Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design

Pfisterer, Matthias; Bertel, Osmund; Bonetti, Piero O.; Rocca, Hans Peter Brunner–La; Eberli, Franz R.; Erné, Paul; Galatius, Soeren; Hornig, Burkhard; Kiowski, Wolfgang; Pachinger, Otmar; Pedrazzini, Giovanni; Rickli, Hans; Servi, Stefano De; Kaiser, Christoph

doi:10.1016/j.ahj.2007.11.011

Cited by 25 publications

(17 citation statements)

References 25 publications

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“…As expected, we found that the vast majority of preexisting literature on comparative effectiveness of EES versus BMS was from randomized controlled trials such as EES versus BMS in ST‐segment elevation myocardial infarction (EXAMINATION) trial (EES < n = 751>, BMS < n = 747>), prolonging dual antiplatelet treatment after grading stent‐induced intimal hyperplasia study (PRODIGY) trial (EES < n = 501>, BMS < n = 502>), Xience or Vision stents for the management of angina in the elderly the XIMA trial (EES < n = 399>, BMS < n = 401>), Basel stent kosten effektivitäts trial prospective validation examination (BASKET‐PROVE) trial (EES < n = 774>, BMS < n = 765>), and SPIRIT First trial (EES < n = 27>, BMS < n = 29>) According to a most recent aggregated patient level meta‐analysis study using data from these five trials, Valgimigli et al found that patients receiving EES had a lower rate of 2‐year myocardial infarction (AHR: 0.71, 95% CI: 0.55–0.93, P = 0.01) and a much lower rate of 2‐year target vessel revascularization (AHR: 0.29, 95% CI: 0.20–0.41, P < 0.001) compared with patients receiving BMS. However, the meta‐analysis study did not find a significant survival advantage of EES (vs. BMS) at 2 years (AHR: 0.84, 95% CI: 0.66–1.07, P = 0.16) .…”

Section: Discussionsupporting

confidence: 58%

Four‐year comparative effectiveness of bare‐metal and everolimus‐eluting stents in New York

Qian

Hannan

2017

Cathet Cardio Intervent

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Section: Discussionsupporting

confidence: 58%

Four‐year comparative effectiveness of bare‐metal and everolimus‐eluting stents in New York

Qian

Hannan

2017

Cathet Cardio Intervent

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“…The study design and methods have been described in detail previously. 14 In brief, patients with stable coronary artery disease or with acute coronary syndrome (ACS) who were referred for coronary angiography/angioplasty to the participating centers were eligible for enrollment in the BASKET-PROVE trial. Patients were included in the trial if they received at least one stent with a diameter ≥3 mm regardless of the stent length.…”

Section: Methodsmentioning

confidence: 99%

Impact of stent diameter and length on in‐stent restenosis after DES vs BMS implantation in patients needing large coronary stents—A clinical and health‐economic evaluation

Zbinden

Felten

Wein

et al. 2016

Cardiovascular Therapeutics

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SummaryAims: The British National Institute of Clinical Excellence (NICE) guidelines recommend to use drug-eluting stents (DES) instead of bare-metal stents (BMS) only in lesions >15 mm in length or in vessels <3 mm in diameter. We analyzed the impact of stent length and stent diameter on in-stent restenosis (ISR) in the BASKET-PROVE study population and evaluated the cost-effectiveness of DES compared to BMS. Methods/Results: The BASKET-PROVE trial compared DES vs BMS in large coronaryarteries (≥3 mm). We calculated incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves with regard to quality-adjusted life years (QALYs) gained and target lesion revascularizations (TLRs) avoided.A total of 2278 patients were included in the analysis. A total of 74 ISR in 63 patients were observed. In-stent restenosis was significantly more frequent in segments treated with a BMS compared to segments treated with a DES (5.4% vs 0.76%; P<.001).The benefit of a DES compared to a BMS regarding ISR was consistent among the subgroups of stent length >15 mm and ≤15 mm, respectively. With the use of DES in short lesions, there was only a minimal gain of 0.005 in QALYs. At a threshold of 10 000 CHF per TLR avoided, DES had a high probability of being cost-effective. Conclusion:In the BASKET-PROVE study population, the strongest predictor of ISR is the use of a BMS, even in patients in need of stents ≥3.0 mm and ≤15 mm lesion length and DES were cost-effective. This should prompt the NICE to reevaluate its recommendation to use DES instead of BMS only in vessels <3.0 mm and lesions >15 mm length. K E Y W O R D SBare-metal stents, Cost-effectiveness, Drug-eluting stents, In-stent restenosis 1

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“…18 The protocol was designed by the steering committee and approved by the ethics committee at each center. The study protocol and a complete list of study group members in the Supplementary Appendix are available with the full text of this article at NEJM.org.…”

Section: Methodsmentioning

confidence: 99%

Drug-Eluting versus Bare-Metal Stents in Large Coronary Arteries

Kaiser¹,

et al. 2010

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In patients requiring stenting of large coronary arteries, no significant differences were found among sirolimus-eluting, everolimus-eluting, and bare-metal stents with respect to the rate of death or myocardial infarction. With the two drug-eluting stents, similar reductions in rates of target-vessel revascularization were seen. (Funded by the Basel Cardiovascular Research Foundation and the Swiss National Foundation for Research; Current Controlled Trials number, ISRCTN72444640.).

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Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design

Cited by 25 publications

References 25 publications

Four‐year comparative effectiveness of bare‐metal and everolimus‐eluting stents in New York

Four‐year comparative effectiveness of bare‐metal and everolimus‐eluting stents in New York

Impact of stent diameter and length on in‐stent restenosis after DES vs BMS implantation in patients needing large coronary stents—A clinical and health‐economic evaluation

Drug-Eluting versus Bare-Metal Stents in Large Coronary Arteries

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