Drug -Eluting Stents in Coronary Heart Disease

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; ALCARAZ, A.; GLUJOVSKY, D.; LOPEZ, A; REY-ARES, L.; BARDACH, A.; CIAPPONI, A; URTASUN M; KLEIN, K

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2012 p. 1 - 30

1668-2793

Coronary stents increased the safety and efficacy of percutaneous angioplasty for the treatment of coronary disease by reducing acute occlusion and restenosis of the treated vascular segment. However, intra-stent restenosis (ISR), as a consequence of its associated fibroproliferative response, led to the development of drug-eluting stent (DES).TechnologyDESs are coated with drugs that inhibit cell proliferation and its placement technique is not different from that of conventional stents (CS).PurposeTo assess the available evidence on the efficacy, safety and coverage policies of the use of drug-eluting stents in coronary disease.MethodsA bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to including systematic reviews, randomized controlled clinical trials, health technology and economic assessments, clinical practice guidelines and coverage policies from other health systems.ResultsThe usefulness of DES on new lesions in acute and stable chronic ischemic heart disease was assessed in intra-stent restenosis and in the diabetic population.Acute Coronary SyndromeTwo systematic reviews (SRs) and one randomized clinical trial (RCT) (totaling 14,071 patients) comparing DES with CS during ST-segment elevation myocardial infarction (STEMI) were identified. The DES group showed lower need for revascularization of the culprit vessel (8.4% vs. 17.3%; OR: 0.44 95% CI: 0.35 to 0.54), with no differences in overall mortality, cardiac mortality and intra-stent thrombosis. One of the SR with 6,769 patients showed a lower incidence of DES-related myocardial re-infarction (ReMI) (3.8% vs. 4.32% ; RR: 0.76 95% CI: 0.58 to 0.98)Chronic Stable AnginaThree SRs (totaling 52,881) compared DES with CS and/or medical management of chronic stable angina, showing a lower need for revascularization of the culprit vessel (HR 0.45; 95% CI: 0.37- 0.54) with no differences in general mortality or ReMI in the DES group.Chronic Stable Angina and Acute Coronary Syndrome in CombinationTwo SRs (71,638 patients) making a comparison among the different DES and versus CS were identified; no differences in overall mortality or intra-stent thrombosis were found. The lower need for revascularization of the culprit vessel was related to DES, being the sirolimus-eluting stent the most efficacious one at short term (4.11% vs. 15.76%; OR: 0.31 95% CI: 0.22 to 0.42).One RCT (2,314 patients) comparing sirolimus-eluting stent with CS showed a reduction for the combination of cardiac mortality events and non-fatal acute myocardial infarction (AMI) (2.6% vs. 4.8%; HR: 0.54 95% CI: 0.31 to 0.93).Multiple Vessel Coronary DiseaseTwo SRs and one RCT (totaling 38,097 patients) comparing DES with myocardial revascularization surgery (MRS) in multiple coronary vessel disease were found. DES was associated to a higher need for revascularization of the culprit vessel (14.6% vs. 6.8%; OR: 2.09 95% CI: 1.72- 2.55), with no differences in the incidence of stroke or AMI. One of the SRs (15,193 patients) showed a 38% increase in DES-related overall mortality (HR: 1.38, 95% CI: 1.20-1.59).One SR comparing DES with CS in multiple coronary vessel disease (n= 5,794) was found and showed a lower need for revascularization of the culprit vessel (OR: 0.58; 95%, CI: 0.45- 0.75) with no differences in general mortality or AMI in the DES group.Left Main Coronary Artery DiseaseOne SR and RCT (totaling 10,129) comparing the use of DES with MRS for left main coronary artery disease treatment were found. They showed a higher incidence of DES-related revascularization, with no differences in overall mortality or AMI between both groups in most of the studies.One SR (10,342 patients) compared DES with CS and it showed an overall mortality decrease (OR: 0.70 95% CI: 0.53-0.92), AMI (OR: 0.49 95% CI: 0.26-0.92) and revascularization of the culprit vessel (OR: 0.46, 95% CI: 0.30-0.69) in the DES group.Total Chronic OcclusionThree SRs (11,428 patients) comparing the use of DES versus CS were identified and showed a lower need for revascularization of the culprit vessel (10.20% vs. 23.19%; OR: 0.38, 95% CI: 0.24-0.60) with no differences in overall mortality, AMI and intra-stent thrombosis.Intra-sent RestenosisThree SRs and six RCTs (totaling 8,045 patients) that associated the use of DES to a lower need for revascularization of the culprit vessel (9.5% vs. 21.2%, OR: 0.35 95% CI: 0.25-0.49) were found and showed no differences in overall mortality, AMI or intra-stent thrombosis when compared versus other techniques such as balloon angioplasty or intravascular brachytherapy.