While we found relatively good st and ards of reporting the study ’s question , population , interventions , comparators and conclusions , the overall reporting was poor , and evidence of unfamiliarity with international guidelines was evident ( i.e. absence of incremental analysis , of discounting long-term costs and effects ) .
Analysis or description of place-to-place variability was infrequent .
Use and acceptance of health economic evaluations ( HEEs ) has been much greater in developed than in developing nations .
Nevertheless , while developing countries lag behind in the development of HEE methods , they could benefit from the progress made in other countries and concentrate on ways in which existing methods can be used or would need to be modified to fulfill their specific needs .
HEEs , as context -specific tools , are not easily generalizable from setting to setting .
Existing studies regarding generalizability and transferability of HEEs have primarily been conducted in developed countries .
Therefore , a legitimate question for policy makers in Latin America and the Caribbean region ( LAC ) is to what extent HEEs conducted in industrialized economies and in LAC are generalizable to LAC ( trans-regional ) and to other LAC countries ( intra-regional ) , respectively .
Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)
BACKGROUND The multicentre , r and omised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina , with one or more de-novo lesions , less than 18 mm long , in vessels of diameter 3 mm or more . METHODS 827 patients were r and omly assigned stent implantation ( 414 patients ) or st and ard balloon angioplasty ( 413 patients ) . The primary clinical endpoint was event-free survival at 6 months , including death , myocardial infa rct ion , and the need for revascularisation . The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months . There was also one-to-one subr and omisation to either clinical and angiographic follow-up or clinical follow-up alone . Analyses were by intention to treat . FINDINGS Four patients ( one stent group , three angioplasty group ) were excluded from analysis since no lesion was found . At 6 months , a primary clinical endpoint had occurred in 53 ( 12.8 % ) of 413 patients in the stent group and 79 ( 19.3 % ) of 410 in the angioplasty group ( p=0.013 ) . This significant difference in clinical outcome was maintained at 12 months . In the subgroup assigned angiographic follow-up , the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group , ( 1.89 [ SD 0.65 ] vs 1.66 [ 0.57 ] mm , p=0.0002 ) , which corresponds to restenosis rates ( diameter stenosis > or = 50 % ) of 16 % and 31 % ( p=0.0008 ) . In the group assigned clinical follow-up alone , event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group ( 0.89 vs 0.79 , p=0.004 ) at a cost of an additional 2085 Dutch guilders ( US$ 1020 ) per patient . INTERPRETATION Over 12-month follow-up , a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty
While we found relatively good st and ards of reporting the study ’s question , population , interventions , comparators and conclusions , the overall reporting was poor , and evidence of unfamiliarity with international guidelines was evident ( i.e. absence of incremental analysis , of discounting long-term costs and effects ) .
Analysis or description of place-to-place variability was infrequent .
Use and acceptance of health economic evaluations ( HEEs ) has been much greater in developed than in developing nations .
Nevertheless , while developing countries lag behind in the development of HEE methods , they could benefit from the progress made in other countries and concentrate on ways in which existing methods can be used or would need to be modified to fulfill their specific needs .
HEEs , as context -specific tools , are not easily generalizable from setting to setting .
Existing studies regarding generalizability and transferability of HEEs have primarily been conducted in developed countries .
Therefore , a legitimate question for policy makers in Latin America and the Caribbean region ( LAC ) is to what extent HEEs conducted in industrialized economies and in LAC are generalizable to LAC ( trans-regional ) and to other LAC countries ( intra-regional ) , respectively .