Significant coronary artery disease is highly prevalent in patients who underwent transcatheter aortic valve implantation (TAVI). Timing of staged percutaneous coronary intervention (PCI) in TAVI candidates remains debated. The present study assessed the impact of timing of the staged PCI on TAVI outcomes. Ninety-six patients (age 81 ± 5 years, 57% men) who had undergone staged PCI within 1 year before TAVI were included. The population was dichotomized according to the median time elapsed between PCI and TAVI (<30 and ≥30 days). Inhospital events and 30-day outcomes after TAVI were defined according to Valve Academic Research Consortium-2 definitions. Forty-eight patients underwent PCI <30 days and 48 patients underwent PCI ≥30 days before TAVI. Patients treated with PCI <30 days had lower hemoglobin levels at baseline (7.2 ± 0.9 mmol/L vs 7.9 ± 0.9 mmol/L, p = 0.002), more frequently atrial fibrillation (27% vs 13%, p = 0.018), and a shorter time interval between computed tomography acquisition and TAVI (7 days [2 to 10] vs 22 days [6 to 39], p <0.001) than their counterparts. Minor bleedings (13% vs 0%, p = 0.011) and overall vascular injury (27% vs 8%, p = 0.016 [minor injury: 17% vs 2%, p = 0.014; major injury: 10% vs 6%, p = 0.460]) were more frequently recorded in patients with staged PCI <30 days before TAVI. There were no differences in the incidence of other events and in 2-year survival. In conclusion, shortly (<30 days) or remote (≥30 days) staged PCI before TAVI resulted in comparable outcomes with the exception of minor vascular injury and minor bleeding events which were more frequently observed in patients treated with shortly staged PCI.
Severe aortic stenosis is frequently associated with significant coronary artery disease (CAD). In patients who underwent transcatheter aortic valve implantation (TAVI), the reported prevalence of significant CAD ranges from 41% to 75%. The impact of significant CAD on the outcome of TAVI remains uncertain. The randomized Placement of Aortic Transcatheter Valves trial excluded patients with significant CAD who required revascularization. However, accumulating evidence shows that severe CAD is associated with adverse clinical outcome after TAVI, and consequently, current recommendations advocate for percutaneous coronary intervention (PCI) in patients with severe, proximal coronary artery lesions with a large area of myocardium at risk. However, the performance of a staged PCI before TAVI is inevitably associated with an additional vascular puncture, repeated injection of contrast material, and dual antiplatelet therapy that may increase the rates of complications after TAVI. Timing of staged PCI (short- or long-term before TAVI) may, therefore, affect the TAVI outcome. However, there is currently no consensus on the optimal timing of staged PCI before TAVI. The present study compared the outcomes of patients who underwent staged PCI shortly (short term) or remotely (long term) before TAVI.
Methods
From a cohort of 308 patients treated with TAVI for severe aortic stenosis or a failing aortic bioprosthesis at the Leiden University Medical Center, 96 patients who had undergone staged PCI within 1 year before the TAVI were evaluated. Patients were treated with TAVI as they were considered to have contraindications or to be at increased risk for surgical aortic valve replacement. Before TAVI, all patients underwent a comprehensive clinical and multitechnique imaging evaluation, including coronary angiography. Aortic valve area was calculated by the continuity equation and the aortic valve pressure gradients by the Bernoulli equation on transthoracic echocardiography. Aortic annulus dimensions and iliofemoral arterial system anatomy were assessed with multidetector row computed tomography (MDCT) as previously described. In patients without previous coronary artery bypass surgery, baseline coronary angiograms were reviewed to assess the extent and complexity of significant CAD using the SYNTAX score. In addition, in patients in whom PCI was performed, the type of targeted lesion was classified as previously described. Data were prospectively collected in the departmental electronic clinical files (EPD Vision, version 11.2.9.0; EPD Vision, Leiden, The Netherlands) and retrospectively analyzed. Periprocedural complications and 30-day outcomes were defined according to the Valve Academic Research Consortium-2 (VARC-2). The institutional review board approved the study and waived the need of patient written informed consent for this retrospective analysis of clinically acquired data.
