Trial Outcomes & Findings for PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial. (NCT NCT02171065)

Last Updated: 2021-08-10

Results Overview

Patient-level rate of non-culprit lesion-related MACE (NC-MACE) evaluated at the longest follow-up available, assessed at the time when the last patient enrolled reaches at least 24 months. NC-MACE is defined as an event arising from an originally untreated NC lesion consisting of the composite of 1) cardiac death, 2) myocardial infarction, 3) unstable angina, or 4) progressive angina or anginal equivalent symptoms either 4a) requiring revascularization by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), and/or 4b) with angiographic core lab-confirmed rapid lesion progression.(NC-MACE).

Recruitment status

COMPLETED

Study phase

Target enrollment

902 participants

Primary outcome timeframe

Median follow-up of 3.7 (first quartile, third quartile; 3.0, 4.4) years

Results posted on

2021-08-10

Participant Flow

Between June 10, 2014, and December 20, 2017, 902 patients at 16 sites were enrolled in PROSPECT II.

Four patients were disenrolled because non-culprit lesion imaging were not acquired. Among the rest of 898 patients, 182 patients with angiographically nonobstructive lesion but with plaque burden\>=65% were enrolled in PROSPECT-ABSORB, and randomized to Absorb-bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) (n=93) versus GDMT alone (n=89).

Participant milestones

Participant milestones
Measure	Guideline Directed Medical Therapy in PROSPECT-ABSORB and PROSPECT II Patients were enrolled in PROSPECT-ABSORB and randomized to guideline-directed medical therapy (GDMT) group. Patients remain in PROSPECT II cohort.	ABSORB BVS + GDMT in PROSPECT-ABSORB and PROSPECT II Patients were enrolled in PROSPECT-ABSORB and randomized to ABSORB-BVS + GDMT group. Patients remain in PROSPECT II cohort.	PROSPECT II Only Patients were not enrolled in PROSPECT-ABSORB. Patients remain in PROSPECT II.
Overall Study STARTED	89	93	716
Overall Study COMPLETED	88	93	715
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Guideline Directed Medical Therapy in PROSPECT-ABSORB and PROSPECT II Patients were enrolled in PROSPECT-ABSORB and randomized to guideline-directed medical therapy (GDMT) group. Patients remain in PROSPECT II cohort.	ABSORB BVS + GDMT in PROSPECT-ABSORB and PROSPECT II Patients were enrolled in PROSPECT-ABSORB and randomized to ABSORB-BVS + GDMT group. Patients remain in PROSPECT II cohort.	PROSPECT II Only Patients were not enrolled in PROSPECT-ABSORB. Patients remain in PROSPECT II.
Overall Study Withdrawal by Subject	1	0	0
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guideline Directed Medical Therapy (GDMT) in PROSPECT-ABSORB and PROSPECT II n=89 Participants Patients were enrolled in PROSPECT-ABSORB and randomized to GDMT group. Patients remain in PROSPECT II cohort.	ABSORB BVS + GDMT in PROSPECT-ABSORB and PROSPECT II n=93 Participants Patients were enrolled in PROSPECT-ABSORB and randomized to ABSORB-BVS + GDMT group. Patients remain in PROSPECT II cohort.	PROSPECT II Only n=716 Participants Patients were not enrolled in PROSPECT-ABSORB. Patients remain in PROSPECT II.	Total n=898 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 9.2 • n=89 Participants	62.0 years STANDARD_DEVIATION 8.6 • n=93 Participants	62.5 years STANDARD_DEVIATION 10.4 • n=716 Participants	62.7 years STANDARD_DEVIATION 10.1 • n=898 Participants
Sex: Female, Male Female	19 Participants n=89 Participants	13 Participants n=93 Participants	121 Participants n=716 Participants	153 Participants n=898 Participants
Sex: Female, Male Male	70 Participants n=89 Participants	80 Participants n=93 Participants	595 Participants n=716 Participants	745 Participants n=898 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	16 Participants n=89 Participants	16 Participants n=93 Participants	226 Participants n=716 Participants	258 Participants n=898 Participants
Region of Enrollment Denmark	65 Participants n=89 Participants	67 Participants n=93 Participants	396 Participants n=716 Participants	528 Participants n=898 Participants
Region of Enrollment Norway	8 Participants n=89 Participants	10 Participants n=93 Participants	94 Participants n=716 Participants	112 Participants n=898 Participants
Body mass index	27.3 kg/m^2 STANDARD_DEVIATION 4.5 • n=89 Participants	27.8 kg/m^2 STANDARD_DEVIATION 3.8 • n=93 Participants	27.9 kg/m^2 STANDARD_DEVIATION 4.6 • n=716 Participants	27.8 kg/m^2 STANDARD_DEVIATION 4.5 • n=898 Participants
Height	174.7 cm STANDARD_DEVIATION 8.1 • n=89 Participants	178.0 cm STANDARD_DEVIATION 7.7 • n=93 Participants	176.2 cm STANDARD_DEVIATION 7.8 • n=716 Participants	176.2 cm STANDARD_DEVIATION 7.8 • n=898 Participants
Weight	83.5 kg STANDARD_DEVIATION 16.2 • n=89 Participants	88.0 kg STANDARD_DEVIATION 13.0 • n=93 Participants	86.7 kg STANDARD_DEVIATION 16.3 • n=716 Participants	86.5 kg STANDARD_DEVIATION 16.0 • n=898 Participants

