BACKGROUND• ROLE OF PERCUTANEOUS CORONARY INTERVENTION – ST SEGMENT ELEVATION MI – UNSTABLE ANGINA – NSTEMI• FOR STABLE CORONARY ARTERY DISEASE – OPTIMAL TREATMENT STRATEGY? • PCI(PERCUTANEOUS CORONARY INTERVENTION) • OMT(OPTIMAL MEDICAL THERAPY)
PERCUTANEOUS CORONARY CLINICAL TRAILS INTERVENTION VERSUS OPTIMAL MEDICAL THERAPYClinical outcomes utilizing No significant difference in outcomesRevascularization and aggressive drugevaluation (COURAGE)Bypass Angioplasty Revascularization No significant difference in outcomesInvestigation 2 Diabetes (BARI 2D)Schömig et al ( 2008)Swiss Interventional Improvement in all-cause mortality in theStudy on Silent revascularized groupIschemia Type II (SWISS-II) andCOURAGE trials
OBJECTIVEwhether revascularizationwith PCI reducescardiovascular outcomes when compared with OMT in patients with stable CAD.
METHODS• PUBMED, EMBASE And CENTRAL Searchs• Using medical subject heading or keywords – Diagnosis of stable CAD – Intervention of PCI – Comparision with medical therapy
Eligible trails• Cohort enrolled- Stable Coronary Artery Disease patients• Comparision of PCI to optimal medical therapy• Reporting outcomes – All-cause mortality – Cardiovascular death – Nonfatal MI – Revascularization – Freedom from angina
Selection and quality assesment Compilation of searches Duplicates removedStudy screened by title and abstract (by two independent reviewer) Qualified study(full text review by(by two independent reviewer)DATA ABSTRACTION AND ASSESMENT FOR SOURCES OF SYSTEMATIC BIAS
Data extraction• Two independent reviewer extracted data• Data abstracted measured – study characteristics – patient characteristics – details regarding the intervention – comparison group – outcome measures
Statistical Analysis• RevMan software provided by Cochrane Collaboration
Sensitivity Analyses• POTENTIAL IMPACT OF INDUSTRY FUNDING• EVOLUTION OF PCI – potential differential effect of stenting as opposed to balloon angioplasty alone.
• 12 randomized clinical trials• participants enrolled from all over the world• 7182 patients• followed-up - 4.9 years (range 1.5–10.2 years).
STUDY YEARS Characteristics of Included Trials Descrip Secondary Exclusion Description Primary FolloOF INCLUSION Criteria tion of of Medical Outcome Outcomes w Up, yENROLMENT, InterveCOUNTRY CRITERIA ntion Therapy 70%–99% stenosis in 6 mo exercise Change inACME- Not reported PTCA 325 mg11987– proximal two thirds of 1 major coronary artery, Aspirin, nitrates, β- stress testing: length of time to onset of 1 degree of stenosis in index lesion, 3 physical well1990 stress test with ≥1 mm ST blockers, mm ST depression, being depression in at least 1 lead calcium questionnaire,USA or filling defect on thallium channel maximal ST segment employment status scan, or MI in past 3 mo blockers depression, maximal work product History of angina, MI Unstable angina PTCA Aspirin plus Primary/seco change inACME-2 refractory to ndary exercise 5 within 3 mo, or ≥3 mm individualiz1987– medical therapy, ed therapy outcomes duration, horizontal ST depression prior PCI, primary not time to onset1990 on exercise testing; cardiac diagnosis of Nitrates, individually of angina, other than CAD, β-blockers, described maximalUSA ≥70% stenosis in ≥50% left main and Angina rate-pressure proximal two thirds of 1 stenosis, 3 vessel Calcium frequency, 6 product, or 2 coronary arteries CAD, LVEF≤30% channel mo exercise percent tolerance diameter (data for 1 vessel CAD blockers testing and stenosis of previously presented as angiography: index lesions ACME-1)
All Cause Mortality PCI VS OMT RESULT longest follow-up duration risk ratio [RR], 0.85; 95% CI, 0.71– 1.01 the ≤1 year RR, 1.34; 95% CI, 0.87–2.08 1 to 5 years RR, 0.97; 95% CI, 0.56–1.69 ≥5 years RR, 0.82; 95% CI, 0.65–1.02• Overall, there was no statistically significant difference in mortality between the PCI and OMT groups; the point estimate at the longest follow-up duration notably did favor the PCI group SWISS-2 and ALKK individually showed the most favorable effects of PCI over OMT; of note, these 2 trials included those with prior recent MIs.
CARDIVASCULAR DEATH PCI VS OMT CARDIVASCULAR DEATH longest follow-up duration RR, 0.71; 95% CI, 0.47–1.06 PCI group (RR, 0.71; 95% CI, 0.47– RR, 0.70; 95% CI, 0.46–1.08 1.06) <5 YEARS RR, 1.53; 95% CI, 0.69–3.38• The point estimate in the longest follow-up duration analysis favored the PCI group and this difference was most apparent in those trials with ≥5 years follow-up although these were not statistically significant.
NONFATAL MIPCI vs OMT resultoverall analysis (RR, 0.93; 95% CI, 0.70–1.24)≤1 year RR, 0.82; (95% CI, 0.37–1.80)1 to 5 years RR 1.11(95% CI, 0.47–2.59),≥5 year RR O.92(95% CI, 0.67–1.27)
RevascularizationPCI VS OMT RESULToverall analysis (RR, 0.93; 95% CI, 0.76– 1.14)≤1 year RR, 1.49; 95% CI1–5 years RR 0.98; 95% CI, 0.74–1.30;≥5 year RR 0.99; 95% CI, 0.75–1.30time points
Freedom From AnginaPCI VS OMT RESULTOVERALL (RR, 1.20; 95% CI, 1.06–1.37≤1 year RR, 1.32; 95% CI, 1.13–1.541–5 years 1.57; 95% CI, 1.06–2.32≥5 year 1.06–2.32; RR, 1.17; 95% CI, 1.00–1.38)
Study limitations• Analysis of symptoms driven revascularization• Freedom from angina• Dosage of medication administered• Evolution of therapy• Variation in target level
Discussion BUT Most updatedanalysis to All-cause date mortality Greater No and cardiac freedom significant death in trial from angina-difference in with longer PCI outcome follow up- PCI
ISCHEMIA-STUDY• International Study of Comparative Health Effectiveness with Medical and Invasive Approaches