BREAKING REAL-WORLD EVIDENCE 2019 CADTH Symposium Michle de Guise, - - PowerPoint PPT Presentation

▶
breaking real world evidence
SMART_READER_LITE
LIVE PREVIEW

BREAKING REAL-WORLD EVIDENCE 2019 CADTH Symposium Michle de Guise, - - PowerPoint PPT Presentation

Jul 10, 2023 115 likes •325 views

INTERHOSPITAL TRANSFER OR DIRECT TRANSPORT TO SPECIALIZED CENTRES FOR THROMBECTOMY: INTERPRETATION OF QUBEC RESULTS IN LIGHT OF LATE BREAKING REAL-WORLD EVIDENCE 2019 CADTH Symposium Michle de Guise, MD, FRCPc Director of health

slide-1
SLIDE 1

INTERHOSPITAL TRANSFER OR DIRECT TRANSPORT TO SPECIALIZED CENTRES FOR THROMBECTOMY: INTERPRETATION OF QUÉBEC RESULTS IN LIGHT OF LATE BREAKING REAL-WORLD EVIDENCE 2019 CADTH Symposium Michèle de Guise, MD, FRCPc Director of health technology assessment, INESSS

  • n behalf of the Cardio-neurovascular Evaluation Unit
slide-2
SLIDE 2

2

INESSS is publicly funded. I have no actual or potential conflict of interest in relation to this topic or presentation.

DISCLOSURE

slide-3
SLIDE 3

3

To reflect on how RWData and RWE are complementary to RCTs in order to provide more adapted and contextualized recommendations. Using as case study the mandate we received from the Ministry of health to evaluate how to

  • ptimize access to endovascular treatment (EVT,

i.e. thrombectomy) in Québec, focusing on the

  • ptimal pathway.

PUR URPO POSE SE OF TH THIS S PRESE SENT NTATION TION

slide-4
SLIDE 4

4

STRUCTURE OF THE SYSTEM OF STROKE CARE IN QUÉBEC (2017-18)

80 hospitals providing different levels of care, 4 thrombectomy programs concentrated in urban areas

slide-5
SLIDE 5

6

First medical contact Non tertiary (NT) centre EVT centre Triage EVT (Door) Scan Needle t-PA First arterial puncture Departure from NT centre Triage NT (Door) Scan Needle t-PA Symptoms

PATIENT FAMILY PREHOSPITAL (EMS) REFERRAL (NT) CENTRES INTERHOSPITAL (EMS) EVT CENTRES

PATIENT TRAJECTORY FOR EVT TREATMENT

POST-PROCEDURE CARE AND REHABILITATION

slide-6
SLIDE 6

7

SYNT NTHE HESIS SIS OF ALL LL T TYPES S OF EVIDE DENCE NCE TO DEVELOP OP PROPOS OPOSED ED RECOM OMMEND ENDATI TION ONS

slide-7
SLIDE 7

8

  • Meta-analyses of five randomized trials:
  • In comparison to thrombolysis, thrombectomy is associated with

improved patient outcomes if treatment is received within 7 hours

  • f the start of symptoms
  • The shorter the treatment delays, the better the outcomes.
  • Among 1000 patients achieving endovascular reperfusion;
  • For every 15 minutes faster emergency department door-to-

reperfusion time

  • 39 patients would have less-disabled outcome at 3 months
  • 25 among those would achieve functionnal independence
  • Assuming we can replicate the condition of the RCTs

SC SCIEN ENTIFIC TIFIC EVIDE DENCE NCE

HERMES collaboration: Saver et al. and Goyal et al. (2016)

slide-8
SLIDE 8

9

  • Selection criteria for patients:
  • the vast majority were functionally independent
  • pre-stroke mRankin score ≤2
  • 2/5 trials had age restrictions (e.g., ≤80 years old)
  • Selection criteria for participating centres:
  • high volume
  • e.g. ≥40-60 EVT/year; >500 stroke patients/year
  • high expertise
  • Study protocols emphasized fast treatment

Thus, patients and hospitals not necessarily representative of those in the real-world context of stroke care

RCT T SE SELE LECTI TION ON CRITE TERIA RIA

slide-9
SLIDE 9

10

Observation period April 1, 2017 March 31, 2018 Hospitals All hospitals with an EVT program (n=4) Patients All patients who presented to an emergency room (by ambulance or other means) and were treated with t-PA or EVT in an EVT centre Data collection Documentation by EVT clinical teams Data collection by INESSS Centralized secure web site (REDCap) Data validation Read only access to REDCap Validation of preliminary results by EVT teams Data analysis Analysis by INESSS in collaboration with clinical expert committee (reps from each EVT program)

FIELD EVALUATION OF EVT BY INESSS

slide-10
SLIDE 10

11

VOLUME EVT ± t-PA (2017-18)