MDCT scans were performed with a 64-row computed tomography scanner (Aquilion 64; Toshiba Medical Systems, Otawara, Japan) or with a 320-detector row computed tomography scanner (AquilionOne; Toshiba Medical Systems, Tochigi-ken, Japan) using protocols that have been previously described. Adjusted to the patient’s body weight, 80 to 100 ml of nonionic contrast material (Ultravist 370; Bayer, Whippany, New Jersey) were administered intravenously if the 64-row system was used (flow rate of 5.0 ml/s), and 60 to 100 ml of contrast material were infused in 3 phases if the 320-detector row system was used: first 60 to 80 ml of contrast material (flow rate 5.0 to 6.0 ml/s), followed by a 1:1 mixture of contrast and saline and additional 25 ml of saline (flow rate 3.0 ml/s). Median time elapsed between computed tomography acquisition and TAVI was 10 days (interquartile range 3 to 24). Patients with chronic kidney disease (defined as an estimated glomerular filtration rate <60 ml/min/1.73 m 2 ) received intravenous hydration (isotonic saline 0.9%) before the scan.
Significant CAD was defined on invasive coronary angiography as ≥70% diameter stenosis of an epicardial coronary artery of >1.5 mm. The decision to perform PCI was based on the presence of symptoms, extent of the viable myocardial tissue at risk, infarcted area, and CAD complexity as assessed with the SYNTAX score. The extent of myocardial tissue at risk was visually estimated by evaluating the myocardial territories being supplied by coronary arteries with significant stenosis. Timing of staged PCI was based on patient’s clinical status and logistical convenience. Staged PCI was performed at a median of 29 days (interquartile range 9 to 81) before TAVI. However, there were no patients treated exactly 29 days before the TAVI, and for simplicity, the groups were divided into patients who underwent PCI <30 days (shortly) before TAVI and ≥30 days (remotely). PCI was preferably performed through the femoral artery using standard techniques. Patients with chronic kidney disease received intravenous hydration (isotonic saline 0.9%) before and after the procedure. Antithrombotic therapy included periprocedural intravenous heparin (5,000 IU) and loading doses of 600 mg of clopidogrel and 300 mg aspirin continued by daily doses of 75 and 100 mg, respectively. Aspirin was prescribed life long, whereas clopidogrel was prescribed for 3 months if a bare-metal stent was implanted and for at least 1 year if a drug-eluting stent was used. If concomitant oral anticoagulants were used, aspirin was not prescribed.
TAVI procedures were performed under general anesthesia and were guided by fluoroscopy and transesophageal echocardiography. During the procedure, intravenous unfractionated heparin was administered to maintain an activated clotting time of >300 ms. The balloon-expandable Edwards SAPIEN valve (23, 26, and 29 mm; Edwards Lifesciences, Irvine, California) was implanted using a transfemoral or transapical approach, whereas the self-expandable Medtronic CoreValve System (23, 26, 29, and 31 mm; Medtronic, Minneapolis, Minnesota) was implanted through a transfemoral access. Aortic valve balloon dilation was performed during rapid right ventricular pacing, and subsequently, deployment of a balloon- or self-expandable prosthesis was performed as previously described. Iomeron 350 (Bracco Imaging Deutschland GmbH, Konstanz, Germany) was used as contrast medium. Patients with chronic kidney disease received intravenous hydration (isotonic saline 0.9%) before and after the procedure. Vascular access was closed using surgical sutures. After TAVI, clopidogrel was indicated for 1 month.
All inhospital events and 30-day outcomes were defined according to the VARC-2 criteria. In addition, the VARC-2 composite end point of early safety (at 30 days), including all-cause mortality, stroke, life-threatening bleeding, stages 2 or 3 of acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring a repeat procedure, was recorded. Outpatient visits were scheduled at 1, 3, 6, and 12 months after discharge and thereafter on discretion of the treating physician. Survival status was obtained by review of the medical files and the Dutch Civil Registry.
Continuous variables are expressed as mean ± SD or as median and interquartile range. Categorical variables are displayed as frequencies and percentages. Based on the median number of days that the staged PCI was performed before TAVI, the population was divided into 2 groups (<30 or ≥30 days). Differences between patients who had undergone staged PCI within 30 days before TAVI and patients who had undergone staged PCI remotely (≥30 days) before TAVI were analyzed using the unpaired Student t test or the Mann-Whitney U test for continuous data and with the chi-square test for categorical data. Survival rates were evaluated with Kaplan-Meier analysis and compared between the 2 groups using the log-rank test. Statistical analyses were 2 sided, and p values <0.05 were considered significant. All statistical analyses were performed with SPSS software (version 20.0; SPSS Inc., Chicago, Illinois).
