Translation Pathway for Coronary Stent Development
Chuck Simonton, MD
This chapter will cover the basic translational steps for coronary stent development, from preclinical research to clinical data necessary for regulatory approvals to reimbursement necessary for a successful business model. Since coronary stent technology broke into the scene of interventional cardiology in the 1990s, there has been a rapid evolution of stent design for improved deliverability and the addition of polymer coatings and antiproliferative drugs to prevent restenosis and repeat revascularization. All of these advances have improved the acute and long-term outcomes of patients with obstructive coronary artery disease needing revascularization, particularly for patients with acute coronary syndrome and acute ST-segment elevation myocardial infarction.
Thus, compared to many of the other technologies discussed in this book, coronary stents (now essentially all drug-eluting stents) represent a more mature class of technology with excellent performance across most of the commercially available stents, with subtle differences between stents in ease of deliverability or certain clinical outcomes. Translational research in coronary stents going forward will focus on increasing clinical data in certain complex patient subsets like patients with diabetes or in improving stent design and function in complex lesions like left main, bifurcations, chronic total occlusions, or heavily calcified lesions. Additionally, research into stent designs that can reduce the need for extended dual antiplatelet therapy (DAPT) to prevent thrombosis is emerging and will continue to evolve.
Importantly, the future of coronary stents will also depend on adjunctive technologies that can improve the acute implant by reducing operator error in plaque assessment (calcium), stent sizing, and adequacy of final stent expansion to maximize the final lumen size providing the best long-term durability of the therapy. Intravascular imaging via intravascular ultrasound or optical coherence tomography will be necessary to accomplish this by adding significant precision to each of the steps of coronary stenting while also providing an opportunity to reduce the reliance on the relatively inaccurate visual estimations from simple angiography. Clinical research in this area is emerging, and technical enhancements in software automation will ultimately change coronary stenting.
It is our hope that the following sections will provide a useful backdrop for those seeking to understand the traditional pathways for coronary stent development, but even more importantly the opportunities for future enhancements.