Long-term Outcomes of contemporary Percutaneous Coronary Intervention with the Xience Drug-Eluting Stent: Results from a Multicentre Australian Registry

doi:10.21203/rs.3.rs-128703/v1

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Research article

Long-term Outcomes of contemporary Percutaneous Coronary Intervention with the Xience Drug-Eluting Stent: Results from a Multicentre Australian Registry

https://doi.org/10.21203/rs.3.rs-128703/v1

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Background

Several large registries have evaluated outcomes after percutaneous coronary intervention (PCI) in the USA, however there are no contemporary data regarding long-term outcomes after PCI in Australia, and little information comparing new second generation drug-eluting stents (DES) with earlier DES. Also, approval of new-generation drug-eluting stents (DES) is almost exclusively based on non-inferiority trials comparing outcomes with first generation DES, and there are limited data comparing safety and efficacy outcomes of new second generation DES with bare metal stents (BMS). This study long-term outcomes after PCI with the Xience DES from a large national multicentre registry, the GenesisCare Outcomes Registry (GCOR).

Methods

The study population comprised the first 1500 patients consecutively enrolled from January 2015 to January 2019 who were treated exclusively with either Xience DES or BMS and were eligible for 1-year follow-up, from a total group of 4,765 PCI patients enrolled during that period. Baseline patient and procedural data, medications and major adverse cardiovascular events (MACE) in-hospital, at 30-days and 1-year were reported and analysed with respect to the type of stent used (Xience DES n = 1000, BMS n = 500).

Results

Of the 4,765 patients enrolled in GCOR during this period, DES were exclusively used in 3621 (76.0%), BMS were exclusively used in 596 (12.5%) with the remainder receiving a combination of DES and BMS. In the study cohort of 1,500 Xience and BMS patients the mean age was 68.4 ± 10.7 years, 76.9% were male, 24.6% had diabetes mellitus and 45.9% presented with acute coronary syndromes. Adverse clinical event rates In the study cohort were low in comparison to international reports at 30-days in terms of mortality (0.20%), target lesion revascularisation (TLR, 0.27%) and MACE (0.47%). Similarly, adverse clinical event rates at 12 months were low in terms of mortality (1.26%), TLR (1.16%) and MACE (1.78%).

Conclusions

Clinical practice and long-term outcomes of PCI with the Xience DES in Australia are consistent with international series. Recent trends indicate DES use has increased in parallel with good outcomes despite an increasingly complex patient and lesion cohort.

Trial registration

Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000899943

This trial was registered retrospectively on 11/09/2020.

Cardiac & Cardiovascular Systems

Cardiothoracic Surgery

Percutaneous coronary intervention

outcomes

Xience

drug-eluting stent

bare metal stent

registry

Percutaneous coronary intervention (PCI) is one of the commonest procedures in cardiology, with rapidly evolving technology and clear guidelines from large-scale randomised clinical trials for post-procedural management. (!,2) Despite this, there are no national data in Australia regarding outcomes after PCI or compliance with medication guidelines.(3,4) Drug-eluting stents (DES) have become the cornerstone of PCI practice after studies indicating the superiority of first generation DES to bare metal stents in terms of reduced rates of restenosis (BMS).(5) However, DES use has expanded greatly both in terms of patient and lesion characteristics and clinical presentation to include use in very long lesions, small vessels, restenosis and ST-elevation myocardial infarction (STEMI). Also, approval of newer second and third generation drug-eluting stents (DES) has been based almost exclusively on non-inferiority trials comparing outcomes with first and early second-generation DES, which have typically shown similar efficacy and similar or superior safety. However, there are limited data comparing safety and efficacy outcomes of new-generation DES with BMS, and the assumption that the performance of all new-generation DES is superior to bare-metal stents (BMS) is less clear. (6) As such, it is timely to compare contemporary outcomes after PCI using DES and specifically newer platforms such as Xience DES with BMS in a real-world cohort to guide optimal clinical practice. Registries offer an important supplementary source of data to inform evidence-based practice as they reflect real world conditions. (1–8)

The GenesisCare Cardiovascular Outcomes Registry (GCOR) is a multi-centre national observational registry that was established to improve the quality of cardiovascular disease management in Australia by reporting and benchmarking local performance and compliance with treatment guidelines against local and international outcomes. (9) GCOR provides a national snapshot and real-time continuous outcomes measures that are not available elsewhere for one of the commonest and most critical cardiovascular procedures performed in Australia.