183 80 77 35 20 40 60 80 100 120 140 160 180 200 A B C D

Total volume EVT ± t-PA in Québec = 375 The four thrombectomy centers have a wide range in volume of cases

slide-11
SLIDE 11

12

PATIENT CHARACTERISTICS: RCT VS QUÉBEC (1)

RCT meta-analysis N=634 Québec 2017-18 N=375 Median age in years (25th-75th percentile) 68 (57-77) 71 (60-80) Age ≥ 80 years 17% 29% Women 48% 51%

slide-12
SLIDE 12

13

PATIENT CHARACTERISTICS: RCT VS QUÉBEC (2)

RCT meta-analysis N=634 Québec 2017-18 N=375 Pre-stroke mRankin ≤ 2 98% 94% Median (25th-75th percentile) Initial ASPECTS score 9 (7-10) 9 (7-10) Initial NIHSS score 17 (14-20) 16 (11-20) Start of symptoms to triage at EVT centre (door) 99 min (52-191) 151 min (60-222)

slide-13
SLIDE 13

14

  • American registry publication (online Jan 31, 2019):
  • 37,260 EVT patients treated at 639 centres, 2012-17

LATE-BREAKING EVIDENCE

slide-14
SLIDE 14

15

RCTs N=634 Québec N=375 USA N=37,260

Mode of arrival: Direct admission Interhospital transfer 70% 30% 41% 59% 57% 42% Use of t-PA 83% 61% 58%

PROCESSES: RCT VS QUÉBEC VS USA REGISTRY

The proportion of transferred patients in Québec were much more similar to the US registry than to the RCTs, but still higher. The proportion of use of t-PA was much more similar to the US registry

slide-15
SLIDE 15

16

RCT VS QUÉBEC VS USA REGISTRY TREATMENT DELAYS FOR TRANSFERRED PATIENTS RCT N=184 Québec N=209 USA N=15,975

Median delay: Start of symptoms to EVT

(25th-75th percentile)

295 (255-342) 247 (202-310) 289 (NR)

Median delay: Door of EVT centre to EVT

(25th-75th percentile)

81 (58-105) 25 (14-43) 68 (NR)

For transferred patients, delays from symptoms to hospital arrival and from triage to thrombectomy results were favourable in comparison to both the trials and the American registry

slide-16
SLIDE 16

17

RCT VS QUÉBEC VS USA REGISTRY TREATMENT DELAYS FOR DIRECTLY ADMITTED PATIENTS RCT N=421 Québec N=166 USA N=21,285

Median delay: Start of symptoms to EVT

(25th-75th percentile)

210 (158-270) 135 (107-185) 213 (NR)

Median delay: Door of EVT centre to EVT

(25th-75th percentile)

116 (82-160 70 (50-100) 128 (NR)

Shorter delays from triage to thrombectomy showed the good performance of our current thrombectomy programs

slide-17
SLIDE 17

18

Outcome Transferred patients N=15,975 Directly admitted patients N=21,285 OR (95% CI) Adjusted OR for treatment delay (95% CI)

In-hospital mortality 14.7% 13.4% 1.17 (1.10, 1.24) 1.01 (0.92, 1.11) P=ns Independent ambulation at discharge 33.1% 37.2% 0.80 (0.76, 0.85) 0.87 (0.80, 0.95) P=0.002

USA REGISTRY EVIDENCE ON OUTCOMES

Shah et al., 2019

slide-18
SLIDE 18

19

USA REGISTRY EVIDENCE ON OUTCOMES

Shah et al., 2019

In comparison to patients treated after inter-hospital transfer, Direct admission EVT was associated with :

  • Significant decrease in in-hospital mortality
  • Significant increase in independent ambulation at

hospital discharge

  • The decrease in mortality was no longer significant

after adjustment for differences in treatment delays

  • Time is brain !
slide-19
SLIDE 19

20

New evidence from our own context in Québec and from a large registry :

  • Was comforting in terms of implementation of the

EVT programs in Québec;

  • Added weight to the conclusions of the RCT meta-

analyses that “Time is brain”;

  • Increased the strength of our recommendations

concerning prioritization of direct transport for EVT;

  • Showed the importance of documentation of real-

world outcomes to aid decision-making.

CONCLUSION

slide-20
SLIDE 20

21

Québec 2535, boulevard Laurier, 5e étage Québec (Québec) G1V 4M3 Téléphone : 418 643-1339 Télécopieur : 418 646-8349 inesss.qc.ca inesss@inesss.qc.ca Montréal 2021, avenue Union, bureau 10.083 Montréal (Québec) H3A 2S9 Téléphone : 514 873-2563 Télécopieur : 514 873-1369