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Impact of Clinical Trial Results on the Temporal Trends of Carotid Endarterectomy and Stenting From 2002 to 2014

View Article: PubMed Central - PubMed

ABSTRACT

Background and purpose—: Randomized trials provide conflicting data for the efficacy of carotid-artery stenting compared with endarterectomy. The purpose of this study was to examine the impact of conflicting clinical trial publications on the utilization rates of carotid revascularization procedures.

Methods—: We conducted a population-level time-series analysis of all individuals who underwent carotid endarterectomy and stenting in Ontario, Canada (2002–2014). The primary analysis examined temporal changes in the rates of carotid revascularization procedures after publications of major randomized trials. Secondary analyses examined changes in overall and age, sex, carotid-artery symptom, and operator specialty–specific procedure rates.

Results—: A total of 16 772 patients were studied (14 394 endarterectomy [86%]; 2378 stenting [14%]). The overall rate of carotid revascularization decreased from 6.0 procedures per 100 000 individuals ≥40 years old in April 2002 to 4.3 procedures in the first quarter of 2014 (29% decrease; P<0.001). The rate of endarterectomy decreased by 36% (P<0.001), whereas the rate of carotid-artery stenting increased by 72% (P=0.006). We observed a marked increase (P=0.01) in stenting after publication of the SAPPHIRE trial (Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy) in 2004, whereas stenting remained relatively unchanged after subsequent randomized trials published in 2006 (P=0.11) and 2010 (P=0.34). In contrast, endarterectomy decreased after trials published in 2006 (P=0.04) and 2010 (P=0.005).

Conclusions—: Although the overall rates of carotid revascularization and endarterectomy have fallen since 2002, the rate of carotid-artery stenting has risen since the publication of stenting-favorable SAPPHIRE trial. Subsequent conflicting randomized trials were associated with a decreasing rate of carotid endarterectomy.

No MeSH data available.


Related in: MedlinePlus

Trends in the rates of carotid revascularization in relation to major clinical trials. These rates (per 100 000 adults ≥40 years old) are reported for 3-month periods from April 1, 2002, to March 31, 2014. Vertical lines represent timing of publication of major clinical trials that may have influenced the rates of carotid endarterectomy and stenting. CREST indicates Carotid Revascularization Endarterectomy Versus Stenting Trial; EVA-3S, Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis; ICSS, International Carotid Stenting Study; SAPPHIRE, Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy; and SPACE, Stent-Supported Percutaneous Angioplasty of the Carotid Artery Versus Endarterectomy.
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Figure 1: Trends in the rates of carotid revascularization in relation to major clinical trials. These rates (per 100 000 adults ≥40 years old) are reported for 3-month periods from April 1, 2002, to March 31, 2014. Vertical lines represent timing of publication of major clinical trials that may have influenced the rates of carotid endarterectomy and stenting. CREST indicates Carotid Revascularization Endarterectomy Versus Stenting Trial; EVA-3S, Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis; ICSS, International Carotid Stenting Study; SAPPHIRE, Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy; and SPACE, Stent-Supported Percutaneous Angioplasty of the Carotid Artery Versus Endarterectomy.

Mentions: A decreasing trend in the rate of carotid endarterectomy was observed after publication of SAPPHIRE in 2004, although this did not reach statistical significance (P=0.06). Subsequent trials appeared to further influence the rate of endarterectomy because it markedly decreased after publication of SPACE and EVA-3S in 2006 (P=0.04) and CREST and ICSS in 2010 (P=0.005). The utilization rate of carotid-artery stenting, on the contrary, significantly increased after publication of SAPPHIRE in 2004 (P=0.01). Rates of stenting did not change after publications of subsequent trials in 2006 and 2010 (P=0.11 and P=0.34, respectively). See Figure 1 for quarterly rates of carotid endarterectomy and stenting per 100 000 adults ≥40 years old in relation to clinical trial publications.