Results
Baseline clinical and echocardiographic characteristics of the patient population (mean age 81 ± 5 years, 57% men) are summarized in Table 1 . Mean logistic EuroSCORE was 23.2 ± 13.9%. Baseline characteristics were comparable between the 2 groups of patients (PCI shortly and remote before TAVI; Table 1 ). Patients treated with PCI within the time range of 30 days before TAVI (shortly before TAVI) had a lower level of hemoglobin before PCI (7.7 ± 1.1 mmol/L vs 8.2 ± 0.9, p = 0.012) and before TAVI (7.2 ± 0.9 mmol/L vs 7.9 ± 0.9 mmol/L, p = 0.002) and showed more frequently atrial fibrillation (27% vs 13%, p = 0.018) than those revascularized with a remote staged PCI (≥30 days). The time interval from MDCT to TAVI was significantly shorter in the patients treated with staged PCI shortly before TAVI than in patients treated remotely (7 days [2 to 10] vs 22 days [6 to 39], p <0.001).
| Variable | Overall population (n = 96) | Staged percutaneous coronary intervention performed | p-value | |
|---|---|---|---|---|
| ≥30 days (n = 48) | <30 days (n = 48) | |||
| Age (years) | 81 ± 5.4 | 81 ± 5.4 | 82 ± 5.4 | 0.808 |
| Male sex | 55 (57%) | 31 (65%) | 24 (50%) | 0.149 |
| Body surface area (m 2 ) | 1.85 ± 0.20 | 1.88 ± 0.21 | 1.82 ± 0.18 | 0.117 |
| Heart rhythm | 0.018 | |||
| Sinus rhythm | 68 (71%) | 34 (71%) | 34 (71%) | |
| Atrial fibrillation | 19 (20%) | 6 (13%) | 13 (27%) | |
| Pacemaker | 9 (9%) | 8 (17%) | 1 (2%) | |
| Hypertension | 74 (77%) | 36 (75%) | 38 (79%) | 0.627 |
| Diabetes mellitus | 30 (31%) | 14 (29%) | 16 (33%) | 0.660 |
| Hypercholesterolaemia | 70 (73%) | 35 (73%) | 35 (73%) | 1 |
| Smoking | 37 (39%) | 16 (33%) | 21 (44%) | 0.294 |
| Previous myocardial infarction | 26 (27%) | 14 (29%) | 12 (25%) | 0.646 |
| Previous coronary artery bypass grafting | 29 (30%) | 15 (31%) | 14 (29%) | 0.824 |
| Preoperative creatinine level (μmol/L) | 98 ± 41 | 98 ± 41 | 98 ± 41 | 0.943 |
| Estimated glomerular filtration rate (ml/min/1.73m 2 ) | 69 ± 26 | 71 ± 26 | 67 ± 25 | 0.432 |
| Hemoglobin (mmol/L) | 7.5 ± 1.0 | 7.9 ± 0.9 | 7.2 ± 0.9 | 0.002 |
| Logistic EuroSCORE (%) | 23.2 ± 13.9 | 24.0 ± 16 | 22.6 ± 11.6 | 0.619 |
| Time elapsed between multi-detector row computed tomography and transcatheter aortic valve implantation (days) | 10 [3-24] | 22 [6-39] | 7 [2-10] | <0.001 |
| Echocardiography | ||||
| Left ventricular ejection fraction, % | 54 ± 13 | 53 ± 14 | 56 ± 13 | 0.235 |
| Aortic valve area, cm 2 /m 2 | 0.74 ± 0.21 | 0.75 ± 0.21 | 0.73 ± 0.21 | 0.655 |
| Mean aortic gradient, mmHg | 40 ± 16 | 37 ± 13 | 43 ± 18 | 0.065 |
| Maximal aortic gradient, mmHg | 66 ± 25 | 60 ± 20 | 71 ± 29 | 0.037 |
| Medication | ||||
| β-blockers | 73 (76%) | 37 (77%) | 36 (75%) | 0.811 |
| Angiotensin converting enzyme inhibitors / Angiotensin receptor blockers | 58 (60%) | 31 (65%) | 27 (56%) | 0.404 |
| Diuretics | 62 (64%) | 30 (63%) | 32 (67%) | 0.670 |
| Calcium channel blocker | 31 (32%) | 15 (31%) | 16 (33%) | 0.827 |
