State of the Stent: PCI Future Intact Despite Costs, Sociopolitical Factors

San Francisco, CA—Since 2008, the number of drug-eluting stents implanted worldwide has increased, a trend which is expected to continue with more than 5 million DES implantations projected in 2018 alone. According to Stephan Windecker, MD, of Bern University Hospital in Switzerland, the reasons for this increase are varied. Significant changes in sociodemographic factors worldwide, including an increasing elderly population, a higher prevalence of diabetes, a lack of decline in smokers over time and an increase in BMI worldwide, have increased the incidence of CVD, contributing to the higher demand for PCI. 

steph.tues.29Emerging data from meta-analyses support the prognostic benefit of PCI over optimal medical therapy and have broadened the indications for use, including spontaneous MI. Unpublished data from a meta-analysis by Windecker and colleagues relating mortality with various revascularization techniques shows an absence of survival benefit with most PCI techniques, with the exception of new generation devices and DES. According to Windecker, the results of the ongoing ISCHEMIA trial should confirm this notion, if correct. ISCHEMIA began enrollment of stable ischemic heart disease patients in January 2012. They are being randomized to an invasive strategy (cardiac catheterization, optimal medical therapy and revascularization if significant CAD is present) or a conservative strategy (optimal medical therapy alone with catheterization and possibly revascularization if the patient is not responding to therapy).

Preference for PCI vs. CABG also has increased for treatment of left main disease. Results of the EXCEL trial are anticipated to shed light on this concept further in a large randomized setting. EXCEL includes 3,100 patients with left main disease and a Syntax score of ≤ 32, who after consultation with a heart team will be randomized to PCI with Xience Prime (Abbott Vascular) or CABG.

Additionally, bioresorbable scaffolds may have potential in both obstructive and nonobstructive lesions using the concept of plaque sealing, with a focus on two important clinical manifestations: diffuse multivessel CAD and nonobstructive lesions, according to Windecker.

Continuous, significant increases in health care costs present a challenge for the further implementation of PCI. Health care costs globally are out of control, forcing governments to implement cost-control measures, Windecker said. 

Regulatory requirements also prove a challenge worldwide. Despite the perception that regulatory approval is more complicated and time consuming in the United States, an article published by Downing and colleagues in The New England Journal of Medicine in 2012 demonstrates that more drugs were licensed in the United States than Europe and Canada (225, 186,and 99, respectively). 

 

PCI.tues.29According to Windecker, it is important to note drug and medical device manufacturers finance all regulatory requirements. A second 2012 study in The New England Journal of Medicine by Kramer and colleagues found that there has been a sharp increase in prescription drug-user fees that will predict a trend for medical device-user fees. 

Despite the challenges, the future of PCI is primed for growth, Windecker concluded, adding that in terms of overall cost, PCI represents the most important area in all CV devices (see Figure). 

Disclosures:

Windecker reports receiving grant/research support from Abbott Vascular, Biosensors, Biotronik, Boston Scientific, Cordis, Medtronic CardioVascular and St. Jude Medical.

Comments