The GCOR-Percutaneous Coronary Intervention Registry (GCOR-PCI) commenced in 2008 and has collected detailed clinical and procedural data on more than 14,000 PCI procedures performed in Australian private hospitals. Nearly 50% of all PCIs in Australia are performed in private hospitals [1, 10]. Overseas data indicate DES are used preferentially in most PCI settings, and an increasing proportion of patients undergoing emergent or semi-urgent PCI (11), however despite an increasing burden of disease and healthcare expenditure, there are no contemporary national data regarding the demographic, procedural and long-term outcomes after PCI with Xience DES in Australia. The aim of this observational study was to analyse the characteristics and outcomes of PCI with Xience DES in Australian patients using GCOR Registry data. Additionally, we aimed to compare the clinical indications for, and outcomes of Xience DES compared to BMS.

This observational cohort study included consecutive patients from the GCOR registry. GCOR-PCI is a prospective clinical quality registry that describes the contemporary management, in-hospital and long-term outcomes of patients undergoing PCI at private hospitals across Australia, while providing continuous performance and outcome measure feedback to participating hospitals and cardiologists and has been previously described. [9] As such, it is more comprehensive and has greater external validity than registries recruiting from single centres or only public sector centres in a single city, such as Melbourne Interventional Group, and which provide no direct outcome feedback to interventionalists. (7) Briefly, data are entered on consecutive patients using a web-based electronic case report form (eCRF). The Registry employs data elements that are aligned with the US National Cardiovascular Data Registry (NCDR), allowing comparisons with international cohorts. The registry is housed at the Centre for Clinical Research Excellence in Therapeutics (CCRET, Monash University, Commercial Road, Prahran). CCRET meets standards relating to the use of paperless records under the Good Clinical Practice regulations and complies with the National E-Health Transition Authority (NEHTA) standard of reporting and storing data. The systems and processes with respect to privacy and data protection comply with relevant Health Records and Information Privacy Acts and Information Privacy Principles. This study is included in the Australian New Zealand Clinical Trials Registry (ANZCTR ACTRN12620000899943). Funding is provided internally to avoid the potential for bias from industry or governmental sources and none of the authors have competing interests. [9]

Inclusion criteria were the first 1500 patients consecutively enrolled in the GCOR registry between January 2015 and January 2019, who underwent PCI with exclusively BMS or Xience DES. Exclusion criteria were use of any non-BMS stent other than Xience or combined use of BMS, Xience and other DES in one procedure.

Procedure details and In-hospital complications were recorded at the time of hospital discharge. Thirty day and 12-month follow-up is performed by research coordinators at each hospital. [12, 13] All cardiac events were documented following review of medical records including death, myocardial infarction (MI), target lesion revascularisation (TLR, defined as revascularisation within 5 mm of a previously treated segment), and target vessel revascularisation (TVR, defined as revascularisation of a previously treated artery). Composite major adverse cardiovascular events (MACE, comprising death, MI, and TVR) were reported. Enrolling sites and 5% of patient data are independently audited each year. (14,15) Over 99% of patients enrolled are followed beyond one year, with continuing follow-up for the entire dataset to 5 years.

Clinical and procedural management was determined by the treating cardiologist with regard to currently accepted guidelines. Stent diameter was used as a surrogate for target vessel diameter, and total stent length for lesion length.

Each centre received written Human Research Ethics Committee (HREC) approval for collection of patient data and follow-up prior to participation (Bellberry HREC Eastwood, S.A.); stored data is de-identified. An opt-out consent process was employed following the example of previous models such as Melbourne Interventional Group (MIG) (7). This strategy has been effective in achieving high rates of participation essential to an effective registry, and in minimising bias such as the “Hawthorne” effect.

We compared patients according to stent type and acuity. Patients were included who received exclusively Xience DES or BMS. We carried out a number of analyses using logistic regression to determine the association between baseline clinical and procedural variables and adverse clinical outcomes at 30-days and 1-year. Firstly, we carried out unadjusted analysis for type of stent used (Xience or BMS). Secondly, we undertook an analysis adjusted for age, gender, previous history of hypercholesterolaemia, family history, MI, PVD, PCI, CVD and CABG), BMI. Continuous variables were summarised as means and SDs and compared using Student t tests. Categorical data were summarised as percentages and compared using X2 tests. Finally, we included a propensity score as a continuous variable in the above model. Using multivariate logistic regression, a propensity score that reflected a patient’s likelihood of receiving a DES during PCI was constructed. The model fit was 97.8% of available PCIs, and the C- statistic was 0.6166. Two-sided P values of < 0.05 were considered statistically significant. All analyses were carried out using statistical software Stata version 14.1.

