Trial Outcomes & Findings for Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions (NCT NCT00081731)

NCT ID: NCT00081731

Last Updated: 2015-10-05

Results Overview

Only the first event per participant is included in the composite

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 947 participants
• Primary outcome timeframe: Measured at every 3 months for the first year and annually thereafter
• Results posted on: 2015-10-05

Participant Flow

Participant milestones

Measure	Optimal Medical Therapy Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Overall Study STARTED	480	467
Overall Study COMPLETED	472	459
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Measure	Optimal Medical Therapy Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Overall Study scientific integrity issue	8	8

Baseline Characteristics

Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions

Baseline characteristics by cohort

Measure	Optimal Medical Therapy n=472 Participants Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting n=459 Participants Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device	Total n=931 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 9.0 • n=5 Participants	69.3 years STANDARD_DEVIATION 9.4 • n=7 Participants	69.15 years STANDARD_DEVIATION 9.2 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	140 Participants n=5 Participants	127 Participants n=7 Participants	267 Participants n=5 Participants
Age, Categorical >=65 years	332 Participants n=5 Participants	332 Participants n=7 Participants	664 Participants n=5 Participants
Sex: Female, Male Female	241 Participants n=5 Participants	225 Participants n=7 Participants	466 Participants n=5 Participants
Sex: Female, Male Male	231 Participants n=5 Participants	234 Participants n=7 Participants	465 Participants n=5 Participants
Region of Enrollment United States	387 participants n=5 Participants	385 participants n=7 Participants	772 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at every 3 months for the first year and annually thereafter

Only the first event per participant is included in the composite

Outcome measures

Measure	Optimal Medical Therapy n=472 Participants Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting n=459 Participants Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy	169 participants Interval 0.76 to 1.17	161 participants Interval 0.76 to 1.17

PRIMARY outcome

Timeframe: Measured at every 3 months for the first year and annually thereafter

Outcome measures

Measure	Optimal Medical Therapy n=472 Participants Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting n=459 Participants Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Cardiovascular or Renal Death	20 participants	20 participants

PRIMARY outcome

Timeframe: Measured at every 3 months for the first year and annually thereafter

Outcome measures

Measure	Optimal Medical Therapy n=472 Participants Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting n=459 Participants Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Myocardial Infarction	27 participants	30 participants

PRIMARY outcome

Timeframe: Measured at every 3 months for the first year and annually thereafter

Outcome measures

Measure	Optimal Medical Therapy n=472 Participants Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting n=459 Participants Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Hospitalization for Congestive Heart Failure	26 participants	27 participants

PRIMARY outcome

Timeframe: Measured at every 3 months for the first year and annually thereafter

Outcome measures

Measure	Optimal Medical Therapy n=472 Participants Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting n=459 Participants Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Stroke	16 participants	12 participants

PRIMARY outcome

Timeframe: Measured at every 3 months for the first year and annually thereafter

Outcome measures

Measure	Optimal Medical Therapy n=472 Participants Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting n=459 Participants Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days	77 participants	68 participants

PRIMARY outcome

Timeframe: Measured at every 3 months for the first year and annually thereafter

Outcome measures

Measure	Optimal Medical Therapy n=472 Participants Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting n=459 Participants Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Need for Renal Replacement Therapy	3 participants	4 participants

Adverse Events

Optimal Medical Therapy

Serious events: 283 serious events

Other events: 441 other events

Deaths: 0 deaths

Stenting

Serious events: 290 serious events

Other events: 429 other events

Deaths: 0 deaths

Serious adverse events

Measure	Optimal Medical Therapy n=472 participants at risk Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting n=459 participants at risk Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Cardiac disorders Cardiac Disorders	24.8% 117/472 • Number of events 117	27.9% 128/459 • Number of events 128
Blood and lymphatic system disorders Blood and Lymphatic System Disorders	2.3% 11/472 • Number of events 11	3.5% 16/459 • Number of events 16
Congenital, familial and genetic disorders Congenital, Familial and Genetic Disorders	0.21% 1/472 • Number of events 1	0.00% 0/459
Ear and labyrinth disorders Ear and Labyrinth Disorders	1.1% 5/472 • Number of events 5	0.22% 1/459 • Number of events 1
Eye disorders Eye Disorders	0.64% 3/472 • Number of events 3	0.44% 2/459 • Number of events 2
Gastrointestinal disorders Gastrointestinal Disorders	8.9% 42/472 • Number of events 42	12.4% 57/459 • Number of events 57
General disorders General Disorders	8.1% 38/472 • Number of events 38	7.8% 36/459 • Number of events 36
Hepatobiliary disorders Hepatobiliary Disorders	1.5% 7/472 • Number of events 7	1.1% 5/459 • Number of events 5
Immune system disorders Immune System Disorders	0.00% 0/472	0.22% 1/459 • Number of events 1
Infections and infestations Infections and Infestations	14.6% 69/472 • Number of events 69	13.7% 63/459 • Number of events 63
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	4.0% 19/472 • Number of events 19	9.2% 42/459 • Number of events 42
Investigations Investigations	0.21% 1/472 • Number of events 1	0.87% 4/459 • Number of events 4
Metabolism and nutrition disorders Metabolism and Nutrition Disorders	5.9% 28/472 • Number of events 28	4.1% 19/459 • Number of events 19
Musculoskeletal and connective tissue disorders Musuloskeletal and Connective Tissue Disorders	6.6% 31/472 • Number of events 31	8.5% 39/459 • Number of events 39
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant and Unspecified	5.5% 26/472 • Number of events 26	5.9% 27/459 • Number of events 27
Nervous system disorders Nervous System Disorders	14.2% 67/472 • Number of events 67	13.3% 61/459 • Number of events 61

Other adverse events

Measure	Optimal Medical Therapy n=472 participants at risk Optimal anti-hypertensive therapy Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension	Stenting n=459 participants at risk Stent procedure plus optimal anti-hypertensive therapy GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Blood and lymphatic system disorders Blood and Lymphatic System Disorders	19.7% 93/472 • Number of events 93	18.5% 85/459 • Number of events 85
Cardiac disorders Cardiac Disorders	43.4% 205/472 • Number of events 205	43.8% 201/459 • Number of events 201
Ear and labyrinth disorders Ear and Labyrinth Disorders	5.1% 24/472 • Number of events 24	7.0% 32/459 • Number of events 32
Eye disorders Eye Disorders	13.3% 63/472 • Number of events 63	13.1% 60/459 • Number of events 60
General disorders General Disorders	55.3% 261/472 • Number of events 261	54.7% 251/459 • Number of events 251
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	25.8% 122/472 • Number of events 122	29.0% 133/459 • Number of events 133
Investigations Investigations	26.5% 125/472 • Number of events 125	27.0% 124/459 • Number of events 124

Additional Information

Christopher Cooper, MD

University of Toledo

Phone: 419-383-6297

Email: christopher.cooper@utoledo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place