International Journal of Cardiology 176 (2014) 1385–1387

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International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard

Letter to the Editor

Clinical outcomes of percutaneous coronary intervention (PCI) at hospital with or without onsite cardiac surgery backup Tomonori Akasaka a, Seiji Hokimoto a,⁎, Shuichi Oshima b, Koichi Nakao c, Kazuteru Fujimoto d, Yuji Miyao d, Hideki Shimomura e, Ryusuke Tsunoda f, Toyoki Hirose g, Ichiro Kajiwara h, Toshiyuki Matsumura i, Natsuki Nakamura j, Nobuyasu Yamamoto k, Shunichi Koide l, Hideki Oka m, Yasuhiro Morikami n, Naritsugu Sakaino o, Koichi Kaikita a, Sunao Nakamura p, Kunihiko Matsui a, Hisao Ogawa a, on behalf of, Kumamoto Intervention Conference Study (KICS) Investigators a

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan Division of Cardiology, Kumamoto Central Hospital, Kumamoto, Japan c Cardiovascular Center, Kumamoto Saiseikai Hospital, Kumamoto, Japan d National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan e Division of Cardiology, Fukuoka Tokushukai Hospital, Fukuoka, Japan f Kumamoto Red Cross Hospital, Kumamoto, Japan g Division of Cardiology, Minamata City Hospital and Medical Center, Minamata, Japan h Division of Cardiology, Arao City Hospital, Arao, Japan i Division of Cardiology, Kumamoto Rosai Hospital, Yatsushiro, Japan j Division of Cardiology, Shinbeppu Hospital, Beppu, Japan k Division of Cardiology, Miyazaki Prefectural Nobeoka Hospital, Nobeoka, Japan l Division of Cardiology, Health Insurance Yatsushiro General Hospital, Yatsushiro, Japan m Division of Cardiology, Health Insurance Hitoyoshi General Hospital, Hitoyoshi, Japan n Division of Cardiology, Kumamoto City Hospital, Kumamoto, Japan o Division of Cardiology, Amakusa Regional Medical Center, Amakusa, Japan p Cardiovascular Center, New Tokyo Hospital, Matsudo, Japan b

a r t i c l e

i n f o

Article history: Received 1 August 2014 Accepted 2 August 2014 Available online 10 August 2014 Keywords: Percutaneous coronary intervention (PCI) Clinical outcomes Cardiac surgery back up

Based on 2011 ACCF/AHA/SCAI PCI guidelines, it is recommended that PCI should be performed at a hospital with onsite cardiac surgery [1]. But, recent data suggests that there is no difference in clinical outcomes following primary [2,3] or elective PCI [4,5] between hospitals with or without onsite cardiac surgery [6]. However, this has not been determined for Japan. We examined the impact of onsite cardiac surgery on clinical outcomes following PCI in Japan. From 2008 to 2011, 6219 patients from various hospitals that had undergone PCI were enrolled in the Kumamoto Intervention Conference ⁎ Corresponding author at: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto 8608556, Japan. Tel.: +81 96 373 5175; fax: +81 96 362 3256. E-mail address: [email protected] (S. Hokimoto).

http://dx.doi.org/10.1016/j.ijcard.2014.08.027 0167-5273/© 2014 Published by Elsevier Ireland Ltd.

Study (KICS) registry, and assigned into two groups: 1) hospitals with (n = 5409), or 2) hospitals without (n = 810) onsite cardiac surgery. Clinical events were monitored and compared between the two groups and patients were followed up for 12 months. Primary endpoints included death in hospital, cardiovascular death, myocardial infarction, and stroke. We also monitored other events including non-cardiovascular deaths, bleeding complications, revascularizations, and emergent CABG. Emergent PCI was defined as patients who underwent PCI within 24 h from admission into the hospital. All others were defined as elective PCI. Successful treatment of the lesion was defined as residual stenosis of the target lesion of less than 50%. Regarding the clinical characteristics of the patients, older patients (N75) and those with ACS were more frequently seen in hospitals without onsite surgery. On the other hand, coronary risk factors (HT, DM, DLP, PAD, and current smoking) and history of cardiovascular disease (MI, stroke) were more frequently seen in hospitals with onsite surgery. With regards to angiographic characteristics, elective PCI and multivessel and LMT stenting were more frequently seen in hospitals with onsite surgery. On the other hand, emergent PCI and one vessel stenting were more frequently seen in hospitals without onsite surgery. There was no overall significant difference in the primary endpoint of patients that had undergone PCI between hospitals with or without onsite cardiac surgery (4.8% vs. 5.6%; P = 0.35). There was also no significant difference between the two groups when events in the primary endpoint were considered separately. For non-primary endpoint events, revascularization in PCI patients was more frequently

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T. Akasaka et al. / International Journal of Cardiology 176 (2014) 1385–1387

Table 1A Clinical outcomes. Number

Table 1B Cox proportional hazards model analysis for the primary endpoint in all patients. With onsite cardiac surgery N (%)

Without onsite cardiac surgery N (%)

5409 Primary endpoint In hospital death Cardiovascular death Non-fatal MI Stroke Others Non cardiovascular death Revascularization PCI CABG Emergent CABG Bleeding complication

Univariate analysis

P

810

260 (4.8) 109 (2.0) 158 (2.9) 41 (0.8) 41 (0.8)

45 (5.6) 15 (1.9) 29 (3.6) 11 (1.4) 3 (0.4)

0.345 0.757 0.306 0.080 0.237

102 (1.9) 1020 (18.9)

17 (2.1) 89 (11.0)

0.680 b0.001

950 (17.6)

88 (10.9)

b0.001

70 (1.3) 5 (0.1) 27 (0.5)

1 (0.1) 0 (0) 4 (0.5)

