CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the Percutaneous Coronary Intervention market 4
Contributing experts 5

CHAPTER 2 PCI DEFINITIONS AND INDICATIONS 7
Percutaneous coronary interventions 7
Physical intervention: 8
Adjunctive pharmacological treatment: 8
Candidates for PCI 9
Treatment goals for PCI patients 10
Pathophysiology of acute coronary syndromes 10
Coronary artery disease and atherosclerosis 10
Vulnerable plaque 11
Histopathology of atherosclerotic lesions 12
Remodeling and role of coronary artery inflammation 14
Indications for PCI 15
Unstable angina (UA) 15
Variant angina 16
ST segment elevated myocardial infarction (STEMI) 16
Non-ST segment elevated myocardial infarction (NSTEMI) 17
New definition of NSTEMI 17
Primary PCI versus Elective PCI 18

CHAPTER 3 DIAGNOSIS OF ACS AND REFERRAL FOR PCI 20
Symptoms 20
Initial and final diagnosis 20
Diagnosis and investigation in ACS 21
Physical examination and chest pain differential 21
Clinical tests in primary investigation 22
ECG and ECG stress testing 22
Monitoring cardiac biomarkers 24
Cardiac troponins 24
Creatine Kinase (CK) 25
Myoglobin 26
C-reactive protein (CRP) 26
Neurohormonal activation markers 26
Novel biomarkers 27
Multimarker approach 27
Risk stratification 27
Classification according to diagnosis 29
Factors dictating referral for PCI procedure 29
STEMI patients 30
NSTEMI patients 30
UA Patients 31
Referral for PCI following angiography 31
Guidelines 33
Recommendations for treatment of NSTEMI and UA 33
Recommendations for treatment of STEMI 34
Specific PCI guidelines 35

CHAPTER 4 PCI MARKET DYNAMICS 36
ACS epidemiology specifics and limitations 36
Prevalence and incidence of ACS in the seven major markets 37
Incidence of STEMI 37
Opinion leader epidemiology estimates 38
Incidence of UA and NSTEMI 38
Change in troponin definition explains rise in NSTEMI cases 39
The PCI market 40
PCI procedural rates 40

CHAPTER 5 PCI VERSUS THROMBOLYSIS 44
Thrombolysis versus primary PCI 44
Evidence from registries 45
The TIME factor in reperfusion 46
Primary PCI is less time dependent than thrombolysis alone 46
Randomized clinical trials show PCI to be the optimum approach 47
Facilitated PCI 47
Current thinking on facilitated PCI 48
Facilitated PCI with GPIIb/IIIa inhibitors 48
Facilitated PCI with thrombolytics 49
GPIIb/IIIa and thrombolytic combination adjunctive therapy 50
Clinical trials in GPIIb/IIIa facilitated PCI 50
TIMI-14 50
SPEED/GUSTO 50
Controversies from ongoing clinical trials 52
ASSENT-4 52

CHAPTER 6 ADJUNCTIVE DRUG THERAPY 54
Drug classes used in combination with PCI 54
Addressing co-morbidities 54
Anti-ischemic agents 54
Nitrates 54
Betablockers 56
Antithrombotics 58
Anticoagulants 59
Heparins 59
Antiplatelet agents 64
COX-1 inhibitors (aspirin) 64
ADP receptor antagonists 66
Exceptions to the rule 69
Clopidogrel versus ticlopidine 69
Novel ADP antagonists 70
Prasugrel 70
GPIIb/IIIa receptor inhibitors 71
Use of GPIIb/IIIa inhibitors 75

CHAPTER 7 STENTS 77
Overview 77
Bare metal stents 78
Drug-eluting stents 79
In-stent restenosis: the man-made condition 80
Branded drug eluting stents 83
Cypher (sirolimus) 83
Taxus (paclitaxel) 84
Next generation drug eluting stents 85
Xience (everolimus) 86
Endeavor (zotarolimus) 87

APPENDIX 89

Bibliography 89
Disclaimer 91

List of Tables 
Table 1: Types of chest pain 22
Table 2: Risk stratification summary for ACS, 2006 29
Table 3: Incidence of ST-segment elevation myocardial infarction (000s) 38
Table 4: Incidence of unstable angina and non-ST segment elevation myocardial infarction (000s), 2005-2015 39

List of Figures 
Figure 1: Development and progression of atherosclerosis 11
Figure 2: Pathogenesis of a plaque leading to rupture 12
Figure 3: Basic diagnostic flow in ACS 21
Figure 4: Percentage of all ACS patients receiving Diagnostic Angiography test, then PCI and then Stenting, 2007. 32
Figure 5: The 10 leading causes of death in high-income countries (%), 2005 projections 36
Figure 6: Number of PCI procedures in the US, 1986- 2003 41
Figure 7: Percentage of PCI patients by indication in Europe, 2008 42
Figure 8: Percentage of ACS patients receiving thrombolysis, PCI, or both, in the 5EU, 2007. 46
Figure 9: Percentage of ACS patients receiving thrombolysis, PCI, or both, in the 5EU, 2007. 56
Figure 10: Percentage of ACS and PCI patients receiving betablockers (BBs), in in the 5EU, 2007. 58
Figure 11: Percentage of ACS and PCI patients receiving UFH, in the 5EU, 2007. 62
Figure 12: Percentage of ACS and PCI patients receiving LMWH, in the 5EU, 2007. 63
Figure 13: Percentage of ACS and PCI patients receiving COX-1 inhibitors, in the 5EU, 2007. 66
Figure 14: Percentage of ACS and PCI patients receiving ADP antagonists in the 5EU, 2007. 68
Figure 15: Percentage of PCI patients receiving ADP antagonists split by prescribed indication, in the 5EU, 2007. 69
Figure 16: Percentage of PCI patients receiving GPIIb/IIIa antagonists, split by indication, in the 5EU, 2007. 72
Figure 17: Antiplatelet therapy in ACS 73
Figure 18: Percentage of ACS and PCI patients receiving GPIIb/IIIa antagonists, in the 5EU, 2007. 75
Figure 19: Percentage stent usage, split by stent type, in Europe, 2007 82