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Abstract
Objectives—To undertake a systematic review of the clinical effectiveness of routine percutaneous transluminal coronary angioplasty (PTCA) plus stenting vs PTCA alone.
Data sources—MEDLINE; EMBASE; Science Citation Index; The Cochrane Library; cardiovascular journals and conference proceedings; Internet resources (including industry supported web pages); and reference lists of included studies and relevant reviews.
Review methods—Study selection included published and unpublished randomized controlled trials (RCTs) comparing the use of coronary stents to PTCA. Outcome measures assessed included death, acute myocardial infarction (AMI), event rate (such as major cardiac adverse events (MACE) or other composite measures), and binary restenosis (BR). Data extraction and quality assessment were conducted according to internationally recognized methods. Data synthesis included meta‐analysis of assessed outcomes, reported as odds ratios (ORs).
Results—Fifty RCTs involving 16 500 patients met the inclusion criteria (39 full articles, 11 abstracts). Of these, 23 studies compared stenting with PTCA in patients with non‐specific coronary artery disease (CAD), 11 compared stents with PTCA following AMI, 8 included patients with small coronary arteries and 8 included patients whose vessels had chronic total occlusion. There were no differences in rates of death or AMI. There were reductions in the rates of MACE (death, AMI or revascularization) with stents compared to PTCA (at 6 months, for non‐specific group OR: 1.64, 95% CI 1.44–1.87; for AMI group OR: 2.36, 95% CI 1.92–2.89; for small vessel group OR: 1.38, 95% CI 1.10–1.74; at 12 months, for non‐specific group OR: 1.31, 95% CI 1.11–1.55; for AMI OR: 2.26, 95% CI 1.47–3.46). Reporting of combined major adverse cardiac events was inconsistent across studies. Most events were revascularizations that may have been partly driven by protocol‐required angiograms. Stents reduced BR rates at angiogram at 6 months compared to PTCA in all groups.
Conclusion—We found no differences in mortality or AMI, but the studies were not powered to identify changes in these endpoints. Coronary stenting is associated with reduced restenosis and combined adverse cardiac events, primarily revascularizations. However, the frequency of revascularization may have been distorted by protocol‐dictated angiography.