The GCOR-PCI Xience/BMS cohort comprised 1500 coronary interventions. Patients were predominantly male (77.3%), with a mean age of 68.4 ± 10.7 years (Table 1).

TABLE 1: Baseline Clinical Characteristics

Characteristics n (%)	Overall n = 1500		BMS only n = 500	Xience n = 1000	P value
Age, years, mean (SD)		68.4 (10.7)	71.5 (11.1)	66.9 (10.1)	<0.001
Male		1153 (76.9)	382 (76.4)	771 (77.1)	0.76
Diabetes		368 (24.6)	107 (21.5)	261 (26.2)	0.051
Hypertension		1094 (73.3)	369 (74.1)	725 (72.9)	0.61
Hypercholesterolaemia[1]		1208 (83.5)	381 (79.4)	827 (85.6)	0.003
Family History of CAD		514 (37.8)	137 (29.3)	377 (42.2)	<0.001
Smoking (past or current)		822 (55.9)	275 (55.9)	547 (55.9)	0.99
BMI, kg/m2 +SD		29.0 (4.9)	29.0 (5.0)	29.0 (4.9)	0.92
LVEF, mean + SD		56.9 (10.4)	55.1 (11.2)	57.9 (9.8)	<0.001
Previous MI		311 (20.8)	83 (16.6)	228 (22.9)	0.005
Previous Peripheral Vascular Disease		120 (8.0)	50 (10.0)	70 (7.0)	0.046
Previous PCI		432 (28.9)	85 (17.1)	347 (34.7)	<0.001
Previous Cerebrovascular disease		114 (7.6)	51 (10.2)	63 (6.3)	0.008
Previous CABG		148 (9.9)	49 (9.8)	99 (9.9)	0.96
Renal impairment [2]		82 (5.9)	38 (7.9)	44 (4.8)	0.019
Clinical presentation
STEMI		143 (9.6)	100 (20.0)	43 (4.3)	<0.001
NSTEMI		360 (24.2)	145 (29.0)	215 (21.7)	<0.001
Unstable angina		244 (16.4)	73 (14.6)	171 (17.3)	ns
Elective		742 (49.8)	182 (36.4)	560 (56.6)	<0.001
Cardiogenic Shock		7 (0.5)	5 (1.0)	2 (0.2%	0.033

[1] Hypercholesterolamia is defined as either (a) Cholesterol level >5.2 and/or (b) Receiving medication

[2] Renal impairment is defined as either (a) Sr. Creatinine >2mg/dl and/or (b) having renal failure/receiving treatment.

In over half (51.2%) of the 1500 procedures the indication for PCI was presentation with an acute coronary syndrome. Of those, 9.6% had ST-segment elevation MI (STEMI), 24.2% non-STEMI and 16.4% unstable angina. Most lesions were de novo (95.0%), and almost half of the cohort had complex lesions (46.6% type B2/C) (Table 2). The mean stent length was 18.1 mm (SD, 5.7 mm) and the mean stent diameter was 3.1 mm (SD, 0.5 mm). Drug-eluting stents (DES) were used exclusively in 76.0% and BMS exclusively in 12% of the overall cohort, with the remainder using a combination of BMS and DES.

Table 2

Lesion & Procedural Characteristics
Characteristics n (%)		BMS n = 500	Xience n = 1000	P-value
Lesions/procedure, mean (SD)	1.3 (0.6)	1.2 (0.5)	1.4 (0.7)	< 0.001
Access site				< 0.001
Radial	460 (30.7)	117 (23.4)	343 (34.3)
Femoral	1036 (69.1)	383 (76.6)	653 (65.4)
Brachial	3 (0.2)	0 (0.0)	3 (0.3)
Lesion Type				0.002
De novo	1425 (95.0)	488 (97.6)	937 (93.7)
Restenosis	2 (0.1)	0 (0.0)	2 (0.2)
In-stent restenosis	62 (4.1)	7 (1.4)	55 (5.5)
Other	10 (0.7)	4 (0.8)	6 (0.6)
ACC/AHA Morphology				< 0.001
A	157 (10.6)	70 (14.1)	87 (8.8)
B1	637 (42.8)	229 (46.0)	408 (41.3)
B2 or C	693 (46.6)	199 (40.0)	494 (49.9)
Target vessel				< 0.001
RCA	496 (33.3)	202 (40.6)	294 (29.7)
LMCA	14 (0.9)	5 (1.0)	9 (0.9)
LAD	628 (42.2)	161 (32.3)	467 (47.1)
LCx	298 (20.0)	105 (21.1)	193 (19.5)
Bypass Graft	53 (3.6)	25 (5.0)	28 (2.8)
Chronic total occlusion	27 (1.8)	5 (1.0)	22 (2.2)	0.096
Multi-vessel disease	526 (35.1)	170 (34.0)	356 (35.6)	0.58
Bifurcation lesion	138 (9.3)	24 (4.8)	114 (11.5)	< 0.001
Lesion success	1481 (99.5)	496 (99.6)	985 (99.5)	0.78
Stents / procedure, mean (SD)	1.4 (0.7)	1.3 (0.7)	1.5 (0.8)	< 0.001
Stent length, mean (SD)	18.1 (5.7)	17.0 (4.7)	18.7 (6.1)	< 0.001
Stent length > 20 mm	387 (25.8)	85 (17.0)	302 (30.2)	< 0.001
Stent diameter, mean (SD)	3.1 (0.5)	3.3 (0.6)	2.9 (0.4)	< 0.001
Vessel ≤ 2.5 mm	316 (21.1)	64 (12.8)	252 (25.2)	< 0.001
IIb/IIIa use during procedure	103 (6.9)	47 (9.4)	56 (5.6)	0.006

