Stakeholder Opinions: Percutaneous Coronary Intervention

Adverse events with drug-eluting stents demand a new safety standard

Publication Date	April 2008
Publisher	Datamonitor
Product Type	Report
Pages	95
ISBN Number	not applicable
Product Code	DAT11457

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Summary

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.

Content

Chapter 1 Executive Summary
- Objective of The Analysis
- Datamonitor Insight into The Percutaneous Coronary Intervention Market
- Contributing Experts
Chapter 2 Pci Definitions and Indications
- Percutaneous Coronary Interventions
- Physical Intervention:
- Adjunctive Pharmacological Treatment:
- Candidates for Pci
- Treatment Goals for Pci Patients
- Pathophysiology of Acute Coronary Syndromes
- Coronary Artery Disease and Atherosclerosis
- Vulnerable Plaque
- Histopathology of Atherosclerotic Lesions
- Remodeling and Role of Coronary Artery Inflammation
- Indications for Pci
- Unstable Angina (Ua)
- Variant Angina
- St Segment Elevated Myocardial Infarction (Stemi)
- Non-St Segment Elevated Myocardial Infarction (Nstemi)
- New Definition of Nstemi
- Primary Pci Versus Elective Pci
Chapter 3 Diagnosis of Acs and Referral for Pci
- Symptoms
- Initial and Final Diagnosis
- Diagnosis and Investigation in Acs
- Physical Examination and Chest Pain Differential
- Clinical Tests in Primary Investigation
- Ecg and Ecg Stress Testing
- Monitoring Cardiac Biomarkers
- Cardiac Troponins
- Creatine Kinase (Ck)
- Myoglobin
- C-Reactive Protein (Crp)
- Neurohormonal Activation Markers
- Novel Biomarkers
- Multimarker Approach
- Risk Stratification
- Classification According to Diagnosis
- Factors Dictating Referral for Pci Procedure
- Stemi Patients
- Nstemi Patients
- Ua Patients
- Referral for Pci following Angiography
- Guidelines
- Recommendations for Treatment of Nstemi and Ua
- Recommendations for Treatment of Stemi
- Specific Pci Guidelines
Chapter 4 Pci Market Dynamics
- Acs Epidemiology Specifics and Limitations
- Prevalence and Incidence of Acs in The Seven Major Markets
- Incidence of Stemi
- Opinion Leader Epidemiology Estimates
- Incidence of Ua and Nstemi
- Change in Troponin Definition Explains Rise in Nstemi Cases
- The Pci Market
- Pci Procedural Rates
Chapter 5 Pci Versus Thrombolysis
- Thrombolysis Versus Primary Pci
- Evidence from Registries
- The Time Factor in Reperfusion
- Primary Pci Is Less Time Dependent than Thrombolysis Alone
- Randomized Clinical Trials Show Pci to Be The Optimum Approach
- Facilitated Pci
- Current Thinking on Facilitated Pci
- Facilitated Pci with Gpiib/Iiia Inhibitors
- Facilitated Pci with Thrombolytics
- Gpiib/Iiia and Thrombolytic Combination Adjunctive Therapy
- Clinical Trials in Gpiib/Iiia Facilitated Pci
- Timi-14
- Speed/Gusto
- Controversies from Ongoing Clinical Trials
- Assent-4
Chapter 6 Adjunctive Drug Therapy
- Drug Classes Used in Combination with Pci
- Addressing Co-Morbidities
- Anti-Ischemic Agents
- Nitrates
- Betablockers
- Antithrombotics
- Anticoagulants
- Heparins
- Antiplatelet Agents
- Cox-1 Inhibitors (Aspirin)
- Adp Receptor Antagonists
- Exceptions to The Rule
- Clopidogrel Versus Ticlopidine
- Novel Adp Antagonists
- Prasugrel
- Gpiib/Iiia Receptor Inhibitors
- Use of Gpiib/Iiia Inhibitors
Chapter 7 Stents
- Overview
- Bare Metal Stents
- Drug-Eluting Stents
- in-Stent Restenosis: The Man-Made Condition
- Branded Drug Eluting Stents
- Cypher (Sirolimus)
- Taxus (Paclitaxel)
- next Generation Drug Eluting Stents
- Xience (Everolimus)
- Endeavor (Zotarolimus)
Appendix
- Bibliography
- Disclaimer
List of Tables
- Table 1: Types of Chest Pain
- Table 2: Risk Stratification Summary for Acs, 2006
- Table 3: Incidence of St-Segment Elevation Myocardial Infarction (000s)
- Table 4: Incidence of Unstable Angina and Non-St Segment Elevation Myocardial Infarction (000s), 2005-2015
List of Figures
- Figure 1: Development and Progression of Atherosclerosis
- Figure 2: Pathogenesis of A Plaque Leading to Rupture
- Figure 3: Basic Diagnostic Flow in Acs
- Figure 4: Percentage of All Acs Patients Receiving Diagnostic Angiography Test, Then Pci and Then Stenting, 2007
- Figure 5: The 10 Leading Causes of Death in High-Income Countries (%), 2005 Projections
- Figure 6: Number of Pci Procedures in The US, 1986- 2003
- Figure 7: Percentage of Pci Patients by Indication in Europe, 2008
- Figure 8: Percentage of Acs Patients Receiving Thrombolysis, Pci, or Both, in The 5eu, 2007
- Figure 9: Percentage of Acs Patients Receiving Thrombolysis, Pci, or Both, in The 5eu, 2007
- Figure 10: Percentage of Acs and Pci Patients Receiving Betablockers (Bbs), in in The 5eu, 2007
- Figure 11: Percentage of Acs and Pci Patients Receiving Ufh, in The 5eu, 2007
- Figure 12: Percentage of Acs and Pci Patients Receiving Lmwh, in The 5eu, 2007
- Figure 13: Percentage of Acs and Pci Patients Receiving Cox-1 Inhibitors, in The 5eu, 2007
- Figure 14: Percentage of Acs and Pci Patients Receiving Adp Antagonists in The 5eu, 2007
- Figure 15: Percentage of Pci Patients Receiving Adp Antagonists Split by Prescribed Indication, in The 5eu, 2007
- Figure 16: Percentage of Pci Patients Receiving Gpiib/Iiia Antagonists, Split by Indication, in The 5eu, 2007
- Figure 17: Antiplatelet Therapy in Acs
- Figure 18: Percentage of Acs and Pci Patients Receiving Gpiib/Iiia Antagonists, in The 5eu, 2007
- Figure 19: Percentage Stent Usage, Split by Stent Type, in Europe, 2007