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

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