Procedural success rates were high (99%) and complication rates very low, consistent with international series. In-hospital mortality was 0.40%, and MI occurred in 2.9%. (Table 3)

Table 3

Clinical Outcomes in Hospital, at 30-days and 12 months
Outcome n (%)	Overall n = 1500	BMS n = 500	Xience n = 1000	P-value
In-hospital
Emergency PCI	3 (0.2%)	2 (0.4%)	1 (0.1%)	0.22
CABG	0	0	0
Major Bleeding*	25 (1.7%)	7 (1.4%)	18 (1.8%)	0.56
Myocardial infarction	44 (3.0%)	12 (2.4%)	32 (3.2%)	0.38
Death	6 (0.4%)	4 (0.8%)	2 (0.2%)	0.083
30-Day Follow-up:
Eligible procedures	1494	496	998
Followed up	1494 (100.0%)	496 (100.0%)	998 (100.0%)
Death	3 (0.2%)	3 (0.6%)	0 (0.0%)	0.014
Myocardial infarction	0	0	0
TVR	4 (0.3%)	2 (0.4%)	2 (0.2%)	0.47
TLR	4 (0.3%)	2 (0.4%)	2 (0.2%)	0.47
MACE (composite)	7 (0.5%)	5 (1.0%)	2 (0.2%)	0.031
Procedures lead to any readmission	103 (6.9%)	52 (10.5%)	51 (5.1%)	< 0.001
Any unplanned readmission	26 (1.7%)	10 (2.0%)	16 (1.6%)	0.57
12-month Follow-up
Eligible procedures	1491	493	998
Followed up	1477 (99.1%)	488 (99.0%)	989 (99.1%)
Death	25 (1.7%)	14 (2.9%)	11 (1.1%)	0.014
Myocardial infarction	9 (0.6%)	4 (0.8%)	5 (0.5%)	0.47
TVR	14 (0.9%)	3 (0.6%)	11 (1.1%)	0.35
TLR	16 (1.1%)	8 (1.6%)	8 (0.8%)	0.15
MACE (composite)^€	47 (3.2%)	20 (4.1%)	27 (2.7%)	0.16
Procedures lead to any readmission	286 (19.4%)	119 (24.4%)	167 (16.9%)	< 0.001
Any unplanned readmission	110 (7.4%)	37 (7.6%)	73 (7.4%)	0.89
* Major bleeding = BARC 3, 4 or 5
** Adjusted for baseline age, gender, previous history (hypercholesterolaemia, family history, previous MI, previous PVD, previous PCI, previous CVD, previous CABG) bmi, cardiogenic shock

At 30-day follow-up of 1494 patients (99.6% of those eligible), rates of unplanned readmission (1.7%) and clinical events such as mortality (0.22%), Mi (0.0%), TVR (0.27%), TLR 0.27%, and overall MACE (0.47%) were low.

At 12 months, follow-up of 1491 patients (96.8% of those eligible) revealed an unplanned readmission rate of 7.4%, with similarly low rates of mortality (1.69%, MI (0.61%), TVR (0.95%), TLR (1.08%) and MACE (3.18%).