| Statins | 82 (85%) | 41 (85%) | 41 (85%) | 1 |
| Aspirin | 58 (60%) | 27 (56%) | 31 (65%) | 0.404 |
| Clopidogrel | 94 (98%) | 46 (96%) | 48 (100%) | 0.153 |
| Oral anticoagulants | 35 (36%) | 18 (38%) | 17 (35%) | 0.832 |
Procedural characteristics of PCI and TAVI are displayed in Table 2 . Extent and complexity of the CAD as assessed by the SYNTAX score and the complexity of the targeted lesions were comparable between groups ( Table 2 ). Patients in whom staged PCI was performed <30 days before TAVI were treated with a higher number of stents than those in whom staged PCI was performed ≥30 days before TAVI (2.3 ± 1.6 vs 1.5 ± 1.2, p = 0.011). The preferred access was femoral, and in both groups, the radial or brachial access was used in only 5 patients (10%). In addition, the frequency of implanting a drug-eluting stent instead of a bare-metal stent and the amount of used contrast during staged PCI did not differ between groups. During TAVI, there were no differences in terms of procedural access or size of implanted prosthesis ( Table 2 ).
| Variable | Overall population (n = 96) | Staged percutaneous coronary intervention performed | p-value | |
|---|---|---|---|---|
| ≥30 days (n = 48) | <30 days (n = 48) | |||
| Staged percutaneous coronary intervention | ||||
| Stable coronary artery disease | 93 (97%) | 45 (94%) | 48 (100%) | 0.078 |
| Acute coronary syndrome | 3 (3%) | 3 (6%) | 0 (0%) | 0.078 |
| Syntax score | 14 ± 10 | 12 ± 10 | 16 ± 9 | 0.079 |
| Syntax score 0-22 | 55 (82%) | 28 (85%) | 27 (79%) | |
| Syntax score 23-32 | 10 (15%) | 4 (12%) | 6 (18%) | |
| Syntax score ≥33 | 2 (3%) | 1 (3%) | 1 (3%) | |
| Type B2 or C targeted lesion | 59 (61%) | 26 (54%) | 33 (69%) | 0.142 |
| Number of stents used per patient | 1.9 ± 1.4 | 1.5 ± 1.2 | 2.3 ± 1.6 | 0.011 |
| Stent in left main | 12 (13%) | 5 (10%) | 7 (15%) | 0.537 |
| Stent in left anterior descending | 41 (43%) | 17 (35%) | 24 (50%) | 0.149 |
| Stent in left circumflex | 27 (28%) | 14 (29%) | 13 (27%) | 0.820 |
| Stent in right coronary artery | 33 (34%) | 12 (25%) | 21 (44%) | 0.053 |
| Stent in graft | 6 (6%) | 4 (8.3) | 2 (4%) | 0.399 |
| Drug-eluting stent | 42 (44%) | 23 (48%) | 19 (40%) | 0.411 |
| Amount of contrast media (ml) | 191 ± 99 | 200 ± 109 | 183 ± 88 | 0.421 |
| Use of closure device | 24 (26%) | 8 (18%) | 16 (33%) | 0.098 |
| Transcatheter aortic valve implantation | ||||
| Transapical approach | 54 (56%) | 27 (56%) | 27 (56%) | 1 |
| Prosthesis size | 0.457 | |||
| Edwards SAPIEN, 23 mm | 18 (19%) | 7 (15%) | 11 (23%) | |
| Edwards SAPIEN, 26 mm | 61 (64%) | 29 (60%) | 32 (67%) | |
| Edwards SAPIEN, 29 mm | 5 (5%) | 4 (8%) | 1 (2%) | |
| Medtronic CoreValve, 26 mm | 3 (3%) | 2 (4%) | 1 (2%) | |
| Medtronic CoreValve, 29 mm | 8 (8%) | 5 (10%) | 3 (6%) | |
| Medtronic CoreValve, 31 mm | 1 (1%) | 1 (2%) | 0 (0%) | |
| Amount of contrast media (ml) | 106 ± 62 | 99 ± 40 | 114 ± 79 | 0.272 |
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