0.003 0.387 0.930

Age N 75 years Male Current smoker Dyslipidemia Diabetes mellitus Hypertension ACS Hemodialysis Previous MI Previous stroke PAD LMT stenting Multi vessel stenting Without onsite cardiac surgery

Multivariate analysis

HR

95% CI

P value

HR

95% CI

P value

2.358 1.466 1.116 2.179 1.032 1.204 4.132 1.869 1.224 1.969 1.623 3.039 1.445

1.882–2.954 1.161–1.851 0.853–1.459 1.739–2.731 0.822–1.296 0.931–1.557 3.10–5.494 1.259–2.778 0.916–1.636 1.506–2.570 1.147–2.299 2.178–4.237 1.070–1.953

b0.001 0.001 0.423 b0.001 0.786 0.157 b0.001 0.002 0.172 b0.001 0.006 b0.001 0.016

1.840 1.225 – 1.856 – – 4.065 1.968 – 1.825 1.690 2.967 1.415

1.451–2.334 0.962–1.559 – 1.474–2.338 – – 3.049–5.435 1.309–2.967 – 1.393–2.392 1.178–2.421 1.524–5.78 1.046–1.915

b0.001 0.099 – b0.001 – – b0.001 0.001 – 0.001 0.004 0.001 0.024

0.874

0.637–1.200

0.406

0.969

0.704–1.333

0.845

Multivariate analysis indicates that onsite cardiac surgery at a hospital is not a predictive factor for clinical events. ACS; acute coronary syndrome, PAD; periphery artery disease, LMT; left main trunk.

There is no significant difference in the primary endpoint between two groups. CABG; coronary artery bypass grafting, MI; myocardial infraction.

seen in hospitals with onsite surgery (revascularization, 18.9% vs. 11.0%; P b 0.001) (Table 1A). Kaplan–Meier survival analysis for the primary endpoint showed that there was no significant difference between hospitals with or without onsite cardiac surgery (log rank P = 0.405) (Fig. 1). When patients were grouped into emergent PCI and elective PCI, there was also no significant difference between two groups in the primary endpoint (log rank P = emergent 0.943, elective 0.419). Using the Cox proportional hazards model analysis for the primary endpoint in all patients, we found that advanced age (N 75), dyslipidemia, ACS, hemodialysis, previous stroke, PAD, LMT and multivessel stenting were predictive factors for the primary endpoint. However, the presence of or lack of onsite cardiac surgery was not a predictive factor for primary endpoint events (HR 0.969, 95% CI 0.7041.333; P = 0.845) (Table 1B). In this study, there are differences in clinical characteristics between hospitals with or without onsite cardiac surgery in this study; thus we adjusted two groups by propensity score matching methods on coronary risk factors (HT, DM, DLP, PAD, and current smoking), history of cardiovascular disease (MI, stroke), status of PCI (emergent or elective), and complex PCI (ACC/AHA classification type B2 or C). The results after correction showed that there was no

difference in the primary endpoint between the two groups. Importantly, our results indicate that PCI performed without onsite cardiac surgery is as safe as PCI with onsite cardiac surgery. It has been reported that the composition of major adverse cardiac events in non-emergency PCI was non-inferior to procedures at hospitals with and without onsite cardiac surgery. Similarly, there was no difference in in-hospital death events, including cardiac death, MI, and stroke. Therefore, the results of the present study are in agreement with those of the previous study [7,8]. Moreover, integrated event rates of cardiovascular death, MI, and stroke were 3.0%, 0.8%, and 0.7%, respectively, which is in agreement with those of the previous Japanese PCI registry [9]. On the other hand, for a non-primary endpoint, revascularization was more frequently seen in hospitals with onsite cardiac surgery (17.9% vs 10.9%; P b 0 · 001). Although, the integrated event rate of revascularization was similar to those of the previous Japanese PCI registry [9], the significant difference in revascularization rate between two groups may be due to the Japanese medical environment. In Japan, the health insurance system for the whole nation is widespread, and

Primary endpoint(%)

10

Log Rank P=0.405 8 without onsite cardiac surgery 6 4 with onsite cardiac surgery 2 0

0

100

200

300

400

Days

Fig. 1. Kaplan–Meier analysis for the primary endpoint in all patients. There is no significant difference in the primary endpoint of all PCIs at hospitals with or without onsite cardiac surgery.

T. Akasaka et al. / International Journal of Cardiology 176 (2014) 1385–1387

cooperation between hospitals and clinics, or between hospitals is well established. Thus, referrals from local hospitals to a central hospital are common for patients with refractory and complex diseases, as well as heart disease, as these local hospitals generally do not have onsite cardiac surgery, while the central hospitals are equipped with onsite cardiac surgery. In this setting, it is possible that complex PCI procedures are more commonly carried out in hospitals with onsite cardiac surgery backup than in hospitals without such facilities. Furthermore, PCI operators of each hospital in Japan understand the limitations of PCI and upon evaluation of individual cases, are able to refer patients from the local hospital (without onsite cardiac surgery) to a central hospital (with onsite cardiac surgery). In our study, about 13% of the patients were relocated from a hospital without onsite surgery to a hospital with surgery in order for a complex PCI or a CABG to be performed. It is suggested that complex PCI (LMT, multi vessel, bifurcation or carcification lesions) increases the rate of revascularization compared with simple PCI [10]. This may explain why revascularizations were seen more frequently in hospitals with onsite cardiac surgery than in hospitals without onsite cardiac surgery. We showed that there was no significant difference in the clinical outcomes of patients that have undergone emergent and elective PCIs between hospitals with or hospitals without onsite cardiac surgery in Japan. Conflict of interest The authors report no relationships that could be construed as a conflict of interest.

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