Data from a total of 1950 lesions treated during 1500 procedures, in patients who received exclusively either Xience DES or BMS, were used for comparison of patient and lesion characteristics and outcomes between those receiving Xience DES and BMS. Of these, Xience DES were used in 1375 (66.7%) and BMS in 585 (33.3%) lesions. Multiple coronary lesions were more commonly treated with Xience DES than BMS (1.41 ± 0.7 vs 1.18 ± 0.5 lesion per procedure, p < 0.001)

Patients receiving Xience DES were younger than those receiving BMS (66.9 ± 10.1 vs 71.5 ± 11.1 years, p < 0.001) however otherwise had more high-risk characteristics including diabetes (26.2 vs 21.5%, p = 0.05), hypercholesterolaemia (85.6 vs 79.4%, p < 0.001), previous MI (23.9 vs 16.6%, p = 0.005) and prior PCI (34.7 vs 17.1%, p < 0.001), however were less likely to have a history of peripheral vascular disease (7.0 vs. 10.0%, p = 0.048) or cerebrovascular disease (6.3 vs 10.2% p = 0.008). However, patients receiving Xience DES were less likely to present with acute coronary syndromes than those receiving BMS (42.9% vs 63.6%, p < 0.001), particularly in the setting of STEMI (4.3 vs. 20.0%, p < 0.001) or cardiogenic shock (0.2 vs 1.0%, p < 0.001). Overall, Xience DES were more often used in elective than acute presentations (56.6% vs 43.4% p < 0.001) whereas BMS were far more likely to be used in acute than elective presentations (63.6%% vs 36.4% p < 0.001)

Patients with complex lesion morphology were more likely to receive Xience DES than BMS, consistent with clinical trial data, Xience DES use was greater for In-stent restenosis (5.5% vs 1.4% P = 0.002), LAD lesions (47.1% vs 32.3%%, p = 0.003), ACC/AHA B2 or C morphology (49.9% vs 40.0% p < 0.001), bifurcations (11.5 vs 4.8%, p < 0.001), long lesions > 20 mm (30.2% vs 17.0%, p < 0.001), and small vessels < 2.5 mm diameter 25.2% vs 12.8%, p < 0.001). (Table 2).

There was a trend towards higher in-hospital mortality in the BMS than the Xience DES cohort although this was not statistically significant (0.8% v 0.2%; P = 0.08), and there was no difference in the rate of major bleeding between groups (BARC 3 or 5 1.4% vs 1.8% p = 0.56). Despite Xience DES patients having more high-risk patient and lesion characteristics, they had lower rates of 30-day mortality (0.0% vs 0.6% p < 0.001) and MACE (0.2% vs 1.0% p < 0.001) than patients receiving BMS (Table 3).

At 12-month follow-up, the association of lower mortality with Xience DES use became more evident, as Xience DES patients had a 70% lower mortality compared to those treated with BMS (1.1% vs 3.5%, OR 0.30, p 0.002). MACE rates were similar between groups 2.9% vs 4.5% OR 0.70, p = 0.12), (Table 3). Myocardial infarction at 30 days and at 12 months was uncommon and late stent thrombosis rare; rates were similar in both cohorts. All these analyses are adjusted for possible confounders. Further adjustment with propensity scoring as a continuous variable reveals similar findings. (16–19)

Compliance with guideline-recommended secondary prevention medications was consistently high in the overall cohort and both stent groups at discharge (aspirin 98.3%, clopidogrel, ticagrelor or Prasugrel 98.5%, statin 94.6%). (Table 4) Compliance remained high at 12 months (antiplatelet therapy 93.3%, statin 94.7%). Patients with DES were more likely to receive dual anti-platelet therapy than patients with BMS at both 30 days (97.8% vs 91.6%; p < 0.001) and 12 months (74.9% vs 43.7%; p < 0.001). The rates of use of β-blockers and angiotensin-converting enzyme inhibitors were lower than expected at both 30 days and 12 months.

