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

Published by: Datamonitor

Published: Apr. 23, 2008 - 95 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the cardiovascular analysis team

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

Abstract

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.

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