PRIMARY outcome

Timeframe: Median follow-up of 3.7 (first quartile, third quartile; 3.0, 4.4) years

Outcome measures

Outcome measures
Measure	Guideline Directed Medical Therapy (GDMT) in PROSPECT-ABSORB and PROSPECT II n=89 Participants Patient were enrolled in PROSPECT-ABSORB and randomized to GDMT group. Patients remain in PROSPECT II cohort.	ABSORB + GDMT in PROSPECT-ABSORB and PROSPECT II n=93 Participants Patients were enrolled in PROSPECT-ABSORB and randomized to ABSORB + BVS + GDMT group. Patients remain in PROSPECT II cohort.	PROSPECT II Only n=716 Participants Patients were not enrolled in PROSPECT-ABSORB. Patients remain in PROSPECT II.
Prospect II: Patient Level Non-culprit Lesion Related Non-Culprit Major Adverse Cardiac Event (NC-MACE) Adjudicated to an Originally Untreated Non-culprit Lesion During the Entire Study Duration	15 Participants	10 Participants	41 Participants

PRIMARY outcome

Timeframe: 25 month

Population: Intention to treat population, defined as patients randomized to each arm and completing 25-month imaging follow-up and analyzable intravascular ultrasound (IVUS) image available

The MLA at the randomized non-culprit lesion site in patients treated with Absorb BVS + GDMT compared to GDMT only as measured at 25 months.

Outcome measures

Outcome measures
Measure	Guideline Directed Medical Therapy (GDMT) in PROSPECT-ABSORB and PROSPECT II n=72 Participants Patient were enrolled in PROSPECT-ABSORB and randomized to GDMT group. Patients remain in PROSPECT II cohort.	ABSORB + GDMT in PROSPECT-ABSORB and PROSPECT II n=84 Participants Patients were enrolled in PROSPECT-ABSORB and randomized to ABSORB + BVS + GDMT group. Patients remain in PROSPECT II cohort.	PROSPECT II Only Patients were not enrolled in PROSPECT-ABSORB. Patients remain in PROSPECT II.
Prospect Absorb: The Minimum Luminal Area (MLA) at the Randomized Non-culprit Lesion Site in Patients Treated With the ABSORB BVS + GDMT Compared to GDMT Only Measured at 25 Months	3.0 mm^2 Standard Deviation 1.0	6.9 mm^2 Standard Deviation 2.6	—

Adverse Events

Guideline Directed Medical Therapy in PROSPECT-ABSORB and PROSPECT II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ABSORB BVS + GDMT in PROSPECT-ABSORB and PROSPECT II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

PROSPECT II Only

Serious events: 2 serious events

Other events: 0 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Guideline Directed Medical Therapy in PROSPECT-ABSORB and PROSPECT II n=89 participants at risk Patients were enrolled in PROSPECT-ABSORB and randomized to GDMT group. Patients remain in PROSPECT II cohort.	ABSORB BVS + GDMT in PROSPECT-ABSORB and PROSPECT II n=93 participants at risk Patients were enrolled in PROSPECT-ABSORB and randomized to ABSORB-BVS + GDMT group. Patients remain in PROSPECT II cohort.	PROSPECT II Only n=716 participants at risk Patients were not enrolled in PROSPECT-ABSORB. Patients remain in PROSPECT II.
Cardiac disorders Intravascular imaging related major complications requiring treatment	0.00% 0/89 • The entire study duration, median follow-up 3.7 (first quartile, third quartile; 3.0, 4.4) years The primary endpoint of PROSPECT II study was measured in the overall PROSPECT II cohort. As a subset of PROSPECT II, 182 patients were enrolled in PROSPECT-ABSORB and randomized to GDMT vs GDMT-ABSORB. Thus, adverse event has been shown for overall PROSPECT II cohort.	0.00% 0/93 • The entire study duration, median follow-up 3.7 (first quartile, third quartile; 3.0, 4.4) years The primary endpoint of PROSPECT II study was measured in the overall PROSPECT II cohort. As a subset of PROSPECT II, 182 patients were enrolled in PROSPECT-ABSORB and randomized to GDMT vs GDMT-ABSORB. Thus, adverse event has been shown for overall PROSPECT II cohort.	0.28% 2/716 • Number of events 2 • The entire study duration, median follow-up 3.7 (first quartile, third quartile; 3.0, 4.4) years The primary endpoint of PROSPECT II study was measured in the overall PROSPECT II cohort. As a subset of PROSPECT II, 182 patients were enrolled in PROSPECT-ABSORB and randomized to GDMT vs GDMT-ABSORB. Thus, adverse event has been shown for overall PROSPECT II cohort.

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator: David Erlinge, MD, PhD

Lund University

Phone: +46-733746165

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place