Table 4

Discharge and 1-Year Medication Compliance rates
Drug therapy n (%)	Overall	BMS	Xience	p-value
	1500	500	1000
Discharged alive, n	1494	496	998
Aspirin	1463 (98.3%)	484 (97.6%)	979 (98.6%)	0.16
Clopidogrel/Prasugrel/Ticagrelor	1472 (98.5%)	487 (98.2%)	985 (98.7%)	0.44
Statin	1407 (94.6%)	468 (94.4%)	939 (94.8%)	0.75
B-blocker	849 (57.2%)	310 (62.5%)	539 (54.5%)	0.003
ACE /ARB	1023 (68.5%)	330 (66.5%)	693 (69.4%)	0.25
30-day outcomes	1494	496	998
Aspirin	1373 (96.4%)	432 (93.7%)	941 (97.7%)	< 0.001
Clopidogrel/Prasugrel/Ticagrelor	1392 (95.8%)	438 (91.6%)	954 (97.8%)	< 0.001
Any Antiplatelet	1424 (98.0%)	460 (96.2%)	964 (98.9%)	< 0.001
Statin	1346 (94.7%)	431 (93.7%)	915 (95.1%)	0.27
B-blocker	766 (53.8%)	279 (60.5%)	487 (50.6%)	< 0.001
ACE /ARB	959 (66.0%)	303 (63.4%)	656 (67.3%)	0.14
12-month outcomes	1477	488	989
Aspirin	1228 (91.6%)	363 (85.4%)	865 (94.4%)	< 0.001
Clopidogrel/Prasugrel/Ticagrelor	903 (64.8%)	197 (43.7%)	706 (74.9%)	< 0.001
Any Antiplatelet	1300 (93.3%)	394 (87.4%)	906 (96.2%)	< 0.001
Statin	1247 (93.3%)	394 (93.1%)	853 (93.4%)	0.85
B-blocker	629 (47.2%)	223 (52.8%)	406 (44.6%)	0.005
ACE /ARB	902 (64.8%)	264 (58.5%)	638 (67.7%)	< 0.001

Table 5

Comparison of BMS and Xience outcomes at 1 year
Outcome	Overall	BMS	Xience	p	OR	p
Completed 1 year Follow-up	1477	488	989
Death	28 (1.9%)	17 (3.5%)	11 (1.1%)	0.002	0.30 (0.10–0.91)	0.03
MACE	51 (3.5%)	22 (4.5%)	29 (2.9%)	0.12	0.70 (0.33–1.48)	0.35
Unplanned readmission	131 (8.9%)	44 (9.0)	87 (8.8%)	0.89	0.88 (0.56–1.38)	0.58

This study is the first to report outcomes following PCI with Xience DES from a national perspective in Australia. It provides a unique snapshot of contemporary practice and outcomes of PCI in Australia, with focus on PCI in private hospitals, a sector of the health system where there is limited data. Despite some perceptions that physicians in private hospitals perform mainly elective procedures for patients with stable ischaemic heart disease, nearly half (46%) of all patients presented with acute coronary syndromes. Similarly, a large proportion had complex lesion types (e.g. type B2/C).

Overall, patient and procedural characteristics in this study were similar to reports from regional public hospitals such as the Melbourne Interventional Group (MIG), and international series including the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) and NCDR Cath-PCI registries (1, 7, 20–24). In this GCOR study, the majority of patients were treated exclusively with DES (76%), consistent with recent international series. (25–28). However, whilst the patients and lesions treated with DES in this study had more high-risk characteristics than those in early trials of DES vs. BMS, in this cohort outcomes with the Xience DES remained consistently superior to BMS in line with the benefits shown in randomised comparisons of earlier generation DES with BMS. (5,8,19)

However, in the GCOR cohort 30-day unplanned readmission rates were significantly lower than in NCDR Cath-PCI (1.7% vs 11.9%, p < 0.001). (35) Rates of 12-month target vessel revascularisation were relatively low in comparison with registries such as MIG (0.9% vs 6.9% overall), and mortality rates were significantly lower than in the MIG cohort at 30 days (0.20% vs 1.9%, p = 0.0001) and 12 months (1.7% vs 5.2%, p = 0.0001). (25) These favourable outcomes are consistent with recent data supporting the increased long-term safety and low late thrombosis rates of newer generations of DES such as Xience. (27, 28)

We have previously reported excellent and continuously improving compliance with guideline pharmacotherapies post-PCI in the GCOR Registry, in part due to continuous quality improvement pathways facilitated by a broad network approach to patient care. (9) In this study group medication compliance was similarly well maintained between 30 days and 12-month follow-up. Dual Antiplatelet therapy (DAPT) was continued in the majority of patients (67.7%) to 12 months, although this was more common in Xience DES than BMS patients (74.9% vs 43.7% p < 0.001), reflecting recently updated American Heart Association / American College of Cardiology guidelines recommending that DAPT can be ceased in elective patients after 1 month with BMS and 6 months in those receiving newer generation DES such as Xience. (23, 31)

Potential limitations of this study are the fact that while this is a large multi-centre registry, involving urban major teaching hospitals and regional centres, only private hospitals in Australia were included. However, given existing data collection limitations, this is the best information of national scope that is available to represent contemporary PCI practice and outcomes in Australia. Whilst patients treated in private hospitals might potentially be considered to differ from those managed in the public sector our data demonstrated patient and lesion characteristics comparable to those in MIG, a large Victorian public hospital registry, and international series such as NCDR Cath-PCI that include large numbers of public hospital patients. (28, 35) Patients managed in other private hospitals may receive different care to those in public hospitals, and hence these data may not reflect outcomes in hospitals not participating in this registry.

