BACKGROUNDCoronary revascularization guided by fractional flow reserve (FFR) is associated with better patient outcomes after the procedure than revascularization guided by angiography alone. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR.
METHODSWe randomly assigned 2492 patients with coronary artery disease, in a 1:1 ratio, to undergo either iFR-guided or FFR-guided coronary revascularization. The primary end point was the 1-year risk of major adverse cardiac events, which were a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization. The trial was designed to show the noninferiority of iFR to FFR, with a margin of 3.4 percentage points for the difference in risk.
RESULTSAt 1 year, the primary end point had occurred in 78 of 1148 patients (6.8%) in the iFR group and in 83 of 1182 patients (7.0%) in the FFR group (difference in risk, −0.2 percentage points; 95% confidence interval [CI], −2.3 to 1.8; P<0.001 for noninferiority; hazard ratio, 0.95; 95% CI, 0.68 to 1.33; P = 0.78). The risk of each component of the primary end point and of death from cardiovascular or noncardiovascular causes did not differ significantly between the groups. The number of patients who had adverse procedural symptoms and clinical signs was significantly lower in the iFR group than in the FFR group (39 patients [3.1%] vs. 385 patients [30.8%], P<0.001), and the median procedural time was significantly shorter (40.5 minutes vs. 45.0 minutes, P = 0.001).
CONCLUSIONSCoronary revascularization guided by iFR was noninferior to revascularization guided by FFR with respect to the risk of major adverse cardiac events at 1 year. The rate of adverse procedural signs and symptoms was lower and the procedural time was shorter with iFR than with FFR. ( Use of Instantaneous Wave-free R atio in PCI F or the past 20 years, physiological measurements obtained during invasive procedures have been used to guide coronary revascularization. Pioneering work supported the use of flow measurements to make safe decisions about revascularization, 1,2 but this approach was soon superseded by the use of fractional flow reserve (FFR), which measures pressure as a surrogate of flow to estimate the severity of stenosis. 3-5 FFR was successful largely because of its technical simplicity and because clinical trials showed that it was associated with improved clinical outcomes after percutaneous coronary intervention (PCI). 6,7 Consequently, FFR is now included in the appropriate-use criteria for coronary angiography and in the American College of Cardiology-American Heart Association-European Society of Cardiology guidelines; despite these recommendations, its adoption remains limited. [8][9][10] FFR must be measured during maximal hyperemia, which is typically induced with the administration of a potent intravenous or intracoronary vasodilator, such as adenosine. 11 Several studies have...
Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227).
Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year.
Background
Scarce data exist about the outcomes after percutaneous coronary intervention (
PCI
) in old patients. This study sought to provide an overview of
PCI
in elderly patients, especially nonagenarians, in a Japanese large prospective nationwide registry.
Methods and Results
We analyzed 562 640 patients undergoing PCI (≥60 years of age) from 1018 Japanese hospitals between 2014 and 2016 in the J‐PCI (Japanese percutaneous coronary intervention) registry. Among them, 10 628 patients (1.9%), including 6780 (1.2%) with acute coronary syndrome (
ACS
) and 3848 (0.7%) with stable coronary artery disease, were ≥90 years of age. We investigated differences in characteristics and in‐hospital outcomes among sexagenarians, septuagenarians, octogenarians, and nonagenarians. Older patients were more frequently women and had a greater frequency of heart failure and chronic kidney disease than younger patients. In addition, older patients had a higher rate of in‐hospital mortality, cardiac tamponade, cardiogenic shock after
PCI
, and bleeding complications requiring blood transfusion. Nonagenarians had the highest risk of in‐hospital mortality (odds ratio, 3.60; 95%
CI
, 3.10–4.18 in
ACS
; odds ratio
,
6.24; 95%
CI,
3.82–10.20 in non‐
ACS
) and bleeding complications (
odds ratio,
1.79; 95%
CI,
1.35–2.36 in
ACS
; odds ratio
,
2.70; 95%
CI,
1.68–4.35 in non‐
ACS
) when referenced to sexagenarians. More important, transradial intervention was an inverse independent predictor of both in‐hospital mortality and bleeding complications.
Conclusions
Older patients, especially nonagenarians, carried a greater risk of in‐hospital death and bleeding compared with younger patients after
PCI
. Transradial intervention might contribute to risk reduction for periprocedural complications in elderly patients undergoing
PCI
.
In contemporary Japanese PCI practice, lower institutional volume was related inversely to in-hospital outcomes, but the association of annual operator volume with outcomes was less clear.
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