Elsevier

The Lancet

Volume 373, Issue 9667, 14–20 March 2009, Pages 911-918
The Lancet

Articles
Percutaneous coronary interventions for non-acute coronary artery disease: a quantitative 20-year synopsis and a network meta-analysis

https://doi.org/10.1016/S0140-6736(09)60319-6Get rights and content

Summary

Background

Over the past 20 years, percutaneous transluminal balloon coronary angioplasty (PTCA), bare-metal stents (BMS), and drug-eluting stents (DES) succeeded each other as catheter-based treatments for coronary artery disease. We undertook a systematic overview of randomised trials comparing these interventions with each other and with medical therapy in patients with non-acute coronary artery disease.

Methods

We searched Medline for trials contrasting at least two of the four interventions (PTCA, BMS, DES, and medical therapy). Eligible outcomes were death, myocardial infarction, coronary artery bypass grafting, target lesion or vessel revascularisation, and any revascularisation. Random effects meta-analyses summarised head-to-head (direct) comparisons, and network meta-analyses integrated direct and indirect evidence.

Findings

61 eligible trials (25 388 patients) investigated four of six possible comparisons between the four interventions; no trials directly compared DES with medical therapy or PTCA. In all direct or indirect comparisons, succeeding advancements in percutaneous coronary intervention did not produce detectable improvements in deaths or myocardial infarction. The risk ratio (RR) for indirect comparisons between DES and medical therapy was 0·96 (95% CI 0·60–1·52) for death and 1·15 (0·73–1·82) for myocardial infarction. By contrast, we recorded sequential significant reductions in target lesion or vessel revascularisation with BMS compared with PTCA (RR 0·68 [0–60·0·77]) and with DES compared with BMS (0·44 [0·35–0·56]). The RR for the indirect comparison between DES and PTCA for target lesion or vessel revascularisation was 0·30 (0·17–0·51).

Interpretation

Sequential innovations in the catheter-based treatment of non-acute coronary artery disease showed no evidence of an effect on death or myocardial infarction when compared with medical therapy. These results lend support to present recommendations to optimise medical therapy as an initial management strategy in patients with this disease.

Funding

US National Institutes of Health.

Introduction

Since its introduction by Andreas Gruntzig in 1977, percutaneous coronary intervention (PCI) has revolutionised the care of patients with coronary artery disease by allowing a catheter-based approach to revascularise coronary arteries that are haemodynamically compromised. In the USA, more than a million patients are treated with PCI every year, often for non-acute coronary artery disease.1

Meta-analyses2, 3 suggest that PCI improves outcomes in high-risk patients with acute coronary syndromes and ST-elevation myocardial infarction. However, their role in the management of patients with non-acute coronary artery disease has been controversial. An early meta-analysis4 suggested percutaneous transluminal balloon coronary angioplasty (PTCA) was better than medical therapy for symptom reduction, albeit with an increase in the rate of subsequent procedures. Later trials tested bare-metal stents (BMS) against PTCA,5 and subsequently drug-eluting stents (DES) against BMS.6, 7 On the basis of these trial results, which showed sequential reductions in the need for target vessel or lesion revascularisation with these technological advances, PCI is now done almost exclusively with stents, most of which are drug eluting in the USA.8

Despite the sequential testing of PTCA versus medical therapy, BMS versus PTCA, and DES versus BMS, the cumulative benefits of technological innovations after 20 years of clinical trials in this area have not been systematically assessed. We undertook a systematic overview of all randomised controlled trials comparing medical therapy, PTCA, BMS, and DES in the treatment of patients with non-acute coronary artery disease. We explored the succession of these interventions over time with traditional meta-analysis and network meta-analysis.9, 10

Section snippets

Literature search

We undertook three incremental electronic Medline searches with the MeSH terms “stents”, “angioplasty”, and “coronary disease” (last search April 28, 2008) to identify English language publications from randomised controlled trials assessing medical therapy, PTCA, BMS, or sirolimus-eluting or paclitaxel-eluting stents (DES) in patients with coronary artery disease. We used a methodological filter to select controlled trials.11 We complemented searches by perusing the reference lists of previous

Results

The electronic searches yielded 2559 citations, which were screened reading the abstract of each. Of these publications, 91 were reviewed in full, and 61 trials (described in 72 publications) were eligible for our comparative effectiveness overview (webappendix pp 1 and 3–6). Two trials (one comparing PTCA vs medical treatment in strata of patients with one-vessel and two-vessel disease,18 and one comparing slow and moderate release paclitaxel-eluting stents vs BMS19) were entered as four

Discussion

Over the past two decades, more than 25 000 patients were enrolled in 61 randomised controlled trials (63 meta-analysis entries) testing PCI for the treatment of non-acute coronary artery disease. Although BMS and DES yielded sequential improvements in reducing the need for revascularisation, we noted no evidence that serial innovations in PCI technologies yielded detectable improvements in the outcomes of death or myocardial infarction compared with medical therapy. Overall, these results lend

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