However, notwithstanding these factors, this is a large contemporary clinical quality registry of PCI practice in Australia which can help health care providers determine the effectiveness of translation of evidence-based guidelines into real-world practice. Importantly, registries are also a key post-marketing surveillance, which serves to protect patients by providing some form of accountability measure following approval by various bodies of either a drug or therapeutic device (DES being a prime example), which is often based on results of randomised controlled trials. These randomised trials typically have inherent limitations including relatively small size and the inability to monitor for low frequency yet high significance events such as stent thrombosis, as well as secondary prevention medication compliance, long-term health, quality of life and cost-effectiveness outcomes that are critical in healthcare. [20, 21, 29, 30]. We are continuing patient follow-up to 5 years to maximise the value of the system to detect late events, provide quality assurance and to continue to improve patient compliance with appropriate medical therapy.

The GCOR Xience DES study found that contemporary PCI practice and outcomes in Australian private hospitals were consistent with international public and private sector reports. Overall clinical event rates were similar to international series, with lower 30-day rates of readmission in GCOR. Despite greater lesion complexity in patients receiving Xience DES, outcomes were superior to those in patients treated with BMS, supporting the increased use of Xience DES. Also, newer second-generation Xience DES used in a patient cohort more complex than earlier comparative trials of first-generation DES and BMS demonstrated at least equivalent safety of the Xience DES to BMS in a real-world cohort, providing support for the continued and expanded use of this newer stent platform to improve patient outcomes.

PCI percutaneous coronary intervention

DES drug-eluting stent

BMS bare metal stent

GCOR GenesisCare Outcomes Registry

MACE major adverse cardiovascular events

TLR target lesion revascularisation

MI myocardial infarction

STEMI ST-elevation myocardial infarction

GCOR-PCI GCOR-Percutaneous Coronary Intervention Registry

NCDR National Cardiovascular Data Registry

SWEDEHEART Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies

CCRET Centre for Clinical Research Excellence in Therapeutics

NEHTA National E-Health Transition Authority

ANZCTR Australian New Zealand Clinical Trials Registry

TVR target vessel revascularisation

HREC Human Research Ethics Committee

CABG coronary artery bypass grafting

ACC/AHA American College of Cardiology / American Heart Association

DAPT dual anti-platelet therapy

Ethics approval and consent to participate

Consent for publication

Not applicable

Availability of data and materials

The datasets used and/or analysed during the current study are not publicly available due to HREC privacy restrictions but are available from the corresponding author on reasonable request

Competing interests

The authors declare that they have no competing interests.

Funding

There was no funding for this study.

Authors’ contributions

Each author has made substantial contributions to the conception and design of the study (DE, CR, PT, SW), the acquisition (DE, MH, TR, PS, AW), analysis (DE, EC, SD), or interpretation of data (DE, EC, SD, CR, DL, SW), and drafting (DE, EC) or revision of the manuscript (SD, CR, PS, CR, DL).

All authors have approved the submitted version and have agreed both to be personally accountable for the author's own contributions, and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature.

Acknowledgements

We wish to acknowledge the tireless assistance of Sonya McColl and the GCOR research co-ordinators with the collection and auditing of data for this study.

