However, recent data suggest that DES may be associated with an increased rate of late (>1 year) stent thrombosis (ST), myocardial infarction (MI), and death compared with BMS, particularly in patients not receiving clopidogrel. Because of concern of adverse late events with DES, the U.S. Food and Drug Administration (FDA) convened a panel to review available data from both pivotal RCT of DES versus BMS and post-RCT registry and single-center studies. Based on review of these data, the panel concluded that when DES were used for their approved indications ("on-label") the risk of late DES thrombosis did not outweigh the advantages over BMS in reducing rates of repeat revascularization. In contrast, the panel concluded, and the FDA concurred, that adverse late events occurred at a sufficient incidence to raise concern about the safety of "off-label" DES use.
Despite the panel's conclusions, there are no RCT comparing outcomes of "on-label" and "off-label" stent treatments between DES and BMS. Moreover, it is uncertain that an adequately powered clinical trial to evaluate these comparisons could be performed or that it would be representative of the results under the conditions of routine practice. To test the hypothesis that late DES outcomes may be inferior to BMS when used in "off-label" stent treatments, we assessed the clinical outcomes in consecutive patients treated with DES when DES utilization was ≥ 90% and compared them with patients who received BMS before the availability of DES. The majority (>75%) of both stent groups were "off-label."
Abstract and Introduction
Abstract
Objective: The aim was to compare 2-year outcomes with the routine use of drug-eluting stents (DES) (>75% “off-label”) with a comparable group treated with bare-metal stents (BMS).
Background: Safety concerns >1 year from implantation have been raised about DES used “off-label.” There are limited data comparing DES and BMS in “off-label” patients.
Methods: Clinical outcomes (nonfatal myocardial infarction [MI], all-cause mortality) were assessed in 1,164 consecutive patients who received BMS in the year before introduction of DES at Wake Forest University Baptist Medical Center and 1,285 consecutive patients who received DES after it became our routine choice. “On-label” stent use was defined as treatment for a single de novo lesion <30 mm, without recent MI or other major illnesses.
Results: At 2 years, the hazard ratio for DES compared with BMS for nonfatal MI or death was 0.77 (95% confidence interval [CI] 0.62 to 0.95), for all-cause mortality 0.71 (0.54 to 0.92), and stent thrombosis (ST) 0.97 (0.49 to 1.91). “On-label” stent procedures were associated with lower risk of MI, death, and ST than “off-label” stent procedures. For “off-label” stent procedures, the hazard ratio for DES compared with BMS for nonfatal MI or death was 0.78 (95% CI 0.62 to 0.98), all-cause mortality 0.72 (0.54 to 0.94), and ST 0.91 (0.46 to 1.80). The hazard of nonfatal MI or death was similar or lower for DES than BMS in high-risk subgroups, including renal failure and recent MI.
Conclusions: The routine clinical use of drug-eluting stents for “off-label” indications was associated with lower nonfatal MI and death at 2 years than in a comparable group of patients treated with BMS.
Introduction
Drug-eluting stents (DES) have reduced the incidence of angiographic and clinical restenosis compared with bare-metal stents (BMS) in randomized clinical trials (RCT) of highly selected patients. This benefit appears to persist for up to 4 years after stent implantation. This has led to the widespread use of DES, including in patients who would not have met the eligibility criteria for inclusion in the RCT of DES versus BMS. However, recent data suggest that DES may be associated with an increased rate of late (>1 year) stent thrombosis (ST), myocardial infarction (MI), and death compared with BMS, particularly in patients not receiving clopidogrel. Because of concern of adverse late events with DES, the U.S. Food and Drug Administration (FDA) convened a panel to review available data from both pivotal RCT of DES versus BMS and post-RCT registry and single-center studies. Based on review of these data, the panel concluded that when DES were used for their approved indications ("on-label") the risk of late DES thrombosis did not outweigh the advantages over BMS in reducing rates of repeat revascularization. In contrast, the panel concluded, and the FDA concurred, that adverse late events occurred at a sufficient incidence to raise concern about the safety of "off-label" DES use.
Despite the panel's conclusions, there are no RCT comparing outcomes of "on-label" and "off-label" stent treatments between DES and BMS. Moreover, it is uncertain that an adequately powered clinical trial to evaluate these comparisons could be performed or that it would be representative of the results under the conditions of routine practice. To test the hypothesis that late DES outcomes may be inferior to BMS when used in "off-label" stent treatments, we assessed the clinical outcomes in consecutive patients treated with DES when DES utilization was ≥ 90% and compared them with patients who received BMS before the availability of DES. The majority (>75%) of both stent groups were "off-label."
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