Impact of Clinical Trial Results on the Temporal Trends of Carotid Endarterectomy and Stenting From 2002 to 2014
Trends in the rates of carotid revascularization in relation to major clinical trials. These rates (per 100 000 adults ≥40 years old) are reported for 3-month periods from April 1, 2002, to March 31, 2014. Vertical lines represent timing of publication of major clinical trials that may have influenced the rates of carotid endarterectomy and stenting. CREST indicates Carotid Revascularization Endarterectomy Versus Stenting Trial; EVA-3S, Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis; ICSS, International Carotid Stenting Study; SAPPHIRE, Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy; and SPACE, Stent-Supported Percutaneous Angioplasty of the Carotid Artery Versus Endarterectomy.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5120767&req=5

Figure 1: Trends in the rates of carotid revascularization in relation to major clinical trials. These rates (per 100 000 adults ≥40 years old) are reported for 3-month periods from April 1, 2002, to March 31, 2014. Vertical lines represent timing of publication of major clinical trials that may have influenced the rates of carotid endarterectomy and stenting. CREST indicates Carotid Revascularization Endarterectomy Versus Stenting Trial; EVA-3S, Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis; ICSS, International Carotid Stenting Study; SAPPHIRE, Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy; and SPACE, Stent-Supported Percutaneous Angioplasty of the Carotid Artery Versus Endarterectomy.
Mentions: A decreasing trend in the rate of carotid endarterectomy was observed after publication of SAPPHIRE in 2004, although this did not reach statistical significance (P=0.06). Subsequent trials appeared to further influence the rate of endarterectomy because it markedly decreased after publication of SPACE and EVA-3S in 2006 (P=0.04) and CREST and ICSS in 2010 (P=0.005). The utilization rate of carotid-artery stenting, on the contrary, significantly increased after publication of SAPPHIRE in 2004 (P=0.01). Rates of stenting did not change after publications of subsequent trials in 2006 and 2010 (P=0.11 and P=0.34, respectively). See Figure 1 for quarterly rates of carotid endarterectomy and stenting per 100 000 adults ≥40 years old in relation to clinical trial publications.

View Article: PubMed Central - PubMed

ABSTRACT

Background and purpose—: Randomized trials provide conflicting data for the efficacy of carotid-artery stenting compared with endarterectomy. The purpose of this study was to examine the impact of conflicting clinical trial publications on the utilization rates of carotid revascularization procedures.

Methods—: We conducted a population-level time-series analysis of all individuals who underwent carotid endarterectomy and stenting in Ontario, Canada (2002–2014). The primary analysis examined temporal changes in the rates of carotid revascularization procedures after publications of major randomized trials. Secondary analyses examined changes in overall and age, sex, carotid-artery symptom, and operator specialty–specific procedure rates.

Results—: A total of 16 772 patients were studied (14 394 endarterectomy [86%]; 2378 stenting [14%]). The overall rate of carotid revascularization decreased from 6.0 procedures per 100 000 individuals ≥40 years old in April 2002 to 4.3 procedures in the first quarter of 2014 (29% decrease; P<0.001). The rate of endarterectomy decreased by 36% (P<0.001), whereas the rate of carotid-artery stenting increased by 72% (P=0.006). We observed a marked increase (P=0.01) in stenting after publication of the SAPPHIRE trial (Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy) in 2004, whereas stenting remained relatively unchanged after subsequent randomized trials published in 2006 (P=0.11) and 2010 (P=0.34). In contrast, endarterectomy decreased after trials published in 2006 (P=0.04) and 2010 (P=0.005).

Conclusions—: Although the overall rates of carotid revascularization and endarterectomy have fallen since 2002, the rate of carotid-artery stenting has risen since the publication of stenting-favorable SAPPHIRE trial. Subsequent conflicting randomized trials were associated with a decreasing rate of carotid endarterectomy.

No MeSH data available.


Related in: MedlinePlus