Author + information
- Mark Kennedy1,
- Rik Hermanides2,
- Eliza Kaplan3,
- Veemal Hemradj4,
- Enrico Fabris5,
- Petra Koopmans6,
- Jan-Henk Dambrink7,
- Marcel Gosselink8,
- Arnoud van't Hof9,
- Jan Paul Ottervanger10,
- Vincent Roolvink11,
- Wouter Remkes12,
- Aize van der Sluis13,
- Harry Suryapranata14 and
- Elvin Kedhi15
- 1Cork University Hospital, Portarlington, Laois, Ireland
- 2Isala, Zwolle, Netherlands
- 6Diagram CRO
- 7Isala Klinieken, Zwolle, Netherlands
- 8Unknown, zwolle, Netherlands
- 9Isala, Zwolle, Zwolle, Netherlands
- 11Isala klinieken, Zwolle, Netherlands
- 12Isala Heartcentre Zwolle, Zwolle, Netherlands
- 13Isala, Zwolle, Netherlands
- 14Zwolle, Netherlands
- 15Isala Klinieken Zwolle, Zwolle, Netherlands
Whether Fractional Flow Reserve (FFR), the gold standard to detect ischemia, is equally safe in subpopulations with accelerated atherosclerosis progression, such as Diabetes Mellitus (DM) patients remains unknown. This study sought to assess the safety and efficacy of deferred versus complete revascularization using a FFR-guided strategy in DM patients.
All DM patients that underwent FFR-guided revascularization between 1/1/2010-31/12/ 2013 were divided into two groups; patients with ≥1 remaining FFR-negative (> 0.80) medically treated lesions [FFR(-)MT] and patients with only FFR-positive lesions (≤ 0.80) undergoing complete revascularization [FFR(+)CR], and followed until 1/7/2015. The primary endpoint was the incidence of major adverse cardiovascular events (MACE); a composite of death, myocardial infarction (MI), target lesion (FFR-assessed) revascularization (TLR) and rehospitalization for acute coronary syndrome (ACS).
A total of 294 patients, 205 (69.7%) vs. 89 (30.3%) in FFR(-)MT and FFR(+)CR, respectively, were analyzed. At a mean follow-up of 32.6 ± 18.1 months, FFR(-)MT was associated with higher MACE rate 44.0% vs 26.6%, logrank p=0.02, Cox regression-adjusted HR:2.01;(95%CI :1.21-3.33, p<0.01), and driven by both safety and efficacy endpoints: Death/MI, HR 2.02;(95%CI: 1.06-3.86, p=0.03), rehospitalization for ACS, HR 2.06;(95%CI; 1.03-4.10, p=0.04) and TLR, HR 3.38;(95%CI: 1.19-9.64, p=0.02). Prior MI was a strong effect modifier within the FFR(-)MT group (HR 1.98;95%CI(1.26-3.13), p<0.01), whilst this was not the case in the FFR(+)CR group (HR 0.66;95%CI(0.27-1.62), p=0.37). Significant interaction for MACE was present between FFR groups and prior MI (P=0.03).
In DM patients, particularly those with prior MI, deferred revascularization is associated with poor medium term outcomes. Combining FFR with imaging modalities may be required to guide our treatment strategy in these high-risk, fast-progressing atherosclerosis patients.