Australian Institute of Health and Welfare 2008. Australian hospital statistics 2006–07. Health services series no. 31. Cat. No. HSE 55. Canberra: AIHW.
Gallagher M and Krumholz H. Public reporting of hospital outcomes: a challenging road ahead. MJA 2011; 194:658-660.
Scott I. Why we need a national registry in interventional cardiology. MJA 2008; 189: 223–227
Moss EA. Developing national health information in Australia. Medinfo 1995;8(Pt 2):1636.
5. Anderson HV, Shaw RE, Brindis RG et A contemporary overview of percutaneous coronary interventions. The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR). JAmCollCardiol 2002; 39:1096–103.
Piccolo R, Bonaa K, Efthimiou O, Varenne O, Baldo, Urban P, Kaiser C et al. Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials. Lancet 2019;393;2503-2510
Ajani AE, Szto G, Eccleston D, et al. The foundation and launch of the Melbourne Interventional Group: a collaborative interventional cardiology project. Heart Lung Circ 2006;15: 44-47.
Masoudi FA Ponirakis A, de Lemos JA, et al. Trends in U.S. Cardiovascular Care: 2016 Report from 4 ACC National Cardiovascular Data Registries. Journal of the American College of Cardiology DOI: 10.1016/j.jacc.2016.12.005
Eccleston D, Horrigan M, Rafter T et al. Improving Guideline Compliance in Australia With a National Percutaneous Coronary Intervention Outcomes Registry. Heart Lung Circ 2017 Feb 28. pii: S1443-9506(17)30072-0. doi: 10.1016/j.hlc.2017.01.008.
Australian Institute of Health and Welfare Canberra. Monitoring acute coronary syndromes using national hospital data: an information paper on trends and issues 2011. Canberra: Australian Institute of Health and Welfare; 2011.
Bufalino VJ, Masoudi FA, Stranne SK et al. The American Heart Association’s recommendations for expanding the applications of existing and future clinical registries: a policy statement from the American Heart Association. Circulation 2011;123: 2167–79.
http://www.euroqol.org/. EQ-5D^TM.
Morisky D, Ang A, Krousel-Wood M, Ward H. Predictive Validity of A Medication Adherence Measure in an Outpatient Setting. J Clin Hypertens. May 2008; 10: 348–354.
Williams DO, Holubkov R, Yeh W et al. Percutaneous coronary intervention in the current era compared with 1985–1986: the National Heart, Lung, and Blood Institute Registries. Circulation 2000; 102:2945–51.
Operating Standards for Australian Clinical Quality Registries. http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/PriorityProgram-08 clinical; 2008
Jaffe R, Strauss BH. Late and very late thrombosis of drug-eluting stents: evolving concepts and perspectives. J Am Coll Cardiol 2007; 50: 119-127.
Maisel WH. Unanswered questions — drug-eluting stents and the risk of late thrombosis. N Engl J Med 2007; 356: 981-984.
Palmerini T., Biondi-Zoccai G., Della Riva D., et al. (2012) Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet379:1393–1402.
Kandzari D. Can’t Bare It Any Longer. JACC: Cardiovascular Interventions Volume 9, Issue 5, March 2016. DOI: 10.1016/j.jcin.2015.12.277
SWEDEHEART: Sweden’s new online cardiac registry, the first of its kind. European Heart Journal (2009) 30, 2165–2173
Shah BR, Drozda J, Peterson ED. Leveraging observational registries to inform comparative effectiveness research. Am Heart J 2010; 160:8–15.
Hannan EL, Arani DT, Johnson LW et al. Percutaneous transluminal coronary angioplasty in New York State. Risk factors and outcomes. JAMA 1992; 268:3092–7.
Masoudi F, Ponirakis A, de Lemos J et al. Trends in U.S. Cardiovascular Care: 2016 Report from 4 ACC National Cardiovascular Data Registries. JACC 2016. 10.1016/j.jacc.2016.12.005
Chan W, et al. Progress towards a National Cardiac Procedure Database - development of the Australasian Society of Cardiac and Thoracic Surgeons (ASCTS) and Melbourne Interventional Group (MIG) registries. Heart Lung Circ 2011 ; 20: 10-8..
Ajani A, Reid C, Duffy S. Outcomes after Percutaneous Coronary Intervention in contemporary Australian practice : insights from a large multicentre registry. MJA 2008 ;189 :423-428.
Pfisterer M, Brunner-La Rocca HP, Buser PT et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare metal stents. J Am Coll Cardiol 2006; 48:2584–91.
James SK, Stenestrand U, Lindback J et al. Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden. N Engl J Med 2009; 360:1933–45.
Olesen KK, Tilsted HH, Jensen LO, Kaltoft A, Krusell LR, Ravkilde J, Christiansen EH, Madsen M, Thayssen P, Sorensen HT, et al. Long-term outcome of sirolimus-eluting and zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a Danish organization for randomized trials on clinical outcome III substudy). Am J Cardiol. 2015;115(3):298–302.
May L. The National E-Health Transition Authority (NEHTA). HIM J 2005;34(1):19–20.
Marko NF, Weil RJ. The role of observational investigations in comparative effectiveness research. Value Health 2010; 13:989–97.
2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet therapy in Patients with Coronary Artery Disease. JACC doi=10.1016/j.jacc.2016.03.513.

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Long-term Outcomes of contemporary Percutaneous Coronary Intervention with the Xience Drug-Eluting Stent: Results from a Multicentre Australian Registry

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