Neil J Wimmer1, David J Cohen2, Jason H Wasfy3, Saif S Rathore3, Laura Mauri1, Robert W Yeh4. 1. Brigham and Women's Hospital, Harvard Medical School, Boston, MA. 2. Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, MO. 3. Massachusetts General Hospital, Harvard Medical School, Boston, MA. 4. Massachusetts General Hospital, Harvard Medical School, Boston, MA. Electronic address: ryeh@partners.org.
Abstract
BACKGROUND: Randomized clinical trials (RCTs) suggest benefits for the transradial approach to percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). However, transradial PCI may delay reperfusion, leading to its avoidance. We sought to quantify the delay in reperfusion from transradial PCI ("transradial delay") that would need to be introduced to offset the potential mortality benefit of transradial PCI, compared with transfemoral, observed in RCTs. METHODS: We developed a decision-analytic model to compare transfemoral and transradial PCI in STEMI. Thirty-day mortality rates were estimated by pooling STEMI patients from 2 RCTs comparing transfemoral and transradial PCI. We projected the impact of transradial delay using estimates of the increase in mortality associated with door-to-balloon time delays. Sensitivity analyses were performed to understand the impact of uncertainty in assumptions. RESULTS: In the base case, a transradial delay of 83.0 minutes was needed to offset the mortality benefit of transradial PCI. When the mortality benefit of transradial PCI was one-quarter that observed in RCTs, the delay associated with equivalent mortality was 20.9 minutes. In probabilistic sensitivity analyses, transradial PCI was preferred over transfemoral PCI in 97.5% of simulations when transradial delay was 30 minutes and in 79.0% of simulations when delay was 60 minutes. CONCLUSIONS: A substantial transradial delay is required to eliminate even a fraction of the mortality benefit observed with transradial PCI in RCTs. Results were robust to changing multiple assumptions and have implications for operators reluctant to transition to transradial PCI in STEMI because of concern for delaying reperfusion.
RCT Entities:
BACKGROUND: Randomized clinical trials (RCTs) suggest benefits for the transradial approach to percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). However, transradial PCI may delay reperfusion, leading to its avoidance. We sought to quantify the delay in reperfusion from transradial PCI ("transradial delay") that would need to be introduced to offset the potential mortality benefit of transradial PCI, compared with transfemoral, observed in RCTs. METHODS: We developed a decision-analytic model to compare transfemoral and transradial PCI in STEMI. Thirty-day mortality rates were estimated by pooling STEMI patients from 2 RCTs comparing transfemoral and transradial PCI. We projected the impact of transradial delay using estimates of the increase in mortality associated with door-to-balloon time delays. Sensitivity analyses were performed to understand the impact of uncertainty in assumptions. RESULTS: In the base case, a transradial delay of 83.0 minutes was needed to offset the mortality benefit of transradial PCI. When the mortality benefit of transradial PCI was one-quarter that observed in RCTs, the delay associated with equivalent mortality was 20.9 minutes. In probabilistic sensitivity analyses, transradial PCI was preferred over transfemoral PCI in 97.5% of simulations when transradial delay was 30 minutes and in 79.0% of simulations when delay was 60 minutes. CONCLUSIONS: A substantial transradial delay is required to eliminate even a fraction of the mortality benefit observed with transradial PCI in RCTs. Results were robust to changing multiple assumptions and have implications for operators reluctant to transition to transradial PCI in STEMI because of concern for delaying reperfusion.
Authors: Mamas A Mamas; Karim Ratib; Helen Routledge; Farzin Fath-Ordoubadi; Ludwig Neyses; Yves Louvard; Douglas G Fraser; Jim Nolan Journal: Heart Date: 2011-12-06 Impact factor: 5.994
Authors: Francesco Burzotta; Carlo Trani; Mario Attilio Mazzari; Antonella Tommasino; Giampaolo Niccoli; Italo Porto; Antonio Maria Leone; Giovanni Tinelli; Valentina Coluccia; Maria De Vita; Marta Brancati; Rocco Mongiardo; Giovanni Schiavoni; Filippo Crea Journal: Am Heart J Date: 2012-01-13 Impact factor: 4.749
Authors: Maarten A Vink; Giovanni Amoroso; Maurits T Dirksen; Rene J van der Schaaf; Mark S Patterson; Jan G P Tijssen; Ferdinand Kiemeneij; Ton Slagboom Journal: Heart Date: 2011-08-31 Impact factor: 5.994
Authors: Ronald P Caputo; Jennifer A Tremmel; Sunil Rao; Ian C Gilchrist; Christopher Pyne; Samir Pancholy; Douglas Frasier; Rajiv Gulati; Kimberly Skelding; Olivier Bertrand; Tejas Patel Journal: Catheter Cardiovasc Interv Date: 2011-05-04 Impact factor: 2.692
Authors: Sanjit S Jolly; Salim Yusuf; John Cairns; Kari Niemelä; Denis Xavier; Petr Widimsky; Andrzej Budaj; Matti Niemelä; Vicent Valentin; Basil S Lewis; Alvaro Avezum; Philippe Gabriel Steg; Sunil V Rao; Peggy Gao; Rizwan Afzal; Campbell D Joyner; Susan Chrolavicius; Shamir R Mehta Journal: Lancet Date: 2011-04-04 Impact factor: 79.321
Authors: Tycho Vuurmans; Jonathan Byrne; Eric Fretz; Christian Janssen; J David Hilton; W Peter Klinke; Ognjenka Djurdjev; Adeera Levin Journal: Heart Date: 2010-07-28 Impact factor: 5.994
Authors: Chetan P Huded; Samir R Kapadia; Jad A Ballout; Amar Krishnaswamy; Stephen G Ellis; Russell Raymond; Leslie Cho; Conrad Simpfendorfer; Chris Bajzer; Joseph Martin; Ravi Nair; A Michael Lincoff; Kathleen Kravitz; Venu Menon; Scott Hantz; Umesh N Khot Journal: Catheter Cardiovasc Interv Date: 2020-02-27 Impact factor: 2.692