Stakeholder Opinions: Percutaneous Coronary Intervention - Adverse events with drug-eluting stents demand a new safety standard

Introduction
While drug eluting stents have been successful in reducing the rate of restenosis following percutaneous coronary intervention, there have been safety scares over a new problem: “in-stent thrombosis”. Opinion leaders are divided over the gravity of this problem, but positive safety data are required to restore physician confidence in drug eluting stents.

Scope
Review of the acute coronary syndromes (ACS) – the indication that drives the PCI market.

Opinion leader commentary on guideline developments and key clinical trials.

Review of the key drug classes used in conjunction with PCI and the current opinion on facilitated PCI.

Opinion leader discussion of currently marketed stents, key clinical trials in stents, and the evolution from bare metal to drug eluting stents.

Report Highlights
Since the introduction of PCI the procedure rate has increased dramatically making it one of the most common interventional procedures for heart disease. Use of PCI differs across the major markets, with this more aggressive revascularization strategy receiving greatest uptake in the United States, where coronary artery disease is most prevalent.

Evidence that facilitated PCI improves clinical outcomes remains inconclusive, although opinion leaders consider the premature interruption of ASSENT-4 to advise against facilitation with thrombolytics; the ACC/AHA guidelines suggest facilitation only in “high risk” patients, whereas the ESC say they find no evidence to recommend it at all.

While drug eluting stents have been successful in reducing restenosis rates from 20-30% to single digits, there have been safety scares over a new problem: “in-stent thrombosis”. Cordis’s Cypher and Boston Scientific’s Taxus have received some unfavourable press, but physicians are still enthusiastic about Abbott’s new stent, Xience.

Reasons to Purchase
Understand the PCI market, the driving indications and the drug classes prescribed in PCI patients.

Gain physician opinion on current treatment practice and how it might evolve.

Understand the negative publicity which has caused the robust drug eluting stent market to falter.